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P398. Outcome of treatment with biological agents in Crohn's disease: 117 patients in 5 years from a tertiary referral center

L. Ramos, A. Hernandez Camba, M. Carrillo Palau, I. Alonso, N. Hernandez Alvarez-Buylla, E. Quintero Carrion, Hospital Universitario de Canarias, Gastroenterology, La Laguna, SantaCruz de Tenerife, Spain

Background

Over the past decade, biological agents as anti-TNF antagonists (aTNFa) have become available as effective treatment for inducing and mantaining clinical remission in luminal and fistulising Crohn's disease (CD). Several large trials have demostrated its efficacy and safety but just during a limited follow-up period. However, few data are available regarding clinical practice and the use of aTNFa. The aim of this study was to evaluate the efficacy and safety of aTNFa during a 5 years-period in a single center.

Methods

All consecutive CD patients receiving aTNFa between January 2007 and December 2012 were retrospectively reviewed untill June 2013. Data regarding time from diagnosis, site of disease, previous medication and indication of aTNFa were collected. Initial and sustained clinical response was evaluated at 3–6 month and at the end of follow-up. Cause of biological discontinuation and adverse effects related to aTNFa were evaluated. Rate of corticosteroids use, hospitalizations and surgery during and after aTNFa were registered.

Results

A total of 117 CD patients (60M/57F, mean age 40.3 years; Infliximab [IFX] n = 86, Adalimumab [ADA] n = 31) were included. The main indication for aTNFa was corticodependency (40%), associated to immunomodulators (89%). Median follow-up lenght was 40.3 months (±12). Five patients received only induction therapy. Mean time of aTNFa treatment was 25 months (±21). Initial clinical response were showed in 72% and 75% of patients at 3 and 6 months, respectively. Significative reduction of PCR levels was determinated after 1 year (23.4±34 vs 8.4±20; p < 0.001). aTNTa was discontinued in 62 (53%) patients (55IFX/7ADA): 11% due to side effects (12 anaphylaxias and 1 tuberculosis-no mortality reported), 13% for loss of response and 21% (25) for clinical remission. Twenty-four patients changed biological agent and mantained clinical efficacy. After aTNFa discontinuation for clinical remission, the rate of relapse and new indication of aTNFa was 16% (4/25) after a follw-up time of 19±13 months.

Conclusion

Conclusions:

  • In our series, aTNFa therapy was very efficacious to obtain clinical response during the first year of treatment (75% - 6 months).
  • Clinical remission determined biological discontinuation in 20% of patients, requiring new indication of aTNFa in 16% of these cases after 19 months.
  • Use of aTNFs was safe in our population after a follow-up of 40 months.