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Immune Responses Following Administration of Influenza and Pneumococcal Vaccines to Patients with Rheumatoid Arthritis Receiving Adalimumab
JEFFREY L. KAINE, ALAN J. KIVITZ, CHARLES BIRBARA, and ALLISON Y. LUO ABSTRACT. Objective. This study compared the immunogenicity of influenza and pneumococcal vaccines in adult patients with rheumatoid arthritis (RA) receiving adalimumab or placebo. Methods. In this double-blind, randomized, multicenter study, patients received adalimumab or placebo on Days 1, 15, and 29. Pneumococcal and influenza vaccines were administered on Day 8 (vaccine baseline). Vaccine response (≥ 2-fold titer increase from baseline in ≥ 3 of 5 pneumococcal antigens and ≥ 4-fold titer increase from baseline in ≥ 2 of 3 influenza antigens) and protective antibody titers (≥ 1.6 µg/ml pneumococcal antibody concentration to ≥ 3 of 5 antigens and ≥ 1:40 influenza antibody titer to ≥ 2 of 3 antigens) were analyzed 4 weeks' postvaccination. Results. Following pneumococcal vaccination, percentages of patients achieving a vaccine response were similar in the adalimumab and placebo groups [37.4% and 40.4%, respectively; 95% CI (confidence interval) –16.2%, 10.3%]. Percentages of patients with protective antibody titers were similar in both treatment groups (adalimumab: 85.9%, placebo: 81.7%). Following influenza vaccination, percentages of patients achieving a vaccine response were lower with adalimumab than placebo (51.5% and 63.3%, respectively; 95% CI –25.2%, 1.6%) — a result explained by the subgroup of patients with preexisting protective antibody titers at baseline. For patients without protective antibody titers at baseline, response rates were similar in the 2 groups (adalimumab: 73.3%, placebo: 73.9%). Percentages of patients with protective antibody titers were similar in both treatment groups (adalimumab: 98%, placebo: 94.5%). Conclusion. Patients with RA treated with adalimumab can be effectively and safely immunized with pneumococcal and influenza vaccines. (J Rheumatol 2007;34:272–9) Key Indexing Terms:
ADALIMUMAB From the Sarasota Arthritis Research Center, Sarasota, Florida; the Altoona Center for Clinical Research, Duncansville, Pennsylvania; the Clinical Pharmacology Study Group, Worcester, Massachusetts; and Abbott Laboratories, Parsippany, New Jersey, USA. Supported by Abbott Laboratories, Abbott Park, Illinois, USA. J.L. Kaine, MD, Director, Sarasota Arthritis Research Center; A.J. Kivitz, MD, Director, Altoona Center for Clinical Research; C. Birbara, MD, Principal Investigator, Clinical Pharmacology Study Group; A.Y. Luo, MD, formerly Associate Medical Director, Abbott Laboratories. Address reprint requests to Dr. J.L. Kaine, Sarasota Arthritis Research Center, 1945 Versailles Street, Suite 101, Sarasota, FL 34239. E-mail: jkainemd@gmail.com Accepted for publication October 25, 2006.
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