An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TECFIDERA

  TERIFLUNOMIDE

  VUMERITY
• Study drug International non-proprietary name (INN) or common name:
  DIMETHYL FUMARATE

  DIROXIMEL FUMARATE

  GLATIRAMER ACETATE

  INTERFERON BETA-1A

  INTERFERON BETA-1B

  TERIFLUNOMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L03AB07) interferon beta-1a

  interferon beta-1a

  (L03AB08) interferon beta-1b

  interferon beta-1b

  (L03AB13) peginterferon beta-1a

  peginterferon beta-1a

  (L03AX13) glatiramer acetate

  glatiramer acetate

  (L04AA31) teriflunomide

  teriflunomide

  (L04AX07) dimethyl fumarate

  dimethyl fumarate

  (L04AX09) diroximel fumarate

  diroximel fumarate
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  Participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) at the initiation of the treatment and participating in Big Multiple Sclerosis Data (BMSD) network registry are eligible to participate in the study.
• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  10500

Study design details

• Main study objective:
  The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.
• Outcomes:
  Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts; Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort
• Data analysis plan:
  The incidence and incidence rates per 100,000 person-years with 95% CIs will be provided for each treatment cohort. Incidence of all reported SAEs will be summarized and presented by system organ class (SOC) and/or preferred term PT, as appropriate. Comparisons of SAEs will be performed between the Vumerity cohort and the other selected DMTs cohort, between the Tecfidera cohort and the other selected DMTs cohort, and between the Vumerity/Tecfidera switch cohort and the other selected DMTs cohort, if the sample size allows. Cox proportional-hazards regression model will be performed adjusting for potential predictors for each comparison. At the end of the study, the propensity score calculated using logistic regression model will be applied to compare the risks between cohorts to control confounders within each registry.