Don't Hold the Biologic or JAK with COVID-19 Vaccination Save
A randomized clinical trial in inflammatory arthritis arthritis shows that temporarily holding biologic or Janus kinase (JAK) inhibitor therapy at the time of COVID-19 vaccination is not warranted.
While holding methotrexate at the time of influenza vaccination (for 1 or 2 weeks) has been shown to improve vaccine outcomes without causing arthritis flares, the same maneuver has not been studied with COVID-19 vaccination or booster shots.
A multicenter randomized clinical trial enrolled 840 patients with inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis) from the Excellence Network in Rheumatology to Innovate Care and High-Impact Research (ENRICH) practice-based network. Patients on stable immunomodulatory therapy (anti–tumor necrosis factor, anti–interleukin-17, abatacept, and a Janus kinase inhibitor) received a primary messenger RNA COVID-19 vaccine series and were either randomized to continue or hold therapy for 2 weeks following their next COVID-19 supplemental dose administration. The primary outcome was change in immunoglobulin G levels against the SARS-CoV-2 spike protein from baseline to 6-week follow-up, expressed as the geometric mean fold rise (GMFR).
Among these 840 participants substantial increases in SARS-CoV-2 spike immunoglobulin G antibody levels were observed across all groups, with no significant difference in humoral immunogenicity between arms.
Yet, holding therapy significantly increased disease flare risk (OR 2.27; 95% CI, 1.41-3.65), which was most seen with JAKi. Flares were assessed using the Outcome Measures in Rheumatology RA Flare Questionnaire and showed a ≥10-point worsening in 21% vs 9.1%. Adverse events were comparable between medication arms and were more frequent in the hold group.
Thus holding select biologic or JAKi therapies for 2 weeks at the time of supplemental COVID-19 vaccine dose did not significantly enhance humoral immunogenicity, but was was associated with transient but clinically meaningful disease flare.
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