Abstract | OBJECTIVE: METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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Authors | Christina Charles-Schoeman, Désirée van der Heijde, Gerd R Burmester, Peter Nash, Cristiano A F Zerbini, Carol A Connell, Haiyun Fan, Kenneth Kwok, Eustratios Bananis, Roy Fleischmann |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 45
Issue 2
Pg. 177-187
(02 2018)
ISSN: 0315-162X [Print] Canada |
PMID | 29142036
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antirheumatic Agents
- Glucocorticoids
- Piperidines
- Protein Kinase Inhibitors
- Pyrimidines
- Pyrroles
- tofacitinib
- Methotrexate
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Topics |
- Adult
- Aged
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Rheumatoid
(drug therapy)
- Disability Evaluation
- Disease Progression
- Double-Blind Method
- Drug Synergism
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Glucocorticoids
(administration & dosage, therapeutic use)
- Health Surveys
- Humans
- Male
- Methotrexate
(therapeutic use)
- Middle Aged
- Piperidines
(administration & dosage, therapeutic use)
- Protein Kinase Inhibitors
(administration & dosage, therapeutic use)
- Pyrimidines
(administration & dosage, therapeutic use)
- Pyrroles
(administration & dosage, therapeutic use)
- Treatment Outcome
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