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

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Post-authorisation safety study
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

TILDRAKIZUMAB

Medical condition to be studied

Psoriasis
Population studied

Short description of the study population

Patients with psoriasis who initiate treatment with Tildrakizumab, other biologics or non-biologic systemic therapies for psoriasis.

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

Immunocompromised

Estimated number of subjects

3757
Study design details

Main study objective

The aim of this PASS is to evaluate the long-term safety of Tildrakizumab used for the treatment of patients with moderate to severe psoriasis and to assess whether Tildrakizumab use is associated with an increased risk of malignancies, MACEs, serious infections, suicidal ideation and behavior (SIB), serious hypersensitivity reactions and inflammatory bowel disease (IBD).

Outcomes

The primary objectives are to evaluate and compare between patients who initiate treatment with Tildrakizumab and patients who initiate treatment with “other biologics” and between patients who initiate treatment with Tildrakizumab and patients who initiate treatment with “non-biologic systemic therapies” specified risks.
To describe the characteristics of patients with psoriasis who initiate treatment with Tildrakizumab, “other biologics” or “non-biologic systemic therapies” for psoriasis.
To evaluate the incidence of all AEs and all SAEs (other than those covered by the primary objectives), by MedDRA SOCs.
To describe information obtained regarding pregnant and lactating women.

Data analysis plan

Data will be summarised descriptively. There is no a priori hypothesis. For continuous variables, descriptive statistics (number of patients, mean, standard deviation SD, standard error of mean, median, minimum, and maximum) will be provided.
Categorical variables will be analysed by frequency tables (absolute and relative frequencies). Stratified analyses by treatment, dose and registry will be performed. Incidence rates will be calculated during current use of exposure in each respective cohort (i.e. Tildrakizumab, “other biologics” and “non-biologic systemic therapies”). The overall incidence rates of each primary and secondary endpoint (see Section 7.3.2) will be reported. Exact 95% confidence intervals for incidence rates and incidence rate ratios will be calculated (i.e. in accordance with Clopper and Pearson et al. 1934).
In order to account for potential confounding crude and adjusted estimates will be provided, obtained within a multiple regression model.