S1534 Disability, Fatigue and Persistent Symptoms in Patients With Inflammatory Bowel Disease 6 Months After Initiation of Advanced Therapy: Insights From TARGET-IBD

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% women, and 40 (69%) Non-Hispanic White. 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). Twenty-six 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). Six CD patients (19%) reported >2.8 soft stools/day; Seven 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. Sixteen (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). Eight of 18 UC patients (44%) reported bowel urgency, mean 2.8 (3.0). Conclusion: 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.