Felten R, Kawka L, Dubois M, et al. Tolerance of COVID-19 vaccination in patients with systemic lupus erythematosus: the international VACOLUP study. Lancet Rheumatol 2021; published online July 21. https://doi.org/10.1016/S2665-9913(21)00221-6
Recopilado por Carlos Cabrera Lozada. Director del postgrado de Medicina Materno Fetal. Universidad Central de Venezuela. ORCID: 0000-0002-3133-5183. 23/07/2021
131 vaccine candidates have been evaluated for SARS-CoV-2 in more than 380 trials, eventually leading to 20 vaccine approvals1 and more than 1·8 billion people vaccinated worldwide as of July 1, 2021. There is a paucity of data regarding the safety of COVID-19 vaccines in patients with rheumatic and musculoskeletal diseases2 such as systemic lupus erythematosus (SLE), because patients with SLE have largely been excluded from vaccine trials.3, 4, 5 Furthermore, the use of mRNA vaccines has raised substantial concerns about the tolerance of these new vaccine technologies in patients with SLE, as toll-like receptor stimulation by nucleic acids might increase the risk of flare. These uncertainties have been shown to be major determinants of reduced vaccination willingness in patients with rheumatic and musculoskeletal diseases.6 Therefore, the primary objective of the international vaccination against COVID in systemic lupus (VACOLUP) study was to assess the tolerance of COVID-19 vaccines in patients with SLE, including the risk of incident flare, from the patients’ perspective.VACOLUP was a cross-sectional study based on a 43-question web-based survey, which took place between March 22, 2021, and May 17, 2021. The study was approved by the ethics review board of Strasbourg medical faculty (#CE-2020-29) and respondents gave their written informed consent to participate in this research via a dedicated question at the beginning of the online questionnaire. The study targeted patients with a self-reported medically confirmed diagnosis of SLE. The primary outcome was the occurrence of side-effects, including flare. The VACOLUP questionnaire and detailed methods are shown in the appendix (pp 1–2, 7–17).