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AB0370 Association of Clinical Efficacy with Serum Level of Adalimumab (ADA) and Anti- Adalimumab Antibody Levels in Patients with Early Rheumatoid Arthritis (RA)
  1. A.S. Avdeeva,
  2. E.N. Aleksandrova,
  3. A.A. Novikov,
  4. D.E. Karateev,
  5. E.L. Luchihina,
  6. M.V. Cherkasova,
  7. E.L. Nasonov
  1. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation

Abstract

Background ADA is effective and safe drug for the treatment of RA. Application of ADA can be accompanied by formation anti-adalimumab antibody (anti-ADA Ab) influencing on efficiency of therapy and the development of adverse events

Objectives To evaluated the correlation of serum levels of ADA and anti-ADA Ab in relation to clinical response in patients (pts) with early RA

Methods Serum levels of ADA (μg/ml) and anti-ADA Ab (positive/negative result) was determined by ELISA in 25 pts with early RA (15 women, mean age – 54,0; 47,0-58,0 years, mean disease duration - 8,0; 5,0-25,0 months, mean DAS 28 – 5,8; 4,9-7,5, SDAI 34,3; 22,8-54,2, CDAI 32,0; 21,7-48,4) baseline and then after 12 and 24 weeks of treatment. All patients received disease-modifying antirheumatic drugs (DMARDs) (100%>methotrexate) and ADA 40mg every 2 weeks. For all patients the ADA was the first biologic

Results On the 12-th week of therapy values [Me; interquartile range] DAS 28 were 3,5 (3,2-4,4); SDAI-13,0 (7,0-16,6); CDAI - 10,8 (7,0-16, 0), 6 pts achieved a good EULAR response, 14- moderate response. On the 24-th week of treatment the value DAS 28 were 3,5 (3,1-4,4), SDAI-11,7 (7,4-17,5) and CDAI - 10,5 (6,2-16, 3), a good response was noted at 7 patients, moderate response - at 9 pts.

The pts was distributed in two groups from serum levels of ADA: <3,0 (the first group n=7) and ≥3,0 (second group n=13). There were no differences between the groups on disease activity, level of acute-phase reactants by the 12th week of therapy (p>0,05). Higher disease activity and also the level of acute-phase reactants were marked out among pts of the first group (DAS 28 – 4,5; 3,3-4,9, ESR – 44; 18-57 mm/h, CRP -10,1; 4,9-34,5 mg/ml) compared with pts of the second group (3,5; 2,9-3,9, 15,0; 6,0-17,0 mm/h, 1,9; 0,75-6,7 mg/ml, respectively, p<0,05) by the 24th week of therapy. Also on the 24th week negative correlation was found with level of ADA and DAS 28 (r= -0,46; p=0,04), CRP (r= -0,54; p=0,02) and ESR (r= -0,5; p=0,02).

Anti-ADA Ab was found in 3 (12,5%) pts at week 12 and in 2 (10%) pts at week 24. By 24th week of treatment at 100% of pts with presence of anti-ADA Ab was absence of clinical effect (ΔDAS28 = -1,36; -3,1-0,4). In the group of pts without anti-ADA Ab we found fewer of “no respondents” (11%) and identified positive dynamics DAS 28 (ΔDAS28=2,5; 1,66-2,9) (p<0,05)

Conclusions Low drug level (<3,0 μg/ml) in serum is associated with a high clinical and laboratory disease activity at pts with early RA receiving the ADA therapy. By 12-24 weeks of ADA therapy anti-ADA Ab is found in 10-12,5% of pts, it's formation is accompanied of decrease in efficacy of therapy

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.2266

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