FRI0055 Safety of etanercept in elderly patients with rheumatoid arthritis: a pooled analysis

Background Both ageing and rheumatoid arthritis (RA) are associated with a higher risk of comorbidities, some of which may be increased by current therapies. However, failure to control RA can lead to a particularly rapid loss of function and independence in the elderly population. Objectives To assess the safety of etanercept (ETN) in older (aged >65 years) vs younger (aged ≤65 years) patients with RA. Methods Patient-level data were pooled from the double-blind, placebo (PBO)-controlled phases of all completed, randomised, Pfizer- or Amgen-sponsored ETN studies in patients with RA. The occurrence of adverse events (AEs,%) in PBO- and ETN-treated patients was analysed by age (≤65 years vs >65 years), using the exact Poisson method to calculate 95% confidence intervals (CI). Fisher’s Exact tests and Breslow Day tests for interaction were used to assess statistical differences. Results Data on 6418 patients were collected from 19 studies (≤65 years: PBO, n=1910; ETN, n=3497;>65 years: PBO, n=364; ETN, n=647). In PBO-treated patients, the occurrence of congestive heart failure (CHF), interstitial lung disease (ILD), and angioedema was significantly higher in older than younger patients (CHF and ILD: figure 1; angioedema: 0.82%, 95% CI 0.17–2.41% and 0%, 95% CI 0–0.19, respectively, p SI included pneumonia, cellulitis, septic arthritis, sepsis, and parasitic infection. Conclusions The occurrence of CHF, SI, and NMSC was higher in older vs younger patients taking ETN. While the analysis suggests an overall acceptable safety profile of ETN, the relative risks and benefits need to be considered when treating older patients. Disclosure of Interest C. J. Edwards Grant/research support from: Pfizer, Abbvie, Biogen, UCB, Janssen, Samsung, Mundipharma, Roche, Lilly, Merck, Consultant for: Pfizer, Abbvie, Biogen, UCB, Janssen, Samsung, Mundipharma, Roche, Lilly, Merck, Speakers bureau: Pfizer, Abbvie, Biogen, UCB, Janssen, Samsung, Mundipharma, Roche, Lilly, Merck, K. Roshak: None declared, J. Bukowski Shareholder of: Pfizer, Employee of: Pfizer, R. Pedersen Shareholder of: Pfizer, Employee of: Pfizer, M. Thakur Shareholder of: Pfizer, Employee of: Pfizer, L. Marshall Shareholder of: Pfizer, Employee of: Pfizer, H. Jones Shareholder of: Pfizer, Employee of: Pfizer