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AbbVie’s Rinvoq notches Crohn’s disease win amid classwide JAK safety concerns

AbbVie’s blockbuster hopeful Rinvoq notched a win in a tricky-to-treat group of Crohn’s disease patients, potentially adding another arrow to the company’s post-Humira quiver.

The JAK inhibitor helped a “significantly” greater proportion of patients achieve clinical remission and endoscopic response than placebo did, phase 3 data from the company’s U-EXCEED study show. The trial studied the AbbVie drug in certain patients with moderate-to-severe Crohn’s disease, and the results came after 12 weeks of treatment with the medicine or placebo.

AbbVie expects to submit its Rinvoq application for Crohn’s disease in 2022. If Rinvoq passes muster at the FDA, it would become the first JAK inhibitor approved for the disease, opening the door to some $1.3 billion in peak Crohn’s disease sales by 2030, Datamonitor Healthcare predicts (PDF).

In the U-EXCEED study, investigators measured clinical remission using the Crohn’s Disease Activity Index (CDAI), plus patient-reported symptoms of stool frequency and abdominal pain (SF/AP). After a dozen weeks, 39% percent of patients who received the daily dose of Rinvoq 45 mg achieved clinical remission on the CDAI, versus 21% of placebo patients. Similar results were drawn from patient responses, too, with 40% of Rinvoq patients hitting remission per SF/AP, compared to 14% in the control arm.

Investigators also measured patient improvement in the intestinal mucosa by endoscopy. At 12 weeks, 35% of Rinvoq patients achieved endoscopic response, versus 4% in the placebo cohort.

Rinvoq’s wins didn’t stop there: Among patients taking corticosteroids at the trial’s start, significantly more on the JAK inhibitor achieved steroid-free clinical remission per CDAI and SF/AP versus those on placebo, AbbVie said.

AbbVie’s study enrolled moderate to severe Crohn’s disease patients who had an inadequate response or who couldn’t tolerate biologic treatments. More than 60% of patients in the trial had previously tried and failed on two or more biologics, AbbVie noted.

As the company’s best-selling drug Humira inches toward a 2023 patent cliff, AbbVie has pinned its growth hopes on its next-gen offerings Rinvoq and the IL-23 inhibitor Skyrizi. Still, Rinvoq’s fate—and that of its oral JAK inhibitor classmates—remains in flux, thanks to recent classwide safety warnings and restrictions.

The FDA this week updated the labels for AbbVie’s Rinvoq, Pfizer’s Xeljanz and Eli Lilly’s Olumiant to include safety warnings about serious heart-related side effects and cancer risks.

Importantly, the update includes a caveat that the drugs can only be used in patients who can’t tolerate or don’t respond well to classic TNF inhibitors like AbbVie’s Humira. For its Crohn’s trial, AbbVie is already studying Rinvoq in this specific patient population.

Safety in U-EXCEED was on par with Rinvoq’s other studies, with no new risks cropping up, AbbVie said.

AbbVie is expecting annual sales of about $8 billion for Rinvoq by 2025. The drug generated $453 million in the third quarter, and it amassed around $1.13 billion in worldwide sales for the first nine months of the year, placing it comfortably within the bounds of blockbuster territory.