AB0328 What Could We Learn from The Sub-Analysis of A Single Nation Cohort in A Worldwide Study? Lesson from The Results Observed in The Italian Cohort of The GO-MORE Trial
Authors: R. Giacomelli, P. Ruscitti, V. Liakouli, P. Cipriani, M. Mecchia
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> GO-MORE Trial investigated the use of Golimumab (GLM) in rheumatoid arthritis (RA) in 3280 patients worldwide [1]. At present, the burden of arthritis is greater in poorer countries than in developed countries due to socioeconomic disparities [2], thus suggesting the usefulness of subgroup investigations. <h3>Objectives</h3> 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 <i>post hoc</i> in nature and many tests were performed without adjustments for multiplicity. <h3>Methods</h3> 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. <h3>Results</h3> 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&lt;0.0001). Furthermore, a lower percentage of Italian patients were treated by high MTX dosage (p&lt;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 [3]. <h3>Conclusions</h3> 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 [4], 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 patient9s compliance and survival of the treatment. <h3>References</h3> Combe B, et al. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study. Ann Rheum Dis. 2014;73:1477–86. Sokka T, et al. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries. Ann Rheum Dis. 2007;66:1491–6. Schulze-Koops H, et al.Factors influencing the patient evaluation of injection experience with the SmartJect autoinjector in rheumatoid arthritis. Clin Exp Rheumatol. 2015;33:201–8. Bykerk VP, et al. The Canadian Early Arthritis Cohort (CATCH): patients with new-onset synovitis meeting the 2010 ACR/EULAR classification criteria but not the 1987 ACR classification criteria present with less severe disease activity. J Rheumatol. 2012;39:2071–80. <h3>Disclosure of Interest</h3> 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