<<

See “Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn’s disease: a subpopu- lation analysis of phase 3 induction and maintenance studies” on page 475-486.

Supplementary Information

List of UNITI-1 investigators in

A Ando, Shiga University of Medical Science Hospital, Otsu, Shiga; T Ashida, Higashi Tokushukai Hospital, Sapporo, ; H Hanai, South Hospital, Minamiku, Hamamatsu; T Ishida, Oita Red Cross Hospital, Oita City, Oita; H Ito, Kinshu-kai Infusion Clinic, City, Osaka; T Matsumoto, Hospital, city, Fukuoka; S Motoya, Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Sapporo-shi, Hokkaido; S Nakamura, Hyogo College of Medicine, Nishi- nomiya, Hyogo; Y Sameshima, Sameshima Hospital, -city, Kagoshima; Y , Toho University, Sakura Medical Center, Sakura-shi, ; K Watanabe, Osaka City University Hospital, Osaka City, Osaka; H Yamagami, Osaka City University Hospital, Osaka City, Osaka; T Yamamoto, Social Insurance Hospital, Department of Surgery, Yokkaichi, ; K Yao, Chikushi Hospital, Chikushi, Fukuoka.

List of UNITI-2 Investigators in Japan

T Ashida, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido; H Hanai, Hamamatsu South Hospital, Minamiku, Ham- amatsu; N Horiki, Hospital, , Tsu; H Iijima, Osaka University Hospital Department of Medicine, Gastroenterology and Hepatology, ; T Ishida, Oita Red Cross Hospital, Oita City, Oita; H Ito, Kinshu-kai Infusion Clinic, Osaka City, Osaka; M Iwabuchi, National Hospital Organization Medical Center, , Sendai; T Kanai, Hospital, -ku, ; R Kunisaki, City University Medical Center, Kanagawa, Minami-ku, Yo- kohama; A Maemoto, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido; K Matsuoka, Keio University Hospital, Shin- juku-ku, Tokyo; S Motoya, Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Sapporo-Shi, Hokkaido; S Nakamura, Hyogo College of Medicine 1-1 Mukogawacho, , Hyogo; T Osada, Juntendo University Hospital, Tokyo; Y Sameshima, Sameshima Hospital, Kagoshima-city, Kagoshima; K Sugimoto, Hamamatsu University Hospital, Higashi-ku, Hama- matsu; S Tanaka, University Hospital, Hiroshima, Minami-ku; K Watanabe, Osaka City University Hospital, Osaka City, Osaka; H Yamagami, Osaka City University Hospital, Osaka City, Osaka; K Yao, Fukuoka University Chikushi Hospital, Chi- kushi, Fukuoka.

List of IM-UNITI Investigators in Japan

A Ando, Shiga University of Medical Science Hospital, Otsu, Shiga; T Ashida, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido; H Hanai, Hamamatsu South Hospital, Minamiku, Hamamatsu; H Iijima, Osaka University Hospital Department of Medicine, Gastroenterology and Hepatology, Suita; T Ishida, Oita Red Cross Hospital, Oita City, Oita; H Ito, Kinshu-kai Infu- sion clinic, Osaka City, Osaka; M Iwabuchi, National Hospital Organization Sendai Medical Center, Miyagi Prefecture, Sen- dai; R Kunisaki, Yokohama City University Medical Center, Kanagawa, Minami-ku, Yokohama; A Maemoto, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido; K Matsuoka, Kei University Hospital, Shinjuku, Tokyo; E Motohiro, Kyushu University Hospital, Fukuoka City, Fukuoka; S Motoya, Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Sapporo-shi, Hokkaido; S Nakamura, Hyogo College of Medicine, Nishinomiya, Hyogo; T Osada, Juntendo University Hospital, Tokyo; Y Sameshima, Sameshima Hospital, Kagoshima-city, Kagoshima; K Sugimoto, Hamamatsu University Hospital, Shizuoka Higashi-ku, Hama- matsu; Y Suzuki, Toho University, Sakura Medical Center, Sakura-shi, Chiba; K Takanori, Keio University Hospital, Shinjuku-ku, Tokyo; S Tanaka, Hiroshima University Hospital, Hiroshima, Minami-ku; K Watanabe, Osaka City University Hospital, Osaka City, Osaka; H Yamagami, Osaka City University Hospital, Osaka City, Osaka; T Yamamoto, Yokkaichi Hazu Medical Center, Yokkaichi, Mie; K Yao, Fukuoka University Chikushi Hospital, Chikushi, Fukuoka; K Yao, Fukuoka University Chikushi Hospital, Chikushi, Fukuoka.

Dose adjustment in IM-UNITI

In patients who subsequently met loss of response criteria at any time between week 8 and week 32 of maintenance, a single- dose adjustment to ustekinumab 90 mg q8w was done and patients were evaluated for 16 weeks for clinical improvement. If there was no improvement, study treatment was discontinued in these patients. Patients in IM-UNITI were allowed to continue treatment until week 272 (5 years) to further evaluate its long-term safety.