Safety and Efficacy of Various Doses of Tofacitinib among Patients with Active Seronegative Spondyloarthritides – A Retrospective Observational Study

Abstract

Introduction: Seronegative spondyloarthritides (SpA) are a family of various joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Treatment goals for SpA are reducing symptoms, decreasing complications associated with the disease, and reducing functional limitations. Aim of the study: The purpose of this study is to find efficacy and safety of various doses of Tofacitinib, an oral Janus kinase inhibitor, compared with placebo in different stages of the treatment in patients with active Seronegative Spondyloarthritides. Methods: This retrospective observational study was carried out in the Popular Medical College Hospital, Bangladesh. Total 203 subjects of both sexes, aged more than 18 years were selected during the period of May 2023 to November 2023. In this 6 months study duration, patients received 16 weeks treatment (12-week treatment, 4-week washout) and were under follow up session for 8 weeks. Study patients with active SpA phase II were grouped to receive (N=25, 25, 25, 25, respectively) placebo or Jakloc (Tofacitinib) 5 mg and Jakloc (Tofacitinib) XR 11 mg manufactured by Popular Phermaceuticals PLC and Tofacitinib 2 mg or 10 mg (manufactured by other phermaceuticals) twice daily. Jakloc (Tofacitinib) XR 11 mg was used for adult patients with inadequate response or intolerance to methotrexate (3 patients). The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine after follow up session for 8 weeks. Safety was monitored. Result: The Emax model analysis of the primary endpoint predicted a Jakloc (Tofacitinib) 10 mg twice daily ASAS20 response rate of 67.4%, which ........