A Phase 2 interventional study of Upadacitinib and Pneumococcal 13-valent conjugate vaccine (PCV-13) in Rheumatoid Arthritis, sponsored by AbbVie. Completed at 124 sites in 18 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib.
All participants received treatment with 6 mg upadacitinib twice a day at the start of the study. Participants may have been up-titrated to 12 mg BID based on protocol-specified criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and participants receiving 12 mg BID were transitioned to 30 mg QD dosing.
An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13; Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled in the main study, the first participant was enrolled on 13 February 2018 and the the last participant completed the sub-study on 9 April 2020.
In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's medical decision or for safety/tolerability concerns.
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Substudy:
Exclusion Criteria:
Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria:
Substudy:
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). Participants who did not achieve a 20% improvement from RCT Baseline in both Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 6 or Week 12 were up-titrated to 12 mg BID. From January 2017 participants were transitioned to a once-daily (QD) regimen of upadacitinib, either 15 mg QD (participants who were taking 6 mg BID) or 30 mg QD (participants taking 12 mg BID). Starting with Protocol Amendment 5 participants receiving 30 mg QD upadacitinib had the option to decrease the dose to 15 mg QD at the investigator's discretion. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
Drug: Upadacitinib · Biological: Pneumococcal 13-valent conjugate vaccine (PCV-13)
Tablet taken orally
Also known as: ABT-494, RINVOQ®
Administered by intramuscular injection
Also known as: Prevnar 13®
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Time frame: Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score \< 2.6.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
The disease activity score-28-CRP (DAS28 \[CRP\]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Tender Joint Count (TJC68) Over Time
Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Patient's Assessment of Pain Over Time
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk, scores between 10 and 17 indicate medium risk, and scores \> 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Change From Baseline in EuroQoL-5D VAS Score Over Time
The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Time frame: Vaccination Baseline and 12 weeks after vaccination
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Time frame: Vaccination Baseline and 4 and 12 weeks after vaccination
Participants must have completed a preceding rheumatoid arthritis (RA) upadacitinib randomized controlled trial (RCT), Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) to be enrolled in this long-term extension study. Participants were enrolled at 113 study sites located in 17 countries (Belgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, Ukraine, and United States/Puerto Rico).
| Milestone | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Started | 306 | 149 | 38 |
| Enrolled in vaccine sub-study | 76 | 24 | 11 |
| Completed | 142 | 51 | 30 |
| Not completed | 164 | 98 | 8 |
| Withdrew: Adverse event | 46 | 25 | 1 |
| Withdrew: Withdrawal by subject | 57 | 21 | 5 |
| Withdrew: Lost to follow-up | 18 | 5 | 1 |
| Withdrew: Lack of efficacy | 10 | 26 | 1 |
| Withdrew: Non-compliance | 15 | 6 | 0 |
| Withdrew: Required alternative / prohibited therapy | 1 | 1 | 0 |
| Withdrew: Coronavirus disease-2019 (covid-19) infection | 1 | 0 | 0 |
| Withdrew: Covid-19 logistical restrictions | 1 | 0 | 0 |
| Withdrew: Other | 15 | 13 | 0 |
| Withdrew: Missing | 0 | 1 | 0 |
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 87.7 | 73.4 | 77.8 |
| Week 12 | 89.0 | 73.8 | 75.7 |
| Week 24 | 91.8 | 73.3 | 88.6 |
| Week 36 | 90.2 | 83.2 | 82.9 |
| Week 48 | 90.0 | 82.1 | 88.2 |
| Week 60 | 95.4 | 83.8 | 85.7 |
| Week 72 | 93.0 | 84.2 | 90.6 |
| Week 84 | 94.6 | 76.3 | 96.9 |
| Week 96 | 92.2 | 86.0 | 90.9 |
| Week 108 | 94.8 | 85.7 | 87.9 |
| Week 120 | 96.2 | 89.5 | 96.6 |
| Week 132 | 93.9 | 87.5 | 96.7 |
| Week 144 | 94.9 | 88.0 | 88.9 |
| Week 156 | 92.0 | 87.7 | 92.6 |
| Week 168 | 91.9 | 88.7 | 82.8 |
| Week 180 | 93.9 | 79.1 | 86.2 |
| Week 192 | 93.5 | 87.1 | 92.9 |
| Week 204 | 94.0 | 81.2 | 86.2 |
| Week 216 | 92.5 | 85.9 | 85.2 |
| Week 228 | 96.0 | 83.6 | 92.9 |
| Week 240 | 92.8 | 85.2 | 89.3 |
| Week 252 | 94.0 | 87.9 | 86.7 |
| Week 264 | 93.3 | 81.5 | 89.3 |
| Week 276 | 93.8 | 84.6 | 81.5 |
| Week 288 | 94.7 | 88.0 | 88.9 |
| Week 300 | 94.4 | 82.0 | 87.0 |
| Week 312 | 92.2 | 87.8 | 88.5 |
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 63.6 | 37.5 | 48.6 |
| Week 12 | 73.5 | 41.8 | 45.7 |
| Week 24 | 75.7 | 49.6 | 60.0 |
| Week 36 | 73.5 | 51.6 | 55.9 |
| Week 48 | 74.2 | 50.0 | 55.6 |
| Week 60 | 79.8 | 52.8 | 65.7 |
| Week 72 | 77.1 | 49.0 | 63.6 |
| Week 84 | 78.8 | 55.8 | 75.8 |
| Week 96 | 74.8 | 53.8 | 63.6 |
| Week 108 | 79.4 | 54.8 | 58.8 |
| Week 120 | 80.7 | 58.0 | 72.4 |
| Week 132 | 79.2 | 56.3 | 69.0 |
| Week 144 | 76.4 | 65.8 | 60.7 |
| Week 156 | 79.5 | 63.4 | 76.9 |
| Week 168 | 79.2 | 61.1 | 75.9 |
| Week 180 | 80.9 | 64.3 | 65.5 |
| Week 192 | 80.7 | 59.4 | 76.9 |
| Week 204 | 82.2 | 59.4 | 79.3 |
| Week 216 | 76.6 | 55.6 | 66.7 |
| Week 228 | 79.2 | 58.2 | 67.9 |
| Week 240 | 79.6 | 63.9 | 71.4 |
| Week 252 | 83.8 | 55.2 | 76.7 |
| Week 264 | 79.7 | 60.0 | 75.0 |
| Week 276 | 84.5 | 52.9 | 66.7 |
| Week 288 | 82.2 | 58.8 | 61.5 |
| Week 300 | 75.6 | 61.2 | 56.5 |
| Week 312 | 84.3 | 69.4 | 69.2 |
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 38.8 | 15.1 | 21.6 |
| Week 12 | 47.1 | 18.1 | 24.3 |
| Week 24 | 45.5 | 27.6 | 37.1 |
| Week 36 | 49.0 | 28.3 | 34.3 |
| Week 48 | 57.1 | 26.7 | 25.0 |
| Week 60 | 60.2 | 30.0 | 42.9 |
| Week 72 | 56.4 | 29.1 | 36.4 |
| Week 84 | 60.3 | 29.5 | 54.5 |
| Week 96 | 57.3 | 34.0 | 42.4 |
| Week 108 | 59.9 | 31.9 | 47.1 |
| Week 120 | 59.4 | 30.7 | 62.1 |
| Week 132 | 61.8 | 33.8 | 48.3 |
| Week 144 | 57.6 | 34.2 | 39.3 |
| Week 156 | 64.7 | 38.9 | 55.6 |
| Week 168 | 62.9 | 42.3 | 58.6 |
| Week 180 | 59.1 | 29.6 | 48.3 |
| Week 192 | 62.0 | 31.9 | 48.1 |
| Week 204 | 65.0 | 42.6 | 58.6 |
| Week 216 | 59.1 | 41.9 | 46.4 |
| Week 228 | 60.0 | 39.3 | 60.7 |
| Week 240 | 66.2 | 38.7 | 46.4 |
| Week 252 | 62.9 | 29.3 | 50.0 |
| Week 264 | 58.5 | 37.0 | 57.1 |
| Week 276 | 66.1 | 34.6 | 48.0 |
| Week 288 | 65.9 | 44.2 | 44.4 |
| Week 300 | 60.8 | 41.2 | 43.5 |
| Week 312 | 63.1 | 39.6 | 55.6 |
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
| percentage of participants | Upadacitinib 15 mg + PCV-13 | Upadacitinib 30 mg + PCV-13 |
|---|---|---|
| Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination | 67.5 (57.4 to 77.5) | 56.5 (36.3 to 76.8) |
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2.
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 70.3 | 43.2 | 43.2 |
| Week 12 | 77.9 | 43.4 | 43.2 |
| Week 24 | 82.4 | 48.5 | 52.8 |
| Week 36 | 80.5 | 50.8 | 55.6 |
| Week 48 | 86.8 | 54.2 | 56.8 |
| Week 60 | 86.2 | 56.4 | 66.7 |
| Week 72 | 84.7 | 51.0 | 69.7 |
| Week 84 | 88.9 | 60.2 | 85.3 |
| Week 96 | 82.4 | 64.9 | 79.4 |
| Week 108 | 88.2 | 66.3 | 70.6 |
| Week 120 | 85.9 | 69.0 | 77.4 |
| Week 132 | 88.6 | 70.1 | 87.1 |
| Week 144 | 85.2 | 68.6 | 82.1 |
| Week 156 | 86.1 | 74.6 | 86.2 |
| Week 168 | 90.0 | 78.3 | 80.0 |
| Week 180 | 90.4 | 69.6 | 80.0 |
| Week 192 | 89.3 | 75.0 | 96.3 |
| Week 204 | 88.6 | 61.4 | 83.3 |
| Week 216 | 89.9 | 70.3 | 82.1 |
| Week 228 | 89.4 | 70.9 | 86.2 |
| Week 240 | 89.5 | 75.8 | 86.2 |
| Week 252 | 91.7 | 67.2 | 83.9 |
| Week 264 | 86.2 | 67.9 | 82.1 |
| Week 276 | 91.7 | 74.1 | 72.0 |
| Week 288 | 90.6 | 71.7 | 76.0 |
| Week 300 | 94.1 | 67.6 | 80.0 |
| Week 312 | 84.5 | 68.8 | 70.4 |
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score \< 2.6.
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 53.0 | 21.2 | 29.7 |
| Week 12 | 56.6 | 25.5 | 27.0 |
| Week 24 | 60.8 | 31.3 | 38.9 |
| Week 36 | 65.0 | 35.2 | 50.0 |
| Week 48 | 66.2 | 36.4 | 35.1 |
| Week 60 | 72.9 | 38.2 | 50.0 |
| Week 72 | 69.0 | 35.6 | 51.5 |
| Week 84 | 72.0 | 36.7 | 52.9 |
| Week 96 | 71.7 | 45.4 | 52.9 |
| Week 108 | 74.4 | 42.4 | 47.1 |
| Week 120 | 74.1 | 49.4 | 45.2 |
| Week 132 | 73.7 | 40.3 | 61.3 |
| Week 144 | 71.0 | 44.3 | 60.7 |
| Week 156 | 74.7 | 50.7 | 65.5 |
| Week 168 | 77.5 | 49.3 | 66.7 |
| Week 180 | 75.3 | 44.9 | 56.7 |
| Week 192 | 76.9 | 47.2 | 55.6 |
| Week 204 | 77.1 | 47.1 | 76.7 |
| Week 216 | 79.2 | 56.3 | 53.6 |
| Week 228 | 80.8 | 49.1 | 69.0 |
| Week 240 | 75.2 | 50.0 | 69.0 |
| Week 252 | 80.7 | 44.8 | 58.1 |
| Week 264 | 73.8 | 39.6 | 67.9 |
| Week 276 | 76.9 | 50.0 | 52.0 |
| Week 288 | 74.5 | 47.8 | 48.0 |
| Week 300 | 75.2 | 43.2 | 55.0 |
| Week 312 | 72.4 | 45.8 | 63.0 |
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10.
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 65.3 | 35.2 | 35.1 |
| Week 12 | 71.1 | 39.7 | 32.4 |
| Week 24 | 80.3 | 46.6 | 51.4 |
| Week 36 | 77.8 | 44.4 | 57.1 |
| Week 48 | 83.0 | 50.8 | 38.9 |
| Week 60 | 85.8 | 58.9 | 63.9 |
| Week 72 | 85.5 | 46.2 | 60.6 |
| Week 84 | 84.4 | 52.6 | 75.0 |
| Week 96 | 81.3 | 63.5 | 57.6 |
| Week 108 | 85.1 | 67.4 | 54.5 |
| Week 120 | 87.2 | 67.0 | 77.4 |
| Week 132 | 87.4 | 72.5 | 76.7 |
| Week 144 | 88.4 | 68.0 | 78.6 |
| Week 156 | 88.8 | 73.2 | 71.4 |
| Week 168 | 90.8 | 82.2 | 83.3 |
| Week 180 | 88.3 | 73.9 | 76.7 |
| Week 192 | 88.1 | 70.0 | 79.3 |
| Week 204 | 89.0 | 71.4 | 82.8 |
| Week 216 | 88.6 | 70.3 | 78.6 |
| Week 228 | 89.3 | 67.9 | 79.3 |
| Week 240 | 87.6 | 72.6 | 75.9 |
| Week 252 | 89.0 | 73.7 | 74.2 |
| Week 264 | 83.5 | 63.0 | 75.9 |
| Week 276 | 87.6 | 67.9 | 67.9 |
| Week 288 | 90.3 | 74.5 | 75.0 |
| Week 300 | 89.8 | 72.0 | 70.8 |
| Week 312 | 86.6 | 70.2 | 73.1 |
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8.
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 23.4 | 4.9 | 10.8 |
| Week 12 | 26.4 | 6.4 | 8.8 |
| Week 24 | 28.3 | 12.8 | 14.3 |
| Week 36 | 32.5 | 9.5 | 17.1 |
| Week 48 | 34.8 | 11.0 | 11.1 |
| Week 60 | 43.1 | 13.1 | 22.2 |
| Week 72 | 43.5 | 12.5 | 9.1 |
| Week 84 | 43.4 | 12.4 | 18.8 |
| Week 96 | 40.4 | 15.6 | 21.2 |
| Week 108 | 44.8 | 16.3 | 18.2 |
| Week 120 | 43.6 | 12.5 | 22.6 |
| Week 132 | 46.7 | 18.8 | 33.3 |
| Week 144 | 38.1 | 14.7 | 28.6 |
| Week 156 | 47.2 | 14.1 | 32.1 |
| Week 168 | 48.6 | 20.5 | 33.3 |
| Week 180 | 48.0 | 15.9 | 20.0 |
| Week 192 | 46.4 | 18.6 | 24.1 |
| Week 204 | 51.2 | 20.0 | 34.5 |
| Week 216 | 46.2 | 21.9 | 28.6 |
| Week 228 | 44.3 | 25.0 | 31.0 |
| Week 240 | 51.6 | 24.2 | 31.0 |
| Week 252 | 52.7 | 19.3 | 22.6 |
| Week 264 | 48.1 | 20.4 | 17.2 |
| Week 276 | 53.5 | 24.5 | 28.6 |
| Week 288 | 51.5 | 25.5 | 28.6 |
| Week 300 | 51.2 | 22.0 | 29.2 |
| Week 312 | 50.4 | 27.7 | 34.6 |
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0.
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 54.2 | 25.4 | 32.4 |
| Week 12 | 61.1 | 33.3 | 23.5 |
| Week 24 | 66.8 | 33.1 | 48.6 |
| Week 36 | 67.8 | 34.9 | 48.6 |
| Week 48 | 73.7 | 38.1 | 41.7 |
| Week 60 | 72.9 | 41.1 | 61.1 |
| Week 72 | 71.5 | 36.5 | 51.5 |
| Week 84 | 74.6 | 40.2 | 62.5 |
| Week 96 | 71.2 | 45.8 | 51.5 |
| Week 108 | 75.8 | 51.2 | 54.5 |
| Week 120 | 74.6 | 55.2 | 64.5 |
| Week 132 | 77.7 | 43.4 | 66.7 |
| Week 144 | 70.7 | 44.3 | 67.9 |
| Week 156 | 75.0 | 58.5 | 64.3 |
| Week 168 | 75.8 | 59.4 | 66.7 |
| Week 180 | 78.7 | 55.9 | 53.3 |
| Week 192 | 76.2 | 52.9 | 66.7 |
| Week 204 | 71.3 | 52.9 | 79.3 |
| Week 216 | 79.0 | 56.3 | 57.1 |
| Week 228 | 77.2 | 56.4 | 69.0 |
| Week 240 | 74.5 | 50.0 | 69.0 |
| Week 252 | 79.0 | 52.6 | 61.3 |
| Week 264 | 71.1 | 51.9 | 67.9 |
| Week 276 | 78.5 | 56.6 | 56.0 |
| Week 288 | 74.5 | 56.5 | 68.0 |
| Week 300 | 78.2 | 50.0 | 63.2 |
| Week 312 | 72.1 | 48.9 | 65.4 |
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3.
| percentage of participants | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 15.0 | 4.2 | 2.7 |
| Week 12 | 17.8 | 2.8 | 5.9 |
| Week 24 | 18.2 | 6.0 | 11.4 |
| Week 36 | 23.6 | 4.0 | 8.6 |
| Week 48 | 25.9 | 7.6 | 8.3 |
| Week 60 | 32.6 | 12.1 | 13.9 |
| Week 72 | 31.0 | 9.6 | 9.1 |
| Week 84 | 32.2 | 8.2 | 12.5 |
| Week 96 | 28.8 | 13.5 | 18.2 |
| Week 108 | 31.4 | 10.5 | 12.1 |
| Week 120 | 33.5 | 8.0 | 12.9 |
| Week 132 | 33.1 | 10.5 | 20.0 |
| Week 144 | 26.3 | 5.7 | 14.3 |
| Week 156 | 33.5 | 7.7 | 28.6 |
| Week 168 | 31.8 | 11.6 | 26.7 |
| Week 180 | 33.1 | 10.3 | 13.3 |
| Week 192 | 32.7 | 12.9 | 14.8 |
| Week 204 | 37.2 | 11.4 | 24.1 |
| Week 216 | 32.5 | 10.9 | 10.7 |
| Week 228 | 30.9 | 16.4 | 24.1 |
| Week 240 | 34.0 | 14.5 | 10.3 |
| Week 252 | 39.9 | 12.3 | 16.1 |
| Week 264 | 32.8 | 11.5 | 7.1 |
| Week 276 | 35.5 | 17.0 | 20.0 |
| Week 288 | 35.8 | 19.6 | 8.0 |
| Week 300 | 34.7 | 16.7 | 26.3 |
| Week 312 | 30.6 | 15.6 | 26.9 |
The disease activity score-28-CRP (DAS28 \[CRP\]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -2.9 ± 1.21 | -2.4 ± 1.28 | -2.5 ± 1.01 |
| Week 12 | -3.1 ± 1.14 | -2.5 ± 1.27 | -2.5 ± 1.03 |
| Week 24 | -3.2 ± 1.07 | -2.7 ± 1.36 | -2.7 ± 1.22 |
| Week 36 | -3.2 ± 1.20 | -2.9 ± 1.11 | -3.0 ± 1.17 |
| Week 48 | -3.4 ± 1.20 | -2.9 ± 1.20 | -2.8 ± 0.97 |
| Week 60 | -3.5 ± 1.15 | -2.9 ± 1.07 | -3.1 ± 0.98 |
| Week 72 | -3.5 ± 1.03 | -2.9 ± 1.24 | -3.1 ± 0.88 |
| Week 84 | -3.5 ± 1.06 | -2.9 ± 1.28 | -3.3 ± 0.62 |
| Week 96 | -3.4 ± 1.11 | -3.1 ± 1.21 | -3.2 ± 0.98 |
| Week 108 | -3.5 ± 1.09 | -3.1 ± 1.24 | -3.1 ± 0.94 |
| Week 120 | -3.5 ± 1.08 | -3.1 ± 1.29 | -3.2 ± 0.86 |
| Week 132 | -3.5 ± 1.02 | -3.1 ± 1.23 | -3.3 ± 1.02 |
| Week 144 | -3.4 ± 1.13 | -3.0 ± 1.18 | -3.4 ± 1.04 |
| Week 156 | -3.5 ± 1.13 | -3.1 ± 1.11 | -3.6 ± 1.00 |
| Week 168 | -3.6 ± 1.17 | -3.2 ± 1.23 | -3.6 ± 1.08 |
| Week 180 | -3.6 ± 1.10 | -3.2 ± 1.24 | -3.5 ± 1.13 |
| Week 192 | -3.6 ± 1.15 | -3.2 ± 1.31 | -3.6 ± 1.06 |
| Week 204 | -3.6 ± 1.13 | -3.1 ± 1.32 | -3.7 ± 1.13 |
| Week 216 | -3.6 ± 1.13 | -3.2 ± 1.15 | -3.5 ± 1.02 |
| Week 228 | -3.6 ± 1.12 | -3.3 ± 1.37 | -3.7 ± 0.91 |
| Week 240 | -3.7 ± 1.12 | -3.2 ± 1.30 | -3.5 ± 0.91 |
| Week 252 | -3.7 ± 1.20 | -3.3 ± 1.18 | -3.3 ± 1.04 |
| Week 264 | -3.5 ± 1.25 | -3.1 ± 1.24 | -3.4 ± 1.01 |
| Week 276 | -3.7 ± 1.01 | -3.1 ± 1.22 | -3.5 ± 0.90 |
| Week 288 | -3.7 ± 1.08 | -3.3 ± 1.44 | -3.2 ± 0.75 |
| Week 300 | -3.7 ± 1.00 | -3.0 ± 1.38 | -3.4 ± 0.81 |
| Week 312 | -3.5 ± 1.10 | -3.2 ± 1.25 | -3.2 ± 1.04 |
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -30.0 ± 12.49 | -27.5 ± 13.54 | -27.2 ± 11.42 |
| Week 12 | -31.6 ± 11.82 | -28.4 ± 13.87 | -27.9 ± 11.12 |
| Week 24 | -32.6 ± 11.81 | -30.6 ± 13.59 | -29.6 ± 11.45 |
| Week 36 | -32.2 ± 12.43 | -31.4 ± 12.67 | -29.6 ± 11.63 |
| Week 48 | -34.0 ± 12.84 | -31.8 ± 13.35 | -29.1 ± 10.82 |
| Week 60 | -34.7 ± 12.52 | -32.4 ± 12.18 | -32.2 ± 12.09 |
| Week 72 | -34.3 ± 11.71 | -32.3 ± 13.33 | -31.8 ± 10.88 |
| Week 84 | -34.9 ± 12.08 | -31.0 ± 13.36 | -33.5 ± 9.66 |
| Week 96 | -33.4 ± 11.71 | -32.1 ± 12.37 | -31.3 ± 10.86 |
| Week 108 | -34.5 ± 11.83 | -32.4 ± 12.79 | -32.3 ± 10.81 |
| Week 120 | -34.8 ± 11.87 | -32.3 ± 12.94 | -34.0 ± 10.75 |
| Week 132 | -35.0 ± 12.24 | -32.7 ± 12.39 | -34.5 ± 12.14 |
| Week 144 | -35.0 ± 12.21 | -33.1 ± 12.67 | -36.2 ± 12.03 |
| Week 156 | -35.6 ± 12.24 | -33.6 ± 12.25 | -36.1 ± 11.80 |
| Week 168 | -36.2 ± 13.01 | -33.8 ± 12.97 | -37.6 ± 13.08 |
| Week 180 | -35.5 ± 12.60 | -34.0 ± 12.13 | -36.9 ± 12.07 |
| Week 192 | -35.6 ± 12.25 | -34.0 ± 12.89 | -38.6 ± 11.76 |
| Week 204 | -36.0 ± 12.36 | -33.8 ± 13.69 | -37.9 ± 12.59 |
| Week 216 | -35.8 ± 13.19 | -33.9 ± 11.87 | -37.3 ± 11.62 |
| Week 228 | -35.6 ± 12.68 | -35.5 ± 13.31 | -37.9 ± 11.55 |
| Week 240 | -36.4 ± 12.95 | -34.7 ± 13.02 | -35.8 ± 11.07 |
| Week 252 | -35.9 ± 13.41 | -35.3 ± 12.58 | -34.3 ± 11.71 |
| Week 264 | -35.5 ± 13.66 | -33.2 ± 12.38 | -33.5 ± 12.49 |
| Week 276 | -36.5 ± 12.59 | -33.6 ± 12.16 | -34.7 ± 11.92 |
| Week 288 | -36.9 ± 13.22 | -35.3 ± 14.34 | -33.5 ± 10.25 |
| Week 300 | -36.0 ± 12.17 | -32.9 ± 11.86 | -34.6 ± 11.27 |
| Week 312 | -35.9 ± 12.43 | -34.4 ± 12.63 | -34.0 ± 11.62 |
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -38.8 ± 25.57 | -37.2 ± 27.36 | -40.8 ± 29.76 |
| Week 12 | -40.6 ± 24.84 | -38.6 ± 26.09 | -41.7 ± 30.24 |
| Week 24 | -42.0 ± 23.35 | -36.7 ± 43.09 | -38.2 ± 33.62 |
| Week 36 | -41.8 ± 25.10 | -41.6 ± 25.59 | -44.5 ± 31.98 |
| Week 48 | -42.9 ± 23.24 | -41.6 ± 25.26 | -44.6 ± 29.09 |
| Week 60 | -44.3 ± 24.21 | -42.5 ± 24.51 | -41.4 ± 22.38 |
| Week 72 | -43.4 ± 24.62 | -41.9 ± 27.31 | -41.8 ± 21.19 |
| Week 84 | -42.7 ± 28.14 | -39.0 ± 31.94 | -44.7 ± 20.79 |
| Week 96 | -42.0 ± 18.50 | -42.4 ± 27.17 | -43.2 ± 22.39 |
| Week 108 | -43.6 ± 27.35 | -42.9 ± 24.31 | -44.0 ± 21.38 |
| Week 120 | -42.7 ± 22.25 | -43.7 ± 25.88 | -43.4 ± 23.39 |
| Week 132 | -43.4 ± 19.92 | -41.4 ± 27.64 | -44.2 ± 23.86 |
| Week 144 | -41.7 ± 22.60 | -43.0 ± 29.91 | -46.0 ± 25.20 |
| Week 156 | -42.8 ± 21.64 | -43.6 ± 29.88 | -48.0 ± 23.98 |
| Week 168 | -43.7 ± 23.75 | -43.2 ± 28.55 | -46.4 ± 23.28 |
| Week 180 | -45.6 ± 26.65 | -45.0 ± 27.57 | -47.2 ± 24.08 |
| Week 192 | -44.7 ± 30.13 | -44.4 ± 27.94 | -48.5 ± 25.36 |
| Week 204 | -44.1 ± 35.23 | -43.5 ± 28.81 | -47.6 ± 24.55 |
| Week 216 | -47.3 ± 27.43 | -44.2 ± 26.69 | -47.4 ± 23.26 |
| Week 228 | -46.0 ± 27.33 | -47.9 ± 28.86 | -48.6 ± 21.47 |
| Week 240 | -46.8 ± 31.40 | -44.2 ± 29.63 | -45.0 ± 21.97 |
| Week 252 | -45.9 ± 25.86 | -45.7 ± 29.98 | -44.3 ± 23.50 |
| Week 264 | -44.9 ± 24.26 | -43.5 ± 30.06 | -44.4 ± 21.96 |
| Week 276 | -46.3 ± 20.01 | -44.2 ± 26.93 | -47.4 ± 20.53 |
| Week 288 | -47.1 ± 22.36 | -48.3 ± 30.14 | -41.6 ± 17.15 |
| Week 300 | -47.4 ± 20.47 | -41.6 ± 26.38 | -42.7 ± 19.05 |
| Week 312 | -45.8 ± 28.64 | -45.8 ± 28.89 | -41.2 ± 17.55 |
Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst).
| joints | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -20.6 ± 12.81 | -21.3 ± 14.53 | -22.1 ± 12.90 |
| Week 12 | -21.3 ± 12.47 | -22.5 ± 14.65 | -20.5 ± 11.18 |
| Week 24 | -22.0 ± 12.96 | -23.9 ± 14.60 | -22.9 ± 12.17 |
| Week 36 | -21.7 ± 12.58 | -24.2 ± 14.45 | -23.4 ± 13.56 |
| Week 48 | -23.1 ± 13.61 | -24.1 ± 14.43 | -24.0 ± 13.13 |
| Week 60 | -23.6 ± 13.56 | -25.0 ± 14.42 | -25.6 ± 13.54 |
| Week 72 | -23.3 ± 13.06 | -24.3 ± 14.48 | -26.1 ± 13.12 |
| Week 84 | -23.2 ± 12.71 | -23.4 ± 14.23 | -27.4 ± 13.32 |
| Week 96 | -23.1 ± 12.90 | -23.9 ± 14.58 | -24.6 ± 11.94 |
| Week 108 | -23.3 ± 12.62 | -23.7 ± 14.22 | -25.2 ± 12.31 |
| Week 120 | -23.1 ± 13.13 | -23.9 ± 14.17 | -26.9 ± 12.72 |
| Week 132 | -23.1 ± 12.79 | -23.7 ± 13.95 | -26.8 ± 13.74 |
| Week 144 | -23.5 ± 13.28 | -23.8 ± 13.50 | -29.3 ± 13.19 |
| Week 156 | -23.7 ± 13.21 | -23.9 ± 13.00 | -28.1 ± 13.63 |
| Week 168 | -24.1 ± 13.82 | -24.4 ± 13.86 | -31.0 ± 14.12 |
| Week 180 | -23.7 ± 13.60 | -24.9 ± 14.12 | -29.5 ± 12.96 |
| Week 192 | -24.0 ± 13.75 | -24.4 ± 14.15 | -31.3 ± 13.80 |
| Week 204 | -24.2 ± 13.77 | -23.6 ± 14.35 | -30.4 ± 14.53 |
| Week 216 | -24.2 ± 13.82 | -24.1 ± 13.87 | -31.6 ± 13.80 |
| Week 228 | -23.9 ± 13.57 | -26.6 ± 14.65 | -30.5 ± 13.69 |
| Week 240 | -24.7 ± 14.09 | -25.6 ± 14.47 | -29.4 ± 14.28 |
| Week 252 | -24.2 ± 13.78 | -25.6 ± 14.14 | -27.5 ± 13.26 |
| Week 264 | -23.7 ± 13.56 | -23.7 ± 13.28 | -27.0 ± 13.76 |
| Week 276 | -23.6 ± 13.55 | -23.9 ± 13.76 | -28.0 ± 14.41 |
| Week 288 | -24.9 ± 14.42 | -25.7 ± 14.87 | -26.6 ± 14.42 |
| Week 300 | -24.3 ± 14.04 | -24.5 ± 15.18 | -28.2 ± 14.10 |
| Week 312 | -24.1 ± 13.82 | -23.2 ± 14.08 | -26.8 ± 14.48 |
Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst).
| joints | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -12.8 ± 7.76 | -13.5 ± 10.89 | -14.5 ± 8.70 |
| Week 12 | -13.7 ± 7.95 | -13.9 ± 11.26 | -13.5 ± 6.72 |
| Week 24 | -14.2 ± 8.31 | -14.7 ± 10.87 | -15.7 ± 5.67 |
| Week 36 | -14.1 ± 8.26 | -15.1 ± 10.39 | -15.6 ± 5.94 |
| Week 48 | -15.3 ± 9.47 | -15.4 ± 11.19 | -16.0 ± 6.10 |
| Week 60 | -15.6 ± 9.52 | -15.9 ± 11.83 | -17.4 ± 9.36 |
| Week 72 | -15.1 ± 8.50 | -15.5 ± 10.47 | -17.0 ± 6.31 |
| Week 84 | -15.6 ± 9.18 | -14.7 ± 9.96 | -17.0 ± 6.68 |
| Week 96 | -15.3 ± 9.27 | -14.7 ± 9.48 | -16.6 ± 6.79 |
| Week 108 | -15.2 ± 8.72 | -15.2 ± 10.17 | -16.6 ± 6.96 |
| Week 120 | -15.6 ± 8.77 | -14.8 ± 9.06 | -17.5 ± 7.15 |
| Week 132 | -15.7 ± 9.23 | -14.6 ± 9.79 | -17.3 ± 7.11 |
| Week 144 | -15.9 ± 9.03 | -15.3 ± 9.81 | -18.6 ± 7.17 |
| Week 156 | -16.1 ± 9.74 | -15.5 ± 9.53 | -17.5 ± 7.89 |
| Week 168 | -16.9 ± 11.11 | -15.8 ± 10.51 | -20.0 ± 9.94 |
| Week 180 | -16.6 ± 10.67 | -16.2 ± 10.61 | -20.0 ± 9.91 |
| Week 192 | -16.4 ± 9.87 | -15.8 ± 9.23 | -20.7 ± 10.08 |
| Week 204 | -16.7 ± 10.60 | -15.9 ± 9.53 | -19.6 ± 10.22 |
| Week 216 | -16.6 ± 10.29 | -16.1 ± 8.86 | -20.4 ± 10.12 |
| Week 228 | -16.2 ± 9.51 | -17.3 ± 10.79 | -19.8 ± 10.16 |
| Week 240 | -16.8 ± 10.41 | -17.0 ± 10.43 | -18.8 ± 7.86 |
| Week 252 | -16.8 ± 10.63 | -16.9 ± 9.37 | -18.1 ± 7.78 |
| Week 264 | -17.7 ± 11.38 | -16.1 ± 8.72 | -18.3 ± 7.55 |
| Week 276 | -17.8 ± 11.35 | -17.0 ± 10.60 | -18.9 ± 7.74 |
| Week 288 | -17.4 ± 11.28 | -17.8 ± 11.76 | -18.7 ± 7.67 |
| Week 300 | -16.7 ± 10.21 | -17.1 ± 10.31 | -19.3 ± 7.72 |
| Week 312 | -16.7 ± 9.71 | -17.4 ± 10.41 | -18.6 ± 7.51 |
The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -46.8 ± 20.58 | -35.5 ± 21.53 | -38.4 ± 24.08 |
| Week 12 | -48.9 ± 20.45 | -39.1 ± 22.99 | -37.5 ± 21.78 |
| Week 24 | -51.2 ± 18.71 | -42.5 ± 21.24 | -40.9 ± 22.79 |
| Week 36 | -51.6 ± 19.08 | -42.7 ± 20.96 | -39.5 ± 24.20 |
| Week 48 | -52.8 ± 19.12 | -45.6 ± 19.29 | -40.6 ± 20.97 |
| Week 60 | -54.2 ± 16.44 | -47.1 ± 19.64 | -44.7 ± 24.33 |
| Week 72 | -53.4 ± 17.46 | -45.9 ± 18.58 | -47.2 ± 18.47 |
| Week 84 | -54.3 ± 16.44 | -43.4 ± 21.41 | -48.5 ± 17.25 |
| Week 96 | -52.3 ± 17.69 | -45.7 ± 20.42 | -46.8 ± 20.97 |
| Week 108 | -55.5 ± 16.72 | -45.9 ± 18.75 | -47.4 ± 21.09 |
| Week 120 | -55.9 ± 16.38 | -48.6 ± 18.23 | -50.1 ± 21.51 |
| Week 132 | -56.1 ± 16.60 | -50.1 ± 17.19 | -52.5 ± 20.62 |
| Week 144 | -56.7 ± 15.79 | -48.2 ± 18.28 | -51.4 ± 19.66 |
| Week 156 | -57.0 ± 16.90 | -48.9 ± 18.89 | -52.4 ± 19.49 |
| Week 168 | -57.0 ± 15.94 | -51.9 ± 20.24 | -55.6 ± 21.25 |
| Week 180 | -57.2 ± 17.11 | -53.0 ± 18.04 | -53.1 ± 19.34 |
| Week 192 | -56.3 ± 17.25 | -52.1 ± 16.56 | -55.1 ± 20.69 |
| Week 204 | -58.0 ± 16.73 | -52.9 ± 18.09 | -54.7 ± 19.50 |
| Week 216 | -58.3 ± 16.50 | -50.8 ± 18.27 | -51.3 ± 20.42 |
| Week 228 | -56.3 ± 19.63 | -53.2 ± 17.28 | -55.0 ± 19.69 |
| Week 240 | -58.1 ± 17.63 | -52.8 ± 16.04 | -49.6 ± 18.67 |
| Week 252 | -57.2 ± 17.56 | -53.9 ± 17.10 | -52.2 ± 18.12 |
| Week 264 | -56.5 ± 16.68 | -50.4 ± 18.09 | -46.4 ± 18.60 |
| Week 276 | -56.9 ± 16.79 | -53.5 ± 17.07 | -50.1 ± 17.96 |
| Week 288 | -57.3 ± 18.97 | -56.3 ± 17.25 | -49.4 ± 16.31 |
| Week 300 | -56.8 ± 17.93 | -52.9 ± 17.33 | -53.6 ± 17.36 |
| Week 312 | -58.7 ± 16.12 | -55.2 ± 17.19 | -49.4 ± 17.96 |
The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -35.4 ± 29.83 | -27.2 ± 27.74 | -26.1 ± 27.46 |
| Week 12 | -37.5 ± 29.00 | -29.2 ± 28.05 | -31.3 ± 23.13 |
| Week 24 | -36.9 ± 28.97 | -30.4 ± 31.16 | -32.9 ± 25.63 |
| Week 36 | -37.1 ± 30.36 | -32.6 ± 28.62 | -34.9 ± 26.00 |
| Week 48 | -39.2 ± 30.36 | -30.7 ± 30.46 | -23.6 ± 26.58 |
| Week 60 | -40.8 ± 28.95 | -34.4 ± 28.36 | -38.3 ± 24.46 |
| Week 72 | -40.3 ± 27.36 | -32.1 ± 30.19 | -26.3 ± 30.70 |
| Week 84 | -40.1 ± 30.37 | -32.0 ± 31.27 | -39.4 ± 21.35 |
| Week 96 | -38.1 ± 30.34 | -33.5 ± 33.51 | -33.5 ± 22.08 |
| Week 108 | -40.8 ± 29.75 | -35.0 ± 29.93 | -32.1 ± 20.65 |
| Week 120 | -40.6 ± 29.76 | -32.4 ± 32.91 | -36.6 ± 28.02 |
| Week 132 | -40.1 ± 29.99 | -37.0 ± 28.43 | -38.4 ± 27.02 |
| Week 144 | -37.7 ± 30.73 | -36.8 ± 28.24 | -33.9 ± 29.68 |
| Week 156 | -39.7 ± 32.65 | -36.9 ± 25.93 | -38.6 ± 21.61 |
| Week 168 | -42.7 ± 29.04 | -37.9 ± 29.10 | -39.0 ± 32.84 |
| Week 180 | -40.3 ± 29.52 | -30.7 ± 33.34 | -33.3 ± 34.03 |
| Week 192 | -41.0 ± 28.73 | -33.4 ± 33.30 | -42.1 ± 23.97 |
| Week 204 | -42.0 ± 29.28 | -33.2 ± 34.00 | -43.7 ± 25.60 |
| Week 216 | -39.0 ± 32.18 | -32.5 ± 30.72 | -35.6 ± 27.03 |
| Week 228 | -38.4 ± 32.29 | -28.5 ± 37.86 | -40.1 ± 24.11 |
| Week 240 | -41.9 ± 30.43 | -37.6 ± 28.56 | -33.3 ± 29.03 |
| Week 252 | -40.6 ± 32.12 | -33.8 ± 31.76 | -33.5 ± 35.96 |
| Week 264 | -38.5 ± 31.53 | -31.6 ± 34.26 | -32.7 ± 34.87 |
| Week 276 | -42.4 ± 27.53 | -36.8 ± 29.40 | -26.0 ± 33.79 |
| Week 288 | -43.3 ± 27.99 | -38.5 ± 32.21 | -32.2 ± 28.16 |
| Week 300 | -38.8 ± 29.04 | -33.4 ± 34.89 | -31.6 ± 25.93 |
| Week 312 | -36.5 ± 32.10 | -39.4 ± 30.60 | -37.7 ± 29.67 |
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -38.5 ± 27.16 | -29.9 ± 24.46 | -30.0 ± 26.37 |
| Week 12 | -41.3 ± 26.07 | -29.9 ± 26.20 | -31.9 ± 20.23 |
| Week 24 | -42.2 ± 25.41 | -30.9 ± 28.77 | -36.0 ± 21.73 |
| Week 36 | -40.6 ± 26.41 | -34.6 ± 26.56 | -34.8 ± 21.83 |
| Week 48 | -42.4 ± 26.50 | -31.9 ± 28.73 | -32.6 ± 23.67 |
| Week 60 | -41.9 ± 27.89 | -32.2 ± 26.50 | -38.6 ± 23.34 |
| Week 72 | -42.5 ± 24.76 | -32.0 ± 25.38 | -31.4 ± 22.95 |
| Week 84 | -42.1 ± 25.87 | -33.3 ± 26.52 | -43.0 ± 20.51 |
| Week 96 | -40.5 ± 28.02 | -34.2 ± 26.14 | -37.6 ± 20.15 |
| Week 108 | -43.6 ± 26.28 | -33.9 ± 27.60 | -36.3 ± 23.12 |
| Week 120 | -43.0 ± 26.67 | -36.2 ± 27.69 | -41.9 ± 21.40 |
| Week 132 | -42.2 ± 26.89 | -36.7 ± 26.71 | -34.4 ± 27.27 |
| Week 144 | -41.7 ± 27.02 | -36.7 ± 27.14 | -33.8 ± 24.60 |
| Week 156 | -43.5 ± 25.72 | -37.4 ± 25.27 | -34.6 ± 24.91 |
| Week 168 | -43.6 ± 27.19 | -38.8 ± 27.67 | -41.6 ± 25.76 |
| Week 180 | -42.7 ± 26.54 | -33.6 ± 30.24 | -36.5 ± 29.20 |
| Week 192 | -41.6 ± 27.90 | -33.8 ± 29.13 | -39.9 ± 25.44 |
| Week 204 | -44.4 ± 25.26 | -33.4 ± 33.05 | -41.9 ± 22.39 |
| Week 216 | -42.2 ± 28.01 | -32.5 ± 32.06 | -33.6 ± 25.98 |
| Week 228 | -45.1 ± 24.96 | -29.6 ± 35.17 | -39.8 ± 24.70 |
| Week 240 | -43.4 ± 27.78 | -34.1 ± 31.98 | -36.1 ± 25.38 |
| Week 252 | -44.4 ± 27.49 | -34.3 ± 28.12 | -38.3 ± 24.92 |
| Week 264 | -44.0 ± 25.43 | -35.6 ± 31.33 | -38.2 ± 24.11 |
| Week 276 | -46.3 ± 24.53 | -35.6 ± 27.39 | -34.1 ± 26.80 |
| Week 288 | -46.2 ± 25.61 | -37.6 ± 28.74 | -33.3 ± 23.30 |
| Week 300 | -43.0 ± 25.18 | -34.7 ± 32.36 | -29.9 ± 30.21 |
| Week 312 | -44.1 ± 25.87 | -40.3 ± 27.37 | -33.4 ± 30.11 |
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -0.7 ± 0.62 | -0.6 ± 0.56 | -0.6 ± 0.47 |
| Week 12 | -0.7 ± 0.64 | -0.6 ± 0.63 | -0.7 ± 0.55 |
| Week 24 | -0.8 ± 0.60 | -0.6 ± 0.61 | -0.7 ± 0.58 |
| Week 36 | -0.7 ± 0.66 | -0.6 ± 0.62 | -0.7 ± 0.66 |
| Week 48 | -0.8 ± 0.63 | -0.7 ± 0.61 | -0.7 ± 0.58 |
| Week 60 | -0.8 ± 0.67 | -0.7 ± 0.66 | -0.7 ± 0.52 |
| Week 72 | -0.8 ± 0.65 | -0.7 ± 0.63 | -0.7 ± 0.54 |
| Week 84 | -0.9 ± 0.62 | -0.7 ± 0.64 | -0.7 ± 0.57 |
| Week 96 | -0.8 ± 0.64 | -0.8 ± 0.69 | -0.8 ± 0.52 |
| Week 108 | -0.9 ± 0.67 | -0.7 ± 0.67 | -0.7 ± 0.58 |
| Week 120 | -0.8 ± 0.64 | -0.7 ± 0.64 | -0.8 ± 0.62 |
| Week 132 | -0.9 ± 0.66 | -0.7 ± 0.64 | -0.8 ± 0.51 |
| Week 144 | -0.8 ± 0.72 | -0.8 ± 0.68 | -0.7 ± 0.61 |
| Week 156 | -0.8 ± 0.69 | -0.7 ± 0.57 | -0.8 ± 0.61 |
| Week 168 | -0.8 ± 0.68 | -0.7 ± 0.67 | -0.8 ± 0.60 |
| Week 180 | -0.8 ± 0.70 | -0.7 ± 0.70 | -0.7 ± 0.64 |
| Week 192 | -0.8 ± 0.68 | -0.7 ± 0.69 | -0.8 ± 0.57 |
| Week 204 | -0.9 ± 0.68 | -0.7 ± 0.79 | -0.8 ± 0.51 |
| Week 216 | -0.8 ± 0.69 | -0.7 ± 0.73 | -0.8 ± 0.61 |
| Week 228 | -0.9 ± 0.72 | -0.7 ± 0.77 | -0.7 ± 0.61 |
| Week 240 | -0.8 ± 0.69 | -0.7 ± 0.77 | -0.6 ± 0.61 |
| Week 252 | -0.9 ± 0.69 | -0.7 ± 0.77 | -0.7 ± 0.59 |
| Week 264 | -0.8 ± 0.68 | -0.7 ± 0.65 | -0.7 ± 0.59 |
| Week 276 | -0.8 ± 0.69 | -0.6 ± 0.66 | -0.7 ± 0.61 |
| Week 288 | -0.9 ± 0.70 | -0.7 ± 0.74 | -0.8 ± 0.61 |
| Week 300 | -0.8 ± 0.76 | -0.7 ± 0.70 | -0.7 ± 0.68 |
| Week 312 | -0.8 ± 0.71 | -0.8 ± 0.74 | -0.7 ± 0.69 |
| mg/L | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -7.9 ± 21.74 | -10.0 ± 21.95 | -13.0 ± 29.00 |
| Week 12 | -9.0 ± 18.96 | -10.7 ± 20.94 | -12.8 ± 26.93 |
| Week 24 | -9.4 ± 17.38 | -7.2 ± 36.97 | -9.1 ± 29.38 |
| Week 36 | -9.5 ± 18.62 | -11.1 ± 22.03 | -13.5 ± 28.34 |
| Week 48 | -8.8 ± 17.50 | -10.2 ± 22.28 | -13.3 ± 22.69 |
| Week 60 | -9.6 ± 17.78 | -10.3 ± 22.10 | -11.0 ± 21.62 |
| Week 72 | -9.2 ± 19.42 | -9.9 ± 22.95 | -11.2 ± 20.16 |
| Week 84 | -8.3 ± 24.66 | -10.0 ± 28.56 | -10.2 ± 16.57 |
| Week 96 | -10.1 ± 17.74 | -10.3 ± 22.36 | -11.1 ± 17.61 |
| Week 108 | -9.8 ± 21.56 | -10.7 ± 19.36 | -10.8 ± 17.39 |
| Week 120 | -8.4 ± 18.27 | -10.9 ± 19.63 | -9.2 ± 18.62 |
| Week 132 | -8.9 ± 15.19 | -9.0 ± 21.32 | -9.3 ± 17.53 |
| Week 144 | -7.3 ± 17.15 | -9.9 ± 23.45 | -5.9 ± 26.82 |
| Week 156 | -8.6 ± 16.60 | -6.0 ± 52.17 | -10.9 ± 18.20 |
| Week 168 | -7.7 ± 18.37 | -7.5 ± 28.96 | -8.8 ± 17.88 |
| Week 180 | -10.0 ± 19.41 | -10.3 ± 21.44 | -9.2 ± 19.16 |
| Week 192 | -9.4 ± 23.81 | -9.9 ± 21.04 | -9.3 ± 20.07 |
| Week 204 | -8.4 ± 28.90 | -9.6 ± 21.29 | -9.0 ± 19.07 |
| Week 216 | -11.5 ± 20.22 | -10.0 ± 22.42 | -8.4 ± 19.70 |
| Week 228 | -11.0 ± 20.71 | -12.2 ± 20.89 | -10.0 ± 17.46 |
| Week 240 | -10.6 ± 24.45 | -9.1 ± 22.38 | -9.2 ± 17.55 |
| Week 252 | -10.4 ± 19.33 | -9.4 ± 24.28 | -9.9 ± 18.83 |
| Week 264 | -11.2 ± 21.02 | -9.9 ± 23.99 | -11.1 ± 18.19 |
| Week 276 | -10.5 ± 18.04 | -11.2 ± 20.20 | -10.9 ± 17.95 |
| Week 288 | -10.6 ± 16.09 | -12.9 ± 21.85 | -7.5 ± 14.48 |
| Week 300 | -11.1 ± 14.63 | -11.4 ± 21.67 | -11.0 ± 19.69 |
| Week 312 | -10.3 ± 22.22 | -12.0 ± 21.14 | -8.7 ± 15.19 |
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 9.5 ± 10.50 | 9.0 ± 9.69 | 8.8 ± 9.26 |
| Week 12 | 9.9 ± 10.49 | 8.7 ± 10.87 | 8.6 ± 10.43 |
| Week 24 | 10.7 ± 10.04 | 10.6 ± 11.60 | 8.3 ± 9.65 |
| Week 36 | 10.1 ± 10.59 | 10.0 ± 11.58 | 8.0 ± 11.50 |
| Week 48 | 10.4 ± 10.58 | 10.8 ± 10.44 | 8.4 ± 10.83 |
| Week 72 | 10.8 ± 9.55 | 10.9 ± 10.64 | 9.2 ± 11.44 |
| Week 96 | 10.3 ± 10.45 | 11.7 ± 12.72 | 9.5 ± 11.27 |
| Week 108 | 10.5 ± 10.49 | 11.9 ± 12.08 | 7.9 ± 10.62 |
| Week 120 | 11.0 ± 10.76 | 11.6 ± 11.95 | 10.7 ± 11.30 |
| Week 132 | 11.4 ± 10.13 | 10.7 ± 11.47 | 10.7 ± 10.36 |
| Week 144 | 9.9 ± 11.36 | 11.2 ± 12.09 | 9.8 ± 11.67 |
| Week 156 | 10.6 ± 10.94 | 11.2 ± 11.48 | 8.6 ± 12.32 |
| Week 168 | 10.8 ± 12.27 | 10.6 ± 12.46 | 11.4 ± 13.18 |
| Week 180 | 11.0 ± 11.59 | 9.6 ± 13.56 | 11.4 ± 12.45 |
| Week 192 | 10.8 ± 10.50 | 10.9 ± 11.82 | 11.5 ± 13.27 |
| Week 204 | 11.3 ± 10.56 | 10.2 ± 13.01 | 11.2 ± 12.70 |
| Week 216 | 11.4 ± 11.93 | 10.4 ± 13.92 | 10.1 ± 12.87 |
| Week 228 | 11.0 ± 11.25 | 10.8 ± 14.00 | 11.1 ± 13.18 |
| Week 240 | 11.9 ± 10.93 | 11.4 ± 13.08 | 9.2 ± 13.81 |
| Week 252 | 11.5 ± 10.83 | 10.2 ± 13.68 | 8.4 ± 13.48 |
| Week 264 | 11.6 ± 10.95 | 10.7 ± 12.52 | 7.8 ± 13.94 |
| Week 276 | 12.1 ± 10.98 | 9.2 ± 13.02 | 7.3 ± 13.02 |
| Week 288 | 11.6 ± 10.88 | 12.3 ± 11.83 | 9.0 ± 13.94 |
| Week 300 | 11.1 ± 11.14 | 9.7 ± 13.12 | 7.0 ± 13.46 |
| Week 312 | 10.7 ± 11.24 | 11.6 ± 12.67 | 8.6 ± 14.35 |
RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk, scores between 10 and 17 indicate medium risk, and scores \> 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | -6.2 ± 5.55 | -3.3 ± 5.51 | -4.1 ± 3.00 |
| Week 12 | -6.6 ± 6.16 | -4.0 ± 6.32 | -4.2 ± 3.35 |
| Week 24 | -7.0 ± 6.51 | -4.6 ± 6.63 | -3.6 ± 3.53 |
| Week 36 | -6.8 ± 6.29 | -4.6 ± 6.21 | -3.3 ± 6.18 |
| Week 48 | -6.8 ± 5.94 | -5.0 ± 6.47 | -3.5 ± 4.98 |
| Week 72 | -7.5 ± 6.83 | -4.8 ± 6.27 | -4.3 ± 4.10 |
| Week 96 | -6.5 ± 6.72 | -6.3 ± 7.55 | -4.0 ± 4.18 |
| Week 108 | -6.8 ± 6.80 | -6.5 ± 6.71 | -3.5 ± 4.80 |
| Week 120 | -7.6 ± 6.66 | -5.1 ± 7.38 | -5.7 ± 4.44 |
| Week 132 | -7.2 ± 6.04 | -5.6 ± 6.99 | -4.7 ± 3.47 |
| Week 144 | -5.9 ± 6.51 | -5.6 ± 7.65 | -4.3 ± 3.41 |
| Week 156 | -6.2 ± 7.13 | -4.3 ± 7.62 | -4.9 ± 3.72 |
| Week 168 | -5.8 ± 6.01 | -4.3 ± 6.96 | -5.1 ± 6.69 |
| Week 180 | -5.3 ± 6.61 | -3.5 ± 7.03 | -4.2 ± 3.19 |
| Week 192 | -5.5 ± 6.42 | -3.5 ± 7.36 | -4.3 ± 2.93 |
| Week 204 | -6.4 ± 7.06 | -3.7 ± 7.52 | -5.0 ± 3.78 |
| Week 216 | -6.0 ± 7.55 | -3.4 ± 7.11 | -5.0 ± 2.92 |
| Week 228 | -6.5 ± 7.16 | -1.9 ± 7.55 | -4.6 ± 4.24 |
| Week 240 | -5.9 ± 7.05 | -3.1 ± 7.61 | -4.5 ± 4.09 |
| Week 252 | -5.8 ± 6.43 | -2.0 ± 8.05 | -5.0 ± 3.70 |
| Week 264 | -5.0 ± 6.53 | -3.4 ± 8.00 | -4.5 ± 3.89 |
| Week 276 | -5.0 ± 6.74 | -2.7 ± 8.27 | -5.0 ± 2.52 |
| Week 288 | -5.0 ± 7.05 | -4.8 ± 7.38 | -4.8 ± 3.45 |
| Week 300 | -4.6 ± 7.23 | -4.3 ± 8.51 | -4.6 ± 4.07 |
| Week 312 | -4.2 ± 7.00 | -3.9 ± 8.37 | -2.9 ± 4.45 |
The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 0.2 ± 0.24 | 0.2 ± 0.27 | 0.2 ± 0.18 |
| Week 12 | 0.2 ± 0.23 | 0.2 ± 0.29 | 0.2 ± 0.14 |
| Week 24 | 0.2 ± 0.23 | 0.2 ± 0.28 | 0.2 ± 0.16 |
| Week 36 | 0.2 ± 0.24 | 0.2 ± 0.27 | 0.2 ± 0.16 |
| Week 48 | 0.2 ± 0.25 | 0.2 ± 0.31 | 0.1 ± 0.20 |
| Week 72 | 0.2 ± 0.24 | 0.2 ± 0.28 | 0.2 ± 0.16 |
| Week 96 | 0.2 ± 0.25 | 0.2 ± 0.28 | 0.2 ± 0.15 |
| Week 108 | 0.2 ± 0.26 | 0.2 ± 0.28 | 0.1 ± 0.16 |
| Week 120 | 0.2 ± 0.26 | 0.2 ± 0.27 | 0.2 ± 0.16 |
| Week 132 | 0.2 ± 0.25 | 0.2 ± 0.26 | 0.2 ± 0.15 |
| Week 144 | 0.2 ± 0.28 | 0.2 ± 0.27 | 0.2 ± 0.17 |
| Week 156 | 0.2 ± 0.27 | 0.2 ± 0.26 | 0.1 ± 0.18 |
| Week 168 | 0.2 ± 0.29 | 0.2 ± 0.28 | 0.2 ± 0.20 |
| Week 180 | 0.2 ± 0.27 | 0.2 ± 0.33 | 0.2 ± 0.20 |
| Week 192 | 0.2 ± 0.27 | 0.2 ± 0.27 | 0.2 ± 0.20 |
| Week 204 | 0.2 ± 0.27 | 0.2 ± 0.31 | 0.2 ± 0.21 |
| Week 216 | 0.2 ± 0.29 | 0.2 ± 0.30 | 0.2 ± 0.18 |
| Week 228 | 0.2 ± 0.26 | 0.2 ± 0.31 | 0.1 ± 0.22 |
| Week 240 | 0.3 ± 0.29 | 0.2 ± 0.26 | 0.1 ± 0.22 |
| Week 252 | 0.2 ± 0.26 | 0.2 ± 0.28 | 0.2 ± 0.22 |
| Week 264 | 0.3 ± 0.29 | 0.2 ± 0.25 | 0.1 ± 0.23 |
| Week 276 | 0.2 ± 0.30 | 0.2 ± 0.26 | 0.1 ± 0.22 |
| Week 288 | 0.3 ± 0.27 | 0.2 ± 0.27 | 0.1 ± 0.23 |
| Week 300 | 0.2 ± 0.28 | 0.2 ± 0.27 | 0.1 ± 0.19 |
| Week 312 | 0.2 ± 0.29 | 0.2 ± 0.26 | 0.1 ± 0.25 |
The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement.
| score on a scale | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down |
|---|---|---|---|
| Week 6 | 23.7 ± 25.21 | 14.4 ± 24.94 | 21.6 ± 20.49 |
| Week 12 | 26.0 ± 25.62 | 15.9 ± 25.83 | 19.4 ± 25.07 |
| Week 24 | 27.5 ± 25.24 | 16.8 ± 27.31 | 20.7 ± 20.67 |
| Week 36 | 27.0 ± 26.29 | 18.6 ± 27.10 | 18.6 ± 21.05 |
| Week 48 | 25.9 ± 26.87 | 19.1 ± 28.61 | 19.7 ± 21.07 |
| Week 72 | 28.0 ± 24.36 | 21.9 ± 26.33 | 26.7 ± 21.43 |
| Week 96 | 27.5 ± 26.86 | 22.4 ± 27.73 | 25.4 ± 19.25 |
| Week 108 | 28.8 ± 25.72 | 23.2 ± 25.81 | 20.5 ± 19.06 |
| Week 120 | 28.4 ± 27.22 | 23.7 ± 25.36 | 27.2 ± 23.54 |
| Week 132 | 26.3 ± 28.75 | 23.5 ± 26.23 | 28.1 ± 19.62 |
| Week 144 | 28.6 ± 26.71 | 23.5 ± 24.29 | 24.7 ± 25.32 |
| Week 156 | 29.9 ± 25.48 | 22.5 ± 24.62 | 22.1 ± 23.52 |
| Week 168 | 30.3 ± 25.29 | 22.6 ± 23.74 | 28.1 ± 24.06 |
| Week 180 | 30.0 ± 24.30 | 22.0 ± 27.24 | 27.0 ± 21.68 |
| Week 192 | 29.7 ± 24.65 | 23.6 ± 26.41 | 30.8 ± 21.96 |
| Week 204 | 32.0 ± 24.41 | 23.1 ± 27.13 | 30.7 ± 22.99 |
| Week 216 | 30.0 ± 26.93 | 24.0 ± 26.40 | 28.0 ± 21.73 |
| Week 228 | 31.6 ± 24.92 | 19.7 ± 26.70 | 29.5 ± 23.85 |
| Week 240 | 31.3 ± 26.18 | 21.9 ± 25.62 | 28.4 ± 26.55 |
| Week 252 | 31.2 ± 24.46 | 22.8 ± 26.74 | 25.6 ± 23.74 |
| Week 264 | 30.8 ± 25.30 | 22.2 ± 23.60 | 21.9 ± 24.81 |
| Week 276 | 32.4 ± 23.37 | 20.5 ± 25.68 | 25.4 ± 20.62 |
| Week 288 | 32.3 ± 24.66 | 24.6 ± 25.54 | 25.3 ± 22.57 |
| Week 300 | 30.5 ± 24.39 | 20.4 ± 27.31 | 23.6 ± 17.27 |
| Week 312 | 31.2 ± 25.15 | 25.8 ± 24.81 | 24.1 ± 25.18 |
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
| percentage of participants | Upadacitinib 15 mg + PCV-13 | Upadacitinib 30 mg + PCV-13 |
|---|---|---|
| Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination | 64.6 (54.0 to 75.1) | 54.5 (33.7 to 75.4) |
| fold-rise | Upadacitinib 15 mg + PCV-13 | Upadacitinib 30 mg + PCV-13 |
|---|---|---|
| Antigen 1: Week 4 | 7.90 (6.096 to 10.244) | 6.53 (3.985 to 10.684) |
| Antigen 1: Week 12 | 8.07 (6.158 to 10.567) | 6.54 (3.922 to 10.911) |
| Antigen 3: Week 4 | 2.59 (2.088 to 3.205) | 2.30 (1.530 to 3.467) |
| Antigen 3: Week 12 | 2.26 (1.805 to 2.824) | 2.24 (1.464 to 3.431) |
| Antigen 4: Week 4 | 5.61 (4.279 to 7.362) | 3.82 (2.283 to 6.402) |
| Antigen 4: Week 12 | 5.17 (3.888 to 6.885) | 3.39 (1.970 to 5.826) |
| Antigen 5: Week 4 | 1.90 (1.521 to 2.366) | 1.60 (1.050 to 2.431) |
| Antigen 5: Week 12 | 1.84 (1.485 to 2.288) | 1.57 (1.043 to 2.367) |
| Antigen 6B: Week 4 | 4.50 (3.325 to 6.077) | 3.10 (1.748 to 5.511) |
| Antigen 6B: Week 12 | 3.90 (2.801 to 5.436) | 3.25 (1.732 to 6.092) |
| Antigen 7F: Week 4 | 3.58 (2.824 to 4.548) | 2.83 (1.797 to 4.446) |
| Antigen 7F: Week 12 | 3.30 (2.552 to 4.255) | 3.02 (1.856 to 4.897) |
| Antigen 9V: Week 4 | 5.69 (4.260 to 7.611) | 2.76 (1.588 to 4.794) |
| Antigen 9V: Week 12 | 6.18 (4.583 to 8.325) | 2.91 (1.649 to 5.138) |
| Antigen 14: Week 4 | 2.97 (2.373 to 3.723) | 2.42 (1.573 to 3.707) |
| Antigen 14: Week 12 | 2.84 (2.231 to 3.613) | 2.41 (1.524 to 3.804) |
| Antigen 18C: Week 4 | 4.52 (3.526 to 5.801) | 3.23 (2.009 to 5.179) |
| Antigen 18C: Week 12 | 4.42 (3.443 to 5.670) | 3.53 (2.201 to 5.666) |
| Antigen 19A: Week 4 | 1.47 (1.264 to 1.702) | 1.12 (0.844 to 1.485) |
| Antigen 19A: Week 12 | 1.44 (1.245 to 1.666) | 1.15 (0.876 to 1.521) |
| Antigen 19F: Week 4 | 2.27 (1.834 to 2.808) | 2.32 (1.549 to 3.476) |
| Antigen 19F: Week 12 | 2.17 (1.761 to 2.671) | 1.99 (1.344 to 2.958) |
| Antigen 23F: Week 4 | 4.32 (3.291 to 5.672) | 3.11 (1.855 to 5.218) |
| Antigen 23F: Week 12 | 4.06 (3.048 to 5.413) | 3.29 (1.908 to 5.666) |
Collected over From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Upadacitinib 6 mg BID/15 mg QD | 5/493 (1%) | 68/493 (13.8%) | 233/493 (47.3%) |
| Upadacitinib 12 mg BID/30 mg QD | 3/187 (1.6%) | 42/187 (22.5%) | 113/187 (60.4%) |
| Upadacitinib 6 mg BID/15 mg QD Post Down-titration | 0/38 (0%) | 5/38 (13.2%) | 23/38 (60.5%) |
| Event | Upadacitinib 6 mg BID/15 mg QD | Upadacitinib 12 mg BID/30 mg QD | Upadacitinib 6 mg BID/15 mg QD Post Down-titration |
|---|---|---|---|
| ANGINA UNSTABLECardiac disorders | 0/493 | 0/187 | 1/38 |
| COVID-19 PNEUMONIAInfections and infestations | 0/493 | 0/187 | 1/38 |
| POSTOPERATIVE WOUND INFECTIONInfections and infestations | 0/493 | 0/187 | 1/38 |
| MULTIPLE FRACTURESInjury, poisoning and procedural complications | 0/493 | 0/187 | 1/38 |
| MULTIPLE INJURIESInjury, poisoning and procedural complications | 0/493 | 0/187 | 1/38 |
| HYPONATRAEMIAMetabolism and nutrition disorders | 0/493 | 0/187 | 1/38 |
| RHEUMATOID ARTHRITISMusculoskeletal and connective tissue disorders | 1/493 | 0/187 | 1/38 |
| INVASIVE DUCTAL BREAST CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/493 | 0/187 | 1/38 |
| CELLULITISInfections and infestations | 1/493 | 3/187 | 0/38 |
| PNEUMONIAInfections and infestations | 7/493 | 3/187 | 0/38 |
| Event | Upadacitinib 6 mg BID/15 mg QD | Upadacitinib 12 mg BID/30 mg QD | Upadacitinib 6 mg BID/15 mg QD Post Down-titration |
|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 49/493 | 38/187 | 3/38 |
| BRONCHITISInfections and infestations | 42/493 | 14/187 | 6/38 |
| URINARY TRACT INFECTIONInfections and infestations | 47/493 | 28/187 | 3/38 |
| HERPES ZOSTERInfections and infestations | 22/493 | 21/187 | 3/38 |
| RHEUMATOID ARTHRITISMusculoskeletal and connective tissue disorders | 21/493 | 21/187 | 0/38 |
| HYPERTENSIONVascular disorders | 22/493 | 19/187 | 1/38 |
| NASOPHARYNGITISInfections and infestations | 47/493 | 16/187 | 3/38 |
| BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations | 34/493 | 17/187 | 3/38 |
| HYPERCHOLESTEROLAEMIAMetabolism and nutrition disorders | 29/493 | 17/187 | 3/38 |
| LOWER RESPIRATORY TRACT INFECTIONInfections and infestations | 1/493 | 1/187 | 3/38 |
The open-label treated population consisted of all participants who had received at least one dose of open-label study medication. Baseline data are from the Baseline of the preceding RCT study (M13-550 or M13-537).
| Age, Continuous(years) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Mean | 55.8 ± 12.62 | 56.0 ± 12.56 | 53.7 ± 8.54 | 55.7 ± 12.33 |
| Age, Customized(Participants) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| < 45 years | 56 | 30 | 5 | 91 |
| 45 - < 65 years | 174 | 76 | 28 | 278 |
| ≥ 65 years | 76 | 43 | 5 | 124 |
| Sex: Female, Male(Participants) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Female | 246 | 117 | 29 | 392 |
| Male | 60 | 32 | 9 | 101 |
| Ethnicity (NIH/OMB)(Participants) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Hispanic or Latino | 76 | 40 | 7 | 123 |
| Not Hispanic or Latino | 230 | 109 | 31 | 370 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| White | 293 | 132 | 37 | 462 |
| Black or African American | 9 | 12 | 1 | 22 |
| Asian | 1 | 2 | 0 | 3 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Multiple | 2 | 3 | 0 | 5 |
| Region(Participants) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Western Europe | 27 | 13 | 5 | 45 |
| Eastern Europe | 144 | 46 | 19 | 209 |
| North America | 90 | 78 | 10 | 178 |
| South/Central America | 42 | 5 | 3 | 50 |
| Other | 3 | 7 | 1 | 11 |
| Duration of RA(years) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Mean | 9.34 ± 8.73 | 9.61 ± 8.36 | 7.66 ± 6.54 | 9.29 ± 8.47 |
| Tender Joint Count(joints) | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Mean | 25.8 ± 14.49 | 30.4 ± 15.90 | 31.3 ± 15.67 | 27.6 ± 15.17 |
6 further baseline measures are reported on the registry.
Showing the first 100 of 124 sites across 18 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
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