The primary efficacy endpoint was met, but the novel small molecule therapeutic did not reduce enthesitis more than placebo, as might have been expected.
VIENNA — The investigational interleukin -17 inhibitor izokibep hit its mark when it came to improving overall disease activity in people with active psoriatic arthritis in a phase 2b/3 trial, but it was no better than placebo at reducing inflammation of the entheses. At just 18.6 kilodaltons in size, izokibep is just"one tenth the size of a standard monoclonal antibody" and is classed as a small protein therapeutic, Mease said.
An exploratory analysis showed that there was a better response for izokibep vs placebo if the analysis included only patients with higher LEI scores at baseline, at 8.0% for placebo, 22.0% for izokibep 160 mg QW, and 50.0% for izokibep 160 mg Q2W.The primary endpoint for the trial was the proportion of patients who had 50% improvement in American College of Rheumatology response criteria at 16 weeks.
In fact, around half of the participants across the three treatment arms had received prior csDMARDs, and almost a quarter had received a TNFi. One patient each in the izokibep arms developed ulcerative colitis, whereas none in the placebo group did. Only two patients developed candidiasis. One was in the placebo group and had a skin infection, and the other was an oral infection in the QW izokibep arm.
Arthropathic Psoriasis Psoriatic Arthropathy Psa Enthesopathy Disease-Modifying Antirheumatic Drugs Dmards DMARD Arthritis Joint Inflammation Grant UK Site Content United Kingdom Site Content United Kingdom UK Ankylosing Spondylitis Rheumatoid Spondylitis Rheumatoid Arthritis Of The Spine Bechterew's Disease Bechterew Syndrome Marie Strumpell Disease
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