Golimumab 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
rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate
golimumab, 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 golimumab for up to 8 years. A
sample of enrolled health plan members without claims evidence of diagnosis or treatment of
Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis 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. No study agents will be administered in this
study. All participants 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