Exabis Library

The treatment of inflammatory bowel disease (IBD) has been revolutionised over the past decade by the increasing use of immunomodulators. With such immunomodulation, the potential for opportunistic infection is a key safety concern for patients with IBD. Opportunistic infections pose particular problems for the clinician: they are often difficult to recognise and are associated with appreciable morbidity or mortality, because they are potentially serious and hard to treat effectively. This led the European Crohn's and Colitis Organisation (ECCO) to update the previous Consensus meeting on opportunistic infections in IBD.

This is the second Nurses European Crohn’s and Colitis Organisation [N-ECCO] Consensus Statements document addressing inflammatory bowel disease [IBD] nursing across Europe. N-ECCO continues to be an active member of the European Crohn’s and Colitis Organisation [ECCO], providing education and networking opportunities for nurses across Europe within three designated nursing sessions, N-ECCO Network Meeting, N-ECCO School and the N-ECCO Research Forum, in addition to e-learning and podcasts.

Previous studies suggested a role for segmental colectomy (SC) and total colectomy (TC) for colonic Crohn’s disease (cCD). TC might reduce recurrence rates, at the cost of impaired quality of life and higher stoma rates. We compared the long-term outcomes of SC and TC.

This is an international, multicentric study on data from the prospective databases of six centres. All consecutive patients operated on between 2000 and 2019 for cCD with SC or TC were included. Exclusion criteria were colorectal cancer, previous bowel resections, and lack of follow-up data. Disease extension was based on involvement of 1 to 5 colonic segments. Resection of 1-3 segments was classified as SC, resection of 4-5 segments as TC. Primary aim was surgical recurrence after SC vs TC. Secondary aims were perioperative complications, stoma formation rate, and predictors of recurrence.

Data of 687 (56.2% women) patients were analysed. Mean age at diagnosis and at surgery were 30±15.8 and 40.4±15.4 years. Disease duration was 10.4 ± 8.6 years. 16.6% of patients were A1, whereas most (62.2%) were diagnosed between 17 and 40 years. Isolated cCD (L2) was present in 61.1%, ileocolic CD (L3) in 38.9%, and concomitant jejuno-ileal CD (L4) in 3.2%. Most had stricturing (B2) cCD (41.9%). Active perianal disease was found in 28.9% patients. SC was performed in 285 patients, TC in 402. The latter more frequently had isolated cCD, inflammatory (B1) disease, current (37.8 vs 16.5%, p<0.001) or previous (56 vs 32.6%, p<0.001) perianal CD, and longer disease duration (11.3 ± 8.9 vs 9.2 ± 7.9, p<0.001). Postoperative complications and mortality were similar, but TC patients more frequently required 90-day readmission (6% vs 2.1%, p=0.02). Temporary (31.6 vs 21.4%, p<0.001) and definitive (39.3vs8%, p<0.001) stomas were more likely after TC. The 15-year cumulative surgical recurrence was 36%, more likely in the TC group (44 vs 27%, Log-Rank p=0.006), and it was not affected by the number of colonic segments involved (23 vs 28%, 1-3 vs 4-5 segments p=0.2) (Fig 1). In patients with 1-3 segments involved, postoperative treatment with biologics, compared to any other regimen, reduced the risk of recurrence (25 vs 51%, p<0.001), while early age at diagnosis (p=0.02) and perianal CD (p=0.01) increased the risk. Omission of biological therapy (HR 5.4, 95%CI 5.1-5.8 p<0.001), and paediatric diagnosis (HR 2.1, 95%CI 2.3-3.1 p<0.001) were the strongest predictors of recurrence in this subgroup.

In this study, SC was safe, required less frequently stoma and repeated surgery, compared with TC. These findings question previous data on the topic and might be supported by the efficacy of postoperative biologic therapy on cCD.

The world wide web and social media platforms have become an unprecedented source for sharing self-experience, potentially allowing the collection and integration of health data with patient experience

StuffThatWorks (STW) is an online open platform that applies machine learning and the power of crowdsourcing where patients with chronic medical conditions can self-report and compare their individual outcomes using a structured online questionnaire. The present study analyzed de-identified self-reported personalized comparative treatments' effectiveness for CD. The design was a cross-sectional, international, crowdsourcing, questionnaire and AI web-based study of patients with Crohn's self-reporting their outcomes by 06/11/21. A proprietary STW Bayesian inference model was built to measures the level of improvement in condition severity and clinical indicators for each treatment and ranks treatment effectiveness. A linear regression model was used to examine co-variate association with the current condition severity as the outcome. Finally, the effectiveness of first-line biological treatments was analyzed by multiple treatment comparisons model and by calculating odds ratio and 95% confidence intervals for each treatment pair.

A total of 5898 self-reported CD patients were included for the analysis. Most participants were female (76.13%) and from English speaking countries (91%). Overall, anti TNF drugs were the most reported tried treatment (71.97%) followed by steroids (46.22%) and diet (43.8%). Among Biologic therapy (BT) tried by STW CD users, Infliximab (IFX) and Adalimumab (ADA) were ranked most effective by the STW effectiveness model, by change in condition severity on 1-5 scale (mean change of 1.19 points, estimated lower-upper bounds 1.10-1.28), followed by Ustekinumab (UST) (mean 1.07, bounds 0.88-1.26), and Vedolizumab (VDZ) (mean 0.96, bounds 0.74-1.17). Bowel surgery (mean 1.19, bounds 0.98-1.40), and cannabis (mean 1.01, bounds 0.72-1.31) were also among the top 5 most effective treatments together with BT. The odds ratio was calculated for each BT pair, with IFX more effective than ADA, UST and VDZ (OR 2.34 (CI 1.88 – 2.80), 3.08 (CI 2.44 – 3,73), 7.16 (CI 6.53 – 7.80), respectively), ADA more effective than UST and VDZ (OR 1.32 (CI 0.74 - 1.9), 3.06 (CI 2.49 - 3.63), respectively), and UST more effective than VDZ (OR 2.32 (CI 1.6 - 3.05)).

We present the first online crowdsourcing platform-based study of treatment self-reported outcomes in CD. Net-based crowdsourcing patient-reported outcomes' platforms can potentially help both clinicians and patients select the best treatment for their condition.

An association between shorter disease duration and improved clinical efficacy has been shown in post hoc analyses of clinical trial data with biological therapies in Crohn’s disease (CD). The efficacy and safety of risankizumab (RZB) as induction and maintenance therapy have been recently reported. Here, the efficacy of RZB stratified by baseline CD duration is reported.

In ADVANCE (NCT03105128) and MOTIVATE (NCT03104413), patients with moderately to severely active CD received intravenous (IV) RZB induction therapy or placebo (PBO) for 12 weeks. Patients with clinical response to RZB IV induction were re-randomised in a 52-week maintenance study (FORTIFY, NCT03105102) to receive subcutaneous (SC) RZB or PBO (ie, withdrawal). For this post-hoc analysis, patient subgroups were stratified by years of CD duration at baseline (< 2, 2–5, > 5–10, and > 10 years). Induction analyses focused on patients who received RZB 600 mg IV or PBO for 12 weeks. As all patients who entered maintenance responded to RZB IV induction, maintenance analyses were limited to those patients who responded to induction and then received RZB 360 mg SC for 52 weeks. Clinical and endoscopic outcomes were evaluated using nonresponder imputation incorporating multiple imputation to handle missing data due to impact of the COVID-19 pandemic. Safety was assessed throughout the studies.

The induction and maintenance analyses included 527 patients who received RZB 600 mg IV and 141 patients who received RZB 360 mg SC, respectively. At the end of induction (week 12), patients with CD duration of < 2 years achieved higher rates of endoscopic outcomes with IV RZB induction vs patients with longer durations of disease (Figure 1), and regardless of baseline CD duration, greater proportions of RZB-treated patients achieved clinical remission (defined by stool frequency and abdominal pain), endoscopic response, endoscopic remission, and ulcer-free endoscopy vs PBO (P ≤ .05). Clinical remission rates at week 12 were numerically higher in patients with CD duration of < 5 years vs > 5 years (Figure 1). Similar results for improved clinical and endoscopic outcomes associated with shorter disease duration were observed at week 52 with RZB 360 mg SC maintenance treatment (Figure 2). RZB was well tolerated with lower rates of serious adverse events and serious infections vs PBO in induction, across CD duration subgroups.

RZB induction and maintenance therapy was effective and well tolerated with a safety profile generally similar across CD duration subgroups. Achievement of clinical and endoscopic endpoints were higher in patients with shorter duration of CD, suggesting that earlier introduction of RZB therapy may lead to improved outcomes.