Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis

Rheumatol Ther 2018 Jun; 5(1):203–14. DOI: 10.1007/s40744-018-0093-7

Methotrexate (MTX) or Glucocorticoid (GC) discontinuation has little effect on CDAI response in patients given tofacitinib (TOF) for up to 3 years. Patients receiving TOF who showed initial improvements benefitted from initiation of MTX or GCs. Concomitant treatments such as MTX or GC are commonly used in combination with RA therapies to improve or accelerate clinical responses. However, their use is associated with many adverse events so clinicians aim to use them for a minimal duration.This post-hoc analysis is the first to analyse the effect of discontinuation or initiation of concomitant treatment of either MTX or GCs. Data were pooled from two multicentre, open-label long-term extension studies: ORAL Sequel and Study A3921041. All patients were given TOF 5 or 10 mg BID and either initiated or discontinued MTX or GC use dependent on use at baseline. CDAI remission, low disease activity (LDA) or incomplete response were measured at baseline, last-post baseline prior to initiation of MTX or GC, and at 3 years. For both MTX and GC, most patients maintained CDAI response from 3 months to 3 years, regardless of MTX or GC discontinuation. After 3 years, patients who initiated either MTX or GC achieved CDAI remission or LDA (50.0% and 55.0%, respectively). Patients who initiated MTX or GC therapy had CDAI response and disease parameters evaluated; with improvements observed in patients who initiated MTX and modest improvements observed for those who initiated GC therapy. The authors of the study concluded that patients achieving CDAI remission or LDA may be able to discontinue concomitant treatments whilst maintaining their responses to TOF therapy, but patients who have an initial improvement with TOF-based therapy may benefit from initiating another agent.