Safety and effectiveness of RZV in adults ≥18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SHINGRIX
• Study drug International non-proprietary name (INN) or common name:
  HERPES ZOSTER VACCINE (RECOMBINANT, ADJUVANTED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BK03) zoster, purified antigen

  zoster, purified antigen
• Medical condition to be studied:
  Systemic lupus erythematosus

  Multiple sclerosis

Population studied

• 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)
• Estimated number of subjects:
  44367

Study design details

• Study design:
  Retrospective cohort study design
• Main study objective:
  • To assess the risk of hospitalized flare within 90 days following any RZV dose in adults with pre-existing SLE. ; • To estimate the VE of 2 doses of RZV in preventing HZ in adults with pre-existing SLE. ; • To estimate the VE of 2 doses of RZV in preventing HZ in adults with pre-existing MS.
• Comparators:
  Unvaccinated patients with SLE or MS will be included as comparators.
• Outcomes:
  Safety: Risk of severe systemic lupus erythematosus (SLE) flare or risk of any multiple sclerosis (MS) relapse.; Effectiveness: Vaccine effectiveness in prevention of herpes zoster (HZ).; Effectiveness: Incidence of post-herpetic neuralgia (PHN).
• Data analysis plan:
  The analysis plan will include descriptive measures to characterize vaccinated and unvaccinated individuals. Cox proportional hazards regression models will be used to compare outcomes in vaccinated and unvaccinated patients using propensity scores to balance potential confounders. ; To evaluate the risk of hospitalized SLE flare after any RZV dose, separate cohorts will be created for RZV Dose 1 and Dose 2, each with matched unvaccinated comparators. ; The risk of hospitalized SLE flares will be assessed in each cohort (Dose 1 or Dose 2) using time-to-event analysis with Cox proportional hazard models, assessing for violations of the ; proportional hazard assumptions. ; A retrospective cohort design with Cox proportional hazards modelling will be used to assess the risks of HZ and incidence of PHN after RZV vaccination. In the primary analysis, patients ; receiving the RZV Dose 2 at least 28 days after RZV Dose 1 will be compared to patients with no prior RZV vaccination.