The efficacy and safety of various tildrakizumab dosing schedules in patients with plaque psoriasis is supported by clinical trial data published in the British Journal of Dermatology. Tildrakizumab initiation, dose adjustment, interruption, and reinitiation were well tolerated by patients.
The investigators abstracted data from 2 randomized placebo-controlled clinical trials of tildrakizumab: reSURFACE 1 and 2. Both studies enrolled adult patients (age ≥18 years) with moderate to severe chronic plaque psoriasis. In Part 1 (weeks 0 to 12), patients were randomly assigned to receive subcutaneous tildrakizumab 200 mg (T200), tildrakizumab 100 mg (T100), placebo (PBO), or etanercept (ETN) 50 mg. In Part 2 (weeks 12 to 28), patients taking PBO were re-randomized to T100 or T200. In Part 3 (weeks 28 to 52 for reSURFACE 1; weeks 28 to 64 for reSURFACE 2), tildrakizumab responders and partial responders were re-randomly assigned to the same dosage of tildrakizumab (T100/T100 or T200/T200), a higher/lower dosage of tildrakizumab (T100/T200 or T200/T100), or PBO (T100/PBO or T200/PBO). At week 28, ETN partial responders and nonresponders were switched to T200. Treatment response was defined as achieving a ≥75% reduction in Psoriasis Area and Severity Index (PASI) score from baseline (PASI75); partial response was described as a 50% to 75% reduction in PASI score. Investigators assessed rates of treatment response in each Part 3 treatment group.
Overall, 1862 patients were randomly assigned to the studies, of whom 1770 completed Part 1. A total of 676 and 794 patients participated in Part 3 of reSURFACE 1 and reSURFACE 2, respectively. Demographic characteristics were similar between the study cohorts. In the T100/T100 (n=40) and T200/T200 (n=102) patients who were partial responders at week 28, the number of treatment responders increased over time. At the end of Part 3, 64% of T100/T100 patients and 52.5% of T200/T200 patients had achieved PASI ≥75%. In patients switched from T100 to a higher dose (T100/T200) who were partial responders at week 28, 38.5% and 63.2% achieved full response at weeks 32 and 52, respectively. Mean time to relapse was 24 weeks in both the T100/PBO and T200/PBO subgroups. However, in patients in the T100/PBO and T200/PBO subgroups who reinitiated treatment, 86% and 83% achieved treatment response by week 64, respectively. In patients switched from ETN to T200 at week 28, 24.1% and 74.7% were treatment responders by week 32 and week 52, respectively. In analyses that redefined treatment response using PASI90, PASI100, or Physician Global Assessment, results were similar.
These data support the efficacy of long-term continuous dosing with tildrakizumab in the treatment of plaque psoriasis. In addition, the results could be regained after interruption and reinitiation. Of note, the small number of partial responders may have underpowered certain analyses. Results must be extrapolated with care. “[These data] demonstrate the efficacy and tolerability of tildrakizumab for patients under various changing treatment scenarios,” the investigators wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures
Kimball AB, Papp KA, Reich K, et al. Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies [published online September 5, 2019]. Br J Dermatol. doi:10.1111/bjd.18484