Eli Lilly and Company has reported promising 52-week results from the Phase IIIb TOGETHER-PsA trial assessing Taltz (ixekizumab) alongside Zepbound (tirzepatide) for active psoriatic arthritis (PsA) in adults with overweight or obesity.
The multicentre, randomised, open-label, assessor-blinded study (NCT06588296) evaluated subcutaneous Taltz in combination with Zepbound, compared with Taltz alone, in participants advised to reduce their calorie intake and exercise.
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The trial enrolled 271 adult patients with active disease and a body mass index (BMI) of at least 30kg/m², or 27 to under 30kg/m² alongside a weight-related comorbidity.
The primary endpoint assessed the proportion of patients who achieved both a 50% improvement according to American College of Rheumatology criteria (ACR50) and at least a 10% reduction in body weight at week 36.
Exploratory 52-week results revealed 39.2% of patients receiving the combination therapy achieved this dual metric, compared to 1.7% of individuals who received the monotherapy.
Furthermore, 43.7% of patients receiving dual therapy achieved an ACR50 response at one year, compared with 15.7% of those receiving Taltz alone.
Weight reductions of 10% or greater occurred in 85.7% of combination participants and 6.7% of monotherapy patients by week 52.
Lilly Immunology’s development senior vice president Mark Genovese said: “It’s remarkable to see the durability of efficacy and breadth of outcomes with Taltz and Zepbound at one year in measures that matter most to patients with psoriatic arthritis and obesity or overweight, from improvements in disease control to physical function and fatigue,
“Data from TOGETHER-PsA continue to evolve our understanding of immunometabolic health and show what may be possible for patients when these chronic conditions are treated together to address the combined disease burden.”
Exploratory analyses showed minimal disease activity (MDA) was attained by 28.2% of dual-treatment patients versus 13.6% for monotherapy at week 52.
Reported adverse events (AEs) were mostly mild to moderate, reflecting the recognised safety profile of each compound without presenting unexpected safety signals.
Frequent AEs affecting at least 5% of combination patients included constipation, diarrhoea, dizziness, headache, injection site reactions, nausea, sinusitis, urinary tract infections, and vomiting.
For patients receiving monotherapy, reported adverse events occurring in at least 5% comprised arthralgia, diarrhoea, injection site reactions, and upper respiratory tract infections.
Baseline patient BMI averaged 37.6, matching broader clinical contexts where around 65% of PsA cases in the US feature concurrent obesity or overweight.
In September this year, Lilly reported findings from an indirect treatment comparison analysing data from the ACHIEVE-3 and PIONEER PLUS studies of its investigational therapy Foundayo (orforglipron) against oral semaglutide in adults with type 2 diabetes.
