Clinical Perspectives in IBD: An IL-23 Inhibitor with Head-to-Head Results in an Open-Label Crohn’s Disease Study

INDICATIONS

Risankizumab is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Risankizumab is indicated for the treatment of moderately to severely active Crohn’s disease (CD) in adults.

IMPORTANT SAFETY CONSIDERATIONS

Risankizumab is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, may occur. If a serious hypersensitivity reaction occurs, discontinue risankizumab and initiate appropriate therapy immediately. Risankizumab may increase the risk of infections. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, discontinue risankizumab until the infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with risankizumab. There is a potential for drug-induced liver injury/hepatotoxicity during induction treatment of UC and CD. Monitor liver enzymes and bilirubin at baseline and during induction (12 weeks). Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Avoid use of live vaccines in patients treated with risankizumab. The most common adverse reactions (>3%) reported during treatment of UC are arthralgia during induction dosing and arthralgia, pyrexia, injection site reactions, and rash during maintenance dosing. The most common adverse reactions (>3%) reported during treatment for CD are upper respiratory infections, headache, and arthralgia during induction dosing and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection during maintenance dosing.

Review accompanying risankizumab-rzaa full Prescribing Information for additional information, visit www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110