IBD prevalence is estimated to be rising, but no detailed, recent UK data are available. The last reported prevalence estimate in the UK was 0.40% in 2003. We aimed to establish the current, and ...project future, prevalence in Lothian, Scotland.
We conducted an all-age multiparameter search strategy using inpatient IBD international classification of disease (ICD-10) coding (K50/51)(1997-2018), IBD pathology coding (1990-2018), primary and secondary care prescribing data (2009-2018) and a paediatric registry, (1997-2018) to identify 'possible' IBD cases up to 31/08/2018. Diagnoses were manually confirmed through electronic health record review as per Lennard-Jones/Porto criteria. Autoregressive integrated moving average (ARIMA) regression was applied to forecast prevalence to 01/08/2028.
In total, 24 601 possible IBD cases were identified of which 10 499 were true positives. The point prevalence for IBD in Lothian on 31/08/2018 was 784/100 000 (UC 432/100 000, Crohn's disease 284/100 000 and IBD unclassified (IBDU) 68/100 000). Capture-recapture methods identified an additional 427 'missed' cases (95% CI 383 to 477) resulting in a 'true' prevalence of 832/100 000 (95% CI 827 to 837).Prevalence increased by 4.3% per year between 2008 and 2018 (95% CI +3.7 to +4.9%, p<0.0001). ARIMA modelling projected a point prevalence on 01/08/2028 of 1.02% (95% CI 0.97% to 1.07%) that will affect an estimated 1.53% (95% CI 1.37% to 1.69%) of those >80 years of age.
We report a rigorously validated IBD cohort with all-age point prevalence on 31/08/2018 of 1 in 125, one of the highest worldwide.
Background and aims:
Tofacitinib is a Janus kinase inhibitor (JAKi) recently approved for the treatment of moderate to severe ulcerative colitis (UC) based on robust efficacy and safety data derived ...from OCTAVE clinical trials. Evidence on the outcomes of tofacitinib therapy in real-world UC patients is needed, as a number of these patients would be deemed ineligible for clinical trials. We have therefore summarised data derived from observational, real-world evidence (RWE) studies on the effectiveness and safety of tofacitinib in moderate to severe UC patients.
Methods:
We searched the PubMed, EMBASE, Scopus, Web of Science and Cochrane databases for observational studies on the use of tofacitinib in UC patients, published between 30 May 2018 and 24 January 2021. Pooled induction (8–14 weeks) and maintenance (16–26 weeks) clinical response and remission rates were calculated, as well as the proportion of reported adverse events using random effects models.
Results:
Nine studies were included, comprising 830 patients, of which 81% were previously treated with anti-tumour necrosis factor (TNF) and 57% with vedolizumab. Induction of clinical response and remission were achieved in 51% (95% confidence interval, 41–60%) and 37% (26–45%) of patients, after a median follow-up of 8 weeks. At the end of a median follow-up of 24 weeks, maintenance of clinical response and remission were met in 40% (31–50%) and 29% (23–36%) of patients, respectively. Thirty-two percent of the patients had at least one adverse event, the most commonly reported being mild infection (13%) and worsening of UC, requiring colectomy (13%). A third of the patients (35%) discontinued tofacitinib, most frequently due to primary non-response (51%).
Conclusion:
Tofacitinib is a safe and effective therapy in real-world UC patients, as previously reported by clinical trials.
Background: Long-term vedolizumab (VDZ) outcomes in real-world cohorts have been largely limited to 1-year follow-up, with few bio-naïve patients or objective markers of inflammation assessed. ...Objectives: We aimed to assess factors affecting VDZ persistence including clinical, biochemical and faecal biomarker remission at 1, 3 and 5 years. Design: We performed a retrospective, observational, cohort study. Methods: All adult inflammatory bowel disease (IBD) patients who had received VDZ induction for ulcerative colitis (UC)/IBD-unclassified (IBDU) were included. Baseline phenotype and follow-up data were collected via a review of electronic medical records. Results: We included 290 patients UC n = 271 (93.4%), IBDU n = 19 (6.6%) with a median time on VDZ of 27.6 months (interquartile range: 14.4–43.2). At the end of follow-up, a total of 157/290 (54.1%) patients remained on VDZ. The median time to discontinuation was 14.1 months (7.0–23.3). Previous exposure to ⩾1 advanced therapy, steroid use at baseline and disease extension (E3 and E2 versus E1) were independent predictors for worse VDZ persistence. Clinical remission (partial Mayo < 2) was 75.7% (171/226), 72.4% (157/217) and 70.2% (127/181) at years 1, 3 and 5, respectively. Steroid use during maintenance VDZ therapy occurred in 31.7% (92/290), hospitalization in 15.5% (45/290) and surgery in 3.4% (10/291). The rate of serious adverse events was 1.2 per 100 patient-years of follow-up. Conclusion: VDZ effectiveness appears enduring with favourable long-term safety profile. VDZ persistence was influenced by previous exposure to biologics/small molecules, disease distribution and steroid use at baseline in our study.
Plain language summary Vedolizumab long-term use in ulcerative colitis What was this study done? • Vedolizumab efficacy and safety in ulcerative colitis have been firmly established by existing evidence. • Long-term data from the GEMINI trial further corroborate the favourable safety profile over an extended duration but there is little data on long-term vedolizumab use over 1 year. What did the researches do? • We performed a retrospective, observational, cohort study. All adult IBD patients who ever received vedolizumab induction from November 2014 to December 2021 for ulcerative colitis/IBDU were included. What did the researchers find? • This real-world study demonstrates that vedolizumab persistence exceeds 80% at 1 year and remains nearly 50% at 5 years with no new safety signals. • Worse vedolizumab persistence is associated with prior exposure to biologics/small molecules, more extensive disease involvement and steroid use at vedolizumab initiation. What do the findings mean? • These findings have important implications for drug positioning and sequencing, as well as for optimizing outcomes when vedolizumab is utilized as first-line therapy. Furthermore, it also emphasizes the long-term safety profile.
Inflammatory bowel disease is a progressive and debilitating condition. Early and effective treatment using a treat-to-target approach is key to improving patient outcomes. Therefore, proactive ...monitoring is essential to ensure that treatment strategies are working and targets are being met. In this review we discuss the current monitoring tools available to us and how they can be used. We also discuss the importance of monitoring during key phases of the disease and propose an optimum treat-to-target monitoring strategy for Crohn’s disease and ulcerative colitis. Regarding the advent of new technology, we discuss how this may improve our monitoring capabilities and how we envisage future monitoring strategies of inflammatory bowel diseases.
Mucosal healing is associated with improved outcomes in patients with Crohn’s disease (CD), but assessment typically requires ileocolonoscopy. Calprotectin can be measured in fecal samples to ...determine luminal disease activity in place of endoscopy—this measurement is an important component of the treat-to-target strategy. We investigated whether levels of fecal calprotectin are associated with subsequent CD progression.
We performed a retrospective study of 918 patients with CD (4218 patient-years of follow-up evaluation; median, 50.6 mo; interquartile range IQR, 32.8–76.0 mo) managed at a tertiary medical center in Edinburgh, United Kingdom, from 2003 through 2015. Patients were included if they had 1 or more fecal calprotectin measurements made 3 months or more after their diagnosis. We collected clinical data and fecal calprotectin measurements and analyzed these data to identify factors associated with a composite outcome of progression in Montreal behavior, hospitalization, and resection.
An increased level of fecal calprotectin at the index visit was associated with subsequent progression of CD, independent of symptoms or disease location. The median level of fecal calprotectin at the index visit was 432 μg/g (IQR, 1365–998 μg/g) in patients who reached the composite end point vs 180 μg/g (IQR, 50–665 μg/g) in patients who did not. In multivariable analysis, a cut-off value of 115 μg/g calprotectin identified patients who met the end point with a hazard ratio of 2.4 (95% CI, 1.8–3.1; P < .0001).
In a retrospective analysis of patients with CD, we found that measurements of fecal calprotectin made during routine monitoring can identify patients at risk for disease progression, independent of symptoms or disease location. It is therefore important to screen asymptomatic patients for mucosal inflammation and pursue complete resolution of inflammation.
OBJECTIVELimited data are available regarding the relationship between anti-tumor necrosis factor (TNF) drug/antibody levels and perianal fistula outcomes in Crohn’s disease. The aims of this study ...were to assess the relationship between maintenance anti-TNF levels and perianal fistula outcomes.
METHODSThis was a retrospective cross-sectional study of patients receiving maintenance adalimumab or infliximab therapy (minimum 24 weeks) for the treatment of Crohn’s disease with associated perianal fistulas, who had anti-TNF drug/antibody levels (trough for infliximab) measured within 4 weeks of clinical assessment. The primary outcome was the association of anti-TNF levels with perianal fistula healing defined as the absence of drainage. The secondary outcome was the association of anti-TNF levels with complete perianal fistula closure.
RESULTSA total of 64 patients (adalimumab, n = 35; infliximab, n = 29) were included. Patients with fistula healing had higher levels of anti-TNF vs. those without fistula healing (adalimumab12.6 vs. 2.7 μg/mL, P < 0.01; infliximab8.1 vs. 3.2 μg/mL, P < 0.01). Patients with fistula closure also had significantly higher anti-TNF levels vs. those without fistula closure (adalimumab14.8 vs. 5.7 μg/mL, P < 0.01; infliximab8.2 vs. 3.2 μg/mL, P < 0.01). For adalimumab, receiver operator characteristic analysis identified an optimum level of >6.8 μg/mL and >9.8 μg/mL for fistula healing and closure, respectively. For infliximab, receiver operator characteristic analysis identified an optimum trough level of >7.1 μg/mL for both fistula healing and closure.
CONCLUSIONHigher maintenance anti-TNF levels are associated with perianal fistula healing and closure in Crohn’s disease.
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