Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Voluntary, post-authorization safety study

Study drug and medical condition

• Name of medicine:
  AVONEX

  PLEGRIDY
• Medical condition to be studied:
  Multiple sclerosis

  Pregnancy

Population studied

• Short description of the study population:
  Female participants diagnosed with multiple sclerosis, aged at least 18 years treated with subcutaneous peginterferon beta-1a therapy or intramuscular interferon beta-1a therapy enrolled in the Patient Support Program (PSP) of Biogen’s German MS Service-Center (MSSC). ; Inclusion criteria: ; • Female patients of at least 18 years at time of informed consent; • Diagnosed RRMS or CIS (CIS indication only applicable for interferon beta-1a); • Exposure to either SC Peginterferon beta-1a therapy or IM Interferon beta-1a therapy before or during pregnancy; • Registered in the PSP of the MSSC and agreed in writing to the privacy policy of the registration form; • Reported pregnancy data (pregnancy report and pregnancy outcome report) available at MSSC. Note: only pregnancy data (i.e. obtained until 15 October 2020) will be considered; ; For the prospective part of the study:; • Ability to understand the purpose of the study and provide signed and dated study-specific informed consent form (ICF); • Pregnancy outcome in the retrospectively collected data was a live birth
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other

  Pregnant women
• Special population of interest, other:
  Multiple Sclerosis patients
• Estimated number of subjects:
  470

Study design details

• Main study objective:
  The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available.
• Outcomes:
  Percentage of Subjects With Live Births Without Congenital Anomalies, Percentage of Subjects With Live Births With Congenital Anomalies, Percentage of Subjects With Ectopic Pregnancies, Percentage of Subjects With Spontaneous Abortions, Percentage of Subjects With Elective Abortions, Percentage of Subjects With Preterm Births, Percentage of Subjects With Stillbirths. To evaluate exposure to SC Peginterferon beta-1a or IM Interferon beta-1a: before and during pregnancy on child development, treatment behavior for pregnant women in daily real life, other MS treatment behavior and use of certain concomitant medications taken during/after pregnancy, on MS disease activity, effect of breastfeeding and benefit of exclusive breastfeeding versus complementary feeding.
• Data analysis plan:
  All documented data are analyzed by descriptive statistics, i.e. absolute frequencies and percentages for categorical variables and mean, standard deviation and percentiles for continuous variables. No formal statistical hypothesis will be formulated, and no statistical tests will be carried out.

Documents

Study results

CSR_PASS_PRIMA_V1.0_Final_2022-05-11_signed_Redacted