Risankizumab
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.
SKYRIZI is an interleukin-23 antagonist indicated for the treatment of:
- moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- active psoriatic arthritis in adults.
- moderately to severely active Crohn's disease in adults.
Recommended Dosage
Plaque Psoriasis and Psoriatic Arthritis:
- 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
- In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs
(DMARDs).
Crohn’s Disease:
- Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI.
- The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The
recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the
lowest effective dosage to maintain therapeutic response.
Most common adverse reactions are:
- Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
- Crohn’s Disease (>3%):
- Induction: upper respiratory infections, headache, and arthralgia.
- Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.
- Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur.
- Infections: SKYRIZI may 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 SKYRIZI until the infection resolves. - Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI.
- Hepatotoxicity in Treatment of Crohn’s Disease: Drug-induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin
levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management. - Administration of Vaccines: Avoid use of live vaccines.