After Tysabri, Ocrevus Seen as Better Than Gilenya at Preventing Relapse
Ocrevus (ocrelizumab) may be more effective than Gilenya (fingolimod) at preventing relapse in relapsing-remitting multiple sclerosis (RRMS) patients who recently transitioned from Tysabri (natalizumab), according to a new study.
Ocrevus is “potentially a better exit strategy than [Gilenya] after [Tysabri] cessation, with an impressive reduction [in] risk of relapse,” the researchers wrote.
The study, “Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study,” was published in the Journal of Neurology.
RRMS is a form of multiple sclerosis (MS) characterized by cycles of new and exacerbated symptoms followed by periods of recovery. Symptoms result from an autoimmune response that targets myelin — the protective coating on nerve cells — leading to increased inflammation and damaged nerves.
Various RRMS treatments are available, and many patients switch between medications over time. The management of this switch is critical “because of a high risk of a return of disease activity,” the researchers wrote.
This is particularly important for therapies such as Biogen’s Tysabri and Novartis’ Gilenya, which prevent lymphocytes — a group of immune cells — from migrating to nerves and causing damage. About one-third of patients who stop Tysabri experience relapses, the researchers noted.
Since 2010, Gilenya has been the standard of care for preventing relapses in patients who stopped using Tysabri.
Ocrevus, Genentech’s MS therapy approved by the U.S. Food and Drug Administration (FDA) in 2017 and for the European Union in 2018, acts by destroying B-cells, a class of immune cells that wrongly target myelin in MS.
“This new drug may be a very good alternative to [Gilenya] but comparative data are needed on the treatment strategy after [Tysabri] cessation,” the researchers wrote.
Scientists in France used the European Database for Multiple Sclerosis (EDMUS) software to retrospectively analyze clinical data covering 102 RRMS patients in that country’s Alsace region given either Gilenya or Ocrevus between 2011 and 2019 within 42 days (six weeks) of Tysabri cessation.
Among patients who moved to Gilenya, 31.5% (17 out of 54) relapsed over the following year compared with 10.4% (five out of 48) who received Ocrevus, reflecting a threefold lower risk of relapse for Ocrevus compared with Gilenya, data showed.
In a multivariate analysis adjusted for age, sex, disease duration, and other clinical features, it was determined that the Ocrevus group had a 70.7% lower relapse rate compared with the Gilenya group. Median time to a relapse after stopping Tysabri did not significantly differ between the two groups (Gilenya, 160 days; Ocrevus, 125 days).
Average disability scores, measured by the expanded disability status scale (EDSS), was comparable across treatments. Among those who had a relapse within the first year after Tysabri cessation, 29.4% (five out of 17) of Gilenya-treated patients and 0% (zero out of five) of Ocrevus patients exhibited EDSS worsening.
New T2 lesions — a measure of disease progression, seen on MRI scans taken after stopping Tysabri — were observed in 16.7% of Gilenya-treated patients (five of 30) and 0% of those on Ocrevus (none of 33 patients). After one year, new T2 lesions were found in 16.7% of the Gilenya group (four of 24) and 5.3% of the Ocrevus group (one of 19).
Evidence of disease activity (EDA) — or the occurrence of at least one relapse, a worsening in EDSS, or new T2 lesions — was observed in 15.2% of Ocrevus-treated patients (five of 33) and 55.8% of Gilenya-treated patients (24 of 43) at one year post-Tysabri cessation.
Overall, “our study showed a superiority of [Ocrevus] to [Gilenya] as an exit strategy after [Tysabri] cessation,” the researchers wrote.
While both treatments suppress parts of the immune response, they act through different mechanisms. The difference in efficacy between them, “could be [explained] by an intrinsic superiority of [Ocrevus] to [Gilenya] on disease activity,” the researchers added.
The team noted that Ocrevus only became available in France in 2018, so not all participants had the same treatment options at the time they stopped using Tysabri, and considered this a study limitation. “These results will need to be confirmed in larger and longer studies,” the researchers wrote.
Recent evidence suggests that the immunosuppressive effects of Ocrevus and Gilenya can inhibit the effectiveness of the COVID-19 vaccine in people with MS. This may be one consideration for deciding when medication switches should occur.
“Vaccinations with inactivated vaccines (pneumococcal or hepatitis B) or COVID-19 vaccines should be done under [Tysabri] … to have better immunization than under [Gilenya] or [Ocrevus],” the researchers suggested.