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Multiple Sclerosis Trust
`information, education, research and support
`
`A to Z of MS
`Click on the relevant link for more information on a topic.
`
`A to Z of MS Alemtuzumab (Lemtrada)
`
`Alemtuzumab is a disease modifying drug for relapsing remitting MS.
`
`Alemtuzumab was approved for use on the NHS in 2014. The drug can be prescribed for adults with active relapsing
`remitting MS (generally defined as having two relapses which have had a substantial effect on health or daily life in the last
`two years).
`
`In clinical trials, alemtuzumab reduced the number of relapses by approximately 70%. Relapse severity was also reduced.
`Alemtuzumab may also slow down the build-up of disability associated with MS.
`Product names
`
`Lemtrada - previously known as Campath.
`How is alemtuzumab taken?
`
`Alemtuzumab is taken as two treatment courses of intravenous (iv) infusions.
`
`the first course consists of iv infusions on five consecutive days
`the second course is taken 12 months later and consists of iv infusions on three consecutive days
`Side effects and contraindications
`
`Three serious side effects have been reported from clinical trials.
`
`overactive or underactive thyroid gland leading to thyroid disorders, affecting approximately 1 in 5 people
`idiopathic thrombocytopenic purpura (ITP), a serious disorder which prevents blood from clotting, affecting about
`1 in 100 people.
`kidney problems
`
`Although potentially serious, these side effects are treatable if caught early enough.
`
`Flu-like symptoms after infusion were reported. As alemtuzumab works by suppressing the immune system, anyone on
`treatment will be more vulnerable to infections such as colds and viruses for some time after the infusion.
`How alemtuzumab works
`
`Alemtuzumab works by binding to and killing immune cells (lymphocytes or white blood cells) which are involved when the
`immune system attacks myelin. It is thought that the cells which grow back after treatment do not cause damage to
`nerves.
`Alemtuzumab research
`
`Results of two large studies found alemtuzumab effective at reducing the number of relapses by approximately 70%
`
`6/2/2015
`
`Alemtuzumab (Lemtrada / Campath) | A to Z of MS | MS Trust - Information, education, research and support
`
`http://www.mstrust.org.uk/atoz/alemtuzumab-lemtrada.jsp
`
`1/3
`
`MYLAN PHARMS. INC. EXHIBIT 1108 PAGE 1
`
`

`
`compared to placebo. Relapse severity was also reduced.
`
`Alemtuzumab may also slow down the build-up of disability associated with MS; in one study (CARE-MS II) which
`measured disability over a two year period, people taking alemtuzumab were less likely to experience worsening of their
`disability compared to those taking beta interferon; this was not seen in a second study (CARE- MS I).
`
`CARE-MS I
`
`CARE-MS I was a two year trial that compared alemtuzumab and interferon beta 1a in 581 people in the first few
`years after diagnosis with relapsing remitting MS who had not had other disease modifying treatments.
`
`Alemtuzumab reduced relapses by 55% compared to interferon beta 1a over the two years of the trial. 78% of
`people in the alemtuzumab group didn't have a relapse during the two years of the trial compared with 59% of the
`interferon group. There was no significant difference in disease progression between the two groups; 8% of the
`alemtuzumab group and 11% of interferon beta group showing a worsening in their EDSS score.
`
`CARE-MS II
`
`CARE-MS II was a two year trial that looked at 667 people who had continued to have relapses despite treatment
`with beta interferon.
`
`The relapse rate of those on alemtuzumab was reduced by 49% compared to those on beta interferon 1a (Rebif),
`65% of people in the alemtuzumab group didn't have a relapse during the two years of the trial compared with
`49% of the interferon group. The risk of disease progression was also reduced by 42% compared to beta
`interferon, with 20% of the interferon group showing sustained accumulation of disability compared to 13% of the
`alemtuzumab group.
`
`Prevention of autoimmunity after alemtuzumab treatment (CAM-THY)
`
`Alemtuzumab works by binding to and killing T-cells (lymphocytes). 1 in 5 people develop an autoimmune disease
`after treatment; as their immune system grows back, it begins to attack other parts of their body, most commonly
`the thyroid gland.
`
`This trial will attempt to reduce the risk of autoimmune disease after treatment with alemtuzumab by combining it
`with a second drug which alters the way in which the immune system grows back. Palifermin works by boosting
`the function of the thymus, a gland in the neck which makes new immune cells.
`Estimated completion date October 2017.
`Further details of this study.
`References
`
`National Institute for Health and Care Excellence (NICE).
`Alemtuzumab for treating relapsing-remitting multiple sclerosis [TA312].
`Available from NICE website
`
`Scottish Medicines Consortium (SMC).
`Advice: alemtuzumab (Lemtrada).
`Available from SMC website
`
`Cohen JA, et al.
`Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a
`randomised controlled phase 3 trial.
`Lancet 2012;380:1819-28.
`Read abstract
`
`6/2/2015
`
`Alemtuzumab (Lemtrada / Campath) | A to Z of MS | MS Trust - Information, education, research and support
`
`http://www.mstrust.org.uk/atoz/alemtuzumab-lemtrada.jsp
`
`2/3
`
`MYLAN PHARMS. INC. EXHIBIT 1108 PAGE 2
`
`

`
`Coles AJ, et al.
`Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled
`phase 3 trial.
`Lancet 2012;380:1829-39.
`Read abstract
`
`Keratinocyte growth factor to prevent autoimmunity after alemtuzumab treatment of multiple sclerosis (CAM-THY).
`Further details of this study.
`Patient Information Leaflet
`
`Lemtrada (EMC website)
`
`Return to index
`
`Find out more
`Disease modifying drug therapy (book)
`Drugs used in the treatment of MS
`
`The MS Trust website uses cookies. They allow us to give you the best experience on our website and mean we can understand
`how you use our site. You can delete and block cookies but parts of our site won't work without them. By using the MS Trust
`website you're confirming that you're happy to accept our use of cookies; read more
`
`Page last modified on 16 December 2014
`All content © 2004-2013 Multiple Sclerosis Trust, Spirella Building, Letchworth Garden City, Herts SG6 4ET. Work 01462 476700 Fax
`01462 476710 info@mstrust.org.uk
`Registered charity no 1088353.
`
`6/2/2015
`
`Alemtuzumab (Lemtrada / Campath) | A to Z of MS | MS Trust - Information, education, research and support
`
`http://www.mstrust.org.uk/atoz/alemtuzumab-lemtrada.jsp
`
`3/3
`
`MYLAN PHARMS. INC. EXHIBIT 1108 PAGE 3

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