Anita Afzali, Silvio Danese, Remo Panaccione, David T Rubin, Bruce E Sands, Walter Reinisch, Julián Panés, Rian Van Rampelbergh, Nat A Terry, Leonardo Salese, Marion Vetter, Jacqueline Yee, C Corbett, Wilbert van Duijnhoven, Tadakazu Hisamatsu, Jane M. Andrews, Geert R D'Haens, the GALAXI 1 investigators, O V Oliĭnyk, Leonid Bilianskyi, Jadwiga Gniady-Jastrzebska, Robert Petryka, Tomasz Arłukowicz, P Gietka, Marcin Zmudziński, Syed Mumtaz, Douglas Wolf, Katarzyna Wojcik, George Duvall, Monika Augustyn, Rafal Filip, Dino Tarabar, Alexander Tkachev, Ursula Seidler, Eran Zittan, Juris Pokrotnieks, Оксана Щукина, Andro Machavariani, Laura Loy, Niazy Abu-farsakh, Pesegova Marina, Slobodan Sreckovic, Martin Laclav, Shu-Chen Wei, Daniel Suiter, A Borsuk, X Hébuterne, Carsten Büning, Adi Lahat-Zok, Wit Danilkiewicz, Bernadetta Frysna, Ivana Jovicic, Olena Datsenko, Maninder Guram, Animesh Jain, Z Zainol Rashid, Sonja Heeren, Natallia Shulga, Ivan Timkin, Srdjan Gornjakovic, M Lukás, Romain Altwegg, Ariadne Desjeux, Jean-Marie Reimund, Manana Giorgadze, C Jochum, Hiroaki Ito, Katsuhiko Nakai, Tomohisa Takagi, Osamu Zaha, Changhwan Choi, Taeoh Kim, Jonghun Lee, Ieva Stundienė, Ida Normiha Hilmi, Rosaida Hj Md Said, Jaroslaw Leszczyszyn, Diana Abdulganieva, Yulia Fominykh, Svetlana Maksyashina, Jozef Baláž, Manuel Van Domselaar, Taylan Kav, P M Dennis, Patricia Henry, Robert Holmes, Christopher Johnson, Matthew Mcbride, Harry Sarles, Gregory Moore, R. E. Yakubtsevich, Vinciane Muls, Stevan Trbojević, Waqqas Afif, Charles Bernstein, Ivo Klarin, Zuzana Šerclová, Miroslava Volfová, Pierre Desreumaux, Cyrielle Gilletta de Saint Joseph
BACKGROUND: The randomized, phase 2 GALAXI 1 study evaluated efficacy and safety of guselkumab, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn's disease. Efficacy and safety through 5 years are reported. METHODS: After completing the 48-week, treat-through GALAXI 1 main study, participants could enter the long-term extension (LTE) and continue the subcutaneous maintenance regimen assigned at randomization. Efficacy for the combined guselkumab dose groups was analyzed by (1) as-observed analysis of LTE participants, (2) nonresponder imputation (NRI) analysis of LTE participants, and (3) NRI analysis of primary efficacy analysis set (all [week 0] randomized participants). The study was not designed for statistical comparisons between groups. RESULTS: Of 185 guselkumab-randomized participants in the primary efficacy analysis set, 151 participated in the LTE. Among those continuing treatment, with available data (as observed), 97.7% (n = 85 of 87) achieved clinical remission, 71.3% (n = 62 of 87) achieved endoscopic response, and 51.7% (n = 45 of 87) achieved endoscopic remission at week 240. Results from NRI analyses also showed durability of efficacy (eg, week-240 clinical remission: 59.2% [n = 84 of 142], LTE analysis set; 46.0% [n = 81 of 176], primary efficacy analysis set). High rates of clinical and endoscopic remission at week 240 were maintained in biologic-naive participants (97.8% [n = 45 of 46] and 54.3% [n = 25 of 46], respectively [as-observed]) and participants with an inadequate response or intolerance to biologic therapy (97.1% [n = 34 of 35] and 54.3% [n = 19 of 35], respectively [as-observed]). Event rates of serious adverse events, discontinuations due to adverse events, and serious infections were low in guselkumab-treated participants. CONCLUSIONS: Long-term guselkumab treatment showed sustained clinical and endoscopic efficacy through week 240. The long-term safety data were consistent with those previously presented in approved indications. CLINICAL TRIAL REGISTRATION: A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI), NCT03466411, https://clinicaltrials.gov/study/NCT03466411.