Minor editorial changes throughout SPC but main changes relate to the addition of the new CIS indication as follows:
4.1 Therapeutic indications
Addition of:
Rebif is indicated for the treatment of
- patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1)
4.2 Posology and method of administration
Addition of:
First demyelinating event
The posology for patients who have experienced a first demyelinating event is 44 micrograms of Rebif given three times per week by subcutaneous injection.
5.1 Pharmacodynamic properties
Addition of:
Single clinical event suggestive of multiple sclerosis
One 2-year controlled clinical trial with Rebif was performed in patients with a single clinical event suggestive of demyelination due to multiple sclerosis. The patients enrolled into the trial had at least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial. Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Patients were randomised in a double-blind manner to either Rebif 44 micrograms given three times per week, Rebif 44 micrograms once weekly, or placebo. If a second clinical demyelinating event occurred confirming definite multiple sclerosis, patients switched to the recommended posology of Rebif 44 micrograms three times per week in an open label manner, while maintaining blinding as to initial randomisation. Efficacy results of Rebif 44 micrograms given three times per week compared to placebo from this study are as follows:
TABLE IS ADDED HERE
For the time being there is no well established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan. In any case, treatment should only be considered for patients classified as high risk.
Section 10. Date of first Authorisation/Renewal of the Authorisation
01/2012
