Non-interventional (observational) post-licensure study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged =18 years with psoriasis or psoriatic arthritis (EPI-ZOSTER-045 VE US 216976)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  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:
  Psoriasis
• Additional medical condition(s):
  Psoriatic arthritis

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:
  12802

Study design details

• Main study objective:
  • To estimate the vaccine effectiveness of 2 doses of recombinant zoster vaccine (RZV) in preventing Herpes Zoster (HZ) in Southern California adults ≥18 years of age with psoriasis (PsO). ; • To assess the rate of flares within 30 days following RZV vaccination as compared to the rate in self-controlled comparison periods, in Southern California adults ≥18 years of age with PsO.
• Outcomes:
  Vaccine effectiveness in preventing HZ in Southern California participants with PsO. ; Rate of flares in Southern California participants with PsO. Vaccine effectiveness in preventing HZ in South California participants with: ; - PsO or PsA (2 doses of RZV), ; - PsA (2 doses of RZV),; - PsO (1 dose of RZV), ; - PsA (1 dose of RZV). ; ; Baseline characteristics in Southern California participants with: ; - PsO (2 doses of RZV), ; - PsA (2 doses of RZV). ; ; Rate of flares in Southern California participants with: ; - PsO or PsA, ; - PsA.
• Data analysis plan:
  Baseline demographic and clinical characteristics of individuals with PsO or PsA, who meet the inclusion criteria will be described. Categorical variables will be presented as absolute numbers and percentages for each cohort. Continuous variables such as age in years will be presented as the mean with standard deviation and/or median with interquartile ranges. For vaccine effectiveness objectives, incidence rates of HZ will be assessed for the PsO and PsA cohort. Unadjusted and adjusted vaccine effectiveness will be calculated using hazard ratios, which will be estimated by Cox proportional hazards regression models with and without adjustment for potential confounders. For safety objectives, rates of PsO or PsA flare for risk periods and comparison periods will be calculated. Incidence rate ratio comparing the rate of flares in the risk and comparison periods will be estimated using conditional Poisson regression.