Resumen de Vedolizumab in the treatment of ulcerative colitis and crohn’s disease

Enrique Juanes Calabuig, Pablo Piera Pérez, J.C. Juárez Jiménez

• Background and objectives: Crohn’s Disease (CD) and Ulcerative Colitis (UC) are Inflammatory Bowel Diseases (IBD) associated with a chronic inflammation of the gastrointestinal tract. IBD are currently not curable and medical treatment aims at reducing the clinical symptoms. In the last few years, vedolizumab and other monoclonal antibodies have been used in patients who do not respond or tolerate first-line treatments. The aim of this paper is to summarize the approved indications for vedolizumab, review the different clinical studies on the use of this drug and assess its security and place in therapy.

  Method: The search has been conducted in different databases such as PubMed,EMBASE, Cochrane Library, TripDataBase and Google as well as health organization websites such as EMA, NICE and AEMPS. The selected studies are phase III and performed for both indications.

  Results: VDZ has shown higher efficacy against placebo in UC (GEMINI I) in the end points "clinical response at week 6" and "clinical remission at week 52" in patients who had failed to respond to conventional treatments and TNF antagonists. In CD, primary end points "clinical remission at week 6" (GEMINI II),clinical remission at week 52" (GEMINI II) and "clinical remission at week 6 in the overall population" (GEMINI III) approached significance. However, two primary end points did not show significance: "clinical response (CDAI-100) at week 6" (GEMINI II) and "clinical remission at week 6 in patients in whom TNF inhibitor treatment failed" (GEMINI III).

  Conclusions: Therapy with VDZ seems to be justified in patients with moderately to severely active UC, patients in which conventional therapy or treatment with a TNF antagonist has failed or when a contraindication exists. Evidence for VDZ in CD is weaker and its efficacy seems to be lower. Therefore, it could be considered as a third-line treatment in cases when the treatment with TNF inhibitors fails, since no other alternative exists