S847 Efficacy of Guselkumab in Patients With Moderately to Severely Active Crohn’s Disease Not in Clinical Response at Week 12: Results From the GALAXI 1 Study

• Published in: The American journal of gastroenterology Vol. 118; no. 10S; p. S626
• Main Authors: Panaccione, Remo, Afzali, Anita, D’Haens, Geert R., Salese, Leonardo, Terry, Natalie A., Sahoo, Aparna, Frustaci, Mary Ellen, Yang, Zijiang, Zittan, Eran, Danese, Silvio, Hisamatsu, Tadakazu
• Format: Journal Article
• Language: English
• Published: New York Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01-10-2023
• Subjects: Crohns disease; Endoscopy; Remission (Medicine)
• ISSN: 0002-9270; 1572-0241
• DOI: 10.14309/01.ajg.0000953028.28572.20

Previously, we reported that pts who were in clinical response after IV induction had higher rates of clinical and endoscopic outcomes at Wk48 than the overall study population.1 In this post hoc analysis, we report outcomes for pts who did not achieve Wk12 clinical response based on CD activity index (CDAI) after IV induction. The study was not powered to evaluate between-group efficacy differences at Wk48; UST was used for reference. Efficacy Outcomes Among Patients Not in Clinical Response(a) at Week 12 Outcome, %b c Combined Guselkumab (N=63) Ustekinumab (N=21) Clinical responsea  Week 16 36.5 42.9  Week 20 47.6 52.4  Week 24 46.0 52.4  Week 28 47.6 42.9  Week 32 54.0 47.6  Week 36 50.8 57.1  Week 40 54.0 52.4  Week 44 52.4 47.6  Week 48 58.7 47.6 Clinical remission at Week 48d 41.3 33.3 PRO-2 remission at Week 48e 42.9 23.8 Endoscopic response at Week 48f 31.7 23.8 AP=abdominal pain; CD=Crohn’s disease; CDAI=Crohn’s disease activity index; PRO-2=Patient-reported CDAI components of AP and SF; SES-CD=Simple Endoscopic Score for CD; SF=stool frequency. aClinical response was defined as ≥100-point reduction from baseline in CDAI or CDAI < 150. bPatients who had a prohibited change in concomitant CD medication, a CD-related surgery, or discontinued study agent due to lack of efficacy, or an adverse event of worsening CD prior to the designated analysis timepoint, were considered not to have achieved the endpoint. cPatients who had insufficient data to calculate the outcome measure at the designated analysis timepoint were considered not to have achieved the endpoint. dClinical remission was defined as a CDAI < 150.e PRO-2 remission was defined as unweighted CDAI component of average daily AP ≤1 and the unweighted CDAI component of average daily SF ≤3, and no worsening of AP or SF from baseline.f Endoscopic response was defined as ≥50% improvement from baseline in SES-CD or SES-CD ≤2.