%0 Journal Article %A Robin L. Thurmond %A Andrew Greenspan %A Waldemar Radziszewski %A Xie L. Xu %A Ye Miao %A Bin Chen %A TingTing Ge %A Bei Zhou %A Daniel G. Baker %A Dace Pavlova %A Christopher T. Ritchlin %A Yoshiya Tanaka %A Tsutomu Takeuchi %A Josef S. Smolen %T Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies %D 2016 %R 10.3899/jrheum.160164 %J The Journal of Rheumatology %P 1637-1642 %V 43 %N 9 %X 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. %U https://www.jrheum.org/content/jrheum/43/9/1637.full.pdf