Older patients with inflammatory diseases on biologic therapy appear to be at increased for infection compared with younger patients receiving these agents or older patients not receiving them, according to results of a systematic review and meta-analysis.  

In order to assess the safety of biologic agents in older patients, the authors utilized PubMed/Medline and Embase to search for studies conducted in older patients with inflammatory bowel disease, rheumatoid arthritis, or psoriasis. “Included studies provided information on patients who began receiving therapy with a biologic agent when they were older than 60 years and a control population (either younger users of biologics or older patients who did not use biologics),“ the study authors explained. They extracted data on overall pooled rates of infections, malignancy, as well as mortality, and calculated pooled odds ratios (ORs).

The meta-analysis included 14 studies with 4719 older biologic agent users, 13,305 younger biologic agent users, and 3961 older non-biologic agent users. “The pooled prevalence of infections in older and younger users of biologics was 13% and 6% respectively, yielding a pooled random effects odds ratio of 2.28 (95% CI, 1.57–3.31),” the study authors reported. A significant increase in the risk of malignancy was also observed for older users of biologics compared to younger users (OR: 3.07; 95% CI: 1.98–4.62).

Results of the study also showed that the risk of infection was 3 times more likely for older biologic users compared with older patients who did not take biologics (OR: 3.60; 95% CI: 1.62–8.01). On the other hand, no significant difference was observed in the risk of malignancy (OR: 0.54; 95% CI: 0.28, 1.05) or death (OR: 1.52; 95% CI: 0.44, 5.28) between the older biologic user group and older non-biologic user group. 

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“Biologic therapy in older patients should be done with caution and in combination with minimizing risks, particularly of preventable infections through appropriate vaccination,” the study authors concluded, adding that additional studies with long-term follow up are needed to examine the safety of these agents in this patient population.


Borren NZ, Ananthakrishnan, AN. Safety of Biologic Therapy in Older Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis. Clinical Gastroenterology and Hepatology. 2019.