Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis: post-hoc analysis from the phase III, double-blind, placebo- and active-comparator–controlled VOYAGE 1/2 trials

Abstract

Background

The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis.

Objectives

To investigate the efficacy and safety of guselkumab in Korean patients.

Methods

The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively.

Results

Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator’s Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5 vs. 20.0%, p<.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4 vs. 3.3%, p<.001). At week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7 vs. 66.7%, p<.001; IGA 0: 52.4 vs. 21.2%, p=.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles.

Conclusion

The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population.

Keywords:

• Psoriasis
• interleukin-23
• VOYAGE 1
• VOYAGE 2

Disclosure statement

No potential conflict of interest was reported by the author(s). Dr. Sang Woong Youn served as a speaker for AbbVie, Cellgene, Eli Lilly, Janssen, LEO pharma, Novartis and Pfizer organized psoriasis symposium or meetings and also performed phase III clinical trials sponsored by Janssen, Novartis, Boeringer Ingelheim, BMS, Eli Lilly, Kyowa Kirin and UCB, and phase IV clinical trials sponsored by CKD pharma, Janssen and LEO pharma. Dae Young Yu is an employee of Janssen Korea. Dr. Tae Yoon Kim has no conflict of interest to declare. Dr. Byung Soo Kim has engaged or been working as a principal investigator or sub-investigator in number of clinical trials sponsored by Astellas, Boehringer Ingelheim, Eli- Lilly, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, LEO Pharma, Novartis, Regeneron and Sanofi. Dr. Seung Chul Lee has served as a clinical study investigator for AbbVie, Boehringer Ingelheim, Janssen, Kang STEM BIOTECH, LEO Pharma, Novatis, and Parexel. Dr. Jeung Hoon Lee has no conflict of interest to declare. Dr. Yong-Beom Choe has no conflict of interest to declare. Dr. Joo-Heung Lee has served as a consultant, adviser or investigator for clinical trials for which he received consulting fee, travel expense, lecture honorarium or research grants from Wyeth, Pfizer, Novratis, Lilly, Janssen, Abbvie, and Behringer-Ingerheim. Dr. Jee-ho Choi has served as clinical study investigator of Janssen and Novartis. Dr. Joo Young Roh has been involved as a clinical investigator for Janssen, Regeneron, Eli Lilly, Abbvie, Boehringer-Ingelheim, BMS and Novartis. Dr. Seong Jin Jo has served as a clinical study investigator for AbbVie, Boehringer Ingelheim, Janssen, Leo Pharma, Novartis, and Pfizer and has received honoraria as a speaker for Janssen, Leo Pharma, and Sanofi. Dr. Eun-So Lee has disclosed the following relevant financial relationships: Served as an advisor or consultant for AbbVie Inc.; Celgene Corporation; Janssen Pharmaceuticals, Inc.; Lilly; Novartis Pharmaceutical Corporation, Received grants for clinical research from AbbVie Inc.; Celgene Corporation; Cell Biotech; Lilly; Janssen Pharmaceuticals, Inc.; Servier. Dr. Min Kyung Shin has served as a clinical study investigator for MedyTox, Il Dong, Sanofi-aventis, Kyowa Hakko Kirin, and Janssen. Dr. Min-Geol Lee has conducted clinical trials or received honoraria for serving as a consultant for Eli Lilly, Janssen, Kyowa Hakko Kirin, Novartis, Pfizer and Bristol-Myer Squibb. Jingzhi Jiang is an employee of Janssen Research & Development, LLC. Dr. YoungJa Lee is an employee of Janssen Korea.

Additional information

Funding

This work was supported by Janssen Research and Development.