Routine data analysis of the drug safety in pregnant multiple sclerosis patients in the context of newly approved, innovative treatments

• Applicant: Dr. Alicia Basoglu
• Subject Area: Public Health, Healthcare Research, Social and Occupational Medicine
• Term: since 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 533201262

Multiple sclerosis (MS) is one of the most common, neurological diseases of young adulthood, in particular affecting women of childbearing age. Disease modifying treatments of pregnant MS patients also affect the health of the unborn child. Hence, this is an important area of concern in this vulnerable population. For many newly approved, innovative MS treatments, there are recommendations for timely discontinuation prior to the onset of pregnancy (e.g., Ocrelizumab: 12 months; Ofatumumab: six months). To investigate the safety of drug therapy, it is therefore important to assess to what extent the respective restrictions are complied with in routine clinical care. A routine data analysis of statutory health insurance (SHI) billing data enables to investigate recent developments in this dynamic area of indication. Therefore, we address the following research question: To what extent is the prescription of contraindicated immunotherapies for pregnant MS patients avoided in routine health care in accordance with guideline recommendations? The aim of this study is to assess the prescriptions of contraindicated treatments for pregnant MS patients in routine practice data of the BARMER health insurance. MS patients of childbearing age of 13 to 49 years are identified in the BARMER billing data for the period 2013 to 2022. Patients with an assured MS diagnosis (ICD-10-GM G35.-) in at least two of four consecutive quarters (M2Q criterion) are included. We consider outpatient prescriptions of disease modifying treatments that were redeemed in a pharmacy. The analysis is structured by input, output and outcome. We describe the characteristics of the MS patients and the specialist groups of the prescribing physicians (input). Assessment of the output comprises prescriptions and physician contacts. In the analysis, we focus on the outcome, that is the inadequate medication with contraindicated immunotherapies before and during pregnancy. Furthermore, we describe whether prescriptions were continued, long-term therapies, or new prescriptions. The daily doses prescribed, prescription intervals, changes in therapy and terminations of therapy are also assessed. We analyze whether MS patients discontinue contraindicated drugs in due time before the beginning of the pregnancy and how often they become pregnant while taking contraindicated drugs. In addition, the pregnancy outcomes of live birth, stillbirth, abortion, and spontaneous abortion will be examined. We derive statements and recommendations to avoid prescriptions of contraindicated MS therapies, that will be discussed with the scientific advisory board in the final project meeting.

• DFG Programme: Research Grants