Background Ph3 studies demonstrated clinical efficacy of 2 different once-daily (QD) doses of baricitinib (bari) (2mg and 4mg) in patients (pts) with active rheumatoid arthritis (RA) and an inadequate response (IR) to conventional synthetic DMARDs1 or biologic DMARDs2. In general, larger, more rapid and more consistent treatment effects were observed for the 4mg dose across measures.
Objectives To investigate the effects of bari dose step-down in patients who had achieved sustained low disease activity (LDA) or remission with bari 4mg QD.
Methods Pts who completed a bari Ph3 Study (RA-BEGIN, RA-BEAM, RA-BUILD, or RA-BEACON) could enter a long-term extension study, RA-BEYOND. In RA-BEYOND, pts who had received bari 4mg for at least 15 months and who had achieved sustained LDA or remission (defined by CDAI score at 2 consecutive visits at least 3 months apart) were re-randomized in a double blind manner to continue receiving bari 4mg or to step down to a 2mg QD dose. Disease activity was assessed at a 12 week (wk) landmark following re-randomization.
Results Among pts who achieved satisfactory and sustained disease control with bari 4mg QD, randomized, double blind dose reduction to 2mg QD was associated with modest, statistically significant increases in disease activity across measures at a subsequent 12 wk landmark assessment (Table). However, a large majority of pts (in both the continued 4mg and reduced to 2mg groups) retained the state of LDA or remission that led to their re-randomization.
Conclusions Consistent with completed studies, these data indicate that 4mg QD was the most efficacious dose of bari for pts with RA in clinical studies. Most pts who had achieved sustained disease control with bari 4mg sustained LDA or remission 12 wks after randomized, blinded dose taper to 2mg QD.
Dougados M et al.Ann Rheum Dis 2015;74(S2):79;
Genovese M et al.Ann Rheum Dis 2015;74(S2):75–76.
Disclosure of Interest T. Takeuchi Grant/research support from: Eli Lilly & Co., Astellas, Bristol-Myers K.K., Chugai, Ltd, Daiichi Sankyo, Eisai, AYUMI Pharmaceutical Corporation, Takeda, Teijin Pharma, AbbVie GK, Asahikasei Pharma, Taisho Toyama Pharmaceutical Co., Consultant for: Eli Lilly & Co., Astra Zeneca K.K., Novartis, Mitsubishi Tanabe, Asahi Kasei Medical, AbbVie GK, Daiichi Sankyo, Bristol-Myers K.K., Nipponkayaku, Janssen, Merck Serono, Takeda, Astellas, Speakers bureau: AbbVie GK, Bristol-Myers K.K., Chugai, Eisai, Janssen, Mitsubishi Tanabe, Pfizer, Takeda, Astellas, Daiichi Sankyo, Celtrion, Nipponkayaku, M. Genovese Grant/research support from: AbbVie, Astellas, Eli Lilly & Co., Galapagos, Pfizer, Vertex, Consultant for: AbbVie, Astellas, Crescendo Bioscience, Eli Lilly &Co., Galapagos, Pfizer, L. Xie Shareholder of: Eli Lilly and Co., Employee of: Eli Lilly and Co., M. Issa Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., A. L. Pinto Correia Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., T. Rooney Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., K. Emoto Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., J. Smolen Grant/research support from: AbbVie, Janssen, Eli Lilly & Co., MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Celtrion, Glaxo, ILTOO, Janssen, Eli Lilly & Co., Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB