Advanced Age Is an Independent Risk Factor for Severe Infections and Mortality in Patients Given Anti–Tumor Necrosis Factor Therapy for Inflammatory Bowel Disease

doi:10.1016/j.cgh.2010.09.026

Clinical Gastroenterology and Hepatology

Volume 9, Issue 1, January 2011, Pages 30-35

https://doi.org/10.1016/j.cgh.2010.09.026 Get rights and content

Background & Aims

Few data are available on effects of biologic therapies in patients more than 65 years old with inflammatory bowel disease (IBD). We evaluated the risk and benefits of therapy with tumor necrosis factor (TNF) inhibitors in these patients.

Methods

We collected data from patients with IBD treated with infliximab (n = 2475) and adalimumab (n = 604) from 2000 to 2009 at 16 tertiary centers. Ninety-five patients (3%) were more than 65 years old (52 men; 37 with ulcerative colitis and 58 with Crohn's disease; 78 treated with infliximab and 17 with adalimumab). The control group comprised 190 patients 65 years old or younger who were treated with both biologics and 190 patients older than 65 years who were treated with other drugs. The primary end points were severe infection, cancer, or death.

Results

Among patients more than 65 years old who received infliximab and adalimumab, 11% developed severe infections, 3% developed neoplasms, and 10% died. No variable was associated with severe infection or death. Among control patients more than 65 years old, 0.5% developed severe infections, 2% developed cancer, and 2% died. Among control patients less than 65 years old, 2.6% developed severe infections, none developed tumors, and 1% died.

Conclusions

Patients older than 65 years treated with TNF inhibitors for IBD have a high rate of severe infections and mortality compared with younger patients or patients of the same age that did not receive these therapeutics. The effects of anti-TNF agents in older patients with IBD should be more thoroughly investigated, because these patients have higher mortality related to hospitalization than younger patients.

Section snippets

Patients and Methods

Sixteen Italian referral centers, which prospectively collected data on the treatment of IBD patients with biological agents since the introduction of these agents on the market, participated in the study.

The following data were collected: age of patients, type and location of inflammatory bowel disease, indication for treatment, comorbidities, concomitant treatment, disease activity scores, side effects, maintenance therapy, time elapsed from start of biologics, surgery after biological

Results

Ninenty-five patients out of 3079 (3%) were over 65 years of age. Demographic characteristics are reported in Table 1. Thirty-six had UC, and 58 had CD. Seventy-eight patients were treated with infliximab (42 CD and 36 UC) and 17 with adalimumab (16 CD and 1 UC). The mean length of follow-up from the first biological treatment was 26 months (range, 3–82). At the start of biological treatment the median CDAI was 211 (range, 149–439) in CD patients, while 22 UC patients had moderate disease and

Discussion

Following the enactment of the Social Security Act in the United States in 1965, most social and medical studies began defining those 65 and older as “elderly.” To the best of our knowledge, no study has been published on the outcomes of elderly IBD patients treated with biologics. This multicenter study shows that anti-TNF therapy in IBD is equally effective in elderly as in adult patients in both diseases, but it is hampered by the high rate of side effects. Severe infections occurred in 11%

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: Conflicts of Interest The authors disclose the following: Dr Mario Cottone has received funds for scholarships and support for participation in international congresses from Abbott, as well as funds for improving services in hospitals and participation in congresses from Schering–Plough. He reports participation in continuing medical education events sponsored by Giuliani, Chiesi, and Sofar. Dr Ambrogio Orlando has received fees for educational courses, satellite symposia, and support for participation in international congresses from Abbott. He reports participation in continuing medical education events sponsored by Giuliani, Chiesi, and Sofar. Dr Maria Cappello reports participation in continuing medical education events sponsored by Giuliani, Schering–Plough, and Abbott. Dr Paolo Gionchetti is on the advisory board of Abbott for 2010. He has received support for participation in international congresses. He reports participation in continuing medical education events sponsored by Ferring, Giuliani, Schering–Plough, and Abbott. Dr Vito Annese reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Anna Kohn reports participation in continuing medical education events sponsored by Giuliani, Schering–Plough, and Abbott. Dr Silvio Danese has received consulting fees from Schering–Plough, Abbott Laboratories, AstraZeneca, UCB Pharma, Actelion, Danone, and Ferring. He reports participation in continuing medical education events sponsored by Abbott Laboratories, Ferring, UCB Pharma, Schering–Plough, Giuliani Pharma, and Chiesi. Dr Walter Fries reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Alessandro Armuzzi reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Gabriele Riegler reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Fabiana Castiglione reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Sandro Ardizzone reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Livia Biancone reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Renata d'Inca reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Fabrizio Bossa reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Luisa Guidi reports participation in continuing medical education events sponsored by Schering–Plough and Abbott. Dr Marco Daperno reports participation in continuing medical education events sponsored by Schering–Plough and Abbott.

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Original article–alimentary tractAdvanced Age Is an Independent Risk Factor for Severe Infections and Mortality in Patients Given Anti–Tumor Necrosis Factor Therapy for Inflammatory Bowel Disease

Background & Aims

Methods

Results

Conclusions

Section snippets

Patients and Methods

Results

Discussion

J Crohn's Colitis

J Crohn's Colitis

Gastroenterology

Gastroenterology

Gastroenterology

Clin Gastroenterol Hepatol

Clin Gastroenterol Hepatol

Dig Liver Dis

Gastroenterology

Consensus development conference on the use of biologics in the treatment of inflammatory bowel disease, June 21–23, 2006

Gastroenterology

Treatment of inflammatory bowel disease in the elderly: an update

Drugs Aging

Original article–alimentary tract
Advanced Age Is an Independent Risk Factor for Severe Infections and Mortality in Patients Given Anti–Tumor Necrosis Factor Therapy for Inflammatory Bowel Disease