Lilly reports one-year data on Taltz and Zepbound combined in psoriatic disease
Eli Lilly and Company (NYSE: LLY) announced 52-week results from two Phase 3b clinical trials evaluating the combined use of Taltz (ixekizumab) and Zepbound (tirzepatide) in adults with psoriatic disease and obesity or overweight.
The TOGETHER-PsO and TOGETHER-PsA trials enrolled 274 and 271 adults, respectively, with moderate-to-severe plaque psoriasis or active psoriatic arthritis. Participants were randomized to receive either Taltz alone or Taltz combined with Zepbound, with all participants also receiving diet and physical activity counseling.
According to results from the company's press release, the combined therapy showed improvements maintained or extended through Week 52 across disease activity, inflammation, and metabolic measures, building on statistically superior results previously reported at the Week 36 primary endpoint.
In TOGETHER-PsO, 30.6% of patients receiving both drugs achieved complete skin clearance plus at least 10% weight loss at Week 52, compared with 4.4% on Taltz alone. In TOGETHER-PsA, 39.2% of combination-arm patients achieved a 50% or greater reduction in disease activity plus at least 10% weight loss, versus 1.7% in the monotherapy group.
Complete skin clearance was maintained in 40.5% of combination patients in the psoriasis trial versus 29.1% for monotherapy. In the psoriatic arthritis trial, 43.7% of combination patients achieved ACR50 at Week 52 compared with 15.7% on Taltz alone.
Improvements in metabolic markers including BMI, blood pressure, glucose, HbA1c, triglycerides, and cholesterol were sustained or further improved in the combination arm. Systemic inflammation, as measured by high-sensitivity C-reactive protein, also showed deeper reductions over time.
Adverse events were described as generally mild to moderate and consistent with the known profiles of each drug. The most common events reported in at least 5% of combination-arm participants were nausea, diarrhea, constipation, injection site reactions, vomiting, dizziness, and headache. No new safety concerns were identified.
Lilly noted the Week 52 analyses are pre-specified exploratory objectives without multiplicity control. Full results are expected to be presented at future medical meetings and published in peer-reviewed journals.
