Background Adalimumab (ADA) has been shown to be safe and effective in patients (pts) with long-standing rheumatoid arthritis (RA).1 Patients with RA are candidates for routine vaccination with inactivated agents, in line with current recommendations of the US Advisory Committee on Immunization Practices.2
Objectives This post hoc report describes the observed use of vaccines in RA pts receiving ADA for up to 10 years.
Methods DE019 was a phase 3, randomized, controlled trial in which pts with advanced RA and inadequate response to methotrexate (MTX) were randomized to ADA (40 mg every other week [eow] or 20 mg weekly) vs placebo (PBO) for 1 year; all pts received concomitant MTX. Patients completing the trial were eligible for an additional 9 years of open-label ADA (40 mg eow). Vaccinations were administered based on the judgment of the study investigators. Descriptive statistics were used to summarize vaccinations, including influenza vaccine. Adverse events (AEs) related to influenza virus infection (within 270 days of influenza vaccination) were collected by a predefined MedDRA Query. At baseline, a subset of pts who had not received pneumococcal vaccination in the preceding 12 months were enrolled in an immunologic sub-study to examine the response to standard polyvalent pneumococcal vaccine administered at week 12; antibody titers were measured pre- and post-vaccination (weeks 16 and 24) to determine response to S. pneumoniae serotypes 3, 7F, 9N, and 14.
Results 553 pts received ≥1 dose of ADA; mean duration on ADA was 5.6 years. A summary of all vaccinations is presented in the Table. Influenza, pneumococcal, and tetanus were the most frequently administered vaccines (n=351, n=42, and n=23, respectively). The majority of pts received only 1 type of vaccination; however, 16 pts received >5 vaccinations, and one subject received 7 influenza vaccinations. Influenza infection-related AEs were reported in 55/382 (14%) of influenza vaccine-naïve pts and 8/171 (5%) of the influenza-vaccinated pts (within 270 days of vaccination). For pts in the S. pneumoniae vaccination sub-study, mean antibody titers to serotypes 3, 7F, and 9N approximately doubled 4 weeks post-vaccination; antibody responses were similar between ADA- and PBO-treated pts.
Conclusions Current recommendations endorse routine vaccination of RA pts. These data suggest that ADA-treated RA pts can be safely immunized with inactive vaccines, including influenza and pneumococcus. Concomitant ADA + MTX treatment did not inhibit humoral responses to pneumococcal vaccination in RA pts, as evidenced by an increase in protective antibody titers.
Keystone EC, et al. Arthritis Rheum 2011;63:2228;
MMWR Recomm Rep 2011;60:1-64.
Acknowledgements Douglas E. Dylla, PhD, AbbVie Inc., for abstract preparation.
Disclosure of Interest N. Mozaffarian Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., S. Liu Shareholder of: AbbVie Inc., Employee of: AbbVie Inc.