Objectives To report side effects seen in a clinical cohort of patients >65 years old with Rheumatoid Arthritis treated with Etanercept and to compare the SEs rate with patients ≤ 65 years old.
Methods All patients with RA that started Etanercept from November 2005 to November 2006 and referring to our Rheumatology Unit until November 2011 were included in this study and prospectively followed to collect side effects related to therapy (Group A patients ≤ 65 years old, group B > 65 years old). All SEs observed during 5 years, primarily infective adverse event (IAE) and Serious adverse event (SAE), were collected. Data were analyzed with Mantel Cox survival analysis
Results Eighty two patients were enrolled in this study from November 2005 to November 2006 and followed until November 2011: 31 (28 females, 3 males) aged ≤ 65 years (Group A), 52 (40 females, 11 males) aged > 65 years (Group B). In the patients > 65 years old the safety profile of Etanercept was similar than in patients ≤ 65 years old (p>0.05) and the survival curves between the groups were similar (p>0.05). Rates of infection were comparable across the groups (p>0.05). Urinary tract infections and upper respiratory tract infections (including nasopharyngitis) were the most frequently reported IAEs. Also rates of SAEs were comparable in the two groups (p>0.05) (Tab. 1)
Mean survival time before that a first AE related to therapy with Etanercept was recorded was 29.6 months ±2.42 in the Group A, 31.3± 2.6 in the Group B. Median survival time was 31.7 months in the Group A and 34.4 in the Group B, (p>0.05). No significant correlation has been found between the survival time until the first adverse event and the age (p=0.63). Mean survival time before definitive therapy suspension with Etanercept due to SAEs was 46.2 months ±2.99 in the ≤ 65 years old group and 47.7± 4.1 in the elderly group (p>0.05). No significant correlation has been found between therapy duration when SAE occurred and the age used as a covariate in the Mantel Cox equation (p=0.728). Finally, a retention rate of 64.7 % at 5 years in the group <65 years old and 63.0 % in the ≥ 65 years old group was observed
Conclusions In our experience, anti-TNFα agent Etanercept has been safe in elderly patients; the risk of SEs (primarily IAE and SAE) in these patients was no greater than in subjects aged ≤ 65 years. However, such inhibitors are associated with various and numerous SEs, elderly patients with RA should be carefully monitored.
Disclosure of Interest None Declared