Investigational MS Therapy Is Safe and Effective for Relapsing MS

Compared with intramuscular interferon β-1a, the investigational therapy known as RPC-1063 yields a significantly lower relapse rate among individuals with relapsing multiple sclerosis (MS) treated for at least 12 months, according to results of the phase 3 SUNBEAM study.

To evaluate the safety and efficacy of RPC-1063 among patients with relapsing MS, the researchers conducted the SUNBEAM trial in 152 academic medical centers and clinical practices across 20 countries. Between December 18, 2014, and November 12, 2015, 1346 participants aged 18 to 55 years with relapsing MS were enrolled. 

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The participants had to have a baseline expanded disability status scale score of 0.0 to 5.0 and either at least 1 relapse within the 12 months before screening or at least 1 relapse within 24 months plus at least 1 gadolinium-enhancing lesion within 12 months before screening.

Participants were randomly assigned to receive either oral RPC-1063, 1.0 mg (n=451), or oral RPC-1063, 0.5 mg (n=451), once daily or weekly interferon intramuscular β-1a, 30 μg (n=448). In all, 29 participants in the RPC-1063, 1.0 mg, group; 26 in the RPC-1063, 0.5 mg, group; and 36 in the interferon β-1a group discontinued the study drug.

Few participants in either RPC-1063 group discontinued treatment due to adverse events, and no first-dose clinically significant bradycardia or second- or third-degree atrioventricular block was reported. Furthermore, the incidence of serious adverse events was low and similar across treatment groups. Finally, no serious opportunistic infections occurred in participants who received RPC-1063.

Among the intention-to-treat population, the researchers assessed for the primary endpoint of the annualized relapse rate during the treatment period.

According to the researchers, the adjusted annualized relapse rates were 0.35 for interferon β-1a; 0.18 for RPC-1063, 1.0 mg; and 0.24 for RPC-1063, 0.5 mg. The rate ratio of RPC-1063, 1.0 mg, vs interferon β-1a was 0.52, and the rate ratio of RPC-1063, 5.0 mg, vs interferon β-1a was 0.69.

Safety was assessed in all participants according to the highest dose of RPC-1063 received. 

“In participants with relapsing multiple sclerosis treated for at least 12 months, RPC-1063 was well tolerated and demonstrated a significantly lower relapse rate than interferon β-1a,” the researchers concluded. “These findings provide support for RPC-1063 as an oral therapy for individuals with relapsing multiple sclerosis.”

—Colleen Murphy

Reference:

Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of [RPC-1063] versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009-1020. https://doi.org/10.1016/S1474-4422(19)30239-X.