Study Hints of Rituximab MS Benefit

Stuart SchlossmanMS Research Study and Reports

By John Gever, Deputy Managing Editor, MedPage Today

Published: June 03, 2013
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner


Most patients receiving off-label rituximab (Rituxan) for secondary progressive multiple sclerosis either improved or showed little further progression, according to results from a small retrospective study.
Among 25 patients with secondary progressive MS treated with rituximab, nine showed decreases in disability and 12 appeared to stabilize after receiving at least three cycles of rituximab given every 6 months, said Christopher Perrone, a fourth-year medical student at the University of Massachusetts Medical School in Worcester, Mass.
Compared with patients’ previous rates of disability progression before starting rituximab, as measured with the Expanded Disability Status Scale (EDSS), further progression appeared to slow markedly while on the drug, Perrone said at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
By the third cycle of rituximab treatment, mean EDSS scores were almost exactly equal to the mean 1 year before starting treatment.
Rituximab is an anti-CD20 monoclonal antibody drug approved for certain hematologic malignancies and for rheumatoid arthritis. It is sometimes used off-label in MS, but its effectiveness and optimal role have never been firmly established.
Perrone told MedPage Today that some patients with secondary progressive MS have been receiving the drug at his institution when they have exhausted other options. He noted that mitoxantrone is FDA-approved for secondary progressive MS but, like other immunosuppressant drugs used in the disorder, it is relatively toxic.
For the current study, he and colleagues at UMass examined records of 30 patients who had received rituximab after failing conventional MS drugs including interferon-beta and glatiramer acetate (Copaxone) as well other therapies such as methotrexate, cyclophosphamide, mycophenolate mofetil, and corticosteroids. Such agents are treatments of last resort in many other autoimmune diseases.
Some patients considered for the study had received natalizumab, but they did not meet all the study’s inclusion criteria and were therefore left out, Perrone said.
Patients in the cohort had shown significant declines in functional ability during the 2 years prior to starting rituximab, gaining about 0.5 EDSS points per year (increased EDSS scores reflect growing disability).
But after the first cycle of rituximab — 1-g intravenous infusions 2 weeks apart — the mean increase in EDSS over the following 6 months was less that 0.1 point. Mean progression after the second cycles was 0.05 points, Perrone reported.
By the time of the third cycle, analysis of each patient’s pretreatment rate of disability progression suggested that the cohort’s mean EDSS score would have reached about 6.2. Instead, it was about 5.6.

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