• Yoshiya Tanaka, Kahaku Emoto, Zhihong Cai, Takehiro Aoki, Douglas Schlichting, Terence Rooney, and William Macias.
• From the First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu; Eli Lilly and Co., Tokyo; Eli Lilly Japan K.K., Kobe, Japan; Eli Lilly and Co., Indianapolis, Indiana, USA.Sponsored by Eli Lilly Japan K.K. and Eli Lilly and Co., manufacturer/licensee of baricitinib. Eli Lilly Japan K.K. and Eli Lilly and Co. were involved in the study design, data collection, data analysis, and preparation of the manuscript. Medical writing assistance was provided by Janelle Keys, PhD, CMPP, and Rebecca Lew, PhD, CMPP, of ProScribe, part of the Envision Pharma Group, and was funded by Eli Lilly Japan K.K. ProScribe's services complied with international guidelines for Good Publication Practice (GPP2). ZC and TA are employees of Eli Lilly Japan K.K. KE, DS, TR, and WM are employees of Eli Lilly and Co. and KE owns stock in the company.Y. Tanaka, MD, PhD, Professor, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health; K. Emoto, MD, PhD, Medical Advisor, Eli Lilly and Co.; Z. Cai, PhD, Senior Associate, Eli Lilly Japan K.K.; T. Aoki, PhD, Senior Associate, Eli Lilly Japan K.K.; D. Schlichting, RN, MS, Principal Research Scientist, Eli Lilly and Co.; T. Rooney, MD, Medical Director, Eli Lilly and Co.; W. Macias, MD, PhD, Distinguished Medical Fellow, Eli Lilly and Co.
• J Rheumatol. 2016 Mar 1; 43 (3): 504-11.

ObjectiveTo 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).MethodsThis 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.ResultsA 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.ConclusionIn 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).

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