At 36 weeks, 27% of patients receiving ixekizumab plus tirzepatide achieved both complete skin clearance and at least 10% weight loss compared with 6% receiving ixekizumab alone, according to a press release from Eli Lilly and Company.
In the phase 3b TOGETHER-PsO trial, concomitant treatment with ixekizumab and tirzepatide met the primary endpoint of superiority vs ixekizumab monotherapy in achieving complete skin clearance and at least 10% weight reduction.
In a key secondary analysis, 41% of patients in the combination arm achieved Psoriasis Area and Severity Index 100 compared with 29% in the monotherapy arm, representing a 40% relative increase in the proportion of patients attaining complete skin clearance.
TOGETHER-PsO was a 52-week, randomized, multicenter, assessor-blinded, open-label phase 3b trial that enrolled 274 adult patients with moderate-to-severe plaque psoriasis and obesity, defined as a body mass index (BMI) of at least 30 kg/m², or overweight, defined as a BMI of at least 27 and less than 30 kg/m² with at least one weight-related comorbid condition. Participants were randomized 1:1 to receive subcutaneous ixekizumab alone or concomitantly with tirzepatide. All patients received counseling on a reduced-calorie diet and increased physical activity.
The study population reflected substantial disease burden, with a mean BMI greater than 39 kg/m² across both treatment arms. On average, approximately 25% of body surface area was affected, and 97% of patients had psoriasis involving high-impact areas, including the face, scalp, or genitals.
Ixekizumab is a monoclonal antibody that selectively binds interleukin 17A and is approved for moderate-to-severe plaque psoriasis in children aged 6 years and older and in adults, as well as for psoriatic arthritis and axial spondyloarthritis. Tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the US for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity, and for moderate-to-severe obstructive sleep apnea in adults with obesity.
Adverse events with concomitant therapy were generally mild to moderate and consistent with the established safety profiles of each agent. The most reported adverse events in the combination arm included nausea, diarrhea, constipation, injection site reactions, vomiting, dizziness, and dosing error. Detailed 36-week results are expected to be published in a peer-reviewed journal.
Source: Eli Lilly and Company
