Eli Lilly announces ‘positive’ topline results from TOGETHER-PsA trial

Eli Lilly (LLY) announced “positive” topline results from the novel TOGETHER-PsA open-label Phase 3b trial evaluating the concomitant use of Taltz and Zepbound compared to Taltz alone in adults with active psoriatic arthritis and obesity or overweight with at least one weight-related condition. At 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all key secondary endpoints for superiority to Taltz monotherapy. In the study, 31.7% of patients in the Taltz plus Zepbound treatment arm achieved a 50% improvement in PsA activity, based on American College of Rheumatology 50, and weight reduction of at least 10%, compared to 0.8% of patients on Taltz monotherapy, meeting the primary endpoint. In a key secondary endpoint, Taltz plus Zepbound delivered a 64% relative increase over Taltz monotherapy in the proportion of patients who achieved ACR50, demonstrating that treatment of obesity or overweight with Zepbound reduced the burden of PsA. The study population included patients with a high disease burden at baseline and an average BMI of 37.6 kg/m2 across both arms. Patients had high disease activity and meaningful functional impairment. More than 60% had prior experience with one or more advanced therapies, reflecting a difficult-to-treat patient population. Adverse events in participants treated with concomitant administration of Taltz and Zepbound were generally mild to moderate, and the types of adverse events were consistent with the known safety profile of each medicine, the company stated. “TOGETHER-PsA represents a pioneering first step leveraging Lilly’s leadership in incretin science to deliver a major advance in disease outcomes for people living with the cumulative burden of psoriatic arthritis and obesity or overweight,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures, and we are particularly impressed with the findings showing significant improvement in PsA disease activity with Zepbound used alongside Taltz, an already rapid-acting and durable PsA treatment. These results demonstrate how an integrated treatment approach has the potential to improve the standard of care in a compelling and comprehensive way.”