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P287. Adverse effects of medication in IBD: A single center prospective observational study


J. Machado1, P. Ministro1, R. Araújo1, R. Ramalho1, E. Cancela1, A. Castanheira1, A. Silva1

1S. Teotónio Hospital, Gastroenterology, Viseu, Portugal



Background: Inflammatory Bowel Disease (IBD) encompasses three chronic clinical entities, Crohn Disease (CD), Ulcerative Colitis (UC) and Unclassified Colitis (UNCC). The aetiology is unknown and therefore a causal therapy is not available. Different therapeutic approaches may be considered during follow-up taking into account disease activity, location and behaviour. Drugs approved to treat IBD have distinct potencies but also have different safety profiles.

The aim of this study was to characterize adverse effects (AE) associated to drugs used in a population of patients with IBD during 36 months.

Methods: A prospective observational study of drug adverse effects in a population with IBD was conducted. Patients with IBD diagnosis (CD, UC or UNCC) of a tertiary medical center treated with Mesalazine (5-ASA), Azathioprine (AZA), Methotrexate (MTX), Infliximab (INF) or Adalimumab (ADA) were included. Data were systematically registered using a predefined form. SPSS 17.0 was used for statistical analysis.

Results: A total of 244 patients were included. The mean age was 44.5±2.3 years. Fifty-three percent (n = 130) were female and 47% (n = 114) were male. Fifty-two percent (n = 127) had UC, 44.7% (n = 109) had CD and 3% (n = 8) had UNCC. Mean follow-up was 1031±153 days. Adverse effects were registered in 17.6% (n = 43) of the patients and 14% (n = 6) of those developed side effects to two or more drugs. A total of 50 adverse effects were registered, 56% (n = 28) of those resulted in temporary disability and 38% (n = 19) were considered serious adverse events (SAE). Fifteen patients were admitted as inpatient. No fatal events were registered. Adverse effects to each drug are registered in table 1.

Table 1
 MesalazineAzathioprineMethotrexateInfliximabAdalimumab
No. of patients treated242825256
AE7% (n = 17)26.8% (n = 22)20% (n = 1)28% (n = 7)33.3% (n = 2)
SAE1.7% (n = 4)7.3% (n = 6)0% (n = 0)24% (n = 6)33.3% (n = 2)

Conclusions: As we expected patients treated with classical imunnosuppressive agents and biological therapies had more adverse effects than those treated with mesalazine. Adverse effects related to biological therapies were more severe than those related to classical imunnosuppressive agents.