More Patients With Relapsing Multiple Sclerosis Are Disease-Free With Natalizumab: Presented at WCTRMS
By Danny Kucharsky
MONTREAL -- September 21, 2008 -- Natalizumab significantly increases the proportion of disease-free patients with relapsing multiple sclerosis (MS) compared with placebo over 2 years, according to study results presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).
The study, led by Eva Havrdova, MD, General Teaching Hospital, Prague, Czech Republic, evaluated the effects of natalizumab on the proportion of MS patients who were disease free as measured by clinical and magnetic-resonance-imaging (MRI) outcomes in the phase 3 Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study.
The study randomised 627 patients to receive intravenous natalizumab 300 mg and 315 patients to placebo once every 4 weeks for up to 116 weeks.
The post hoc analyses, presented on September 18 by Dr. Havrdova and colleagues, found the proportion of disease-free patients was significantly higher in the natalizumab group compared with the placebo group.
Criteria for clinical disease-free status were no relapse and no disability progression for 12 weeks, free of MRI disease activity, no gadolinium-enhancing (Gd+) lesions, and no new or enlarging T2-hyperintense lesions.
Based on clinical outcomes, 70.6% of natalizumab patients had no relapse over 2 years compared with 43.3% of the placebo group. Progression-free status was achieved in 83.6% of natalizumab and 71.7% of placebo patients, and 64.3% of natalizumab and 38.9% of placebo patients were clinically disease-free (P < .0001, for all outcomes).
Natalizumab monotherapy significantly increased the proportion of patients with no Gd+ lesions (94.9% natalizumab vs 56.6% placebo), the proportion with no new or enlarging T2 lesions (58.3% vs 14.9%), and the proportion of patients with no MRI lesion activity (57.7% vs 14.2%) over 2 years compared with placebo (P < .0001, for all outcomes).
The proportion of patients who were free of clinical and MRI disease activity was significantly greater with natalizumab than placebo over 2 years (36.7% vs 7.2%, P < .0001).
Dr. Havrdova said the disease-free concept has not been well considered by the MS community, but should be discussed "because this goal is potentially within reach as more effective therapies are introduced."
Funding for this study was provided by Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.
[Presentation title: Natalizumab Increases the Proportion of Disease-Free Patients in Relapsing Multiple Sclerosis. Abstract P62]