Risankizumab Demonstrates Superiority and Efficacy Overall Among Adult Patients with Moderate Plaque Psoriasis Advances

The long-term safety of risankizumab, an IL-23 inhibitor, has been extensively evaluated in patients with moderate to severe plaque psoriasis (PsO) and psoriatic arthritis (PsA). This study pooled safety data from 17 clinical trials in PsO and 4 trials in PsA, encompassing a total of 3197 patients with PsO and 1542 patients with PsA. The findings revealed low and comparable rates of treatment-emergent adverse events (AEs), serious AEs, and discontinuations due to AEs across both groups. These results reinforce the long-term safety of risankizumab for treating psoriatic disease, with low rates of AEs observed over extended treatment periods.

Risankizumab has consistently shown a favorable safety profile in patients with moderate to severe PsO, according to data from phase I–III clinical trials. In the short-term safety assessment, 1306 patients receiving risankizumab were compared with 300 receiving a placebo. Long-term safety data included 3072 patients treated with risankizumab over 7927 patient-years (PY). The study found no increase in exposure-adjusted AE rates with long-term treatment, supporting the consistent safety of risankizumab in both short- and long-term use. Serious AEs occurred at a rate of 7.8 per 100 PY, with low rates of serious infections, nonmelanoma skin cancer (NMSC), and malignant tumors.

The efficacy of risankizumab was also demonstrated in the phase III UltIMMa-1 and UltIMMa-2 trials, where it was shown to be superior to placebo and ustekinumab in treating moderate to severe PsO. These trials included over 900 patients and found that a significantly higher proportion of patients receiving risankizumab achieved a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16 compared to those receiving placebo or ustekinumab. The safety profiles were similar across all treatment groups, with no unexpected AEs reported, further supporting the safety and efficacy of risankizumab.

In another phase III trial, risankizumab was evaluated in a randomized, double-blind, placebo-controlled study involving 507 patients with moderate to severe PsO. The results were compelling: at 16 weeks, 73.2% of patients receiving risankizumab achieved PASI 90, compared to only 2.0% of those receiving a placebo. After 52 weeks, 87.4% of patients continuing risankizumab maintained clear or almost clear skin, compared to 61.3% after treatment withdrawal. At 104 weeks, 81.1% of those on risankizumab maintained skin clearance vs 7.1% on placebo. These results, coupled with the fact that risankizumab was well tolerated with no unexpected safety issues over 2 years, highlight its potential as a long-term treatment option for PsO.

The phase III IMMvent study further demonstrated the efficacy and safety of risankizumab by comparing it with adalimumab, a commonly used biologic for moderate to severe PsO. At week 16, 72% of patients receiving risankizumab achieved PASI 90, compared to 47% of those on adalimumab. Additionally, 84% of risankizumab patients achieved a clear or almost clear skin score (sPGA 0/1) vs 60% on adalimumab. Among adalimumab intermediate responders, 66% achieved PASI 90 after switching to risankizumab by week 44. The similar AE profiles between treatments confirmed risankizumab’s safety and efficacy for long-term PsO management.

The LIMMitless study, an ongoing phase III open-label extension, provided further evidence of the long-term safety and efficacy of risankizumab. This study involved 706 of 897 patients who continued treatment through 304 weeks. The interim analysis found that treatment-emergent AEs were low, with few leading to discontinuation. By week 256, 85.1% of patients achieved PASI 90, 52.3% achieved PASI 100, 85.8% had clear or almost clear skin (sPGA 0/1), and 76.4% reported no impact on life quality (Dermatology Life Quality Index 0/1). These results underscore the sustained efficacy and safety of risankizumab over a prolonged treatment period.

A separate study assessed the short- and long-term malignancy rates in patients with moderate to severe PsO treated with risankizumab. Short-term data from 5 phase II–III trials showed low malignancy rates across different treatment groups, including risankizumab, adalimumab, ustekinumab, and placebo. Longer-term data, covering up to 47 months and 2471 risankizumab-treated patients, also demonstrated low rates of NMSC and other malignant tumors. The incidence of malignant tumors was consistent over time, with the most frequent being melanoma, prostate, and breast cancers. Overall, risankizumab showed a favorable long-term safety profile regarding malignancy risks.

Risankizumab has demonstrated a consistent and favorable safety profile in both short- and long-term use for treating moderate to severe PsO and PsA. The low rates of treatment-emergent AEs, serious AEs, and malignancies, along with the sustained efficacy over extended periods, support risankizumab as a reliable and effective treatment option for patients with psoriatic disease. Its safety profile remains consistent across various trials, with no unexpected AEs, making it a promising choice for long-term management of these conditions.

Reference
SKYRIZI (risankizumab) psoriasis and psoriatic arthritis safety profiles. Press release. AbbVie. Accessed August 27, 2024. https://www.skyrizihcp.com/dermatology/pso-psa-safety-profile#seven-year-data

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