Background Clinical studies demonstrated that baseline disease activity including C-reactive protein (CRP) level was a predictor variable for radiographic joint damage in patients with rheumatoid arthritis (RA).
Objectives To identify variables associated with radiographic joint damage in patients with RA treated with intravenously administered golimumab (GLM) + Methotrexate (MTX) or MTX + placebo (PBO).
Methods GO-FURTHER was a multicenter, randomized, placebo-controlled study. Adult patients with active RA despite MTX therapy (≥6 tender and swollen joints, CRP ≥1.0 mg/dL, and RF and/or anti-CCP positive) were randomized to placebo (PBO) + MTX or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 week thereafter (GLM group). Patients in PBO group with <10% improvement in tender and swollen joint count from baseline at week 16 entered early escape (EE) and received a 2 mg/kg GLM infusion at weeks 16 and 20 and every 8 weeks subsequent. Radiographic progression was measured using Total Sharp score (TSS). The correlations of TSS with hemoglobin, disease activity score (DAS28-CRP)and physical function evaluated with Health Assessment Questionnaire (HAQ) were assessed using Spearman's correlation or multivariable liner regression model. Anemia was defined based on World Health Organization (WHO) criteria as Hgb <12 g/dl in women and <13 g/dl in men.
Results Moderate to severe RA was demonstrated by a mean DAS28 score of 5.9 with TSS of 48.5 in all patients group at baseline. In linear regression models, baseline DAS28, HAQ score, and Hgb level was correlated with baseline TSS with Spearman's correlation coefficient (r) of 0.148 (p<0.01), 0.0.193 (p<0.001) and -0.129 (p<.001), respectively. Similar correlation relationships of TSS score with DAS28, HAQ and Hgb were observed at Week 24. In multiple linear regression models, after adjusting for effect of other factors, Hgb level demonstrated significant correlation with TSS at the baseline or Week 24. The change in Hgb at Week 20 also was correlated with change in TSS at Week 24 after adjusting for change in DAS28 and HAQ. GLM IV + MTX-treated patients demonstrated less radiographic damage than MTX+PBO-treated patients regardless of their anemia status at baseline or week 20.
Conclusions Hemoglobin level is an independent variable predicting radiographic progression in MTX refractory RA patients.
Disclosure of Interest R. Westhovens Grant/research support from: Janssen R & D, LLC, C. Han Employee of: Johnson & Johnson Pharmaceutical Services, LLC, M. Weinblatt Grant/research support from: Janssen R & D, LLC, L. Kim Employee of: Janssen R & D, LLC, E. Hsia Employee of: Janssen R & D, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, C. Bingham III Grant/research support from: Janssen R & D, LLC