Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis

Background: Methotrexate, an anti‐folate drug, is a widely accepted and commonly used DMARD for the treatment of PsA. Tofacitinib is a JAK inhibitor, and relatively new drug for this condition. Aims: To assess and compare safety and efficacy of Tofacitinib and Methotrexate in the treatment of PsA. Methodology: This open label, randomized, prospective study was conducted in Department of Rheumatology, BSMMU, Dhaka for 1½ years from September, 2017 to February, 2019. 61 patients, aged >18 years with the diagnosis of PsA for ≥3 months were randomized into two groups. 29 patients (Tofacitinib 5mg BD) and 32 patients (MTX from 15 mg/week to 25 mg/week over 1 month) were enrolled and followed‐up at the end of 1, 3 and 6 months. Primary endpoint was ACR 20 response at the end of 3 months. Patients who achieved treatment target on the basis of DAPSA score at the end of 3 months were allowed to continue previuos treatment and assessed for safety and efficacy till 6 months. Patients not achieving treatment target in Tofacitinib group were put on Tofacitinib 10 mg BD and in MTX group were put on Tofacitinib 5 mg BD. These patients were followed‐up for safety and efficacy at the end of 6 months. Secondary outcome measures were EULAR response, 66/68 joints SJC/TJC, VAS for pain, ESR, CRP, DAPSA, DAS28, PASI, PASI 75 response, MASES and HAQ‐DI. Safety assessment was done on the basis of clinical history, examination and laboratory findings at each follow‐up. Ethical clearance was obtained from IRB, BSMMU at the beginning. Statistical analysis was done using chi‐square test, Fisher's exact test, paired sample t‐test and independent sample t‐test. Missing data were dealt with intention to treat (ITT) analysis.