#ACTRIMS2018 – Relapsing MS Patients With Impaired Vision Improved on Ocrevus, Updated Trial Data Show
Ocrevus (ocrelizumab) improved vision among relapsing multiple sclerosis (MS) patients who participated in the Phase 3 clinical trials of the treatment, according to updated analyses recently presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018.
While Ocrevus-treated patients improved their ability to read low-contrast letters over the course of the two trials, people who received Rebif (interferon beta-1a) did not.
Laura J. Balcer, a neurologist at New York University Langone Medical Center, shared the data in a presentation titled, “Effect of Ocrelizumab on Visual Outcomes in Patients with Baseline Visual Impairment in the OPERA Studies in Relapsing Multiple Sclerosis.”
Balcer had earlier shared data on the visual outcomes of relapsing patients in the OPERA I and OPERA II Phase 3 clinical trials of Ocrevus (NCT01247324 and NCT01412333) at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, last year.
This time, her presentation focused only on patients who had visual impairment when they enrolled in the trials. Among a total of 1,656 participants, 375 of those treated with Ocrevus and 373 in the Rebif group had visual impairment.
Researchers tested vision using a low-contrast letter acuity test. The test is similar to an ordinary vision test, with letters of different sizes on a chart. But the low-contrast test uses gray letters — instead of black — on a white background. Researchers included charts with two shades of gray to test different contrast levels.
These tests can detect reduced visual function.
At the beginning of the trials, both groups performed in a similar manner — correctly identifying about 35 letters on a chart with somewhat higher contrast. After 96 weeks, those receiving Ocrevus identified on average 3.4 more letters, while Rebif-treated patients worsened by 0.5 letters — a significant difference, Balcer said.
Researchers tested vision every 12 weeks. At the end of the trials, they found that 39 percent more patients in the Ocrevus groups had a cumulative improvement of at least 10 letters, compared to those treated with Rebif. At this time, 26.4 percent of Ocrevus-treated patients improved 10 letters or more, compared to 19.8 percent in the Rebif group.
The difference between the groups for at least seven letters was 54 percent, with Ocrevus-treated patients performing better. Researchers believe that a seven-letter change is the minimal clinically important difference for the test.
Based on the results, researchers believe that the findings demonstrate Ocrevus’ ability to reverse visual impairment in relapsing MS.
The ACTRIMS Forum 2018 is being held in San Diego, California, Feb. 1–3.