ObjectiveTo investigate whether antidrug antibodies and/or drug non‐trough levels predict the long‐term treatment response in a large cohort of patients with rheumatoid arthritis (RA) treated with adalimumab or etanercept and to identify factors influencing antidrug antibody and drug levels to optimize future treatment decisions.MethodsA total of 331 patients from an observational prospective cohort were selected (160 patients treated with adalimumab and 171 treated with etanercept). Antidrug antibody levels were measured by radioimmunoassay, and drug levels were measured by enzyme‐linked immunosorbent assay in 835 serial serum samples obtained 3, 6, and 12 months after initiation of therapy. The association between antidrug antibodies and drug non‐trough levels and the treatment response (change in the Disease Activity Score in 28 joints) was evaluated.ResultsAmong patients who completed 12 months of followup, antidrug antibodies were detected in 24.8% of those receiving adalimumab (31 of 125) and in none of those receiving etanercept. At 3 months, antidrug antibody formation and low adalimumab levels were significant predictors of no response according to the European League Against Rheumatism (EULAR) criteria at 12 months (area under the receiver operating characteristic curve 0.71 [95% confidence interval (95% CI) 0.57, 0.85]). Antidrug antibody–positive patients received lower median dosages of methotrexate compared with antidrug antibody–negative patients (15 mg/week versus 20 mg/week; P = 0.01) and had a longer disease duration (14.0 versus 7.7 years; P = 0.03). The adalimumab level was the best predictor of change in the DAS28 at 12 months, after adjustment for confounders (regression coefficient 0.060 [95% CI 0.015, 0.10], P = 0.009). Etanercept levels were associated with the EULAR response at 12 months (regression coefficient 0.088 [95% CI 0.019, 0.16], P = 0.012); however, this difference was not significant after adjustment. A body mass index of ≥30 kg/m2 and poor adherence were associated with lower drug levels.ConclusionPharmacologic testing in anti–tumor necrosis factor–treated patients is clinically useful even in the absence of trough levels. At 3 months, antidrug antibodies and low adalimumab levels are significant predictors of no response according to the EULAR criteria at 12 months.

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The present study was designed to assess the effectiveness of the n-3 fatty acids in modifying serum total, low density lipoprotein and high density lipoprotein (HDL) cholesterol, as well as serum triglycerides, over a seven-year period. Changes in plasma fibrinogen were recorded and long term safety assessed. A total of 365 subjects with ischemic heart disease (IHD), hyperlipidemia or a strong family history of IHD had their diet supplemented with MaxEPA (Seven Seas Ltd., Hull, England) fish oil containing 18-19% eicosapentaenoic acid. Venous blood samples were taken at regular intervals for lipid and fibrinogen assays and routine clinical chemistry and hematological profiling. Current medication was recorded and no further dietary modification was attempted. Triglyceride and fibrinogen were significantly reduced, whereas a significant reduction in total cholesterol occurred only in the subjects with a pre-oil level greater than 6.5 mmol/L. HDL cholesterol significantly increased over the study period. Clinical chemistry and hematological profiles were not adversely affected, and platelet count did not change significantly. The type of lipid changes observed were those usually considered antiatherogenic. Reducing fibrinogen may result in beneficial changes in the pathological processes leading to thrombotic occlusion. The consumption of MaxEPA by our patients over a seven-year period did not indicate any adverse effects.

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