Levilimab–methotrexate combination improves RA response rates
medwireNews: The addition of levilimab to methotrexate improves response rates among patients with rheumatoid arthritis (RA) who are resistant to methotrexate, show phase 3 SOLAR data presented in a poster at the EULAR 2021 Virtual Congress.
The study participants, who were enrolled from 21 clinical sites in Russia and Belarus, had an RA duration of at least 2 years and active disease despite taking stable methotrexate for the prior 12 weeks.
In total, 102 patients were randomly assigned to receive the anti-interleukin-6 antibody levilimab 162 mg subcutaneously once a week with methotrexate and 52 patients were given placebo with methotrexate.
By week 12, 71% of 99 patients in the levilimab group with available data achieved an ACR20 response, which was significantly greater than the 40% response rate among the 50 patients in the placebo group.
In addition, over half (52%) of the 102 patients given levilimab achieved low disease activity by week 24, with a DAS28-CRP score below 3.2 points, compared with 6% of the 52 patients given placebo, a significant difference.
Presenting researcher Maxim Korolev (Federal Research Center Institute of Cytology and Genetics, Novosibirsk, Russian Federation) explained that even in sensitivity analysis where all missing data for ACR20 responses were counted as nonresponses, levilimab was still associated with a significantly superior 12-week ACR20 response rate compared with placebo, at 69% versus 39%.
Secondary outcomes including changes in CDAI, SDAI, and HAQ-DI at week 24 all improved to a significantly greater degree on average for patients given levilimab versus those given placebo.
In terms of safety, 66.7% and 53.8% of levilimab- and placebo-treated patients, respectively, had a treatment-emergent adverse event (TEAE) of any grade, including one patient in each group who had a serious AE. The frequency of grade 3 to 5 TEAEs was a corresponding 14.7% and 1.9%.
In total, 4.9% and 1.9% of levilimab- and placebo-treated patients, respectively, discontinued treatment due to TEAEs or serious AEs, but no deaths were reported.
Korolev concluded: “The study confirmed superior efficacy of levilimab plus [methotrexate] over placebo plus [methotrexate] in subjects with [methotrexate] resistant active RA.”
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