Skyrizi (Risankizumab-rzaa) a New Treatment Option Approved by the FDA for Patients with Moderate-to-Severe Plaque Psoriasis

More than 8 million people in the United States are affected by psoriasis, a chronic skin disease associated with overactive inflammatory and immune responses.1,2 Approximately 80% to 90% of individuals with psoriasis have plaque psoriasis, the most common form of the disease, which is characterized by thick, raised patches (plaques) that can present anywhere on the skin, but most often appear on the knees, elbows, lower back, and scalp.3,4 In addition, plaque psoriasis is often accompanied by pruritus (severe itching), pain, and, in some cases, bleeding of psoriatic patches.4

Plaque psoriasis imposes a substantial burden on the patient’s physical, social, and psychological well-being.5 Overall, 60% of patients report that psoriasis is very problematic in their everyday life; moderate-to-severe disease inflicts the greatest negative impact on quality of life.1 Furthermore, as many as 35% of people with psoriasis will eventually have psoriatic arthritis.5 In addition, individuals with psoriasis are at an increased risk for depression, cardiovascular disease, type 2 diabetes, kidney disease, metabolic syndrome, and eye disorders.6

Patients with plaque psoriasis may receive treatment with topical agents, phototherapy, conventional systemic therapies (ie, cyclosporine, methotrexate, retinoids) and other systemic therapies, including an oral phosphodiesterase-4 inhibitor, biologic therapies (ie, tumor necrosis factor inhibitors, interleukin [IL]-17 antagonists, IL-23 antagonists, and an IL-12/IL-23 antagonist), and biosimilar agents.7-9


On April 23, 2019, risankizumab-rzaa (Skyrizi; AbbVie), an IL-23 antagonist, was approved by the US Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.10

Commenting on the approval of risankizumab, ­Kenneth B. Gordon, MD, Professor and Chair of Dermatology, Medical College of Wisconsin, and chief inves­tigator for the UltIMMa-1 clinical trial, stated, “The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals.”10 Dr Gordon added, “In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”10


IL-23 is a naturally occurring cytokine that plays a role in the inflammatory and immune responses that are implicated in the pathogenesis of psoriasis.11

Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, selectively binds to the p19 subunit of human IL-23 cytokine and blocks its interaction with the IL-23 receptor, thereby inhibiting the release of proinflammatory cytokines and chemokines.11


Risankizumab is available for injection as a 75-mg/­0.83-mL solution in a single-dose prefilled syringe.11

The recommended dose of risankizumab is 150 mg (two 75-mg injections) administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter. Patients should be evaluated for tuberculosis infection before initiating treatment with risankizumab.11


UltIMMa-1 and UltIMMa-2

The efficacy and safety of risankizumab were eval­uated in 2 phase 3 clinical trials, UltIMMa-1 and ­UltIMMa-2, double-blind, randomized, placebo-controlled studies that included 997 patients (mean age, 48 years in UltIMMa-1 and 47 years in UltIMMa-2) with moderate-­to-severe plaque psoriasis.12

Patients in both studies received treatment at weeks 0, 4, and every 12 weeks thereafter. In both studies, a significantly greater proportion of patients receiving risankizu­mab achieved a 90% improvement in Psoriasis Area and Severity Index (PASI; PASI 90) and static Physician’s Global Assessment (sPGA) score of 0 or 1 at week 16 compared with patients receiving placebo (Table).11,12

Figure 1

The treatment response with risankizumab was sustained at 1 year.11,12 In the UltIMMa-1 trial, 58% of patients who received treatment with risankizumab achieved an sPGA score of 0, 82% achieved a PASI 90, and 56% achieved a PASI 100 at week 52. In the ­UltIMMa-2 trial, 60% of the patients who received treatment with risankizumab achieved an sPGA score of 0, 81% achieved a PASI 90, and 60% achieved a PASI 100 at week 52.12

Among patients in UltIMMa-1 and UltIMMa-2 who received risankizumab and achieved a PASI 100 at week 16, 80% who continued with risankizumab treatment maintained a PASI 100 at week 52; of those who achieved a PASI 90 at week 16, 88% of patients maintained a PASI 90 at week 52.12

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