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      Side effects and flares risk after SARS-CoV-2 vaccination in patients with systemic lupus erythematosus

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          Abstract

          The objective of this study is to identify post SARS-CoV-2 vaccine BNT162b2 (BioNTech & Pfizer) side effects in patients with systemic lupus erythematosus (SLE) at the Cayetano Heredia Hospital, Lima, Peru. A descriptive observational study was designed in patients with SLE at the Immuno-Rheumatology Department of the Cayetano Heredia Hospital, Lima, Peru, immunized with the BNT162b2 vaccine from May 21 to June 30, 2021. Of the total number of patients seen in the service, 100 received the vaccine’s 1st dose, and 90 patients received the 2nd dose; 90% and 92.2% presented symptoms within 10 days after immunization (1st and 2nd doses, respectively), being pain at the inoculation site the most frequent (87%); most of the symptoms presented were of mild intensity. There were 27 episodes of post-immunization flare, 9% and 20% after the 1st and 2nd doses, respectively; the predominant type of flare was articular (85.1%), followed by dermal (18.5%). It was found that a history of renal involvement was associated with the risk of developing flare RR 0.38 (0.15–0.91) and the use of hydroxychloroquine and azathioprine prior to immunization 0.20 (0.06–0.63) and 7.96 (2.70–23.43) respectively. In 100 SLE patients immunized with BNT162b2 vaccine against SARS-CoV-2, 27% of SLE reactivation episodes occurred, two patients were hospitalized for flare severity, and none died.

          Key Points

          • Up to 92.2% presented some type of symptom after vaccination, being mostly local and of mild intensity.

          • Of the population studied, there were 27 episodes of post-vaccination flare, most of which were mild.

          • In the studied population, taking hydroxychloroquine and having a history of renal disease were associated with a lower risk of presenting post-vaccination flare.

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          Most cited references12

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          Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus.

          The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new knowledge regarding the immunology of SLE. The classification criteria were derived from a set of 702 expert-rated patient scenarios. Recursive partitioning was used to derive an initial rule that was simplified and refined based on SLICC physician consensus. The SLICC group validated the classification criteria in a new validation sample of 690 new expert-rated patient scenarios. Seventeen criteria were identified. In the derivation set, the SLICC classification criteria resulted in fewer misclassifications compared with the current ACR classification criteria (49 versus 70; P = 0.0082) and had greater sensitivity (94% versus 86%; P < 0.0001) and equal specificity (92% versus 93%; P = 0.39). In the validation set, the SLICC classification criteria resulted in fewer misclassifications compared with the current ACR classification criteria (62 versus 74; P = 0.24) and had greater sensitivity (97% versus 83%; P < 0.0001) but lower specificity (84% versus 96%; P < 0.0001). The new SLICC classification criteria performed well in a large set of patient scenarios rated by experts. According to the SLICC rule for the classification of SLE, the patient must satisfy at least 4 criteria, including at least one clinical criterion and one immunologic criterion OR the patient must have biopsy-proven lupus nephritis in the presence of antinuclear antibodies or anti-double-stranded DNA antibodies. Copyright © 2012 by the American College of Rheumatology.
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            2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

            To develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). This international initiative had 4 phases: 1) Evaluation of anti-nuclear antibody (ANA) as an entry criterion through systematic review and meta-regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort and a patient survey. 2) Criteria reduction by Delphi and nominal group technique (NGT) exercises. 3) Criteria definition and weighting based on criterion performance and on results of a multi-criteria decision analysis. 4) Refinement of weights and threshold scores in a new derivation cohort of 1001 subjects and validation compared to previous criteria in a new validation cohort of 1270 subjects. The 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in 7 clinical (constitutional, hematologic, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and 3 immunological (antiphospholipid antibodies, complement proteins, SLE-specific antibodies) domains, and weighted from 2 to 10. Patients accumulating ≥10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared to 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria. These new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered and weighted criteria reflect current thinking about SLE and provide an improved foundation for SLE research.
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              Is Open Access

              Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination

              Background: Infectious diseases and vaccines can occasionally cause new-onset or flare of immune-mediated diseases (IMDs). The adjuvanticity of the available SARS-CoV-2 vaccines is based on either TLR-7/8 or TLR-9 agonism, which is distinct from previous vaccines and is a common pathogenic mechanism in IMDs. Methods: We evaluated IMD flares or new disease onset within 28-days of SARS-CoV-2 vaccination at five large tertiary centres in countries with early vaccination adoption, three in Israel, one in UK, and one in USA. We assessed the pattern of disease expression in terms of autoimmune, autoinflammatory, or mixed disease phenotype and organ system affected. We also evaluated outcomes. Findings: 27 cases included 17 flares and 10 new onset IMDs. 23/27 received the BNT - 162b2 vaccine, 2/27 the mRNA-1273 and 2/27 the ChAdOx1 vaccines. The mean age was 54.4 ± 19.2 years and 55% of cases were female. Among the 27 cases, 21 (78%) had at least one underlying autoimmune/rheumatic disease prior the vaccination. Among those patients with a flare or activation, four episodes occurred after receiving the second-dose and in one patient they occurred both after the first and the second-dose. In those patients with a new onset disease, two occurred after the second-dose and in one patient occurred both after the first (new onset) and second-dose (flare). For either dose, IMDs occurred on average 4 days later. Of the cases, 20/27 (75%) were mild to moderate in severity. Over 80% of cases had excellent resolution of inflammatory features, mostly with the use of corticosteroid therapy. Other immune-mediated conditions included idiopathic pericarditis ( n = 2), neurosarcoidosis with small fiber neuropathy ( n = 1), demyelination ( n = 1), and myasthenia gravis ( n = 2). In 22 cases (81.5%), the insurgence of Adverse event following immunization (AEFI)/IMD could not be explained based on the drug received by the patient. In 23 cases (85.2%), AEFI development could not be explained based on the underlying disease/co-morbidities. Only in one case (3.7%), the timing window of the insurgence of the side effect was considered not compatible with the time from vaccine to flare. Interpretation: Despite the high population exposure in the regions served by these centers, IMDs flares or onset temporally-associated with SARS-CoV-2 vaccination appear rare. Most are moderate in severity and responsive to therapy although some severe flares occurred. Funding: none.
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                Author and article information

                Contributors
                ernestozav123@gmail.com
                Journal
                Clin Rheumatol
                Clin Rheumatol
                Clinical Rheumatology
                Springer International Publishing (Cham )
                0770-3198
                1434-9949
                16 November 2021
                : 1-9
                Affiliations
                [1 ]Cayetano Heredia Hospital, Av. Honorio Delgado, N°262, San Martin de Porres, Lima, Peru
                [2 ]GRID grid.11100.31, ISNI 0000 0001 0673 9488, Cayetano Heredia Peruvian University, FMH-UPCH, ; Lima, Peru
                Author information
                http://orcid.org/0000-0002-7389-5576
                https://orcid.org/0000-0002-9221-3040
                https://orcid.org/0000-0003-1232-5200
                https://orcid.org/0000-0001-8640-6658
                Article
                5980
                10.1007/s10067-021-05980-5
                8592807
                34782941
                b52baff4-f62a-4acd-a658-438424f23daf
                © International League of Associations for Rheumatology (ILAR) 2021

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                : 20 August 2021
                : 18 September 2021
                : 31 October 2021
                Categories
                Brief Report

                Rheumatology
                (mesh nlm): coronavirus,autoimmune diseases,covid-19,systemic lupus erythematosus,vaccines

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