Bristol Myers Unveils Positive Phase 3 Results for Sotyktu in Psoriatic Arthritis

On Saturday, Bristol Myers Squibb & Co BMY revealed data from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).

The POETYK PsA-2 trial met its primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20% improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 39.4%, respectively; p=0.0002).

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The overall safety profile of Sotyktu through 16 weeks of treatment was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.

The new data, representing the first disclosure of data for the Phase 3 POETYK trials in PsA, were presented at the American Academy of Dermatology.

Additionally, treatment with Sotyktu met important secondary endpoints across PsA disease activity at Week 16, demonstrating improvement across clinical signs and symptoms, extra-articular manifestations, and patient-reported outcomes.

More Sotyktu-treated patients achieved a Psoriasis Area and Severity Index (PASI) 75 response compared with placebo.

In the POETYK PsA-2 trial, no new safety signals were identified.

Bristol Myers Squibb will work with key investigators to present additional Phase 3 POETYK PsA program data at upcoming medical congresses this year.

Sotyktu is approved for the treatment of adults with moderate-to-severe plaque psoriasis.

Price Action: BMY stock is up 2.82% at $62.82 at the last check Monday.

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