Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis; Treatment Adherence and Compliance

• Registration Number: NCT04674085
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

The investigators aimed to present the efficacy and safety data for patients with RA who received tofacitinib therapy in outpatient clinics.

Detailed Description

This retrospective cohort study included 35 patients with rheumatoid arthritis who received tofacitinib therapy in rheumatology outpatient clinic between June 2015 and December 2019. Patients who received tofacitinib due to unresponsiveness to ≥2 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or ≥1 biological disease-modifying anti-rheumatic drugs (bDMARDs) were retrospectively evaluated. Demographic characteristics of the patients, the disease activity score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS 28-4 (ESR)), change in DAS-28, health assessment questionnaire score, visual analogue scale score, and laboratory parameters such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, hemogram, lipid parameters, and uric acid were recorded. The data at six months of treatment were compared with baseline data. The effects related to the treatment as well as the undesired consequences were evaluated.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-12
• Last Update Submitted: 2020-12-12
• Study First Posted: 2020-12-19
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients who received tofacitinib due to unresponsiveness to ≥2 csDMARDs and/or ≥1 bDMARDs were retrospectively evaluated.

Exclusion Criteria

Patients who could not tolerate the treatment and whose follow-up results could not be reached were excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluates the effects of tofacitinib therapy by measuring change in DAS 28-4 (ESR) and improvement in DAS-28	6 months	Clinical and laboratory parameters (DAS 28-4 (ESR), improvement in DAS-28) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.
Evaluates the effects of tofacitinib therapy by measuring change C-reactive protein (CRP) level	6 months	Laboratory parameters (C-reactive protein (CRP) level) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.
Evaluates the effects of tofacitinib therapy by measuring change uric asid	6 months	Laboratory parameters (uric asid) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.
Evaluates the effects of tofacitinib therapy by measuring change hemogram	6 months	Laboratory parameters (hemogram) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.
Evaluates the effects of tofacitinib therapy by measuring change lipid parameters	6 months	Laboratory parameters (lipid parameters , Total Cholesterol; LDL, Low-Density Lipoprotein; HDL, High-Density Lipoprotein; TG, triglyceride) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.
Evaluates the effects of tofacitinib therapy by measuring change in health assessment questionnaire score, visual analogue scale score	6 months	Clinical parameters (health assessment questionnaire score, visual analogue scale score) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.
Evaluates the effects of tofacitinib therapy by measuring change in erythrocyte sedimentation rate (ESR)	6 months	Laboratory parameters (erythrocyte sedimentation rate (ESR)) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.