Therapeutic decisions are based on efficacy, but clinicians need to consider medication safety in this process. The introduction of new classes of medications for spondyloarthritis highlights the importance of safety consideration in this regard.
The safety of ustekinumab (UST), an IL-12/IL-23 inhibitor used for the management of active psoriasis, psoriatic arthritis (PsA) and Crohn's disease (CD), was evaluated by combining data from phase 2 and 3 clinical trials (3 PsA, 5 CD, 4 PsO). Overall, 5884 patients exposed to UST were evaluated. The effect of concomitant methotrexate (MTX) on adverse events was also assessed (20.5% were using MTX).
Overall, the rates of serious adverse events were comparable in the UST and placebo groups for all diseases. The rates of infections and serious infections were numerically lower in the UST vs. placebo, however, the difference was not statistically significant. The rate of major cardiovascular events was comparable in UST exposed patients and controls and the rate of events was similar across patients with PsA, psoriasis and CD. Event rates of malignancy were also comparable across all disease states.
Based on pooled data from clinical trials, UST appears to be safe across patients with psoriasis, PsA and CD. The use of UST appears to be safe and well-tolerated. It should be noted however, that patients that participate in clinical trials differ substantially from patients normally seen in the clinical setting. Additionally, some adverse effects may have a longer lag period, thus assessing data from other sources, such as patient registries, is important to ensure long-term safety of new biologic medications.
Dr. Lihi Eder is an Assistant Professor of Medicine at the University of Toronto and Staff Rheumatologist and Director of the Psoriatic Arthritis Research Program at Women’s College Hospital. Dr. Eder is a Scientist at Women’s College Research Institute and associate member of the graduate faculty at the Institute of Medical Science.View Full Bio