Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


The Efficacy and Safety of Vaccination Against H1N1 in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis.

Elkayam2,  Ori, Amir2,  Sharon, Mandelboim1,  Michal, Mendelson1,  Ella, Wollman2,  Jonathan, Arad2,  Uri, Paran2,  Daphna

Center of Virology, Sheba Medical Center
Department of Rheumatology, Tel Aviv Medical Center

Background:

In spring 2009, a new swine-origin influenza virus A (H1N1) quickly spread worldwide prompting the development of pandemic H1N1 influenza vaccine launched by the end of 2009.

Purpose:

To assess the efficacy and clinical safety of vaccination against H1N1 in patients suffering from Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) in comparison with healthy controls.

Patients and Methods:

The study population comprised 4 groups of patients and healthy controls: 41RA patients: 56% female, age: 52.6±14.5, disease duration: 9 years;21SLE patients: 66% female, age: 41.7±11.5, disease duration: 11 years;17 PsA: 35% female, age: 48.5±11.8, disease duration: 12 years; 15 AS: 20% female, age: 47.2±13.3, disease duration: 14 years; 17 healthy controls: 60% female, age: 47.3±11.3. All the subjects were vaccinated against H1N1 using the Novartis MF59-adjuvanted H1N1v monovalent influenza vaccine, Focetria®. Each 0.5 ml dose contained 7.5 mg H1N1 HA antigen and the full dose of the oil-in water emulsion adjuvant, MF59®, containing 9.75 mg squalene. The immunogenicity of the vaccine was assessed on day 1 and 4 weeks after by hemagglutination inhibition (HI) assay. Geometric mean titers (GMT) and seroconversion rates were calculated for each group. Seroconversion rates were calculated as the percentages of each group that displayed seroconversion in initially seronegative subjects or a significant increase in titer in initially seropositive subjects (a four-fold increase in titer in those < 40 prevaccination).The safety of the vaccine was evaluated using Disease activity score (DAS) for RA and PsA, Systemic Lupus Index disease activity (SLEDAI) for SLE and BASDAI for AS.

Results:

The proportion of baseline protective levels of antibodies against H1N1 was similar in most groups, except for AS patients: RA: 23%, SLE: 24%, PsA: 29%, AS: 7% and healthy controls: 29%.A significant increase in GMT was observed in the 5 groups. A substantial proportion of patients and controls responded to the vaccine, Healthy controls demonstrating a better response (Table 1). Multivariate logistic regression analysis identified RA and PsA as parameters of significant lower response. Treatment with Infliximab and Leflunomide was associated with a lower response.DAS, BASDAI and SLEDAI remained unchanged after vaccination.

Table 1

 Healthy controls (n = 17)RA (n = 41)SLE (n = 21)PsA (n = 17)AS (n = 15)
GMT04.385.726.915.62.33
GMT185.6764.2970.9355.557.04
Proportion of responders82%56%67%59%53%
%seroprotection 029%23%24%29%7%
%seroprotection 188%71%76%76%60%
0 - Baseline 1–4 weeks after vaccination.

Conclusions:

Vaccination against H1N1 using an adjuvanted H1N1v monovalent influenza induced an appropriate response in patients with RA, SLE, PsA and AS. The vaccine was found to be safe in this cohort of patients.

To cite this abstract, please use the following information:
Elkayam, Ori, Amir, Sharon, Mandelboim, Michal, Mendelson, Ella, Wollman, Jonathan, Arad, Uri, et al; The Efficacy and Safety of Vaccination Against H1N1 in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :697
DOI: 10.1002/art.28465

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