Session Information
Session Title: Fibromyalgia, Soft Tissue Disorders and Pain II
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Fibromyalgia syndrome (FMS) is considered to result from exposure of a genetically susceptible individual to various “triggers” including physical trauma, stress etc. Viral infections have also been linked to FMS etiology. A possible role of vaccination in FMS etiology has been raised. Gulf war syndrome, an entity with considerable clinical overlap with FMS, has been linked with exposure to multiple vaccinations. The possibility that vaccination – related adjuvants induce a multisystem disorder characterized by symptoms such as fatigue, cognitive impairment and arthralgia has also been raised.In view of this background, the aim of the current study was to evaluate the efficacy and safety of influenza vaccination in FMS patients.
Methods:
Patients (19) were recruited at a specialized FMS clinic. After informed consent, patients underwent physical and dolorimetric examination and fulfillment of ACR 1990 FMS classification criteria was documented. Patients answered the Fibromyalgia Impact Questionnaire (FIQ) as well as the widespread pain index (WPI) and Symptoms severity scale (SSS) – components of the 2010 diagnostic criteria. 38 Healthy subjects were recruited as controls. All participants were vaccinated with inactivated split virion influenza vaccine, recommended by the WHO and serum was collected for antibody titer determination.
Six weeks after vaccination, patients were re-evaluated. Sera were tested by Haemagglutination (HI) against the three antigens included in the vaccine: A/California (H1N1), A/Perth (H3N2) and B/Brisbane. Humoral response was defined as either a fourfold or more rise in titer, or a rise from a non-protective baseline level of <1/40 to 1/40. Geometric mean titers of antibodies were calculated.
Results:
No severe vaccination reactions were observed. As shown in the table, no significant change was observed between WPI, SSS and FIQ values before and after vaccination, indicating no worsening of FMS symptoms.
|
FMS patients (n=19) |
Pre-Vaccination |
Post-vaccination |
P value |
|
WPI (SD) |
13.3(4.7) |
11(5.4) |
0.19 |
|
SSS (SD) |
9.1(1.6) |
9.0(2.7) |
0.88 |
|
FIQ (SD) |
67.3(14.2) |
65.9(22.0) |
0.82 |
Vaccine immunogenicity: Six weeks after vaccination, FMS patients displayed significant increases in geometric mean titers of HI antibody against H1N1 and B/Bri viruses: from 29.9 to 387.9 (p=0.0011), from 82.9 to 460.9 (p=0.0007) and from 28.8 to 96.0 (p=0.08) respectively. The rates of sero-protection (defined as antibody levels above 1/40) increased from 22.9% for H1N1 to 89.5% post vaccination. Significant increase in HI antibody titers were also demonstrated among healthy controls: H1N1 (p=0.000435), B/Bri (p=0.000331) and Perth (p=0.004953).
Conclusion:
Influenza vaccination was both safe and effective in FMS patients. Neither severe adverse reactions nor significant worsening of FMS symptoms were recorded following vaccination and serological evidence of sero-conversion was observed, similar to healthy controls. In view of these results, FMS patients should be encouraged to undergo influenza vaccination according to standard WHO recommendations.
Disclosure:
J. N. Ablin,
Pfizer Inc,
8;
V. Aloush,
None;
A. Brill,
None;
M. Berman,
None;
M. Barzilai,
None;
D. Caspi,
None;
M. Mandelboim,
None;
D. Levartovsky,
None;
A. Polachek,
None;
Y. Wolman,
None;
D. Paran,
None;
M. Barkagan,
None;
O. Elkayam,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-of-influenza-vaccination-in-patients-suffering-from-fibromyalgia/