US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from the pivotal Phase III POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) studies for its drug Sotyktu (deucravacitinib). These studies assessed the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA).
Achievement of Primary and Secondary Endpoints
In both POETYK PsA-1 and PsA-2 studies, a significantly greater proportion of patients treated with Sotyktu achieved an ACR20 response, indicating at least a 20 percent improvement in signs and symptoms of the disease, after 16 weeks of treatment compared to placebo. This achievement met the primary endpoint of the trials. Additionally, important secondary endpoints were also met, demonstrating the drug’s effectiveness in managing PsA.
Consistency in Safety Profile
The overall safety profile of Sotyktu through 16 weeks of treatment in these trials was found to be consistent with previous findings, adding to the body of evidence supporting the drug’s safety and tolerability.
Sotyktu’s Unique Positioning in Psoriasis Treatment
Sotyktu, the world’s first and only allosteric tyrosine kinase 2 (TYK2) inhibitor, has been approved for the treatment of adults with moderate-to-severe plaque psoriasis in the US and China in September 2022 and October 2023, respectively. Its success in the POETYK PsA trials further expands the potential therapeutic applications of this innovative drug.-Fineline Info & Tech