Brepocitinib shows promising results in patients with psoriatic arthritis
USA: A phase IIb randomized clinical trial published in Arthritis & Rheumatology recently generated promising efficacy and safety data for brepocitinib in adults with moderately to severely active psoriatic arthritis.
The study found that once-daily Brepocitinib 30 and 60 mg were superior to placebo at reducing signs and symptoms of psoriatic arthritis. Throughout the 52-week study, brepocitinib was generally well tolerated, with a safety profile consistent with other brepocitinib clinical trials.
Brepocitinib is an oral drug that inhibits certain enzymes involved in inflammation-called tyrosine kinase 2, and Janus kinase 1-and is being tested for the treatment of several immunological diseases.
Overall, 218 randomised participants received brepocitinib or a placebo for one year. After 16 weeks of treatment, 30 and 60 mg daily doses of brepocitinib were superior to placebo at reducing signs and symptoms of psoriatic arthritis. Response rates were maintained or improved through week 52. Side effects were mostly mild or moderate.
The study led to the following findings:
- At week 16, brepocitinib 30 and 60 mg QD groups had significantly greater ACR20 response rates (66.7% and 74.6%, respectively), versus placebo (43.3%) and significantly higher ACR50/70, PASI75/90, and MDA response rates.
- Response rates were maintained or improved through week 52.
- Adverse events were mostly mild/moderate; serious AEs (15) in 5.5% of participants included infections in 2.8% patients in brepocitinib 30 and 60 mg QD groups.
- No major adverse cardiovascular events or deaths occurred.
“These data demonstrate striking efficacy and confirm the relevance of multiple signaling pathways dependent on the kinases targeted by brepocitinib in psoriatic arthritis,” said corresponding author Philip Mease, MD, of Swedish Medical Center/Providence St. Joseph Health and the University of Washington, in Seattle. “The safety is also reassuring for brepocitinib in this study.”
Referenses:- Philip Mease MD, Philip Helliwell PhD, DM, BM BCh, FRCP, MA, Paula Silwinska-Stanczyk MD, PhD, Malgorzata Miakisz MD, Andrew Ostor MD, Elena Peeva MD, MSc, Michael S. Vincent MD, PhD, Qiankun Sun PhD, Vanja Sikirica PharmD, MPH, Randall Winnette MSc, Ruolun Qiu PhD, Gang Li PhD, Gang Feng MD, PhD, Jean S. Beebe PhD, David A. Martin MD
