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Clinical Trial
. 2024 Jul;91(1):91-99.
doi: 10.1016/j.jaad.2024.03.025. Epub 2024 Mar 28.

Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b study

Kurt Gebauer  1 , Lynda Spelman  2 , Paul S Yamauchi  3 , Jerry Bagel  4 , Tushar Nishandar  5 , Michael Crane  6 , Iris Kopeloff  6 , Mudgal Kothekar  7 , Siu-Long Yao  6 , Howard L Sofen  3
Affiliations
Free article
Clinical Trial

Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b study

Kurt Gebauer et al. J Am Acad Dermatol. 2024 Jul.
Free article

Abstract

Background: Scalp psoriasis is common and difficult to treat.

Objective: To evaluate efficacy and safety of tildrakizumab for the treatment of scalp psoriasis.

Methods: In this Phase 3b, randomized, double-blind, placebo (PBO)-controlled study (NCT03897088), patients with moderate-to-severe plaque psoriasis affecting the scalp (Investigator Global Assessment modified [IGA mod] 2011 [scalp] ≥3, Psoriasis Scalp Severity Index [PSSI] ≥12, ≥30% scalp surface area affected) received tildrakizumab 100 mg or PBO at W0 and W4. The primary endpoint was IGA mod 2011 (scalp) score of "clear" or "almost clear" with ≥2-point reduction from baseline at W16 (IGA mod 2011 [scalp] response). Key secondary endpoints were PSSI 90 response at W12 and W16 and IGA mod 2011 (scalp) response at W12. Safety was assessed from adverse events.

Results: Of patients treated with tildrakizumab (n = 89) vs PBO (n = 82), 49.4% vs 7.3% achieved IGA mod 2011 (scalp) response at W16 (primary endpoint) and 46.1% vs 4.9% at W12; 60.7% vs 4.9% achieved PSSI 90 response at W16 and 48.3% vs 2.4% at W12 (all P < .00001). No serious treatment-related adverse events occurred.

Limitations: Only short-term data are presented.

Conclusion: Tildrakizumab was efficacious for the treatment of scalp psoriasis with no new safety signals.

Keywords: efficacy; itch; psoriasis; safety; scalp; tildrakizumab.

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Conflict of interest statement

Conflicts of interest KG has received grants and/or honoraria as a consultant, investigator, and/or speaker for Abbott, AbbVie, Amgen, Anacor, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Regeneron Pharmaceuticals, Sandoz, Sanofi-Aventis, Schering-Plough, Sun Pharma, UCB, and Wyeth Pharmaceuticals, and has been on an advisory board for AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen, and LEO Pharma. LS has been a consultant, paid investigator, advisory board member and/or speaker for AbbVie, Amgen, Anacor, Ascend, Astellas Pharma, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol-Myers Squibb, Celgene Corporation, Connect Biopharmaceuticals Australia, Dermira, Eli Lilly, Enkang Pharmaceuticals, Equillium Inc., Evelo Biosciences, Genesis Care, Galderma, Genentech, GSK, Hexima, InCyte, InflaRx GmbH, Invion, Janssen, Kiniksa Pharmaceuticals, KoBioLabs, LEO Pharma, LG Chem, Lipidio Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Nektar Therapeutics, Novartis, Olix Pharmaceuticals, Otsuka, Pfizer, Phosphagenics Limited, Photon MD, Principia, Regeneron Pharmaceuticals, Ribon, Samumed, Sanofi, SHR, Sun Pharma, Takeda, UCB, and Zai Lab. JB has received research funds for the Psoriasis Treatment Center from AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Corrona LLC, Dermavant Sciences, Dermira, Eli Lilly, Glenmark Pharmaceuticals Ltd, Janssen Biotech, Kadmon Corporation, LEO Pharma, LTD, Lycera Corp, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sun Pharma, Taro Pharmaceutical Industries Ltd, and UCB; is or has been a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly, Janssen Biotech, Novartis, Sun Pharma, and UCB; and is or has been a speaker for AbbVie, Celgene Corporation, Eli Lilly, Janssen Biotech, and Novartis. TN is an employee of Sun Pharmaceutical Industries Limited, Goregaon (E), Mumbai, India. MK is an employee of Sun Pharma Advanced Research Company Limited. MC and SLY are employees of Sun Pharmaceutical Industries, Inc. IK is a former employee of Sun Pharmaceutical Industries, Inc., and a current employee of Formation Bio. HLS has served as a clinical investigator for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences, Eli Lilly, Janssen, LEO Pharma, Novartis, Sun Pharma, and UCB.

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