Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi, Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi

Abstract

Background/aims: A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.

Methods: Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.

Results: Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, -27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.

Conclusions: Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14).

Keywords: Inflammatory bowel disease; Maintenance; Subcutaneous; Ulcerative colitis; Vedolizumab.

Conflict of interest statement

Conflict of Interest

Hibi T has received payment for lectures including service on speakers bureaus from Aspen Japan, AbbVie, Ferring, Gilead Sciences, Janssen, JIMRO, Kissei Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, and Zeria Pharmaceutical; and has received grants from AbbVie, EA Pharma, JIMRO, Otsuka Holdings, and Zeria Pharmaceutical. Kobayashi T has received personal fees as an advisor from Alfresa Pharma, Covidien, Eli Lilly, Ferring Pharmaceuticals, Janssen, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kyaku, Pfizer, Takeda Pharmaceutical, Thermo Scientific, AbbVie, Gilead Sciences, Celltrion, and EA Pharma; personal fees for lectures from AbbVie, Pfizer, Astellas, Alfresa Pharma, Cellitron, EA Pharma, Kyorin Pharmaceutical, Nippon Kyaku, Mochida Pharmaceutical, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Zeria Pharmaceutical, Gilead Sciences, Janssen, JIMRO, and Covidien; and grants from JIMRO, AbbVie, EA Pharma, Zeria Pharmaceutical, Kyorin Pharmaceutical, Mochida Pharmaceutical, Thermo Fisher Scientific, Alfresa Pharma, and Nippon Kayaku. Ito H has received payment for lectures including service on speakers bureaus from Mitsubishi Tanabe Pharma, AbbVie, Takeda Pharmaceutical, EA Pharma, Zeria Pharmaceutical, Janssen, Mochida Pharmaceutical, Nippon Kayaku, and Pfizer. Ashida T has received payment for lectures including service on speakers bureaus from Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, and Kissei Pharmaceutical. Yokoyama T has received grants from Mochida Pharmaceutical, Takeda Pharmaceutical, AbbVie, EA Pharma, and Ferring Pharmaceuticals. Nagahori M has received consultancy fees from Takeda Pharmaceutical; and payment for lectures including service on speakers bureaus from Kissei Pharmaceutical, and Takeda Pharmaceutical, Kyorin Pharmaceutical, Mochida Pharmaceutical, AbbVie, Mitsubishi Tanabe Pharma, Nippon Kayaku, Asahi Kasei Medical, Zeria Pharmaceutical, Astellas, Nichi-Iko, and Janssen. Watanabe M has received payment for lectures including service on speakers bureaus from Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, EA Pharma, Zeria Pharmaceutical, Janssen, Gilead Sciences, Celltrion Healthcare, and Pfizer; and grants from EA Pharma, Zeria Pharmaceutical, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Nippon Kayaku, Mochida, Kissei, Miyarisan, Asahi Kasei, JIMRO, Kyorin Pharmaceutical, AbbVie, Kyowa Hakko Kirin, Alfresa, Ayumi, Astellas, MSD, Daiichi Sankyo, Taiho, Toray, Chugai, Gilead Sciences, and Fujirebio. Shikamura M, Yamaguchi T, Hori T, and Pinton P are employed by Takeda Pharmaceutical. Inaba T has nothing to declare.

Hibi T and Watanabe M are editorial board members of the journal but were not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1.
Fig. 1.
Patient disposition diagram. IV, intravenous.

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Source: PubMed

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