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Experimental antibody falls short of improving disease activity in RA

Key clinical point: A clinical trial of the experimental, humanized, anti-fractalkine monoclonal antibody E6011 in rheumatoid arthritis (RA) patients with insufficient response to methotrexate found no significant difference in achieving an ACR20 level of response at 12 weeks when compared with placebo.

Major finding: After 12 weeks, ACR20 response rates were 37.0% in the placebo group, compared with 39.3%, 48.1%, and 46.3% in the 100-mg, 200-mg, and 400/200-mg treatment groups, respectively. However, ACR20 response was significantly greater in the 200-mg and 400/200-mg groups at the secondary endpoint of 24 weeks (53.7% and 57.4%, respectively, vs. 35.2% with placebo).

Study details: The data come from a phase 2, double-blind, placebo-controlled study including 169 adults with rheumatoid arthritis who received E6011 at doses of 100 mg, 200 mg, a combination of 400 mg/200 mg, or a placebo at week 0, 1, and 2, then every 2 weeks for 24 weeks.

Disclosures: The study was supported by Eisai. Multiple authors disclosed financial relationships with Eisai and other pharmaceutical companies.

Citation:

Tanaka Y et al. Arthritis Rheumatol. 2020 Oct 10. doi: 10.1002/art.41555.