The Sustained Disease Activity Free Status as a Measure of Therapeutic Response & the Long Term Impact of Immunomodulatory Treatment (PD5.001)

Abstract

Objective: To examine the effects of Interferon beta (IFNb) and Glatiramer Acetate (GA) on sustained disease activity free (DAF) status. Background IFNb and GA provide similar levels of efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). However, they have not been demonstrated to induce disease remission. The sustained DAF status is a novel concept and viable goal of therapy based on clinical and radiological measures. Design/Methods: DAF status was defined as no activity on clinical measures (relapses and change in EDSS),and radiological measures (gadolinium-enhancing lesions and new/enlarging T2 lesions on cranial MRI). We assessed the impact of IFNb and GA on the proportion of DAF patients based on individual and combined components. All patients were matched according to baseline characteristics and treatment exposure. Results: This is a retrospective, observational study of 245 naive and RRMS patients who received immunomodulators over 10 (9.77+-3.28) years of follow up. 41 (35%) of 117 patients taking IFNb and 46 (35.9%) of 128 taking GA were free of clinical disease activity ([OR]0.96, 95% CI 0.56-1.62; p=0.8). 73 (77.7%) of 94 and 86 (81.9%) of 105 patients receiving IFNb and GA, respectively, were free of radiological disease activity ([OR]0.76 95% CI 0.38-1.53; p=0.45). Freedom from combined activity was observed in 26 (28.3%) of 92 patients taking IFNb and 40 (37%) of 108 taking GA ([OR]0.67, 95% CI 0.36-1.21; p=0.18). Although no differences were found between group treatments, subgroups analysis demonstrated a greater proportion of patients free from clinical disease activity among those on >=5 years of GA therapy ([OR] 0.32, 95% CI 0.12-0.82; p Conclusions: Both IFNb and GA induced DAF status in patients with RRMS, sustained in the long term. DAF status could be an important measure of therapeutic response in MS, yet applicable to immunomodulators currently in use. Disclosure: Dr. Carra has received personal compensation for activities with Biogen Idec, Merck Serono, Bayer Schering, Novartis, and Teva Neuroscience. Dr. Rojas has nothing to disclose. Dr. Vrech has nothing to disclose. Dr. Lindembaum has nothing to disclose.