Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

The participants included in this study will be drawn from the Ingenix Normative Health
Informatics Database, a proprietary research database containing claims and enrollment data
dating back to 1993 for members of a large, geographically diverse US health plan. This
study will include cohorts of participants who have claims consistent with a diagnosis of
psoriasis and who initiate ustekinumab, anti-TNF biologics, non-anti-TNF biologics, or
systemic non-biological treatments. Participants will be identified by claims bearing codes
for dispensed drugs, procedures or diagnoses and followed after the launch of ustekinumab
for up to 8 years. A sample of enrolled health plan members without claims evidence of
diagnosis or treatment of psoriasis will also be selected. The claims database will be used
to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB)
and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected
outcomes. Potential cases of the study outcome identified through claims may be confirmed
through medical record review. No study agents will be administered in this study. All
patients will receive standard-of-care treatment as prescribed by their physician.

Inclusion Criteria:

- Complete medical coverage and pharmacy benefits

- Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria:

- Participants will be excluded if they do not have information on age, gender or
enrollment