Korean Post-marketing Surveillance for Xeljanz XR

Study Overview
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Brief Summary
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Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the Regulation on Safety of Medicinal Products, etc. in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.

Official Title
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Korean Post-marketing Surveillance for Xeljanz XR (Registered)

Conditions
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Active Psoriatic Arthritis, Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Tofacitinib XR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Xeljanz® XR is administered according to indications on the approved labeling Treatment of moderate to severe active RA in adult patients (18 years of age or older) who have had an inadequate response or are intolerant to methotrexate In combination with methotrexate, treatment of active psoriatic arthritis (PsA) in adult patients (18 years of age or older) who have had an inadequate response or who have been intolerant to a prior DMARD therapy. Treatment of active ankylosing spondylitis (AS) in adult patients (18 years of age or older) who have responded inadequately to conventional therapy In the following patients, Xeljanz® XR should be used only for patients who have had an inadequate response or are intolerant to the existing treatment. A. Patients aged 65 or older B. Cardiovascular high-risk patients C. Patients at risk for malignancy Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz® XR, are also eligible for registration in the study Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: Patients with a history of hypersensitivity to any ingredients of this product. Patients with serious infection (sepsis, etc.) or active infection including localized infection. Patients with active tuberculosis. Patients with severe hepatic function disorder. Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3. * Patients with a lymphocyte count <500 cells/mm3. * Patients with a hemoglobin level <9 g/dL. * Pregnant or possibly pregnant women. * Do not initiate Xeljanz XR in the following cases: ANC; absolute neutrophil count <1,000 cells/mm3 ALC; absolute lymphocyte count <500 cells/mm3 Hemoglobin<9 g/dL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tofacitinib XR|Tofacitinib XR 11mg|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to end of this PMS after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Xeljanz XR was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Maximum of 52 weeks from the time of initial administration of Xeljanz XR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Disease Activity Score based on 28-joints Count (DAS28) | DAS28, a modified version of the original Disease Activity Score (DAS), is a quantitative measure of disease activity used to monitor the treatment of RA. | Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product | 
| Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria is used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. | Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product | 
| Number of Participants With an American College of Rheumatology 20% (ACR20) Response | ACR20 response: greater than or equal to (≥) 20 percent (%) 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 C-Reactive Protein (CRP). | Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product | 
| Assessment of Ankylosing Spondylitis response (ASAS20) | The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (BASFI), and Inflammation (last 2 questions of BASDAI). | Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product | 
| Changes from baseline in the number of tender joints and swollen joints | The number of tender joints and swollen joints, which are the specific components of the ACR20 response, are measured. The improvement from baseline after treatment is assessed. | Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product |