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International Neurologists Conference on the Treatment of Multiple Sclerosis, Berlin, 10 March 2001

 

 

Each year Schering hosts a symposium for neurologists on the use of interferons in Multiple Sclerosis (MS). This year drew in the largest audience in its 5-year history, with over 400 neurologists from around the world attending. This convention provides opportunities for neurologists to be presented with information on a wide aspect of MS related topics and ask questions to the experts in those fields.



The symposium was introduced by Professor Günter Stock, from Schering, with a speech summarising the history of interferon use in MS. He outlined how these agents have been of interest since the 1980s, when little was known about them. Initially, studies were carried out to find if they could be used as antibiotic or anticancer agents. It was in 1993 that Schering found interferons to be of use in MS and ß interferons were the first proven therapy for MS. Since then magnetic resonance imaging (MRI) has been used to diagnose and follow MS etkinligini.

 

Presentations given at the conference:

 

 

In the clinical situation it can be very difficult to judge whether a patient is responding to treatment or not. Professor Deisenhammer described how markers are needed to monitor interferon ß therapy, such as the MxA protein. This marker has been shown to be present in higher levels in responders, indicating an association between the marker and clinical responses. Several studies have reported that this marker increases with dose and, therefore, it may be that some patients are not responding to treatment as they are not receiving a sufficiently high dose. Markers can therefore be used by a neurologist to measure a patients response to a specific therapy, enabling them to adjust the dose or prescribe a different therapy in order to optimise treatment.

 

A renewed interest has been shown recently in axonal loss in MS and how this can be observed using MRI. Dr Frederik Barkhof reviewed MRI markers used in MS. The end stage of MS shows cell death of the cerebral cortex. The amount of persistently hypointense lesions (black holes) seen in MRI scans is the most specific markers for disability and cognitive impairment (EDSS). These black holes are indicative of a more destructive pathology and axonal loss, and reflect the increase of free water in the widened extracellular space that accompanies tissue lesions. They are especially common in secondary progressive (SP) MS patients.

The SP MS trial showed that one type of interferon ß reduced lesions and the development of black holes, but the relationship between this agent and axonal loss is currently unclear. However, it may be possible that the progressive axonal loss occurs some time after a lesion is identified and so earlier treatment could prove advantageous.

 

Professor Ludwig Kappos discussed the results of the European SP MS trial in perspective to three other studies. The European SP MS trial found less disease progression with treatment and a delay in confirmed disability progression of 9-12 months. Another study, with a different type of interferon ß administered once-weekly, recently reported some effect on disease progression. These results indicate that immunomodulatory and immunosuppressive treatments are effective in slowing disease progression.

 

Professor George Rice followed up from his presentation last year with further data on the long-term treatment of patients with relapsing-remitting (RR) MS with one type of interferon ß. As of the beginning of March 2001, 61% of the patients remain on the drug in the twelfth year. The mean duration of interferon treatment has been 11.5 years. The initial flu-like symptoms that many people experience have largely disappeared and toleration of the therapy is generally very good. Injection site reactions and skin necrosis events are still rare. These reactions could be avoided by adjusting the administration of the drug. Like Professor Deisenhammer, Professor Rice discussed the evolution of neutralising antibodies (NAbs). This study had found that although NAbs are common, they disappear in all patients. It can therefore be concluded that interferon ß-1b can be taken safely in the long term and that side effects are manageable. Professor Rice concluded that maintaining patients on therapy for such a long period of time was made possible by ensuring early treatment, regular follow-ups, efficient side effect management and funding support.

 

Quality of life and effects on cognition were discussed by Dr Carolin Miltenburger. Quality of life can be defined as the patient's assessment of how the disease and its treatment affect their ability to carry out the activities and roles that they want to. Clinical trials only study clinical outcomes, such as EDSS scores, but they may prove more informative if they capture aspects of the disease that are relevant to patients, such as their view of the treatment. Currently very little is known about the quality of life of MS patients.

The European SP MS study was the first large study to include quality of life and cognition measures. A questionnaire was used at initiation of the trial and 6-monthly intervals to assess a patient's quality of life, and a noticeable positive effect in patient-reported physical ability was observed. These results support the clinical findings and suggest that interferon ß-1b may delay the deterioration in quality of life reported by SP MS patients. Further feedback from patients is required to define that the quality of life measurements used are the most relevant.

In addition, neurological tests were used to monitor any cognitive changes over the 3 years. After 3 years, the placebo group was more likely to experience cognitive impairment than the treatment group. Dr Miltenburger concluded that, although 3 years may not be long enough to study patients for changes in cognitive function, these results suggest a positive effect of interferon ß-1b in delaying new or further cognitive decline.

 

Finally, Dr Xavier Montalban presented some new perspectives in the early treatment of MS. It is currently debated whether patients should be treated when they have their first MS attack or only when they have clinically active RR MS, i.e. they are suffering relapses and remissions. Two placebo-controlled studies, CHAMPS and ETOMS, showed that treatment with interferons at a very low dose reduced the proportion of patients presenting with a first demyelinating event and an abnormal MRI who converted to clinically definite MS. The number of attacks in the first 2 years can be indicative of long-term disease progression. Therefore, if the number of attacks is reduced in these first 2 years it may be possible to have a positive effect on subsequent disability. A new study (BENEFIT) will start this year and will evaluate the safety, tolerability, and efficacy of a high and a low dosing schedule in patients with a first demyelinating event suggestive of MS. This should help in establishing the potential use of early intervention with high dose interferon and any long-term benefits associated.

This symposium has provided evidence of treatments that are safe and effective in both RR and secondary progressive MS. Efficacy has been shown in reducing both disability and cognitive decline in these groups, improving the patients' quality of life. With the current investigations into MR markers and the new BENEFIT study it may soon be possible to determine when a patient should start treatment and to predict their response. This, in turn, may lead to more effective monitoring of patients' therapy and optimal management of their MS.

 

 

Bu sayfadaki bilginin en son güncellendiği/doğrulandığı tarih:

11/09/2001

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