Rituximab is a monoclonal antibody currently being investigated as a potential therapy for multiple sclerosis.

Rituximab is an approved treatment for various types of blood cancer, and is marketed under the name Rituxan (in the U.S.) and MabThera (in Europe).

How rituximab works

Rituximab is a monoclonal antibody (a protein designed to target and attach to a specific protein) that interferes with the growth and spread of leukemia and lymphoma cancer cells. It works by targeting thee CD20 antigen, a substance found on the surface of certain immune cells called B-cells. Rituximab binds to the antigen on the cell surface which activates B-cell death. Because B-cells contribute to myelin damage in multiple sclerosis, rituximab may be helpful for treating the disease.

Studies involving rituximab for RRMS

Early studies of rituximab in people with neuromyelitis optica (NCT00501748) tested the drug’s safety. Although preliminary results from a group of eight people with neuromyelitis optica showed that B-cell depletion may enhance neurological recovery from attacks, there is still no published data from this study.

Rituximab has undergone other clinical studies in patients with different types of MS.

A Phase 2 study (NCT00097188) evaluated the safety and effectiveness of rituximab in adults with remitting-relapsing multiple sclerosis  (RRMS). Participants showed reduced numbers of new brain lesions and a 50% reduction in relapses.

A Phase 2/3 study (NCT00087529) evaluated the safety and effectiveness of rituximab in adults with primary progressive multiple sclerosis (PPMS). This trial compared rituximab to a placebo. Though rituximab did not prove effective, it was safe for people with PPMS.

A study (NCT01212094) involving people with secondary progressive multiple sclerosis (SPMS) was terminated because cerebrospinal fluid biomarkers failed to reach the criteria for continuation. This trial included 27 people with SPMS who received rituximab injections intrathecally (into the spine).

There are no Phase 3 trials currently planned for rituximab in MS, though the drug is licensed for other diseases and is currently used off-label for MS. Off-label use of rituximab for MS has received positive response — the observed annualized relapse rate and MRI disease activity were low during rituximab treatment, providing evidence that it is a safe and effective treatment for MS for up to 2 years. The compiled data for the outcome of off-label rituximab use in MS patients has been analysed and published in the scientific journal, Neurology.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

 

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Newly Diagnosed MS Patients Stay Longer on Rituxan Than Other Therapies, Study Finds

Multiple sclerosis patients whose first treatment is Genentech’s Rituxan (rituximab) stay on it longer than other disease-modifying drugs that patients start with, a Swedish study reports.

When they stop taking Rituxan,  it usually isn’t for lack of effectiveness or side effects — the reasons that lead to the discontinuation of the other drugs, according to the Karolinska Institutet researchers.

They also said that patients on Rituxan have fewer relapses and fewer new brain lesions than those on other therapies. Brain lesions are areas where the myelin sheath that protects nerve cells has deteriorated.

The team wanted to explore differences in patients’ discontinuation of Rituxan, compared with other treatments. The study covered newly diagnosed relapsing-remitting MS patients in two counties in Sweden — Västerbotten and Stockholm.

Their work, “Comparative Effectiveness of Rituximab and Other Initial Treatment Choices for Multiple Sclerosis,” appeared in the journal JAMA Neurology.

The study covered 494 patients with relapsing-remmitting MS whose median age of 34.4 years.

Rituxan was neurologists’ drug of choice as a first-line treatment for patients in Västerbotten County, which is in northern Sweden. Eighty-one 81 percent of patients there were taking it.

In contrast, only 18 percent of patients in Stockholm County in the south were receiving Rituxan.

Treatments that other patients were taking included the injected drugs interferon beta and Copaxone (glatiramer acetate), Gilenya (fingolimod), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). Copaxone’s maker is Teva Neuroscience, Gilenya’s is Novartis, and Tecfidera and Tysabri’s is Biogen.

Patients taking Rituxan stayed on it significantly longer than other patients stuck with their drugs, researcher discovered. Among 120 patients treated with Rituxan, only seven quit during the four-year study period.

The main reason for discontinuation in four of the patients was pregnancy. One patient quit because their disease improved, and one because of side effects.

Researchers said patients on the injected therapies Tecfidera and Gilenya had the highest rates of discontinuing treatment due to their disease worsening or side effects. Thirty-eight percent stopped because their disease worsened and  28 percent because of side effects.

The main reason that Tysabri-treated patients quit was because tests showed they had John Cunningham virus. The virus is usually dormant. A compromised immune system can lead to it causing a lfe-threatening brain disease known as progressive multifocal leukoencephalopathy. A third of the patients on Tysabri tested positive for the virus.

Another finding was that increases in relapse rates and new brain lesions were more common in patients using treatments other than Rituxan.

In addition, patients taking injected therapies experienced mild side effects more often than those on Rituxan. Rates of moderate and severe adverse events were similar in the two groups.

“Collectively, our findings suggest that Rituximab performs better than other commonly used DMTs [disease-modifying drugs] in patients with newly diagnosed RRMS,” the researchers wrote.

While the study offered a glimpse of the effectiveness and safety of these drugs in a real-world setting, the team said more research of this kind is needed.