Background/Purpose: We assessed residual plaque psoriasis in patients successfully treated with anti–interleukin-23p19 monoclonal antibody tildrakizumab (TIL) who interrupted treatment, relapsed, and were retreated vs continuously treated patients in a post hoc analysis of reSURFACE 1.

Methods: reSURFACE 1 was a 3-part, double-blind, randomized, controlled, 64-week phase 3 study of TIL 100 mg in adults with moderate-to-severe plaque psoriasis (NCT01722331).¹ Patients receiving TIL 100 mg at weeks 0, 4, and 16, and every 12 weeks thereafter who achieved ≥75% relative improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 28 were rerandomized to receive placebo (N = 113) or continue TIL 100 mg (N = 116). Residual disease (PASI score) and adverse events (AEs) were evaluated every 4 weeks through week 64. Relapse was defined as ≥50% loss of maximum PASI response; successful retreatment as regaining ≥50% of previous maximum PASI response. Patients rerandomized to placebo who relapsed were reassigned to TIL 100 mg; those retreated for ≥12 weeks were included in efficacy analyses. Missing data were imputed using last-observation-carried-forward.

Results: The 61/113 (54.0%) patients rerandomized to placebo who relapsed had median PASI scores at baseline, week 28, and time of relapse of 20.3, 0.8, and 11.0, respectively. Median (interquartile range [IQR]) time to relapse was 238 (167, 294) days. Among 51 patients retreated for ≥12 weeks, median (IQR) time to regain response was 28 (28, 48) days. Median PASI scores were 5.9, 3.2, and 2.7 after 4 (n = 51), 8 (n = 46), and 12 weeks (n = 33) of retreatment, respectively. At week 64 (n = 61), 72.1%/31.2%/13.1% of these patients achieved PASI 75/90/100 responses, respectively.

The 52/113 (46.0%) patients who did not relapse 36 weeks after rerandomization to placebo (week 64) had median PASI scores of 0.8, 2.6, and 4.0 at weeks 28, 52, and 64, respectively. Of patients who continued TIL, 8/116 (6.9%) relapsed after week 28—7 on only 1 visit—and 100% completed the study with median (IQR) PASI score 1.4 (0.0, 3.4). For 108/116 (93.1%) patients who maintained response on TIL 100 mg, median (IQR) PASI at weeks 28, 52, and 64 was 1.0 (0.0, 2.2), 1.0 (0.0, 2.4), and 1.2 (0.0, 3.0).

Two AEs of interest occurred in 2/113 (1.8%) responders rerandomized to placebo after week 28 (cerebellar infarction and basal cell carcinoma). In patients rerandomized to TIL after week 28 (including partial responders), 3/135 (2.2%) reported 4 AEs of interest (basal cell carcinoma, Bowen’s disease, carcinoma in situ of the skin, and sinusitis).

Conclusion: In reSURFACE 1, 46.5% of patients treated with TIL 100 mg for 28 weeks and rerandomized to placebo for 36 weeks did not relapse 48 weeks after last TIL dose. In patients who relapsed, residual disease was successfully treated with TIL 100 mg within a median of 28 days. Continuation of TIL was associated with low residual disease; 93.1% of patients responded and all completed the study. Approximately 50% of patients who continued TIL 100 mg to week 52 had residual PASI scores ≤1.0.

Medical writing support was provided by Judy Phillips, DVM, PhD, of AlphaBioCom, LLC.

References:

1. Reich K, et al. Lancet. 2017;390:276–288.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-tildrakizumab-100-mg-for-plaque-psoriasis-in-patients-randomized-to-treatment-continuation-vs-treatment-withdrawal-with-retreatment-upon-relapse-in-a-phase-3-study/