{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T22:49:25Z","timestamp":1793227765332,"version":"4.5.0"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson & Johnson","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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\u2019s disease. Efficacy and safety through 5\u2009years are reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn\u2019s Disease (GALAXI), NCT03466411, https:\/\/clinicaltrials.gov\/study\/NCT03466411<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izag055","type":"journal-article","created":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T12:16:13Z","timestamp":1773404173000},"page":"1669-1682","source":"Crossref","is-referenced-by-count":4,"title":["Five-year efficacy and safety of guselkumab for moderately to severely active Crohn\u2019s disease: Results from the phase 2 GALAXI 1 trial"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4397-9576","authenticated-orcid":false,"given":"Anita","family":"Afzali","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, University of Cincinnati College of Medicine , Cincinnati, OH,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele , Milan,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Unit, University of Calgary , Calgary, AB,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T","family":"Rubin","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center, University of Chicago Medicine , Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5762-5042","authenticated-orcid":false,"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai Dr. Henry D. 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