Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

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

IXEKIZUMAB

Medical condition to be studied

Psoriasis
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

4000
Study design details

Main study objective

To assess the long-term safety of ixekizumab compared with other therapies used in the treatment of adults with moderate-to-severe psoriasis (may include psoriatic arthritis) in the course of routine clinical care

Outcomes

Malignancy, excluding non-melanoma skin cancer, Non-melanoma skin cancer, serious infections, opportunistic infections (including tuberculosis), inflammatory bowel disease, major adverse cardiac events, serious hypersensitivity reactions, demyelinating disease, and gastrointestinal perforation

Data analysis plan

A number of descriptive statistics and crude rates will be generated to understand the registry data before comparative analyses begin. Propensity score models will be used to account for channeling bias. The models will include variables that are known risk factors for safety outcomes and associated with systemic treatments for psoriasis. Before initiating the outcome analysis, the ability of the propensity score stratification to balance the distribution of baseline confounders and reduce channeling bias will be evaluated. Cox proportional hazards models will be used to evaluate the rate of study outcomes among ixekizumab treated patients relative to the comparator populations. Several sensitivity analyses will be performed to examine the impact of assumptions on study conclusions.