Integrated Long-Term Safety of Risankizumab in Psoriasis and Psoriatic Arthritis

Integrated Long-Term Safety of Risankizumab in Psoriasis and Psoriatic Arthritis

Saakshi Khattri, MD, summarizes integrated long-term safety data across risankizumab’s psoriasis and psoriatic arthritis programs.

In this segment, Saakshi Khattri, MD, turns to long-term safety, reviewing an integrated analysis that pooled data across the psoriatic disease clinical trial program for risankizumab in both psoriasis and PsA. She explains that safety outcomes were reported as exposure-adjusted event rates per 100 patient-years, enabling assessment of adverse events over prolonged treatment durations. With chronic immune-mediated diseases, she notes, clinicians and patients are particularly attentive to whether new safety concerns emerge with longer exposure.

According to Khattri, the integrated analysis did not identify new or emerging safety signals with long-term risankizumab use. There was no evidence of cumulative toxicity, and no meaningful increase in serious events over time.

Specifically, she remarks on the absence of signals for tuberculosis reactivation, lymphoma, inflammatory bowel disease, or major adverse cardiovascular events in the analyzed dataset. These findings, in her view, support a favorable long-term safety profile for IL-23 inhibition in psoriatic disease.

Clinically, Khattri underscores that such long-term safety data are central to patient counseling, given that many individuals with psoriasis or PsA may require lifelong biologic therapy. The assurance that extended risankizumab exposure has not been associated with new safety concerns offers reassurance to both prescribers and patients. She positions this integrated safety analysis as an important complement to the long-term efficacy and radiographic data in informing shared decision-making.