TY - JOUR T1 - Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies JF - The Journal of Rheumatology JO - J Rheumatol DO - 10.3899/jrheum.160164 SP - jrheum.160164 AU - Robin L. Thurmond AU - Andrew Greenspan AU - Waldemar Radziszewski AU - Xie L. Xu AU - Ye Miao AU - Bin Chen AU - TingTing Ge AU - Bei Zhou AU - Daniel G. Baker AU - Dace Pavlova AU - Christopher T. Ritchlin AU - Yoshiya Tanaka AU - Tsutomu Takeuchi AU - Josef S. Smolen Y1 - 2016/07/15 UR - http://www.jrheum.org/content/early/2016/07/12/jrheum.160164.abstract N2 - Objective To assess toreforant (selective histamine H4 receptor antagonist) in active rheumatoid arthritis (RA). Methods In a phase IIa, double-blind, placebo-controlled test, 86 patients were randomized (2:1) to once-daily toreforant 100 mg or placebo for 12 weeks. In phase IIb, double-blind, placebo-controlled, dose-range–finding evaluations, 272 patients were randomized (1:1:1:1) to once-daily placebo or toreforant 3/10/30 mg. Primary efficacy endpoints for both studies were Week 12 changes in 28-joint Disease Activity Score–C-reactive protein (DAS28-CRP). Results Phase IIa testing was terminated prematurely (patient fatality; secondary hemophagocytic lymphohistiocytosis). Posthoc analyses indicated toreforant 100 mg/day reduced RA signs/symptoms through Week 12. Phase IIb testing, however, showed no significant Week 12 improvement in DAS28-CRP with toreforant. Conclusion Toreforant was not effective in phase IIb testing. ER -