FDA approves first oral treatment for moderately to severely active Crohn’s disease

Action

FDA has approved Rinvoq (upadacitinib) for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Rinvoq is the first approved oral product available to treat moderately to severely active Crohn’s disease.

Patients should start with 45 mg of Rinvoq once daily for 12 weeks. Following the 12-week period, the recommended maintenance dosage is 15 mg once a day. A maintenance dosage of 30 mg once daily can be considered for patients with refractory, severe, or extensive Crohn’s disease.

Disease or Condition

Crohn's disease is a chronic inflammatory bowel disease that causes inflammation in the digestive tract. It can affect any part of your digestive tract, and usually affects the small intestine and the beginning of the large intestine. The symptoms of Crohn's disease depend on where and how severe the inflammation is. The most common symptoms include diarrhea, cramping and stomach pain, and weight loss.

Effectiveness

The efficacy and safety of Rinvoq were evaluated in two randomized induction trials of 857 patients with moderately to severely active Crohn’s disease, CD-1 (NCT03345836) and CD-2 (NCT03345849). Patients were randomized 2:1 to receive 45 mg of Rinvoq or placebo once a day for 12 weeks. At week 12, a greater proportion of patients treated with 45 mg of Rinvoq, as compared to placebo, achieved clinical remission based on the Crohn’s Disease Activity Index (CDAI), which measures clinical and laboratory variables that estimate disease activity in Crohn’s disease. Similarly, a greater proportion of patients treated with 45 mg of Rinvoq demonstrated improvement in intestinal inflammation as assessed by colonoscopy.

To assess Rinvoq as a maintenance treatment, CD-3 (NCT03345823) evaluated 343 patients who responded to 12 weeks of 45 mg of Rinvoq once daily. Patients were re-randomized to receive a maintenance regimen of 15 or 30 mg of Rinvoq once daily or placebo for 52 weeks, representing a total of at least 64 weeks of therapy. At week 52, a greater proportion of patients treated with 15 mg or 30 mg of Rinvoq, as compared to placebo, achieved clinical remission based on the CDAI, and demonstrated improvement in intestinal inflammation as assessed by colonoscopy.

Safety Information

The most common side effects of Rinvoq as indicated for Crohn’s disease are upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. Rinvoq is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biological therapies for Crohn’s disease, or with strong immunosuppressants such as azathioprine and cyclosporine. Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have occurred with JAK inhibitors such as Rinvoq. See full prescribing information for additional information on risks associated with Rinvoq.

Designations

Rinvoq received standard review for this indication.