From the Guidelines
Risankizumab is a highly effective IL-23 inhibitor for treating moderate to severe plaque psoriasis and psoriatic arthritis, with a standard dosing regimen of 150 mg administered subcutaneously at week 0, week 4, and then every 12 weeks thereafter. This medication works by selectively binding to the p19 subunit of interleukin-23, preventing this inflammatory cytokine from binding to its receptor and thereby interrupting the inflammatory cascade that drives skin inflammation and plaque formation in psoriasis [ 1 ].
Mechanism of Action and Efficacy
Risankizumab's mechanism of action is based on its ability to block IL-23, a cytokine that plays a crucial role in the pathogenesis of psoriasis by promoting the development and maintenance of Th17 cells, which produce inflammatory cytokines [ 2 ]. The efficacy of risankizumab has been demonstrated in several clinical trials, including the KEEP-sAKE 1 and KEEP-sAKE 2 studies, which showed significant improvements in symptoms of psoriatic arthritis, including ACR 20 response, MDA, PASI90, enthesitis, dactylitis, fatigue, and physical function [ 1 ].
Dosing and Administration
The standard dosing regimen for risankizumab is 150 mg administered subcutaneously at week 0, week 4, and then every 12 weeks thereafter [ 3 ]. This dosing regimen applies to both plaque psoriasis and psoriatic arthritis. The medication comes in prefilled syringes or pens that patients can self-administer after proper training.
Safety Considerations
Before starting treatment with risankizumab, patients should be screened for tuberculosis and other infections, as the medication can increase infection risk [ 2 ]. Live vaccines should be avoided during treatment, and patients should be monitored for hypersensitivity reactions, particularly during initial doses.
Key Points
- Risankizumab is an IL-23 inhibitor that treats moderate to severe plaque psoriasis and psoriatic arthritis.
- The standard dosing regimen is 150 mg administered subcutaneously at week 0, week 4, and then every 12 weeks thereafter.
- Risankizumab is highly effective in improving symptoms of psoriatic arthritis and plaque psoriasis.
- Patients should be screened for infections and monitored for hypersensitivity reactions before and during treatment.
From the FDA Drug Label
Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.
Risankizumab is used for treating moderate to severe plaque psoriasis and psoriatic arthritis.
- The mechanism of action is through selectively binding to the p19 subunit of human IL-23 cytokine and inhibiting its interaction with the IL-23 receptor.
- The dosing for risankizumab is as follows:
- 150 mg subcutaneously at Weeks 0, 4, and every 12 weeks thereafter for plaque psoriasis and psoriatic arthritis.
- Other dosing regimens are available for Crohn’s disease and ulcerative colitis, but are not relevant to this question. 4
From the Research
Overview of Risankizumab
- Risankizumab is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting IL-23-dependent cell signaling 5.
- It is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and those who have an inadequate response to conventional therapies 5, 6.
Mechanism of Action and Dosing
- Risankizumab works by inhibiting the IL-23 pathway, which plays a key role in the development of psoriasis and psoriatic arthritis 5, 7.
- The recommended dosing regimen for risankizumab is 150 mg administered subcutaneously at weeks 0, 4, and 16, and then every 12 weeks thereafter 8, 9.
Efficacy in Plaque Psoriasis
- Risankizumab has been shown to be effective in treating moderate to severe plaque psoriasis, with significant improvements in Psoriasis Area and Severity Index (PASI) scores and static Physician's Global Assessment scores compared to placebo and other biologic therapies 5, 8, 6.
- In a phase III trial, risankizumab was superior to secukinumab in achieving PASI 90 at week 52, with a difference of 29.8% (95% CI 20.8-38.8, P < 0.001) 8.
Efficacy in Psoriatic Arthritis
- Risankizumab has also been shown to be effective in treating active psoriatic arthritis, with significant improvements in American College of Rheumatology (ACR) scores and patient-reported outcomes compared to placebo 9.
- In a phase 3 trial, risankizumab resulted in significant improvements versus placebo in key disease outcomes, including ACR20, and was well tolerated in patients with psoriatic arthritis who were biologic-intolerant or had an inadequate response to conventional therapies 9.
Safety and Tolerability
- Risankizumab has been generally well tolerated in clinical trials, with a safety profile similar to other biologic therapies 5, 8, 6, 7, 9.
- Serious adverse events and serious infections were reported in a small percentage of patients treated with risankizumab, but were not significantly different from those reported in patients treated with placebo 9.