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1 Treatments-related side effects MS: from the diagnosis to the disease management MSc, MD, José Flores Rivera Instituto Nacional de Neurología y Neurocirugía

2 Safety issues: beta interferon Depression/suicidal ideation Leukopenia/thrombocytopenia Liver enzyme elevation/hepatic injury Thyroid dysfunction Pregnancy category C

3 Safety issues: beta interferon CBC and liver panel Thyroid function tests Monitor for depression

4 Safety issues: glatiramer acetate Pregnancy category B

5 Interferon beta 1a, s.c- new formulation (RNF) Human serum albumin-free Fetal bovine serum-free Reduced injection site reactions 30.8% vs 85.8% Increase in flu-like side effects 71% vs 48%

6 Fingolimod Side effects: - Clinically asymptomatic elevations of liver enzymes - Initial reduction of the heart rate - Modest decrease of forced expiratory volume - No serious infections reported*

7 Fumaric acid derivate BG00012 When patients on placebo were switched to BG mg/day for the extension phase the relapse rate was reduced by 52% Side effects: Favorable safety profile Reported: flushing,increased liver enzymes, no infections Phase III in progress

8 TERIFLUNOMIDE Side effects: Generally well tolerated Most common side effects: upper respiratory tract infections and headache In RA patients- toxic liver necrosis and pancytopenia have been described.

9 Alemtuzumab Side effects: Six patients developed ITP Infusion related side effects Severe Infections were infrequent Thyroid related events were less then expected Two phase III studies to start: CARE-MS I - Alemtuzumab as a first line therapy CARE-MS II Alemtuzumab in patients which continued to experience relapses

10 Natalizumab Current MS Treatment Patterns The groups differed in how many total patients and MS patients they see in a typical month Neurologists in Germany and the UK had a mean of 218 total patients and 66 MS patients in a typical month while Italian, Spanish, and French neurologists reported an average of 127 total patients and 23 MS patients seen in a typical month. Relapse remitting patients were the most frequently reported MS patients being treated by Italian, Spanish, and French neurologists Secondary progressive patients were the most frequently reported MS patients in Germany and the United Kingdom INF beta 1a i.m (in Italy, Spain, and France) and INF beta 1a s.c (in Germany and the UK) were reported as the most commonly used treatments for relapse remitting patients Natalizumab Use Neurologists in Germany and the UK indicated that they have used Natalizumab on an average of about 13 patients since it was approved Natalizumab is currently most frequently used as a second- or third-line treatment INF beta 1a s.c was indicated as the treatment that neurologists have most frequently switched their patients from to Natalizumab Mitoxantrone was selected most frequently as the second-line treatment that would be used after failure of a first medication if Natalizumab was not available 10

11 Executive Summary Natalizumab Use (cont d) Neurologists reported that patients are more likely to be eligible for Natalizumab use if it is used as a second line of treatment than if it is used as a first-line treatment Neurologists didn t show a preference for using Natalizumab indefinitely versus using it for a specified period of time Neurologists from the UK and Germany expect typical Natalizumab use to last an average of 38 months per patient, which significantly longer than the 23 months predicted by Italian, Spanish, and French neurologists Morre than half of the neurologists in Germany and the UK indicated that premium pricing will result in limited use of Natalizumab while very few of the neurologists in Italy, Spain, and France felt that premium pricing would result in any limited use Neurologists indicated that about 30% of relapsing remitting MS patients request Natalizumab and that about 20% of relapsing remitting MS patients will not receive Natalizumab because of patient refusal PML Neurologists in Italy, Spain, and France reported that they require patient check-ups for MS patients every 6 months while neurologists in Germany and the UK indicated that they require these check-ups every 5 months PML monitoring: Neurologists reported that they would use other monitoring types most frequently Neurologists in Italy, Spain, and France reported that follow-up MRIs are most likely to occur 6 months after the initial infusion Neurologists in Germany and the UK indicated that these follow-up MRIs would most likely occur every 6 months thereafter. 11

12 Executive Summary PML Risk Most (68%) Italian, Spanish, and French neurologists indicated extreme concern while most (56%) neurologists in the UK and Germany only reported being somewhat concerned about the risk of PML Both groups of neurologists felt that there is more risk for PML when Natalizumab s used in combination with other treatments than when it is used as a monotherapy Neurologists in the UK and Germany found it more believable that an MRI scan, CSF testing, and frequent neurological assessments would be sufficient for PML detection than did Italian, Spanish, and French neurologists. PML Education Neurologists in Germany and the UK rated Biogen Idec/Elan highly (3.3 on a 5 point scale) in how well they educate neurologists for minimizing morbidity and mortality due to PML and for distinguishing between PML and MS relapse Neurologists in Italy, Spain, and France feel that the level of education isn t as high PML Effect on Natalizumab Use A little more than half neurologists in the UK and Germany indicated that 2-5 cases of PML would impact Natalizumab usage while half of neurologists in Italy, Spain, and France claimed that 5-20 cases would have an impact 12

13 Executive Summary Future Practice INF 1a s.c and INF beta 1a i.m were reported as the treatments that currently are used most frequently and will be used the most 4 and 12 months from now for relapsing remitting MS patients Currently a very small majority of Italian, Spanish, and French neurologists indicated that they would use Natalizumab only as a salvage therapy In the next 12 months, they reported that Natalizumab would be more frequently used as a first- or second-line treatment Neurologists in the UK and Germany indicated that natalizumab currently is used most frequently as a third-line treatment. In 12 months, they believe it will be used mostly as a second- or third-line treatment Neurologists in Italy, Spain, and France stated that they would most likely have been using Interferon beta 1b s.c before switching to Natalizumab currently, in the next 4 months, and in 12 months Neurologists from Germany and the UK indicated that they would most likely have been using INF beta 1a s.c before switching to Natalizumab currently, in the next 4 months, and in the next 12 months 13

14 Conclusions Beta interferon and glatiramer are generally well-tolerated

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