Phase 3 Trial Finds Kevzara Superior to Humira, and Just as Safe, in Treating Rheumatoid Arthritis

Phase 3 Trial Finds Kevzara Superior to Humira, and Just as Safe, in Treating Rheumatoid Arthritis

The drug Kevzara (sarilumab) is more effective than Humira (adalimumab) — and just as safe — in treating rheumatoid arthritis (RA) in patients who cannot tolerate or don’t respond to methotrexate (MTX) treatment, concludes MONARCH (NCT02332590), which tested both drugs in a randomized, double-blind, parallel-group Phase 3 trial.

The study, “Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial,” appeared in the journal Annals of the Rheumatic Diseases.

Both Kevzara and Humira arebiological disease-modifying antirheumatic drugs (bDMARDs) — biological agents that reduce the rate of damage to bone and cartilage. Both target inflammatory cytokines, which are naturally occurring proteins that can promote inflammation in the body.

Kevzara is an investigational interleukin-6 receptor (IL-6R) antibody in development for the treatment of patients with RA. The U.S. Food and Drug Administration (FDA) has not yet approved this therapy, but Sanofi and Regeneron Pharmaceuticals have obtained approval for its use in Canada and the approval process is underway in EuropeAbbvie’s Humira is a FDA-approved tumor necrosis factor (TNF) blocker.

The study included 369 patients with RA who either did not tolerate or did not respond to MTX. It included 86 study centers in Europe, Israel, Russia, South Africa, South America, South Korea and the United States. A total of 185 patients received Humira and 184 received Kevzara. The subjects were treated with one of the two drugs for 24 weeks. The first patient was enrolled in February 2015 and the last patient completed the study in January 2016.

Kevzara was found to be superior to Humira concerning the change in DAS28-ESR (a measure of RA severity using clinical and laboratory data), with a score of −3.28 for Kevzara and a score of −2.20 for Humira. Kevzara-treated patients also achieved significantly higher American College of Rheumatology 20/50/70 response rates (how many subjects showed 20, 50, or 70 percent improvement in tender or swollen joint counts), with Kevzara-treated patients achieving scores of 71.7%/45.7%/23.4% and Humira-treated patients scoring 58.4%/29.7%/11.9%.

At week 24, 7.1 percent of patients receiving Kevzara showed remission, compared to 2.7 percent of those on Humira, as measured by the Clinical Disease Activity Index. Researchers also observed low disease activity in 41.8 percent of Kevzara-treated patients, compared to 24.9 percent of Humira-treated patients.

Adverse events were similar in the two groups: 63.6 percent in the group that received Humira and 64.1 percent in the Kevzara-treated group. The most common such events were neutropenia (low white blood cell count) and injection site reactions with Kevzara, and headache and worsening RA with Humira. Infections were reported in 28.8 percent of Kevzara-treated patients and 27.7 percent of those on Humira, while serious infections occurred in 1.1 percent of both groups.

“Collectively, these data demonstrate that sarilumab improves signs and symptoms and functional disability of RA and is an appropriate, effective and superior monotherapy compared with TNF-α inhibition for patients who are unsuitable candidates for continued treatment with MTX due to intolerance or inadequate response,” the authors concluded.

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