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Anti-drug antibodies may predict response to TNF inhibitors in patients with RA
The presence of anti-drug antibodies may be predictive of treatment response to Humira, but the antibodies were not detected with the use of Enbrel in patients with rheumatoid arthritis, according to the results of an observational, prospective study.
Researchers enrolled 311 patients with rheumatoid arthritis (RA), 171 of whom received Enbrel (etanercept, Amgen) and 160 of whom received Humira (adalimumab, AbbVie) at 60 centers across the U.K. between November 2008 and March 2013. Patients met the 1987 American College of Rheumatology criteria for RA, and active disease was established using a 28-joint Disease Activity Score (DAS28) of 5.1 or greater. Inclusion criteria included active disease despite treatment with at least two prior disease-modifying anti-rheumatic drugs (DMARDs), white race and imminent initiation of treatment with adalimumab or etanercept.
Median DAS28 at baseline was 5.8, 73% of the patients had rheumatoid factor and 76.4% were positive for anti-cyclic citrullinated peptide antibodies (anti-CCP). Additionally, the majority of patients were women.
Patients who received adalimumab received 40 mg subcutaneously every other week, and patients who received etanercept received 50 mg every week through the study duration.
Anti-drug antibodies (ADAbs) were measured and the amounts of each drug present in patient sera were quantified at 3, 6 and 12 months after initiation of tumor necrosis factor-alpha (TNF-a) inhibitor therapy. Clinical evaluation, including the DAS28 and other questionnaires, was also administered at 3, 6 and 12 months.
Adalimumab ADAbs were present in 31 of 125 patients who completed 12 months of treatment (24.8%) and in 31 of all patients who were tested (19.3%). The antibodies were also associated with lower adalimumab blood concentrations at 3, 6 and 12 months, according to the researchers.
Immunogenicity was observed at 6 months in 28 of 31 patients with ADAbs, and three more developed immunogenicity between 6 months and 12 months. A high DAS28 was associated with patients with ADAbs.
At baseline, median disease duration was almost twice as long, and higher doses of methotrexate at baseline were more likely in patients who developed ADAbs. No ADAbs were detected in patients who received etanercept. – by Shirley Pulawski
Disclosure s : Jani reports receiving honoraria from UCB and Pfizer outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.