Rituximab Bests Commonly Used Drugs in Newly Diagnosed MS
By Megan Brooks
NEW YORK (Reuters Health) - As initial therapy for relapsing-remitting multiple sclerosis, rituximab works better than commonly used disease-modifying treatments (DMTs), hint results of a comparative real-world effectiveness study from Sweden.
Patients treated initially with rituximab had lower clinical relapses and neuroradiologic disease activity and were more apt to continue the drug than those treated with MS-labeled DMTs, Dr. Fredrik Piehl from Karolinska Institute in Stockholm and colleagues report in JAMA Neurology, online January 8.
“The results were striking,” Dr. Piehl noted in a telephone interview.
“If you go through the list of all our MS medications, what we call platform therapies, their efficacy is pretty modest and many patients complain about side effects, and often after a couple of years we see that many patients stop treatment. Rituximab outperforms most labeled MS drugs we have,” Dr. Piehl said.
“Off-label use of rituximab in patients with MS has increased considerably in Sweden but with large regional differences,” the researchers note in their paper. They used these regional differences to compare outcomes for MS patients initiating DMT in Stockholm, a county using a traditional escalating strategy, with Vasterbotten, where rituximab is more commonly used upfront.
The total cohort included 494 patients (median age, 34; 68% women). Of the 442 patients from Stockholm, 78 (18%) received rituximab as initial therapy. Of the 52 patients from Vasterbotten, 42 (81%) received rituximab upfront.
Drug discontinuation rates were lower with rituximab (6%) than with injectable DMTs (interferons, glatiramer acetate, 81%), dimethyl fumarate (37%), fingolimod (47%) and natalizumab (48%). Rates of clinical relapse also were lower with rituximab (5%) than with the other agents (27%, 12%, 18% and 20%, respectively), as were rates of neuroradiologic disease activity and adverse events.
Vasterbotten County, where rituximab was used as initial treatment in the majority of patients, had “better outcomes in most measured variables,” the researchers report. In Sweden, all DMTs are covered by the national public health insurance, including off-label medications.
“Our results demonstrate that a traditional treatment approach, including novel oral treatment options, is associated with a relatively poor medium term performance,” the investigators report. “In most cases, the reason to switch was breakthrough disease activity manifested as clinical relapses and/or active inflammation on MRI, with the second most common reason being side effects. John Cunningham virus serology results were the most frequent cause to interrupt natalizumab treatment.”
“In my mind,” said Dr. Piehl, “there are three aspects you would like to see from an MS treatment. It should be effective, safe and have a good tolerability profile. I think we have overlooked the tolerability issue. Drug survival, the proportion of patients who stay on treatment, is fairly lousy with our traditional frontline treatments.”
He noted that the study was not randomized, “but there is a strength in the study in that we used a cohort from northern Sweden, where most patients were offered rituximab firstline; whereas we in Stockholm used a more traditional approach, although we've seen an increase in rituximab use over the last few years of the inclusion period.”
Given their findings, rituximab “can be considered an option for treatment-naive patients with relapsing-remitting multiple sclerosis,” the investigators conclude.
The study had no commercial funding. Three authors reported financial relationships with manufacturers of MS medications, including Biogen and Novartis.
JAMA Neurol 2018.
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