Background GO-MORE Trial investigated the use of Golimumab (GLM) in rheumatoid arthritis (RA) in 3280 patients worldwide . At present, the burden of arthritis is greater in poorer countries than in developed countries due to socioeconomic disparities , thus suggesting the usefulness of subgroup investigations.
Objectives We evaluated the GLM as add-on therapy for RA patients in the Italian cohort of GO-MORE trial and we compared the baseline characteristics and efficacy after 6 months between Italian patients and the enrolled patients worldwide. A limit of these analyses is that they are post hoc in nature and many tests were performed without adjustments for multiplicity.
Methods Ninety-eight Italian patients with active RA, fulfilling the 1987 ACR criteria, naïve for biologic drugs were enrolled. Statistical analyses were performed to assess: i. the differences in baseline characteristics; ii. the efficacy after 6 months; between Italian and Rest of the World GO-MORE populations.
Results The majority of Italian patients were older than the worldwide patients (p=0.01). Compared to Rest of the World population, Italian patients showed a lower value of DAS28-ESR (p=0.045), DAS28-CRP (p=0.0001), and a significantly short disease duration (≤2 years) (p=0.045). Differently from the Rest of the World patients, the large majority of Italian patients received biologic therapy after the failure of the first sDMARD (p<0.0001). Furthermore, a lower percentage of Italian patients were treated by high MTX dosage (p<0.0001). After 6 months of GLM treatment, the therapeutic response of the Italian patients did not differ from those observed in Rest of the World cohort. More than 90% of patients reported that the overall autoinjection experience was favourable and these results mirrored those observed worldwide .
Conclusions The analysis of the Italian GO-MORE subset confirms that differences among patients may be shown, depending from different approaches in different health systems. The Italian cohort (early onset of the disease and already fulfilling the 1987 ACR criteria) is probably affected by a more severe disease with poor outcome , but the efficacy in this subset response rate of Italian subset did not differ from worldwide patients. GLM in the Italian patients showed a favourable benefit/risk profile and the positive autoinjection experience may help for patient's compliance and survival of the treatment.
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Disclosure of Interest R. Giacomelli Grant/research support from: RG has received a grant from MSD for educational purpose, P. Ruscitti: None declared, V. Liakouli: None declared, P. Cipriani: None declared, M. Mecchia Employee of: MM is an employee of MSD Italy