Taltz and Zepbound Phase 3b for psoriatic arhtritis

[Fred]

This was passed to me by Waine

Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with active psoriatic arthritis and obesity or overweight.

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Eli Lilly and Company announced positive topline results from the novel TOGETHER-PsA open-label Phase 3b trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared to Taltz alone in adults with active psoriatic arthritis (PsA) 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. TOGETHER-PsA is the first controlled study to evaluate an incretin therapy used with a PsA biologic. An estimated 65% of adults with PsA in the U.S. also have obesity (BMI ≥30 kg/m²) or overweight (BMI 27-29.9 kg/m²) with at least one additional weight-related comorbidity, highlighting a need for integrated treatment approaches that address the full burden of their diseases.

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 (ACR50), and weight reduction of at least 10%, compared to 0.8% of patients on Taltz monotherapy, meeting the primary endpoint (p<.001). In a key secondary endpoint, Taltz plus Zepbound delivered a 64% relative increase over Taltz monotherapy in the proportion of patients who achieved ACR50 (33.5% of patients vs. 20.4%, respectively, p<.05), 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.

"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."

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 most common adverse events occurring in ≥5% of participants were nausea, diarrhea, constipation and injection site reactions in the concomitant treatment arm, and injection site reactions and upper respiratory tract infections in the Taltz monotherapy arm.

Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. Zepbound is the only FDA-approved dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity management medication.

"While treatment guidelines for psoriatic arthritis recommend management of obesity, the reality is these two chronic diseases are often addressed separately and moving the needle in psoriatic arthritis has remained challenging," said Joseph F. Merola, M.D., Professor and Chair, Department of Dermatology and Professor of Internal Medicine in the Division of Rheumatic Diseases, UT Southwestern Medical Center. "The observed benefit with treatment using Taltz and Zepbound appears to meaningfully impact psoriatic disease activity, indicating that for many patients, PsA is an obesity-related condition. This integrated therapy approach represents a potential paradigm shift and could lead to better outcomes for those living with both diseases."

Source: lilly.com

Taltz (ixekizumab)

[Caroline]

Super interesting. !!