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Severely impaired humoral response against SARS-CoV-2 variants of concern following two doses of BNT162b2 vaccine in patients with systemic lupus erythematosus (SLE)
  1. Arthur Mageau1,2,3,
  2. Valentine Marie Ferré3,4,
  3. Tiphaine Goulenok1,
  4. Charlotte Charpentier3,4,
  5. Nicole Delory1,
  6. Chrystel Francois1,
  7. Nadhira Houhou-Fidouh4,
  8. Thomas Papo1,
  9. Diane Descamps3,4,
  10. Karim Sacre1,2
  1. 1Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Université Paris Cité, Paris, France
  2. 2Centre de Recherche sur l’Inflammation, Laboratoire d’Excellence Inflamex, INSERM UMR1149, CNRS ERL8252, Paris, France
  3. 3Infection, antimicrobiens, modélisation, évolution (IAME), INSERM UMR 1137, Université Paris Cité, Paris, France
  4. 4Virologie, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Université Paris Cité, Paris, France
  1. Correspondence to Dr Karim Sacre, Département de Médecine Interne, APHP, Paris 75018, France; karim.sacre{at}

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Severe COVID-19 is associated with a poor prognosis among patients with systemic lupus erythematosus (SLE).1 Accordingly, patients with SLE receiving immunosuppressive drugs have been prioritised for vaccination in France.2 However, patients with autoimmune diseases—especially those receiving anti-CD20—are now known to mount a suboptimal humoral response following COVID-19 vaccination.3 Furthermore, vaccine-induced humoral protection against omicron, the current dominant variant of concern (VOC) worldwide, is not known in SLE.

Patients with SLE were prospectively enrolled in the vaccine task force set up between March and May 2021 in our national centre for autoimmune diseases.4 Humoral vaccine responses against B (ancestral), alpha, delta and omicron variants were assessed using a specific multiplex ELISA assay (CoViDiag kit, Innobiochips, Loos, France). Humoral response was defined by a specific SARS-CoV-2 anti-spike IgG (anti-S) level in serum >260 binding antibody units (BAU)/mL, according to French Health Authorities.5 Data were compared between groups using Fisher’s exact test for dichotomous variables and Mann-Whitney test for continuous variables.

Fifty-five patients with SLE were enrolled in the vaccine task force. Among them, 10 had prior COVID-19 and 10 were under immunosuppressive drugs and received three-dose primary series of BNT162b2 vaccine following national recommendation.2 Eventually, 35 COVID-19-naive patients with SLE (43.4 (36.0, 48.6) years; 88.6% female; table 1) and 9 healthy volunteers (HV) (59.0 (56.0, 62.0) years; 88.8% female) who received two doses of BNT162b2 vaccine 4 weeks apart were screened for humoral vaccine responses at baseline, at second dose, and 2 and 5 months …

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  • Handling editor Josef S Smolen

  • AM and VMF contributed equally.

  • Contributors KS and TG directed the project. AM, VMF, TG, DD and KS designed the study. AM, VMF, CC and NH-F conducted analysis. ND, CF and TP were involved in the project development and edited the manuscript. AM and KS wrote the manuscript. All authors reviewed and approved of the final manuscript.

  • Funding AM was supported by a PhD fellowship provided by Fondation pour la Recherche Médicale (FDM202106013488). This work was supported by Agence Nationale de la Recherche (no ANR-21-COVR-0034 COVALUS) and by the Agence Nationale de la Recherche sur le SIDA et les Maladies Infectieuses Emergentes (ANRS MIE), AC43 Medical Virology and Emergen Programme.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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