Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study

Abstract

ObjectivesTo evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission.MethodsGO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received add-on monthly 50-mg subcutaneous golimumab for 6 months. The percentage of patients with good/moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)–erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28–ESR remission was measured.Results3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6 years and mean DAS28–ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (∼25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population.ConclusionsAdd-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen.

The tumor necrosis factor-α inhibitor golimumab in the treatment of rheumatoid arthritis

“…Сравнение поз-волило установить, что по ответу по ACR20, ACR50, ACR70 препараты достоверно не различаются. Метаанализ показал (2,55,6,85) 3,324 (1,71,6,47) 4,736 (3,10,7,25) 8,901 (4,86,16,31) 4,904 (3,42,7,04) 6,393 (2,51,16,30) 5,541 (2,01,15,27) 7,027 (3,55,13,93) 10,240 (4,19,25,01) 7,20 (4,70,11,02) 7,404 (1,73,31,70) 4,051 (1,29,12,75) 13,500 (3,22,56,56) 10,75 (2,47,46,…”

“…Столь высокая привер-женность больных терапии ГЛМ обусловлена выраженно-стью эффекта, значительным улучшением качества жизни, а также, по-видимому, удобством использования инжек-торной иглы и возможностью самостоятельного проведе-ния инъекций 1 раз в месяц. В исследовании GO-MORE [47] сравнивали две формы ГЛМ: для подкожного введения (50 мг 1 раз в месяц) и для внутривенного введения (2 мг/кг 1 раз в месяц). В этом исследовании больные отвечали на вопрос, каково их впечатление от самостоятельных инъек-ций.…”

Efficacy of golimumab in Belgian patients with active rheumatoid arthritis despite treatment with non-biologic disease-modifying anti-rheumatic drugs: sub-analysis of the GO-MORE study

“…6 When used in combination with methotrexate, golimumab improves a variety of outcome measures, including disease activity index, patient-reported outcomes, and structural damage. 7 The GO-MORE study (NCT00975130), completed in 2011, 8 as an add-on therapy in biologic-naïve adults with active RA in a real-life clinical setting. GO-MORE was an open-label, multinational, multicenter, and prospective phase 3 trial that included patients who had active RA despite stable DMARD treatment for at least one month.…”

Long-term results of golimumab therapy for rheumatoid arthritis. Therapy compliance issues

“…Кроме того, проведено ма-ксимально приближенное к реальной клинической практи-ке открытое исследование эффективности и безопасности подкожного применения ГЛМ в дозе 50 мг один раз в месяц на фоне терапии БПВП (моно-и комбинированная тера-пия) ± глюкокортикоиды (ГК) у пациентов с РА без исполь-зования ГИБП в анамнезе (GO-MORE, часть 1) [14].…”

“…В исследовании GO-MORE [14] продемонстрирована равная эффективность ГЛМ при различных дозах МТ при сопутствующем его приеме, числе ранее неэффективных БПВП и у больных, получающих или не получающих ГК (рис. 1).…”