Tildrakizumab Consistent in Reducing Plaque Psoriasis Regardless of Prior Biologic Exposure

September 19, 2018

By Jenny Powers

PARIS -- September 18, 2018 -- Tildrakizumab is highly effective in patients with moderate to severe plaque psoriasis regardless of whether they had received prior biologic therapy, according to findings from a post hoc pooled analysis of data from the reSURFACE-1 and reSURFACE-2 trials presented here at the 27th Congress of the European Academy of Dermatology and Venereology (EADV).

“Overall, the PASI [Psoriasis Area Severity Index] improvement was the highest for PASI 100 and the lowest for PASI MD, MBA, Oregon Medical Research Center, Portland, Oregon, on September 14. “Patients demonstrating PASI 90 to 100 at week 28 had shown rapid PASI improvement by week 4 with tildrakizumab, which indicates that ‘super responders’ might be identified early during the therapy.”

This analysis of patients who had not received prior biologic therapy (bio-naive) treated with 100 mg tildrakizumab showed that PASI 100 response was achieved by 24.4%, PASI 90 to 99 by 29.9%, PASI 75 to 89 by 24.2%, PASI 50 to 74 by 14.5%, and PASI

In the biologic-experienced cohort, PASI 100, 90 to 99, 75 to 89, 50 to 74, and

Both bio-naive and bio-experienced patients receiving tildrakizumab at either dose level and who achieved week-28 PASI 90 to 100 showed a ≥44% PASI improvement at week 4.

Dr. Blauvelt and colleagues evaluated the efficacy of tildrakizumab using data from the reSURFACE-1 and -2 trials that were stratified by week-28 response levels and prior biologic use. Both studies used a 3-part study design. Part 1 randomised patients to placebo or tildrakizumab 100 or 200 mg. Part 2 rerandomised placebo patients to tildrakizumab. In part 3, patients were rerandomised according to a PASI response of ≥50 (PASI 50) to continue tildrakizumab at adjusted doses or to receive placebo (reSURFACE 1 only).

The analysis included patients receiving tildrakizumab at 100 or 200 mg over the first 28 weeks in the trials, and the data were further stratified within 100- or 200-mg dose cohorts according to whether the patients received prior biologic treatment for psoriasis. Each subcohort was further divided into 5 mutually exclusive groups based on achievement of PASI 100, 90 to 99, 75 to 89, 50 to 74, and

The reSURFACE 1 and reSURFACE 2 trials comprised 926 adults with moderate to severe plaque psoriasis; this analysis included 475 bio-naive and 100 bio-experienced patients who received tildrakizumab 100 mg and 482 bio-naive and 99 bio-experienced patients treated with tildrakizumab 200 mg in the trials.

“The majority of bio-naive and bio-experienced patients achieved a PASI ≥50 response at week 28. These PASI improvements were maintained or expanded from week 28 to 52,” Dr. Blauvelt noted.

Recently, the US Food and Drug Administration approved tildrakizumab for adults with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy. Tildrakizumab is a selective interleukin-23p19 inhibitor that is administered by subcutaneous injection.

Funding for this study was provided by Merck & Co., Kenilworth, New Jersey, for the reSURFACE studies.

[Presentation title: Tildrakizumab Efficacy Over Time Stratified by Week-28 Response Levels and by Prior Biologic Use. Abstract P1952]