Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data The National Multiple Sclerosis Society of the U.S. (1) and the Canadian Multiple Sclerosis Society (2) have both recommended that relapsing multiple sclerosis (RMS) patients should be started on immunomodulating therapy soon after diagnosis. The pivotal trials of glatiramer acetate (Copax- one Ò ), lasting 30 months and each of the interf- erons, all showed significant benefits for relapse reduction, accumulation of disability or both leading to successful FDA approval and wide- spread use. Subsequent placebo controlled trials such as the European-Canadian MRI trial of glatiramer acetate (GA) (3) have substantiated these short-term results. However, multiple sclero- sis (MS) is a life-long disease so one may question if there is longer-term evidence to confirm the validity of the current recommendation for early and continued therapy. The glatiramer acetate study is now over 10 years in duration, divided into a double-blind, placebo- controlled phase of approximately 30 months and an ongoing open-label phase. The participating patients are rigorously evaluated for neurologic disability and safety status every 6 months and during a suspected relapse. It is therefore possible to compare the patients who have been treated con- tinuously with GA since randomization (group A) with those who received placebo for approximately 30 months and were then switched to GA (group B) to determine whether a delay in active therapy had any long-term negative consequences. This study also allows for the assessment of potential late appearing adverse effects and long-term patient tolerance. Methods The placebo-controlled phase of the trial was composed of two parts, the originally planned 2-year comparison and an extension of between 2 and 11 months to allow all patients to have at least 24 months of drug or placebo. The conduct of both parts, the initial study and the extension, was identical (4, 5). Acta Neurol Scand 2005: 111: 42–47 DOI: 10.1111/j.1600-0404.2004.00351.x Copyright Ó Blackwell Munksgaard 2004 ACTA NEUROLOGICA SCANDINAVICA Johnson KP, Ford CC, Lisak RP, Wolinsky JS. Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data. Acta Neurol Scand 2005: 111: 42–47. ÓBlackwell Munksgaard 2004. Objective – To assess the long-term effectiveness of continuous glatiramer acetate (GA) therapy in relapsing-remitting multiple sclerosis (RRMS). Methods – This open-label extension followed a randomized, placebo-controlled, double-blind study of GA of approximately 30 months duration. Patients originally randomized to GA continued on it (group A) and those randomized to placebo switched to GA (group B). Results – Of 251 original patients, 142 (56.6%) remained in the study after 8 years. Annual relapse rate for both groups declined to approximately 0.2 (approximately one relapse every 5 years). However, a significantly larger proportion of patients in group A had stable or improved Expanded Disability Status Scale scores compared with group B (65.3% vs 50.4%, respectively; P ¼ 0.0263), possibly attributable to the delay of GA treatment for approximately 30 months in group B. GA was well tolerated and no drug-related laboratory changes were observed. Conclusions – These data support early initiation of GA therapy as an efficacious and well- tolerated long-term treatment for RRMS patients. K. P. Johnson 1 , C. C. Ford 2 , R. P. Lisak 3 , J. S. Wolinsky 4 1 Maryland Center for MS, Baltimore, MD; 2 MIND Imaging Center, Albuquerque, NM; 3 Wayne State University, Detroit, MI; 4 University of Texas, Houston, TX, USA Key words: disability; glatiramer acetate; long-term therapy; multiple sclerosis therapy; relapses; relapsing remitting multiple sclerosis Kenneth P. Johnson MD, Maryland Center for MS, 11 S. Paca Street, 4th Floor, Baltimore, MD 21201, USA Tel.: +410 328 7601 Fax: +410 328 5425 e-mail: kjohnson@som.umaryland.edu Accepted for publication September 14, 2004 42