PT  - JOURNAL ARTICLE
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
TI  - Toreforant, A Histamine H4 Receptor Antagonist, in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Results of 2 Phase II Studies
AID  - 10.3899/jrheum.160164
DP  - 2016 Sep 01
TA  - The Journal of Rheumatology
PG  - 1637--1642
VI  - 43
IP  - 9
4099  - http://www.jrheum.org/content/43/9/1637.short
4100  - http://www.jrheum.org/content/43/9/1637.full
SO  - J Rheumatol2016 Sep 01; 43
AB  - 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.