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Janssen's guselkumab shows positive results in mid-stage psoriatic arthritis study

Published 11/15/2016, 09:55 AM
Janssen's guselkumab shows positive results in mid-stage psoriatic arthritis study
JNJ
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  • Results from a Phase 2 clinical trial assessing Janssen's (NYSE:JNJ) anti-interleukin 23 (IL-23) monoclonal antibody guselkumab in patients with psoriatic arthritis (PA) showed a significant treatment benefit compared to placebo. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
  • The study met its primary endpoint of a statistically valid proportion of patients treated with guselkumab achieving ACR20 (20% improvement in PA symptoms) at week 24 versus placebo (58% vs. 18.4%; p<0.001). All secondary endpoints were also met.
  • At week 16, the proportion of subjects achieving ACR20 also favored guselkumab (60% vs. 16.3%; p<0.001), as did those achieving ACR50 (34% vs. 10.2%; p=0.002) and PASI 75 (78.6% vs. 12.5%; p<0.001).
  • Patients receiving guselkumab experienced greater improvements in enthesitis (inflammation at the sites where tendons & ligaments attach to bone) and dactylitis (inflammation of the fingers or toes).
  • The incidence of adverse events (AEs) was 36.0% for guselkumab and 32.7% for placebo. The most common AEs were infections.
  • The company announced positive results in a Phase 3 trial in plaque psoriasis last month.
  • Previously: Janssen's psoriasis candidate guselkumab tops Humira in late-stage study (Oct. 3)

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