Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy?
OBJECTIVE
To assess the efficacy and safety of pandemic 2009 influenza A (H1N1) in SLE under different therapeutic regimens.


METHODS
A total of 555 SLE patients and 170 healthy controls were vaccinated with a single dose of a non-adjuvanted preparation. According to current therapy, patients were initially classified as SLE No Therapy (n = 75) and SLE with Therapy (n = 480). Subsequent evaluations included groups under monotherapy: chloroquine (CQ) (n = 105), prednisone (PRED) ≥20 mg (n = 76), immunosuppressor (IS) (n = 95) and those with a combination of these drugs. Anti-H1N1 titres and seroconversion (SC) rate were evaluated at entry and 21 days post-vaccination.


RESULTS
The SLE with Therapy group had lower SC compared with healthy controls (59.0 vs 80.0%; P < 0.0001), whereas the SLE No Therapy group had equivalent SC (72 vs 80.0%; P = 0.18) compared with healthy controls. Further comparison revealed that the SC of SLE No Therapy (72%) was similar to the CQ group (69.5%; P = 0.75), but it was significantly reduced in PRED ≥20 mg (53.9%; P = 0.028), IS (55.7%; P = 0.035) and PRED ≥20 mg + IS (45.4%; P = 0.038). The concomitant use of CQ in each of these later regimens was associated with SC responses comparable with SLE No Therapy group (72%): PRED ≥20 mg + CQ (71.4%; P = 1.00), IS + CQ (65.2%; P = 0.54) and PRED ≥20 mg + IS + CQ (57.4%; P = 0.09).


CONCLUSIONS
Pandemic influenza A H1N1/2009 vaccine response is diminished in SLE under immunosuppressive therapy and antimalarials seems to restore this immunogenicity. Trial registration. www.clinicaltrials.gov, NCT01151644.
Faculdade de Medicina da Universidade de São Paulo, Reumatologia Av. Dr Arnaldo, n 455, 3 andar, sala 3190, São Paulo 05403-010, Brazil. eborba@lim17.fm.usp.br
Eduardo F
EF
Borba
Carla G S
CG
Saad
Sandra G
SG
Pasoto
Ana L G
AL
Calich
Nadia E
NE
Aikawa
Ana C M
AC
Ribeiro
Julio C B
JC
Moraes
Elaine P
EP
Leon
Luciana P
LP
Costa
Lissiane K N
LK
Guedes
Clovis A A
CA
Silva
Celio R
CR
Goncalves
Ricardo
R
Fuller
Suzimara A
SA
Oliveira
Maria A
MA
Ishida
Alexander R
AR
Precioso
Eloisa
E
Bonfa
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D000962:Antimalarials / Q000008:administration & dosage*; D002738:Chloroquine / Q000008:administration & dosage; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007107:Immune System / Q000187:drug effects / Q000276:immunology; D016867:Immunocompromised Host / Q000276:immunology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D000962:Antimalarials; D007252:Influenza Vaccines; D002738:Chloroquine; D011241:Prednisone