Newer disease-modifying treatments for multiple sclerosis (MS) are effective but also known to carry a greater risk of infections in a patient group already more likely to be troubled by infections — and this higher risk is particularly evident in treatment with rituximab, a DMT often used off-label in Sweden, a nationwide study into its use reports.
The study “Infection Risks Among Patients With Multiple Sclerosis Treated With Fingolimod, Natalizumab, Rituximab, and Injectable Therapies” was published in the journal Jama Neurology.
Compared to the public at large, MS patients are thought to be at an increased risk of infections, because disease-modifying therapies used to lower relapse rates act by dampening the immune system. Although helpful, such therapies can raise a risk of subsequent infections.
Evidence suggests that treatment with first-generation DMTs, such as beta-interferon (sold as Avonex and Rebif, among others) or glatiramer acetate (Copaxone and its generic, Glatopa), do not raise this infection risk further. In contrast, newer, second-generation DMTs are linked to a greater infection risk. These DMTs include Tysabri (natalizumab) and Gilenya (fingolimod).
However, “the magnitude of potential risk increase is not well established in real-world populations,” the researchers wrote, as this evidence has largely been gathered in clinical trials.
Moreover, few data are available regarding the risk of infection with rituximab, an engineered antibody developed by Roche to specifically target the cell surface protein CD20 often found in immune B-cells. Rituximab is sold under the brand name Rituxan in the U.S. and MabThera in Europe, among others, approved largely to treat certain blood cancers. It is used off-label in MS, meaning it is not approved specifically for this disease.
Researchers in Sweden performed a nationwide observational study to better determine actual infection rates among Swedish MS patients being treated with rituximab, Tysabri, Gilenya, Copaxone, and interferon beta.
They analyzed data from relapsing-remitting MS (RRMS) patients registered in the Swedish MS register (SMSreg), treated between 2011 and 2017. SMSreg covers approximately 80% of all MS patients in Sweden. As controls, researchers evaluated five people without MS for each patient they studied, all matched for age, sex, and region.
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