Cure8 trial brief
Older adults with IBD face tradeoffs between effectiveness and safety of advanced therapies; this study aims to identify immune‑aging and frailty markers that might predict who is more likely to benefit without serious harms.
If successful, the research could help personalize therapy decisions for people aged 60+ starting biologics or small molecules.
Older adults with Crohn’s disease or ulcerative colitis starting advanced therapies; clinicians who treat geriatric IBD patients; researchers studying immunosenescence, frailty, and treatment safety in IBD.
This is a prospective, multicenter observational cohort study (not yet recruiting) enrolling adults ≥60 with Crohn’s disease, ulcerative colitis, or IBD‑unclassified who are starting a new advanced therapy as part of routine care.
The study will collect clinical frailty and nutritional assessments plus blood-based immune‑aging markers (for example CD4/CD8 ratio, IL‑6, neutrophil-to-lymphocyte ratio) and follow participants through week 52 (with longer safety follow-up planned) to measure a composite “net clinical benefit” outcome: steroid‑free remission at 52 weeks without serious infection, treatment discontinuation for adverse events, IBD‑related hospitalization, or IBD‑related surgery.
The study does not assign treatments; clinicians choose and manage advanced therapies (vedolizumab, ustekinumab, anti‑TNF agents, JAK inhibitors, S1P modulators, etc.) per usual care.
Planned analyses will test whether baseline immune‑aging and frailty measures predict the balance of benefits and harms, and whether simple clinical/lab markers add prognostic value beyond age and disease factors. This record describes study design, planned measures, and outcomes but does not report results.
It is intended to generate prospective data to help individualize treatment decisions for older adults with IBD based on biological aging and vulnerability rather than chronological age alone.
This is an observational, not randomized, study that will follow treatments chosen in routine care. The record describes planned measurements and outcomes but contains no results; it is not peer‑reviewed research findings. Enrollment status is not yet recruiting.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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