Adalimumab clinical efficacy is associated with rheumatoid factor and anti-cyclic citrullinated peptide antibody titer reduction: a one-year prospective study

Fabiola Atzeni¹ , Piercarlo Sarzi-Puttini¹ , Donata Dell' Acqua¹ , Simona de Portu² , Germana Cecchini³ , Carola Cruini³ , Mario Carrabba¹ and Pier Luigi Meroni³

¹Rheumatology Unit, Department of Medicine, L Sacco University Hospital, 74 Via GB Grassi, 20157 Milano, Italy

²CIRF/Center of Pharmacoeconomics, Faculty of Pharmacy, University of Naples, Federico II, Napoli, Italy

³Allergy, Clinical Immunology and Rheumatology Unit, Department of Internal Medicine, University of Milan, IRCCS Istituto Auxologico Italiano, Milano, Italy

author email corresponding author email

Arthritis Research & Therapy 2006, 8:R3doi:10.1186/ar1851


Published:	9 November 2005

Abstract

Studies on autoantibody production in patients treated with tumor necrosis factor-α (TNF-α) inhibitors reported contradictory results. We investigated in a prospective study the efficacy of a treatment with human monoclonal anti-TNF-α antibody (adalimumab) in patients with rheumatoid arthritis (RA) and we evaluated the relationship between treatment efficacy and the incidence and titers of disease-associated and non-organ-specific autoantibodies. Fifty-seven patients with RA not responsive to methotrexate and treated with adalimumab were enrolled. Antinuclear, anti-double-stranded(ds)DNA, anti-extractable nuclear antigens, anti-cardiolipin (aCL), anti-β₂glycoprotein I (anti-β₂GPI) autoantibodies, rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) autoantibodies were investigated at baseline and after 6 and 12 months of follow-up. Comparable parameters were evaluated in a further 55 patients treated with methotrexate only. Treatment with adalimumab induced a significant decrease in RF and anti-CCP serum levels, and the decrease in antibody titers correlated with the clinical response to the therapy. A significant induction of antinuclear autoantibodies (ANA) and IgG/IgM anti-dsDNA autoantibodies were also found in 28% and 14.6% patients, respectively, whereas aCL and anti-β₂GPI autoantibodies were not detected in significant quantities. No association between ANA, anti-dsDNA, aCL and anti-β₂GPI autoantibodies and clinical manifestations was found. Clinical efficacy of adalimumab is associated with the decrease in RF and anti-CCP serum levels that was detected after 24 weeks and remained stable until the 48th week of treatment. Antinuclear and anti-dsDNA autoantibodies, but not anti-phospholipid autoantibodies, can be induced by adalimumab but to a lower extent than in studies with other anti-TNF blocking agents.