Background/Purpose: Etanercept (ETN), an anti-TNF medication, was among the first biologics approved for psoriasis. Additional psoriasis medications that have been developed, or are in development, may benefit patients (pts) who do not adequately respond to ETN. The efficacy of tildrakizumab (TIL), a high-affinity, humanized, anti–interleukin-23p19 monoclonal antibody, was evaluated in pts with moderate to severe chronic plaque psoriasis who were partial responders (Psoriasis Area and Severity Index [PASI] ≥50–<75) or nonresponders (PASI <50) to ETN and were subsequently rerandomized to TIL in a phase 3 trial.

Methods: Pts with psoriasis (≥10% body surface area, Physician’s Global Assessment [PGA] ≥3, and PASI ≥12) participated in a 3-part, 52-week, randomized controlled trial (reSURFACE 2; NCT01729754). In Part 1 (Week [W]0–W12), pts were randomized to subcutaneous placebo (PBO), TIL 100 mg, or TIL 200 mg administered at W0 and W4, or ETN 50 mg administered 2x/wk. In Part 2 (W12–W28), TIL and ETN pts remained on the same treatment (TIL administered at W16; ETN 1x/wk), whereas PBO pts were rerandomized to TIL 100 or 200 mg. In Part 3 (W28–W52), ETN responders (PASI ≥75) were discontinued; partial and nonresponders were switched to TIL 200 mg (administered at W32, W36, W48). For this post hoc analysis, the proportions of pts (±SD) with PASI responses and PGA response (score of 0 [“clear”] or 1 [“minimal”] with at least a 2-grade score reduction from baseline) were determined at W52.

Results: In all, 1090 pts were randomized. Of the 313 pts randomized to ETN, by W28 there were 83 partial responders and 39 nonresponders. At W52 (after 20 weeks of TIL treatment) for ETN partial responders, 75%±5%, 34%±5%, 15%±4%, and 58%±5% had achieved PASI 75, 90, 100, and PGA responses, respectively, with TIL 200-mg treatment. At W52 for ETN nonresponders, 54%±6%, 31%±5%, 10%±3%, and 56%±5% had achieved PASI 75, 90, 100, and PGA responses, respectively, with TIL 200-mg treatment. Adverse events were similar in pts switched from ETN to TIL at W28 compared with the pts who were maintained on TIL through W52.

Conclusion: A substantial portion of patients with moderate to severe chronic plaque psoriasis who are partial responders or nonresponders to ETN may respond after switching to treatment with TIL 200 mg. TIL may be a reasonable option for those with inadequate response to ETN.

Analyses presented at the American Academy of Dermatology Annual Meeting, February 16–20, 2018, San Diego, CA, USA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-tildrakizumab-in-etanercept-partial-responders-or-nonresponders/