The use of glucocorticoids (GCs) in patients with rheumatoid arthritis (RA) does not appear to affect the clinical or radiographic efficacy of tofacitinib, whereas the use of methotrexate plus GCs exhibited a trend toward inhibition of radiographic progression to a greater degree than the use of methotrexate alone, according to the results of a post hoc analysis of data from 6 phase 3 trials (ClinicalTrials.gov Identifiers: NCT01039688, NCT00814307, NCT00847613, NCT00853385, NCT00856544, and NCT00960440) conducted in Germany and published in the Journal of Rheumatology.
Methotrexate-naive patients, or those with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic DMARDs, were treated with tofacitinib 5 or 10 mg twice daily alone or with a csDMARD, with or without concomitant GCs. Those patients who received GC (≤10 mg/d of prednisone or an equivalent) before enrollment maintained a stable dosage throughout.
Outcomes included the following: percentage of patients achieving American College of Rheumatology 20/50/70 response rates (ie, improvement from baseline of ≥20%, ≥50%, and ≥70% in the number of tender and swollen joints), Clinical Disease Activity Index (CDAI)-defined low disease activity (CDAI ≤10) and remission (CDAI ≤2.8), changes from baseline in CDAI and 28-joint count Disease Activity Score using erythrocyte sedimentation rate, Health Assessment Questionnaire-Disability Index, pain visual analog scale, and modified total Sharp score.
A total of 3200 patients received tofacitinib therapy. Overall, 39.3% (1258 of 3200) of the tofacitinib-treated patients received tofacitinib monotherapy and 60.7% (1942 of 3200) of them received tofacitinib plus a csDMARD. In addition, 55.2% (1767 of 3200) of participants received concomitant GC treatment.
American College of Rheumatology 20/50/70 response rates, rates of CDAI low disease activity and remission, and improvements in CDAI, 28-joint count Disease Activity Score using erythrocyte sedimentation rate, Health Assessment Questionnaire-Disability Index, and pain visual analog scale among tofacitinib-treated patients were similar to those receiving GCs and those not receiving GCs.
The use of GCs did not appear to affect radiographic progression in tofacitinib-treated, methotrexate-naive individuals. The concomitant use of methotrexate and GCs did appear to inhibit radiographic progression to a numerically greater degree than treatment with methotrexate alone.
The investigators concluded that additional research in a randomized clinical trial designed to evaluate the efficacy in tofacitinib-treated, GC-naive patients with RA, with or without concomitant oral GC use, is warranted to definitively describe the efficacy and safety profile of tofacitinib in combination with GCs.
Charles-Schoeman C, van der Heijde D, Burmester GR, et al. Effect of glucocorticoids on the clinical and radiographic efficacy of tofacitinib in patients with rheumatoid arthritis: a posthoc analysis of data from 6 phase III studies [published online November 15, 2017]. J Rheumatol. doi:10.3899/jrheum.170486