PMID- 31712995 OWN - NLM STAT- MEDLINE DCOM- 20200513 LR - 20200513 IS - 1179-1969 (Electronic) IS - 1170-229X (Linking) VI - 37 IP - 1 DP - 2020 Jan TI - An Analysis of Real-World Data on the Safety of Etanercept in Older Patients with Rheumatoid Arthritis. PG - 35-41 LID - 10.1007/s40266-019-00721-5 [doi] AB - OBJECTIVE: The aim of this study was to use real-world data to evaluate potential interactions between age, treatment, and the risk of developing four adverse events (AEs) common in the elderly: congestive heart failure, serious infections, non-melanoma skin cancer, and interstitial lung disease. These AEs were identified as important in a prior age-based analysis ( 65 years) of etanercept- or placebo-treated patients with rheumatoid arthritis (RA) in controlled clinical trials. METHODS: Real-world data (1 January 2013 to 31 January 2018) were obtained from the IBM Watson Health MarketScan((R)) Database. Patients were included if aged >/= 18 years, enrolled for >/= 1 year prior to RA diagnosis, and without any of the four AEs of interest prior to RA diagnosis or between RA diagnosis and first etanercept exposure. Logistic regression analysis was applied following propensity matching of patients receiving or not receiving etanercept based on age at diagnosis, age status at the beginning of observation (> 65 years or not), sex, geographic region, and follow-up duration. RESULTS: The overall cohort comprised 403,689 patients. The absolute risk of each of the four AEs increased with age. In propensity-matched cohorts, etanercept was associated with significantly higher odds of developing each of the four AEs (p < 0.001 for all). However, the relative risk of experiencing the four AEs in patients who received etanercept versus those who did not was similar between patients 65 years of age. CONCLUSIONS: In patients with RA, the relative increase in etanercept-associated risk of experiencing congestive heart failure, serious infection, non-melanoma skin cancer, or interstitial lung disease was similar between elderly and non-elderly. FAU - Edwards, Christopher J AU - Edwards CJ AD - Rheumatology Department, NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK. cedwards@soton.ac.uk. FAU - Bukowski, Jack F AU - Bukowski JF AD - Pfizer, Collegeville, PA, USA. FAU - Burns, Sara M AU - Burns SM AD - Pfizer, Cambridge, MA, USA. FAU - Jones, Heather E AU - Jones HE AD - Pfizer, Collegeville, PA, USA. FAU - Pedersen, Ron AU - Pedersen R AD - Pfizer, Collegeville, PA, USA. FAU - Sopczynski, Joan AU - Sopczynski J AD - Pfizer, Collegeville, PA, USA. FAU - Marshall, Lisa AU - Marshall L AD - Pfizer, Collegeville, PA, USA. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Drugs Aging JT - Drugs & aging JID - 9102074 RN - 0 (Antirheumatic Agents) RN - OP401G7OJC (Etanercept) SB - IM MH - Adolescent MH - Age Factors MH - Aged MH - Antirheumatic Agents/administration & dosage/*adverse effects/therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Cohort Studies MH - Databases, Factual MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology MH - Etanercept/administration & dosage/*adverse effects/therapeutic use MH - Female MH - Humans MH - Incidence MH - Logistic Models MH - Male MH - Middle Aged MH - Risk Factors MH - Treatment Outcome EDAT- 2019/11/13 06:00 MHDA- 2020/05/14 06:00 CRDT- 2019/11/13 06:00 PHST- 2019/11/13 06:00 [pubmed] PHST- 2020/05/14 06:00 [medline] PHST- 2019/11/13 06:00 [entrez] AID - 10.1007/s40266-019-00721-5 [pii] AID - 10.1007/s40266-019-00721-5 [doi] PST - ppublish SO - Drugs Aging. 2020 Jan;37(1):35-41. doi: 10.1007/s40266-019-00721-5.