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

Abstract

Objectives: To 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.

Methods: GO-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.

Results: 3366 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.

Conclusions: Add-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.

Trial registration: ClinicalTrials.gov NCT00975130.

Keywords: DMARDs (biologic); Methotrexate; Rheumatoid Arthritis.

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Figures

Figure 1

Study design of GO-MORE parts 1 and 2 (A) and details of part 2 (B). DAS28, 28-joint disease activity score; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; GLM, golimumab; IV, intravenous; IV golimumab2, IV golimumab 2 mg/kg; SC, subcutaneous. aA flare was defined as DAS28–ESR of 2.6 or greater (not retaining remission).

Figure 2

Patient disposition. GLM, golimumab; IV, intravenous; SC, subcutaneous.

Figure 3

Response to golimumab treatment over 6 months in part 1: percentage of patients with good or moderate EULAR response (A),a percentage of patients who achieved good or moderate EULAR DAS28 response by the number of previously failed DMARDs (B), percentage of patients who achieved good or moderate EULAR DAS28 response by concomitant methotrexate dose (C), and percentage of patients who achieved low disease activity or remission (D).b DAS28, 28-joint disease activity score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; GLM, golimumab; MTX, methotrexate. aA good or moderate response was defined as DAS28–ESR improvement of more than 1.2 from any baseline score or an improvement of 0.6–1.2 from a baseline score of 5.1 or less. bLow disease activity was defined as DAS28–ESR of ≤3.2. Remission was defined as DAS28–ESR of less than 2.6.

Figure 4

Percentage of patients with DAS28–ESR remission by treatment group in part 2. DAS28, 28-joint disease activity score; ESR, erythrocyte sedimentation rate; GLM, golimumab; IV, intravenous; SC, subcutaneous.