AbbVie’s Rinvoq Shows Promise as Maintenance Drug for Ulcerative Colitis
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AbbVie’s Rinvoq (upadacitinib) hit the mark as a maintenance drug for ulcerative colitis in a Phase III study. The company said more patients treated with Rinvoq in the 52-week study achieved clinical remission compared to placebo.
Additionally, all secondary endpoints in the study were met, including the achievement of histologic-endoscopic mucosal improvement (HEMI) and corticosteroid-free clinical remission at one year, AbbVie said.
AbbVie noted that 49% of patients treated with 15 mg of Rinvoq and 62% of patients treated with 30 mg of the medication achieved endoscopic improvement at 52 weeks compared to 14% of patients in the placebo group. In addition, 35% of patients on 15 mg Rinvoq and 49% of patients on the 30 mg dose achieved HEMI compared to 12% of patients in the placebo group.
In the Phase III study, adult patients with moderate to severe ulcerative colitis who saw a clinical response to Rinvoq treatment following an eight-week study period of once-daily induction of 45 mg of the medication, were re-randomized to receive with 15mg or 30 mg of Rinvoq or placebo.
The dosing at these levels continued for one year. Full results from the Phase III maintenance study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
Dr. Michael Severino, president and vice chairman of AbbVie, pointed to the difficulties of ulcerative colitis due to the unpredictable symptoms and frequent flares that patients deal with. Severino said the company is encouraged by the Phase III results that show Rinvoq’s potential as a treatment option for patients with moderate to severe ulcerative colitis.
Ulcerative colitis is an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. Symptoms typically develop over time, but the discomfort can be debilitating and can sometimes lead to life-threatening complications, according to the Mayo Clinic. Some medications can reduce signs and symptoms of the disease and bring about remission, but there is no cure. Ulcerative colitis affects approximately 907,000 people in the United States.
Remo Panaccione, a professor of medicine and director of the Inflammatory Bowel Disease unit at the University of Calgary, said the results from the maintenance study demonstrate the potential of Rinvoq in helping patients achieve improvements in clinical, endoscopic, and histological outcomes at 52 weeks.
“This is promising news for the IBD community,” Panaccione said in a statement.
Rinvoq is a small molecule JAK inhibitor. It is seen by the company as a potential successor to blockbuster drug Humira, which loses patent protection in 2023. Rinvoq was first approved as a treatment for rheumatoid arthritis in 2019. It has also received regulatory approval for the treatment of active psoriatic arthritis and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. AbbVie has been assessing the medication in other inflammatory disease indications, including in atopic dermatitis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis.
Last week, the company announced a delay in potential approval for Rinvoq in active psoriatic arthritis and adults with active ankylosing spondylitis. In a brief note, AbbVie said the U.S. Food and Drug Administration cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating Xeljanz (tofacitinib) in patients with rheumatoid arthritis as a reason for delay of review for its supplemental New Drug Applications.
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