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Clinical Trial
. 2019 Aug;46(8):686-694.
doi: 10.1111/1346-8138.14941. Epub 2019 Jun 25.

Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial

Mamitaro Ohtsuki  1 , Hideki Fujita  2 , Mitsunori Watanabe  3 , Keiko Suzaki  3 , Mary Flack  4 , Xin Huang  5 , Susumu Kitamura  6 , Joaquin Valdes  5 , Atsuyuki Igarashi  7
Affiliations
Clinical Trial

Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial

Mamitaro Ohtsuki et al. J Dermatol. 2019 Aug.

Abstract

Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, selectively inhibits interleukin-23, a key cytokine in the pathogenesis of psoriasis, by binding to its p19 subunit. In SustaIMM (ClinicalTrials.gov/NCT03000075), a phase 2/3, double-blinded, placebo-controlled study, Japanese patients with moderate to severe plaque psoriasis (n = 171) were stratified by bodyweight and concomitant psoriatic arthritis and randomized 2:2:1:1 to 75 mg risankizumab, 150 mg risankizumab, placebo with cross-over to 75 mg risankizumab and placebo with cross-over to 150 mg risankizumab. Dosing was at weeks 0, 4, 16, 28 and 40, with placebo cross-over to risankizumab at week 16. The primary end-point was 90% or more improvement from baseline in Psoriasis Area and Severity Index (PASI-90) at week 16 for risankizumab versus placebo. Missing data were imputed as non-response. All primary and psoriasis-related secondary end-points were met for both risankizumab doses (P < 0.001). At week 16, PASI-90 responses were significantly higher in patients receiving 75 mg (76%) or 150 mg (75%) risankizumab versus placebo (2%). Corresponding response rates were 86%, 93% and 10% for static Physician Global Assessment (sPGA) score of clear/almost clear; 90%, 95% and 9% for PASI-75; and 22%, 33% and 0% for PASI-100, with significantly higher responses for both risankizumab doses versus placebo. Through week 52, PASI and sPGA responses increased or were maintained and treatment-emergent adverse events were comparable across treatment groups. Both doses of risankizumab were superior to placebo in treating patients with moderate to severe plaque psoriasis. The safety profile was consistent with previous risankizumab trials, with no new or unexpected safety findings.

Keywords: Japanese patient; interleukin-23; plaque psoriasis; psoriasis; risankizumab.

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Conflict of interest statement

The authors and AbbVie scientists designed the study and analyzed and interpreted the data. All authors contributed to the development of the content, all authors and AbbVie reviewed and approved the manuscript, and the authors maintained control over the final content. M. O. has received honoraria or fees for serving on advisory boards, as a speaker and as a consultant, and grants as an investigator from AbbVie, Celgene, Eisai, Eli Lilly and Company, Janssen, LEO Pharma, Maruho, Mitsubishi‐Tanabe, Novartis and Torii. H. F. has received honoraria or fees for serving on advisory boards and as a speaker and grants as an investigator from AbbVie, Celgene, Eisai, Eli Lilly and Company, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi‐Tanabe, Novartis, Taiho and Torii. M. W., K. S. and M. F. are full‐time employees of Boehringer Ingelheim. X. H., S. K. and J. V. are full‐time employees of AbbVie and may own stock/options. A. I. has received honoraria or fees for serving on advisory boards, as a speaker and as a consultant, and grants as an investigator from AbbVie, Celgene, Eli Lilly, Janssen, Kyowa Hakko Kirin, Maruho and Novartis.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Patient disposition. AE, adverse event.
Figure 3
Figure 3
Percentage of patients with PASI‐90 responses at weeks 16 and 52. PASI‐90, 90% or more improvement from baseline in Psoriasis Area and Severity Index. ***P < 0.001 vs placebo.
Figure 4
Figure 4
sPGA 0/1, PASI‐75, PASI‐100 and DLQI 0/1 responses at weeks 16 and 52. DLQI 0/1, Dermatology Life Quality Index showing no effect on patient's life; PASI‐75/PASI‐100, 75% or more/100% improvement from baseline in Psoriasis Area and Severity Index; sPGA 0/1, static Physician Global Assessment of clear/almost clear. ***P < 0.001 vs placebo.
Figure 5
Figure 5
Changes in the rates of clinical response over time, measured as PASI‐90 and ‐100. PASI‐90/PASI‐100, 90% or more/100% improvement from baseline in Psoriasis Area and Severity Index. *P < 0.05; **P < 0.01; ***P < 0.001 vs placebo.
See this image and copyright information in PMC

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