PMID- 31292906
OWN - NLM
STAT- MEDLINE
DCOM- 20191211
LR  - 20200309
IS  - 1179-1969 (Electronic)
IS  - 1170-229X (Linking)
VI  - 36
IP  - 9
DP  - 2019 Sep
TI  - Efficacy and Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis: 
      A Post-Hoc Analysis of Randomized Controlled Trials.
PG  - 853-862
LID - 10.1007/s40266-019-00691-8 [doi]
AB  - BACKGROUND: Elderly individuals are disproportionately affected by rheumatoid 
      arthritis (RA), but few studies have addressed the efficacy and safety of 
      treatments in this population. OBJECTIVE: Our objective was to assess the 
      efficacy and safety of etanercept in elderly patients (aged >/= 65 years) with RA. 
      METHODS: The efficacy analysis was a post hoc analysis of data from the 
      open-label period of three phase IV clinical trials of etanercept for RA. Least 
      squares (LS) change from baseline (cfb) in 28-joint Disease Activity Score 
      (DAS28), Health Assessment Questionnaire Disability Index (HAQ-DI), and modified 
      Total Sharp Scores (mTSS) were analyzed by age (< 65 vs. >/= 65 years) for each 
      study. The safety analyses were of data pooled from the double-blind, 
      placebo-controlled periods of 19 phase I-IV randomized studies of etanercept in 
      patients with RA. The percentage occurrence of adverse events (AEs) in placebo- 
      and etanercept-treated patients was analyzed by age (< 65 vs. >/= 65 years). 
      RESULTS: There were no significant differences in LS mean cfb in DAS28 or mTSS 
      between the two age groups. LS mean cfb in HAQ-DI scores was consistently lower 
      in elderly than in non-elderly patients, although significant differences were 
      not observed in all trials. Overall, AE occurrence was higher in elderly than 
      non-elderly patients, regardless of treatment. In etanercept-treated patients, 
      there were small yet statistically significant increases in the occurrence of 
      congestive heart failure, serious infections, and non-melanoma skin cancers in 
      elderly versus non-elderly patients. For most AEs, occurrence did not 
      significantly differ between elderly and non-elderly patients. CONCLUSION: 
      Overall, there were no substantial differences in the efficacy or safety of 
      etanercept between elderly and non-elderly patients with RA.
FAU - Edwards, Christopher J
AU  - Edwards CJ
AD  - NIHR Clinical Research Facility, University Hospital Southampton, Southampton, 
      Hampshire, UK. cedwards@soton.ac.uk.
FAU - Roshak, Katherine
AU  - Roshak K
AD  - Pfizer, Collegeville, PA, USA.
FAU - Bukowski, Jack F
AU  - Bukowski JF
AD  - Pfizer, Collegeville, PA, USA.
FAU - Pedersen, Ronald
AU  - Pedersen R
AD  - Pfizer, Collegeville, PA, USA.
FAU - Thakur, Mazhar
AU  - Thakur M
AD  - RegSafe Consulting Ltd, Wokingham, UK.
FAU - Borlenghi, Cecilia
AU  - Borlenghi C
AD  - Pfizer Argentina, Buenos Aires, Argentina.
FAU - Curiale, Cinzia
AU  - Curiale C
AD  - Pfizer Italy, Rome, Italy.
FAU - Jones, Heather
AU  - Jones H
AUID- ORCID: 0000-0002-1186-0669
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  - Aged
MH  - Antirheumatic Agents/*adverse effects/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Double-Blind Method
MH  - Etanercept/*adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - *Randomized Controlled Trials as Topic
MH  - *Safety
MH  - Treatment Outcome
EDAT- 2019/07/12 06:00
MHDA- 2019/12/18 06:00
CRDT- 2019/07/12 06:00
PHST- 2019/07/12 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2019/07/12 06:00 [entrez]
AID - 10.1007/s40266-019-00691-8 [pii]
AID - 10.1007/s40266-019-00691-8 [doi]
PST - ppublish
SO  - Drugs Aging. 2019 Sep;36(9):853-862. doi: 10.1007/s40266-019-00691-8.