The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.

Summary Background There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. Aim To assess the real‐world, short‐term effectiveness of ustekinumab in refractory Crohn's disease (CD) Methods Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey‐Bradshaw Index (HBI), C‐reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. Results Three hundred and five patients were analysed (≥2 previous anti‐TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 µg/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti‐TNF agent and fewer previous anti‐TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response. Conclusion This is the first study to show the real‐world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.

Summary Background Effectiveness of vedolizumab in real world clinical practice is unknown. Aim To evaluate the short and long‐term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). Methods Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey‐Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short‐term response was assessed at week 14. Variables associated with short‐term remission were identified by logistic regression analysis. The Kaplan‐Meier method was used to evaluate the long‐term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. Results 521 patients were included (median follow‐up 10 months [interquartile range 5‐18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient‐year of follow‐up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. Conclusions Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short‐ and long‐term response. Vedolizumab seems to be safe in clinical practice.

Treatment with CyA showed a lower rate of SAE and a similar efficacy to that of IFX thereby supporting the use of either CyA or IFX in SR-ASUC. In addition, the risk-benefit of sequential CyA-IFX for CyA non-responders is acceptable.

A longer time on the waiting list and referral by a general practitioner are factors associated with patients failing to keep their endoscopy appointment.