Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


Pandemic Unadjuvanted Influenza A 2009 Vaccine in Adult Dermatomyositis and Polymyositis: Immunogenicity Independent of Therapy and No Harmful Effect in Disease.

Shinjo1,  Samuel K., Neto1,  Maurício Levy, Silva1,  Clovis A., Moraes1,  Julio C. B., Ribeiro1,  Ana C. M., Saad1,  Carla G.S., Aikawa1,  Nadia E.

Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil
Butantan Institute, Sao Paulo, Brazil
Instituto Adolfo Lutz, São Paulo, Brazil

Background/Purpose:

There are specific recommendations for influenza vaccination in systemic autoimmune diseases and the WHO recently recommended that the 2010–2011 trivalent seasonal flu vaccine must contain the A/California/7/2009 (H1N1) virus. The vaccine potential deleterious effect in adult dermatomyosisits (DM) and polymyositis (PM) and the influence of therapy in antibody response in these diseases has not been explored in our previous report (Ann Rheum Dis, 2011).

Methods:

Fifty-eight patients (37 DM and 21 PM - Bohan and Peter's criteria, 1975) were gender and age-matched to 116 healthy controls. All subjects were vaccinated with a unadjuvanted influenza A/California/7/2009 (H1N1) strain and evaluated pre- and 21 days post-vaccination. Patients with fever, egg allergy, and autoimmune neurological diseases were not included. Antibody titers were evaluated by hemagglutination inhibition (HAI) assay. Percentage of seroprotection (titer >=1:40) before and after immunization, and seroconversion (pre-vaccination titer <1:10 and a post vaccination HIA titer >=1:40 or pre-vaccination titers >=1:10 and a >= 4-fold rise post-vaccination) were calculated. Adverse events of vaccination were also analyzed. DM/PM muscle enzyme and scores (patient's visual analog scale (VAS), physician's VAS and MMT-8 (manual muscle strength score)) were evaluated before and after vaccination.

Results:

Mean age (43.1±9.9 vs. 43.8±8.4 years, P=0.607) and frequency of female gender (P=1.000) were comparable in patients and controls with a mean DM/PM duration of 7.3±3.0 years. Seroprotection (72.4%vs. 84.5%, P=0.058) and seroconversion rates (72.4%vs. 78.5%, P=0.377) were similar in both groups. Of note, patients under glucocorticoids and/or immunosupressors (72.4%) also reached an adequate seroconversion rate (69.8%vs. 78.5%, P=0.254), including those 9 patients under prednisone >=0.5mg/kg/day (88.9%vs. 78.5%, P=0.254). Disease activity and muscle parameters remained stable during the protocol (pre and post-vaccination): CK 224.1±209.0 vs. 242.1±256.9U/L, aldolase 5.8±5.9 vs. 5.8±5.4U/L, MMT-8 77.7±5.3 vs. 77.8±5.2, patient's VAS 9.5±0.9 vs. 9.5±0.9, physician's VAS 9.3±0.8 vs. 9.6±0.7 (all P>0.05) and seroconversion rate was similar to controls in eight patients with active disease (75.0 vs. 78.5%, P=0.819). The frequencies of minor local reactions (8.6 vs. 11.2%, P=0.597) and of mild systemic reactions (15.5 vs. 25.7%, P=0.123) were alike in patients and controls, without any report of severe side effects.

Conclusion:

This prospective study of pandemic influenza A H1N1/2009 vaccination in DM/PM patients emphasizes its recommendation supported by novel evidence of its adequate immunogenicity in spite of therapy with no short-term harmful effect in disease itself (ClinicalTrials.gov number, NCT01151644).

To cite this abstract, please use the following information:
Shinjo, Samuel K., Neto, Maurício Levy, Silva, Clovis A., Moraes, Julio C. B., Ribeiro, Ana C. M., Saad, Carla G.S., et al; Pandemic Unadjuvanted Influenza A 2009 Vaccine in Adult Dermatomyositis and Polymyositis: Immunogenicity Independent of Therapy and No Harmful Effect in Disease. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :821
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