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Background and Study Aims: Vedolizumab (VDZ) is a gutselective integrin inhibitor used to treat Crohn's disease (CD) and ulcerative colitis (UC). This retrospective study assessed effectiveness and treatment persistence of VDZ in a Belgian reallife cohort of CD and UC patients., Patients and Methods: CD and UC patients from 15 Belgian centers, who started VDZ between 01/09/2015 and 31/06/2016 and attended ≥1 visit after the first VDZ infusion, were included. Data were collected before first infusion, at week (W)10, W14 (CD patients only), month (M)6 and last follow-up. Treatment response and remission rates (changes in disease activity scores) and treatment persistence (Kaplan-Meier analysis) were assessed., Results: Of the 348 patients receiving at least one dose of VDZ, 325 (202 CD, 45 biologic-naïve; and 123 UC, 42 biologic-naïve) patients were included in data analyses. At M6, 87.6% (176/201) of CD and 86.1% (105/122) of UC patients were still on VDZ treatment, 75.6% (34/45) and 83.9% (26/31) achieved clinical response, and 66.7% (44/66) and 42.9% (15/35) were in remission. At M6 remission rates was significantly higher while response rates tended to be higher among biologic-naïve versus biologic-failure CD patients., Conclusions: VDZ offers an effective treatment option in real-life settings and treatment effectiveness appears higher in biologic-naïve versus biologic-failure CD patients. (Acta gastroenterol. belg., 2020, 83, 15-23)., (© Acta Gastro-Enterologica Belgica.)

Background: The natural history of ulcerative colitis (UC) is unpredictable. Factors associated with the need for different types of step-up therapy in UC patients failing on 5-aminosalicylic acid (5-ASA) or corticosteroids are understudied., Aims: Describe step-up therapy in patients with UC the first year after failing on 5-ASA or corticosteroids., Methods: A Belgian, multi-center, prospective, non-interventional observational study comprising adult UC patients failing on 5-ASA or corticosteroids and naïve to immunomodulators/ biologicals. During a 12 months follow-up, patient characteristics, demography, medical therapy, biomarkers, therapy adherence and quality of life (QoL) were assessed., Results: After 1 year, 35% of the patients were on biological therapy. Use of anti-TNF differed depending on baseline treatment: corticosteroid-refractory patients (55.8%), 5-ASA refractory (20.0%), and corticosteroid-dependent (16.0%) patients (p<0.001). The decision to start a line of therapy was based on the Mayo combined severity but not on biomarkers like faecal calprotectin, haemoglobin, CRP, albumin, platelets, and number of extraintestinal manifestations. At year 1, 84.2% of the patients had only mild UC or remission and a significant improvement of fatigue (p=0.004) and IBDQ scores (p<0.001) were observed implying an improved QoL., Conclusion: Treatment step-up, based on clinical scores in immunomodulatory and anti-TNF naïve patients with UC, provides good clinical outcomes and QoL., (© Acta Gastro-Enterologica Belgica.)

Background and Study Aims: Anti-TNF monoclonal antibodies are a cornerstone in the treatment of Crohn's disease. Prospective data on switching from the subcutaneous and human adalimumab (ADM) to the intravenous and chimeric infliximab (IFX) are scarce., Patients and Methods: In this prospective, observational, multicentre cohort study we included 21 patients with loss of response to ADM despite at least 4 consecutive weekly injections. Clinical response (CDAI drop≥70 points) and remission (CDAI≤150) were assessed after switching from ADM to IFX after 10 weeks, 6 and 12 months. Predictive factors of response/remission, the need for therapy intensification, discontinuation and safety were investigated., Results: Short-term response and remission (10 weeks) were seen in 57% and 48% respectively. Mid- and long-term clinical response and remission were achieved in 40% and 25% after 6 months and in 45% and 20% after 12 months respectively. At 12 months, 81% still were on IFX. IFX therapy intensification was needed in half of the patients at 6 months and three quarter of patients at 12 months. Undetectable ADM trough levels (despite weekly injections) were a predictive factor for short-term response and remission to IFX. About half of the patients with response at week 10 maintained response at 6 and 12 months., Conclusions: Switching from ADM to IFX can be efficacious in patients with loss of response, in particular in case of undetectable ADM trough levels. The majority of patients however will need IFX therapy intensification during their first year of treatment., (© Acta Gastro-Enterologica Belgica.)

Biologicals have become an important component in the treatment of Crohn's disease in children. Their increased and long term use raises safety concerns. We describe safety and cost of infliximab in Belgian pediatric Crohn's disease patients. All patients on infliximab as part of the present or past treatment for Crohn's Disease until January 1st 2011 were selected from an existing database. Information on disease phenotype, medication and adverse events were extracted. Adverse events occurred in 25.9% of patients exposed to infliximab of which 29.6% were severe. In total 31.7% of patients stopped infliximab therapy. The main reasons for discontinuation were adverse events in 45.4% and loss of response in 30.3%. No malignancies or lethal complications occurred over this 241 patient year observation period. Immunomodulators were concomitant medication in 75% of patients and were discontinued subsequently in 38.4% of them. The cost of infliximab infusions per treated patient per year in the Belgian health care setting is approximately 9 474 euro, including only medication and hospital related costs. Even though infliximab is relatively safe in pediatric CD on the short term, close follow-up and an increased awareness of the possible adverse reactions is highly recommended. Adverse reactions appeared in 25.9% of all patients and were the main reason for discontinuation. Treatment cost has to be balanced against efficacy and modifications in disease course. In the Belgian health care system, the medication is available to all patients with moderate to severe CD.

Thiopurines (TP) are widely used in the management of inflammatory bowel diseases. Side-effects and inefficacy are a major concern as they lead to withdrawal of the drug. Tools investigating TP metabolism are useful to avoid inadequate cessation of TP therapy. TP metabolism is complex and many enzymes are involved. Among them, Thiopurine methyltransferase (TPMT) is the only one routinely measured by pheno- or genotyping. In this review, the rationale for TPMT and thiopurine metabolites, 6-thioguanine nucleotides and 6-methylmercaptopurine, determination in clinical practice is discussed, specifically in case of thiopurine failure and recommendations are given about their interpretation and potential dose optimization of TP drugs.

Unlabelled: Stricturing subocclusive small bowel Crohn's disease (CD) is often an indication for surgery. We embarked on an open label pilot study to assess the safety and efficacy of infliximab in patients with stricturing subocclusive CD., Patients and Methods: A cohort of patients with a documented and symptomatic small bowel stricture caused by CD was studied. Patients had to be refractory to corticosteroids and/or immunosuppressives, and not in need for immediate surgery. The patients were treated by a single infusion of infliximab 5 mg/kg and followed up at w1, w2, w4 and w8., Results: After the 6th patients, the study was prematurely discontinued because the predefined safety thresholds of more than 2 surgeries within the first 5 patients was reached. Only two patients completed the 8 weeks study, with a positive response to infliximab and improvement of inflammation confirmed by the CRP and CT scan. Two patients had to be operated early and the last two patients first did well but worsened after one month and were operated 35 and 42 days after infliximab, respectively. No surgical complications occurred in the 4 operated patients. In conclusion, a subset of patients with subocclusive small bowel stricturing CD may benefit from infliximab.

The association of inflammatory bowel disease and acute febrile neutrophilic dermatitis (Sweet's syndrome) has infrequently been reported in the literature. We describe the case of a 41-year-old Caucasian woman with ileo- anal Crohn's disease who presented simultaneously an erythema nodosum and a Sweet's syndrome. A dramatic regression of the cutaneous lesions was observed after infliximab treatment, indicating that this therapy might be useful for both Crohn's disease and Sweet's syndrome.