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Author: Admin | 2025-04-28
Where they can cause inflammation. Velsipity is the second S1P modulator to gain FDA approval for treating ulcerative colitis. The first one, called Zeposia (ozanimod), was approved in 2021 to treat ulcerative colitis and relapsing forms of multiple sclerosis in adults. Efficacy and Safety of Velsipity A phase 3 trial tested the efficacy of a once-daily 2-milligram dose of Velsipity in patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Two-thirds of the participants had never taken a biologic or JAK inhibitor drug. After three months, 27% of patients on Velsipity went into clinical remission, compared to about 7% taking the placebo. After a year, the results were the same in the placebo group and increased to 32% in remission in the treatment group. Another three-month clinical trial yielded similar results to the first trial. Endoscopy showed that people taking the drug had less severe disease and higher mucosal healing, defined as the disappearance of ulcers and other lesions. Most of the side effects from Velsipity were mild, including headache, elevated liver tests, and worsening of ulcerative colitis. Because Velsipity is an anti-inflammatory medication, it can also hinder the immune system. Pfizer said patients may be more susceptible to infections in the five weeks after starting Velsipity. Longman noted that while the study showed that the drug works well for some people, the results were “lukewarm.” There wasn’t a massive difference in outcomes between the treatment and placebo groups. Still, he emphasized that Velsipity will be “very helpful” for some patients and that its approval gives providers another much-needed option for treating a notoriously difficult disease. Besides, as more data on Velsipity is published, providers may better understand how it can be used in combination with other therapies for
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