Conference Coverage
Preliminary results promising from ublituximab phase II study for MS
NEW ORLEANS – The investigative agent ublituximab was well tolerated and demonstrated rapid B-cell depletion in relapsing multiple sclerosis.
Rituximab was associated with a lower drug discontinuation rate versus all other commonly prescribed disease-modifying treatments (DMTs) used as initial therapy for relapsing-remitting multiple sclerosis (RRMS) in a retrospective study of patient data from a Swedish multiple sclerosis registry.
In addition, relapse rates were lower with rituximab (Rituxan) than they were with injectable DMTs and dimethyl fumarate (Tecfidera), according to results of the study, which appeared online Jan. 8 in JAMA Neurology.
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Anti-CD20 agents such as rituximab are “likely to become an additional treatment option” for RRMS, and off-label use of rituximab for this indication has “increased considerably” in Sweden in recent years, the investigators said. RRMS is not an approved indication for rituximab in the United States, whereas across Sweden “there is no difference in reimbursement policy ... because all DMTs are covered by the national health insurance, including off-label medications.”
The addition of new DMTs for RRMS has changed the treatment landscape recently, although in real-world practice, there is a lack of “detailed knowledge about how to tailor therapy,” the authors said. They noted that the majority of patients discontinue traditional first-line treatment with injectable DMTs (that is, interferon beta and glatiramer acetate) within 2 years, suggesting a need for better treatment options.
To evaluate the real-world effectiveness of rituximab in this setting, Dr. Granqvist and his colleagues selected patient registry data for two Swedish counties that 494 included who received a diagnosis of RRMS between January 1, 2012, and October 31, 2015.
The largest subset of patients (n = 215) received injectable DMTs, while the rest received rituximab (n = 120), dimethyl fumarate (n = 86), natalizumab (Tysabri; n = 50), fingolimod (Gilenya; n = 17), or another treatment (n = 6), according to data in the report.
The proportion of patients who stayed on treatment was significantly higher for rituximab versus all other DMTs, study authors found. Compared with rituximab, the hazard ratios for drug discontinuation after adjusting for covariates and propensity score were 11.4 (95% confidence interval, 4.7-27.4) for injectable DMTs, 15.1 (95% CI, 3.9-58.0) for dimethyl fumarate, 5.9 (95% CI, 1.5-23.4) for fingolimod, and 11.3 (95% CI 3.2-39.4) for natalizumab.
Rituximab-treated patients also had lower rates of clinical relapse, neuroradiologic disease activity, and adverse events, compared with injectable DMTs or dimethyl fumarate, according to the investigators.
In comparison with fingolimod and natalizumab, relapse rates and gadolinium-enhancing lesions with rituximab were less frequent, but the authors said those differences did not reach statistical significance in all analyses.
The study was funded by the Swedish Medical Research Council, among other sources. Study authors reported conflicts of interest related to Biogen, Novartis, and Genzyme.
SOURCE: Granqvist M et al. JAMA Neurol. 2018 Jan 8. doi: 10.1001/jamaneurol.2017.4011
