Tildrakizumab may be effective long-term psoriasis treatment
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Tildrakizumab continued to demonstrate efficacy after 5 years of treatment for psoriasis, according to pooled data from the reSURFACE 1 and reSURFACE 2 trials.
The two randomized, double-blind, placebo-controlled, parallel-group phase 3 trials evaluated Ilumya (tildrakizumab, Sun Pharmaceutical), a humanized IgG1 kappa monoclonal antibody designed to selectively bind to the p19 subunit of IL-23, in patients with moderate to severe plaque psoriasis.
“Moderate to severe plaque psoriasis is a chronic disease that typically requires ongoing treatment,” study co-author Stephen J. Rozzo, PhD, senior director of dermatology medical affairs at Sun Pharmaceutical, told Healio. “Treatments that work very quickly or are safe and effective in the short term do not necessarily safely maintain long-term disease control. Long-term efficacy and safety data of biological therapies are crucial to inform clinical practice.”
Five-year data from the long-term extensions of the trials, as reported in the British Journal of Dermatology, focused on those who responded to tildrakizumab 100 mg or 200 mg at week 28 and continued the same dose.
Of those who received tildrakizumab 100 mg, 75% or greater reduction in Psoriasis Area and Severity Index was reported in 99.7%, PASI 90 was reported in 70.8% and PASI 100 was reported in 28.6% at week 28. At week 244, 88.7%, 65.9% and 32.8% achieved PASI 75/90/100, respectively.
Of those in the 200 mg group, PASI 75/90/100 was reported in 100%, 73.1% and 36.6%, respectively, at week 28 and 92.5%, 69.5% and 40.8%, respectively, at week 244.
Some patients who had a partial response or nonresponse to etanercept in the initial trial were switched to tildrakizumab 200 mg for the continuation trial. Of these 81.3%, 49.5% and 21.5% achieved PASI 75/90/100, respectively, at week 244.
“At week 244, across participating subjects who had at least a 90% reduction in their PASI score at week 28 with either dose of drug, 93% maintained that extent of improvement,” Rozzo said. “These clinical trial results suggest that tildrakizumab’s efficacy and safety profiles may be both favorable and well sustained in long-term treatment.”