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Safety, efficacy shown in RA patients in mavrilimumab phase 2 trial

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Mavrilimumab inhibited macrophage activation and survival by blocking granulocyte-macrophage colony-stimulating factor receptor-alpha in rheumatoid arthritis patients with swollen joints who were treated with methotrexate, according to data presented at the American College of Rheumatology Annual Meeting.

Researchers studied 326 patients aged 18 years to 80 years of age (mean age 51.8 years; 86.5% female) who inadequately responded to methotrexate. In the phase 2b randomized, double-blind, multicenter trial, patients received either 30-mg, 100-mg or 150-mg subcutaneous mavrilimumab or a placebo for 24 weeks in addition to receiving methotrexate ranging from 7.5 mg to 25 mg per week. Patients were evaluated based on DAS28-CRP (day 1 to week 12) and ACR20 response rate at week 24. Adverse events were recorded.

Patients showed a statistically significant change in DAS28-CRP at week 12 for all doses of mavrilimumab vs. placebo. As early as the first week, the researchers found that a 150-mg dosage of mavrilimumab was associated with higher ACR50 and ACR70 response rates.

At week 24, a significant number of patients treated with mavrilimumab met the ACR20 co-primary endpoint compared to the placebo group. Adverse events included headache (2.5% in placebo and 6.2% to 7.6% among mavrilimumab recipients), nasopharingitis (7.4% placebo, 3.5% to 7.6% among recipients) and bronchitis (7.4% among placebo group, 1.2% to 5.7% among recipients). Two patients reported pneumonia — one patient in the placebo group and one patient receiving 30 mg of mavrilimumab. No dose-related relationships were shown and no deaths or anaphylaxis events were reported.

Researchers found that nonresponders were more likely to drop out of the trial, but there was no change in the dropout pattern for patients who received the 150mg dose.

References:

Burmester G. Paper #2821.

Kremer J. Paper #1485.

McInnes I. Paper #1486.

Wu C. Paper #1496.

All presented at: American College of Rheumatology Annual Meeting, Nov. 14 -19, 2014; Boston.

Disclosures: See the meeting abstracts for the authors’ full disclosure information.