Author Topic: (Abst.) Risk evaluation and monitoring in MS therap-eutics  (Read 70 times)

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Offline agate

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(Abst.) Risk evaluation and monitoring in MS therap-eutics
« on: August 26, 2014, 02:08:52 pm »
From Multiple Sclerosis Journal, August 26, 2014:

Quote
Risk evaluation and monitoring in multiple sclerosis therap-eutics

Michel C Clanet1
Jerry S Wolinsky2
Raymond J Ashton3
Hans-Peter Hartung4
Stephen C Reingold5

1Department of Neurosciences University Hospital Toulouse, France
2Department of Neurology, The University of Texas Health Science Center at Houston, USA
3AshtonMediCom, UK
4Department of Neurology and Center for Neuropsychiatry, Medical Faculty, Heinrich-Heine-Universität im UKD, Germany
5Scientific and Clinical Review Associates LLC, USA

Michel Clanet, Department of Neurosciences, Pôle Neurosciences CHU Toulouse Purpan Place Dr BAYLAC TSA 40031 31059 Toulouse Cedex 9, France. Email: michel.clanet@inserm.fr

Background:

Risk for multiple sclerosis (MS) disease-modifying therapies (DMT) must be assessed on an ongoing basis. Early concerns regarding the first-approved DMTs for MS have been mitigated, but recently licensed therapies have been linked to possibly greater risks.

Objectives:

The objective of this review is to discuss risk assessment in MS therap-eutics based on an international workshop and comprehensive literature search and recommend strategies for risk assessment/monitoring.

Results:

Assessment and perception of therap-eutic risks vary between patients, doctors and regulators. Acceptability of risk depends on the magnitude of risk and the demonstrated clinical benefits of any agent. Safety signals must be distinguishable from chance occurrences in a clinical trial and in long-term use of medications. Post-marketing research is crucial for assessing longer-term safety in large patient cohorts. Reporting of adverse events is becoming more proactive, allowing more rapid identification of risks. Communication about therap-eutic risks and their relationship to clinical benefit must involve patients in shared decision making.

Conclusions:

It is difficult to produce a general risk-assessment algorithm for all MS therapies. Specific algorithms are required for each DMT in every treated-patient population. New and evolving risks must be evaluated and communicated rapidly to allow patients and physicians to be well informed and able to share treatment decisions.
« Last Edit: September 29, 2015, 07:42:05 pm by agate »
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