Risankizumab Confirms Long-Term Safety in Treating Psoriatic Disease
Rates of adverse events leading to discontinuation were similar between populations of moderate-to-severe psoriasis and psoriatic arthritis.
Kenneth B. Gordon, MD
Credit: Medical College of Wisconsin
Risankizumab has a favorable safety profile when used in the long-term treatment of patients with psoriatic disease, including moderate-to-severe psoriasis (PsO) and psoriatic arthritis (PsA), according to a recent, comprehensive study on risankizumab trials.1
“Psoriatic disease... is a chronic, immune-mediated inflammatory condition associated with high individual and societal burden, leading to cumulative life course impairment for patients that requires long-term continuous treatment to achieve disease control,” lead investigator Kenneth B. Gordon, MD, Professor and Chair, Dermatology, Medical College of Wisconsin, Milwaukee, and colleagues wrote.1
Gordon and colleagues evaluated long-term safety data from 3658 participants in 20 clinical trials for plaque PsO (13,329.3 patient years [PY]) and from 1542 participants in 4 trials for PsA (3803.0 PY) that received at least 1 dose of risankizumab. The median treatment duration was 4.1 years (range, 0.2-8.8) in patients with PsO and 2.8 years (range, 0.2-4.0) in patients with PsA.1
“Achievement of clear or almost clear skin, combined with control of joint symptoms, is associated with improvements in the physical and psychosocial effects of psoriatic disease. Durability of treatment response over years can lead to sustained improvements in health-related quality of life. Biologics are recommended for the treatment of moderate-to-severe psoriatic disease, but some are associated with adverse events (AEs), such as infections,” Gordon and colleagues wrote.1
The investigators found a rate of 145.5 treatment-emergent adverse events (TEAEs) per 100 PY, 7.4 serious AEs per 100 PY, and 1.9 AEs per 100 PY leading to discontinuation in the PsO population. In the PsA population, the investigators found rates of 142.6 TEAEs/100 PY, 8.6 serious AEs/1000 PY, and 1.8 AEs/100 PY leading to discontinuation.1
Rates of serious infections (excluding COVID-19 related infections) were 1.2/100 PYinthe PsO population and 1.4/100 PY in the PsA population. Both populations had rates of less than 0.1/100 PY of opportunistic infections (excluding tuberculosis and herpes zoster). The rate of nonmelanoma skin cancer (NMSC) and malignant tumors excluding NMSC was 0.6/100 PY in the PsO population and 0.5/100 PY in the PsA population. Adjudicated major cardiovascular event rates were 0.5 E/100 PY in PsO and 0.3 E/100 PY in PsA. These rates are within the benchmark set by previous epidemiological studies.1
Gordon and colleagues noted limitations of their research, including potential heterogeneity in patient characteristics, treatment protocols and follow-up durations across pooled trials, the lack of a control group, and a potential tendency for healthier patients to remain in studies for an extended duration.
“This comprehensive integrated safety analysis is the largest and longest safety report on risankizumab in the PsO and PsA population to date,” Gordon and colleagues concluded.1 “Thus, this comprehensive, long-term safety evaluation of risankizumab for patients with psoriatic disease provides further support for the safety profile of risankizumab and its suitability for long-term use in treating the PsO and PsA populations.”
While the focus of this study was on safety, another recent paper published in Rheumatology and Therapy found that for patients with PsA, bimekizumab seems to be more efficacious than either ustekinumab or risankizumab treatment.
Investigators found that patients who were biologic disease-modifying anti-rheumatic drug naïve or with a previous inadequate response or an intolerance to tumor necrosis factor inhibitors had better chances of reaching American College of Rheumatology (ACR) 20/50/70 response criteria and minimal disease activity.2
