Toreforant, a histamine H4 receptor antagonist, in patients with active rheumatoid arthritis despite methotrexate therapy: Results of 2 phase II studies

Robin L. Thurmond, Andrew Greenspan, Waldemar Radziszewski, Xie L. Xu, Ye Miao, Bin Chen, Ting Ting Ge, Bei Zhou, Daniel G. Baker, Dace Pavlova, Christopher T. Ritchlin, Yoshiya Tanaka, Tsutomu Takeuchi, Josef S. Smolen

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8 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1637-1642
Number of pages6
JournalJournal of Rheumatology
Volume43
Issue number9
DOIs
Publication statusPublished - 2016 Sep 1

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Keywords

  • Clinical trial
  • Histamine H receptor antagonist
  • Methotrexate
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Thurmond, R. L., Greenspan, A., Radziszewski, W., Xu, X. L., Miao, Y., Chen, B., Ge, T. T., Zhou, B., Baker, D. G., Pavlova, D., Ritchlin, C. T., Tanaka, Y., Takeuchi, T., & Smolen, J. S. (2016). Toreforant, a histamine H4 receptor antagonist, in patients with active rheumatoid arthritis despite methotrexate therapy: Results of 2 phase II studies. Journal of Rheumatology, 43(9), 1637-1642. https://doi.org/10.3899/jrheum.160164