The risk of invasive cancer may be slightly higher in multiple sclerosis (MS) patients treated with Gilenya (fingolimod) compared with those treated with rituximab, and with people from the general population, a Swedish study suggests.
The study, “Cancer Risk for Fingolimod, Natalizumab, and Rituximab in MS Patients,” was published in the journal Annals of Neurology.
Disease-modifying therapies (DMTs) have revolutionized how MS disease is managed. The first DMTs, including interferon-beta (sold as Avonex and Rebif, among others), or glatiramer acetate (sold as Copaxone and its generic Glatopa) were introduced more than two decades ago.
Since then, newer and more effective DMTs have been launched. These include Gilenya, marketed by Novartis; Tysabri (natalizumab) by Biogen; and Roche’s rituximab, sold under the brand name Rituxan in the U.S. and MabThera in Europe. Of note, rituximab, an approved treatment for various types of blood cancer, is used as an off-label therapy in MS.
In Sweden, Gilenya, Tysabri, and rituximab are the most used DMTs both for initial stages and more aggressive forms of MS. However, unlike older therapies, studies on the long-term safety profile for newer DMTs are missing.
Thus, researchers in Sweden compared the risk of cancer in a large population of MS patients treated with rituximab, Gilenya, or Tysabri.
The team analyzed data from the Swedish nationwide MS registry, which contains information on MS therapies used, and crossed it with data from the Swedish Cancer Register, as well as other national healthcare and census registers. The data were collected between 2011 and 2017.
In total, the analysis included 6,136 MS patients with 7,477 treatment initiations — 4,187 for rituximab, 1,620 for Gilenya, and 1,670 for Tysabri. As controls, they included 37,801 people without MS from the general population, matched for age, sex, and location.
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