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P104. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis in Mexican population

F. Gonzalez1, T. Cortes1, M. Ramos1, 120 de Noviembre National Medical Center, ISSSTE, Gastroenterology, Mexico City, Mexico

Background

Despite the available treatments for ulcerative colitis (UC), a big number of patients relapse. Adalimumab (ADA) is a human monoclonal antibody targeted to TNF-α. It has been recently approved in Europe, and in the United States the use of ADA in UC is based on the ULTRA-1 and ULTRA-2 trials.

Methods

Retrospective, cross-sectional trial.

Determine the location and activity of the disease prior to the use of ADA and evaluate the clinical response obtained by week 12 using the mayo score, the endoscopic activity index and C reactive protein (CRP) in patients naïve to treatment with biologics, and in patients previously treated with biologics (Infliximab) who did not achieved remission of the disease after 24 weeks of treatment.

Results

20 patients were analyzed. 11 had prior treatment with biologics and 9 were naïve to biological treatments. In the group treated with biologics, 36% were males, mean age 44.7 years; females represented 63% with a mean age of 46 years. In the biological treatment naïve group 67% were females, mean age 50.6 years; 33% for males and mean age of 61.3 years. The location of the disease measured by the Montreal classification for the biological treatment naïve group was 66% in E3, E2 22%, and E1 11%. For the pretreated patients with biological treatment the extension of the disease was of 36% in E2 and E1, and 28% in E3. The clinical activity evaluated according to the Mayo Score in the biological treatment naïve group was in average 9 for the pre-treatment, and 6 post-treatment (p 0.0001). In the group treated with biologics an average Mayo Score of 9 in the pre-treatment, and 6 post-treatment (p 0.0001) were observed. The endoscopic index evaluated in both groups showed no statistically significant difference in the biologics naïve patients group (p 0.63). With respect to CRP no statistically significant difference was observed in the reduction for the group previously treated with biologics (p 0.24).

Conclusion

The availability of controlled clinical trials has allowed investigators to count on an additional tool for the treatment of the UC. In our population we found a decrease of the disease activity measured by the Mayo score with standard doses of ADA at 12 weeks. While ADA induces a clinical remission according to the Mayo Score, no statistically significant reduction was seen for the endoscopic index in the biologics naïve group, so we must consider the extension and the disease activity for this group of patients.