Burmester, Gerd R.;
McInnes, Iain B.;
Kremer, Joel M.;
Miranda, Pedro;
Vencovský, Jiří;
Godwood, Alex;
Albulescu, Marius;
Michaels, M. Alex;
Guo, Xiang;
Close, David;
Weinblatt, Michael
Mavrilimumab, a Fully Human Granulocyte–Macrophage Colony‐Stimulating Factor Receptor α Monoclonal Antibody : Long‐Term Safety and Efficacy in Patients With Rheumatoid Arthritis
: Long‐Term Safety and Efficacy in Patients With Rheumatoid Arthritis
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Medientyp:
E-Artikel
Titel:
Mavrilimumab, a Fully Human Granulocyte–Macrophage Colony‐Stimulating Factor Receptor α Monoclonal Antibody : Long‐Term Safety and Efficacy in Patients With Rheumatoid Arthritis
:
Long‐Term Safety and Efficacy in Patients With Rheumatoid Arthritis
Beteiligte:
Burmester, Gerd R.;
McInnes, Iain B.;
Kremer, Joel M.;
Miranda, Pedro;
Vencovský, Jiří;
Godwood, Alex;
Albulescu, Marius;
Michaels, M. Alex;
Guo, Xiang;
Close, David;
Weinblatt, Michael
Beschreibung:
<jats:sec><jats:title>Objective</jats:title><jats:p>Mavrilimumab, a human monoclonal antibody, targets granulocyte–macrophage colony‐stimulating factor receptor α. We undertook to determine the long‐term safety and efficacy of mavrilimumab in rheumatoid arthritis patients in 2 phase <jats:styled-content style="fixed-case">II</jats:styled-content>b studies (1071 and 1107) and in 1 open‐label extension study (ClinicalTrials.gov identifier: <jats:styled-content style="fixed-case">NCT</jats:styled-content>01712399).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In study 1071, patients with an inadequate response to disease‐modifying antirheumatic drugs (<jats:styled-content style="fixed-case">DMARD</jats:styled-content>s) received mavrilimumab (30, 100, or 150 mg) or placebo every other week plus methotrexate. In study 1107, patients with an inadequate response to anti–tumor necrosis factor agents and/or <jats:styled-content style="fixed-case">DMARD</jats:styled-content>s received 100 mg mavrilimumab every other week or 50 mg golimumab every 4 weeks plus methotrexate. Patients entering the open‐label extension study received 100 mg mavrilimumab every other week plus methotrexate. Long‐term safety and efficacy of mavrilimumab were assessed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 442 patients received mavrilimumab (14 of 245 patients from study 1071, 9 of 70 patients from study 1107, and 52 of 397 patients from the open‐label extension study discontinued mavrilimumab treatment throughout the studies). The cumulative safety exposure was 899 patient‐years; the median duration of mavrilimumab treatment was 2.5 years (range 0.1–3.3 years). The most common treatment‐emergent adverse events (<jats:styled-content style="fixed-case">AE</jats:styled-content>s) were nasopharyngitis (n = 69; 7.68 per 100 patient‐years) and bronchitis (n = 51; 5.68 per 100 patient‐years). At weeks 74 and 104, 3.5% and 6.2% of patients, respectively, demonstrated reduction in forced expiratory volume in 1 second, while 2.9% and 3.4% of patients, respectively, demonstrated reduction in forced vital capacity (>20% reduction from baseline to <80% predicted). Most pulmonary changes were transient and only infrequently associated with <jats:styled-content style="fixed-case">AE</jats:styled-content>s. Mavrilimumab at 100 mg every other week demonstrated sustained efficacy; at week 122, 65.0% of patients achieved a Disease Activity Score in 28 joints using the C‐reactive protein level (<jats:styled-content style="fixed-case">DAS</jats:styled-content>28‐<jats:styled-content style="fixed-case">CRP</jats:styled-content>) of <3.2, and 40.6% of patients achieved a <jats:styled-content style="fixed-case">DAS</jats:styled-content>28‐<jats:styled-content style="fixed-case">CRP</jats:styled-content> of <2.6.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Long‐term treatment with mavrilimumab maintained response and was well‐tolerated with no increased incidence of treatment‐emergent <jats:styled-content style="fixed-case">AE</jats:styled-content>s. Safety data were comparable with those from both phase <jats:styled-content style="fixed-case">II</jats:styled-content>b qualifying studies.</jats:p></jats:sec>