Indianapolis — Eli Lilly and Company announced 52-week results from two Phase 3b studies showing that Taltz and Zepbound used together maintained or further improved outcomes in adults with psoriatic disease and obesity or overweight.
The TOGETHER-PsO and TOGETHER-PsA trials evaluated Taltz (ixekizumab) plus Zepbound (tirzepatide) compared with Taltz alone in adults with moderate-to-severe plaque psoriasis or active psoriatic arthritis, respectively, who also had obesity or overweight with at least one additional weight-related condition.
At Week 36, the combination had already shown statistically superior improvements in disease activity and metabolic outcomes compared with Taltz alone. Lilly said the new data showed those benefits were maintained or further improved through Week 52, with no new safety concerns identified.
“The primary results from these first-of-their-kind studies were already remarkable, showing that Taltz and Zepbound used together improved outcomes for patients with psoriatic disease and obesity. What’s especially exciting now is seeing those improvements further deepened or sustained at one year, across disease activity, inflammation and metabolic outcomes,” said Mark Genovese, M.D., Senior Vice President of Lilly Immunology Development.
In TOGETHER-PsO, 30.6% of patients receiving Taltz plus Zepbound achieved complete skin clearance and at least 10% weight loss at Week 52, compared with 4.4% of patients receiving Taltz alone.
In TOGETHER-PsA, 39.2% of patients receiving the combination achieved at least a 50% reduction in psoriatic arthritis disease activity and at least 10% weight loss, compared with 1.7% with Taltz alone.
Complete skin clearance was achieved by 40.5% of patients receiving Taltz and Zepbound in the psoriasis study, compared with 29.1% receiving Taltz alone. In the psoriatic arthritis trial, 43.7% of combination-treated patients achieved an ACR50 response, compared with 15.7% receiving Taltz alone.
Lilly also reported deeper improvements in systemic inflammation and sustained or improved metabolic measures, including body mass index, blood pressure, glucose, HbA1c, triglycerides and total cholesterol.
Adverse events with the combination were generally mild to moderate and were consistent with the known safety profiles of the two medicines. The most commonly reported events included nausea, diarrhea, constipation, injection-site reactions, vomiting, dizziness and headache.
The TOGETHER-PsO trial enrolled 274 adults with moderate-to-severe plaque psoriasis, while TOGETHER-PsA enrolled 271 adults with active psoriatic arthritis. Participants were randomized to receive Taltz alone or Taltz with Zepbound for 52 weeks.
