多发性硬化症新药奥扎莫德有多厉害？

Ulcerative colitis (UC) is a chronic non-specific inflammatory disease of the colon and rectum whose cause is not yet fully understood. The lesions are limited to the large intestinal mucosa and submucosa. The lesions are mostly located in the sigmoid colon and rectum, but can also extend to the descending colon or even the entire colon3. The course of the disease is long and the disease often relapses. This disease occurs at any age, but is most common in those in their 20s and 30s. Its occurrence mechanism may be related to a variety of factors and has the characteristics of multi-level and multi-target points. Developed by Receptos, it was acquired by Celgene of the United States for 7.2 billion in 2015. Multiple sclerosis is its main indication, but at the same time, the drug also has very good effects on ulcerative colitis.

In 2016, Celgene published the 2-year Phase II clinical data of Ozamod. In patients with relapsing multiple sclerosis, Ozamod can significantly reduce MRI damage activity and obtain a good safety guarantee within 24 weeks. It is an immunomodulator that acts on lymphocyte sphingosine-1-phosphate receptors S1PR-1 and S1PR-5.

TOUCHSTONE is a phase II, randomized, double-blind, placebo-controlled clinical trial. 197 patients with moderate to severe ulcerative colitis were enrolled and divided into the Ozamod 1 mg/d group (n=67), the 0.5 mg/d group (n=65) or the placebo group (n=65) for a total of 8 weeks. The primary endpoint was the proportion of patients in remission (Mucosal Histology Scale ≤ 2) at 8 weeks. The secondary endpoint is the proportion of patients with an effective response (mucosal histology score scale ≤3, rectal bleeding reduction and mucosal improvement, etc.). At 8 weeks, patients with a mucosal histology score of 2 achieved histological remission. After 8 weeks, effective patients entered the 32-week maintenance period and continued their original treatment. At 32 weeks, 31% of patients in the ozanimod 1 mg/d group achieved histological remission, 23% of patients in the 0.5 mg/d group achieved histological remission, and 8% of patients in the placebo group achieved histological remission, so the therapeutic effect of the administration group was significant.

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