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Reflection and Reaction
http://neurology.thelancet.com Vol 4 June 2005 331
Glatiramer acetate and interferon beta-1a: a patient’s view
I was glad to read Comi and colleagues’ comment.1 As apractising clinician and patient with multiple sclerosis(MS), I understand and appreciate feelings associatedwith both the disease and its treatment.
At age 14 years, I had neuritis retrobulbaris. At thattime, around the end of the 1970s, steroids were the onlytreatment. As a young clinician age 25 years, I began tofeel weakness in my left leg; shortly after, a diagnosis ofrelapsing-remitting MS was made. I was again treatedwith steroid. However, steroids have no place in longtermMS therapy, unless one has acute relapses.
In Hungary, as perhaps elsewhere, two main groups ofdrugs are available: glatiramer acetate (GA) and interferonbeta.2,3 At first, I used GA, then a new drug—its side-effectprofile was very favourable.4 The daily treatment, givensubcutaneously, posed no problem and didn’t interferewith my daily work. Unexpected side-effects appearedabout 6 months after first use. At that time, there were noreports of the frightening set of symptoms—blushing,heavy breathing, chest tightness, palpitation, anxiety, anddyspnoea. I continued to use the drug. 2 months later Ihad the symptoms again, and not for only a few seconds,but for several minutes. Soon after came the third attacklasting almost 20 min.5,6 Fortunately, I have a very goodneurologist and after these events and consulting withhim, I decided to stop taking GA. At that time, only a fewpeople used GA in Hungary. One wonders how the drug,made up of known amino acids, could evoke such
symptoms. Many people assumed that there was apsychological cause. In one trial, the side-effects werepresent in the placebo control group as well.
After all these experiences, I began to use interferonbeta-1a. I had the side-effects mentioned in the drug’sdescription—flu-like symptoms, fever, myalgia, and jointpains; but after almost 10 years, these have become mildand their onset can be predicted.7
I believe it is important both patient and physiciandiscuss potential therapies’ benefits and expected andunexpected side-effects. Patients should also have theright to decide what treatment they will use after beinggiven this information.
Zsuzsa Keszthelyi1st Department of Medicine, University of Pecs Medical School,
H-7624, Pécs, Hungary [email protected]
I have no conflicts of interest
1 Comi G, Hartung H-P, Boneschi FM. Evidence of use of glatiramer acetatein multiple sclerosis. Lancet Neurol 2005; 4: 75–76.
2 Francis GS. Importance of benefit-to-risk assessment for disease-modifyingdrugs used to treat MS. J Neurol 2004; 251 (suppl 5): 42–49.
3 Rizvi SA, Agius AM. Current approved options for treating patients withmultiple sclerosis. Neurology 2004; 63: 8–14.
4 Munari LM, Filippini G. Lack of evidence for use of glatiramer acetate inmultiple sclerosis. Lancet Neurol 2004; 3: 641.
5 GalettaSL, Markovitz C. US FDA-approved disease-modifying treatmentsfor multiple sclerosis: review of adverse effect profiles. CNS Drugs 2005; 19: 239–52.
6 Francis DA. Glatiramer acetate (Copaxone). Int J Clin Pract 2005; 55: 394–98.7 JS Wolinsky. Glatiramer acetate for the treatment of multiple sclerosis
Expert Opin Pharmacother 2005; 5: 875–91.
The results in the Cochrane reviews on the relative risksof exacerbation are, during the first year of treatmentwith interferon or GA in RRMS, very similar. At 2 yearsthe effect of recombinant interferon is uncertain becauseof methodological flaws in the studies and the effect ofGA is borderline significant.
If Cochrane reviews are used to decide whichtreatment is superior, the whole review should be readand not only the conclusion. The confusion discussedabove could be prevented by deciding what the bestprimary outcome measure is for a disease and the use ofthis in all reviews of that disease.
Brigit A de Jong, Marc Engelen, Ivo N van Schaik,Marinus Vermeulen
Department of Neurology, Academic Medical Center,
PO Box 22660, 1100 DD Amsterdam, Netherlands
BAdJ has received a travel grant from Aventis (manufaturers of Copaxone [GA]).We have no other conflicts of interest.
1 The IFNB Muliple Sclerosis Study Group. Interferon beta-1b is effective inrelapsing-remitting multiple sclerosis: I Clinical results of a multicenter,randomized, double-blind, placebo-controlled trial. Neurology 1993; 43: 655–61.
2 Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rateand improves disability in relapsing-remitting multiple sclerosis: results of aphase III multicenter, double-blind, placebo-controlled trial. Neurology1995; 45: 1268–76.
3 Filippini G, Munari L, Incorvaia B, et al. Interferons in relapsing remittingmultiple sclerosis: a systematic review. Lancet 2003; 361: 545–52.
4 Rice GP, Incorvaia B, Munari L, et al. Interferon in relapsing remittingmultiple sclerosis. Cochrane Database Syst Rev 2004; 3: CD002002.
5 Munari L, Lovati R, Boiko A. Therapy with glatiramer acetate for multiplesclerosis Cochrane Database Syst Rev 2004; 3: CD004678.
