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


The IMMhance trial was a randomized, double-blind, placebo-controlled, phase 3 clinical trial that included 507 patients (median age, 49.2 years) who were randomized to risankizumab or to placebo at weeks 0, 4, and every 12 weeks thereafter.11,13 At week 16, risan­kizumab demonstrated superior response rates versus placebo in the co-primary efficacy end points of sPGA score of 0 or 1 (84% vs 7%, respectively) and PASI 90 (73% vs 2%, respectively).11,13

Patients who originally received risankizumab and achieved an sPGA score of 0 or 1 at week 28 were rerandomized to continue treatment with risankizumab every 12 weeks or to withdraw from receiving risankizumab. At 52 weeks, 87% of patients rerandomized to continue ­risankizumab achieved an sPGA score of 0 or 1 versus 61% of the patients who were rerandomized to withdraw from risankizumab treatment.11,14


The most common adverse events (≥1%) associated with risankizumab-rzaa are upper respiratory infections (13%), headache (3.5%), fatigue (2.5%), injection-site reactions (1.5%), and tinea infections (1.1%).11

During the first 16 weeks of treatment, infections were reported in 22.1% of the patients who received risankiz­umab versus 14.7% of the patients who received placebo. Serious infections (in ≤0.4% of patients in the ris­ankizumab and placebo groups) included cellulitis, ­osteomyelitis, sepsis, and herpes zoster.11

The rates of adverse reactions at week 52 were similar to those reported during the first 16 weeks of risankizumab exposure, and no new adverse events were identified. Through week 52, serious infections leading to study discontinuation included pneumonia.11

There are no contraindications for the use of ­risankizumab.11


Live vaccines should not be administered during treatment with risankizumab.11


Data on the use of risankizumab in pregnant women are insufficient to assess the risk for birth defects, miscarriage, or adverse effects for the mother or the fetus. It is possible for risankizumab to be transferred from the mother to the developing fetus.11

Data are not available on the presence or effect of ­risankizumab on the breastfed infant or on the mother’s milk production. The health benefits of breastfeeding should be weighed against the mother’s need for risan­kizumab treatment and any potential adverse effects on the breastfed child from risankizumab treatment or from the mother’s underlying condition.11

The overall number of patients aged ≥65 years was not sufficient to establish whether they respond different from younger patients. Of 2234 patients exposed to ­risankizumab (243 aged ≥65 years and 24 aged ≥75 years), no overall differences were seen in treatment response or safety between the older and younger patients.11


Risankizumab may increase the risk for infections. Patients should be advised to seek medical advice if the signs or symptoms of infection occur. If the patient has an infection, risankizumab should be discontinued until the infection is resolved.11

Patients should be evaluated for tuberculosis before initiating treatment with risankizumab. For patients with a history of latent or active tuberculosis whose adequate treatment course cannot be confirmed, antituberculosis therapy should be considered before initial treatment with risankizumab. Treatment with risankizumab should not be administered to patients with active tuberculosis.11

Age-appropriate immunizations should be considered before initiating treatment with risankizumab. Live vaccines should not be administered during ­risankizumab treatment.11


The FDA approval of risankizumab-rzaa, an IL-23 antagonist, provides a new treatment option for patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or for phototherapy. Treatment with risankizumab demonstrated significant improvements in psoriasis manifestations at 16 weeks, as was shown by the proportion of patients who achieved an sPGA score of 0 or 1, PASI 90, and PASI 100. For the majority of patients who responded to and continued receiving risankizumab, their treatment response was sustained through week 52.

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