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3 results on '"Traboco, Ls"'

1. Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study.

Author

Naveen R, Nikiphorou E, Joshi M, Sen P, Lindblom J, Agarwal V, Lilleker JB, Tan AL, Salim B, Ziade N, Velikova T, Gracia-Ramos AE, Kuwana M, Day J, Makol A, Distler O, Chinoy H, Traboco LS, Wibowo SAK, Tehozol EAZ, Serrano JR, García-De La Torre I, Aggarwal R, Gupta L, Agarwal V, and Parodis I

Subjects
Adult, Female, Humans, Male, Chills, SARS-CoV-2, Vaccination adverse effects, Autoimmune Diseases, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Exanthema, Lupus Erythematosus, Systemic, Vaccines
Abstract

Objective: To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HC)., Methods: Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March-December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type and background treatment., Results: Among 9462 complete respondents, 583 (6.2%) were SLE patients (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs were reported by 83.0% of SLE patients, major by 2.6%, hospitalization by 0.2%. AE and hospitalization frequencies were similar between patients with active and inactive SLE. Rashes were more frequent in SLE patients vs HC (OR; 95% CI: 1.2; 1.0, 1.5), chills less frequent in SLE vs AIRDs (0.6; 0.4, 0.8) and nrAIDs (0.5; 0.3, 0.8), and fatigue less frequent in SLE vs nrAIDs (0.6; 0.4, 0.9). Pfizer-recipients reported higher overall AE (2.2; 1.1, 4.2) and injection site pain (2.9; 1.6, 5.0) frequencies than recipients of other vaccines, Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5, 3.0), Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6, 4.3). Hospitalization frequencies were similar across vaccine types. AE frequencies were similar across treatment groups, although chills were less frequent in antimalarial users vs non-users (0.5; 0.3, 0.9)., Conclusion: While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Published
2023
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2. Vaccine hesitancy decreases in rheumatic diseases, long-term concerns remain in myositis: a comparative analysis of the COVAD surveys

Author

Sen, P, Naveen, R, Houshmand, N, Kia, Sm, Joshi, M, Saha, S, Jagtap, K, Agarwal, V, Nune, A, Nikiphorou, E, Tan, Al, Shinjo, Sk, Ziade, N, Velikova, T, Milchert, M, Parodis, I, Gracia-Ramos, Ae, Cavagna, L, Kuwana, M, Knitza, J, Makol, A, Patel, A, Pauling, Jd, Wincup, C, Barman, B, Tehozol, Eaz, Serrano, Jr, de la Torre, I, Colunga-Pedraza, Ij, Merayo-Chalico, J, Chibuzo, Oc, Katchamart, W, Goo, Pa, Shumnalieva, R, Chen, Ym, Hoff, Ls, El Kibbi, L, Halabi, H, Vaidya, B, Shaharir, Ss, Hasan, Atmt, Dey, D, Gutierrez, Cet, Caballero-Uribe, Cv, Lilleker, Jb, Salim, B, Gheita, T, Chatterjee, T, Distler, O, Saavedra, Ma, Day, J, Chinoy, H, COVAD Study Grp, Kardes, S, Kardes, Sa, Andreoli, L, Lini, D, Screiber, K, Vince, Mn, Singh, Yp, Ranjan, R, Jain, A, Pandya, Sc, Pilania, Rk, Sharma, A, Manoj, Mm, Gupta, V, Kavadichanda, Cg, Patro, Ps, Ajmani, S, Phatak, S, Goswami, Rp, Chowdhury, Ac, Mathew, Aj, Shenoy, P, Asranna, A, Bommakanti, Kt, Shukla, A, Pande, Ar, Chandwar, K, Ghodke, A, Boro, H, Fazal, Zz, Cansu, Du, Yildirim, R, Gasparyan, Ay, Del Papa, N, Sambataro, G, Fabiola, A, Govoni, M, Parisi, S, Bocci, Eb, Sebastiani, Gd, Fusaro, E, Sebastiani, M, Quartuccio, L, Franceschini, F, Sainaghi, Pp, Orsolini, G, De Angelis, R, Danielli, Mg, Venerito, V, Grignaschi, S, Giollo, A, Alluno, A, Ioannone, F, Fornaro, M, Traboco, Ls, Wibowo, Sak, Loarce-Martos, J, Prieto-Gonzalez, S, Gonzalez, Ra, Yoshida, A, Nakashima, R, Sato, S, Kimura, N, Kaneko, Y, Gono, T, Tomaras, S, Proft, Fn, Holzer, Mt, Gromova, Ma, Aharonov, O, Griger, Z, Hmamouchi, I, El Bouchti, I, Baba, Z, Giannini, M, Maurier, F, Campagne, J, Meyer, A, Langguth, D, Limaye, V, Needham, M, Srivastav, N, Hudson, M, Landon-Cardinal, O, Zuleta, Wgr, Arbelaez, A, Cajas, J, Silva, Jap, Fonseca, Je, Zimba, O, Bohdana, D, Ima-Edomwonyi, U, Dedeke, I, Airenakho, E, Madu, Nh, Yerima, A, Olaosebikan, H, Becky, A, Koussougbo, Od, Palalane, E, So, H, Ugarte-Gil, Mf, Chinchay, L, Bernaola, Jp, Pimentel, V, Fathi, Hm, Mohammed, Rha, Harifi, G, Fuentes-Silva, Y, Cabriza, K, Losanto, J, Colaman, N, Cachafeiro-Vilar, A, Bautista, Gg, Ejg, Ho, Gonzalez, R, Nunez, Ls, Vergara, Mc, Baez, Jt, Alonzo, H, Pastelin, Cbs, Salinas, Rg, Obiols, Aq, Chavez, N, Ordonez, Ab, Argueta, S, Llerena, Gar, Sierra-Zorita, R, Arrieta, D, Hidalgo, Er, Saenz, R, Escalante, Mi, Morales, R, Calapaqui, W, Quezada, I, Arredondo, G, Aggarwal, R, and Gupta, L

Subjects
Rheumatology, idiopathic inflammatory myopathies, COVID-19 vaccines, vaccine hesitancy, registries, Pharmacology (medical), autoimmune disease
Abstract

ObjectiveCOVID-19 vaccines have a favorable safety profile in patients with autoimmune rheumatic diseases (AIRDs) such as idiopathic inflammatory myopathies (IIMs); however, hesitancy continues to persist among these patients. Therefore, we studied the prevalence, predictors and reasons for hesitancy in patients with IIMs, other AIRDs, non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs), using data from the two international COVID-19 Vaccination in Autoimmune Diseases (COVAD) e-surveys.MethodsThe first and second COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analysed using regression models in different groups.ResultsWe analysed data from 18 882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) (OR: 0.26; 95% CI: 0.24, 0.30, P ConclusionVaccine hesitancy has decreased from 2021 to 2022, long-term safety concerns remain among patients with IIMs, particularly in Caucasians and those with poor physical function.

Published
2023

3. COVID-19 Vaccination In Autoimmune Diseases (COVAD) Study: Vaccine Safety In Idiopathic Inflammatory Myopathies

Author

Gil‐vila, A, Naveen, R, Selva‐o'Callaghan, A, Sen, P, Nune, A, Gaur, Ps, Gonzalez, Ra, Lilleker, Jb, Joshi, M, Agarwal, V, Kardes, S, Kim, M, Day, J, Makol, A, Milchert, M, Gheita, T, Salim, B, Velikova, T, Gracia‐ramos, Ae, Parodis, I, Nikiphorou, E, Tan, Al, Chatterjee, T, Cavagna, L, Saavedra, Ma, Shinjo, S, Katsuyuki, Zn, Knitza, J, Kuwana, M, Distler, O, Chinoy, H, Aggarwal, R, Gupta, L, Barman, B, Singh, Yp, Ranjan, R, Jain, A, Pandya, Sc, Pilania, Rk, Sharma, A, Manesh, Mm, Gupta, V, Kavadichanda, Cg, Patro, Ps, Ajmani, S, Phatak, S, Goswami, Rp, Chowdhury, Ac, Mathew, Aj, Shenoy, P, Asranna, A, Bommakanti, Kt, Shukla, A, Pandey, Akr, Chandwar, K, Cansu, Dü, Pauling, Jd, Wincup, C, Del Papa, N, Sambataro, G, Atzeni, F, Govoni, M, Parisi, S, Bocci Bartoloni, E, Sebastiani, Gd, Fusaro, E, Sebastiani, M, Quartuccio, L, Franceschini, F, Sainaghi, Pp, Orsolini, G, De Angelis, R, Danielli, Mg, Venerito, V, Traboco, Ls, Wibowo, Sak, Tehozol, Eaz, Serrano, Jr, García‐De La Torre, I, Loarce‐martos, J, Prieto‐gonzález, S, Yoshida, A, Nakashima, R, Sato, S, Kimura, N, Kaneko, Y, Tomaras, S, Gromova, Ma, Aharonov, Om, Hmamouchi, I, Hoff, Ls, Giannini, M, Maurier, F, Campagne, J, Meyer, A, Nagy‐vincze, M, Langguth, D, Limaye, V, Needham, M, Srivastav, N, Hudson, M, Landon‐cardinal, O, Shaharir, Ss, Zuleta, Wgr, Silva, Jap, Fonseca, Je, Zimba, O, Institut Català de la Salut, [Gil-Vila A, Selva-O'Callaghan A] Unitat d’Inflamació i Autoimmunitat, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Ravichandran N] Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. [Sen P] Maulana Azad Medical College, Delhi, India. [Nune A] Southport and Ormskirk Hospital NHS Trust, Southport, UK. [Gaur PS] Smt. Kashibai Navale Medical and General Hospital, Pune, India, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Adult, Male, COVID-19 Vaccines, dermatomyositis, Physiology, Simian Acquired Immunodeficiency Syndrome, rheumatology, Keywords: COVID-19, Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], Autoimmune Diseases, Myositis, Inclusion Body, Cellular and Molecular Neuroscience, Physiology (medical), Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Other subheadings::Other subheadings::/adverse effects [Other subheadings], virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Animals, Humans, BNT162 Vaccine, enfermedades musculoesqueléticas::enfermedades musculares::miositis [ENFERMEDADES], Malalties autoimmunitàries, Immune System Diseases::Autoimmune Diseases [DISEASES], enfermedades del sistema inmune::enfermedades autoinmunes [ENFERMEDADES], COVID-19, Immunoglobulins, Intravenous, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], myositis, vaccination, Exanthema, Musculoskeletal Diseases::Muscular Diseases::Myositis [DISEASES], Inflamació, terapéutica::terapia biológica::inmunomodulación::inmunoterapia::inmunización::inmunoterapia activa::vacunación [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Female, Neurology (clinical), COVID-19 (Malaltia) - Vacunació, Hydroxychloroquine
Abstract

COVID-19; Dermatomyositis; Vaccination COVID-19; Dermatomiositis; Vacunación COVID-19; Dermatomiositis; Vacunació Introduction/Aims In this study we investigated COVID-19 vaccination–related adverse events (ADEs) 7 days postvaccination in patients with idiopathic inflammatory myopathies (IIMs) and other systemic autoimmune and inflammatory disorders (SAIDs). Methods Seven-day vaccine ADEs were collected in an international patient self-reported e-survey. Descriptive statistics were obtained and multivariable regression was performed. Results Ten thousand nine hundred respondents were analyzed (1227 IIM cases, 4640 SAID cases, and 5033 healthy controls [HCs]; median age, 42 [interquartile range, 30-455] years; 74% female; 45% Caucasian; 69% completely vaccinated). Major ADEs were reported by 76.3% of the IIM patients and 4.6% reported major ADEs. Patients with active IIMs reported more frequent major (odds ratio [OR], 2.7; interquartile range [IQR], 1.04-7.3) and minor (OR, 1.5; IQR, 1.1-2.2) ADEs than patients with inactive IIMs. Rashes were more frequent in IIMs (OR, 2.3; IQR, 1.2-4.2) than HCs. ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs (OR, 1.9; IQR, 1.1-3.3; and OR, 2.2; IQR, 1.1-4.3, respectively). Overall, ADEs were less frequent in inclusion-body myositis (IBM) and BNT162b2 (Pfizer) vaccine recipients. Discussion Seven-day postvaccination ADEs were comparable in patients with IIMs, SAIDs, and HCs, except for a higher risk of rash in IIMs. Patients with dermatomyositis with active disease may be at higher risk, and IBM patients may be at lower risk of specific ADEs. Overall, the benefit of preventing severe COVID-19 through vaccination likely outweighs the risk of vaccine-related ADEs. Our results may inform future guidelines regarding COVID-19 vaccination in patients with SAIDs, specifically in those with IIMs. Studies to evaluate long-term outcomes and disease flares are needed to shed more light on developing future COVID-19 vaccination guidelines. National Institution for Health Research Manchester Biomedical Research Centre (to H.C.).

Published
2022

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