Background Prior work on real-world burden of moderate RA patients highlighted low health-related quality of life (HRQOL) and high disease burden at time of biologic therapy initiation . The impact of biologics on clinical and patient-reported measures in moderate patients remains unclear.
Objectives To assess change over time in disease status, HRQOL, disease-modifying antirheumatic drug (DMARD) treatment and adverse events (AEs) in etanercept (ETN)-treated patients.
Methods A subset of patients aged ≥18 years with moderate RA (3.2<DAS28≤5.1) recruited to a UK longitudinal cohort study 2001-2009 comparing a non-biologic treated group (nBG) exposed to at least one traditional DMARD to a biologic group (BG) treated with ETN, were analyzed. Anonymous data were provided by the British Society for Rheumatology Biologics Register. HRQOL was assessed by the Health Assessment Questionnaire (HAQ) disability index score and SF-36 [physical component score (PCS), mental component score (MCS)]. Groups were matched on factors predisposing to progression (i.e. age, gender, disease duration, baseline HAQ and DAS28, previous DMARDs). Change from baseline to 6 months, and disease remission and progression were assessed by multivariate regression.
Results 1754 patients were assessed (211 BG/1543 nBG). BG compared to nBG had 1) a greater reduction in DAS28 and HAQ, 2) disease remission occurring more often (OR=2.7, CI:1.3-5.5, p=0.006) and 3) disease progression occurring in fewer patients (OR=0.3, CI:0.2-0.7, p=0.002). BG were more likely to be “good responders” (OR=2.4, CI:1.4-4.1, p=002). There were no significant differences between groups in PCS/MCS, DMARD therapy changes and time to DMARD discontinuation. BG had a higher overall incidence of “other serious infection” (not bone/joint infection, septicaemia) and “other CNS-related events” (not optic neuritis and peripheral neuropathy); with no significant differences in associated hospitalisation rates or deaths.
Conclusions BG had significantly reduced disease activity and better HRQOL after 6 months compared to matched nBG (the possibility of unmeasured confounding remains). BG were more likely to be “good responders” and have disease remission, but less likely to progress. The ETN group reported higher incidences of “other serious infection” and “other CNS-related events”, neither leading to higher hospitalisation rates.
Hyrich K, Deighton C. et al. Benefit of anti-TNF therapy in RA patients with moderate disease activity. Rheumatology 2009;48:1323–1327.
Disclosure of Interest S. Kotak Shareholder of: Pfizer, Employee of: Pfizer, J. Mardekian Shareholder of: Pfizer, Employee of: Pfizer, N. Horowicz-Mehler Consultant for: Pfizer, A. Shah Consultant for: Pfizer, A. Burgess Consultant for: Pfizer, J. Kim Consultant for: Pfizer, E. Gemmen Consultant for: Pfizer, H. Boyd Employee of: Pfizer, A. Koenig Shareholder of: Pfizer, Employee of: Pfizer