Efficacy of interferon beta-1a in Iranian multiple sclerosis

Objective: To evaluate the clinical efficacy of onceweekly intramuscular interferon beta-1a (IFN B1a, Avonex Biogen) in Iranian multiple sclerosis (MS) patients. Methods: A 12 months, single blind clinical trial conducted from January 2001 to September 2003. Eighty patients with definite MS age 20 to 50 years were allocated to two groups. The first group received 30 microgram (6MIU) IFN B1a weekly. Patients with nearly similar clinical disease but did not receive any active treatment were followed up as the control group. The relapse rates and disability at 2, 4, 6, 12 months after commencement of study were compared between the two groups. Results: The female : male ratio was 3 : 1. Mean Extended Disability Scale Score (EDSS) showed no significant increase in the treatment group (2.97 to 3.01, p>0.05), but a significant increase in the control group (2.71 to 3.06, p<0.001). The frequency of yearly relapses decreased in both groups with greater changes in the treatment than the control group (1.5 to 0.6 vs 1.1 to 0.9, p<0.005). Within the treatment group, the EDSS increased more in the patients with EDSS of 4 and above as compared to patients with score of lower than 4 (0.53 vs 0.07, p<0.001). There was no significant differences in change of EDSS between the treatment and control groups in patients with secondary progressive MS (0.45 vs 0.67, p>0.05) Conclusion: IFN B-1a was effective in the reduction of relapse rate and worsening of disability in Iranian MS patients. Neurology Asia 2005; 10 : 109 – 112 Address correspondence to: Fereshteh Ashtari, Neurology Department, Alzahra Medical Centre, Isfahan Islamic Republic of IRAN. Fax: 98 311 6684510, E mail:[email protected] INTRODUCTION Multiple sclerosis (MS) is a chronic, inflammatory, demyelinative disease of the central nervous system (CNS) that most commonly affects women, with an onset typically between 20 and 40 years of age.1,2 It represents the second most common cause of neurological disability in young adult.3 The disease is unpredictable and clinically variable from patient to patient. Its most characteristic clinical course is the occurrence of relapses with acute or subacute onset of clinical dysfunction that usually reaches its peak from several days to several weeks, followed by a remission during which the symptoms and signs resolves to a variable extent. Eventually progressive clinical course intervenes leading to permanent disability.4,5 Although the aetiology of MS is not established, the bulk of evidence suggests that it is an immune-mediated disease characterized by localization of several types of inflammatory cells in the MS lesions with altered levels of inflammatory cytokines in the serum, cerebrospinal fluid and CNS.5 In the second half of the twentieth century the treatment of MS has advanced from relief of symptoms to the use of disease-modifying agents.6 The beta interferons are a family of cytokines with anti-viral, anti-proliferative and immunomodulating properties.7,8 The multiple actions of the beta interferon suggest that they may be beneficial in controlling the MS disability.9 Interferon beta-1a (IFN B-1a, Avonex) is a natural sequence glycosylated recombinant Chinese hamster ovary product with a structure basically identical to that of natural human interferon. It has been shown to be beneficial in the treatment of patients with established MS. The benefits include slowing of the progression of physical disability, reducing the rate of clinical relapse and reducing the brain lesions as assessed by magnetic resonance imaging (MRI).7,8 The efficacy was at the range of 30-40%.10 The present study was performed to assess the effectiveness of IFN B-1a in Iranian MS patients. Neurology Asia December 2005