This extension study investigated the long-term efficacy and safety of tildrakizumab for patients with plaque psoriasis.
Data from the extension of the reSURFACE 2 trial of tildrakizumab in patients with plaque psoriasis indicated that both safety and efficacy were maintained over a 3-year period.
Melinda Gooderham, MD, dermatologist at the Skin Centre for Dermatology, Peterborough, Ontario, spoke with MD Magazine® about the data at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC.
“What we found in the extension is that the level of response that patients achieved in the first 52 weeks was maintained throughout the 3-year period,” Gooderham told MD Mag. She added that no safety signals were seen outside of the typical rates of infections, malignancies, and cardiovascular events for this patient population.
The poster, “Efficacy and Safety of Long-term Tildrakizumab for Plaque Psoriasis: 3-Year Results From reSURFACE 2,” was shared at the AAD Annual Meeting, held March 1-5, 2019.
MD Mag: Which patients were eligible for the reSURFACE 2 extension?
Gooderham: The patients who completed the base study, which was 52 weeks, and had a PASI
50 response or greater, were eligible to continue on into the extension study.
What efficacy and safety results did you see in the reSURFACE 2 extension?
I think well, the 2 main things we were looking at are efficacy and safety. What we found in the extension is that the level of response that patients achieved in the first 52 weeks was maintained throughout the 3-year period that has been presented this week. And these patients are still enrolled and still in the trial, so, we'll continue to gather more data about them. But the patients who reached complete clear skin maintained their clear skin and patients with almost clear skin maintained that almost clear skin throughout the 3-year period, which was really—from a patient's point of view—quite amazing that they could have that durable response with this therapy.
The other main thing we look for in longer studies is safety. Obviously, that's how we pick up rare events—the more patients you have and the longer time, it is more likely you'll pick up these rare things, which was not the case. We haven't seen any signals or things that we're worried about such as serious infections, malignancy—we were not seeing any new signals coming up throughout this time period, in either of the studies, which is 700+ patients through time. So, I think with serious infection rates like 1.2, 1.3 per 100 patient years. Malignancy was 1 per 100 patient years. Major adverse cardiovascular events or MACE events was, I think, 0.6 or less and these are all the rates that we would typically see in that patient population anyway. So, it's not they're not related to the therapy that the patients are taking for this chronic condition.