Metabolic syndrome does not appear to affect the safety and efficacy of tildrakizumab (Ilumya), according to a recent poster study. These findings were presented at the 2019 Society of Dermatology Physician Assistants Fall Conference in Scottsdale, AZ.
Using data from the phase 3 reSURFACE 1 and reSURFACE 2 trials, the researchers assessed the proportion of participants with and without metabolic syndrome with 75% or more improvement from baseline in Psoriasis Area and Severity Index (PASI 75) and PASI change from baseline to week 52. In addition, they assessed treatment-emergent adverse events and serious adverse events among participants with and without metabolic syndrome.
Among the 369 participants treated with 100 mg of tildrakizumab and 330 participants treated with 200 mg of tildrakizumab, 79 participants and 67 participants had metabolic syndrome. Compared with participants without metabolic syndrome, those with metabolic syndrome had higher median weight, body mass index, and prevalence of cardiovascular disease and diabetes.
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By week 12, 67% of participants with metabolic syndrome and 73% of participants without metabolic syndrome treated with 100 mg tildrakizumab achieved PASI 75, the researchers said. These rates were similar at week 52, with 80% of participants with metabolic syndrome and 86% without metabolic syndrome achieving PASI 75, they added.
In the 200 mg tildrakizumab group, PASI 75 was achieved by 55% of participants with metabolic syndrome and 64% of participants without metabolic syndrome at week 12 and 81% and 76%, respectively at week 52, the researchers stated.
In addition, the researchers observed decreases in PASI scores from baseline to week 52 in 88% and 91% of participants with and without metabolic syndrome, respectively, treated with 100 mg tildrakizumab and 85% and 88% of participants with and without metabolic syndrome treated with 200 mg of tildrakizumab.
Infections were the most common adverse event. Among participants with metabolic syndrome treated with 100 mg of tildrakizumab, gastrointestinal and cardiovascular disorders were the most common serious adverse events. Injury and procedural complications and nervous system disorders were the most common serious adverse events among participants with metabolic syndrome treated with 200 mg tildrakizumab. In addition, fatal adverse events occurred in 2 participants with metabolic syndrome and 2 participants without metabolic syndrome.
However, there were no reports of worsening diabetes by metabolic syndrome status, they added.
“Tildrakizumab efficacy was maintained in patients with metabolic syndrome and was comparable to patients without metabolic syndrome,” the researchers concluded. “Safety outcomes were consistent with the known safety profiles of tildrakizumab and did not differ based upon metabolic syndrome comorbidity.”
Lebwohl MG, Mehta NN, Gottlieb AB, Mendelsohn AM, Parno J, Rozzo SJ. Efficacy and safety of tildrakizumab in patients with preexisting metabolic syndrome: Post hoc analysis of 2 phase 3 clinical studies (reSURFACE 1 and reSURFACE 2). Presented at: 17th Society of Dermatology Physician Assistants Annual Fall Dermatology Conference; November 20-24, 2019; Scottsdale, AZ.