Controversy: To Treat or Not to Treat in Clinically Isolated Syndrome

Abstract

99The decision whether to treat or not to treat patients presenting with a clinically isolated syndrome suggestive of multiple sclerosis (MS) can be a difficult one. If the results of magnetic resonance imaging (MRI) are normal, most clinicians would not treat, as the risk of development of MS is low. If the MRI is abnormal, however, the decision is considerably more difficult. At present, we do not have any good markers that would allow us to determine which individuals will go on to develop MS and which individuals will remain stable.An advantage of early treatment is a 15% to 20% further reduction in attack frequency over and above the approximately 30% decrease that occurs with later treatment. This has been a consistent finding with early treatment with the interferons and glatiramer acetate. Nevertheless, with early treatment we are subjecting many patients to a regimen that will not help them in order to improve the outcome in those who will develop clinically definite MS. This "medicalizes" those patients, who will suffer the same side effects as those who need the medication.On the other hand, the placebo patients from the phase 3 trials who were treated with their second attack subsequently have more attacks than those treated early, and probably more disability. The long-term subcutaneous interferon beta-1b (Betaseron) results showed a much higher 17-year mortality rate in those receiving placebo than in those treated with either low-dose or high-dose Betaseron in the phase 3 trial.

Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study

“…Primarily diagnosed in young adults at a mean age of 29 years, it follows four recognized disease courses: relapsing/remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), and progressive relapsing MS (PRMS) [ 1 - 4 ]. Approximately 20% of patients have a mild form of the disease, yet MS can also render a person unable to write, speak, or walk, with up to 60% of patients losing ambulatory capability within 20 years after onset [ 1 , 2 , 5 ]. Since most people with MS have a fairly normal life expectancy, this chronic disease evokes very significant social, medical and economic impacts.…”

“…The decision to begin or continue MS therapy is complex and controversial [ 5 ]. The National Multiple Sclerosis Disease Management Consensus Statement [ 21 ] recommends initiating interferon beta or glatiramer DMD therapy as soon as possible following definite diagnosis of active, relapsing MS, and also to consider DMD therapy for selected high risk patients with a first attack.…”

“…The National Multiple Sclerosis Disease Management Consensus Statement [ 21 ] recommends initiating interferon beta or glatiramer DMD therapy as soon as possible following definite diagnosis of active, relapsing MS, and also to consider DMD therapy for selected high risk patients with a first attack. Although the DMDs have positively affected the treatment and course of RRMS, numerous factors including their parenteral route of administration, injection anxiety, side effects, unobservable improvement, adjunctive therapy, and treatment fatigue can affect the initiation and continuation of DMD therapies [ 5 , 17 , 23 , 25 - 29 ].…”