A/H1N1 influenza vaccination in patients with systemic lupus erythematosus: Safety and immunity
Introduction
The A/H1N1 and A/H3N2 influenza viruses have caused potent pandemics. A novel swine influenza A (A/H1N1) virus that clinically mimics seasonal influenza was identified in two children in the United States in March and April 2009 [1], [2] and was responsible for an explosion of respiratory tract infections in Mexico [3]. When the transmission seemed to persist and increase in the Northern Hemisphere during the autumn and winter of 2009, the World Health Organization immediately proclaimed a worldwide pandemic, characterized by uncontained community-level transmission of the A/H1N1 virus in multiple areas of the world [4].
Some patients required admission to intensive care units for acute respiratory distress syndrome or septicaemia [5], [6], [7]. The elderly, the obese, and those with accompanying underlying medical conditions such as chronic obstructive pulmonary disease, immunodeficiency, and neurological diseases tended to have more severe disease [7], [8], [9]. Thus, in 2009 the Advisory Committee on Immunization Practices recommended the use of the monovalent A/H1N1 vaccine to prevent mortality and morbidity from A/H1N1 infection and to mitigate the pandemic [10]. Recent studies had confirmed the safety and immunogenicity of this A/H1N1 vaccine in Taiwanese [11], [12], [13].
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease. A defect in B lymphocytes causes abnormalities in apoptosis and persistent production of autoantibodies [14], [15], [16]. Dysregulation of B cells and immunosuppressive therapy in SLE patients might cause impaired humoral immune responses to the A/H1N1 influenza virus, which can occasionally lead to the complications of pulmonary infection and fatal organ dysfunction.
Previous reports recognized the safety and antibody response to influenza vaccination in SLE patients. Morbidity and mortality caused by A/H1N1 infection were diminished significantly after mass vaccination, although several reports claimed that vaccination might exacerbate autoimmunity [17]. Neither increased generation of autoantibodies nor clinical exacerbation of disease activity was observed in influenza-vaccinated SLE patients [18], but no information describing the safety and efficacy of this new A/H1N1 influenza vaccine in SLE patients is available.
In this report, we describe the clinical manifestations, autoimmunity, and humoral immune response including the seroprotection and seroconversion rates in A/H1N1 influenza-vaccinated SLE patients. The specific antibody response to A/H1N1 influenza virus in SLE patients met the European Committee for Proprietary Medicinal Products (CPMP) guidelines. We also demonstrated immunity in A/H1N1-vaccinated SLE patients under immunosuppressive therapy.
Section snippets
Study design
Twenty-one patients with SLE defined according to the American College of Rheumatology criteria were selected during the 2009–2010 winter and, after giving informed consent, were vaccinated against A/H1N1 influenza virus. All patients were at low SLE disease activity index (SLEDAI scores < 8 and/or stable disease activity (defined as disease not demanding any increase in therapy for at least three weeks)) at the time of enrollment and without any contraindications (egg allergy or previous allergy
Demographics
Twenty-one SLE patients and 15 normal controls were enrolled into this study. All SLEDAI scores of the SLE patients were <8 before vaccination. One SLE patient (4.8%) and six (40%) of the normal controls had received the seasonal trivalent influenza vaccination in winter 2009 before this H1N1 vaccination (p = 0.013). Eighteen (85.7%) of the SLE patients and eight controls (53.3%) had never before received an influenza vaccination (p = 0.058). The demographic features of the SLE patients and normal
Discussion
Published studies of trivalent influenza vaccination (A/H1N1, A/H3N2, and type B influenza) in SLE patients investigated whether disease activity and autoantibodies change after vaccination, especially in patients with pre-existing nephritis or neurological manifestations [25], [26], [27], [28], [29], [30], [31]. Recent reports proved the safety of trivalent influenza vaccination in patients with quiescent SLE, but the vaccine may have lower efficacy [32] and patients may have reduced humoral
Acknowledgements
The authors thank Dr. Feng-Yee Chang, Dr. Hui-Kang Sytwu, and Dr. Tzong-Shi Chiueh for their assistance in virus vaccinations; Mr. Shan-Yuan Kuo and Mr. Chen-Hung Chen for their clinical supervision; and Mrs. Li-Hsiu Wu, Ms. Tan-Me Liu, and Mr. Chih-Chieh Wang for their technical support.
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