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Clinical Trial
. 2024 Mar;51(3):365-379.
doi: 10.1111/1346-8138.17074. Epub 2024 Jan 24.

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results from an open-label, phase 3 trial

Shinichi Imafuku  1 , Yukari Okubo  2 , Yayoi Tada  3 , Mamitaro Ohtsuki  4 , Elizabeth Colston  5 , Andrew Napoli  5 , Yanqiu Shao  5 , Subhashis Banerjee  5 , Akimichi Morita  6
Affiliations
Clinical Trial

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results from an open-label, phase 3 trial

Shinichi Imafuku et al. J Dermatol. 2024 Mar.

Abstract

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adult patients with plaque (PP), generalized pustular (GPP), and erythrodermic (EP) psoriasis who have had an inadequate response to conventional systemic therapies. This approval is based on results from the global phase 3 POETYK PSO-1 and PSO-2 trials in which deucravacitinib was associated with significantly improved efficacy outcomes compared with placebo in adults with moderate to severe plaque psoriasis, and results described here from POETYK PSO-4, an open-label, single-arm, phase 3 trial (NCT03924427), which evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adult Japanese patients with PP, GPP, or EP. The coprimary endpoints were the proportion of patients achieving a ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1) with at least a two-point improvement from baseline at week 16. Nonresponder imputation was used for missing data. Efficacy responses, adverse events (AEs), and serious AEs (SAEs) were recorded for up to 52 weeks. Seventy-four patients were treated (PP, n = 63; GPP, n = 3; EP, n = 8). At week 16, 76.2%, 66.7%, and 37.5% of patients with PP, GPP, and EP, respectively, had achieved PASI 75, and 82.5%, 0.0%, and 50.0% had achieved sPGA 0/1. Responses were overall maintained through week 52. AEs occurred in 74.6% of patients with PP, 100% of patients with GPP, and 87.5% of patients with EP. The most common AEs were nasopharyngitis and acne. Rates of SAEs and discontinuations were low. There were no deaths. Deucravacitinib was effective and well tolerated in Japanese patients with moderate to severe PP and in a limited number of patients with GPP or EP.

Keywords: Asian population; clinical trial; phase 3; psoriasis; tyrosine kinase 2.

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Conflict of interest statement

S.I. has received grants and personal fees from AbbVie, Eisai, Janssen, Kyowa Kirin, Leo Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin, and has received personal fees from Amgen (Celgene), Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Novartis, and UCB. Y.O. has received research grants from AbbVie, Eisai, Maruho, Shiseido, Sun Pharma, and Torii Pharmaceutical; has received honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Janssen Pharma, Jimro, Kyowa Kirin, Leo Pharma, Maruho, Novartis Pharma, Pfizer, Sanofi, Sun Pharma, Taiho Pharmaceutical, Tanabe‐Mitsubishi, Torii Pharmaceutical, and UCB; and has conducted clinical trials for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, Maruho, Pfizer, Sun Pharma, and UCB. Y.T. has received research grants from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Jimro, Kyowa Kirin, Leo Pharma, Maruho, Sun Pharma, Taiho Pharmaceutical, Tanabe‐Mitsubishi, Torii Pharmaceutical, and UCB; has received honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Janssen, Jimro, Kyowa Kirin, Leo Pharma, Maruho, Novartis, Pfizer, Sun Pharma, Taiho Pharmaceutical, Tanabe‐Mitsubishi, Torii Pharmaceutical, and UCB; and has received consulting fees from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Maruho, Novartis, Taiho Pharmaceutical, and UCB. M.O. has received honoraria and/or research grants from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Leo Pharma, Maruho, Mitsubishi Tanabe Pharma, Nichi‐Iko, Nippon Kayaku, Novartis, Pfizer, Sanofi, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB. E.C., A.N., Y.S., and S.B. are employees of and shareholders in Bristol Myers Squibb. A.M. has received honoraria as meeting chair/lecturer for AbbVie, AYUMI Pharmaceutical, Boehringer Ingelheim Japan, Celgene K.K., Eisai, Eli Lilly Japan K.K., Inforward, Janssen Pharmaceutical K.K., Kyowa Kirin, Maruho Co., Mitsubishi Tanabe Pharma, Nippon Kayaku, Novartis Pharma K.K., Taiho Pharmaceutical, Torii Pharmaceutical, and Ushio; has received funding from AbbVie GK, Eisai, Eli Lilly Japan K.K., Kyowa Kirin, Leo Pharma K.K., Maruho, Mitsubishi Tanabe Pharma, Novartis Pharma K.K., Taiho Pharmaceutical, and Torii Pharmaceutical; and has received consulting fees from AbbVie GK, Boehringer Ingelheim Japan, Bristol Myers Squibb, Celgene K.K., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., Kyowa Kirin, Maruho, Mitsubishi Tanabe Pharma, Nichi‐Iko Pharmaceutical, Nippon Kayaku, Novartis Pharma K.K., Pfizer Japan, Sun Pharma, Torii Pharmaceutical, and UCB Japan. Shinichi Imafuku and Yayoi Tada are Editorial Board members of Journal of Dermatology and co‐authors of this article. To minimize bias, they were excluded from all editorial decision‐making related to the acceptance of this article for publication.

Figures

Figure 1
Figure 1
The POETYK PSO‐4 study design. †Patients who did not roll over into the POETYK LTE trial entered a 4‐week safety follow‐up through week 56. EP, erythrodermic psoriasis; GPP, generalized pustular psoriasis; PASI 75, ≥75% reduction from baseline in the Psoriasis Area and Severity Index; PP, plaque psoriasis; QD, once daily; sPGA 0/1, static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a two‐point improvement from baseline.
Figure 2
Figure 2
PASI 75 and sPGA 0/1 responses at week 16 in patients with PP (NRI). NRI, nonresponder imputation; PASI 75, ≥75% improvement from baseline in the Psoriasis Area and Severity Index; PP, plaque psoriasis; sPGA 0/1, static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a two‐point improvement from baseline.
Figure 3
Figure 3
PASI 75 and sPGA 0/1 at week 16 in patients with PP by baseline BMI (NRI). BMI, body mass index; NRI, nonresponder imputation; PASI 75, ≥75% improvement from baseline in the Psoriasis Area and Severity Index; PP, plaque psoriasis; sPGA 0/1, static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a two‐point improvement from baseline.
Figure 4
Figure 4
PASI 75/90/100 at week 16 in patients with PP by prior biologic use (as observed). PASI 75/90/100, ≥75%/≥90%/100% reduction from baseline in the Psoriasis Area and Severity Index; PP, plaque psoriasis.
Figure 5
Figure 5
PASI 75/90/100 in patients with PP through week 52. PASI 75 data are presented as both NRI and as observed. PASI 90 and 100 data presented as observed. NRI, nonresponder imputation; PASI 75/90/100, ≥75%/≥90%/100% reduction from baseline in the Psoriasis Area and Severity Index; PP, plaque psoriasis; sPGA 0/1, static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a two‐point improvement from baseline.
Figure 6
Figure 6
sPGA 0/1 and sPGA 0 in patients with PP. sPGA 0/1 presented as NRI and as observed. sPGA 0 presented as observed. NRI, nonresponder imputation; PASI 75, ≥75% reduction from baseline in the Psoriasis Area and Severity Index; PP, plaque psoriasis; sPGA 0/1, static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) with at least a two‐point improvement from baseline.
Figure 7
Figure 7
Hematologic, lipid, and laboratory parameters. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; EP, erythrodermic psoriasis; GPP, generalized pustular psoriasis; LLN, lower limit of normal; PP, plaque psoriasis; SD, standard deviation; ULN, upper limit of normal.
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