Table 4.

Methodological limitations in prespecified analyses and analytical solutions based on a post hoc approach

Study limitation	Analytical solution
1. Inclusion of prevalent and incident usersa	Incident user analysis
2. Imbalances in baseline characteristics across cohorts	Incident user analysis Modified Cox analysis/PS adjustment More comparable active comparator
3. Limited availability of relevant data after baselineb	Not able to mitigate
4. Divergence of characteristics across cohorts over time	Incident user analysis More comparable active comparator

PS propensity scoring

^aPrevalent users include those with ongoing use of biologics (with initiation of treatment pre-dating registry entry in some patients), while incident users include only those who started treatment at enrollment or during registry participation

^bRelevant data not collected after baseline include new or worsened comorbidities and concomitant non-psoriasis medication; inconsistently collected after baseline includes body weight and smoking status