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Abstract
Background Previously an association has been demonstrated between drug levels and clinical activity in Spondyloarthritis (SpA) patients treated with Infliximab, Adalimumab or Etanercept. Until now, there is not enough evidence about the correlation between Golimumab (Gol) trough levels and clinical outcomes in SpA patients
Objectives to study the association between Gol trough levels,clinical activity and C reactive protein (CRP)in SpA patients treated with Gol
Methods In this prospective observational study we have included 30 SpA patients (pts) treated with Gol once monthly (24 pts from Spain and 6 pts from Netherlands). The clinical activity and improvement were measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) and delta-ASDAS, respectively, at baseline (30 pts), 6 month (26 pts) and 1 year (20 pts). An important clinically improvement (ICI) was considered when delta-ASDAS was ≥1.1.Gol levels were measured by a TNF-capture ELISA, designed by Sanquin, Amsterdam. To carry out the statistical analysis the Gol levels were stratified in two groups: Group-1 (Gol levels ≤1.5 μg/ml, n=18 patients) and Group-2 (Gol levels=≥1.5 μg/ml, n=12 patients). Last observation was carried forward for pts who dropped out before 1 year or if pts did not have follow-up to 1 year
Results At baseline the mean age was 45±1.67 years and the disease duration was 11±7.86 years. Most patients were men (21/30, 70%) and HLA-B27 positive (19/24, 79.2%). All SpA pts had active disease at baseline measured by ASDAS (3,61±0.95). At 6 months, Gol trough levels were significantly higher in pts with inactive disease (ID) than those with moderate-high disease activity (M-HDA) by ASDAS (Mdn, IQR:1.78,1.61-2.49μg/ml in ID vs 1.08,0.61-1.61 μg/ml in M-HDA, p=0.018) (Fig. 1). Gol levels were higher in patients with an important clinical improvement at 6 months, but not statiscally significant (1.61,0.98-2.14 μg/ml with ICI vs 1.08,0.42-1.71μg/ml without ICI, p=0.128). At the end of this study, Gol drug levels were not statistical significant different (1.6,0.81-1.99μg/ml with ID vs 1.08,0.77-1.80 μg/ml with M-HDA, p=0.382) (fig.1), although Gol levels were higher in patients with ICI (1.80,0.94-2.02μg/ml with ICI vs 0.85,0.34-1.55μg/ml without ICI, p=0.020). The CRP levels were lower in patients with higher Gol levels in the different studied time points (At 6 months:0.54±0.47 mg/l in Group-2 vs 18.04±40.95 mg/l in Group-1, p=0.001; at the end of the study: 0.62±0.64 mg/l in Group-2 vs 10.50±33.16 mg/l in Group-1, p=0.003)
Conclusions In our 30 SpA patients the Gol trough levels were higher in patient with inactive disease at 6 months and in those who reached an important clinically improvement at 1 year. CRP was lower in SpA with Gol high levels along the study
Disclosure of Interest C. Plasencia Grant/research support: Pfizer, E. Kneepkens: None declared, C. Krieckaert Speakers bureau: Abbvie, Pfizer, A. Balsa Grant/research support: Pfizer, Speakers bureau: Pfizer, UCB, D. Pascual-Salcedo Grant/research support: Pfizer, Speakers bureau: Pfizer, M. Nurmohamed Grant/research support: Abbvie, BMS, MSD, Pfizer, UCB and Roche, Consultant for: Abbott, BMS, Pfizer and Roche, Paid instructor for: Abbvie, Pfizer and Roche, Speakers bureau: Abbvie, Pfizer and Roche, T. Rispens: None declared, D. Van der Kleij: None declared, G. Wolbink Grant/research support: Pfizer, Speakers bureau: Pfizer, Amgen
DOI 10.1136/annrheumdis-2014-eular.3225