Sotyktu Promising in Phase 3 Psoriatic Arthritis Trials

Bristol Myers Squibb (BMS) has announced promising results from two phase 3 clinical trials of Sotyktu (deucravacitinib), its oral TYK2 inhibitor, for the treatment of adults with active psoriatic arthritis (PsA). This condition, often linked with psoriasis, affects up to 30% of individuals with psoriasis, which itself impacts over eight million people in the United States. Psoriatic arthritis is characterized by symptoms such as joint pain, stiffness, and swelling.

The first study, named POETYK PsA-1, focused on patients who had not previously received biologic disease-modifying antirheumatic drugs (bDMARD naïve). The second study, POETYK PsA-2, included both bDMARD naïve patients and those who had previously been treated with TNFα inhibitors. Both trials achieved their primary objectives, demonstrating that a significantly higher proportion of patients treated with Sotyktu experienced at least a 20% improvement in disease signs and symptoms after 16 weeks, compared to those given a placebo.

In addition to meeting primary endpoints, the trials also satisfied important secondary endpoints related to PsA disease activity at the 16-week mark. According to Bristol Myers Squibb, the safety profile of Sotyktu observed in these trials aligns with the established safety profile of the drug.

Speaking on these findings, Roland Chen, Senior Vice President and head of immunology, cardiovascular, and neuroscience development at BMS, expressed optimism about the results. He stated that the data suggests Sotyktu could become the first TYK2 inhibitor available for individuals managing PsA. Chen also indicated that the company is eager to discuss these findings with health authorities.

Sotyktu is already approved in several major markets for treating patients with moderate-to-severe plaque psoriasis. In previous late-stage trials, the drug was shown to enhance skin clearance, reduce symptom burden, and improve quality of life for patients. Additionally, BMS has recently reported positive outcomes from the phase 3b/4 PSORIATYK SCALP study, which evaluated Sotyktu in patients with moderate-to-severe scalp psoriasis.

The results from this scalp psoriasis study, presented at the 2024 European Academy of Dermatology and Venereology Congress, indicated that more than three times as many patients treated with Sotyktu achieved a scalp-specific Physician’s Global Assessment response of zero or one, which means clear or almost clear, at week 16 when compared to the placebo group (48.5% vs. 13.7%). Moreover, a significantly higher percentage of those on Sotyktu showed at least a 90% improvement in the Psoriasis Scalp Severity Index response and experienced a marked reduction in scalp-specific itch compared to placebo.

Overall, these studies highlight the potential of Sotyktu as a treatment option for individuals suffering from psoriatic arthritis and various forms of psoriasis, offering hope for enhanced management of these challenging conditions.