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P419 Efficacy of vedolizumab in patients with inflammatory bowel disease and failure of anti-TNF-antibodies

C. Höög*, M. Eberhardson, S. Almer

Karolinska Institute, Stockholm, Sweden

Background

Vedolizumab is an integrin blocking alfa4beta7-receptor inhibitor that blunts the migration of lymphocytes into gut mucosa. In studies vedolizumab was shown to give a significant reduction of symptoms and to induce mucosal healing in patients with Crohn’s disease (CD) and ulcerative colitis (UC). At Karolinska University Hospital we started treatment with vedolizumab when the drug was approved in Sweden in May 2014. This is a retrospective observational study of the effects of vedolizumab in a clinical setting.

Methods

As of November 2015, 45 patients (16 UC and 29 CD) had received induction treatment with vedolizumab (300 mg weeks 0, 2, and 6) and were included. All patients had previously failed treatment with immunomodulators and at least one anti-TNF-antibody. After induction, vedolizumab 300 mg was given every 8 weeks. Patients were assessed at baseline and after induction (week 10–12) using the Harvey–Bradshaw Index (HBI) for CD or partial Mayo score (PMS) for UC, as well as C-reactive protein (CRP), faecal calprotectin (FC), endoscopy (mild, moderate, or severe inflammation), and a physician global assessment of clinical response (no response, partial response, or remission). Patients continuing vedolizumab were evaluated again at 6 months for clinical response.

Results

After induction therapy, mean PMS decreased from 5.8 to 3.4 in the UC group. In the CD group HBI decreased from 9.7 to 6.6. Mean FC decreased from 1 712 to 452 in UC and from 1275 to 492 in CD. CRP was not affected in either group. Median grading of endoscopic inflammation was moderate at baseline and mild at follow-up week 10–12 in both groups. In UC patients, 50% had a partial response, and 19% were in remission after induction, whereas in CD patients, 40% had a partial response, and 15% were in remission. At 6 months, 45% of UC patients were in remission, 18% were partial responders, and 36% had stopped vedolizumab. Corresponding figures for 22 CD patients were 27% in remission, 36% partial responders, and 36% had stopped treatment. The reasons for withdrawal of vedolizumab were side effects, mainly aggravation of symptoms (n = 4), and in the others, treatment failure (n = 8).

Conclusion

In a clinical setting, treatment with vedolizumab for inflammatory bowel disease and previous failure of anti-TNF-therapy, induced a partial response in 30% and remission in additional 33% at 6 months. The response at 6 months was better than after induction therapy for those who continued with vedolizumab.