Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Non-intervention

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 19 years and older with moderately to severely active ulcerative colitis

Description

Inclusion Criteria:

• Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling

Exclusion Criteria:

• Patients meeting any of the following criteria as per local labeling will not be included in the study.

  1. Patients with a history of hypersensitivity to any ingredients of this product.
  2. Patients with serious infection (sepsis, etc.) or active infection including localized infection.
  3. Patients with active tuberculosis.
  4. Patients with severe hepatic function disorder.
  5. Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3.
  6. Patients with a lymphocyte count <500 cells/mm3.
  7. Patients with a hemoglobin level <9 g/dL.
  8. Pregnant or possibly pregnant women.
  9. Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From first dose of Xeljanz until 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	From first dose of Xeljanz until 24 weeks

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Immune System Diseases; safety; Autoimmune Diseases; Ulcerative colitis; Tofacitinib; Molecular Mechanisms of Pharmacological Action; Jak inhibitor
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A3921343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.