Korean Post-marketing Surveillance for Xeljanz

Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients

The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

• Study Type: Observational
• Enrollment (Actual): 1041

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Gyeonggi-do, Korea, Republic of
    • Korea University Ansan Hospital
  • Busan, Korea, Republic of, 47392
    • Inje university busan paik hospital
  • Busan, Korea, Republic of, 607-702
    • Kosin university gospel hospital
  • Busan, Korea, Republic of, 612-896
    • Inje University Haeundae Paik Hospital
  • Chungcheongbuk-do, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center, Department of Rheumatology
  • Daejeon, Korea, Republic of, 302-799
    • Eulji University Hospital, Internal Medicine, Rheumatology
  • Giheung-gu, Yongin-si, Gyeonggi-do, Korea, Republic of
    • Yongin Severance Hospital
  • Goyang-si, Gyeonggi-do, Korea, Republic of
    • Inje University IlsanPaik Hospital
  • Gyeonggi-do, Korea, Republic of
    • Dongguk University Ilsan Medical Center
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Hospital
  • Incheon, Korea, Republic of
    • Division of Rheumatology
  • Jeju Special Self-Goverming Province, Korea, Republic of
    • Jeju National University Hospital
  • Metropolitan City, Daejeon, Korea, Republic of
    • Division of Rheumatology
  • Pusan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Dong-A University Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 130-872
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 139-711
    • Eulji Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Department of Internal Medicine
  • Seoul, Korea, Republic of, 133-792
    • Hanyang University Hospital, Department of Rheumatology
  • Seoul, Korea, Republic of, 04782
    • Hanyang Rheuma Uhm Wan-Sik Clinic
  • Seoul, Korea, Republic of, 07061
    • Division of Rheumatology, SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 134-890
    • Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center, Division of Rheumatology, Department of Medicine
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 140-887
    • Soonchunhyang University Hospital Seoul/Department of Rheumatology
  • Seoul, Korea, Republic of
    • Division of Rheumatology
  • Seoul, Korea, Republic of
    • Hallym University Kangnam Sacred Heart Hospital
  • Chonbuk
    • Chonju, Chonbuk, Korea, Republic of, 561-712
      • Chonbuk National University Hospital, Department of Rheumatology
  • Chungcheongnam-do
    • Chunan-si, Chungcheongnam-do, Korea, Republic of, 330-721
      • Soonchunhyang University Cheonan Hospital, Department of Rheumatology
  • Daegu
    • Jung-Gu, Daegu, Korea, Republic of, 700-712
      • Keimyung University Dongsan Medical Center
  • Daejon
    • Seo-gu, Daejon, Korea, Republic of, 35365
      • Kongyang University Hospital / Rheumatology
  • Deogyang-gu
    • Goyang-si, Deogyang-gu, Korea, Republic of, 10475
      • Myongji Hospital / Rheumatology
  • Gangdong-gu
    • Seoul, Gangdong-gu, Korea, Republic of, 05278
      • Kyung Hee University Hospital at Gangdong / Rheumatology
    • Seoul, Gangdong-gu, Korea, Republic of, 05367
      • VHS Medical Center / Rheumatologist
  • Gangwon-do
    • Chuncheon-si, Gangwon-do, Korea, Republic of, 24253
      • Hallym University Chuncheon Sacred Heart Hospital
  • Gwang JU
    • Dong Gu, Gwang JU, Korea, Republic of, 61453
      • Chosun University Hospital, Rheumatism Department
  • Gyeongg-do
    • Seongnam-si, Gyeongg-do, Korea, Republic of
      • Division of Rheumatology
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center
  • Gyeongsangnam-do
    • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital
    • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
      • Yangsan Hospital-Pusan National University
  • Jeonlabuk-do
    • Iksan, Jeonlabuk-do, Korea, Republic of, 570711
      • Wonkwang University Hospital / Division of Rheumatology
  • Kyeongki-do
    • Suwon-si, Kyeongki-do, Korea, Republic of, 442-712
      • Ajou University Hospital, Department of Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved

Description

Inclusion Criteria:

To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any ingredients of the product.
2. Patients with serious infection (eg, sepsis) 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) <500 cells/mm3.
6. Patients with a lymphocyte count <500 cells/mm3.
7. Patients with a hemoglobin concentration <8 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.

According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Duration of Adverse Events	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Severity	The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Outcome	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Seriousness Criteria	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included 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. Only participants with available seriousness assessment data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Causality to Xeljanz	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events According to Demographic Characteristics	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (<) 40 years, greater than or equal to (>=) 40 and < 50 years and >= 50 years and <60 years; >= 60 and <70 years; geriatric (>=65 years). Only participants with available demographic and AE assessment data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events According to Other Baseline Characteristics	Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population	An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.	From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in DAS28 (ESR)	DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate [ESR]) was calculated from: DAS28 (ESR) = 0.56*√(tender joint counter [TJC] 28) + 0.28*√(swollen joint count [SJC] 28) + 0.014*VAS+ 0.70*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Change From Baseline in DAS28 (CRP)	DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein [CRP]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With EULAR Response	European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline >1.2 and DAS28 based EULAR <=3.2 were good responders; participants with improvement in DAS28 from baseline >0.6 and <=1.2 and DAS28 based EULAR >3.2 and <=5.1 were moderate responders; participants with improvement in DAS28 from baseline <=0.6 and DAS28-based EULAR >5.1 were none responders.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6	ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Effectiveness	The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Effectiveness by Demographic Characteristics	The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis	The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.	From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)

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 13, 2016
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic
• Other Study ID Numbers: A3921249

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.