Incidence of liver failure and non-viral hepatitis in Multiple Sclerosis (MS) patients and in the general population - a study using the CPRD

Application Number
17_058
Lay Summary

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system of autoimmune origin. Liver test abnormalities in MS patients have been reported and the possibility remains that MS itself or environmental factors associated with MS could increase the risk of liver injury in these patients. This study is being initiated as part of Teva's activities that include constant monitoring of safety reports on all marketed products. The aim of the study is to evaluate the occurrence of liver failure and non-viral hepatitis in the population of MS patients and in the general population. Rates generated from this study will be used for comparison with Teva's safety database. The study population will comprise patients who had a diagnosis of MS during the study period between the dates of 01/01/1999 until the present, i.e. until latest available data. Patients will be followed from the first MS event date. The general population will be defined as all patients registered in the CPRD database at any time during the study period. The occurrence of liver failure and non-viral hepatitis will be calculated by age groups, sex, and year.

Technical Summary

Liver test abnormalities in multiple sclerosis (MS) patients have been reported by the literature and the possibility remains that MS itself or environmental factors associated with MS could increase the risk of liver injury in these patients. This study is being initiated in the context of the routine pharmacovigilance activities that include constant monitoring of safety reports on all marketed products. This study will estimate the incidence rates of liver failure and non-viral hepatitis in MS patients and in the general population in order to obtain a reference incidence rate for Teva's safety data. The study population will comprise individuals who had a diagnosis of MS during the study period between the dates of 01/01/1999 until the present, i.e. until latest available data. Patients will enter this cohort and will be followed from the first MS event date. The general population will be defined as all acceptable patients registered in the CPRD database at any time during the study period. The distribution of the incidence rate of liver failure and non-viral hepatitis will be calculated by age groups, sex, and year.

Health Outcomes to be Measured

Incidence of liver failure and non-viral hepatitis in:
(a) Multiple Sclerosis patients;
(b) the general population.

Collaborators

Dvora Frankenthal - Chief Investigator - Teva Pharmaceuticals Ltd
Dvora Frankenthal - Corresponding Applicant - Teva Pharmaceuticals Ltd
Sigal (Sigalit) Kaplan - Collaborator - Teva Pharmaceuticals Ltd