Investigators report 12 weeks of treatment provided a strong foundation for further evaluation of TAK-279 across the psoriatic arthritis disease spectrum.
Takeda announced results from its Phase 2b trial evaluating TAK-279, a novel oral tyrosine kinase 2 (TYK2) inhibitor, in patients with active psoriatic arthritis. The study, which met its primary endpoint, demonstrated improvements in key secondary endpoints, offering hope for patients seeking effective and convenient treatment options. Results will be presented on November 14 at the American College of Rheumatology Convergence 2023 in San Diego, California.
The study revealed that 53.3% and 54.2% of patients treated with TAK-279 at 15 mg and 30 mg respectively achieved an American College of Rheumatology 20 (ACR 20) response, compared to only 29.2% in the placebo group at week 12. This statistically significant result (p = 0.002) marks a significant advancement in psoriatic arthritis treatment options.
Secondary Endpoints and Safety Profile
TAK-279 also exhibited positive outcomes in key secondary endpoints, including ACR 50 and ACR 70 responses, Psoriasis Area and Severity Index (PASI) 75, and Physician Global Assessment of Psoriasis (PGA-PsO). These results signify a comprehensive improvement in disease activity, joint health, and skin involvement. Importantly, the safety and tolerability profile of TAK-279 mirrored that observed in the Phase 2b psoriasis study, reassuring both clinicians and patients.
Alan Kivitz, MD, MACR, served as the study’s principal investigator. He explained how rapid improvements witnessed in just 12 weeks of treatment provide a strong foundation for further evaluation of TAK-279 across the psoriatic arthritis disease spectrum.
There remains a critical unmet need for psoriatic arthritis treatment options that not only improve the signs and symptoms of the condition, but are well tolerated and convenient for patients,” he said in a press release. “These results support the continued evaluation, across the psoriatic arthritis disease spectrum, of TAK-279, a once-daily oral TYK2 inhibitor with next generation selectivity.”
Takeda said Phase 3 studies in the development of TAK-279 in both plaque psoriasis and psoriatic arthritis will be initiated. Additionally, the exploration of TAK-279 in Crohn’s disease, ulcerative colitis, systemic lupus erythematosus, and other indications signifies a potential revolution in immune-mediated inflammatory disease treatment.
The Phase 2b trial results for TAK-279 present a significant milestone psoriatic arthritis treatment. With its promising efficacy and favorable safety profile, TAK-279 holds great potential to become a vital addition to the arsenal of treatment options for this debilitating condition. The ongoing research and development efforts by Takeda promise a brighter future for patients with psoriatic arthritis and other immune-mediated inflammatory diseases.
Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting. Business Wire. November 7, 2023. Accessed November 7, 2023. https://www.businesswire.com/news/home/20231107469846/en/Takeda-Announces-Late-Breaking-Data-from-Phase-2b-Study-of-TAK-279-an-Investigational-Oral-Once-Daily-TYK2-Inhibitor-in-Patients-with-Active-Psoriatic-Arthritis-at-American-College-of-Rheumatology-Convergence-Annual-Meeting