Drug retention and safety of TNF inhibitors in elderly patients with rheumatoid arthritis

Abstract

BackgroundThe concerns about the development of adverse events (AEs) in elderly RA patients as a result of age-related changes in drug metabolism and the presence of comorbid illnesses are emphasizing due to increasing prevalence of rheumatoid arthritis (RA) in old age. However, they tend to be inadequately represented in RA clinical trials because of the exclusion criteria that are commonly applied. The tolerability and safety of TNF inhibitors in elderly patients have not been also evaluated in clinical practice. This study aimed to evaluate the retention rate and safety of TNF inhibitors (TNFI) in elderly RA patients.MethodsTotal 429 RA patients (838 person-years [PYs]) treated with TNFI from a retrospective biologic DMARDs registry. Patients were divided into an elderly (age ≥60 years) and a younger group (<60 years). The drug retention rates of both groups were compared using Kaplan-Meier curves. Potential predictors of TNFI discontinuation in the elderly were examined using Cox regression analysis. The incidence rate (IR) of serious adverse events (SAEs) in the elderly group was compared to that of the young group.ResultsOf the patients, 24.9 % (n = 107, 212 PYs) were in the elderly group. Regarding the retention rates of TNFI in 3 years, there was no significant difference between the elderly and younger group (p = 0.33). The major cause of discontinuation in elderly patients was AE (34.3 %), whereas that was drug ineffectiveness (41.7 %) in younger patients. Age (HR 1.09, CI 1.02-1.16) was a predictor of discontinuation, while the presence of comorbidity (HR 0.37, CI 0.15-0.91) had a protective effect against drug discontinuation in the elderly. The IR of SAEs in the elderly (6.13/100 PYs) was higher than in the younger group (5.11/100 PYs).ConclusionsThe retention rate of TNFI in the elderly was comparable with that in younger patients. The major cause of discontinuation in the elderly patients was AEs, while it was drug ineffectiveness in younger patients. The IR of SAEs in the elderly was higher than in the younger patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1185-6) contains supplementary material, which is available to authorized users.

Safety of Biologic Therapy in Older Patients With Immune-Mediated Diseases: A Systematic Review and Meta-analysis

“…[19][20][21][22][23][24][25][26][27][28][29][30][31] Thus, our final analysis included 14 unique studies. [7][8][9][32][33][34][35][36][37][38][39][40][41][42] Of these, 3 studies had only the abstract available for review, but sufficient detailed information could be extracted to allow for inclusion. 9,41,42 Most studies were retrospective cohorts; only 2 were prospective studies.…”

“…Of these 14 studies, 6 were among patients with IBD (n ¼ 349 older biologic patients), 7,8,32,33,41,42 1 study included those with psoriasis (n ¼ 135 older biologic patients), 40 and 7 examined those with RA (n ¼ 4235 older biologic patients). 9,[34][35][36][37][38][39] The mean age of included participants was 71 years of age for older biologic users (data from 11 studies), 43 years of age for younger biologic users (data from 10 studies), and 72 years of age in the older nonbiologic control patients (data from 6 studies). More than half the patients in each subgroup were women: 61% of older biologic users (9 studies), 65% of younger biologic users (8 studies), and 51% of older control subjects (3 studies).…”

Safety and effectiveness of abatacept in Japanese non-elderly and elderly patients with rheumatoid arthritis in an all-cases post-marketing surveillance

“…Previous studies have reported the safety and effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) directed against tumor necrosis factor (TNF) and interleukin (IL)-6 receptor for the treatment of RA; caution has been raised regarding their use in elderly patients [4,5]. These reports suggested that the risk-benefit balance should be carefully considered, particularly for elderly patients who will receive these medications [6][7][8].…”

Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan

“…Indeed, this notion is supported by previous studies demonstrating that poor treatment persistence of biologics can blunt the effectiveness [22,23]. While several studies have revealed that overall treatment persistence of biologic agents in elderly RA patients is not inferior to that in younger RA patients [24,25], large variation in treatment persistence as well as reasons for discontinuation among different biologic agents have been noted [25,26]. As to GLM, there are no published studies on treatment persistence measured for patients aged 75 years or above in real-world practice in Japan.…”