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- Title
Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study.
- Authors
Yoshiya Tanaka; Kahaku Emoto; Zhihong Cai; Takehiro Aoki; Schlichting, Douglas; Rooney, Terence; Macias, William; Tanaka, Yoshiya; Emoto, Kahaku; Cai, Zhihong; Aoki, Takehiro
- Abstract
<bold>Objective: </bold>To evaluate efficacy and safety, baricitinib [Janus kinase (JAK) 1/JAK2 inhibitor] was compared with placebo in Japanese patients with active rheumatoid arthritis (RA) despite background treatment with methotrexate (MTX).<bold>Methods: </bold>This was a phase IIB, double-blind, randomized, placebo-controlled study (clinicaltrials.gov: NCT01469013). Patients had moderate to severe active adult-onset RA despite stable treatment with MTX. Patients (n = 145) were randomized in a 2:1:1:1:1 ratio to placebo or 1 mg, 2 mg, 4 mg, or 8 mg oral baricitinib daily for 12 weeks. The primary analysis compared the combined 4/8-mg dose groups with placebo for the American College of Rheumatology (ACR) 20 response rate at 12 weeks. Other outcomes included additional measures of disease activity, physical function, laboratory abnormalities, and adverse events.<bold>Results: </bold>A significantly higher proportion of patients in the combined 4/8-mg baricitinib group (37/48, 77%) compared with the placebo group (15/49, 31%) had at least an ACR20 response after 12 weeks of treatment (p < 0.001). Significant improvements in disease activity, remission, and physical function were observed as early as Week 2 of treatment with baricitinib, particularly with daily doses of ≥ 4 mg. Only 1 patient receiving baricitinib discontinued because of an adverse event. Adverse event rates with baricitinib doses ≤ 4 mg daily were similar to placebo, but there was a higher incidence of adverse events and laboratory abnormalities in the 8-mg group.<bold>Conclusion: </bold>In this phase II study, baricitinib was well tolerated and rapidly improved the signs, symptoms, and physical function of Japanese patients with active RA, supporting continued development of baricitinib (clinicaltrials.gov NCT01469013).
- Subjects
RHEUMATOID arthritis diagnosis; SYMPTOMS; ANTIRHEUMATIC agents; COMBINATION drug therapy; CLINICAL trials; COMPARATIVE studies; DOSE-effect relationship in pharmacology; HETEROCYCLIC compounds; RESEARCH methodology; MEDICAL cooperation; METHOTREXATE; RESEARCH; RHEUMATOID arthritis; EVALUATION research; SULFONAMIDES; RANDOMIZED controlled trials; TREATMENT effectiveness; DISEASE remission; BLIND experiment; SEVERITY of illness index; DIAGNOSIS; THERAPEUTICS
- Publication
Journal of Rheumatology, 2016, Vol 43, Issue 3, p504
- ISSN
0315-162X
- Publication type
journal article
- DOI
10.3899/jrheum.150613