It is recommended that Multiple Sclerosis Natalizumab treatment be reserved as an option only for cases of rapidly evolving severe relapsing–remitting multiple sclerosis or (RES). RES is defined as two or more debilitating relapses in a year, and one or more gadolinium-enhancing lesions on a brain MRI.
MS Natalizumab therapy is given by intravenous injection and the dose is 300 mg every 28 days. Monitoring for symptoms of immunogenicity and hypersensitivity is required and recommended. Multiple Sclerosis Natalizumab therapy has statistically reduced the probability of disability progression compared with placebo groups in both ITT and RES patient trials. In addition, MS Natalizumab treatment led to a reduction in the relapse rate, with a risk reduction of 0.68 in the ITT patients and 0.81 in the RES patients. The manufacturer also showed evidence that, compared with placebo, MS Natalizumab infusions significantly improved health-related quality of life. And since MS doesn’t necessarily reduce the length of the patients life, the quality of it is extremely important.
Multiple Sclerosis Natalizumab Therapy approved in 2006 after two controlled trials
Marketed under the brand name Tysabri, natalizumab was, in its final approval, evaluated in two multi-year clinical trials. One of them compared Tysabri to placebo in MS patients who had not got any interferon-beta or glatiramer acetate for at least a half year prior. The other was with MS patients who had at least one relapse while they were on Avonex therapy. Half of these patients got Tysabri with Avonex; the other half got a placebo and Avonex combination. In both of the studies, those taking Tysabri had reduced risk of progression of the disability and experienced fewer relapses. Neither of the studies involved any children or any patients with the primary progressive form of MS.
Cost effectiveness of Multiple Sclerosis Natalizumab treatment questioned.
Although there were many positive and hopeful findings in the study, conducted in Wales, the cost of the drug is being questioned. It may not be the best choice for the limited financial resources of most patients. As part of the study, they noted that it was probably not a cost effective option for someone with a life expectancy of less than 20 years, and also questioned the manufacturer’s economic model stating it contained considerable questionable assumptions, but that Multiple Sclerosis Natalizumab treatment was probably a cost effective alternative for people with RES and a life expectancy longer than 20 years, given its effect on quality of life and reduction in relapses.
