Background and rationale
During the last years, multiple new drugs have been developed to slow down the progression of MS. Acting all on the immune system, these disease-modifying drugs (DMD) have distinct effects on relapses and progression of the handicap, but also dissimilar safety profiles and modes of administration. Some DMD may cause very frequent low-intensity adverse effects, whereas other DMD promotes the development of very rare but potentially fatal complications.
Therapeutic decision in MS is thus very complicated for patients as well as healthcare providers. Efforts have been made to tailor the DMD choice to the patient’s characteristics, however the lack of comparative data often leads to subjective decisions based on personal experience.
The Innovative Medicines Initiative (IMI) through the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) has developed and published an innovative and simple process to evaluate the benefit-risk ratio of a DMD. This evaluation is based on the relative frequency and patient’s evaluation of the relative importance of each possible benefit and side-effect of that DMD.
Whereas the relative frequency of each possible benefit and side-effect of a DMD are known from the results of phase III trials, patient’s evaluation of the importance of these issues are mostly unknown and may differ largely between patients.
To elaborate a web-based application able to help a patient suffering from multiple sclerosis (MS) or his caregiver to determine the benefit-risk ratio of a DMD in his particular clinical situation.
Patients and caregivers will be invited to evaluate the importance they give to each benefit of risk linked to a MS drug through an interactive session on a web-based application. Each session will introduce the possible benefits and side effects of a drug before asking the participant about their own evaluation of the importance of each specific issue.
The application will then evaluate the individualized participant’s benefit-risk ratio of the MS drug using the PROTECT process.
The user may compare his results to those collected from other patients or caregivers. The results may be tailored to his particular condition.
The data obtained may be used to better define the parameters that influence the patient and caregiver perception of a therapy.
Using a robust and validated process, this application will allow patients and caregivers to evaluate their individual benefit-risk ratio for a specific MS drug.