An observational study in Ulcerative Colitis, sponsored by Pfizer. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Pfizer · Observational
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.
This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (ie, investigators). The study population will be adult patients with moderately to severely active UC who have had an inadequate response or intolerance to the basic treatments or biological agents. Clinical Severity of Ulcerative Colitis is classified as mild, moderate, or severe based on the Mayo score or partial Mayo score. Xeljanz will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect patient data and record the information on each patient's case report form (CRF).
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 110 is below the median of 158 across 404 observational studies indexed under Colitis, Ulcerative.
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Adults aged 19 years and older with moderately to severely active ulcerative colitis
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Exclusion Criteria:
Patients meeting any of the following criteria as per local labeling will not be included in the study.
Non-intervention observational study
Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. Serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. 95% confidence interval (CI) was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users (i.e. treated with Xeljanz for at least 52 weeks).
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. A serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions
Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. SAE: any untoward medical occurrence in participant administered medicinal/nutritional product at any dose that resulted in death was life-threatening. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users
Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. SAE: any untoward medical occurrence in participant administered medicinal/nutritional product at any dose that resulted in death was life-threatening. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Percentage of Participants With Adverse Events of Special Interest
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events of Special Interest in Long Term Users
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Severity
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that interfered significantly with usual activities, or the clinical status and the medicinal product was stopped due to AE. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Severity in Long Term Users
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that interfered significantly with usual activities, or the clinical status and the medicinal product was stopped due to AE. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Outcomes
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Outcomes in Long Term Users
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Seriousness
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Seriousness in Long Term Users
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Action Taken
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Action taken with regard to the medicinal product included: permanently discontinued; temporarily discontinued or delayed; dose reduced; dose increased; no change; and not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Action Taken in Long Term Users
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Action taken with regard to the medicinal product included: permanently discontinued; temporarily discontinued or delayed; dose reduced; dose increased; no change; and not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Causality Assessment
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Causal relationship of AEs to the medicinal product was allocated by the investigator according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified, unassessible/unclassifiable, not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Causal relationship of AEs to the medicinal product was allocated by the investigator according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified, unassessible/unclassifiable, not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Other Causality Assessment
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events by their other causality assessment (in case of unlikely) were classified as: Disease under the study, Other diseases, Concomitant treatment medication or non-medication, and Other. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events by their other causality assessment (in case of unlikely) were classified as: Disease under the study, Other diseases, Concomitant treatment medication or non-medication, and Other. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure included only long term users. This outcome measure was analyzed only in long term users.
Time frame: From first dose of Xeljanz until 52 weeks
Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24
Mayo score (MS): measured disease activity (DA) of UC; total score range=0 to 12, higher score=severe DA. Mayo index was based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding, Endoscopy finding, Physician's global assessment(PGA).Each sub-score range=0 to 3,higher score=more severe DA.Stool frequency:0=normal number of stool, 1=1 to 2 stool/day \>normal, 2=3 to 4 stool/day \>normal, 3= \>4 stool/day \>normal; Rectal bleeding:0=None,1=Visible blood with stool less than half time, 2=Visible blood with stool\>half time, 3=Mostly blood with rare stool; Endoscopic finding:0=Normal/inactive, 1=Mild with erythema, decreased vascular pattern, mild friability, 2=Moderate with marked erythema, absent vascular pattern, friability, erosion, 3=Severe with spontaneous bleeding, ulceration, pseudopolyp; PGA: 0=Normal/inactive, 1=Mild, 2=Moderate, 3=severe Partial MS=sum of all evaluation criteria, except endoscopy finding.Partial MS score range=0 to 9;higher score=more severe DA.
Time frame: Baseline, Week 8, Week 16 and Week 24
Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
Mayo score (MS): measured disease activity (DA) of UC; total score range=0 to 12, higher score=severe DA. Mayo index was based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding, Endoscopy finding, Physician's global assessment (PGA). Each sub-score range=0 to 3,higher score=more severe DA. Stool frequency:0=normal number of stool, 1=1 to 2 stool/day \>normal, 2=3 to 4 stool/day \>normal, 3= \>4 stool/day \>normal; Rectal bleeding:0=None,1=Visible blood with stool less than half time, 2=Visible blood with stool\>half time, 3=Mostly blood with rare stool; Endoscopic finding:0=Normal/inactive, 1=Mild with erythema, decreased vascular pattern, mild friability, 2=Moderate with marked erythema, absent vascular pattern, friability, erosion, 3=Severe with spontaneous bleeding, ulceration, pseudopolyp; PGA: 0=Normal/inactive, 1=Mild, 2=Moderate, 3=severe. Partial MS=sum of all evaluation criteria, except endoscopy finding.Partial MS score range=0 to 9; higher score=more severe DA.
Time frame: Baseline, Week 8, Week 16, Week 24 and Week 52
Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24
Mucosal healing was defined by Mayo or partial Mayo endoscopic score of 0 or 1 where 0=Normal/inactive disease,1=Mild disease with erythema, decreased vascular pattern, mild friability.
Time frame: Week 8, Week 16 and Week 24
Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
Mucosal healing was defined by Mayo or partial Mayo endoscopic score of 0 or 1 where 0=Normal/inactive disease,1=Mild disease with erythema, decreased vascular pattern, mild friability.
Time frame: Week 8, Week 16, Week 24 and Week 52
Number of Participants With Remission at Week 8, Week 16 and Week 24
Clinical remission was defined as Mayo score being less than or equal to 2 or partial MS \<=1 and other sub-scores not more than 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
Time frame: Week 8, Week 16, and Week 24
Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
Clinical remission was defined as Mayo score being less than or equal to 2 or partial MS \<=1 and other sub-scores not more than 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
Time frame: Week 8, Week 16, Week 24 and Week 52
Number of Participants With Clinical Response at Week 8, Week 16 and Week 24
Clinical response was defined as Mayo score being greater than or equal to 3 point, 30% from baseline, decrease of 1 or more in Rectal bleeding score or rectal bleeding score of 0 or 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
Time frame: Week 8, Week 16 and Week 24
Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users
Clinical response was defined as Mayo score being greater than or equal to 3 point, 30% from baseline, decrease of 1 or more in Rectal bleeding score or rectal bleeding score of 0 or 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
Time frame: Week 8, Week 16, Week 24 and Week 52
Number of Participants According to Final Effectiveness Evaluation by Investigator
The final effectiveness evaluation was determined by the investigator into 4 categories ('Improved', 'Unchanged', 'Aggravated', 'Not assessible'). Improved: Symptoms of ulcerative colitis have improved or showed adequate maintenance effect after taking Xeljanz; Unchanged: Symptoms have not changed much since taking Xeljanz; Aggravated: Symptoms have worsened after taking Xeljanz; Not assessible.
Time frame: From first dose of Xeljanz until 24 weeks
Adult participants with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to basic treatments or biological agents and were prescribed Xeljanz (tofacitinib) for the first time as part of routine practice at Korean healthcare centers were observed in this post-marketing surveillance study.
| Milestone | Tofacitinib |
|---|---|
| Started | 110 |
| Safety population | 107 |
| Completed | 107 |
| Not completed | 3 |
| Withdrew: Protocol violation | 3 |
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. Serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. 95% confidence interval (CI) was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users (i.e. treated with Xeljanz for at least 52 weeks).
| Percentage of participants | Tofacitinib |
|---|---|
| Adverse events | 40.19 (30.82 to 50.11) |
| Adverse drug reactions | 24.30 (16.53 to 33.54) |
| Serious adverse events | 7.48 (3.28 to 14.20) |
| Serious adverse drug reactions | 0.93 (0.02 to 5.10) |
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. A serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Adverse events | 27 |
| Adverse drug reactions | 18 |
| Serious adverse events | 3 |
| Serious adverse drug reactions | 0 |
Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. SAE: any untoward medical occurrence in participant administered medicinal/nutritional product at any dose that resulted in death was life-threatening. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.
| Percentage of participants | Tofacitinib |
|---|---|
| Unexpected adverse events | 22.43 (14.93 to 31.51) |
| Unexpected adverse drug reactions | 12.15 (6.63 to 19.88) |
| Unexpected serious adverse events | 3.74 (1.03 to 9.30) |
| Unexpected serious adverse drug reactions | 0 (0 to 0) |
Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. SAE: any untoward medical occurrence in participant administered medicinal/nutritional product at any dose that resulted in death was life-threatening. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Unexpected adverse events | 13 |
| Unexpected adverse drug reactions | 9 |
| Unexpected serious adverse events | 1 |
| Unexpected serious adverse drug reactions | 0 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.
| Percentage of participants | Tofacitinib |
|---|---|
| Percentage of Participants With Adverse Events of Special Interest | 1.87 (0.23 to 6.59) |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Number of Participants With Adverse Events of Special Interest in Long Term Users | 2 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that interfered significantly with usual activities, or the clinical status and the medicinal product was stopped due to AE. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
| Participants | Tofacitinib |
|---|---|
| Mild | 35 |
| Moderate | 11 |
| Severe | 4 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that interfered significantly with usual activities, or the clinical status and the medicinal product was stopped due to AE. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Mild | 24 |
| Moderate | 4 |
| Severe | 1 |
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
| Participants | Tofacitinib |
|---|---|
| Recovered | 33 |
| Recovered with sequelae | 0 |
| Recovering | 13 |
| Not recovered | 6 |
| Unknown | 1 |
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Recovered | 21 |
| Recovered with sequelae | 0 |
| Recovering | 7 |
| Not recovered | 3 |
| Unknown | 1 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
| Participants | Tofacitinib |
|---|---|
| Results in death | 0 |
| Life-threatening | 0 |
| Requires inpatient hospitalization or prolongation of hospitalization | 8 |
| Results in persistent or significant disability/incapacity | 0 |
| Results in congenital anomaly/birth defect | 0 |
| Other important medical event | 0 |
| Non-Serious | 41 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Results in death | 0 |
| Is life-threatening | 0 |
| Requires inpatient hospitalization or prolongation of hospitalization. | 3 |
| Results in persistent or significant disability/incapacity | 0 |
| Results in congenital anomaly/birth defect | 0 |
| Other important medical event | 0 |
| Non-Serious | 26 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Action taken with regard to the medicinal product included: permanently discontinued; temporarily discontinued or delayed; dose reduced; dose increased; no change; and not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
| Participants | Tofacitinib |
|---|---|
| Permanently discontinued | 8 |
| Temporary discontinued or delayed | 2 |
| Dose reduced | 2 |
| Dose increased | 3 |
| No change | 35 |
| Not applicable | 1 |
An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Action taken with regard to the medicinal product included: permanently discontinued; temporarily discontinued or delayed; dose reduced; dose increased; no change; and not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Permanently discontinued | 0 |
| Temporary discontinued or delayed | 0 |
| Dose reduced | 1 |
| Dose increased | 2 |
| No change | 26 |
| Not applicable | 0 |
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Causal relationship of AEs to the medicinal product was allocated by the investigator according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified, unassessible/unclassifiable, not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
| Participants | Tofacitinib |
|---|---|
| Certain | 1 |
| Probable/likely | 0 |
| Possible | 9 |
| Unlikely | 22 |
| Conditional/ unclassified | 6 |
| Unassessible/ unclassifiable | 13 |
| Not applicable | 0 |
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Causal relationship of AEs to the medicinal product was allocated by the investigator according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified, unassessible/unclassifiable, not applicable. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Certain | 0 |
| Probable/likely | 0 |
| Possible | 4 |
| Unlikely | 11 |
| Conditional/unclassified | 5 |
| Unassessible/unclassifiable | 11 |
| Not applicable | 0 |
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events by their other causality assessment (in case of unlikely) were classified as: Disease under the study, Other diseases, Concomitant treatment medication or non-medication, and Other. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.
| Participants | Tofacitinib |
|---|---|
| Disease under the study | 13 |
| Other diseases | 5 |
| Concomitant treatment medication or non-medication | 2 |
| Other | 5 |
An AE was any untoward medical occurrence in a participant when administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events by their other causality assessment (in case of unlikely) were classified as: Disease under the study, Other diseases, Concomitant treatment medication or non-medication, and Other. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure included only long term users. This outcome measure was analyzed only in long term users.
| Participants | Tofacitinib |
|---|---|
| Disease under the study | 6 |
| Other diseases | 3 |
| Concomitant treatment medication or non-medication | 1 |
| Other | 2 |
Mayo score (MS): measured disease activity (DA) of UC; total score range=0 to 12, higher score=severe DA. Mayo index was based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding, Endoscopy finding, Physician's global assessment(PGA).Each sub-score range=0 to 3,higher score=more severe DA.Stool frequency:0=normal number of stool, 1=1 to 2 stool/day \>normal, 2=3 to 4 stool/day \>normal, 3= \>4 stool/day \>normal; Rectal bleeding:0=None,1=Visible blood with stool less than half time, 2=Visible blood with stool\>half time, 3=Mostly blood with rare stool; Endoscopic finding:0=Normal/inactive, 1=Mild with erythema, decreased vascular pattern, mild friability, 2=Moderate with marked erythema, absent vascular pattern, friability, erosion, 3=Severe with spontaneous bleeding, ulceration, pseudopolyp; PGA: 0=Normal/inactive, 1=Mild, 2=Moderate, 3=severe Partial MS=sum of all evaluation criteria, except endoscopy finding.Partial MS score range=0 to 9;higher score=more severe DA.
| Units on a scale | Tofacitinib |
|---|---|
| Stool frequency (Baseline) | 2.41 ± 0.70 |
| Rectal bleeding (Baseline) | 1.57 ± 0.84 |
| Physician's global assessment (Baseline) | 2.15 ± 0.62 |
| Finding of endoscopy (Baseline) | 2.56 ± 0.56 |
| Mayo score (Baseline) | 8.64 ± 1.56 |
| Partial Mayo score (Baseline) | 6.13 ± 1.40 |
| Stool frequency (Week 8) | 1.23 ± 1.12 |
| Rectal bleeding (Week 8) | 0.53 ± 0.74 |
| Physician's global assessment (Week 8) | 0.82 ± 0.87 |
| Finding of endoscopy (Week 8) | 1.14 ± 1.07 |
| Mayo score (Week 8) | 4.00 ± 3.56 |
| Partial Mayo score (Week 8) | 2.57 ± 2.28 |
| Stool frequency (Week 16) | 0.86 ± 0.96 |
| Rectal bleeding (Week 16) | 0.30 ± 0.57 |
| Physician's global assessment (Week 16) | 0.60 ± 0.74 |
| Finding of endoscopy (Week 16) | 1.44 ± 1.08 |
| Mayo score (Week 16) | 3.17 ± 2.67 |
| Partial Mayo score (Week 16) | 1.76 ± 1.91 |
| Stool frequency (Week 24) | 0.80 ± 0.92 |
| Rectal bleeding (Week 24) | 0.30 ± 0.56 |
| Physician's global assessment (Week 24) | 0.42 ± 0.59 |
| Finding of endoscopy (Week 24) | 0.50 ± 0.71 |
| Mayo score (Week 24) | 1.00 ± 1.41 |
| Partial Mayo score (Week 24) | 1.52 ± 1.71 |
Mayo score (MS): measured disease activity (DA) of UC; total score range=0 to 12, higher score=severe DA. Mayo index was based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding, Endoscopy finding, Physician's global assessment (PGA). Each sub-score range=0 to 3,higher score=more severe DA. Stool frequency:0=normal number of stool, 1=1 to 2 stool/day \>normal, 2=3 to 4 stool/day \>normal, 3= \>4 stool/day \>normal; Rectal bleeding:0=None,1=Visible blood with stool less than half time, 2=Visible blood with stool\>half time, 3=Mostly blood with rare stool; Endoscopic finding:0=Normal/inactive, 1=Mild with erythema, decreased vascular pattern, mild friability, 2=Moderate with marked erythema, absent vascular pattern, friability, erosion, 3=Severe with spontaneous bleeding, ulceration, pseudopolyp; PGA: 0=Normal/inactive, 1=Mild, 2=Moderate, 3=severe. Partial MS=sum of all evaluation criteria, except endoscopy finding.Partial MS score range=0 to 9; higher score=more severe DA.
| Units on a scale | Tofacitinib |
|---|---|
| Stool frequency (Baseline) | 2.38 ± 0.72 |
| Rectal bleeding (Baseline) | 1.48 ± 0.91 |
| Physician's global assessment (Baseline) | 2.08 ± 0.65 |
| Finding of endoscopy (Baseline) | 2.55 ± 0.57 |
| Mayo score (Baseline) | 8.5 ± 1.55 |
| Partial score (Baseline) | 5.95 ± 1.42 |
| Stool frequency (Week 8) | 0.96 ± 1.04 |
| Rectal bleeding (Week 8) | 0.43 ± 0.71 |
| Physician's global assessment (Week 8) | 0.65 ± 0.75 |
| Finding of endoscopy (Week 8) | 1.00 ± 0.00 |
| Mayo score (Week 8) | 3.50 ± 0.71 |
| Partial Mayo score (Week 8) | 2.04 ± 2.02 |
| Stool frequency (Week 16) | 0.59 ± 0.72 |
| Rectal bleeding (Week 16) | 0.22 ± 0.46 |
| Physician's global assessment (Week 16) | 0.47 ± 0.60 |
| Finding of endoscopy (Week 16) | 1.29 ± 1.05 |
| Mayo score (Week 16) | 2.37 ± 1.88 |
| Partial Mayo score (Week 16) | 1.29 ± 1.44 |
| Stool frequency (Week 24) | 0.70 ± 0.81 |
| Rectal bleeding (Week 24) | 0.23 ± 0.48 |
| Physician's global assessment (Week 24) | 0.38 ± 0.57 |
| Finding of endoscopy (Week 24) | 1.00 ± NA |
| Mayo score (Week 24) | 2.00 ± NA |
| Partial Mayo score (Week 24) | 1.32 ± 1.52 |
| Stool frequency (Week 52) | 0.74 ± 0.85 |
| Rectal bleeding (Week 52) | 0.18 ± 0.44 |
| Physician's global assessment (Week 52) | 0.56 ± 0.67 |
| Finding of endoscopy (Week 52) | 1.46 ± 1.33 |
| Mayo score (Week 52) | 3.54 ± 3.48 |
| Partial Mayo score (Week 52) | 1.48 ± 1.57 |
Mucosal healing was defined by Mayo or partial Mayo endoscopic score of 0 or 1 where 0=Normal/inactive disease,1=Mild disease with erythema, decreased vascular pattern, mild friability.
| Participants | Tofacitinib |
|---|---|
| Week 8 — Achieved | 5 |
| Week 8 — Not achieved | 2 |
| Week 16 — Achieved | 37 |
| Week 16 — Not achieved | 27 |
| Week 24 — Achieved | 2 |
| Week 24 — Not achieved | 0 |
Mucosal healing was defined by Mayo or partial Mayo endoscopic score of 0 or 1 where 0=Normal/inactive disease,1=Mild disease with erythema, decreased vascular pattern, mild friability.
| Participants | Tofacitinib |
|---|---|
| Week 8 — Achieved | 2 |
| Week 8 — Not achieved | 0 |
| Week 16 — Achieved | 25 |
| Week 16 — Not achieved | 16 |
| Week 24 — Achieved | 1 |
| Week 24 — Not achieved | 0 |
| Week 52 — Achieved | 6 |
| Week 52 — Not achieved | 7 |
Clinical remission was defined as Mayo score being less than or equal to 2 or partial MS \<=1 and other sub-scores not more than 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
| Participants | Tofacitinib |
|---|---|
| Week 8 — Achieved | 34 |
| Week 8 — Not achieved | 52 |
| Week 16 — Achieved | 42 |
| Week 16 — Not achieved | 49 |
| Week 24 — Achieved | 34 |
| Week 24 — Not achieved | 26 |
Clinical remission was defined as Mayo score being less than or equal to 2 or partial MS \<=1 and other sub-scores not more than 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
| Participants | Tofacitinib |
|---|---|
| Week 8 — Achieved | 23 |
| Week 8 — Not achieved | 25 |
| Week 16 — Achieved | 31 |
| Week 16 — Not achieved | 28 |
| Week 24 — Achieved | 29 |
| Week 24 — Not achieved | 18 |
| Week 52 — Achieved | 27 |
| Week 52 — Not achieved | 23 |
Clinical response was defined as Mayo score being greater than or equal to 3 point, 30% from baseline, decrease of 1 or more in Rectal bleeding score or rectal bleeding score of 0 or 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
| Participants | Tofacitinib |
|---|---|
| Week 8 — Achieved | 78 |
| Week 8 — Not achieved | 22 |
| Week 16 — Achieved | 88 |
| Week 16 — Not achieved | 12 |
| Week 24 — Achieved | 57 |
| Week 24 — Not achieved | 43 |
Clinical response was defined as Mayo score being greater than or equal to 3 point, 30% from baseline, decrease of 1 or more in Rectal bleeding score or rectal bleeding score of 0 or 1. Total MS score range=0-12, where higher score=severe DA. MS based on 4 clinical evaluation criteria: Stool frequency, Rectal bleeding (RB), Finding of endoscopy, PGA. Each sub score range=0 to 3,higher score=more severe DA. Partial MS= sum of all evaluation criteria, except endoscopy finding. Partial MS total score=0 to 9 where, higher score=more severe disease activity.
| Participants | Tofacitinib |
|---|---|
| Week 8 — Achieved | 45 |
| Week 8 — Not achieved | 15 |
| Week 16 — Achieved | 58 |
| Week 16 — Not achieved | 2 |
| Week 24 — Achieved | 46 |
| Week 24 — Not achieved | 14 |
| Week 52 — Achieved | 49 |
| Week 52 — Not achieved | 11 |
The final effectiveness evaluation was determined by the investigator into 4 categories ('Improved', 'Unchanged', 'Aggravated', 'Not assessible'). Improved: Symptoms of ulcerative colitis have improved or showed adequate maintenance effect after taking Xeljanz; Unchanged: Symptoms have not changed much since taking Xeljanz; Aggravated: Symptoms have worsened after taking Xeljanz; Not assessible.
| Participants | Tofacitinib |
|---|---|
| Effective, Improved | 90 |
| Not-effective, Unchanged | 9 |
| Not-effective, Aggravated | 2 |
| Not assessible | 0 |
Collected over From first dose of Xeljanz until 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib | 0/107 (0%) | 8/107 (7.5%) | 41/107 (38.3%) |
| Event | Tofacitinib |
|---|---|
| Colitis ulcerativeGastrointestinal disorders | 2/107 |
| Abdominal painGastrointestinal disorders | 1/107 |
| PouchitisGastrointestinal disorders | 1/107 |
| Drug ineffectiveGeneral disorders | 1/107 |
| Anal abscessInfections and infestations | 1/107 |
| COVID-19Infections and infestations | 1/107 |
| Cytomegalovirus colitisInfections and infestations | 1/107 |
| Event | Tofacitinib |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 7/107 |
| Colitis ulcerativeGastrointestinal disorders | 5/107 |
| HyperlipidaemiaMetabolism and nutrition disorders | 4/107 |
| PyrexiaGeneral disorders | 3/107 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/107 |
| HeadacheNervous system disorders | 3/107 |
| Aspartate aminotransferase increasedInvestigations | 2/107 |
| Blood cholesterol increasedInvestigations | 2/107 |
| RashSkin and subcutaneous tissue disorders | 2/107 |
| Abdominal painGastrointestinal disorders | 1/107 |
Safety analysis set included all participants registered for this study who were prescribed at least 1 dose of Xeljanz according to the local label and followed up for safety data.
| Age, Continuous(Years) | Tofacitinib |
|---|---|
| Mean | 40.83 ± 13.37 |
| Sex: Female, Male(Participants) | Tofacitinib |
|---|---|
| Female | 31 |
| Male | 76 |
| Race and Ethnicity Not Collected(Participants) | Tofacitinib |
|---|
Documents are hosted by the registry — open the source record to download them.
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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