Previously, Rinvoq was indicated for adults with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The updated indication statement also allows the use of Rinvoq for patients after they have received at least one approved systemic therapy in the event TNF blockers are clinically inadvisable.
Official Commentary on the Indication Update
"At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "Ulcerative colitis and Crohn's disease can impact every aspect of a patient's life. This label update gives healthcare providers the option to prescribe Rinvoq for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician."
SAFETY CONSIDERATIONS
Rinvoq may cause serious side effects, including:
Serious infections. Rinvoq can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
Serious allergic reactions. Do not take if allergic to Rinvoq or its ingredients.
Tears in the stomach or intestines; changes in certain laboratory test results.
