Friday, 9 December 2011

Rebif for CIS

Epub ahead of printComi et al. Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial. Lancet Neurol. 2011 Dec 2.

BACKGROUND:  In subjects presenting with a first clinical demyelinating event that is suggestive of MS, treatment with interferon beta can delay the occurrence of further attacks and the onset of MS. This study investigated the effects of two dosing frequencies of subcutaneous interferon beta-1a (Rebif) in subjects with a first clinical demyelinating event.

METHODS: Subjects with a single clinical event suggestive of MS, and at least two clinically silent T2 lesions on brain MRI were randomly assigned in a 1:1:1 ratio to receive subcutaneous interferon beta-1a 44 μg three times a week or once a week (plus placebo twice a week for masking), or placebo three times a week for up to 24 months. 


FINDINGS: 517 subjects were randomly assigned. The 2-year cumulative probability of McDonald MS (second lesion on MRI) was significantly lower in patients treated with subcutaneous interferon beta-1a (three times a week 62·5%, p<0·0001, hazard ratio [HR] 0·49 [95% CI 0·38-0·64]; once a week 75·5%, p=0·008, HR 0·69 [0·54-0·87]) versus placebo (85·8%). 2-year rates of conversion to CDMS (second clinical event or relapse) were lower for both interferon beta-1a dosing regimens (three times a week 20·6%, p=0·0004, HR 0·48 [0·31-0·73]; once a week 21·6%, p=0·0023, HR 0·53 [0·35-0·79]) than for placebo (37·5%). Adverse events were within the established profile for subcutaneous interferon beta-1a.

INTERPRETATION: Both regimens of subcutaneous interferon beta-1a delayed clinical relapses and subclinical MRI disease activity. The potential differences between the regimens warrant longer-term study.

"The final study in the tetralogy of the injectables. Avonex, Betaferon/Betaseron and Copaxone already have a license for use after the first clinical event or CIS. Although the higher dose was slightly more effective on MRI there was no differences in relation to the occurrence of clinical events. This means that from a clinical perspective once weekly Rebif is as good as 3x per week Rebif. Using once weekly injections would be a major cost-saving for individuals and healthcare systems feeling the strain in this time of austerity. I wonder if the NHS will get wise to this? Then under the Department of Health's risk-sharing scheme guidance we are not meant to be using DMTs for CIS."


"Anybody interested in the NAB rates? I am!"

CoI: Multiple

9 comments:

  1. Sure you all know what Prof G is on about other wise you would say so?

    NAB = Neutralising antibody
    i.e something that binds to the active site of the drug and stops (neutralises) its function

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  2. As with the post below, I think a lot of MSer's are diagnosed with transverse myelitis rather than a CIS. Perhaps neurologists think it's kinder not to suggest 'we think you've got MS' on initial presentation?

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  3. I'm not sure how NAB rates are linked to the rest of the post

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  4. Any idea why in the original clinical trial, a high dose was more beneficial, yet in this case there was no difference?

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  5. His face on here - OMG - hope it is not becoming a Tory blog!

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  6. Re: "His face on here - OMG - hope it is not becoming a Tory blog!"

    Not a Tory blog at all; just the hard reality of austerity in in the NHS. I am not sure if the general public are aware of the impact the cuts (or in the case of the NHS freeze) on public expenditure are going to have on healthcare. This will be particularly brutal for chronic diseases such as MS.

    Another issue are all the NHS PFI (public funding initiatives); this is the way the government has been funding public service infrastructure renewals. Our hospital is no exception; we have to find massive cost savings, or in management speak efficiency gains (doing more with less staff).

    Do you want a picture of Nick Clegg for balance?

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  7. Re: "Perhaps neurologists think it's kinder not to suggest 'we think you've got MS' on initial presentation?"

    Welcome to patronising_doctors.org! Business as usual.

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  8. I can understand why, in the past, doctors might not have wanted to diagnose MS after one episode suggestive of MS. This was (maybe) because there were no effective treatments available, and there was (and still is) the possibility that the person won't have any more attacks. But now that there are treatments that are effective to varying levels, the situation is different. However it must be very difficult to give that diagnosis to an apparently fit and healthy 20 - something, right at the beginning of their adult life. Someone who might never have another attack. It seems to me that this is an area where thee would be a benefit in thinking through a policy of what amount of information to do, depending on the circumstances. I know that is tricky!

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  9. Hey, I wasn't getting at neurologists by suggesting they were trying to be kind- I agree with anon's post of Dec. 10th, it is a tricky tightrope to walk as to the info you give people on a first presentation. I know drs. are now taught how to give bad news- perhaps there needs to be a bit on the possibility of MS. Someone said, I know easier that I've been kind than I've been right.

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