P3560 - Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Non-Complicated Crohn’s Disease: Results from the EVOLVE Expansion Study

Tuesday, October 24, 2023

10:30 AM – 4:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

MF

Marc Ferrante, MD

University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium

Marc Ferrante, MD¹, Britt Christensen, MD², Brian Bressler, MD, MS, FRCPC³, Neil R.. Brett, PhD⁴, Lauren Gianchetti, MPH⁵, Pravin Kamble, PhD⁶, Shashi Adsul, MD, MBA⁶, Zeinab Farhat, PhD⁶, Michael Scharl, MD⁷
¹University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium; ²University of Melbourne and Royal Melbourne Hospital, Melbourne, Victoria, Australia; ³St. Paul’s Hospital, Vancouver, BC, Canada; ⁴PPD, part of Thermo Fisher Scientific, Montreal, PQ, Canada; ⁵PPD, Part of Thermo Fisher Scientific, Philadelphia, PA; ⁶Takeda Pharmaceuticals, Cambridge, MA; ⁷University of Zurich, Zurich, Zurich, Switzerland

Introduction: Crohn’s disease (CD) complexity may affect treatment (Tx) outcomes. This analysis compared real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in bio-naïve patients with non-complicated CD.

Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective study analyzing medical charts of bio-naïve patients with CD aged ≥ 18 who initiated VDZ or UST (index) from 2016 to 2021 in Australia, Belgium, or Switzerland. Outcomes in pts with non-complicated CD (defined as no active fistula at index, no prior CD-related surgeries, and no CD-related hospitalizations in 12 months prior to index) were evaluated in a subgroup analysis. Data were collected from index to chart abstraction initiation, Tx discontinuation, death, or loss to follow-up, whichever was first. Time-to-event analyses for clinical outcomes (clinical response, clinical remission, and mucosal healing, assessed using published algorithms¹) and Tx persistence during 36 months of Tx were conducted using Kaplan-Meier method. Safety (serious adverse events [SAEs], serious infections [SIs]) and healthcare resource utilization (HCRU; CD exacerbations, CD-related hospitalizations, CD-related surgeries) were also analyzed. Baseline characteristics between cohorts were balanced using inverse probability of treatment weighting (IPTW).

Results: Overall, 425 pts (VDZ 244, UST 181) were included in this analysis. After IPTW, baseline characteristics were similar between groups (Table 1). During 36 months of Tx, weighted cumulative rates of clinical response (VDZ 85.0%, UST 85.6%; p=0.70), clinical remission (VDZ 93.3%, UST 91.3%, p=0.80), mucosal healing (VDZ 90.6%, UST 91.7%, p=0.14), and Tx persistence (VDZ 71.8%, UST 83.7%, p=0.07) were similar between both cohorts. During 36 months, risks of SAEs (HR=1.23; 95% CI, 0.62-2.46; p=0.55), SIs (HR=1.26; 95% CI 0.22-7.24; p=0.80), CD exacerbations (HR=1.09; 95% CI 0.74-1.61; p=0.66), CD-related surgeries (HR=1.11; 95% CI 0.47-2.62; p=0.82), and CD-related hospitalizations (HR=0.71; 95% CI 0.33-1.56; p=0.40) were similar between VDZ and UST cohorts.

Discussion: Over 36 months in a real-world clinical setting, cumulative rates of clinical response, clinical remission, mucosal healing, and Tx persistence, and rates of SAEs, SIs, and HCRU outcomes were not significantly different in patients with non-complicated CD who initiated VDZ or UST as a first-line biologic.

Reference: 1. Bressler B, et al. J Crohns Colitis. 2021;15(10):1694-1706.

Disclosures:

Marc Ferrante: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. AgomAb Therapeutics – Consultant. Amgen – Grant/Research Support, Speakers Bureau. Biogen – Grant/Research Support, Speakers Bureau. Boehringer Ingelheim – Consultant, Speakers Bureau. Celgene – Consultant. Celltrion – Consultant. EG – Grant/Research Support. Eli Lily – Consultant. Falk – Speakers Bureau. Ferring – Speakers Bureau. Janssen – Grant/Research Support. Janssen-Cilag – Consultant, Speakers Bureau. Lamepro – Speakers Bureau. Medtronic – Consultant. MSD – Consultant, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Regeneron – Consultant. Samsung Bioepis – Consultant. Sandoz – Consultant, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. Thermo Fisher – Consultant. Truvion Healthcare – Speakers Bureau. Viatris – Grant/Research Support, Speakers Bureau.

Britt Christensen: AbbVie – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. BMS – Advisory Committee/Board Member, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Falk – Advisory Committee/Board Member, Speakers Bureau. Ferring – Advisory Committee/Board Member, Speakers Bureau. Fresenius Kabi – Advisory Committee/Board Member, Speakers Bureau. Gilead – Advisory Committee/Board Member, Speakers Bureau. Janssen – Grant/Research Support. Janssen-Cilag – Advisory Committee/Board Member, Speakers Bureau. MSD – Advisory Committee/Board Member, Speakers Bureau. Pfizer – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Speakers Bureau. Takeda – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau.

Brian Bressler: AbbVie – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Alimentiv – Advisory Committee/Board Member. Allergan – Advisory Committee/Board Member. Alvine – Grant/Research Support. Amgen – Advisory Committee/Board Member, Grant/Research Support. AMT – Advisory Committee/Board Member. Bausch Health – Advisory Committee/Board Member. Boehringer Ingelheim – Grant/Research Support. Bristol Myers Squibb – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Celgene – Advisory Committee/Board Member, Grant/Research Support. Ferring – Advisory Committee/Board Member, Speakers Bureau. Fresenius Kabi – Advisory Committee/Board Member. Genentech – Advisory Committee/Board Member, Grant/Research Support. Gilead – Advisory Committee/Board Member. GlaxoSmithKline – Grant/Research Support. Iterative Scopes – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Merck – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Microbiome Insights – Advisory Committee/Board Member. Mylan – Advisory Committee/Board Member. Novartis – Advisory Committee/Board Member, Speakers Bureau. Pendopharm – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member, Speakers Bureau. Protagonist – Advisory Committee/Board Member. Qu Biologic – Grant/Research Support, Stock Options. Takeda – Advisory Committee/Board Member, Speakers Bureau.

Neil Brett: PPD, part of Thermo Fisher Scientific – Employee.

Lauren Gianchetti: PPD, Part of Thermo Fisher Scientific – Employee.

Pravin Kamble: Takeda – Employee, Stock Options.

Shashi Adsul: Takeda – Employee, Stock Options.

Zeinab Farhat: Takeda – Employee, Stock Options.

Michael Scharl: AbbVie – Grant/Research Support. Axalbion – Grant/Research Support. Basilea Pharmaceuticals – Grant/Research Support. Calypso Biotech – Grant/Research Support. Celltrion – Consultant. Falk Pharma – Speakers Bureau. Fresenius – Consultant. Gilead – Consultant, Grant/Research Support. Herbodee – Grant/Research Support. NodThera – Grant/Research Support. PharmaBiome – Grant/Research Support, Stock Options. Recolony – Stock Options. Roche – Grant/Research Support. Takeda – Consultant, Grant/Research Support. Topadur – Consultant. Vifor – Grant/Research Support, Speakers Bureau. Zealand Pharma – Grant/Research Support.

Marc Ferrante, MD¹, Britt Christensen, MD², Brian Bressler, MD, MS, FRCPC³, Neil R.. Brett, PhD⁴, Lauren Gianchetti, MPH⁵, Pravin Kamble, PhD⁶, Shashi Adsul, MD, MBA⁶, Zeinab Farhat, PhD⁶, Michael Scharl, MD⁷. P3560 - Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Non-Complicated Crohn’s Disease: Results from the EVOLVE Expansion Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.