Skyrizi (risankizumab-rzaa)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2019

Specific Treatments:

plaque psoriasis

Therapeutic Areas

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General Information

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) antagonist. IL-23 is involved in inflammation and is thought to be associated to several chronic immune-mediated diseases, including psoriasis.

Skyrizi is specifically indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 

Skyrizi is supplied as an injection for subcutaneous administration. The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

Clinical Results

FDA Approval

The FDA approval of Skyrizi was based on AbbVie's global Phase 3 psoriasis program, which assessed the safety and efficacy of Skyrizi in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo.

In ULTIMMA-1 and ULTIMMA-2, 997 subjects were enrolled (including 598 subjects randomized to the Skyrizi 150 mg group, 200 subjects randomized to the placebo group, and 199 to the biologic active control group). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter. In ultIMMa-1 and ultIMMa-2 at 16 weeks, PASI 90 was achieved in 75 percent of patients treated with Skyrizi, compared to 5 and 2 percent receiving placebo, respectively (p<0.001). PASI 100 was achieved in 36 and 51 percent of patients treated with Skyrizi, compared to 0 and 2 percent receiving placebo, respectively (p<0.001). At one year (52 weeks), 82 and 81 percent of patients treated with Skyrizi achieved PASI 90, and 56 and 60 percent achieved PASI 100, respectively (p<0.001). An integrated analysis of ultIMMa-1 and ultIMMa-2 showed most patients treated with Skyrizi who achieved PASI 90 and PASI 100 at week 16 maintained this response at one year (88 and 80 percent, respectively).

IMMHANCE enrolled 507 subjects (407 randomized to Skyrizi 150 mg and 100 to placebo). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter. At Week 16, Skyrizi was superior to placebo on the co-primary endpoints of sPGA 0 or 1 (84% Skyrizi and 7% placebo) and PASI 90 (73% Skyrizi and 2% placebo). The respective response rates for Skyrizi and placebo at Week 16 were: sPGA 0 (46% Skyrizi and 1% placebo); PASI 100 (47% Skyrizi and 1% placebo); and PASI 75 (89% Skyrizi and 8% placebo).

IMMvent was a multinational, phase 3, randomized, double-blind, double-dummy, active-controlled trial – Part A, patients were randomized 1:1 to receive via subcutaneous injection RZB 150 mg at weeks 0 and 4 or ADA 80 mg at week 0 and 40 mg every 2 weeks from week 1 to week 15 (Figure 1) – Part B (weeks 16-44), patients initially randomized to receive ADA who achieved PASI 50 to <90 at week 16 were re-randomized 1:1 to receive RZB 150 mg at weeks 16, 20, and 32 or ADA 40 mg every 2 weeks up to week 41. Skyrizi demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at Week 16 (p<0.001). Following re-randomization at Week 16, 66 percent of patients who started on adalimumab and switched to Skyrizi  achieved PASI 90, compared to 21 percent who continued on adalimumab at Week 44 (p<0.001). The co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 were met (p<0.001).

 

 

Side Effects

Adverse effects associated with the use of Skyrizi may include, but are not limited to, the following:

upper respiratory infections

headache

fatigue

injection site reactions

tinea infections

Skyrizi may also increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer SSkyrizi until the infection resolves. Patients should be tested for tuberculosis prior to administration of Skyrizi.

Mechanism of Action

Skyrizi (risankizumab-rzaa), an interleukin-23 antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. It selectively binds to the p19 subunit of human interleukin 23 (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.

Additional Information

For additional information regarding Skyrizi or plaque psoriasis, please visit https://www.skyrizi.com/