Why carry out this study?

Reports of the real-world safety profile of tofacitinib in psoriatic arthritis (PsA) are limited, although the safety of tofacitinib in patients with PsA and rheumatoid arthritis (RA) has been demonstrated in clinical studies of up to 4 and 9.5 years, respectively.

To date, post-marketing surveillance (PMS) safety data for tofacitinib from spontaneous and voluntary adverse event (AE) reports have been published for RA, but not for PsA.

This analysis informs the real-world safety profile of tofacitinib in PsA using AE reports submitted to the Pfizer safety database, with RA data included for context.

What was learned from the study?

The data collected in this PMS study were aligned with the established safety profile of tofacitinib, and were consistent between PsA and RA.

While these results should be interpreted in the context of the limitations of PMS studies and spontaneous AE reporting, these data provide insight to the clinician regarding expected real-world safety outcomes in patients with PsA treated with tofacitinib.