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Background Clinical trials may not readily reflect clinical practice. We aimed to assess the clinical effectiveness of vedolizumab in a real-world cohort of patients with ulcerative colitis (UC). Methods This is a prospective, observational, multi-centre cohort study. Eligible patients had active UC confirmed by a Mayo endoscopic subscore ≥2 at initiation of vedolizumab and had started treatment from 1/6/2015. Exclusion criteria included concurrent participation in a clinical trial in which UC treatment is dictated and contraindications to vedolizumab. All patients provided a written consent. Data on clinical characteristics, treatment patterns, disease activity and the short health scale were recorded at baseline and prospectively, using an electronic Case Record Form, integrated with the Swedish National Quality Registry for IBD (SWIBREG). The primary outcomes were A) clinical response, defined as a decrease in partial Mayo score of ≥2 and a reduction of ≥25 % from baseline, with a decrease ≥1 on the rectal bleeding score or an absolute rectal bleeding score of 0 or 1, at week 12 and B) clinical remission, defined as a partial Mayo score Results In total, 117 eligible UC patients were included during the study period 1/6/2015 to 2/6/2018. Clinical and demographical characteristics of patients are shown in Table 1; 101/117 (86%) patients had failed prior anti-TNF therapy. The drug persistence rate was 106/117 (91%) at 12 weeks and 79/117 (68%) at 52 weeks. The clinical response rate at 12 weeks was 59/117 (50%) and the clinical remission rate at 52 weeks was 57/117 (49%). Altogether, 35/117 (30%) had an endoscopic Mayo score ≤1 at 12 weeks and 41/117 (35%) at 52 weeks. However, data on endoscopy were not available for 42 vedolizumab treated patients at 12 weeks and 30 at 52 weeks. Among patients who continued vedolizumab, the median partial Mayo score decreased from 4 (3–5) at baseline to 1 (0–2) at 52 weeks (p < 0.0001). Correspondingly, the median faecal calprotectin decreased from 646 (333–1130) µg/g to 162 (42–382) µg/g (p = 0.0002) and the median C-reactive protein from 5.0 (2.1–8.0) mg/L to 3.5 (1.6–5.0) mg/L (p = 0.008). Consistently, quality of life improved in vedolizumab treated patients, with a significant reduction of the overall short health scale score at 52 weeks (p < 0.0001). Conclusion Vedolizumab treated patients with UC represented a treatment-refractory group. Long-term (52 weeks) effectiveness of vedolizumab can be achieved, in terms of clinical- and inflammatory activity as well as in quality of life. The study was financially supported by Takeda.

Background Orofacial granulomatosis (OFG) is a rare syndrome characterised by swelling of the orofacial area secondary to an underlying granulomatous inflammatory process. Concurrent intestinal Crohn’s disease (CD) has been described in 20–50% of adult patients with OFG. Methods This was a multicentre case series supported by the European Crohn’s and Colitis Organisation (ECCO) and performed as part of the Collaborative Network of Exceptionally Rare case reports (CONFER) project. A call was made to report on cases of OFG in CD, with clinical data recorded in a standardised collection form. Results This report includes 28 patients with OFG associated with CD: 14 males with mean age of 32 years ( ± 12.4 SD, range 14–60) and 14 females with mean age of 40.3 years ( ± 21.0 SD, range 11–79). Crohn’s distribution was ileal in six patients, colonic in six patients, ileocolonic in 15 patients and isolated upper gastrointestinal tract (UGI) disease in a single patient; six patients (21.4%) had UGI involvement and 11 patients (39%) had perianal disease. The diagnosis of OFG was made prior to CD diagnosis in 5 patients (mean of 0.9 years prior, range 1 month to 2 years), at the same time as CD in 4 cases, and after CD diagnosis in 19 cases (mean of 11.4 years after, range 6 months to 33 years). CD was undiagnosed in 5 patients, quiescent in 11 patients and active in 12 patients. The distribution of OFG involved the lips in 16 cases, buccal mucosa in 18 cases, tongue in eight cases and gums in five cases, with many patients having multiple areas involved. Angular cheilitis was present in 15 cases and aphthous or deep ulcers in 16 cases. Pyostomatitis vegetans and facial palsy were present in 1 case each. Pain was present in 25 cases, with impaired swallowing or speaking in 6 cases and psychological distress in 9 cases. A number of different treatments led to remission, including topical therapies in 2 cases, steroid injections in 2 cases, exclusive enteral nutrition in 1 case, anti-TNFs in 11 cases, Vedolizumab in 1 case, Ustekinumab in 1 case and Thalidomide in 2 cases. A further 7 cases were resistant to therapy including anti-TNFs and a single case had spontaneous remission without therapy. Conclusion This case series of OFG in CD highlights multiple points. The diagnosis of OFG usually occurs after that of CD and can be many decades after, but may also occur prior to or at the time of diagnosis of intestinal disease. Perianal disease and UGI disease are common associations, and there is a significant symptom burden due to pain and impaired swallowing, leading to psychological distress in many. Remission can be obtained with a variety of treatments, including topical and intralesional agents, biologic agents, and thalidomide.

Background Randomised controlled trials may not correctly reflect clinical practice. We aimed to assess the clinical effectiveness of ustekinumab in a real-world cohort of patients with ulcerative colitis (UC). Methods This observational, multi-centre cohort study explored ustekinumab treated patients with UC from the Swedish inflammatory bowel disease register (SWIBREG), a nationwide quality register. Prospectively collected clinical data were extracted December 2020. The primary outcome was the 16-week ustekinumab continuation rate. Secondary outcomes included A) drug continuation rate at the end of follow-up, B) corticosteroid-free biochemical remission, defined as f-Calprotectin Results In total, 145 patients were included and followed for a median period of 32 (19-56) weeks. Baseline characteristics are presented in Table 1. The drug continuation rate was 87% (126/145) at 16 weeks and 69% (100/145) at end of follow-up (Figure 1-2). Corticosteroid-free clinical and biochemical remission rates at follow-up visits are shown in Figure 3. The 6-point Mayo score decreased from 5 (3-6) at baseline to 2 (2-4) at 16 weeks (p Conclusion Ustekinumab was associated with clinical effectiveness in this nationwide real-world treatment refractory cohort.

Background We aimed to evaluate the effectiveness of tumour necrosis factor antagonist (anti-TNF) compared with vedolizumab (VDZ) as a second-line biological treatment in IBD. Methods A propensity score-matched cohort was created using data from the Swedish National Patient Register, the Swedish Quality Register for IBD (SWIBREG) and the Swedish Prescribed Drug Register. Patients with Crohn’s disease (CD) or ulcerative colitis (UC) exposed to anti-TNF as a first-line biologic, who initiated a second biologic agent 1 May 2014 – 31 December 2016 were included (n = 1363). We compared patients exposed to anti-TNF vs. patients exposed to VDZ as a second-line biologic treatment. The primary outcome was drug continuation rate at 12 months. Secondarily, we assessed survival without hospitalisation (because of IBD, complications of IBD or IBD-related surgery) and survival without IBD-related surgery. Risk of infections was investigated as survival without a) prescription of antibiotics and b) hospitalisation because of infection. Additionally, the proportion of patients on corticosteroids at 12 months was assessed. Results After 1:1 propensity score matching, the cohort was restricted to 400 patients (CD, n = 198; UC, n = 202). For CD, estimated drug continuation rate at 12 months was 72.7% in the VDZ-treated patients, compared with 73.7% in the anti-TNF treated patients (Figure 1A). Survival without IBD-related hospitalisation (81.8% vs. 87.9%, p = 0.25), IBD-related surgery (81.8% vs. 88.9%, p = 0.17), prescription of antibiotics (64.6% vs. 70.7%, p = 0.33) and hospitalisation due to infection (94.9 % vs. 87.9%, p = 0.08) did not significantly differ between the groups. Likewise, there was no statistically significant difference in proportions of patients on corticosteroids at 12 months (21.2% vs. 22.2%, p = 0.86). For UC, estimated drug continuation rate at 12 months was 69.3% in the VDZ-treated patients, compared with 62.4% in the anti-TNF treated patients (Figure 1B). VDZ treated patients had lower survival without IBD-related hospitalisation (82.2% vs. 93.1%, p = 0.02) and IBD-related surgery (82.2% vs. 94.1%, p = 0.01). Survival without antibiotics (81.2% vs. 70.3%, p = 0.08) and hospitalisation due to infection (92.1% vs. 92.1%, p = 0.97) as well as corticosteroid treatment at 12 months (17.8% vs. 23.8%, p = 0.30) did not differ significantly between the groups. Conclusion In this propensity score-matched cohort, the effectiveness and safety of anti-TNF and vedolizumab appear comparable when used as a second-line biologic in CD. In patients with UC, risk of hospitalisation and surgery was lower in patients treated with anti-TNF. Randomised controlled trials are needed to confirm these findings. Support provided by Takeda.

Background: Studies comparing drug survival in different anti-tumour necrosis factor (TNF) agents in IBD patients are scarce, especially for second-line anti-TNF agents. We aimed to (A) assess drug ...

Pregnancy outcomes in IBD patients treated with vedolizumab, anti-TNF, or conventional therapy

Clinical effectiveness of golimumab : Interim analysis of the observational study of patients with ulcerative colitis on golimumab in the Swedish National Quality Registry for IBD-GO-SWIBREG

Clinical effectiveness of vedolizumab : Interim analysis of the Swedish observational study on vedolizumab assessing effectiveness and healthcare resource utilisation in patients with ulcerative colitis (SVEAH UC)

A Swedish observational study (SVEAH) on vedolizumab assessing effectiveness and healthcare resource utilization in patients with inflammatory bowel disease

The impact of thiopurine drugs on the natural history and surgical outcome of ulcerative colitis : A cohort study