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Guidelines for the prescribing of IFN-beta and GA
Fulfil the following 4 criteria:
1. Able to walk independently
2. At least two clinically significant relapses in the last two years
Where possible, the patient’s history of relapses should have been confirmed by neurological examination or from another source e.g. hospital or general practitioner’s records, or by discussion with the patient’s main carer.
3. Adult age group (18 years or older)
no recommendations are possible in the paediatric age group, since trials have not been performed in this cohort.
4. There are no contraindications
Association of British Neurologists Guidelines for the use of Beta Interferons and Glatiramer Acetate in MS, January 2001.
Guidelines for the prescribing of Natalizumab
Natalizumab is recommended as an option for the treatment only of rapidly evolving severe relapsing–remitting multiple sclerosis (RES). RES is defined by two or more disabling relapses in 1 year,
and one or more gadolinium-enhancing lesions on brain magnetic
resonance imaging (MRI) or a significant increase in T2 lesion load
compared with a previous MRI.
1st-line or naïve MSers or 2nd-line (IFN-beta or GA failures)
NICE - Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis; August 2007.
Definition of a disabling relapse
There is no accepted definition of a disabling relapse; the following is a working definition I proposed after Natalizumab got its license:
“A disabling relapse is a relapse that causes sufficient neurological impairment to impact on the social and/or occupational wellbeing of the MSer, i.e. to affect their pre-relapse or baseline activities of daily living. In other words from the MSer’s perspective, the disability must be of sufficient severity to cause a handicap.
From a physician’s perspective a disabling relapse would typically require treatment with corticosteroids and/or admission to hospital.”
Giovannoni, Personal communication; August 2007.
Guidelines for the prescribing of Fingolimod
Fingolimod is recommended as an option for the treatment of highly active relapsing–remitting multiple sclerosis in adults, only if:
1. they have an unchanged or increased relapse rate or on-going severe relapses compared with the previous year despite treatment with beta interferon, and
2. the manufacturer provides fingolimod with the discount agreed as part of the patient access scheme.
NICE Fingolimod: final appraisal determination document; 16 March 2012 .
The relapsing MS DMT doughnut
The relapsing MS DMT doughnut
Inactive RRMS
CIS
RIS or asymptomatic MS
Suboptimal responders ?
Active RRMS
Highly active RRMS
The relapsing MS DMT doughnut
Inactive RRMS
CIS
RIS or asymptomatic MS
Suboptimal responders ?
Active RRMS
IFNbeta or GA
Highly active RRMS Natalizumab
The relapsing MS DMT doughnut
Inactive RRMS
CIS
RIS or asymptomatic MS
Suboptimal responders ?
Active RRMS
IFNbeta or GA
IFNbeta
Highly active RRMS Fingolimod Natalizumab
The relapsing MS DMT doughnut
Inactive RRMS
CIS
RIS or asymptomatic MS
Suboptimal responders ?
Active RRMS
IFNbeta or GA
IFNbeta
Highly active RRMS Fingolimod Natalizumab
Treat-to-a-target of
Disease activity free
