RT Journal Article
SR Electronic
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
FD The Journal of Rheumatology
SP 1637
OP 1642
DO 10.3899/jrheum.160164
VO 43
IS 9
A1 Robin L. Thurmond
A1 Andrew Greenspan
A1 Waldemar Radziszewski
A1 Xie L. Xu
A1 Ye Miao
A1 Bin Chen
A1 TingTing Ge
A1 Bei Zhou
A1 Daniel G. Baker
A1 Dace Pavlova
A1 Christopher T. Ritchlin
A1 Yoshiya Tanaka
A1 Tsutomu Takeuchi
A1 Josef S. Smolen
YR 2016
UL http://www.jrheum.org/content/43/9/1637.abstract
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.