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Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs.
- Source :
-
Annals of the rheumatic diseases [Ann Rheum Dis] 2016 Jul; Vol. 75 (7), pp. 1293-301. Date of Electronic Publication: 2015 Aug 14. - Publication Year :
- 2016
-
Abstract
- Objectives: Biological disease-modifying antirheumatic drugs (bDMARDs) have shown diminished clinical response following an inadequate response (IR) to ≥1 previous bDMARD. Here, tofacitinib was compared with placebo in patients with an IR to conventional synthetic DMARDs (csDMARDs; bDMARD-naive) and in patients with an IR to bDMARDs (bDMARD-IR).<br />Methods: Data were taken from phase II and phase III studies of tofacitinib in patients with rheumatoid arthritis (RA). Patients received tofacitinib 5 or 10 mg twice daily, or placebo, as monotherapy or with background methotrexate or other csDMARDs. Efficacy endpoints and incidence rates of adverse events (AEs) of special interest were assessed.<br />Results: 2812 bDMARD-naive and 705 bDMARD-IR patients were analysed. Baseline demographics and disease characteristics were generally similar between treatment groups within subpopulations. Across subpopulations, improvements in efficacy parameters at month 3 were generally significantly greater for both tofacitinib doses versus placebo. Clinical response was numerically greater with bDMARD-naive versus bDMARD-IR patients (overlapping 95% CIs). Rates of safety events of special interest were generally similar between tofacitinib doses and subpopulations; however, patients receiving glucocorticoids had more serious AEs, discontinuations due to AEs, serious infection events and herpes zoster. Numerically greater clinical responses and incidence rates of AEs of special interest were generally reported for tofacitinib 10 mg twice daily versus tofacitinib 5 mg twice daily (overlapping 95% CIs).<br />Conclusions: Tofacitinib demonstrated efficacy in both bDMARD-naive and bDMARD-IR patients with RA. Clinical response to tofacitinib was generally numerically greater in bDMARD-naive than bDMARD-IR patients. The safety profile appeared similar between subpopulations.<br />Trial Registration Numbers: (NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385).<br /> (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
- Subjects :
- Adult
Antirheumatic Agents adverse effects
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions etiology
Female
Humans
Male
Methotrexate adverse effects
Methotrexate therapeutic use
Middle Aged
Piperidines adverse effects
Pyrimidines adverse effects
Pyrroles adverse effects
Treatment Outcome
Antirheumatic Agents therapeutic use
Arthritis, Rheumatoid drug therapy
Piperidines therapeutic use
Pyrimidines therapeutic use
Pyrroles therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1468-2060
- Volume :
- 75
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Annals of the rheumatic diseases
- Publication Type :
- Academic Journal
- Accession number :
- 26275429
- Full Text :
- https://doi.org/10.1136/annrheumdis-2014-207178