Tildrakizumab Provides Durable, Quality-of-Life Improvements in Moderate-to-Severe Plaque Psoriasis
By Jenny Powers
PARIS -- September 18, 2018 -- Tildrakizumab provided significant improvements to the Dermatology Life Quality Index (DLQI) that were sustained up to 64 weeks in patients with moderate-to-severe psoriasis, according to results from a post hoc pooled analysis of data from the reSURFACE-1 and reSURFACE-2 trials reported here at the 27th Congress of the European Academy of Dermatology and Venereology (EADV).
“Tildrakizumab 200 mg and 100 mg were efficacious compared with placebo and etanercept and were well tolerated in the treatment of patients with moderate-to-severe chronic plaque psoriasis,” said Kristian Reich, MD, PhD, Dermatologikum Berlin and Sciderm Research Institute, Hamburg, Germany, on September 14. “This response was significant and sustained,” Dr. Reich added.
In both of the reSURFACE trials, the proportion of patients achieving DLQI 0/1 after tildrakizumab treatment increased from baseline to week 28 (P
A significant proportion of patients showed no response or a partial response to etanercept. Of these patients, 17.5% of nonresponders and 48.3% of partial responders crossing over to 200 mg tildrakizumab at week 28 achieved DLQI 0/1 by week 52 (P
The reSURFACE1 and reSURFACE2 trials were 3-part, parallel-group, double-blinded, randomised controlled trials. Enrolled patients were required to have moderate-to-severe chronic plaque psoriasis affecting ≥10% of their body surface area plus scores of ≥3 on the Physicians Global Assessment scale (score range, 1 [mild disease] to 5 [severe disease]) and scores of ≥12 on the Psoriasis Area and Severity Index (PASI; scores ≥12 indicate moderate-to-severe disease).
Dr. Reich and colleagues evaluated the endpoints of reSURFACE-1 (64 weeks) and reSURFACE-2 (52 weeks). In reSURFACE-1, at week 12 of part 1, patients were randomised 2:2:1 to receive tildrakizumab 200 or 100 mg or placebo. In reSURFACE-2, patients were randomised 2:2:1:2 to receive tildrakizumab 200 or 100 mg, placebo, or etanercept. In part 2 of reSURFACE-1, patients receiving placebo were rerandomised to receive tildrakizumab 200 or 100 mg. In part 3, responders achieving PASI ≥75% were randomised to continue to receive the same tildrakizumab dose or placebo with retreatment on relapse. In reSURFACE-2, patients responding to the 200-mg tildrakizumab dose were randomised to receive tildrakizumab 200 or 100 mg; those responding to the 100-mg dose continued on the same dose.
In both studies, partial responders demonstrating PASI ≥50 to
Dr. Reich and colleagues assessed the DLQI at baseline and weeks 12, 28, 40, and 52. A total of 622 patients received tildrakizumab 200 mg, 616 received tildrakizumab 100 mg, 311 received placebo, and 313 received etanercept. The mean baseline DLQI pooled scores were 20.2, 19.8, 19.9, and 15.2, respectively.
Tildrakizumab is a high-affinity anti-interleukin-23p19 monoclonal antibody in development for the treatment of chronic plaque psoriasis. The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended tildrakizumab for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Funding for this study was provided by Merck & Co., Kenilworth, New Jersey, for the reSURFACE studies.
[Presentation title: Improvements in Dermatology-Specific Health-Related Quality of Life in Patients With Moderate-to-Severe Psoriasis Treated With Tildrakizumab: Pooled Results From reSURFACE 1 and reSURFACE 2 Phase 3 Trials. Abstract P1919]