Objective: To assess the efficacy and safety of vaccination against pandemic H1N1 virus in patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) compared with healthy controls.
Methods: The study population comprised 41 RA patients, 21 SLE patients, 17 PsA patients, 15 AS patients, and 25 healthy controls. All were vaccinated using the Novartis MF59-adjuvanted H1N1v monovalent influenza vaccine. The immunogenicity of the vaccine was assessed on day 1 and again 4 weeks later by hemagglutination inhibition assay. Geometric mean titers and seroconversion rates were calculated for each group. The safety of the vaccine was evaluated using the 28-joint Disease Activity Score (DAS28) for RA and PsA, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Results: The proportion of baseline protective levels of antibodies against H1N1 was similar in all but the AS group, in which it was lower. The geometric mean titers increased significantly in all 5 groups. A substantial proportion of patients and controls responded to the vaccine. The healthy controls demonstrated a better response than each of the other groups: 84% versus 56% for RA, 67% for SLE, 59% for PsA, and 53% for AS. Multivariate logistic regression analysis identified RA and PsA as parameters of significantly lower response. The DAS28, BASDAI, and SLEDAI remained unchanged after vaccination.
Conclusion: Vaccination against pandemic H1N1 using an adjuvanted H1N1v monovalent influenza is safe and induced an appropriate response in patients with RA, SLE, PsA, and AS.
Trial registration: ClinicalTrials.gov NCT01006681.
Copyright © 2011 by the American College of Rheumatology.