Background Data on efficacy of biologic drugs in Inflammatory Bowel Diseases Unclassified (IBDU) are lacking as these patients are commonly excluded from randomised controlled trials. In addition, real world data on the use of biologic agents in IBDU are scarce. We explored the effectiveness of first line biologic therapy in patients with IBDU and compared between drugs and with outcomes for patients with Ulcerative Colitis (UC) in the UK IBD BioResource. Methods Demographic, disease, treatment and outcome data were retrieved from the UK IBD BioResource, capturing >36,000 subjects across >100 UK centres. Treatment failure was assessed according to persistence on therapy with clinician assessment of treatment success, without the need for treatment change or surgery. Dose-escalation was not considered indicative of treatment failure. Inverse probability of treatment weighting (IPTW) was used to balance groups using a propensity score-weighting approach accounting for baseline patient or disease related clinical characteristics. We compared Kaplan Meier curves for treatment survival using log rank test. Results In total, 198 and 3856 evaluable patients with IBDU and UC respectively received first line biologic therapy and were included in the analysis. Median follow up was 2.6 years (IQR 1.1-4.6). In the IBDU group, 104 were female (52.5%), median age at diagnosis was 28 years (IQR 19.7-42) and median disease duration was 10.4 years (IQR 6.7-15.7). The majority of IBDU patients used infliximab (n=143), while the rest used adalimumab (n=42) and vedolizumab (n=13) with no difference in biologic therapy persistence before and after adjustment (before IPTW adjustment, log rank p = 0.062; after IPTW, log rank p = 0.135, Figure 1). No difference was found in biologic therapy persistence between patients with IBDU and UC (before IPTW adjustment, log rank p = 0.581; after IPTW, log rank p = 0.438, Figure 2). Conclusion Outcomes for patients with IBDU receiving first line biologic therapy were similar for those observed in patients with UC. This should lend confidence to patients and physicians using biologic therapy for this under-investigated condition. For patients with IBDU, although persistence on vedolizumab was numerically better than for anti-TNFs, this difference did not reach significance and the vedolizumab sample was small. Adalimumab and infliximab appeared to offer similar efficacy for patients with IBDU.
Background Faecal calprotectin (FC) measurement is used to stratify risk of IBD in primary care. Typically the normal range for FC is 0–50 ug/g, and in established practice FC>200 mandates gastroenterology referral for further investigations, including colonoscopy. The optimal FC threshold for referral is, however, debated: most people with FC>200 do not have IBD and some with IBD have FC<200. We aimed to assess FC at different thresholds, and whether the threshold might be safely raised (hence reducing the numbers referred for colonoscopy) by combining FC with other easily ascertained parameters without significantly impacting IBD diagnostic yield. Methods We included all patients aged 18–45 in whom FC testing was requested in primary care in 2018 and 2019, regardless of FC result, and who subsequently underwent colonoscopy at Cambridge University Hospitals (CUH). We excluded patients with a prior IBD diagnosis. Based on the retrospective review of findings at colonoscopy and case notes, we classified the final diagnosis as one of (1) normal (2) IBD/subtype (3) non-IBD intestinal inflammation (e.g. infection, microscopic colitis, NSAID enteropathy) and (4) cancer. Results 852 patients were included, 60% female, median age 33. The FC ranged from 10 to >600. 98/189 with FC>600 had IBD, compared to 17/166 with FC 200–600 and 15/497 with FC<200 (Figure 1). Only 52% with small bowel CD had FC>600 (Figure 2). 74% of colonoscopies showed no inflammation. 10.5% of these patients had FC >600 and 18.6% had FC 200–600. Of the 32/130 (24.6%) patients with newly diagnosed IBD who had FC<600, 24 reported rectal bleeding, 13 had raised CRP >6, and 6 had a family history (FH) of IBD (table 1). Only one patient with FC <600 subsequently diagnosed with IBD had none of these parameters. Sensitivity and specificity data are provided in table 2. For patients with intermediate FC the UK advice is to repeat the test. In our cohort 168 patients had an initial FC of <600 and had a repeat. In this group the subsequent FC was <50 in 88. 6 cases of IBD were identified in those in whom the repeat FC was >50 but <600, but all had one or more of rectal bleeding, raised CRP or FH of IBD. 12/852 were found to have colorectal cancer, however, 8 of them had been referred to CUH on the ‘suspected cancer’ pathway. Of the 4 referred on the ‘suspected IBD’ pathway, only 1 had FC >600 – others were in the 50–600 range. Conclusion Based on our observations, using an FC threshold of >600, or 50–600 with one or more of rectal bleeding, raised CRP or FH of IBD, would substantially reduce the number of colonoscopies undertaken and have a minimal impact on diagnosis of IBD. Repeat testing following a modestly elevated FC had no further utility. These data require independent validation.
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