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P599 Adverse efffects in patients with Inflammatory Bowel Disease on biological treatment

P. Ramirez de la Piscina*1, L. Urtasun1, I.M. Duca1, K. Spicakova1, I. Ganchegui1, A. Campos1, A. Sanchez1, S. Estrada1, M.D.R. Calderón2, M. Salvador1, E. Delgado1

1HUA- Txagorritxu, Gastroenterology, Vitoria, Spain, 2Hospital de Zumarraga, Gastroenterology, Zumarraga, Spain

Background

Inflammatory bowel disease affects an increasing number of people. There are different treatments, including immunosuppressive drugs and biological therapy, which can be used both in monotherapy and in combined therapy.

However, using these drugs can lead to potential risks, as they have adverse effects that can be from mild to potentially severe. Nevertheless, they have a good safety profile if they are used properly.

The aim of our study is to analyse the frequency and characteristics of adverse effects of biological therapy (both in monotherapy and in combination) in our patients.

Methods

We have carried out a retrospective descriptive study of 170 patients who received biological treatment (adalimumab, certolizumab, infliximab or golimumab). 116 patients (68.2%) received concomitantly immunosuppressive treatment (azathioprine, 6-mercaptopurine or methotrexate).42.4% were women. 65.2% were diagnosed of Crohn's disease (40.5% inflammatory pattern, 34.2% stenosing pattern, 25.2% fistulizing pattern, 17.1% had perianal disease too). 34.8% had ulcerative colitis (6.7% rectitis, 33.9 left sided colitis and 59.4% pancolitis).

Results

13 patients developed infectious complications, of which 38.4% received biological drugs in monotherapy and 61.6% in combined therapy. The infections consisted on the following: tuberculosis (7 patients), pneumonia (2 patients), sepsis (2 patients) and fever (2 patients).

11 patients presented infusional reactions: 10 (91%) received combined therapy and only 1 (9%) monotherapy with a biological drug. Infusional reactions were: local reaction (1 patient), fluctuations in blood pressure (2 patients), facial flush (3 patients), dyspnoea (1 patient), asthenia (2 patients) and arthralgia (3 patients).

3 patients developed tumours; 100% of them were under combined treatment. One of them developed colonic neoplasia (he did not follow endoscopic controls), another one developed laryngeal neoplasia (he had smoking habit and chronic alcoholism) and the third one developed a thyroid tumour.

Conclusion

Although in general the biologic treatment is safe, it has adverse effects that need to be known, so that they can be prevented and treated as long as it is possible. In our case, the percentage of adverse effects was 17%, and the rate of infusional reactions (6.47%) was similar to that described in other series (3-15%).

Tumours developed in our series are not typically associated to the treatment related neoplasia described in literature, and they could be related to other etiological factors.

Whether to continue, decrease or stop the therapy, it should be decided individually.

Furthermore, it has been described that doing an appropriate selection of the patients, the security profile of these drugs is accurate.