• Christina Charles-Schoeman, Désirée van der Heijde, Gerd R Burmester, Peter Nash, Zerbini Cristiano A F CAF From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands, Carol A Connell, Haiyun Fan, Kenneth Kwok, Eustratios Bananis, and Roy Fleischmann.
• From the University of California at Los Angeles (UCLA), Los Angeles, California, USA; Leiden University Medical Center, Leiden, the Netherlands; Charité-University Medicine Berlin Free University and Humboldt University of Berlin, Berlin, Germany; Department of Medicine, University of Queensland, Queensland, Australia; Centro Paulista de Investigação Clinica, São Paulo, Brazil; Pfizer Inc., Groton, Connecticut; Pfizer Inc., Collegeville, Pennsylvania; Pfizer Inc., New York, New York; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA.
• J Rheumatol. 2018 Feb 1; 45 (2): 177-187.

ObjectiveTofacitinib has been investigated for the treatment of rheumatoid arthritis (RA) in phase III studies in which concomitant glucocorticoids (GC) were allowed. We analyzed the effect of GC use on efficacy outcomes in patients with RA receiving tofacitinib and/or methotrexate (MTX) or conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in these studies.MethodsOur posthoc analysis included data from 6 phase III studies (NCT01039688; NCT00814307; NCT00847613; NCT00853385; NCT00856544; NCT00960440). MTX-naive patients or patients with inadequate response to csDMARD or biological DMARD received tofacitinib 5 or 10 mg twice daily alone or with csDMARD, with or without concomitant GC. Patients receiving GC (≤ 10 mg/day prednisone or equivalent) before enrollment maintained a stable dose throughout. Endpoints included the American College of Rheumatology (ACR) 20/50/70 response rates, rates of Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA; CDAI ≤ 10) and remission (CDAI ≤ 2.8), and changes from baseline in CDAI, 28-joint count Disease Activity Score (DAS28-4)-erythrocyte sedimentation rate (ESR), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain visual analog scale (VAS), and modified total Sharp score.ResultsOf 3200 tofacitinib-treated patients, 1258 (39.3%) received tofacitinib monotherapy and 1942 (60.7%) received tofacitinib plus csDMARD; 1767 (55.2%) received concomitant GC. ACR20/50/70 response rates, rates of CDAI LDA and remission, and improvements in CDAI, DAS28-4-ESR, HAQ-DI, and pain VAS with tofacitinib were generally similar with or without GC in monotherapy and combination therapy studies. GC use did not appear to affect radiographic progression in tofacitinib-treated MTX-naive patients. MTX plus GC appeared to inhibit radiographic progression to a numerically greater degree than MTX alone.ConclusionConcomitant use of GC with tofacitinib did not appear to affect clinical or radiographic efficacy. MTX plus GC showed a trend to inhibit radiographic progression to a greater degree than MTX alone.

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