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Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis

Authors :
Linda Stein Gold
Tianyu Zhan
Gabriela Alperovich
Howard Sofen
Benjamin Lockshin
Kenneth B. Gordon
Andrew Blauvelt
Patricia C. Lee
Jerry Bagel
Ziqian Geng
Ahmed M. Soliman
Source :
Journal of Dermatological Treatment. 33:2085-2093
Publication Year :
2021
Publisher :
Informa UK Limited, 2021.

Abstract

Risankizumab is approved for treatment of moderate to severe plaque psoriasis. Availability of a patient-controlled single self-injection of risankizumab may improve adherence and long-term management of psoriasis.To investigate efficacy, safety, and usability of a new risankizumab 150 mg/mL formulation administered as a single subcutaneous injection via prefilled syringe (PFS) or autoinjector (AI).Efficacy, safety, usability, and acceptability of risankizumab 150 mg/mL PFS or AI were investigated in adults with moderate to severe psoriasis in two phase 3 studies. Study 1 was a multicenter, randomized, double-blinded, placebo-controlled study that investigated 150 mg/mL risankizumab PFS; study 2 was a multicenter, single-arm, open-label study that investigated 150 mg/mL risankizumab AI.At week 16, risankizumab 150 mg/mL demonstrated efficacy vs. placebo (Psoriasis Area and Severity Index ≥90% improvement (PASI 90), 62.9% vs. 3.8%; static Physician Global Assessment (sPGA) 0/1, 78.1% vs. 9.6%; bothThe efficacy, safety, and usability of 150 mg/mL risankizumab delivered as a single PFS or AI injection support use of this new formulation in patients with moderate to severe plaque psoriasis.NCT03875482 and NCT0387508.

Details

ISSN :
14711753, 09546634, and 03875482
Volume :
33
Database :
OpenAIRE
Journal :
Journal of Dermatological Treatment
Accession number :
edsair.doi.dedup.....a4fff9e12acbac947aa85e1c982af577