S1295 A New, Multifaceted STRIDE II-Based Monitoring Protocol for Advanced Therapy Starts in Inflammatory Bowel Disease
Bibliographic record
Abstract
Introduction: Outreach monitoring in inflammatory bowel disease (IBD) has been shown to be cost-effective and reduce healthcare utilization. The STRIDE-II guidelines recommend collection of patient-reported outcomes (PRO’s), biomarkers (e.g., fecal calprotectin (FCP), C-reactive protein (CRP)), and endoscopy to determine if patients with IBD are reaching defined therapeutic targets. The optimal way to apply these recommendations to new advanced therapies in IBD Fifty-four remains unclear. We designed a proactive, outreach monitoring protocol for new advanced therapy starts in IBD to assess clinical response and facilitate responsive disease management. Methods: IBD patients complete 24 weeks of outreach monitoring after starting a new advanced therapy. PRO’s are collected on days 0, 3, and 7, and every 2 weeks thereafter. Serum labs are collected at baseline and weeks 4, 8, 12, 16, and 24 and FCP is collected at baseline and weeks 8, 16, and 24. Self-reported medication adherence is assessed at baseline and weeks 12 and 24. Endoscopy is booked 6-12 months from the start date. Granular clinical reports summarizing these results and the dates of last IBD review and last flare are sent to each treating gastroenterologist via our electronic medical record. Results: Sixty-two patients have been monitored with our protocol on the following biologic and small molecule therapies: ustekinumab (n = 30), tofacitinib (n = 14), risankizumab (n = 11), upacitinib (n = 4), vedolizumab (n = 2), and infliximab (n = 1). Forty-one patients (66.1%) had failed 1+ prior advanced therapies and 7 (11.3%) had prior IBD surgery. In 5 cases (8.1%), the patient was switched from their initial agent before 24 weeks due to lack of response. Fifty-four patients (87.0%) complied with all FCP collections and 60 (96.8%) completed 95+% of PRO’s. Per STRIDE-II definitions, 38 patients (61.3%) demonstrated clinical response during the protocol and 20 (35.1%) achieved and maintained remission at 24 weeks. 14 patients (22.6%) received steroid courses, 9 (14.5%) presented to an emergency department, and 5 (8.1%) were hospitalized for their IBD during monitoring. Conclusion: Our STRIDE II based outreach monitoring protocol provided granular detail of clinical response to advanced IBD therapies to treating physicians. Patients were highly compliant with serial collection of PRO’s, FCP, and serum labs. This protocol allows for highly responsive disease management for IBD patients and may lead to treatment-specific monitoring recommendations and reduced healthcare utilization (see Figure 1, Table 1).Figure 1.: An overview of our proactive outreach monitoring protocol for inflammatory bowel disease patients starting on new advanced therapies. Table 1. - Patient outcomes during monitoring for overall sample and by advanced therapy Overall Sample (n = 62) FCP Compliance Yes: 54 (87.0%), No: 8 (12.9%) PRO Compliance Yes: 60 (96.8%), No: 2 (3.2%) MARS-5 Scores Baseline Week 12 Week 24 Mean (SD) 24.1 (1.1) 24.0 (1.5) 24.3 (0.9) Steroid Prescribed Yes: 15 (24.2%), No: 47 (75.8%) ED Presentation Yes: 9 (14.5%), No: 53 (85.5%) Hospitalization Yes: 5 (8.1%), No: 57 (91.9%) Advanced Therapy Clinical Response* Remission at 24 Weeks* Therapy Switched Ustekinumab(n = 30; IBD-U = 1; UC = 29) 18 (60.0%) 10 (33.3%) 1 (3.3%) Tofacitinib(n = 14; UC = 14) 9 (64.3%) 4 (28.6%) 3 (21.4%) Risankizumab(n = 11; CD = 11) 6 (54.5%) 3 (27.3%) 0 (0.0%) Upadacitinib(n = 4; CD = 2, UC = 2) 3 (75.0%) 1 (25.0%) 0 (0.0%) Vedolizumab(n = 2; CD = 1, UC = 1) 2 (100.0%) 1 (50.0%) 0 (0.0%) Infliximab(n = 1; UC = 1) 0 (0.0%) n/a 1 (100.0%) *Definitions per STRIDE-II Guidelines.CD = Crohn's Disease, ED = emergency department, FCP = fecal calprotectin, IBD-U = inflammatory bowel disease unclassified, MARS-5 = 5-item Medication Adherence Report Scale, PRO = patient-reported outcome, UC = ulcerative colitis.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.033 | 0.038 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.025 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".