Background: During the last 15 years we have gained extensive clinical experience about anti tumour necrosis factor-alpha (anti TNF-α) in the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Infliximab (IFX) and adalimumab (ADA) are most commonly used. Many patients have no, weak or diminishing effect of these drugs and some experience unacceptable side effects. In these patients, the anti-integrin vedolizumab (VDZ) is a novel treatment option, and combination therapy with anti TNF-α in a transition period until maximum VDZ effect is expected might represent a favourable clinical strategy and may reduce the need for prednisolone. Since VDZ is bowel-specific and not a systemic immunosuppressant, the combination with anti TNF-α may have an acceptable safety profile. The aim of this study was to examine the safety of the combination of VDZ and anti TNF-α in clinical practice.
Methods: IBD patients starting combination therapy with VDZ and anti TNF-α between November 2015 and June 2016 were followed prospectively. At baseline (start of combination therapy), diagnosis, extent and behaviour of disease, previous drug -and surgical treatment were recorded. During the observation period, adverse events, changes in medication and surgical interventions were recorded. By the end of 2016, all patients have been followed for at least six months.
Results: Fifteen patients with mean 3.9 years (range 0–16) of biological treatment, started combination treatment (10 UC and five CD). Eleven were given combination therapy with IFX and VDZ, two ADA and VDZ and two golimumab and VDZ. Ten patients received additional treatment with immunomodulator or prednisolone at inclusion.
As of today (30.11.16), the mean follow-up is 9 (5–12) months. Seven patients still receive combination biological therapy, seven have stopped anti TNF-α. The mean time on combination treatment of the latter group was 4.4 (1.4 to 8.4) months. One UC patient underwent a colectomy. This patient had onset of severe pustulosis during treatment with VDZ, IFX and methotrexate. One patient had a flare of monoarthritis after stopping IFX. Three patients received short-term, systemic prednisolone during follow-up and two were steroid dependent throughout follow-up. Three patients were given antibiotics; two for upper respiratory infections and one for pouchitis.
Conclusions: The novel combination therapy with VDZ and anti TNF-α seems to have a frequency of adverse events comparable to therapy with anti TNF-α and conventional immunomodulators. Thus, these first experiences in clinical practice suggest that combination of VDZ and anti TNF-α is acceptable with regards to safety in IBD patients.