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.

• 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. ( 1.1 ) active psoriatic arthritis in adults.ICD-10: L40.50, L40.9

• SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )] .contraindicated

For the treatment of Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. ( 2.1 , 5.4 ) Complete all age-appropriate vaccinations as recommended by current immunization guidelines ( 2.1 , 5.5 ) Recommended Dosage Plaque Psoriasis and Psoriatic Arthritis: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 , 2.4 ) In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). ( 2.4 ) Crohn’s Disease: 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. ( 2.6 ) Ulcerative Colitis: The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours 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.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. ( 5.1 ) 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. ( 5.2 ) Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI. ( 5.3 ) Hepatotoxicity in Treatment of Inflammatory Bowel 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. ( 5.4 ) Administration of Vaccines: Avoid use of live vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1 )]. 5. 2 Infections SKYRIZI may increase the risk of infections [see Adverse Reactions ( 6.1 )] . Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur.

The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity in Treatment of Inflammatory Bowel Disease [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ( 6.1 ) Crohn’s Disease (>3%): ◦ Induction : upper respiratory infections, headache, and arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. ( 6.1 ) Ulcerative Colitis (≥3%): ◦ Induction : arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, pyrexia, injection site reactions, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com. Risk Summary Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero - exposed infant . There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations) . In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data) . The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg).

Metabolism

Risankizumab-rzaa plasma concentrations, after single dose administration increased dose proportionally from 18 mg to 360 mg when administered subcutaneously (0.12 to 2.4 times the lowest recommended dose and 0.05 to 1 times the highest recommended dose) and from 200 mg to 1,800 mg when administered as an up to 3-hour intravenous infusion (0.2 to 3 times the recommended dose) in healthy subjects.

• Apr 23, 2019BLABLA761105Abbvie Inc
• Jun 16, 2022BLABLA761262Abbvie Inc

1. 1Psoriasis7,5789.9%
2. 2Drug Ineffective3,3824.4%
3. 3Pain3,0193.9%
4. 4Fatigue2,8903.8%
5. 5Arthralgia2,8663.7%
6. 6Pruritus2,6003.4%
7. 7Covid-192,2342.9%
8. 8Surgery2,0612.7%
9. 9Death2,0222.6%
10. 10Fall2,0032.6%
11. 11Device Issue1,9132.5%
12. 12Diarrhoea1,8282.4%
13. 13Headache1,7962.3%
14. 14Crohn^s Disease1,7822.3%
15. 15Rash1,4141.8%

The 10 most recently updated of 118 ClinicalTrials.gov registrations naming Risankizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
  Recruiting · Phase 3 · Interventional · 600 enrolled · MoonLake Immunotherapeutics AG
  NCT06641089updated 2026-06-12
• A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
  Recruiting · Phase 3 · Interventional · 530 enrolled · Janssen Research & Development, LLC
  NCT07499232updated 2026-06-05
• A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
  Active not recruiting · Phase 3 · Interventional · 684 enrolled · UCB Biopharma SRL
  NCT06624228updated 2026-06-05
• Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
  Recruiting · Phase 2 · Interventional · 540 enrolled · AbbVie
  NCT06548542updated 2026-06-05
• A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
  Recruiting · Phase 3 · Interventional · 120 enrolled · AbbVie
  NCT07071519updated 2026-06-04
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors
  Recruiting · Interventional · 36 enrolled · University Hospitals Cleveland Medical Center
  NCT06399432updated 2026-06-03
• A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
  Active not recruiting · Phase 3 · Interventional · 573 enrolled · AbbVie
  NCT06880744updated 2026-06-03
• A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
  Recruiting · Phase 3 · Interventional · 110 enrolled · AbbVie
  NCT05995353updated 2026-05-29
• Risankizumab Long-term Remission Study
  Completed · Phase 4 · Interventional · 24 enrolled · Jaehwan Kim
  NCT04630652updated 2026-05-27

Frequently asked questions

How does Risankizumab work?

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.

What is Risankizumab used for?

According to FDA labeling, Risankizumab carries indications including: 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. ( 1.1 ) active psoriatic arthritis in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Risankizumab?

Risankizumab is classified as Interleukin inhibitors, Interleukin-23 Antagonist, Interleukin-23 Antagonists, Decreased Cytokine Activity.

What are the brand names for Risankizumab?

Risankizumab is marketed under brand names including Skyrizi.

What are the contraindications for Risankizumab?

Risankizumab labeling lists contraindications including: SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )] .. Always consult the full prescribing information and a clinician.