Vedolizumab is an integrin receptor antagonist used when anti-TNF treatment has failed or is contraindicated in moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). The aim of this study was to evaluate efficacy and side effects of vedolizumab in daily clinical practice. A review of medical records for the time period 2014–2018 at Østfold Hospital Trust was performed. Symptoms (based on the Mayo score and the Harvey–Bradshaw Index) and the use of concomitant medications were recorded at 4–6 months, 12 months, >12 months and if applicable, after discontinuation of the treatment. Measurements of faecal calprotectin and vedolizumab drug levels were obtained. The disease activity was classified as complete remission (CR), partial response (PR) or non-response (NR) based on calprotectin levels, symptoms and endoscopy/radiology findings. Calprotectin < 100 mg/kg was used as a marker for CR, 100–300 mg/kg for PR and >300 mg/kg for NR. A total number of 77 patients (53% with UC) received vedolizumab during the defined period, of which 4/77 were biological-naïve. In 52/77, one biological drug had been used prior to vedolizumab treatment, while 21/77 had used ≥2. Before starting vedolizumab, 65% of CD patients had undergone IBD-related surgery. CR was achieved in 13/77 (17%) and PR in 28/77 (36%). A total number of 36/77 was defined as NR at the most recent follow-up. The mean time of observation was 15 months (median 13, range 2–49 months). Time until achieved CR was 4–6 months (n = 1), 12 months (n = 7) and >12 months (n = 5). Discontinuation of treatment occurred in 28 patients (36%) (therapeutic failure = 16/28, therapeutic failure + side effects = 4/28, side effects only = 4/28, and other causes =4/28). In CD, 14% had undergone surgical intervention during treatment and 6% following discontinuation of vedolizumab. In UC, 32% underwent colectomy shortly after termination (mean/median time between discontinuation and colectomy: 3.4/2 months). F-calprotectin and p-vedolizumab in CR and PR. F-calprotectin and p-vedolizumab in CR and PR. Half of the patients who received vedolizumab responded to treatment, of which 2/3 had PR and 1/3 had CR. The effect tends to be better in UC compared with CD. One in five patients had CR and this effect was noted mainly from 12 months and/or more of active treatment. It is of utmost importance to carry out an objective assessment of therapeutical response before 12 months to evaluate if there is indication for continuation or cessation of treatment.

Anti-tumour necrosis factor (a-TNF) is an established treatment for moderate to severe Crohn disease (CD) and ulcerative colitis (UC). Treatment failure occurs frequently. Long-term observational studies are few and little is known about outcomes following discontinuation of a-TNF therapy. A systematic review of medical records for the period 2001–2017 was performed, and data regarding sosio-demographic, clinical and therapeutical aspects were collected. Moreover, symptoms, calprotectin measurements, surgical procedures and use of concomitant medication before, during and after a-TNF were collected. Disease activity was classified as complete remission (CR) or partial response (PR) based on a composite assessment of symptoms, calprotectin values and results of additional endoscopy/radiology. Two hundred and forty-two patients (male 56%) who started a-TNF therapy between 2001 and 2011 were included. In CD (n = 154), 51% had ileocolic affection, 53% luminal disease and 33% had undergone a prior intestinal resection. In UC (n = 88), 80% had a pancolitis. Initially n = 212 (88%) received infliximab and n = 30 (12%) adalimumab. Dose-escalation was performed in 35%. Fifty-three patients (22%) switched to another a-TNF due to treatment failure or intolerance. In UC, 32 (36%) had a colectomy, while 55 CD-patients (36%) had an intestinal resection during/following a-TNF therapy, of whom 43 were surgical naive before starting a-TNF. Malignant disease was diagnosed in 11 patients (5%) and mortality due to septicaemia occurred in four patients. One-year evaluation: CR was achieved in n = 106 (44%) and PR in n = 63 (26%), while n = 73 (30%) had no response/discontinued a-TNF therapy. Last evaluation on maintenance a-TNF (max 17 years observation; median 9 years): CR was achieved in n = 46 (19%); CD 26% and UC 7%, respectively. Evaluation of patients who had discontinued a-TNF (max 16 years observation; median 6 years): During the observation period, 170 of 242 (70%) had discontinued a-TNF therapy, of which treatment failure or severe side effects (36% vs. 26%) were the most frequent causes. Altogether CR was achieved in 62% of those patients who had stopped a-TNF. In CD, 12% had discontinued therapy due to clinical remission, while the comparable number in UC was 34%. Of those who had discontinued a-TNF due to clinical remission, 13 (27%) have re-started biological therapy. One out of five patients was in complete remission using the primary a-TNF drug 9 years after start of therapy. The efficacy was better in CD-patients, but more UC-patients had stopped a-TNF due to remission. One out of three patients had been operated, regardless of diagnosis.

Background: TNF inhibitor is a well-established treatment in moderate to severe ulcerative colitis (UC). Treatment failure occurs in a large proportion of patients. There are few long-term observational real-life studies and the clinical course in the period following discontinuation of TNF treatment, has been little focused. Methods: We conducted a systematic review of all patient records for the period of 2001–2014. Demographic, clinical and management data were collected. In addition, disease activity, calprotectin level and ongoing use of TNF inhibitor and/or other anti-inflammatory medication at the last follow-up control was especially emphasized. All data were analysed using PASW version 24. Results: A total of 87 patients started infliximab treatment until the end of 2011. Of these, 61% were men, mean age 41. Seventy-nine percent had extensive colitis (E3). At start of anti-TNF therapy, 75% used concomitant steroids and 25% used immunomodulators (IMM). 1-year evaluation: Complete remission (CR) (calprotectin <100 mg/kg) was achieved in 45% and partial remission (PR) in 14%. At 1 year, 41% of the patients had discontinued infliximab due to treatment failure or severe adverse events. The last evaluation (up to 14 years of observation; median 6 years): Eleven patients (13%) were in CR and 3 (3%) in PR, 25 (29%) had undergone colectomy, and 27 (31%) had stopped infliximab due to remission. Of these, 10 patients (37%) restarted anti-TNF (4 years observation), all with complete response. After discontinuation of TNF inhibitor (up to 13 years of observation; median 4 years): Sixty-five percent of the patients were classified as being in CR and 23% in PR at the last evaluation (excluding all post-colectomy patients). Thirty-seven percent of the patients were using IMM and 19% used oral steroids. Conclusions: Among patients starting infliximab only 13% were in long-term complete remission. Stopping infliximab due to remission was successful in one third. A high proportion of patients were in steroid free complete remission median 4 years after stopping infliximab. Exit strategies after successful remission-induction anti-TNF treatment in UC patients is highly requested.