AbbVie's Skyrizi aces ulcerative colitis study en route to new IBD showdown with J&J, Takeda

AbbVie’s Skyrizi, which is already making inroads in Crohn’s disease, has clinched a win in another inflammatory bowel disease (IBD).

Skyrizi as an induction therapy helped significantly more patients with moderate to severe ulcerative colitis achieve clinical remission compared with placebo in a phase 3 trial, AbbVie said Thursday.

In addition to hitting that primary endpoint, the phase 3 trial, dubbed Inspire, met all other secondary endpoints, including clinical response rate, endoscopic improvement and histologic outcomes, AbbVie said.

Clinical remission and clinical response are measured by the Adapted Mayo Score. Clinical remission looks at the resolution of certain symptoms as a result of controlled inflammation of the colon, while clinical response is defined by the levels of improvement per the scorecard.

A positive readout in ulcerative colitis wasn’t a surprise for Skyrizi, given the IL-23 inhibitor won an FDA approval in Crohn’s disease last June. Ulcerative colitis represents a smaller subtype of the two IBD groups.

The induction trial win moves Skyrizi one step closer to a final approval in ulcerative colitis to compete with other biologics such as Johnson & Johnson’s Stelara and Takeda’s Entyvio, as well as small-molecule JAK inhibitors including AbbVie’s own Rinvoq and S1P modulators like Bristol Myers Squibb’s Zeposia. But before that, AbbVie is awaiting data from an ongoing maintenance study.

In an investor update last month, AbbVie said it expects to file an application for Skyrizi in ulcerative colitis this year. The company expects a potential approval in 2024.

AbbVie believes Skyrizi could generate about $2.5 billion in 2025 sales in IBD. For Rinvoq, the Illinois pharma giant expects $1.8 billion sales from IBD that year.

Together, AbbVie expects the drugs will reach $21 billion at peak, eventually eclipsing their predecessor Humira.

For now, Skyrizi’s data suggest it could put up a fight in this field. The drug’s Inspire trial enrolled patients who were intolerant or had an inadequate response to other treatments, including advanced classes of therapies mentioned above.

At week 12, 20.3% of patients receiving Skyrizi in the phase 3 induction study achieved clinical remission, compared with 6.2% of patients receiving placebo. Moreover, 64.3% of Skyrizi takers logged a clinical response, versus 35.7% for the control group.

By comparison, J&J’s Stelara, an IL-12/23 dual inhibitor, recorded a 19% remission rate and a 58% response rate after eight weeks during its own induction study. Takeda’s Entyvio, an integrin inhibitor, triggered a response in 39% of anti-TNF-experienced patients at week 6 in its own clinical trial.

Still, there’s a looming threat for the entire field. J&J’s Stelara is expected to lose U.S. exclusivity as early as the second half of this year, potentially enabling biosimilars to change the market pricing dynamics. Entyvtio could lose patent protection in the U.S. as early as mid-2026, although Takeda recently pushed back that timeline by a few years.

Skyrizi and Rinvoq are the two newer immunology drugs that AbbVie has tasked to replenish the revenue losses from the megablockbuster Humira, which just started to face its own U.S. biosimilar attack.

Also on Thursday, AbbVie announced that it’s pushing Rinvoq into phase 3 testing in systemic lupus erythematosus based on positive topline results from a phase 2 study. The phase 2 trial examined Rinvoq either alone or in combination with a BTK inhibitor called elsubrutinib.