Lilly: Taltz + Zepbound superior to Taltz alone in psoriatic arthritis with obesity
- Phase 3b TOGETHER-PsA randomized 52-week trial (NCT06588296) with 271 adults compared Taltz (ixekizumab) plus Zepbound (tirzepatide) versus Taltz alone, with primary endpoint at 36 weeks.
- Primary endpoint at 36 weeks: ACR50 plus ≥10% weight reduction achieved in 31.7% with combination versus 0.8% with Taltz alone.
- Combination also showed higher ACR50 (33.5% vs 20.4%), ≥10% weight loss (84.5% vs 4.5%) and improvements in MDA, fatigue, function, hsCRP and cardiometabolic markers.
- Adverse events with the combination were generally mild-to-moderate; most common (≥5%) were nausea, diarrhea, constipation and injection-site reactions.
Study design
TOGETHER-PsA is a 52-week, randomized, multicenter, assessor-blinded, open-label Phase 3b trial (NCT06588296) in 271 adults with active psoriatic arthritis and obesity/overweight plus ≥1 weight-related comorbidity; participants were randomized 1:1 to subcutaneous ixekizumab (Taltz) alone or concomitant ixekizumab and tirzepatide (Zepbound); primary endpoint was proportion achieving ACR50 and ≥10% weight reduction at Week 36.
Efficacy
At Week 36 the combination met the primary endpoint: 31.7% vs 0.8% (combination vs Taltz). Combination also showed higher ACR50 (33.5% vs 20.4%), ACR20+≥5% weight loss (69.7% vs 10.3%), ≥10% weight loss (84.5% vs 4.5%) and increased Minimal Disease Activity (26.3% vs 15.3%). Improvements were observed in hsCRP (−1.79 vs −0.44 mg/L), HAQ-DI (−0.5 vs −0.3), FACIT-Fatigue (8.6 vs 4.8) and SF-36 Mental Component Score (3.1 vs 0.4). An increased ACR50 was seen as early as Week 4, prior to clinically meaningful weight loss.
Safety
Adverse events with concomitant therapy were generally mild to moderate and consistent with known profiles; most common (≥5%) in the combination arm were nausea, diarrhea, constipation and injection-site reactions; Taltz monotherapy most commonly reported injection-site reactions and upper respiratory tract infections.
Dissemination
Results were presented as a late-breaking presentation at the 2026 AAD Annual Meeting and published in Arthritis & Rheumatology.
Source: Lilly