P3195 - Treat-to-Target Gaps in Crohn’s Disease: Insights From Real-World Practice

Bruce E. Sands, MD, MS, FACG¹, Yasmmyn D. Salinas, PhD, MPH², Teresa Bufford, PhD², Julie M. Crawford, MD², Derek R. Gazis, MS², Kathleen Hurwitz, ScD², Ebuwa Igho-Osagie, MBBS, DPH, MBA³, Gui Liu, PhD, MPH⁴, Jeremy Shao, MD, PhD⁵, Millie D. Long, MD, FACG⁶
1Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York, NY; 2Target RWE, Durham, NC; 3Merck, Rahway, NJ; 4Merck Sharp & Dohme LLC, Philadelphia, PA; 5Merck & Co, South San Francisco, CA; 6Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, Chapel Hill, NC

Introduction: Treat-to-target strategies in Crohn’s disease (CD) emphasize objective monitoring to assess therapeutic response and guide early therapeutic escalation. However, data on real-world application of treat-to-target recommendations remains limited. We evaluated post-treatment monitoring, remission, and treatment patterns during the first year after initiation of advanced therapy (AT) for CD.

Methods: We analyzed data from TARGET-IBD, a longitudinal U.S. registry of patients with clinician-diagnosed IBD. Adult patients initiating a new AT (anti-IL-12/23, anti-integrin, anti-TNF, JAK inhibitors, S1P modulators) between October 2014 and September 2021 were included for follow-up. Objective reassessment was defined as endoscopy or fecal calprotectin (FC) testing within 12 months. Remission was evaluated at 2–4 and 10–14 months post-initiation (mimicking induction and maintenance windows in clinical trials). Outcomes included endoscopic remission (SES-CD 0–4, or 0–3 for ileal-only disease, or narrative indication of inactive disease) and corticosteroid-free remission (no systemic corticosteroid use in the 14 days before endoscopy), overall and by line of advanced therapy (first-line [1L] AT vs. second-line or later [2L+] AT). Treatment persistence and corticosteroid use were also summarized.

Results: Among 1189 CD patients, 38% underwent objective reassessment within 12 months; FC testing was rare (12%). At AT initiation, 39% had inflammatory CD, 35% fistulizing, and 27% stricturing disease. Ileocolonic disease was most common (56%), followed by isolated ileal (27%) and colonic (17%). At 2–4 months, only 55 patients (5%) underwent endoscopy: 31% achieved endoscopic remission and 26% corticosteroid-free remission (Figure 1). At 10–14 months, 156 patients (13%) underwent endoscopy: 45% achieved endoscopic remission and 39% corticosteroid-free remission. At this time window, remission proportions were higher for patients on 1L AT compared to 2L+ AT. Among patients with endoscopy at 10-14 months, 46% required at least one corticosteroid prescription after initiating AT. At 10-14 months, 33% had switched or discontinued their initial AT.

Discussion: In this national registry cohort of CD patients initiating a new AT, objective monitoring was infrequent, and corticosteroid use was high over the first year. Remission rates were modest, and many patients required treatment changes. These findings highlight real-world gaps in treat-to-target implementation and early care optimization.


Figure: Figure 1. Remission proportions among Crohn’s disease (CD) patients initiating advanced therapies. Bar graph shows the percentage of patients achieving endoscopic remission (blue) and corticosteroid (CS)-free remission (orange) at 2–4 months and 10–14 months post-treatment initiation, stratified by line of advanced therapy (1L: first-line advanced therapy ; 2L+: second-line or later advanced therapy).

Disclosures:
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, speaking fees. Adiso Therapeutics – Consultant. Agomab Therapeutics – Consultant. Alimentiv – Consultant. Amgen – Consultant. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Artugen Therapeutics – Consultant. Astra Zeneca – Consultant. Biolojic Design – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, speaking fees. Calibr – Consultant. Celgene – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Eli Lilly & Company – Consultant, speaking fees. Enthera – Consultant. Enveda Biosciences – Consultant. Equillium – Consultant. Evommune – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Fzatat – Consultant. Galapagos – Consultant. Genentech (Roche) – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. Imhotex – Consultant. Index Pharmaceuticals – Consultant. Innovation Pharmaceuticals – Consultant. Inotrem – Consultant. Janssen R&D – Consultant, Grant/Research Support, speaking fees. Kaleido – Consultant. Kallyope – Consultant. Merck & Co., Inc., Rahway, NJ, USA – Consultant. Microba – Consultant. Mobius Care – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. Nexus Therapeutics – Consultant. Nimbus Discovery – Consultant. Odyssey Therapeutics – Consultant. Pfizer – Consultant, Grant/Research Support, speaking fees. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. Rasayana Therapeutics – Consultant. Recludix Therapeutics – Consultant. Reistone Biopharma – Consultant. Sanofi – Consultant. Spyre Therapeutics – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support, speaking fees. Target RWE – Consultant. Teva – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. Tr1X – Consultant. Union Therapeutics – Consultant. Ventyx Biosciences – Consultant, Stock Options.
Yasmmyn Salinas: Target RWE – Employee, Stock Options.
Teresa Bufford: Target RWE – Employee, Stock Options.
Julie Crawford: Target RWE – Employee, Stock Options.
Derek Gazis: Target RWE – Employee, Stock Options.
Kathleen Hurwitz: Target RWE – Employee, Stock Options.
Ebuwa Igho-Osagie: Merck & Co., Inc., Rahway, NJ, USA – Employee.
Gui Liu: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc – Employee.
Jeremy Shao: Merck Sharp & Dohme LLC – Employee, Stock Options.
Millie Long: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Celltrion – Consultant, Grant/Research Support. Intercept – Consultant. Johnson & Johnson – Consultant. Lilly – Consultant, Grant/Research Support. Merck – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus – Consultant. Roivant – Consultant. Sanofi – Consultant. Spyre – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant.

Bruce E. Sands, MD, MS, FACG¹, Yasmmyn D. Salinas, PhD, MPH², Teresa Bufford, PhD², Julie M. Crawford, MD², Derek R. Gazis, MS², Kathleen Hurwitz, ScD², Ebuwa Igho-Osagie, MBBS, DPH, MBA³, Gui Liu, PhD, MPH⁴, Jeremy Shao, MD, PhD⁵, Millie D. Long, MD, FACG⁶. P3195 - Treat-to-Target Gaps in Crohn’s Disease: Insights From Real-World Practice, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.