Background The treatment of rheumatoid arthritis (RA) has been transformed by the development of novel agents targeting biological factors. The idea of “treat to target” has emerged. Early aggressive treatment with methotrexate (MTX) and tumor necrosis factor inhibitors can lead to clinical, radiological and even functional remission in a large proportion of patients with RA. However, there is a population of patients with RA who cannot be treated with MTX. A few clinical studies have reported the efficacy of GLM 100 mg/4 weeks as monotherapy. However, few papers have so far compared GLM 50 mg/4 weeks plus MTX with GLM 100 mg/4 weeks monotherapy.
Objectives The aim of this study was to compare GLM 50 mg/4 weeks plus MTX with GLM 100 mg/4 weeks monotherapy in patients with RA.
Methods The subjects were 115 RA patients (92 females; 23 males) who started receiving GLM treatment after September 2011 at Gunma University Hospital and four other institutes (the Gunma Rheumatoid Arthritis Network: GRN). The mean age (range) of the patients was 64 years (17–87), and the mean disease duration was 10 years (0.6–48). Seventy-two of the 114 patients were bio-naïve patients. Eighty-three patients received GLM 50 mg/4 weeks plus MTX (C group) and 32 patients received GLM 100 mg/4 weeks as monotherapy (M group). The mean MTX dosage in the GLM 50 mg/4 weeks plus MTX group was 7.9 mg/week. The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, matrix metalloproteinase-3 (MMP-3) level, the swollen and tender joint counts and the disease activity score in 28 joints using the ESR (DAS28-ESR) were examined at baseline and six months later. The remission rate and continuation rates at six months were also examined.
Results The age was significantly higher and the disease duration was significant longer in the M group, however, there were no significant differences in the serum markers or disease activity between the groups at baseline. Additionally, there were also no significant differences in the serum markers or disease activity of the two groups at six months after treatment. The DAS28-ESR remission (DAS28-ESR <2.6) rate was 38% in the C group and 21% in the M group. The continuation rate of GLM at six months was 80% in the C group and 84% in the M group.
Conclusions In this study, monotherapy improved the disease activity and as well as the combination therapy. These results suggest that GLM 100 mg/4 weeks monotherapy can have a sufficient therapeutic effect in RA patients who cannot use MTX.
Smolen, JS., et al. FGolimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009.
Takeuchi T. et al. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis. 2013.
Disclosure of Interest : None declared