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  • Rheumatoid arthritis disease activity assessed by patient-reported outcomes and flow cytometry before and after an additional dose of COVID-19 vaccine

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Rheumatoid arthritis disease activity assessed by patient-reported outcomes and flow cytometry before and after an additional dose of COVID-19 vaccine
  1. Sara K Tedeschi1,2,
  2. Jacklyn Stratton1,
  3. Jack Elias Ellrodt1,
  4. Mary Grace Whelan1,
  5. Keigo Hayashi1,
  6. Kazuki Yoshida1,2,
  7. Lin Chen1,
  8. Ifeoluwakiisi Adejoorin1,
  9. Kathryne Elizabeth Marks1,2,
  10. A. Helena Jonsson1,
  11. Deepak A Rao1,2,
  12. Daniel H Solomon1,2
  1. 1 Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA
  2. 2 Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Sara K Tedeschi, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA; stedeschi1{at}bwh.harvard.edu

https://doi.org/10.1136/annrheumdis-2022-222232

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    The Centers for Disease Control and Prevention has recommended that moderately/severely immunosuppressed individuals receive an additional dose (AddDose) of COVID-19 vaccine at least 28 days after an initial mRNA vaccine series, or at least 2 months after a single adenovirus vector vaccine.1 Rheumatoid arthritis (RA) is frequently treated with immunosuppressive disease-modifying antirheumatic drugs (DMARDs), meaning that most patients with RA are eligible for an AddDose. The American College of Rheumatology suggests patients interrupt use of (‘hold’) certain DMARDs around the time of COVID-19 vaccination in attempt to boost immunogenicity.2 A small number of reports have noted no significant change in RA disease activity pre vaccination versus post vaccination against COVID-19, but they assessed RA disease activity infrequently and did not compare results for patients who held versus continued DMARDs. Furthermore, data are lacking on the assessment of immune cellular populations possibly correlated with RA disease activity around the time of COVID-19 vaccination.

    We conducted a prospective observational study of patients with RA treated at Brigham and Women’s Hospital who were previously vaccinated against COVID-19 (two doses of mRNA vaccine or one dose of adenovirus vector vaccine). Subjects enrolled between July and November 2021, prior to receiving an AddDose. RA disease activity was assessed weekly using the validated patient-reported RA Disease Activity Index—5 (RADAI-5) from enrolment through 4 weeks post-AddDose via online data entry.3 Subjects completed an additional online survey 2 days after the AddDose regarding vaccine reactogenicity and whether they held or continued DMARDs. We compared mean RADAI-5 in the 4 weeks pre-AddDose versus the 4 weeks post-AddDose using the generalised estimating equation in SAS (V.9.4) to account for correlated …

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    Footnotes

    • DAR and DHS are joint senior authors.

    • Handling editor Josef S Smolen

    • Twitter @kaz_yos, @deepakarao

    • Contributors SKT and DHS were responsible for conceiving the study, overseeing recruitment and data interpretation. SKT drafted the first version of the manuscript. JS, JEE, and MGW were responsible for subject recruitment, conducting study visits, data entry and provided comments on the manuscript. KH performed data analysis and provided comments on the manuscript. KY provided biostatistical input and provided comments on the manuscript. LC, IA and KEM performed flow cytometry and data analyses and provided comments on the manuscript. AHJ contributed to study design and provided critical feedback on the manuscript. DAR contributed to study design, oversaw flow cytometry analyses and provided critical feedback on the manuscript.

    • Funding ModernaTx provided support to Brigham and Women’s Hospital for an Investigator Sponsored Study and ModernaTx approved the final manuscript, but was not involved with study design, study conduct, data analysis, results interpretation or drafting the manuscript. Additional support for the investigators’ time came from the National Institutes of Health (K23 AR075070, L30 AR070514, K23 AR076453, K08 AR072791, P30 AR072577 and P30 AR070253). DAR receives support from the Clinical Scientist Development Award from the Doris Duke Charitable Foundation.

    • Competing interests ModernaTx provided support for this investigator-sponsored study (PI: DHS) with payments made directly to Brigham and Women’s Hospital. SKT: research support to Brigham and Women’s Hospital from NIH; consulting fees from NGM Biopharmaceuticals. KY: research support to Brigham and Women’s Hospital from NIH; consulting fees from OM1, Inc. AHJ: research support to Brigham and Women’s Hospital from Amgen. DAR: research support to Brigham and Women’s Hospital from Doris Duke Charitable Foundation, Jansen, Merck, NIH; scientific advisory board member for Bristol Myers Squibb; patent submitted on T peripheral helper cells as a biomarker in autoimmune disease; consulting fees from Jansen. DHS: research support to Brigham and Women’s Hospital from ModernaTx, Amgen, Abbvie, CorEvitas, and NIH; royalties from UpToDate for a chapter related to NSAIDs.

    • 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.