TAK-279 Demonstrates Improvements in ACR 20 Response for Psoriatic Arthritis

Approximately, 53.3% and 54.2% of individuals with psoriatic arthritis (PA) treated with 15 mg and 30 mg, respectively, of TAK-279 (Takeda) achieved at least an American College of Rheumatology (ACR) 20 response at 12 weeks compared to 29.2% of those in the placebo arm, according to positive results of a phase 2b trial (NCT05153148).

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TAK-279 is an investigational oral allosteric tyrosine kinase 2 inhibitor for active PA, according to a statement. The results of the study will be presented November 14, 2023, as a late-breaking poster session at the ACR Convergence 2023 in San Diego, California.

“There remains a critical unmet need for [PA] treatment options that not only improve the signs and symptoms of the condition, but are well tolerated and convenient for patients,” Alan Kivitz, MD, MACR, a physician at the Altoona Arthritis & Osteoporosis Center, said in a statement. “The improvements seen with just 12 weeks of treatment in this Phase 2b study in patients with a low mean baseline C-reactive protein level are particularly encouraging. These results support the continued evaluation, across the [PA] disease spectrum, of TAK-279, a once-daily oral TYK2 inhibitor with next generation selectivity.”

The trial was a randomized, placebo-controlled, double-blinded study used to assess the efficacy, safety, and tolerability of TAK-279 in individuals with active PA. Individuals aged 18 years and older were included if they had PA symptoms for 6 or more months prior to screening, met Classification Criteria for Psoriatic Arthritis, and had 3 or more tender or 3 or more swollen joints at enrollment, despite using non-steroid anti-inflammatory drugs, disease-modifying anti-rheumatic drugs, or biologic treatment, according to the news release.

A total of 290 individuals were randomly assigned 1 of 3 doses of TAK-279 or the placebo once daily for 12 weeks and an additional 4 weeks of safety follow-up.

In addition to the primary endpoint, the study results also showed improvements in key secondary endpoints. Investigators reported that recipients of the 15 mg and 30 mg doses of TAK-279 achieved ACR 50 responses at 26.7% and 26.4%, respectively, compared to 9.7% of those taking the placebo. For ACR 70, approximately 14.7% and 13.9% taking TAK-279 15 mg and 30 mg, respectively, achieved this response compared to 5.6% taking the placebo.

Furthermore, for individuals with an affected body surface area of 3% or greater at baseline, Psoriasis Area and Severity Index 75 was achieved for 45.7% of individuals receiving 30 mg of TAK-279, 28.3% receiving 15 mg, 25.6% receiving 5 mg, and 15.4% receiving the placebo. For individuals with Physician Global Assessment of Psoriasis of 2 or greater at baseline, 32.8%, 20.6%, 20.4%, and 15.8% achieved a score of 0 (clear) or 1 (almost clear), and at least a 2-point improvement from baseline.

There were also greater reductions in the mean change from baseline in the tender joint count and swollen joint count in the 15 mg and 20 mg groups compared to the placebo and 5 mg groups. Further, minimal disease activity responses were achieved at 28% in the 15 mg group, 29.2% in the 20 mg group, and 12.5% in the placebo group, according to the statement.

“Based on these promising efficacy and safety results, achieved at 12 weeks, we plan to initiate a phase 3 study of TAK-279 in [PA] as well as commence a phase 3 study in plaque psoriasis,” Andy Plump, president of Research & Development at Takeda, said in the statement. “We are also advancing the development of TAK-279 in Crohn disease, ulcerative colitis, and systemic lupus erythematosus and exploring a range of other potential indications. These opportunities are being explored in parallel with the psoriasis and psoriatic arthritis programs.”

The most common treatment-emergent adverse events included nasopharyngitis, upper respiratory tract infection, headache, and rash.

Reference

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. News release. November 7, 2023. Accessed November 7, 2023. https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Phase-2b-TAK-279-data-in-psoriatic-arthritis-ACR-Convergence/