FDA’s Rinvoq Approval Brings Another Ulcerative Colitis Option

The FDA recently gave an additional indication to AbbVie Inc.’s Rinvoq (upadacitinib) in ulcerative colitis, broadening that therapeutic class even more. And while a study revealed some concerns around another agent with a similar mechanism of action, payers and gastroenterologists last year expressed interest in Rinvoq over other late-stage pipeline agents.

On March 16, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. The recommended starting dose for the tablet is 45 mg once daily for eight weeks, followed by a maintenance dose of 15 mg once daily. The wholesale acquisition cost for a 30-day supply is $5,671.26.

For the Managed Care Biologics and Injectable Index: Q3 2021, between Aug. 24, 2021, and Oct. 11, 2021, Zitter Insights polled 40 commercial payers covering 123.8 million lives and 53 gastroenterologists. Payers with 71% of covered lives said they were extremely aware of Rinvoq when compared with two other drugs in the late-stage ulcerative colitis pipeline at the time: Eli Lilly and Co.’s mirikizumab, an interleukin-23 (IL-23) inhibitor, and Gilead Sciences Inc.’s Jyseleca (filgotinib), also a JAK inhibitor. Gastroenterologists also were most aware of Rinvoq compared with the other two therapies.

Zitter Insights and AIS Health are both MMIT companies.

Payers with more than one-quarter of covered lives said they had high interest in Rinvoq for ulcerative colitis, citing its efficacy and portfolio contracting opportunities (see chart below). Similarly, 36% of gastroenterologists said they had high interest in Rinvoq, with 45% expressing their interest as moderate.

In September 2021, the FDA said it was requiring revisions about increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots and death to the labels of the JAK inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Rinvoq. The move followed the agency’s review of a large, randomized safety clinical trial of Xeljanz in people with rheumatoid arthritis. The FDA also limited the approved uses for all the drugs to certain people who have not responded to or cannot tolerate at least one TNF inhibitor.

During the same Zitter survey, 44% of gastroenterologists said that the safety study was highly influential in their prescribing of Xeljanz for ulcerative colitis, while 38% said the study was very influential in their overall JAK inhibitor prescribing.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.

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