Multiple sclerosis is a disease of the nervous system whose causes are unknown, characterised by widespread lesions or plaques in the central nervous system. It often affects young adults, progressing via a series of relapses which are hard to predict. The reference treatment, for want of anything better, is interferon beta, whose efficacy in preventing further relapses is modest, and which has not been proved to slow the disease’s progression, despite numerous adverse effects. When glatiramer was licensed in 2003, Prescrire stressed its unfavourable risk-benefit balance for multiple sclerosis.
According to several new trials, there is still no evidence that glatiramer is any more effective than interferon beta, nor that it delays in any way the worsening of the disease.
In progressive multiple sclerosis, glatiramer’s efficacy is no better than that of placebo.
Post-marketing studies confirm that local reactions to the injection site are common and sometimes severe, skin necrosis in particular. Other adverse effects have been reported, including liver damage. In short, the reference treatment for relapsing remitting multiple sclerosis is still interferon beta, for want of anything better. This example confirms the importance of post-marketing follow-up and re-evaluation.
©Prescrire January 2010
"Glatiramer (multiple sclerosis)" Prescrire Int 2009;18 (104): 252 (pdf, subscribers only).