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.
Afzali, A., Danese, S., Panaccione, R., Rubin, D. T., Sands, B. E., Reinisch, W., Panés, J., Van Rampelbergh, R., Terry, N. A., Salese, L., Vetter, M. L., Yee, J., Corbett, C., Van Duijnhoven, W., Hisamatsu, T., Andrews, J. M., D'Haens,, Geert, R., Gasbarrini, A., Galaxi, 1. I., Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial, <<INFLAMMATORY BOWEL DISEASES>>, N/A; 32 (9): 1669-1682. [doi:10.1093/ibd/izag055] [https://hdl.handle.net/10807/346084]
Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial
Danese, Silvio;Gasbarrini, Antonio;
2026
Abstract
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.
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
