An observational study in Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis, sponsored by Pfizer. Completed at 180 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-24.
Sponsored by Pfizer · Observational
The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
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Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany
Exclusion Criteria:
Drug: Etanercept
Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12
Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 12
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 24
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 12 up to Week 52
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Week 24 up to Week 52
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time frame: Week 12
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Time frame: Week 12
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Time frame: Week 12
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time frame: Week 24
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Time frame: Week 24
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24
DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.
Time frame: Week 24
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS)
Time frame: Baseline up to Weeks 12, 24, 36, 52
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
Time frame: Baseline up to Weeks 12, 24, 36, 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Time frame: Baseline up to Weeks 12, 24, 36, 52
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Time frame: Baseline up to Weeks 12, 24, 36, 52
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
Time frame: Weeks 12, 24, 36, 52
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52
Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
Time frame: Weeks 12, 24, 36, 52
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Weeks 12, 24, 36, 52
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52
Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Time frame: Weeks 12, 24, 36, 52
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52
PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
Time frame: Weeks 12, 24, 36, 52
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52
The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
Time frame: Weeks 12, 24, 36, 52
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time frame: Weeks 12, 24, 36, 52
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Weeks 12, 24, 36, 52
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Weeks 12, 24, 36, 52
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Weeks 12, 24, 36, 52
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events
Percentage of participants who discontinued etanercept before completing the study, was reported.
Time frame: Baseline up to Week 52
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation
Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
Time frame: Baseline up to Week 52
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52
FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicated better daily activities.
Time frame: Weeks 12, 24, 36, 52
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Weeks 12, 24, 36, 52
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: Weeks 12, 24, 36, 52
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52
BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
Time frame: Weeks 12, 24, 36, 52
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52
An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
Time frame: Weeks 12, 24, 36, 52
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52
Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Time frame: Weeks 12, 24, 36, 52
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52
Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Time frame: Weeks 12, 24, 36, 52
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52
Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
Time frame: Weeks 12, 24, 36, 52
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Time frame: Baseline, Weeks 12, 24, 36, 52
Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO)
PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Time frame: Baseline up to Week 24
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO)
PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time frame: Weeks 12, 24, 36, 52
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO)
PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time frame: Weeks 12, 24, 36, 52
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI \< 2; small effect at 2 \<=DLQI \<= 5; moderate effect at 6 \<=DLQI \<= 10; very large effect at 11\<=DLQI \<= 20; extremely large effect at 21 \<= DLQI \<= 30.
Time frame: Weeks 12, 24, 36, 52
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".
Time frame: Weeks 12, 24, 36, 52
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Weeks 12, 24, 36, 52
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Weeks 12, 24, 36, 52
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
Time frame: Weeks 12, 24, 36, 52
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52
To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
Time frame: Weeks 12, 24, 36, 52
Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA)
Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
Time frame: Baseline
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Time frame: Weeks 36, 52
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Time frame: Weeks 36, 52
Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time frame: Weeks 36, 52
Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
Time frame: Weeks 36, 52
| Milestone | Etanercept |
|---|---|
| Started | 1534 |
| Treated | 1523 |
| Completed | 858 |
| Not completed | 676 |
| Withdrew: Discontinued prematurely | 410 |
| Withdrew: Documentation not completed | 255 |
| Withdrew: Excluded due to legal reasons | 8 |
| Withdrew: Not treated | 3 |
Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
| Participants | Etanercept |
|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | 194 |
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
| Participants | Etanercept |
|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | 203 |
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
| Participants | Etanercept |
|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | 58 |
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
| Participants | Etanercept |
|---|---|
| Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | 88 |
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
| Participants | Etanercept |
|---|---|
| Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | 5 |
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
| Participants | Etanercept |
|---|---|
| Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | 38 |
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
| Participants | Etanercept |
|---|---|
| Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | 92 |
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
| Participants | Etanercept |
|---|---|
| Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 | 11 |
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
| Participants | Etanercept |
|---|---|
| Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | 28 |
DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.
| Participants | Etanercept |
|---|---|
| Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | 106 |
| percentage of participants | Etanercept |
|---|---|
| Up to Week 12 | 89.5 |
| Up to Week 24 | 81.2 |
| Up to Week 36 | 75.6 |
| Up to Week 52 | 71.6 |
| percentage of participants | Etanercept |
|---|---|
| Up to Week 12 | 89.4 |
| Up to Week 24 | 81.1 |
| Up to Week 36 | 75.6 |
| Up to Week 52 | 71.6 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
| Participants | Etanercept |
|---|---|
| Up to Week 12 | 417 |
| Up to Week 24 | 567 |
| Up to Week 36 | 651 |
| Up to Week 52 | 699 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
| Participants | Etanercept |
|---|---|
| Up to Week 12 | 416 |
| Up to Week 24 | 564 |
| Up to Week 36 | 646 |
| Up to Week 52 | 694 |
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
| Participants | Etanercept |
|---|---|
| Week 12 | 278 |
| Week 24 | 305 |
| Week 36 | 263 |
| Week 52 | 271 |
Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
| mm | Etanercept |
|---|---|
| Week 12 | 39.8 ± 24.9 |
| Week 24 | 35.5 ± 25.1 |
| Week 36 | 32.7 ± 23.8 |
| Week 52 | 30.5 ± 23.3 |
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
| mm | Etanercept |
|---|---|
| Week 12 | 40.9 ± 30.1 |
| Week 24 | 37.7 ± 29.5 |
| Week 36 | 36.1 ± 28.9 |
| Week 52 | 33.5 ± 27.8 |
Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
| mm | Etanercept |
|---|---|
| Week 12 | 38.3 ± 26.9 |
| Week 24 | 34.9 ± 26.3 |
| Week 36 | 32.9 ± 25.6 |
| Week 52 | 31.1 ± 24.7 |
PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
| mm | Etanercept |
|---|---|
| Week 12 | 32.5 ± 21.1 |
| Week 24 | 26.9 ± 20.5 |
| Week 36 | 23.8 ± 19.4 |
| Week 52 | 21.7 ± 18.9 |
The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
| units on a scale | Etanercept |
|---|---|
| Week 12 | 2.0 ± 1.6 |
| Week 24 | 1.8 ± 1.6 |
| Week 36 | 1.7 ± 1.5 |
| Week 52 | 1.6 ± 1.5 |
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12: PtGA versus (vs.) Fatigue | 0.514 (0.456 to 0.567) |
| Week 12: PtGA vs. Pain | 0.825 (0.799 to 0.847) |
| Week 12: PtGA vs. PHQ-2 | 0.450 (0.387 to 0.507) |
| Week 12: PtGA vs. PGA | 0.603 (0.552 to 0.649) |
| Week 12: Fatigue vs. Pain | 0.586 (0.535 to 0.633) |
| Week 12: Fatigue vs. PHQ-2 | 0.577 (0.525 to 0.624) |
| Week 12: Fatigue vs. PGA | 0.370 (0.303 to 0.433) |
| Week 12: Pain vs. PHQ-2 | 0.529 (0.473 to 0.581) |
| Week 12: Pain vs. PGA | 0.612 (0.562 to 0.657) |
| Week 12: PHQ-2 vs. PGA | 0.376 (0.312 to 0.436) |
| Week 24: PtGA vs. Fatigue | 0.588 (0.532 to 0.638) |
| Week 24: PtGA vs. Pain | 0.859 (0.837 to 0.879) |
| Week 24: PtGA vs. PHQ-2 | 0.526 (0.465 to 0.582) |
| Week 24: PtGA vs. PGA | 0.600 (0.545 to 0.650) |
| Week 24: Fatigue vs. Pain | 0.621 (0.569 to 0.668) |
| Week 24: Fatigue vs. PHQ-2 | 0.591 (0.536 to 0.641) |
| Week 24: Fatigue vs. PGA | 0.389 (0.317 to 0.456) |
| Week 24: Pain vs. PHQ-2 | 0.558 (0.500 to 0.611) |
| Week 24: Pain vs. PGA | 0.556 (0.497 to 0.610) |
| Week 24: PHQ-2 vs. PGA | 0.379 (0.309 to 0.445) |
| Week 36: PtGA vs. Fatigue | 0.664 (0.611 to 0.710) |
| Week 36: PtGA vs. Pain | 0.839 (0.810 to 0.863) |
| Week 36: PtGA vs. PHQ-2 | 0.513 (0.445 to 0.574) |
| Week 36: PtGA vs. PGA | 0.609 (0.550 to 0.661) |
| Week 36: Fatigue vs. Pain | 0.646 (0.591 to 0.694) |
| Week 36: Fatigue vs. PHQ-2 | 0.614 (0.556 to 0.665) |
| Week 36: Fatigue vs. PGA | 0.463 (0.391 to 0.529) |
| Week 36: Pain vs. PHQ-2 | 0.532 (0.466 to 0.592) |
| Week 36: Pain vs. PGA | 0.576 (0.514 to 0.632) |
| Week 36: PHQ-2 vs. PGA | 0.367 (0.291 to 0.438) |
| Week 52: PtGA vs. Fatigue | 0.666 (0.609 to 0.715) |
| Week 52: PtGA vs. Pain | 0.861 (0.835 to 0.884) |
| Week 52: PtGA vs. PHQ-2 | 0.507 (0.434 to 0.574) |
| Week 52: PtGA vs. PGA | 0.632 (0.571 to 0.685) |
| Week 52: Fatigue vs. Pain | 0.649 (0.591 to 0.700) |
| Week 52: Fatigue vs. PHQ-2 | 0.574 (0.507 to 0.633) |
| Week 52: Fatigue vs. PGA | 0.485 (0.409 to 0.554) |
| Week 52: Pain vs. PHQ-2 | 0.545 (0.475 to 0.607) |
| Week 52: Pain vs. PGA | 0.641 (0.582 to 0.693) |
| Week 52: PHQ-2 vs. PGA | 0.445 (0.367 to 0.515) |
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12:PtGA vs. Fatigue | 0.582 (0.492 to 0.658) |
| Week 12: PtGA vs. Pain | 0.899 (0.872 to 0.921) |
| Week 12: PtGA vs. PHQ-2 | 0.526 (0.427 to 0.611) |
| Week 12: PtGA vs. PGA | 0.606 (0.520 to 0.679) |
| Week 12: Fatigue vs. Pain | 0.547 (0.453 to 0.628) |
| Week 12: Fatigue vs. PHQ-2 | 0.487 (0.384 to 0.576) |
| Week 12: Fatigue vs. PGA | 0.369 (0.256 to 0.470) |
| Week 12: Pain vs. PHQ-2 | 0.530 (0.433 to 0.614) |
| Week 12: Pain vs. PGA | 0.617 (0.533 to 0.688) |
| Week 12: PHQ-2 vs. PGA | 0.392 (0.285 to 0.488) |
| Week 24: PtGA vs. Fatigue | 0.668 (0.584 to 0.737) |
| Week 24: PtGA vs. Pain | 0.904 (0.874 to 0.926) |
| Week 24: PtGA vs. PHQ-2 | 0.495 (0.383 to 0.591) |
| Week 24: PtGA vs. PGA | 0.495 (0.383 to 0.591) |
| Week 24: Fatigue vs. Pain | 0.664 (0.578 to 0.734) |
| Week 24: Fatigue vs. PHQ-2 | 0.634 (0.543 to 0.709) |
| Week 24: Fatigue vs. PGA | 0.445 (0.326 to 0.548) |
| Week 24: Pain vs. PHQ-2 | 0.492 (0.379 to 0.588) |
| Week 24: Pain vs. PGA | 0.515 (0.405 to 0.608) |
| Week 24: PHQ-2 vs. PGA | 0.449 (0.335 to 0.549) |
| Week 36: PtGA vs. Fatigue | 0.720 (0.641 to 0.782) |
| Week 36: PtGA vs. Pain | 0.914 (0.886 to 0.935) |
| Week 36: PtGA vs. PHQ-2 | 0.630 (0.533 to 0.709) |
| Week 36: PtGA vs. PGA | 0.586 (0.481 to 0.672) |
| Week 36: Fatigue vs. Pain | 0.728 (0.650 to 0.789) |
| Week 36: Fatigue vs. PHQ-2 | 0.691 (0.606 to 0.759) |
| Week 36: Fatigue vs. PGA | 0.530 (0.415 to 0.626) |
| Week 36: Pain vs. PHQ-2 | 0.637 (0.540 to 0.715) |
| Week 36: Pain vs. PGA | 0.591 (0.487 to 0.677) |
| Week 36: PHQ-2 vs. PGA | 0.483 (0.366 to 0.583) |
| Week 52: PtGA vs. Fatigue | 0.717 (0.634 to 0.782) |
| Week 52: PtGA vs. Pain | 0.912 (0.882 to 0.934) |
| Week 52: PtGA vs. PHQ-2 | 0.586 (0.476 to 0.676) |
| Week 52: PtGA vs. PGA | 0.548 (0.432 to 0.644) |
| Week 52: Fatigue vs. Pain | 0.743 (0.666 to 0.803) |
| Week 52: Fatigue vs. PHQ-2 | 0.676 (0.584 to 0.749) |
| Week 52: Fatigue vs. PGA | 0.457 (0.328 to 0.567) |
| Week 52: Pain vs. PHQ-2 | 0.629 (0.527 to 0.711) |
| Week 52: Pain vs. PGA | 0.603 (0.497 to 0.690) |
| Week 52: PHQ-2 vs. PGA | 0.420 (0.290 to 0.533) |
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12: PtGA vs. Fatigue | 0.630 (0.542 to 0.703) |
| Week 12: PtGA vs. Pain | 0.892 (0.862 to 0.916) |
| Week 12: PtGA vs. PHQ-2 | 0.609 (0.518 to 0.686) |
| Week 12: PtGA vs. PGA | 0.509 (0.402 to 0.601) |
| Week 12: Fatigue vs. Pain | 0.664 (0.583 to 0.731) |
| Week 12: Fatigue vs. PHQ-2 | 0.601 (0.508 to 0.678) |
| Week 12: Fatigue vs. PGA | 0.324 (0.198 to 0.438) |
| Week 12: Pain vs. PHQ-2 | 0.628 (0.540 to 0.701) |
| Week 12: Pain vs. PGA | 0.529 (0.425 to 0.618) |
| Week 12: PHQ-2 vs. PGA | 0.381 (0.262 to 0.488) |
| Week 24: PtGA vs. Fatigue | 0.656 (0.565 to 0.730) |
| Week 24: PtGA vs. Pain | 0.881 (0.844 to 0.909) |
| Week 24: PtGA vs. PHQ-2 | 0.562 (0.454 to 0.652) |
| Week 24: PtGA vs. PGA | 0.559 (0.451 to 0.649) |
| Week 24: Fatigue vs. Pain | 0.674 (0.586 to 0.744) |
| Week 24: Fatigue vs. PHQ-2 | 0.620 (0.521 to 0.700) |
| Week 24: Fatigue vs. PGA | 0.374 (0.243 to 0.490) |
| Week 24: Pain vs. PHQ-2 | 0.607 (0.507 to 0.690) |
| Week 24: Pain vs. PGA | 0.630 (0.534 to 0.708) |
| Week 24: PHQ-2 vs. PGA | 0.410 (0.285 to 0.520) |
| Week 36: PtGA vs. Fatigue | 0.692 (0.603 to 0.762) |
| Week 36: PtGA vs. Pain | 0.913 (0.884 to 0.935) |
| Week 36: PtGA vs. PHQ-2 | 0.645 (0.546 to 0.724) |
| Week 36: PtGA vs. PGA | 0.513 (0.392 to 0.614) |
| Week 36: Fatigue vs. Pain | 0.724 (0.642 to 0.788) |
| Week 36: Fatigue vs. PHQ-2 | 0.710 (0.624 to 0.777) |
| Week 36: Fatigue vs. PGA | 0.423 (0.290 to 0.539) |
| Week 36: Pain vs. PHQ-2 | 0.658 (0.561 to 0.735) |
| Week 36: Pain vs. PGA | 0.532 (0.414 to 0.631) |
| Week 36: PHQ-2 vs. PGA | 0.357 (0.218 to 0.480) |
| Week 52: PtGA vs. Fatigue | 0.753 (0.671 to 0.815) |
| Week 52: PtGA vs. Pain | 0.908 (0.874 to 0.933) |
| Week 52: PtGA vs. PHQ-2 | 0.696 (0.599 to 0.771) |
| Week 52: PtGA vs. PGA | 0.565 (0.439 to 0.666) |
| Week 52: Fatigue vs. Pain | 0.760 (0.680 to 0.820) |
| Week 52: Fatigue vs. PHQ-2 | 0.726 (0.637 to 0.794) |
| Week 52: Fatigue vs. PGA | 0.430 (0.285 to 0.553) |
| Week 52: Pain vs. PHQ-2 | 0.683 (0.584 to 0.761) |
| Week 52: Pain vs. PGA | 0.581 (0.459 to 0.679) |
| Week 52: PHQ-2 vs. PGA | 0.498 (0.364 to 0.609) |
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12: PtGA vs. Fatigue | 0.350 (0.107 to 0.550) |
| Week 12: PtGA vs. Pain | 0.606 (0.414 to 0.742) |
| Week 12: PtGA vs. PHQ-2 | 0.563 (0.353 to 0.715) |
| Week 12: PtGA vs. PGA | 0.606 (0.415 to 0.741) |
| Week 12: Fatigue vs. Pain | 0.679 (0.515 to 0.791) |
| Week 12: Fatigue vs. PHQ-2 | 0.681 (0.512 to 0.795) |
| Week 12: Fatigue vs. PGA | 0.175 (-0.075 to 0.403) |
| Week 12: Pain vs. PHQ-2 | 0.647 (0.464 to 0.772) |
| Week 12: Pain vs. PGA | 0.384 (0.147 to 0.575) |
| Week 12: PHQ-2 vs. PGA | 0.265 (0.016 to 0.479) |
| Week 24: PtGA vs. Fatigue | 0.651 (0.450 to 0.784) |
| Week 24: PtGA vs. Pain | 0.692 (0.508 to 0.812) |
| Week 24: PtGA vs. PHQ-2 | 0.485 (0.231 to 0.672) |
| Week 24: PtGA vs. PGA | 0.713 (0.537 to 0.825) |
| Week 24: Fatigue vs. Pain | 0.802 (0.669 to 0.881) |
| Week 24: Fatigue vs. PHQ-2 | 0.577 (0.348 to 0.736) |
| Week 24: Fatigue vs. PGA | 0.377 (0.107 to 0.591) |
| Week 24: Pain vs. PHQ-2 | 0.466 (0.208 to 0.658) |
| Week 24: Pain vs. PGA | 0.470 (0.216 to 0.659) |
| Week 24: PHQ-2 vs. PGA | 0.219 (-0.062 to 0.465) |
| Week 36: PtGA vs. Fatigue | 0.627 (0.377 to 0.785) |
| Week 36: PtGA vs. Pain | 0.687 (0.463 to 0.822) |
| Week 36: PtGA vs. PHQ-2 | 0.585 (0.319 to 0.759) |
| Week 36: PtGA vs. PGA | 0.519 (0.233 to 0.716) |
| Week 36: Fatigue vs. Pain | 0.744 (0.553 to 0.855) |
| Week 36: Fatigue vs. PHQ-2 | 0.812 (0.661 to 0.895) |
| Week 36: Fatigue vs. PGA | 0.288 (-0.034 to 0.550) |
| Week 36: Pain vs. PHQ-2 | 0.659 (0.426 to 0.803) |
| Week 36: Pain vs. PGA | 0.411 (0.104 to 0.640) |
| Week 36: PHQ-2 vs. PGA | 0.167 (-0.150 to 0.450) |
| Week 52: PtGA vs. Fatigue | 0.418 (0.074 to 0.665) |
| Week 52: PtGA vs. Pain | 0.625 (0.350 to 0.794) |
| Week 52: PtGA vs. PHQ-2 | 0.464 (0.137 to 0.693) |
| Week 52: PtGA vs. PGA | 0.753 (0.544 to 0.868) |
| Week 52: Fatigue vs. Pain | 0.579 (0.281 to 0.768) |
| Week 52: Fatigue vs. PHQ-2 | 0.598 (0.307 to 0.780) |
| Week 52: Fatigue vs. PGA | 0.278 (-0.083 to 0.568) |
| Week 52: Pain vs. PHQ-2 | 0.404 (0.064 to 0.653) |
| Week 52: Pain vs. PGA | 0.421 (0.085 to 0.664) |
| Week 52: PHQ-2 vs. PGA | 0.208 (-0.132 to 0.500) |
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12: FFbH vs. Morning stiffness | -0.439 (-0.498 to -0.375) |
| Week 24: FFbH vs. Morning stiffness | -0.486 (-0.547 to -0.420) |
| Week 36: FFbH vs. Morning stiffness | -0.520 (-0.582 to -0.451) |
| Week 52: FFbH vs. Morning stiffness | -0.502 (-0.571 to -0.427) |
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12: FFbH vs. Morning stiffness | -0.493 (-0.589 to -0.381) |
| Week 24: FFbH vs. Morning stiffness | -0.640 (-0.719 to -0.542) |
| Week 36: FFbH vs. Morning stiffness | -0.615 (-0.703 to -0.504) |
| Week 52: FFbH vs. Morning stiffness | -0.560 (-0.667 to -0.428) |
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
| spearman correlation coefficient | Etanercept |
|---|---|
| Week 12: FFbH vs. Morning stiffness | -0.523 (-0.608 to -0.425) |
| Week 24: FFbH vs. Morning stiffness | -0.523 (-0.617 to -0.413) |
| Week 36: FFbH vs. Morning stiffness | -0.565 (-0.658 to -0.453) |
| Week 52: FFbH vs. Morning stiffness | -0.600 (-0.690 to -0.489) |
Percentage of participants who discontinued etanercept before completing the study, was reported.
| percentage of participants | Etanercept |
|---|---|
| Due to lack of Efficacy | 15.2 |
| Due to Adverse Events | 8.5 |
Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
| Participants | Etanercept |
|---|---|
| Abatacept | 15 |
| Adalimumab | 53 |
| Apremilast | 7 |
| Azathioprin | 1 |
| Azathioprin, Leflunomid, Diclofenac | 1 |
| Azathioprin, Prednisolon | 1 |
| Baricitinib | 3 |
| Biological NOS | 5 |
| Certolizumab | 26 |
| Etanercept Biosimilar | 10 |
| Golimumab | 6 |
| Hydroxychloroquin | 1 |
| Leflunomid | 4 |
| Methotrexate (MTX) | 6 |
| MTX, Adalimumab | 2 |
| MTX, Prednisolon | 3 |
| MTX, Tocilizumab | 1 |
| Prednisolon | 13 |
| Prednisolon, Diclofenac | 1 |
| Remsima (Infliximab-Biosimilar) | 1 |
| Rituximab | 12 |
| Roactemra | 10 |
| Secukinumab | 27 |
| Sulfasalazin | 1 |
| Sulfasalazin, Leflunomid | 1 |
| Tapentadol | 2 |
| Tocilizumab | 25 |
| Tofacitinib | 2 |
| Ustekinumab | 7 |
| Etoricoxib | 1 |
| Ibuprofen | 2 |
| Ibuprofen, Metamizol | 1 |
| Ibuprofen, Prednisolon, Oxycodon, Pregabalin | 1 |
| Inflectra (Infliximab Biosimilar) | 1 |
| Infliximab | 1 |
| NSAR | 1 |
| Corticosteroid | 1 |
| PUVA | 1 |
| Unknown | 5 |
| None | 56 |
| Missing values | 92 |
FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicated better daily activities.
| units on a scale | Etanercept |
|---|---|
| Week 12 | 71.4 ± 22.2 |
| Week 24 | 72.2 ± 22.4 |
| Week 36 | 73.4 ± 22.3 |
| Week 52 | 73.7 ± 22.5 |
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
| units on a scale | Etanercept |
|---|---|
| Week 12 | 12.7 ± 9.7 |
| Week 24 | 11.0 ± 9.4 |
| Week 36 | 10.1 ± 8.9 |
| Week 52 | 9.2 ± 9.1 |
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
| units on a scale | Etanercept |
|---|---|
| Week 12 | 14.3 ± 11.0 |
| Week 24 | 12.0 ± 11.3 |
| Week 36 | 11.1 ± 9.7 |
| Week 52 | 10.1 ± 10.2 |
BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
| units on a scale | Etanercept |
|---|---|
| Week 12 | 3.8 ± 2.3 |
| Week 24 | 3.5 ± 2.3 |
| Week 36 | 3.2 ± 2.1 |
| Week 52 | 3.3 ± 2.2 |
An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
| enthesis | Etanercept |
|---|---|
| Week 12 | 1.0 ± 1.8 |
| Week 24 | 0.6 ± 1.2 |
| Week 36 | 0.4 ± 1.1 |
| Week 52 | 0.3 ± 1.0 |
Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
| cm | Etanercept |
|---|---|
| Week 12 | 6.7 ± 10.7 |
| Week 24 | 6.6 ± 11.3 |
| Week 36 | 6.3 ± 11.2 |
| Week 52 | 6.0 ± 11.0 |
Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
| percentage of BSA | Etanercept |
|---|---|
| Week 12 | 8.5 ± 12.8 |
| Week 24 | 5.9 ± 9.2 |
| Week 36 | 4.8 ± 7.1 |
| Week 52 | 5.4 ± 10.9 |
Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
| finger or toes | Etanercept |
|---|---|
| Week 12 | 1.4 ± 2.1 |
| Week 24 | 0.7 ± 1.3 |
| Week 36 | 0.7 ± 1.4 |
| Week 52 | 0.6 ± 1.3 |
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
| units on a scale | Etanercept |
|---|---|
| Baseline | 16.8 ± 10.1 |
| Change at Week 12 | -9.6 ± 10.3 |
| Change at Week 24 | -13.0 ± 10.6 |
| Change at Week 36 | -14.4 ± 10.9 |
| Change at Week 52 | -14.8 ± 11.0 |
PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
| days | Etanercept |
|---|---|
| Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) | 100 ± 85.6 |
PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
| units on a scale | Etanercept |
|---|---|
| Week 12, Erythema | 1.4 ± 0.7 |
| Week 12: Induration | 1.2 ± 0.7 |
| Week 12: Desquamation | 1.1 ± 0.7 |
| Week 24: Erythema | 1.0 ± 0.7 |
| Week 24: Induration | 0.9 ± 0.6 |
| Week 24: Desquamation | 0.9 ± 0.7 |
| Week 36: Erythema | 0.7 ± 0.6 |
| Week 36: Induration | 0.6 ± 0.5 |
| Week 36: Desquamation | 0.6 ± 0.5 |
| Week 52: Erythema | 0.7 ± 0.7 |
| Week 52: Induration | 0.5 ± 0.5 |
| Week 52: Desquamation | 0.6 ± 0.6 |
PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
| units on a scale | Etanercept |
|---|---|
| Week 12, Head | 0.4 ± 0.8 |
| Week 12: Trunk | 1.6 ± 2.0 |
| Week 12: Upper extremities | 1.4 ± 1.6 |
| Week 12: Lower extremities | 3.5 ± 3.7 |
| Week 24: Head | 0.2 ± 0.5 |
| Week 24: Trunk | 0.6 ± 0.8 |
| Week 24: Upper extremities | 0.9 ± 1.0 |
| Week 24: Lower extremities | 2.3 ± 2.7 |
| Week 36: Head | 0.2 ± 0.4 |
| Week 36: Trunk | 0.5 ± 0.9 |
| Week 36: Upper extremities | 0.5 ± 0.5 |
| Week 36: Lower extremities | 1.5 ± 2.0 |
| Week 52: Head | 0.1 ± 0.3 |
| Week 52: Trunk | 0.5 ± 1.0 |
| Week 52: Upper extremities | 0.5 ± 0.5 |
| Week 52: Lower extremities | 1.4 ± 1.9 |
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI \< 2; small effect at 2 \<=DLQI \<= 5; moderate effect at 6 \<=DLQI \<= 10; very large effect at 11\<=DLQI \<= 20; extremely large effect at 21 \<= DLQI \<= 30.
| units on a scale | Etanercept |
|---|---|
| Week 12 | 8.3 ± 7.4 |
| Week 24 | 5.5 ± 5.8 |
| Week 36 | 4.8 ± 5.5 |
| Week 52 | 3.7 ± 4.6 |
Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".
| units on a scale | Etanercept |
|---|---|
| Week 12 | 35.5 ± 30.9 |
| Week 24 | 22.4 ± 23.8 |
| Week 36 | 24.2 ± 26.6 |
| Week 52 | 14.8 ± 15.8 |
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
| mm/hr | Etanercept |
|---|---|
| Week 12 | 19.7 ± 18.4 |
| Week 24 | 19.4 ± 18.8 |
| Week 36 | 18.4 ± 17.4 |
| Week 52 | 18.2 ± 17.6 |
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
| mg/L | Etanercept |
|---|---|
| Week 12 | 10.9 ± 33.9 |
| Week 24 | 10.9 ± 37.4 |
| Week 36 | 10.2 ± 31.4 |
| Week 52 | 9.7 ± 30.3 |
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
| Participants | Etanercept |
|---|---|
| Week 12 | 310 |
| Week 24 | 259 |
| Week 36 | 208 |
| Week 52 | 173 |
To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
| unit per milliliter (U/mL) | Etanercept |
|---|---|
| Week 12 | 236.2 ± 695.7 |
| Week 24 | 202.2 ± 615.6 |
| Week 36 | 178.6 ± 635.3 |
| Week 52 | 176.2 ± 714.4 |
Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
| Participants | Etanercept |
|---|---|
| Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) | 223 |
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
| Participants | Etanercept |
|---|---|
| Week 36 | 35 |
| Week 52 | 32 |
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
| Participants | Etanercept |
|---|---|
| Week 36 | 93 |
| Week 52 | 87 |
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
| Participants | Etanercept |
|---|---|
| Week 36 | 13 |
| Week 52 | 14 |
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
| Participants | Etanercept |
|---|---|
| Week 36 | 173 |
| Week 52 | 187 |
Collected over Baseline up to Week 52. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etanercept | 5/1,465 (0.3%) | 151/1,465 (10.3%) | 606/1,465 (41.4%) |
| Event | Etanercept |
|---|---|
| Condition aggravatedGeneral disorders | 16/1465 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 11/1465 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 5/1465 |
| Drug ineffectiveGeneral disorders | 5/1465 |
| BronchitisInfections and infestations | 4/1465 |
| PneumoniaInfections and infestations | 4/1465 |
| Atrial fibrillationCardiac disorders | 4/1465 |
| ArthritisMusculoskeletal and connective tissue disorders | 3/1465 |
| Joint swellingMusculoskeletal and connective tissue disorders | 3/1465 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 3/1465 |
| Event | Etanercept |
|---|---|
| Drug ineffectiveGeneral disorders | 203/1465 |
| NasopharyngitisInfections and infestations | 62/1465 |
| Condition aggravatedGeneral disorders | 35/1465 |
| Injection site erythemaGeneral disorders | 34/1465 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 23/1465 |
| Injection site reactionGeneral disorders | 22/1465 |
| BronchitisInfections and infestations | 20/1465 |
| Respiratory tract infectionInfections and infestations | 16/1465 |
| PruritusSkin and subcutaneous tissue disorders | 16/1465 |
| FatigueGeneral disorders | 13/1465 |
Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an adverse event (AE) documented.
| Age, Continuous(years) | Etanercept |
|---|---|
| Mean | 54.9 ± 14.5 |
| Sex: Female, Male(Participants) | Etanercept |
|---|---|
| Female | 901 |
| Male | 564 |
| Race and Ethnicity Not Collected(Participants) | Etanercept |
|---|
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Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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