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Temporary hold of mycophenolate augments humoral response to SARS-CoV-2 vaccination in patients with rheumatic and musculoskeletal diseases: a case series
  1. Caoilfhionn M Connolly1,
  2. Teresa Po-Yu Chiang2,
  3. Brian J Boyarsky2,
  4. Jake A Ruddy2,
  5. Mayan Teles2,
  6. Jennifer L Alejo2,
  7. Allan Massie2,
  8. William A Werbel3,
  9. Ami A Shah1,
  10. Lisa Christopher-Stine1,
  11. Jacqueline Garonzik-Wang2,
  12. Dorry L Segev2,4,
  13. Julie J Paik1
  1. 1 Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA
  2. 2 Surgery, Johns Hopkins University, Baltimore, Maryland, USA
  3. 3 Infectious Diseases, Johns Hopkins University, Baltimore, Maryland, USA
  4. 4 Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  1. Correspondence to Dr Dorry L Segev, Surgery, Johns Hopkins, Baltimore, Maryland 21205, USA; dorry{at}

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Mycophenolate is the mainstay of treatment for many organ and life-threatening manifestations of rheumatic and musculoskeletal diseases (RMD). In contrast to most patients with RMD, those taking mycophenolate have an attenuated humoral response to SARS-CoV-2 mRNA vaccination.1 2 The American College of Rheumatology recently recommended withholding mycophenolate for 1 week after vaccination to enhance immunogenicity in this vulnerable population.3 Thus, we sought to analyse the impact of withholding perivaccination mycophenolate in 24 patients with RMD.

We leveraged our observational prospective cohort of patients with RMD without prior COVID-19 who underwent SARS-CoV-2 vaccination between 17 December 2020 and 13 May 2021.2 Information on demographics, diagnoses, immunosuppressive regimens and management of perivaccination immunosuppression was collected via electronic questionnaire. One month following vaccination, venipuncture samples were obtained and tested on the semiquantitative Roche Elecsys anti-SARS-CoV-2 S enzyme immunoassay which tests for antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein; a consistent correlate of neutralising antibody.4 We compared the percentage of participants with detectable anti-RBD antibody in the group that withheld mycophenolate (n=24) to the group that continued mycophenolate (n=171) using Fisher’s exact test (online supplemental table 1). Crude and adjusted logistic regression analyses were performed to assess associations between antibody response and the primary variable of withholding mycophenolate, as well as after adjusting for clinical characteristics (age, sex, race, vaccine type (mRNA vs adenovirus vector), use of rituximab and glucocorticoids). Wilcoxon rank-sum test was used to compare anti-RBD titers of the patients …

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  • Handling editor Josef S Smolen

  • Twitter @CaoilfhionnMD, @JenLAlejo

  • Contributors Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work: CMC, TP-YC, BJB, MT, JLA, AM, AAS, WAW, JG-W, DLS, JJP. Drafting the work or revising it critically for important intellectual content: CMC, TP-YC, JAR, BJB, MT, JLA, AM, LC-S, AAS, WAW, JG-W, DLS, JJP. Final approval of the version to be published: CMC, TP-YC, JAR, BJB, JLA, AM, LC-S, AAS, WAW, DLS, JG-W, JJP. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: CMC, TP-YC, JAR, BJB, JLA, LC-S, WAW, JG-W, DLS, JJP.

  • Funding This work was made possible by the generous support of the Ben Dov family. This work was supported by grant number F32DK124941 (Boyarsky), 5T32DK007713 (Alejo),K01DK101677 (Massie) and K23DK115908 (Garonzik‐Wang) from the National Institute of Diabetes and Digestive and Kidney Diseases, K24AI144954 (Segev) from National Institute of Allergy and Infectious Diseases, K23AR073927 (Paik) from National Institute of Arthritis and Musculoskeletal and Skin Diseases.

  • Disclaimer The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organisations imply endorsement by the US Government.

  • Competing interests DLS, MD PhD, has the following financial disclosures: consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, Thermo Fisher Scientific.Lisa Christopher-Stine has the following financial disclosures: consultant fees from Janssen, Boehringer-Ingelheim, Mallinckrodt, EMD-Serono, Allogene and ArgenX.

  • 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.