Background Anti-TNF agents have been in used in Canada for the last ten years. Although a vast body of clinical experience has been accumulated since that time, there are still areas of uncertainty in their usage. One of them is whether usage in monotherapy has a similar clinical efficacy profile than usage in combination with a DMARDS. Products monograph actually disclosed that both usage are officially indicated base on short term Phase III and Phase IV trials results.
Objectives The primary objective of this study is to compare the survival rates of two different anti-TNF agents, adalimumab (ADA) and etanercept (ETA) used as first biologic agent with and without associated DMARDS in the treatment of rheumatoid arthritis (RA) using the data coming from the Rhumadata computarized database at the Institute of Rheumatology of Montreal.
The secondary objective is to evaluate the influence of baseline demographic and clinical data on the primary outcome.
Methods Data for all patients with rheumatoid arthritis according to the ACR criteria included in the database since 2005 and exposed for the first time only to an anti-TNF agents were extracted. Only patients exposed to adalimumab and etanercept were included in this analysis to standardize route of administration. Demographics and baseline clinical data are: age, gender, disease duration,tender joint count (TJC), swollen joint count (SJC), disease activity score including DAS 28 ESR and CRP 3-4 variables, CDAI, SDAI, Rheumatoid Factor and Anti-CCP baseline status, ESR and CRP at baseline, HAQ score, VAS fatigue scale, VAS pain Scale, morning stiffness duration, Dmards and glucocorticoid usage.
Results Data from 249 patients with rheumatoid arthritis are used. 95 and 154 patients were respectively using adalimumab or etanercept. All baseline demagraphic and clinical variables were comparable for both group (performed T-Test=non significant). There was slightly more usage of Dmards with ADA than ETA (89% vs 78%, p=0.02). TJC slightly lower for ETA than ADA (7.3 vs 9.5, p=0.04). There were more female patients in the monotherapy group than in the combination group (75% vs 90%, p=0.01). The 4 year survival rates (Kaplan-Meier survival proportion) for ADA+DMARDS vs ADA mono are respectively 56% and 11% (p=0.03 Log-rank statistic), for ETA+DMARDS vs ETA mono, 67% vs 47% (p=0.007), for combined ETA-ADA+DMARDS vs ETA-ADA MONO, 62% vs 40% (p=0.001) and for ADA or ETA both on MTX, 67% vs 57% (p=0.12).
Conclusions Combination of etanercept or adalimumab with a traditional DMARDS agent such as methotrexate exhibit a far better survival rate at 4 years than adalimumab or etanercept used in monotherapy.
Disclosure of Interest None Declared
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.