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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Treatment Adherence and Compliance

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 Type: Observational
• Enrollment (Actual): 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retrospective cohort study

Description

Inclusion Criteria:

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

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Exclusion Criteria:

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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluates the effects of tofacitinib therapy by measuring change in DAS 28-4 (ESR) and improvement in DAS-28	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.	6 months
Evaluates the effects of tofacitinib therapy by measuring change in health assessment questionnaire score, visual analogue scale score	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.	6 months
Evaluates the effects of tofacitinib therapy by measuring change in erythrocyte sedimentation rate (ESR)	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.	6 months
Evaluates the effects of tofacitinib therapy by measuring change C-reactive protein (CRP) level	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.	6 months
Evaluates the effects of tofacitinib therapy by measuring change hemogram	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.	6 months
Evaluates the effects of tofacitinib therapy by measuring change lipid parameters	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.	6 months
Evaluates the effects of tofacitinib therapy by measuring change uric asid	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.	6 months

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; tofacitinib; disease activity
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Umraniye ERH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No