P092 Induction of clinical remission with certolizumab pegol in patients with ulcerative colitis who are not responders in Mexican population

Abstract

BACKGROUND: The TNF alpha inhibitor have revolutionized the treatment of inflammatory bowel disease (IBD), both in ulcerative colitis (UC) and in Crohn's disease (CD), achieving not only clinical remission even the healing of the affected mucosa. In our population, 70% of patients with IBD are diagnosed as UC and 30% CD. Currently, there are only 2 biologics approved for UC: infliximab and adalimumab. One third of patients will not respond to anti-TNF after induction and up to 50% of them will lose efficacy in the first year. Certolizumab pegol (CZP) has shown therapeutic efficacy in CD. In our country there are no studies that evaluate its use in UC. The aim of this work is to assess the efficacy of CZP in patients with UC with secondary failure to 2 anti-TNF alpha. METHODS: Study proof of concept. Six patients with UC diagnosis referred to our hospital center due to secondary failure to 2 anti-TNF alpha were studied. The severity of the disease was staged according to the Mayo score. Prior authorization of the patient for treatment with CZP, we administered it, at a dose of 400 mg subcutaneously at week 0, 2 and every 4 weeks, for 12 weeks. Clinical response was reviewed at 8 and 12 weeks after the beginning of the application of the biological and also endoscopically at 8 and 12 weeks. RESULTS: 50% corresponded to female sex with a female: male 1 to 1. The median age was: 52.50 [23–63] years. Of the 6 patients, 5 had left colitis and 1 had pancolitis. 4 patients fulfilled criteria of Mayo for severe activity and 2 with moderate activity. 4 patients with an endoscopic subscore Mayo 2 and 2 patients with endoscopic subscore Mayo 3. At the baseline measurement, 50% (3) had a normal CRP and 100% had albumin within normal parameters. At 8 weeks of follow-up, 50% of patients entered clinical remission by Mayo score. 4 patients had an endoscopic subscore May 1 or lower. At 12 weeks of biological application, the same results were observed. By laboratory it was observed at 12 weeks that 83.3% had CRP within normal parameters and 66.7% had normal albumin. No secondary events were observed during the 12 weeks of treatment. CONCLUSION(S): In this work proof of concept, CZP seems to be an option in patients with UC who have had secondary failure to other anti-TNF; however, because of the small size of the sample, a prospective and randomized study is required to confirm these findings. The present work does not have conflict of interests.