Biogen Multiple Sclerosis Pregnancy Exposure Registry

The Biogen Multiple Sclerosis Pregnancy Exposure Registry is a prospective, observational
registry designed to evaluate pregnancy outcomes in women with multiple sclerosis (MS) who
were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility
window for that product. Women of childbearing potential are a considerable segment of the
patient population affected by MS and are likely to be exposed to a Registry-specified Biogen
MS product around the time of conception and during pregnancy. Biogen completed pregnancy
registries for Avonex and Tysabri; however, formal studies in pregnant women have not been
conducted. Therefore, it is important to evaluate, in a global Pregnancy Registry, how
exposure to a marketed Biogen MS product specified in this Pregnancy Registry may affect
pregnancy and infant outcomes. Data will be collected on prospective pregnancies (i.e.
enrollment prior to knowledge of outcome) at time of enrollment, 6 to 7 months gestation, and
approximately 4,12, and 52 weeks after estimated date of delivery. The prevalence of
spontaneous abortions, birth defects, and other pregnancy and infant outcomes will be
calculated and compared to background rates from external sources such as the European
Surveillance of Congenital Anomalies.

Key Inclusion Criteria:

- Patient consent

- Patient has a diagnosis of MS.

- Documentation that the patient was exposed to a Registry-specified Biogen MS product
during the eligibility window for that product.

- DMF: Exposure since the first day of her last menstrual period (LMP) prior to
conception or at any time during pregnancy.

- Peginterferon beta-1a: Exposure since 17 days prior to the first day of her LMP prior
to conception or at any time during pregnancy.

- DMT unexposed pregnancy cohort: Never received DMT therapy

- Patient agrees to sign the Release of Medical Information Form, thereby permitting the
Registry to contact her health care provider (HCP(s)) and the pediatric HCP for
medical information.

Key Exclusion Criteria:

- The outcome of the pregnancy (i.e., pregnancy loss or live birth) must not be known at
the time of enrollment.

- Initial maternal health assessment upon confirmation of pregnancy does not preclude
participation in the Registry unless a patient tests positive for a medical condition
associated with negative pregnancy outcomes (e.g., toxoplasmosis screen and syphilis
[venereal disease research laboratory test and rapid plasma reagin test] blood screen)
in the opinion of the healthcare provider (HCP).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.