Skyrizi’s Breakthrough: Promising Results in Ulcerative Colitis Maintenance Study Pave the Way for FDA Approval

AbbVie’s Skyrizi has posted another victory in a maintenance trial after completing a study on the induction treatment of ulcerative colitis. Now, it appears that achieving approval in 2024 is possible. AbbVie stated that continuing Skyrizi helped significantly more patients with moderate to severe ulcerative colitis achieve clinical remission at one year compared to discontinuing therapy.

In the Phase 3 COMMAND experiment, Skyrizi not only met the primary target but also several secondary endpoints, such as improvement shown during an endoscopy. According to corporate officials, AbbVie is prepared to submit Skyrizi for authorization in ulcerative colitis this year, with a potential FDA approval in 2024.

According to a statement from AbbVie’s Chief Medical Officer, Roopal Thakkar, Skyrizi is already approved for the treatment of Crohn’s disease, and the results of the COMMAND study suggest that the medication may also be a viable treatment option for ulcerative colitis. In the maintenance study, Skyrizi generated universally favorable results across a number of trial objectives, similar to what it achieved in the Phase 3 INSPIRE induction investigation. However, the need for a large dosage of the IL-23 inhibitor during the maintenance period raises one concern.

AbbVie rerandomized patients who had responded to Skyrizi induction treatment for COMMAND to either continue receiving active medication or discontinue it.

By assessing stool frequency, rectal bleeding, and endoscopic performance with the Adapted Mayo Score at week 52, 40% of patients using Skyrizi 180 mg had achieved clinical remission. However, Skyrizi’s response rate was relatively comparable at 360 mg, at 38%. In the induction-only group, 25% of patients achieved remission.

Across all of the trial’s secondary outcomes, the low-dose group performed considerably better than the high-dose group. For the two Skyrizi arms, the rate of endoscopic improvement was 51% and 48%, respectively, compared to 32% for the control group. Furthermore, compared to 37% for the high dose and 25% for the control group, 40% of patients on modest doses of Skyrizi were in remission and free of steroids.

In terms of safety, patients in the low-dose and high-dose groups experienced major side effects at rates of 5.2% and 5.1%, respectively, compared to 8.2% in the control group. A patient in the high-dose group passed away from cancer that was thought to be unrelated to the medication.

Skyrizi is a component of AbbVie’s strategy for treating inflammatory diseases following the expiration of Humira’s patent. The Illinois-based drugmaker projects that sales of the medication for Crohn’s disease and ulcerative colitis combined will reach $2.5 billion in 2025.

The JAK inhibitor Rinvoq, another component of AbbVie’s comprehensive Humira replacement strategy, received approval for the treatment of ulcerative colitis in March of last year and for Crohn’s disease in April. AbbVie has estimated that Rinvoq will generate $1.8 billion in sales for the two inflammatory bowel diseases by 2025.

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