Rinvoq shows promise as a maintenance drug for ulcerative colitis – PharmaLive
AbbVieRinvoq (upadacitinib) was established 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.
In addition, all secondary endpoints of the study were met, including achievement of histologic-endoscopic mucosal improvement (HEMI) and clinical remission without corticosteroids 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 drug achieved endoscopic improvement at 52 weeks, compared with 14% of patients in the placebo group. In addition, 35% of patients receiving 15 mg Rinvoq and 49% of patients receiving the 30 mg dose achieved an IHE compared to 12% of patients in the placebo group.
In the phase III study, adult patients with moderate to severe ulcerative colitis who experienced a clinical response to treatment with Rinvoq after an eight-week study period of once-daily induction of 45 mg of the drug, were re-randomized to receive 15 mg or 30 mg of Rinvoq or placebo.
Dosage at these levels continued for one year. The full results of the phase III interview study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
Dr Michael Severino, president and vice-president of AbbVie, highlighted the difficulties of ulcerative colitis due to the unpredictable symptoms and frequent flare-ups that patients face. Severino said the company is encouraged by the Phase III results which show the potential of Rinvoq as a treatment option for patients with moderate to severe ulcerative colitis.
Ulcerative colitis is an inflammatory bowel disease that causes inflammation and long-lasting ulcers in the digestive tract. Symptoms usually 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 the signs and symptoms of the disease and cause remission, but there is no cure. Ulcerative colitis affects approximately 907,000 people in the United States.
Remo Panaccione, professor of medicine and director of the inflammatory bowel disease unit at the University of Calgary, said the results of the interview study demonstrate the potential of Rinvoq to help patients achieve improvements in clinical, endoscopic and histological results 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 considered by the company to be a potential successor to the successful drug Humira, which loses patent protection in 2023. Rinvoq was first approved as a treatment for rheumatoid arthritis in 2019. It also received regulatory approval for the treatment of active psoriatic arthritis and for the treatment of active ankylosing spondylitis (AS) in adult patients who responded inadequately to treatment. conventional. AbbVie has evaluated the drug for other indications of inflammatory diseases, including atopic dermatitis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu’s 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 United States Food and Drug Administration cited its ongoing review of Pfizer’s post-market study, ORAL Surveillance, evaluating Xeljanz (tofacitinib) in patients with rheumatoid arthritis as due to the delay in reviewing his additional new drug requests. .