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

Charles-Schoeman, Christina, van der Heijde, Désirée, Burmester, Gerd R, Nash, Peter, Zerbini, Cristiano A F, Connell, Carol A, Fan, Haiyun, Kwok, Kenneth, Bananis, Eustratios and Fleischmann, Roy (2017) 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. Journal of Rheumatology, 45 2: 177-187. doi:10.3899/jrheum.170486


Author Charles-Schoeman, Christina
van der Heijde, Désirée
Burmester, Gerd R
Nash, Peter
Zerbini, Cristiano A F
Connell, Carol A
Fan, Haiyun
Kwok, Kenneth
Bananis, Eustratios
Fleischmann, Roy
Title 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
Journal name Journal of Rheumatology   Check publisher's open access policy
ISSN 0315-162X
1499-2752
Publication date 2017-11-15
Year available 2018
Sub-type Article (original research)
DOI 10.3899/jrheum.170486
Open Access Status Not yet assessed
Volume 45
Issue 2
Start page 177
End page 187
Total pages 11
Place of publication Toronto, ON., Canada
Publisher Journal of Rheumatology Publishing
Language eng
Subject 2745 Rheumatology
2723 Immunology and Allergy
2403 Immunology
Abstract Tofacitinib 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.

Our 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.

Of 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.

Concomitant 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.
Keyword CLINICAL EFFICACY
GLUCOCORTICOIDS
RADIOGRAPHY
RHEUMATOID ARTHRITIS
TOFACITINIB
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Medicine Publications
 
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Created: Wed, 29 Nov 2017, 12:03:50 EST