Glen S Hazlewood1, Jordi Pardo Pardo1, Cheryl Barnabe1, Orit Schieir1, Claire E H Barber1, Sasha Bernatsky1, Ines Colmegna1, Carol Hitchon1, Mark Loeb1, Dominik Mertz1, Laurie Proulx1, Dawn P Richards1, Rosie Scuccimarri1, Peter Tugwell1, Holger J Schünemann1, Reza D Mirza1, Alan L Zhou1, Roko P A Nikolic1, Megan Thomas1, Helena Chase1, Maede Ejaredar1, Robby Nieuwlaat1. 1. G.S. Hazlewood, MD, PhD, Associate Professor of Medicine, C. Barnabe, MD, MSc, Associate Professor of Medicine, C.E. Barber, MD, PhD, Assistant Professor of Medicine, Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, and Arthritis Research Canada, Richmond, British Columbia; J.P. Pardo, LDO, Managing Editor, Centre for Global Health, University of Ottawa, Ottawa, Ontario; O. Schieir, PhD, Canadian Early Arthritis Cohort Study, Toronto, Ontario; S. Bernatsky, MD, PhD, Professor of Medicine, Research Institute of the McGill University Health Centre (RI-MUHC), Montreal, Quebec; I. Colmegna, MD, Associate Professor of Medicine, Division of Rheumatology, Department of Medicine, McGill University, Montreal, Quebec; C. Hitchon, MD, MSc, Associate Professor of Medicine, Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba; M. Loeb, MD, MSc, Professor, D. Mertz, MD, MSc, Associate Professor of Medicine, H.J. Schünemann, MD, MSc, PhD, Professor of Medicine and Clinical Epidemiology, Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster GRADE Centers, Hamilton; L. Proulx, B.Com, D.P. Richards, PhD, Canadian Arthritis Patient Alliance, Toronto, Ontario; R. Scuccimarri, MD, Associate Professor of Pediatrics, Division of Pediatric Rheumatology, Department of Pediatrics, McGill University, Montreal, Quebec; P. Tugwell, MD, Professor of Medicine, A.L. Zhou, MD, Department of Medicine, University of Ottawa, Ottawa, Ontario; R.D. Mirza, MD, Department of Medicine, University of Toronto, Toronto, Ontario; R.P. Nikolic, BSc, Cumming School of Medicine, University of Calgary, Calgary, Alberta; M. Thomas, BHSc, M. Ejaredar, PhD, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta; H. Chase, University of Ottawa, Ottawa, Ontario; R. Nieuwlaat, MSc, PhD, Associate Professor, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. JPP has received funding from Canadian Rheumatology Association to Cochrane Musculoskeletal to provide methodological support for guideline development. CB has received honoraria for advisory boards (Gilead, Pfizer) and speaker fees (Sanofi, Novartis) in the past 3 years and was a nonvoting member of the guidelines panel. ML has received payment for advisory boards (Pfizer, Medicago, Sanofi, Seqirus) and data safety monitoring committee (CanSino Biologics), and was a nonvoting member of the guidelines panel. LP serves as volunteer Vice President of Canadian Arthritis Patient Alliance which receives the majority of its funding from independent grants from pharmaceutical companies, and has received payment and travel support in the last 3 years from Lilly Canada (sharing patient perspectives at an event). DPR serves as volunteer Vice President of Canadian Arthritis Patient Alliance which receives the majority of its funding from independent grants from pharmaceutical companies. DPR's employer, Five02 Labs Inc., has received payment in the last 3 years from NovoNordisk (speaking about arthritis advocacy) and Lilly Canada (sharing patient story, participating in an advisory board). CH has received research funds from Research Manitoba, Health Sciences Centre Foundation, Pfizer, and UCB Canada for unrelated work, and was a nonvoting member of the guidelines panel. HJS serves as co-chair for the GRADE Working Group, has received funding from the Canadian Institutes of Health Research (CIHR; FRN VR4-172741), and was a nonvoting technical expert. The remaining authors report no conflicts of interest relevant to this article. Address correspondence to Dr. G.S. Hazlewood, Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada. Email: gshazlew@ucalgary.ca. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication May 14, 2021.
Abstract
OBJECTIVE: To develop guidance on the use of coronavirus disease 2019 (COVID-19) vaccines in patients with autoimmune rheumatic diseases (ARD). METHODS: The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel including rheumatologists, researchers, methodologists, vaccine experts, and patients. The panel used the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Outcomes were prioritized according to their importance for patients and clinicians. Evidence from the COVID-19 clinical trials was summarized. Indirect evidence for non-COVID-19 vaccines in ARD was also considered. The GRADE evidence-to-decision (EtD) framework was used to develop a recommendation for the use of the 4 COVID-19 vaccines approved in Canada as of March 25, 2021 (BNT162b2, mRNA-1273, ChAdOx1, and Ad26.COV2.S), over 4 virtual panel meetings. RESULTS: The CRA guideline panel suggests using COVID-19 vaccination in persons with ARD. The panel unanimously agreed that for the majority of patients, the potential health benefits of vaccination outweigh the potential harms in people with ARDs. The recommendation was graded as conditional because of low or very low certainty of the evidence on the effects in the population of interest, primarily due to indirectness and imprecise effect estimates. The panel felt strongly that persons with autoimmune rheumatic diseases who meet local eligibility should not be required to take additional steps compared to people without ARDs to obtain their vaccination. Guidance on medications, implementation, monitoring of vaccine uptake, and research priorities are also provided. CONCLUSION: This recommendation will be updated over time as new evidence emerges, with the latest recommendation, evidence summaries, and EtD available on the CRA website.
OBJECTIVE: To develop guidance on the use of coronavirus disease 2019 (COVID-19) vaccines in patients with autoimmune rheumatic diseases (ARD). METHODS: The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel including rheumatologists, researchers, methodologists, vaccine experts, and patients. The panel used the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Outcomes were prioritized according to their importance for patients and clinicians. Evidence from the COVID-19 clinical trials was summarized. Indirect evidence for non-COVID-19 vaccines in ARD was also considered. The GRADE evidence-to-decision (EtD) framework was used to develop a recommendation for the use of the 4 COVID-19 vaccines approved in Canada as of March 25, 2021 (BNT162b2, mRNA-1273, ChAdOx1, and Ad26.COV2.S), over 4 virtual panel meetings. RESULTS: The CRA guideline panel suggests using COVID-19 vaccination in persons with ARD. The panel unanimously agreed that for the majority of patients, the potential health benefits of vaccination outweigh the potential harms in people with ARDs. The recommendation was graded as conditional because of low or very low certainty of the evidence on the effects in the population of interest, primarily due to indirectness and imprecise effect estimates. The panel felt strongly that persons with autoimmune rheumatic diseases who meet local eligibility should not be required to take additional steps compared to people without ARDs to obtain their vaccination. Guidance on medications, implementation, monitoring of vaccine uptake, and research priorities are also provided. CONCLUSION: This recommendation will be updated over time as new evidence emerges, with the latest recommendation, evidence summaries, and EtD available on the CRA website.
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