After acing a study for the induction treatment of ulcerative colitis, AbbVie’s Skyrizi has snatched another win in a maintenance trial. An approval now looks within reach for 2024.
Compared with stopping treatment, continuing Skyrizi helped significantly more patients with moderate to severe ulcerative colitis achieve clinical remission at one year, AbbVie said Thursday.
Besides hitting the primary endpoint in the phase 3 COMMAND trial, Skyrizi also met other secondary endpoints such as improvement observed through an endoscopy.
AbbVie has made plans to file Skyrizi for approvals in ulcerative colitis this year with a potential FDA approval in 2024, company executives said during a conference call in April.
Skyrizi is already approved in Crohn’s disease, and the COMMAND trial results showed that the drug can be a potentially effective option for ulcerative colitis as well, AbbVie’s chief medical officer, Roopal Thakkar, M.D., said in a statement.
Just as it did in the phase 3 INSPIRE induction study, Skyrizi delivered all-around positive readouts across various trial goals in the maintenance study. One question, however, is whether a high dose of the IL-23 inhibitor is necessary during the maintenance phase.
For COMMAND, AbbVie rolled over patients who had responded to Skyrizi induction treatment and re-randomized them to either continue active therapy or withdraw.
At week 52, 40% of patients who received Skyrizi at 180 mg achieved clinical remission, as defined by the Adapted Mayo Score measuring stool frequency, rectal bleeding and endoscopic performance. But at 360 mg, Skyrizi’s response rate was quite similar at 38%. The induction-only group experienced a 25% remission rate.
The low-dose arm performed marginally better than the high-dose group across the trial’s secondary endpoints. The rate of endoscopic improvement was 51% and 48%, respectively, for the two Skyrizi arms, versus 32% for control. And 40% of patients on low-dose Skyrizi were in remission and steroid-free, versus 37% for the high dose and 25% for control.
On the safety side, serious side effects happened in 5.2% and 5.1% of patients in the low- and high-dose groups, respectively, whereas the control group saw an 8.2% rate of serious side effects. One patient in the high-dose arm died of cancer that was deemed unrelated to treatment.
Skyrizi is part of AbbVie’s inflammatory disease follow-on plan after Humira’s fall off the patent cliff. The Illinois pharma expects the drug to generate $2.5 billion sales in Crohn’s disease and ulcerative colitis combined in 2025.
Another piece of AbbVie’s big Humira replacement plan, the JAK inhibitor Rinvoq, scored its own ulcerative colitis approval last March and added a Crohn’s disease nod last month. For Rinvoq, AbbVie has put its 2025 sales estimate in the two inflammatory bowel diseases at $1.8 billion.
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