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Multiple sclerosis: wasted opportunities

The drugs on the market have been so poorly evaluated that healthcare professionals are not able to make the best use of the available treatments, to the detriment of patients.

Numerous drugs have been authorised over the past 15 years for treatment of multiple sclerosis.

Eight drugs have been authorised in Europe since the market introduction of interferon beta (Avonex°, Betaferon° or other brands) and glatiramer (Copaxone° or other brands). These eight drugs were granted marketing authorisation on the basis of 16 clinical trials, 11 of which compared the new drug with placebo, while the other trials compared it with interferon beta-1a (the standard therapy, in the absence of a better alternative). The primary endpoint in 11 trials was the mean annualised relapse rate. In other words, when first introduced on the market, most of these drugs had not been compared with the standard treatment, and their effect on disease progression in the long term had not been evaluated.

Two-thirds (34) of the 52 randomised clinical trials conducted after the eight drugs had obtained marketing authorisation compared the drug with placebo, and 17% (9 trials) with interferon or glatiramer. Only one of the trials whose final results had been published compared two drugs head-to-head, and only one trial evaluated disease progression as an endpoint, and without demonstrating any efficacy.

In short, we are unable to determine the first-choice drugs for multiple sclerosis because the drugs were not compared with one another, and the opportunity provided by post-approval trials to better evaluate efficacy in slowing disease progression was wasted. Healthcare professionals are obliged to base their treatment decisions more on personal experience, possibly influenced by key opinion leaders, than on convincing data.

Inadequate drug evaluation is a waste of society's resources and a lost opportunity for patients to benefit from better treatments.

©Prescrire 1 April 2019

"Multiple sclerosis: wasted opportunities" Prescrire Int 2019; 28 (203): 87. (Pdf, free)

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See also:

Multiple sclerosis:
a drug that should never
have been authorised
(July 2018)

Multiple sclerosis:
neither natalizumab
nor alemtuzumab
(March 2015)

Ocrelizumab (Ocrevus°)
in multiple sclerosis.
Uncertain long-term
harm-benefit balance
Prescrire Int 2019;
28 (203): 92-94.
Pdf, subscribers only

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