Wednesday, 3 February 2016

ClinicSpeak & ResearchSpeak: natalizumab is more effective than fingolimod

Natalizumab vs. Fingolimod? Horses for courses. Who is the winner? #ClinicSpeak #ResearchSpeak #MSBlog #MSResearch

"The study below confirms the MSBase dataset that natalizumab is more effective than fingolimod in preventing inflammatory events in people with active MS. Inflammatory events are new lesions on MRI and clinically apparent relapses, which occurs when a new lesion affects the functioning of an eloquent neurological pathway. Please note that these results are an average across a group of pwMS. All it means is that a greater proportion of pwMS are rendered NEDA-3 on natalizumab compared to fingolimod."

"What about downstream events, i.e. delayed loss of axons and the resultant brain atrophy that occurs? The data for natalizumab has only just emerged and based on raw comparisons it appears that you have a greater chance of having your brain atrophy rate normalised in year 3 and 4 on natalizumab compared to fingolimod. The important point to make is that both these DMTs have an impact on end-organ damage; they are therefore in the upper echelon of treatments that do this. Please be aware that in Europe natalizumab and fingolimod have different licences and therefore the characteristics of the patient groups starting on each of these agents is different. Natalizumab is used in more active pwMS, whereas fingolimod is used second-line. The takehome message is that it is horses for courses and each of these agents has a different profile and hence the reasons for going onto one agent compared to the other should be personalised. What is important is monitoring if you on one of these drugs and you have breakthrough activity you should be switched to another agent. This is the philosophy behind treat-2-target of NEDA."



Epub: Barbin et al. Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study. Neurology. 2016 . pii: 10.1212/WNL.0000000000002395.

OBJECTIVE: To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis.

METHODS: Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected for 326 patients treated with natalizumab and 303 with fingolimod.

RESULTS: The confounder-adjusted proportion of patients with at least one relapse within the first and second year of treatment was lower in natalizumab-treated patients compared to the fingolimod group (21.1% vs 30.4% at first year, p = 0.0092; and 30.9% vs 41.7% at second year, p = 0.0059) and supported the trend observed in non-adjusted analysis (21.2% vs 27.1% at 1 year, p = 0.0775). Such statistically significant associations were also observed for gadolinium (Gd)-enhancing lesions and new T2 lesions at both 1 year (Gd-enhancing lesions: 9.3% vs 29.8%, p < 0.0001; new T2 lesions: 10.6% vs 29.6%, p < 0.0001) and 2 years (Gd-enhancing lesions: 9.1% vs 22.1%, p = 0.0025; new T2 lesions: 16.9% vs 34.1%, p = 0.0010) post treatment initiation.

CONCLUSION: Taken together, these results suggest the superiority of natalizumab over fingolimod to prevent relapses and new T2 and Gd-enhancing lesions at 1 and 2 years.

CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RRMS, natalizumab decreases the proportion of patients with at least one relapse within the first year of treatment compared to fingolimod.

CoI: multiple

2 comments:

  1. Re: "it appears that you have a greater chance of having your brain atrophy rate normalised in year 3 and 4 on natalizumab compared to fingolimod" Dr. G you have commented before that the reason the ASCEND trial did not show positive data for reduction of brain atrophy was due to short duration of the study, 96 weeks. Why is there a lag in axonal loss and brain atrophy as opposed to lesions using natalizumab?

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    1. The brain is swelled by inflamation. Natalizumab is almost perfectly reduced it when blocked the migration of the immun cella through the BBB. So the swell disappear and the brain shrinks remarkably. The highly effective drugs protect the brain integrity and preserve brain volume loss! It is a fact.

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