AMSTERDAM, Netherlands — To say ulcerative colitis is no fun would be a serious understatement. A long-term condition characterized by inflammation of both the colon and rectum, millions of people currently live with ulcerative colitis — and the condition is only becoming more common. Even worse, current available treatments often fail to alleviate symptoms. On a more positive note, exciting new research out of Amsterdam reveals that there is a promising new drug that appears capable of effectively treating the chronic condition.
Clinical trials involving the new drug mirikizumab — available under the brand name Omvoh — doubled the rates of remission, to up to 50 percent among certain groups with the condition. Ulcerative colitis patients usually suffer from symptoms including bloody diarrhea, abdominal pain, anemia, and fatigue. For many people, the condition seriously interferes with quality of life. Current treatments don’t always prove effective, leaving patients with no other options besides undergoing surgery (colectomy) with a stoma or a pouch-construction. It’s also worth noting that chronic colon inflammation has also been linked to a higher cancer risk.
“There is still a high unmet need for safe and effective treatments for ulcerative colitis. This new medicine meets this need for an important proportion of patients,” says Geert D’Haens, lead author and Professor of Gastroenterology at Amsterdam UMC, in a media release.
Researchers from Amsterdam University Medical Centers identified Interleukin-23 as a key protein when it comes to triggering and maintaining gut inflammation, both in connection with Crohn’s disease and ulcerative colitis (and the chronic skin disease psoriasis). Prior research has shown that blocking interleukin-23 with specific therapeutic antibodies is highly effective for psoriasis and Crohn’s disease patients. Mirikizumab is the first of these antibodies to be tested for ulcerative colitis.
Over the past few years, a large number of scientists all over the world have performed two Phase 3 clinical trials aimed at assessing the safety and efficacy of mirikizumab among 1,281 adult ulcerative colitis patients living with moderate to severe inflammation. To facilitate comparisons, a “control group” of comparable ulcerative colitis patients was not treated with mirikizumab, instead being given a placebo.
Patients received either 300 mg of mirikizumab or a placebo (in a 3:1 ratio) through an infusion every four weeks for a total of 12 weeks (LUCENT-1 study). If patients responded well to the mirikizumab during those first 12 weeks (544 out of 1,281 patients), they were then placed in the LUCENT-2 study where they received 200 mg mirikizumab or a placebo (in a 2:1 ratio) through an injection every four weeks for another 40 weeks.
Patients who were treated with real mirikizumab were more likely to achieve clinical remission at both the end of the LUCENT-1 and LUCENT-2 studies in comparison to patients treated with placebos (LUCENT-1 24.2% vs. 13.3% and LUCENT-2 49.9% vs. 25.1%). Those taking mirikizumab also showed higher clinical response, endoscopic remission, and less bowel movement urgency. Importantly, researchers add that mirikizumab treatment appears quite safe. Adverse events or side-effects were no more common among the mirikizumab group than among those taking a placebo.
“If we combine these results together, we see that mirkizumab is an effective drug for those patients with moderately severe and severe forms of ulcerative colitis. We hope that it will be available as a treatment option in Europe this year,” Prof. D’Haens concludes.
The study is published in the New England Journal of Medicine.