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Abstract
Background There are conflicting reports regarding whether concomitant administration of HMG-CoA reductase inhibitors (statins) affects the clinical efficacy of rituximab (RTX) in RA.1,2
Objectives To investigate the impact of statin co-administration on RTX efficacy in patients from RA clinical trials.
Methods Retrospective pooled analysis of data from 4 RA clinical trials (DANCER, REFLEX, SERENE and IMAGE) involving patients with moderate to severe RA treated with RTX (investigational dose of 2 x 500 mg or approved dose of 2 x 1000 mg) + MTX per protocol, with stable oral corticosteroid dose (≤10 mg prednisone or equivalent). Baseline characteristics and efficacy responses (change in DAS28-ESR from baseline, ACR20, ACR50) at 24 wks following one course of RTX, were compared in patients receiving statins for ≥8 wks of the 24-wk treatment period (STY) vs receiving statins for <8 wks, or not at all (STN). A sensitivity analysis comparing patients receiving statins at baseline vs those who were not was also undertaken. Change in DAS28-ESR between groups was tested using an analysis of covariance (ANCOVA) model adjusted for RTX dose, age, sex, RA duration, RF status and baseline DAS28-ESR. Interactions between age and RA duration, and RTX dose and statin use were also tested. ACR20 and ACR50 responses were tested using a logistic regression model adjusting for the same covariates as the ANCOVA except for baseline DAS28-ESR.
Results Of 1460 patients, 104 (7.1%) had received concomitant statins. Baseline characteristics are shown in the table. On average, STY patients were older, more frequently male, had longer RA disease duration, and had received more prior DMARD and biologic therapy vs STN patients. DAS28-ESR was similar between groups.
Conclusions Whilst acknowledging the limitations inherent in a retrospective efficacy analysis of pooled data from several RTX clinical trials in RA, this analysis evaluated the possible impact of concomitant administration of statins at baseline or for ≥8 wks during a 24-wk treatment period, and adds to the data available on this topic.
References
Arts et al. Ann Rheum Dis 2010;70:877;
Das et al. Ann Rheum Dis 2012;71(Suppl 3):196.
Disclosure of Interest: A. Vashishtha Employee of: Genentech Inc., P. Lehane Employee of: Roche Products Ltd, E. Hessey Shareholder of: F. Hoffmann La-Roche, Employee of: Roche Products Limited