BG-12 Phase III Results: it is efficacious in subgroups of relapsing-remitting MS

Despite BG-12 being effective in all subgroups of RRMSers European MSers must wait. For how long? #MSBlog #MSResearch

EpubHutchinson et al. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study. J Neurol. 2013 Jun 8.

Background: In the phase 3, randomized, placebo-controlled and active reference (glatiramer acetate) comparator CONFIRM study in RRMSers, oral BG-12 (dimethyl fumarate) reduced the annualized relapse rate (ARR; primary endpoint), as well as the proportion of MSers relapsed, magnetic resonance imaging lesion activity, and confirmed disability progression, compared with placebo.

Objectives & Methods: To investigate the clinical efficacy of BG-12 240 mg twice daily (BID) and three times daily (TID) in MSer subgroups stratified according to baseline demographic and disease characteristics including gender, age, relapse history, McDonald criteria, treatment history, Expanded Disability Status Scale score, T2 lesion volume, and gadolinium-enhancing lesions. 

Results: BG-12 treatment demonstrated generally consistent benefits on relapse-related outcomes across MSer subgroups, reflecting the positive findings in the overall CONFIRM study population. Treatment with BG-12 BID and TID reduced the ARR and the proportion of MSer relapsed at 2 years compared with placebo in all subgroups analyzed. Reductions in ARR with BG-12 BID versus placebo ranged from 34 % [rate ratio 0.664 (95 % confidence interval 0.422-1.043)] to 53 % [0.466 (0.313-0.694)] and from 13 % [0.870 (0.551-1.373)] to 67 % [0.334 (0.226-0.493)] with BG-12 TID versus placebo. Treatment with glatiramer acetate reduced the ARR and the proportion of patients relapsed at 2 years compared with placebo in most MSer subgroups. 

Conclusion: The results of these analyses indicate that treatment with BG-12 is effective on relapses across a broad range of patients with relapsing-remitting multiple sclerosis with varied demographic and disease characteristics.

"The results of this subgroup analysis are in keeping with the overall results. BG-12 is an effective DMT in RRMS."

George Scangos

"It is a great pity that Biogen-Idec have delayed the launch of the drug in Europe pending a clarification of a legal issue in relation to data exclusivity on the product. I was told at the ENS by a colleague that if successful this would prevent generic equivalents from entering the market by a several years. This decision reflects very badly on Biogen-Idec. They claim to be a company that has MSers interest at heart and they then decide to delay the launch of an effective drug simply for business reasons. Why couldn't they have launched the drug and sought the clarification in parallel?All the MSologists I spoke to in Barcelona about this were very upset about Biogen's actions; particularly as the reasons for the delay had not been explained to the community and we have no idea what to tell MSers in our care waiting to go onto BG-12. As I write this I have no idea how long it will take for them to clarify their position and when the drug will become available to MSers in Europe. More galling was the recent announcement of Biogen-Idec's CEO's (George Scangos) remuneration package for last year; it was one of the largest in the industry in 2012 ($13.45 million - a 19% increase from $11.33 million he received the previous year). Who said MS was not a profitable industry for Pharma? No wonder Big Pharma's reputation is in tatters."

CoI: multiple

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