A Retrospective Study on Clinical Experience with Tofacitinib in the Treatment of Rheumatoid Arthritis at a Tertiary Care Center

Abstract

Abstract Introduction: Tofacitinib is the first oral Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis (RA). Since the expiry of its patent, the drug has become affordable to patients in India. The present study describes our experience with tofacitinib in patients with RA. Objective: To retrospectively study the 6-month outcome of patients with RA treated with tofacitinib. Methods: We retrieved the records of all consecutive patients with RA who were commenced on tofacitinib in the rheumatology clinic of our tertiary care hospital from December 2020 to December 2021. The drug was prescribed as per recommended indications at a dose of 5 mg twice daily. Age, sex, duration of disease, and prior treatment received were noted. Baseline and 6-month data on the tender joint count, swollen joint count, patient global assessment, and physician global assessment were obtained from the records. Similarly, baseline and 6-month laboratory parameters (CBC, Erythrocyte sedimentation rate, C-reactive protein, LFT, and KFT) were also retrieved. Disease activity was assessed using SDAI at baseline and after 6 months. Adverse effects documented in the records were carefully noted. Results: Seventy-five patients had been commenced on tofacitinib between December 2020 and December 2021. Five patients were lost to follow-up. Twelve patients had stopped the drug after 2–3 months because of inefficacy while 7 had stopped the drug because of adverse effects. Thus, 51 patients (out of 75) had taken tofacitinib for 6 months or more. Of these, 39 achieved EULAR good response (low-disease activity-23, remission-16) and 12 achieved EULAR moderate response. Adverse effects occurred in 27 (36%) patients and included weight gain (8%), cytopenia (6.6%), folliculitis (4%), and alopecia (4%). Others included anxiety, dyspepsia, constipation, chest pain, dyslipidemia, herpes zoster, hypertension, oral thrush, sensory neuropathy, somnolence, and urinary tract infection. Conclusion: Tofacitinib treatment resulted in remission in 16/75 (21%) and LDA in 23/75 (31%) in RA patients who were inadequate responders to conventional synthetic disease-modifying antirheumatic drugs/biological drugs. Adverse effects occurred in 36%.