P1095 - Disability, Fatigue and Persistent Symptoms in Patients With Inflammatory Bowel Disease 6 Months After Initiation of Advanced Therapy: Insights From TARGET-IBD

Millie D. Long, MD, FACG¹, Gui Liu, PhD, MPH², Ebuwa Igho-Osagie, MBBS, DPH, MBA³, Julie M. Crawford, MD⁴, Keith D. Knapp, PhD⁴, Derek R. Gazis, MS⁴, Jeremy Shao, MD, PhD⁵, Bruce E. Sands, MD, MS, FACG⁶
1Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, Chapel Hill, NC; 2Merck Sharp & Dohme LLC, Philadelphia, PA; 3Merck, Rahway, NJ; 4Target RWE, Durham, NC; 5Merck & Co, South San Francisco, CA; 6Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York, NY

Introduction: We assessed whether real world patients with Crohn’s disease (CD) or ulcerative colitis (UC) are meeting STRIDE II treatment targets. These results are from an ongoing study.

Methods: This substudy prospectively enrolls adults with CD or UC from 15 community or academic sites in the longitudinal US-based consortium, TARGET-IBD. Gastroenterologists consent patients to complete patient reported outcomes (PROs) at 6 months (+/- 4 weeks) after initiating advanced therapy (AT). We excluded UC patients with prior total colectomy. Analytic outcomes were: inflammatory bowel disease disability index (IBD-DI, score of ≥15 indicates mild or worse disability), FACIT-Fatigue (score of < 30 indicates severe fatigue), PRO-2 CD, PRO-2 UC and NRS Urgency. PRO-2 CD active disease is stool frequency >2.8 stools/day or abdominal pain >1.0 (range 0-3). PRO-2 UC active disease is stool frequency of more than 1-2 stools per day more than normal or any rectal bleeding. Active bowel urgency is a score ≥2. Patient characteristics and PROs were analyzed descriptively.

Results: Of 196 patients currently enrolled, 58 (32 CD and 26 UC) had completed 6-month PROs at the datacut, with mean (SD) age of 38.9 years (15.0), 50% female, and 40 (69%) Non-Hispanic White. Table 1 shows the distribution of treatments. In the following, denominators represent respondent counts for each PRO.

Most patients (41 of 55, 75%) reported mild or worse disability (76% CD and 73% UC). 26 patients (46%) reported severe fatigue (53% CD and 38% UC).

The mean PRO-2 CD score was 6.7 (5.7). CD patients had a mean of 1.7 (2.0) soft stools/day and mean abdominal pain score of 0.7 (0.7). 6 CD patients (19%) reported >2.8 soft stools/day; 7 CD patients (23%) reported abdominal pain score >1.

The mean PRO-2 UC score was 1.3 (1.3), 5 patients (20%) reported ≥3 “stools/day more than normal”, and 6 (24%) patients reported rectal bleeding. 16 (64%) UC patients were in remission.

Of 49 patients responding to the NRS Urgency measure, 33 (67%) reported bowel urgency (≥2). Among 31 CD patients, 25 (81%) reported bowel urgency, mean score 3.5 (2.6). 8 of 18 UC patients (44%) reported bowel urgency, mean 2.8 (3.0).

Discussion: In this analysis of 58 patients with moderate to severe CD or UC, many still had suboptimal quality of life 6 months after starting AT. Numerous patients missed STRIDE-II treatment goals, especially in disability and fatigue. These findings show key unmet needs in IBD care.


Figure: Table 1. Demographic and clinical characteristics of the study population by disease type

Disclosures:
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.
Gui Liu: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc – Employee.
Ebuwa Igho-Osagie: Merck & Co., Inc., Rahway, NJ, USA – Employee.
Julie Crawford: Target RWE – Employee, Stock Options.
Keith Knapp: Target RWE – Employee, Stock Options.
Derek Gazis: Target RWE – Employee, Stock Options.
Jeremy Shao: Merck Sharp & Dohme LLC – Employee, Stock Options.
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.

Millie D. Long, MD, FACG¹, Gui Liu, PhD, MPH², Ebuwa Igho-Osagie, MBBS, DPH, MBA³, Julie M. Crawford, MD⁴, Keith D. Knapp, PhD⁴, Derek R. Gazis, MS⁴, Jeremy Shao, MD, PhD⁵, Bruce E. Sands, MD, MS, FACG⁶. P1095 - Disability, Fatigue and Persistent Symptoms in Patients With Inflammatory Bowel Disease 6 Months After Initiation of Advanced Therapy: Insights From TARGET-IBD, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.