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* = Presenting author

P637 Anti-TNF alpha therapy in Inflammatory Bowel Disease - safety profile in elderly patients

C. Bernardes*, D. Carvalho, P. Russo, J. Saiote, J. Ramos

Hospital de Sto António dos Capuchos, Gastroenterology, Lisbon, Portugal

Background

Infliximab (IFX) and Adalimumab (ADA) are tumor necrosis factor α (TNF α ) antagonists, which is a key cytokine in immune regulation and defense against infections and malignancies. The ageing process has been associated with immune system functional changes, which could increase susceptibility to adverse events (AE). Advanced age has been suggested as a risk factor for infectious complications among patients with Inflammatory Bowel Disease (IBD) treated with anti-TNF α agents; however, safety data regarding biological therapy in elderly patients with IBD is still limited. The aim of this study was to evaluate the AE of elderly patients with IBD treated with anti-TNF α agents.

Methods

A retrospective analysis was conducted in all IBD patients ≥ 60 years treated with anti-TNF α drugs between 2000 and 2013 at a tertiary referral center for IBD. The probability of a causal association between each AE and the drug was determined by using an imputability score based in chronologic and clinical criteria and then classified as "not related", "doubtful", "possible", "likely" or "definite".

Results

Twenty-three patients (15 females) were included - 12 with Ulcerative Colitis and 11 with Crohn's Disease. Twenty-one patients were treated with IFX and 8 with ADA (6 after switching from IFX) for a mean treatment time of 35 months, performing a total of 368 IFX and 493 ADA administrations. Ninety-three AE were recorded (mean of 0,8 AE/patient/year): 73 with IFX and 20 with ADA. There was at least one AE in 21 of the patients (91%). The most frequently reported events were infections (n=50, in 16 patients), episodes of serum sickness-like disease (n=16, in 7 patients) and infusion reactions (n=14, in 4 patients). The likelihood of association with the anti-TNF α was considered possible in 26%, likely in 11% and definite in 23% of the AE. Seventeen of the 93 AE were severe, 14 of which had an association that was at least possible with the drug. Nine events led to definitive discontinuation or drug switch and 10 events directly or indirectly led to IBD relapse or hospitalization. Only 1 event resulted in permanent disability and/or progressive disease. Mortality was null and there were no cases of tuberculosis infection.

Conclusion

In this series, the annual rate of AE related with the anti-TNF α therapy was low in elderly patients. The range and severity of events were similar to those previously described for younger individuals. Although serious AE were relatively rare, the majority of them showed a plausible correlation with the biological therapy. More comparison studies are required to determine the relative risks of biological therapy in this age group.