P0891 Efficacy and safety of subcutaneous guselkumab rescue therapy in patients with moderately to severely active Crohn’s disease and inadequate response to ustekinumab: Phase 2 GALAXI 1 study long-term extension results
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Le résumé fourni par la source
Abstract Background Guselkumab (GUS) is a dual-acting IL-23p19 subunit inhibitor that is being evaluated in Crohn’s disease (CD). The GALAXI 1 study (NCT03466411) is a phase 2b study that evaluated GUS in participants (pts) with moderately to severely active CD. Pts treated with ustekinumab (UST) who met inadequate response criteria during long term extension (LTE) could cross over to GUS 200 mg q4w SC. Here, we present efficacy and safety results in pts who received GUS after experiencing an inadequate response to UST in the LTE. Methods Individuals with prior inadequate response or intolerance to UST were excluded from GALAXI 1; however, during the LTE, pts treated with UST ~6 mg/kg IV→UST 90 mg SC q8w who met inadequate treatment response criteria (not in clinical response [≥100-point reduction in CDAI score from baseline or CDAI<150] and CDAI ≥220) between Weeks 52-80 of the LTE were eligible for a treatment switch to GUS 200 mg q4w SC, without IV induction. Clinical response and clinical remission were both assessed 16 weeks after treatment switch. Endoscopic response and endoscopic remission were assessed at Weeks 96 and 144 (definitions in Figure). Safety was assessed through Week 144. Results In total, 17 pts treated with UST underwent treatment switch to continuing GUS 200 mg q4w SC therapy due to meeting inadequate treatment response criteria between Weeks 52-80 of the LTE. Pts who crossed over to GUS exhibited similar baseline demographics and disease characteristics to all GUS LTE pts (Table). The proportions of pts achieving clinical response and clinical remission 16 weeks after treatment switch from UST to GUS 200 mg SC q4w were 58.8% and 52.9%, respectively. The proportions of pts achieving endoscopic response and endoscopic remission were 52.9% and 35.3% at study Week 96, respectively, and were maintained through Week 144 (Figure). Key safety event rates through Week 144 were consistent with the known safety profile of GUS in approved indications. Conclusion Among pts who experienced inadequate response to UST in the LTE, more than half achieved clinical remission 16 weeks after treatment switch to GUS 200 mg SC q4w and >50% were in endoscopic response at Week 96. These data suggest pts with an inadequate treatment response to UST may benefit from GUS treatment. Results are limited by small sample size and direct treatment switch to GUS SC maintenance dosing without IV induction.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- P0891 Efficacy and safety of subcutaneous guselkumab rescue therapy in patients with moderately to severely active Crohn’s disease and inadequate response to ustekinumab: Phase 2 GALAXI 1 study long-term extension results
- Date Crossref
- 01/01/2025
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Cincinnati Medical Center pays non établi dans la noticeÉtablissement de santé
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Atlanta Gastroenterology Associates pays non établi dans la noticeInstitution
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Macquarie University pays non établi dans la noticeUniversité ou école supérieure
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Janssen (Switzerland) pays non établi dans la noticeEntreprise
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Hospital Clínic de Barcelona pays non établi dans la noticeÉtablissement de santé
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Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas pays non établi dans la noticeStructure de recherche
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Consorci Institut D'Investigacions Biomediques August Pi I Sunyer pays non établi dans la noticeStructure de recherche
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University of Cincinnati- College of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Janssen Research & Development- LLC pays non établi dans la noticeInstitution
University of Cincinnati Medical Center, Atlanta Gastroenterology Associates et Macquarie University, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.