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Multiple Sclerosis Abstracts

Clinical Trials

Intramuscular Interferon-ß-1a for Disease Progression in Relapsing Multiple Sclerosis

The accepted standard treatment of Relapsing Multiple Sclerosis consists of medications for disease symptoms, including treatment for acute exacerbations.

However, currently there is no therapy that alters the progression of physical disability associated with this disease.

The purpose of this study was to determine whether Interferon-ß-1a could slow the progressive, irreversible, Neurological disability of Relapsing Multiple Sclerosis.

Three hundred and one patients with Relapsing Multiple Sclerosis were randomized into a double-blinded, placebo-controlled, multicenter phase III trial of Interferon-ß-1a. Interferon-ß-1a, 6.0 million units (30µg), was administered by intramuscular injection weekly.

The primary outcome variable was time to sustained disability progression of at least 1.0 point on the Kurtzke Expanded Disability Status Scale (EDSS). Interferon-ß-1a treatment produced a significant delay in time to sustained EDSS progression (p = 0.02).

The Kaplan-Meier estimate of the proportion of patients progressing by the end of 104 weeks was 34.9% in the placebo group and 21.9% in the Interferon-ß-1a group.

Patients treated with Interferon-ß-1a also had significantly fewer exacerbations (p = 0.03) and a significantly lower number and volume of Gadolinium-enhanced Brain lesions on Magnetic Resonance Images (p-values ranging between 0.02 and 0.05).

Over 2 years, the annual exacerbation rate was 0.90 in the placebo-treated patients versus 0.61 in Interferon-ß-1a treated patients. There were no major adverse events related to treatment.

Interferon-ß-1a had a significant beneficial Arial Black, Billboard in Relapsing Multiple Sclerosis patients by reducing the accumulation of permanent physical disability, exacerbations frequency, and disease activity measured by Gadolinium-enhanced lesions on Brain Magnetic Resonance Images.

This treatment may alter the fundamental course of Relapsing Multiple Sclerosis.

Jacobs LD, Cookfair DL, Rudick RA et al,
The Multiple Sclerosis Collaborative Research Group (MSCRG)
Ann Neurol Mar 1996;9:285-294

Copolymer-1 Reduces Relapse Rate & Improves Disability in Relapsing/Remitting Multiple Sclerosis:
Results of a Phase III Multicenter, Double-Blind Placebo-Controlled Trial

We studied Copolymer-1 (Copaxone) in a multicenter (11-university) phase III trial of patients with Relapsing/Remitting Multiple Sclerosis (MS).

Two hundred fifty-one patients were randomized to receive Copolymer-1 (n = 125) or placebo (n = 126) at a dosage of 20 mg by daily subcutaneous injection for 2 years. The primary end point was a difference in the MS relapse rate.

The final 2-year relapse rate was 1.19 +/- 0.13 for patients receiving Copolymer-1 and 1.68 +/- 0.13 for those receiving placebo, a 29% reduction in favor of Copolymer-1 (p = 0.007) (annualized rates = 0.59 for Copolymer-1 and 0.84 for placebo).

Trends in the proportion of relapse-free patients and median time to first relapse favored Copolymer-1. Disability was measured by the Expanded Disability Status Scale (EDSS), using a two-Neurologist (examining and treating) protocol.

When the proportion of patients who improved, were unchanged, or worsened by > or = 1 EDSS step from baseline to conclusion (2 years) was evaluated, significantly more patients receiving Copolymer-1 were found to have improved and more receiving placebo worsened (p = 0.037).

Patient withdrawals were 19 (15.2%) from the Copolymer-1 group and 17 (13.5%) from the placebo group at approximately the same intervals. The treatment was well tolerated.

The most common adverse experience was an injection-site reaction. Rarely, a transient self-limited systemic reaction followed the injection in 15.2% of those receiving Copolymer-1 and 3.2% of those receiving placebo.

Johnson KP; Brooks BR; Cohen JA; et al.
The Copolymer-1 Multiple Sclerosis Study Group
Neurology Jul 1995 45; 7: 1268-76 To Page Top


Is Sporadic MS Caused by Adolescence & Early Adulthood Infection ?
A Case-Control Study of Birth Order Position

Birth order position was examined in 164 cases with sporadic Multiple Sclerosis (MS), i.e. no other family members with MS, and spousal controls, matched for sibship size, socioeconomic status and opposite sex.

The results did not find an association between birth order position and the subsequent development of MS and thus do not support the concept of an infectious cause for MS where early exposure is protective and exposure to the infection is a single event of short duration.

Gaudet JP; Hashimoto L; Sadovnick AD; Ebers GC,
A case-control study of birth order position
Acta Neurol Scand, Jan 1995 ; 91(1): 19-21

Viking voyages: the Origin of Multiple Sclerosis?
An essay in Medical History

Multiple Sclerosis is most frequently found in Scandinavia, Iceland, the British Isles and the countries settled by their inhabitants and their descendants, i.e. the United States, Canada, Australia and New Zealand.

This suggests that the Vikings may have been instrumental in disseminating Genetic susceptibility to the disease in those areas, as well as in other parts of the world.

The Vikings raided most European countries and settled in Normandy and in Sicily and southern Italy.

They engaged in trade with the Arabs along the river routes to the Caucasus, to the Black and Caspian Seas, and penetrated Persia, India and probably China. They also migrated to the East and established the Russian state.

Under the name Varangians, they became part of the Byzantine army and were active in all the military activities of the Byzantine Empire.

They participated in the Crusades. Russians, many of Scandinavian origin also constituted a regiment of the Mongol army and roamed throughout that Empire as well.

The custom of capturing and keeping or selling women and children, which was widespread in the early Middle Ages, as well as the flourishing slave trade in men, were important factors in this Genetic dissemination.

Poser CM,
An essay in Medical History
Acta Neurol Scand Suppl, 1995 ;161:11-22

Role of Bacterial Infection in Exacerbation of Multiple Sclerosis

One hundred consecutive patients admitted to the hospital with a diagnosis of exacerbation of Multiple Sclerosis were evaluated for an infectious process.

All patients received a complete blood count, urinalysis, urine culture with susceptibility studies, blood cultures, and a chest x-ray at the time of admission.

A control group of 55 patients carrying the diagnosis of Multiple Sclerosis but without symptoms of neurologic decline were also studied.

Thirty-five percent of patients experiencing exacerbation of their disease were identified as having a significant bacterial infection compared with 11% in the control group with quiescent disease. These results were significant with a P value of < 0.001.

When presumptive Viral and bacterial infections diagnosed before admission were included, almost 50% of patients could have had an exacerbation of their disease in response to an infectious process.

Bacterial infection might well play a role in precipitating relapse in Multiple Sclerosis as well as influencing treatment.

Rapp NS; Gilroy J; Lerner AM,
Am J Phys Med Rehabil, Nov-Dec 1995 74;6:415-8 Page Top

Psycho-Social Issues

A Purchaser Perspective of Managing New Drugs:
Interferon Beta as a Case Study

Many new drugs in the future will be very expensive and have major resource implications. Given current structures and legislation covering the prescribing of drugs.

There are no clear means of controlling the use of these drugs to avoid diverting money away from other health care services and into drug treatment.

This paper considers what mechanisms might be used by a purchaser to manage the introduction of an expensive new drug and uses Interferon-beta-1b for treating Multiple Sclerosis as an example.

The most likely mechanism is the prescribing of the drug by a general practitioner on the advice of a Neurologist. This would achieve a good benefit for the resources invested but would not control total expenditure.

Devolving a limited budget for the drug to a specialist center so that Neurologists may prescribe it directly would be preferable, as this would link clinical, prescribing, and budgetary responsibility.

These issues need to be addressed urgently by purchasers if major disruptions of services are to be avoided

Walley T; Barton S,
Interferon Beta as a Case Study
BMJ Sep 23 1995;311(7008): 796-9

Multiple Sclerosis: Sexual Dysfunction & its Response to Medications

To determine the frequency and nature of sexual dysfunction, as well as its response to medications, in a sample of patients with Multiple Sclerosis (MS).

Retrospective and prospective survey of 65 female and 36 male patients with MS.

Sixty-three percent of patients reported that they had less sexual activity, and 35% said that they had less interest in lovemaking than before their diagnosis of MS.

Fifty-seven patients reported that they had problems with sexual dysfunction. Sexual dysfunction preceded the diagnosis of MS in only 10 of these patients.

A higher percentage of men (78%) than women (45%) reported that they experienced sexual dysfunction (P = .002).

Men had prominenterectile dysfunction, women had problems with vaginal lubrication, and both sexes had problems with decreased sensation and achieving orgasm.

The presence of sexual dysfunction was associated with the presence of Urinary problems (P = .02) and with a history of treatment of (P = .04)or a current report of (P = .02) depression.

No association could be found between sexual dysfunction and duration of disease, type of disease, disability score, or presence of fatigue.

Twenty of 57 patients with sexual dysfunction reported that they had associated marital problems.

Forty-three of 60 patients who discussed sexual problems with their spouses and four of six who tried formal counseling found it helpful.

Surprisingly, CorticoSteroid treatments that were started for problems other than sexual dysfunction resulted in improved sexual functioning in many patients.

Sexual dysfunction is common in patients with MS.

Determining the frequency and nature of problems allows issues of sexual dysfunction to be addressed as part of comprehensive care of patients with MS and suggests treatments that could improve their quality of life.

Mattson D; Petrie M; Srivastava DK; McDermott M,
Sexual dysfunction and its response to medications
Arch Neurol Sep 1995 52;9:862-8

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