ACR Releases COVID-19 Vaccine Clinical Guidance for Patients With Rheumatic and Musculoskeletal Diseases

The American College of Rheumatology (ACR) coronavirus disease 2019 (COVID-19) Vaccine Clinical Guidance Task Force has issued consensus-based recommendations for the use of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases (RMDs). While the full manuscript is pending journal peer review, a draft summary was published on the ACR website.

The task force panel, including 9 rheumatologists, 2 infectious disease specialists, and 2 public health experts, convened in December 2020 and January 2021. The panel was divided into subgroups and assigned clinical questions to evaluate using evidence reviews. The reviews were combined into proposed vaccine guidance statements that were refined by consensus building, using the modified Delphi process. Panel members rated their agreement using a numeric scoring system, with consensus scored as either “strong” or “moderate.” Overall, they approved 6 general considerations and 8 recommendations for COVID-19 vaccination in patients with RMDs.

General Considerations for COVID-19 Vaccination in Patients with RMDs

• Rheumatology providers should engage patients with RMDs in a shared decision-making process about receiving the COVID-19 vaccine. (Strong-Moderate)
• Patients with autoimmune and inflammatory rheumatic diseases (AIIRDs) are at higher risk for hospitalization and poorer outcomes due to COVID-19. (Moderate)
• Patients with AIIRDs should be prioritized for the COVID-19 vaccine before individuals without AIIRD of similar age and sex. (Moderate)
• There are no additional contraindications for patients with AIIRD to be vaccinated against COVID-19, apart from known allergies to vaccine components. (Moderate)
• The immune response to the COVID-19 vaccine may be reduced in magnitude and duration in patients receiving systemic immunomodulatory therapies vs the general population. (Moderate)
• There is a potential risk for AIIRD flares or disease worsening following COVID-19 vaccination; however, the benefits of vaccination outweigh the risks for new onset autoimmunity in patients with RMDs. (Moderate)

Recommendations for COVID-19 Vaccination in Patients with RMDs

• Patients with RMDs and AIIRDs should receive COVID-19 vaccination, if age-eligible (aged ≥16 years). (Moderate)
• Patients with RMDs, with or without an AIIRD, receiving immunomodulatory therapy should be vaccinated against COVID-19 in a similar manner. (Moderate)
• Of the messenger RNA (mRNA) COVID-19 vaccines available in the United States, there is no preference for 1 vaccine over another, and patients should receive the vaccine that is available to them. (Moderate)
• Multidose vaccines should be administered as recommended, even if there are nonserious adverse events observed with the first dose. (Strong)
• Healthcare providers should not routinely order lab tests to assess the need for vaccination in an unvaccinated individual or to evaluate immunity after COVID-19 vaccination. (Strong)
• Following COVID-19 vaccination, patients with RMDs should continue to follow public health guidelines, including physical distancing and other recommended preventive measures. (Strong)
• Household members and other close contacts should receive the COVID-19 vaccine to protect the patient with an AIIRD; however, prioritized vaccination of these individuals may not be recommended. (Moderate)
• Except for patients with life-threatening illnesses, patients with AIIRDs should receive the COVID-19 vaccine soon as possible, regardless of disease activity and severity. (Strong-Moderate)

The ACR task force also developed guidance on the use and timing of COVID-19 vaccination and immunomodulatory therapies in patients with RMDs.

• Panel members suggested no modifications to immunomodulatory therapy or vaccination timing in patients receiving hydroxychloroquine; glucocorticoids; prednisone-equivalent doses of less than 20 mg/day; disease-modifying antirheumatic drugs, including sulfasalazine, leflunomide, mycophenolate, and azathioprine; oral cyclophosphamide; tumor necrosis factor inhibitors; intravenous immunoglobulin; interleukin (IL) inhibitors, including IL-1, IL-17, IL-12, and IL-23; belimumab; and oral calcineurin inhibitors.
• Providers should hold treatment 1 week after each dose of the COVID-19 vaccine in patients receiving methotrexate, cyclophosphamide, and janus kinase inhibitors, with no modifications to vaccination timing.
• For patients receiving subcutaneous abatacept, the panel recommended to hold treatment both 1 week before and after the first COVID-19 vaccine dose only. For patients receiving intravenous abatacept, COVID-19 vaccination should be timed such that the first vaccine dose occurs 4 weeks after infusion, with the subsequent infusion postponed by 1 week.
• For patients receiving rituximab, providers must schedule COVID-19 vaccination 4 weeks before the next treatment cycle. Following the first vaccine dose, rituximab must be delayed 2 to 4 weeks after the second vaccine dose, if possible.
• The panel did not reach a consensus for vaccination timing in patients receiving prednisone-equivalent doses of 20 mg/day or more.

The task force added, “These statements were based on a dearth of high-quality data and are not intended to replace clinical judgement. Modifications made to treatment plans, particularly in complex rheumatic disease patients, are highly disease-, patient-, geography-, and time-specific, and therefore, must be individualized as part of a shared decision-making process. This guidance is provided as part of a ‘living document,’ recognizing rapidly evolving evidence and the anticipated need for frequent updates as such evidence becomes available.”

Reference

American College of Rheumatology. COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases. Published February 8, 2021. Accessed February 16, 2021. https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf