P1641 - Patient-Reported Outcomes of Response and Remission Following Guselkumab Induction Treatment as Measured by the Inflammatory Bowel Disease Questionnaire: Results Through Week 12 of the Phase 2 GALAXI 1 Study

David T. Rubin, MD, FACG¹, Remo Panaccione, MD, FRCP², Geert D’Haens, MD, PhD³, Chenglong Han, MD, PhD⁴, Susana Gonzalez, MD⁵, Kathleen Weisel, MS⁵, Mary Ellen Frustaci, BS, MAS⁵, Zijiang Yang, PhD⁵, Jewel Johanns, PhD⁵, Matthew Germinaro, MD⁵, Silvio Danese, MD, PhD⁶, Bruce E. Sands, MD, MS⁷, Julian Panés, MD, PhD^8
1University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; ²Inflammatory Bowel Disease Clinic, Gastrointestinal Research, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; ³Amsterdam UMC, University of Amsterdam, Amsterdam, Noord-Holland, Netherlands; ⁴Janssen Global Services, LLC, Malvern, PA; ⁵Janssen Research & Development, LLC, Spring House, PA; ⁶Inflammatory Bowel Diseases Center, Humanitas Clinical and Research Center IRCCS and Hunimed, Milan, Lombardia, Italy; ⁷Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY; ⁸Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain

Introduction: GALAXI 1 is a phase 2, double-blind, placebo-controlled study of guselkumab (GUS), an IL-23 antagonist, for the treatment of patients (pts) with moderately to severely active Crohn’s disease (CD) who had inadequate response or intolerance to conventional therapies (corticosteroid, immunosuppressant) and/or biologics (TNF antagonist, vedolizumab). Patient-reported outcomes from the Inflammatory Bowel Disease Questionnaire (IBDQ) through Week (Wk) 12 following GUS induction are reported here for the interim analysis population.

Methods: Pts with moderate to severe CD (CDAI score 220-450) were randomized 1:1:1:1:1 to GUS 200, 600, or 1200mg IV at Wks 0, 4, 8; ustekinumab (UST) ~6mg/kg IV at Wk 0 and 90mg SC at Wk 8; or placebo (PBO) IV. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, emotional function, systemic symptoms, and social function. IBDQ scores range from 32 to 224 with higher scores indicating better quality of life. IBDQ scores were evaluated at Wk 8 and Wk 12 for change from baseline, IBDQ response (defined as ≥16-point improvement from baseline), and IBDQ remission (defined as IBDQ score ≥170) for the GUS combined and PBO treatment groups. UST was a reference arm.

Results: Two hundred fifty pts were evaluated; approximately 50% failed previous biologic therapy. Baseline demographics and disease characteristics were generally similar across treatment groups. However, some differences were observed between the groups, the most notable of which included a slightly lower disease duration in the GUS 1200mg IV group (6.2 yrs) compared with the GUS 200mg IV group (11.7 yrs), and a lower mean baseline IBDQ total score in the PBO group (117.3) compared with the GUS combined and UST groups. IBDQ scores change from baseline at Wk 8 and Wk 12 are presented in Table 1. Mean change from baseline in total IBDQ and each of the 4 IBDQ domains was greater among pts in the combined GUS group compared with the PBO group. The proportion of pts who achieved IBDQ response at Wk 8 and Wk 12 was higher in the combined GUS treatment group compared with PBO (Figure 1). A similar trend was seen for IBDQ remission.

Discussion: In pts with moderately to severely active CD, pts treated with GUS (combined) induction therapy reported greater improvement in IBDQ scores compared with PBO as early as Wk 8. A higher proportion of pts treated with GUS compared with PBO achieved IBDQ response and remission at Wks 8 and 12, and this treatment benefit (as delta) increased from Wk 8 to Wk 12.




Disclosures:


David T. Rubin, MD, FACG¹, Remo Panaccione, MD, FRCP², Geert D’Haens, MD, PhD³, Chenglong Han, MD, PhD⁴, Susana Gonzalez, MD⁵, Kathleen Weisel, MS⁵, Mary Ellen Frustaci, BS, MAS⁵, Zijiang Yang, PhD⁵, Jewel Johanns, PhD⁵, Matthew Germinaro, MD⁵, Silvio Danese, MD, PhD⁶, Bruce E. Sands, MD, MS⁷, Julian Panés, MD, PhD⁸. P1641 - Patient-Reported Outcomes of Response and Remission Following Guselkumab Induction Treatment as Measured by the Inflammatory Bowel Disease Questionnaire: Results Through Week 12 of the Phase 2 GALAXI 1 Study, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.