Efficacy and Safety of Tofacitinib Compared to Cyclophosphamide in Early Diffuse Cutaneous Systemic Sclerosis: A Randomized Controlled Trial
Abstract
Objective: This study aims to determine the efficacy of tofacitinib in the treatment of early diffuse cutaneous systemic sclerosis. Materials and methods: This open-label randomized controlled clinical trial was conducted at the Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University, Dhaka. The trial was registered at ClinicalTrials.gov (identifier: NCT06044844). Consecutive sampling was used in this study. Forty-six patients were randomized to groups A and B using block randomization, with 23 patients in each group. In group A, tofacitinib (5 mg) was administered twice daily. Group B received cyclophosphamide (500 mg/m² monthly). Primary efficacy was assessed by the change in the Modified Rodnan Skin Score (mRSS) from baseline after 24 weeks. Secondary efficacy was assessed by the change in the Disease Activity Score for 28 joints (DAS28) in response to changes in C-reactive protein (CRP) level and erythrocyte sedimentation rate (ESR). The Bangla version of the Health Assessment Questionnaire-Disability Index (B-HAQ) response from baseline to 24 weeks was analyzed. Oral prednisolone (≤10 mg/day), calcium channel blockers, and phosphodiesterase 5 inhibitors (sildenafil and tadalafil) were administered. Follow-up was performed at four, 12, and 24 weeks. History, physical examination, and relevant investigations were used to assess adverse effects. Changes in acute-phase reactants and composite measures within the groups from baseline to 24 weeks were also…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 23 participants or records.
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