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Background: In the current situation of the SARS-CoV-2 pandemic, the Spanish Society of Rheumatology recommends vaccination of patients with chronic infammatory diseases (CID) under treatment with biological DMARDs (bDMARDs). However, the data regarding the generation of protective antibody titers after mRNA vaccines in patients with CID is limited. Objectives: To determine the seroconversion rate and safety after the SARS-CoV-2 vaccine in patients with CID under treatment with bDMARDs Methods: Cross-sectional observational study of 81 patients with CID from the HURS in Córdoba, who have received full vaccination for SARS-CoV-2 (without having previously suffered from COVID-19 disease) according to national guidelines. A determination of specifc IgG-type antibodies against the trimeric spike protein of SARS-CoV2 was performed on all of them. The chemilumines-cence technique with the kit was used in serum samples taken 4-5 weeks after administration of the second dose of the vaccine. Information about sociode-mographic characteristics, disease, type of bDMARDs, concomitant treatments and adverse effects after the second dose of the vaccine were collected in each patient. Results: 81 patients were included (mean age 59.5, 72.8% females). 50.6% of patients had RA, 17.3% SpA, 11% PsoA and 18.5% other CID. 23.5% were under treatment with Rituximab, 38.8% antiTNF, 13.6% Tocilizumab, 9.9% abatacept, 5% anti-JAK and 14.2% under other treatments. Anti-SARS-CoV-2 antibodies and neutralizing activity were detected in 80% of study participants. Rituximab treatment was signifcantly associated with negative seroconver-sion in comparison with patients under antiTNF treatment (OR 84.0 (95%CI 12.9-1709.2)). No interaction was found between the bDMARDs treatment and the type of vaccine with regard to the seroconversion, nor between bDMARDs and concomitant synthetic DMARD. When we evaluated IgG titers against the spike protein of SARS-CoV2, we found that patients under treatment with Rituximab showed the lowest titers levels in comparison with patients with other treatments (Figure 1, Table 1). In addition, patients who received AstraZeneca vaccine developed lower titers of antibodies in comparison with patients who received Pfzer (Table 1). Interestingly, among patients with antiTNF treatment, AstraZeneca was associated with lower IgG titers in comparison with Pfzer and Moderna [405.9 (553.0) vs. 1084.1 (791.2) vs. 1264.0 (1012.6), p=0.016, respectively]. No differences between vaccines were found in patients with the other type of bDMARDs. Only 18.9% presented mild adverse effects. No serious adverse effects were observed and no patient experienced a disease fare after vaccination. Conclusion: Our results show that SARS-CoV-2 mRNA vaccines produce sero-conversion in most patients with CID, except in the case of patients with rituxi-mab. No severe adverse effects or CID reactivation were found. Despite the small number of patients included, this study suggests the need for revaccination in the group of patients treated with rituximab or vaccinated with Astrazeneca.
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Introduction Afin d’évaluer l’adhésion des patients souffrant de rhumatismes inflammatoires chroniques (RIC) à leurs traitements, de nombreux auto-questionnaires existent dont celui dédié et validé par la British Society of Rheumatology, le Compliance Questionnaire for Rheumatology (CQR) à 19 questions. Dans un souci de facilité et de rapidité d’utilisation en pratique clinique, a été développée et validée une version à 5 items (CQR-5) permettant de définir soit un profil hautement adhérent soit faiblement adhérent. L’objectif de cette étude a été de traduire et valider la traduction française du CQR-5 en suivant les recommandations internationales [1]. Matériels et méthodes Une étude observationnelle et monocentrique a été menée chez des patients atteints de RIC ayant eu une consultation médicale en rhumatologie entre mai 2019 et avril 2020. Les patients inclus étaient traités par un biomédicament sous forme sous-cutanée depuis au moins 3 mois. Les patients ont été invités à compléter en ligne deux fois le questionnaire CQR-5 ainsi que le questionnaire Routine Assessment of Patient Index Data 3 (RAPID3) à sept jours d’intervalle pour s’assurer de la stabilité de la maladie. L’adhésion des patients a été aussi évaluée grâce au Medication Possession Ratio (MPR) sur une période de 6 mois (juillet 2020 à janvier 2021) par un appel au pharmacien d’officine déclaré préalablement par le patient. La validité du CQR-5 a été évaluée par le coefficient α de Cronbach, par la méthode du test-retest à 7jours et par la comparaison au MPR en utilisant le coefficient de corrélation de Mathews. Résultats Au total, 92 patients ont été inclus (moyenne d’âge : 47,5±13,6 ans et 56,5 % de femmes). Les patients étaient atteints de spondyloarthrite (75 %), de polyarthrite rhumatoïde (23,9 %) ou d’arthrite juvénile (1,1 %). Parmi les biomédicaments, les anticorps monoclonaux anti TNF-α étaient prescrits chez 78,3 % des patients. Selon le CQR-5 français, 81,5 % (n=75) des patients étaient hautement adhérents. Selon le MPR, 79 % des patients étaient hautement adhérents. Selon le MPR, la sensibilité et la spécificité du CQR-5 étaient respectivement de 85 % et 32 % (corrélation : 0,17). La consistance interne du CQR-5 français est fiable (α Cronbach : 0,74 ;IC95 % :0,66-0,83), a une seule dimension (les 5 items explorent bien un seul concept : l’adhésion) et est reproductible (Kappa : 0,82 (95 %CI 0,51-0,96)). Discussion La faible spécificité de la version française par rapport au MPR peut être expliquée par la période de recueil de données (la pandémie COVID19 ayant entraîné des suspensions de biomédicament) et par l’espacement médicalement autorisé des injections par les patients, ce qui a contribué à sous-estimer le MPR. Conclusion La traduction française du CQR-5 est un outil pratique, rapide et reproductible en pratique clinique comme outil d’évaluation de l’adhésion aux biomédicaments chez les patients atteints de RIC.
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OBJECTIVE: To describe whether rheumatic inflammatory diseases (RID) are associated with a higher risk of hospitalization and/or mortality from COVID-19 and identify the factors associated with hospitalization and mortality in RID and COVID-19 in different Hospitals in Andalusia. METHODS: Design: Multicentre observational case-COntrol study. PATIENTS: RID and COVID-19 from different centres in Andalusia. CONTROLS: patients without RIS matched by sex, age and CRP-COVID. Protocol A list of patients with PCR for COVID-19 was requested from the microbiology service from March 14 to April 14, 2020. The patients who had RID were identified and then consecutively a paired control for each case. Variables The main outcome variable was hospital admission and mortality from COVID-19. Statistical analysis Bivariate followed by binary logistic regression models (DV: mortality/hospital admission). RESULTS: One hundred and fifty-six patients were included, 78 with RID and COVID-19 and 78 without RID with COVID-19. The patients did not present characteristics of COVID-19 disease different from the general population, nor did they present higher hospital admission or mortality. The factor associated with mortality in patients with RID was advanced age (OR [95% CI], 1.1 [1.0-1.2]; P= .025), while the factors associated with hospitalization were advanced age (OR [95% CI], 1.1 [1.0-1.1]; P = .007) and hypertension (OR [95% CI], 3.9 [1.5-6.7]; P = .003). CONCLUSION: Mortality and hospital admission due to COVID-19 do not seem to increase in RID. Advanced age was associated with mortality in RID and, in addition, HTN was associated with hospital admission.
Subject(s)
COVID-19 , Hypertension , Rheumatic Diseases , Case-Control Studies , Comorbidity , Hospitalization , Humans , Hypertension/epidemiology , Rheumatic Diseases/complications , Rheumatic Diseases/epidemiology , Risk Factors , SARS-CoV-2ABSTRACT
OBJECTIVE: To describe whether rheumatic inflammatory diseases (RID) are associated with a higher risk of hospitalization and/or mortality from COVID-19 and identify the factors associated with hospitalization and mortality in RID and COVID-19 in different Hospitals in Andalusia. METHODS: Design: Multicentre observational case-control study. PATIENTS: RID and COVID-19 from different centres in Andalusia. CONTROLS: patients without RIS matched by sex, age and CRP-COVID. Protocol A list of patients with PCR for COVID-19 was requested from the microbiology service from March 14 to April 14, 2020. The patients who had RID were identified and then consecutively a paired control for each case. Variables The main outcome variable was hospital admission and mortality from COVID-19. Statistical analysis Bivariate followed by binary logistic regression models (DV: mortality/hospital admission). RESULTS: One hundred and fifty-six patients were included, 78 with RID and COVID-19 and 78 without RID with COVID-19. The patients did not present characteristics of COVID-19 disease different from the general population, nor did they present higher hospital admission or mortality. The factor associated with mortality in patients with RID was advanced age (OR [95% CI], 1.1 [1.0-1.2]; p = 0.025), while the factors associated with hospitalization were advanced age (OR [95% CI], 1.1 [1.0-1.1]; p = 0.007) and hypertension (OR [95% CI], 3.9 [1.5-6.7]; p = 0.003). CONCLUSION: Mortality and hospital admission due to COVID-19 do not seem to increase in RID. Advanced age was associated with mortality in RID and, in addition, HTN was associated with hospital admission.