RRMS

Zeposia was shown to be effective at reducing the number of relapses in two main studies involving a total of 2,666 patients with RRMS.

In the first study lasting over one year, the average number of relapses per year in patients treated with the standard dose of Zeposia was about half that in patients treated with another medicine, interferon beta-1a (0.18 versus 0.35 relapses).

In the second study, which lasted two years, patients treated with the standard dose of Zeposia had on average 0.17 relapses per year, compared with 0.28 for patients given interferon beta-1a.

Ulcerative colitis

One main study showed that Zeposia, taken together with aminosalicylates (anti-inflammatory medicines) and/or corticosteroids, was more effective than placebo (a dummy treatment) in producing or maintaining remission (a period when the disease is not active or causing noticeable symptoms) in adults with moderate to severe ulcerative colitis for whom standard treatment or treatment with biological agents did not work well enough or could not be used.

The study was divided into two parts lasting one year in total. One part involved 645 patients and studied the effect of initial (induction) treatment with Zeposia for 10 weeks. The other part involved 457 patients who had responded to the 10-week induction treatment and studied the effect of Zeposia as maintenance treatment for 42 weeks.

After induction treatment, around 18% (79 of 429) of the patients taking Zeposia had achieved remission compared with around 6% (13 of 216) of the patients taking placebo. After maintenance treatment, around 37% (85 of 230) of the patients taking Zeposia were in remission compared with 19% (42 of 227) of the patients taking placebo.