Bristol Myers Squibb has announced positive results from arthritis two pivotal Phase 3 trials, POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), which evaluated the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, demonstrating that significantly more arthritis patients treated with Sotyktu achieved an ACR20 response (at least a 20% improvement in arthritis disease signs and symptoms) after 16 weeks of arthritis treatment compared to those on placebo.
These Phase 3 trials also met several key secondary endpoints, assessing PsA disease activity at week 16. The results confirmed that Sotyktu is effective in reducing arthritis disease activity and improving symptoms across a broad range of PsA manifestations. Additionally, the safety profile of Sotyktu observed in these trials was consistent with the previously established safety data from earlier studies, including a Phase 2 PsA clinical trial and Phase 3 trials involving moderate-to-severe plaque psoriasis.
Dr. Roland Chen, Senior Vice President and Head of Immunology, Cardiovascular, and Neuroscience Development at Bristol Myers Squibb, emphasized the significance of these findings: “Psoriatic arthritis is a complex and varied disease, with symptoms ranging from joint pain and swelling to psoriatic skin lesions. Despite the therapies available today, there remains a need for a safe and effective oral treatment option. The results from POETYK PsA-1 and POETYK PsA-2 show that oral Sotyktu has the potential to become the first TYK2 inhibitor for people living with PsA, reinforcing the strong efficacy and safety profile of the drug.”
Sotyktu is a TYK2 inhibitor, a class of drug targeting the Janus kinase (JAK) pathway, which plays a critical role in immune system regulation. In these Arthritis Phase 3 trials, Sotyktu demonstrated its ability to address multiple aspects of PsA, including joint inflammation and skin lesions. The results also highlight the potential of Sotyktu to become a new treatment option for PsA patients, offering the benefit of oral administration, which is an advantage over some biologic treatments that require injections or infusions.
Sotyktu Shows Superior ACR20 Response in Psoriatic Arthritis Patients
In the trials, both POETYK PsA-1 and POETYK PsA-2 achieved statistical significance for the primary endpoint of ACR20 response. The proportion of arthritis patients achieving this improvement was notably higher in the Sotyktu-treated groups compared to the placebo groups, demonstrating its potential to alleviate symptoms effectively. Additionally, the trials assessed secondary endpoints such as improvements in disease activity, physical function, and the reduction of psoriatic skin lesions, further supporting the efficacy of Sotyktu in treating the broad spectrum of PsA symptoms.
The safety profile of Sotyktu in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with earlier studies. No new safety concerns emerged, and the side effects observed were similar to those reported in previous clinical trials of Sotyktu for other conditions, including moderate-to-severe plaque psoriasis. Sotyktu’s side effects were generally manageable, aligning with the established safety profile seen in earlier studies.
Bristol Myers Squibb plans to present the detailed results from these trials at upcoming medical congresses to further inform the medical community about the potential benefits of Sotyktu in the treatment of psoriatic arthritis. These topline results mark the first Phase 3 trials for Sotyktu in a rheumatic condition, adding to its established efficacy in treating moderate-to-severe plaque psoriasis, for which it is already approved in several countries worldwide.
Bristol Myers Squibb also expressed gratitude to the Arthritis patients, investigators, and clinical trial sites who participated in the trials. Their contributions were essential in generating the data that will help inform future treatment options for PsA.
The positive results from the POETYK PsA-1 and POETYK PsA-2 trials highlight the promise of Sotyktu as a treatment option for psoriatic arthritis. The drug’s potential to provide significant symptom relief with the convenience of oral administration makes it a compelling option for patients living with this chronic and often debilitating condition. As the company looks ahead, it aims to work closely with health authorities to discuss these results and seek regulatory approval for Sotyktu as a treatment for PsA.
Overall, the success of these Phase 3 trials represents a major milestone for Bristol Myers Squibb, reinforcing its commitment to developing innovative therapies that can improve the lives of patients living with chronic autoimmune diseases like psoriatic arthritis.
