Mavrilimumab demonstrates long-term safety, efficacy in rheumatoid arthritis
Long-term treatment with mavrilimumab appears to yield clear and sustained benefits in measures of rheumatoid arthritis (RA) disease outcomes without raising new safety signals or evidence of clinically meaningful lung function deterioration, a study has found.
Researchers analysed data from two phase IIb studies (1071, 1107) and an open-label extension (OLE). In 1071, RA patients with disease-modifying antirheumatic drug (DMARD)-inadequate responses were given mavrilimumab 30, 100 or 150 mg or placebo every other week (eow), plus methotrexate. In 1107, patients with antitumour necrosis factor agent- and/or DMARD-inadequate responses received mavrilimumab 100 mg eow or golimumab 50 mg every 4 weeks, in addition to methotrexate. Patients who entered the OLE received mavrilimumab 100 mg eow plus methotrexate.
Overall, 442 patients received mavrilimumab. The cumulative safety exposure was 899 patient-years (PY), while the median duration of treatment was 2.5 years (range 0.1–3.3). Commonly reported treatment-emergent adverse events included nasopharyngitis (n=69; 7.68/100 PY) and bronchitis (n=51; 5.68/100 PY).
At weeks 74 and 104, 3.5 percent and 6.2 percent patients, respectively, showed a decline in forced expiratory volume in 1 second; and 2.9 percent and 3.4 percent, respectively, exhibited reduced forced vital capacity (>20% reduction from baseline to <80% predicted). Most changes in pulmonary parameters were temporary and infrequently associated with adverse events.
Mavrilimumab 100 mg eow demonstrated sustained efficacy, with 65.0 percent and 40.6 percent patients achieving Disease Activity Score 28–C-reactive protein <3.2 and <2.6, respectively, at week 122.
Mavrilimumab is a human monoclonal antibody that inhibits the granulocyte-macrophage colony-stimulating factor receptor alpha, reducing macrophage and neutrophil numbers and function in rheumatoid inflammatory lesions. [Ann Rheum Dis 2015;74:1924-1930; Arthritis Res Ther 2016;18:287]