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BackgroundBelimumab (BLM) is a monoclonal antibody that inhibits B-lymphocyte stimulating factor (BlyS) approved as a specific treatment for systemic lupus erythematosus (SLE) in 2011. We present the experience with BLM in a Spanish cohort with more than 460 patients.ObjectivesTo describe demographic characteristics, efficacy and safety of BLM in patients with SLE in Spanish population since its approval.MethodsDescriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding SLE patients treated with BLM were collected from medical records (2011-2022). Demographic features, efficacy, laboratory variables, SLEDAI, renal involvement, steroid dose, administration routes and safety were assessed. To see whether a trend in BLM prescription had changed or not over time, two periods of time were analyzed: 2011-2016 (period1) and 2017-2022 (period2).ResultsBaseline characteristics of patients are summarized in Table 1.A total of 462 patients (36 hospitals) were included, 50.9% were on intravenous (IV), 34% on subcutaneous (SC) and 15.1% switched from IV to SC route. The median number of pre-BLM csDMARD use was 2.0 (2.0-3.0), being hydroxychloroquine (HCQ) the most frequently used (94.5%). Fifty-two patients were treated with IV cyclophosphamide with a median of 6 bolus received. At the time of BLM start, 443 patients were on prednisone with a median dose of 6.2 mg (5.0-10.0). Significant decreases in prednisone dose, SLEDAI and anti-DNA antibodies were observed from baseline until the last visit, whereas complement C3 and C4 values raised (Figure 1). A total of 118 patients (27.4%) had renal involvement with a median proteinuria of 1.0 g/day (0.5-2.4). Renal biopsy was done in 102 out of 118 patients, being class IV (33%), class III (21%) and class V (16%) the most frequently reported. After BLM, 73.3% of these patients improved (median proteinuria of 0.2 g/day (0.1-0.7).In period1, 100 patients started BLM compared to 362 in period2. The median time from SLE diagnosis to BLM begin was 7.1 (4.0-13.7) and 6.2 (2.1 -14.4) years in period1 and period2, respectively (p=0.454). We found a trend to use more csDMARD before BLM treatment in period1: 2.5 (2-3) vs. 2 (2-3) (p=0.088).A total of 143 (30.5%) patients discontinued treatment mostly due to inefficacy (55.9%) and infections (11.9%). In fact, 116 patients developed infections, mostly mild;2 patients died, 16 had COVID-19 and 4 patients developed tumors requiring discontinuation of the drug.ConclusionIn our cohort of SLE patients in a real-world setting, BLM has been effective, safe and seems to be a good choice to treat renal involvement.References[1]Navarra SV, Guzmán RM, Gallacher AE, et al. Lancet. 2011;377(9767):721-31.[2]Stohl W, Hiepe;rt al. Arthritis Rheum. 2012;64(7):2328-37.[3]Furie R, Rovin BH, Houssiau F, et al. N Engl J Med. 2020;383(12):1117-1128.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BACKGROUND: SARS-CoV-2 infection was an unprecedented pandemic with unprecedented global health and socio-economic impact. More than 13 million cases had been confirmed in Spain by August 2022, and diagnostic testing to detect cases of infection in the country has helped to partially mitigate the spread of the virus. In 2021, the first self-testing antigen tests were marketed for dispensing in community pharmacies, and over-the-counter dispensing was allowed from July of that year. The network of community pharmacies played a key role, not only in the informed dispensing of these tests, but also in actively participating in the performance, supervision and reporting of results to the health authorities, and even in the issuing of digital certificates. A compilation has been made of all the available data on the subject, with a deadline of 13 February 2022, which is considered to be the end of the sixth wave of the epidemic in Spain. The results of the action taken by community pharmacies in twelve Autonomous Communities, which somehow participated in these initiatives by carrying out or supervising a total of 1,043,800 tests, from which 109,570 positive cases (10.5% of the total) were detected and reported to the National Health System, are presented in this article. Although the results are provisional, because many of the programmes are still ongoing, they are a clear demonstration of the potential that community pharmacies can play in Public Health work.
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Background: In the northern hemisphere, Respiratory Syncytial Virus (RSV) is more frequently detected from December to February. In Italy, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) presented a peak in incidence from the end of December 2021 to February 2022. Aim(s): To evaluate how SARS-CoV-2 pandemic has influenced RSV circulation. Method(s): We evaluated 389 children, aged 0-18 years, admitted for respiratory tract infections from September 2021 to January 2022 throughout Italy, from the north to the south. Children underwent nasal washing from 1 to 3 days after hospitalization. A (RT)-PCR was developed for detecting 15 respiratory viruses, including RSV, influenza virus A and B, human coronavirus OC43, 229E, NL-63 and HUK1, adenovirus, rhinovirus, parainfluenza virus 1-3, human bocavirus and human metapneumovirus. Result(s): We detected a virus in 338 children (86.9%): RSV was found in 267 (68.7%), other viruses in 71 (18.3%). 51 children (13.1%) resulted negative. Dividing our observational period in two-week timeframes, we found that RSV showed an early peak from October to the first half of December 2021 compared to its usual seasonality. In a previous study, we have demonstrated that RSV circulation was incredibly low from September 2020 to January 2021, in contrast with what we found in the same period in 2021-2022. Comparing RSV and SARS-CoV-2 incidences, we found that these two viruses spread in opposite ways: when SARS-CoV-2 present an incidence peak, RSV circulation reduced and viceversa. Conclusion(s): The relationship between RSV and SARS-CoV-2 showed that viral interference plays a crucial role in their epidemiology.
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SARS-CoV-2 infection was an unprecedented pandemic with unprecedented global health and socio-economic impact. More than 13 million cases had been confirmed in Spain by August 2022, and diagnostic testing to detect cases of infection in the country has helped to partially mitigate the spread of the virus. In 2021, the first self-testing antigen tests were marketed for dispensing in community pharmacies, and over-the-counter dispensing was allowed from July of that year. The network of community pharmacies played a key role, not only in the informed dispensing of these tests, but also in actively participating in the performance, supervision and reporting of results to the health authorities, and even in the issuing of digital certificates. A compilation has been made of all the available data on the subject, with a deadline of 13 February 2022, which is considered to be the end of the sixth wave of the epidemic in Spain. The results of the action taken by community pharmacies in twelve Autonomous Communities, which somehow participated in these initiatives by carrying out or supervising a total of 1,043,800 tests, from which 109,570 positive cases (10.5% of the total) were detected and reported to the National Health System, are presented in this article. Although the results are provisional, because many of the programmes are still ongoing, they are a clear demonstration of the potential that community pharmacies can play in Public Health work.
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SARS-CoV-2 infection was an unprecedented pandemic with unprecedented global health and socio-economic impact. More than 13 million cases had been confirmed in Spain by August 2022, and diagnostic testing to detect cases of infection in the country has helped to partially mitigate the spread of the virus. In 2021, the first self-testing antigen tests were marketed for dispensing in community pharmacies, and over-the-counter dispensing was allowed from July of that year. The network of community pharmacies played a key role, not only in the informed dispensing of these tests, but also in actively participating in the performance, supervision and reporting of results to the health authorities, and even in the issuing of digital certificates. A compilation has been made of all the available data on the subject, with a deadline of 13 February 2022, which is considered to be the end of the sixth wave of the epidemic in Spain. The results of the action taken by community pharmacies in twelve Autonomous Communities, which somehow participated in these initiatives by carrying out or supervising a total of 1,043,800 tests, from which 109,570 positive cases (10.5% of the total) were detected and reported to the National Health System, are presented in this article. Although the results are provisional, because many of the programmes are still ongoing, they are a clear demonstration of the potential that community pharmacies can play in Public Health work.;La infección por SARS-CoV-2 ha constituido una pandemia con un impacto sanitario y socioeconómico global sin precedentes. Con más de trece millones de casos confirmados en España hasta agosto de 2022, la realización de pruebas diagnósticas para detectar los casos de infección ha permitido atenuar parcialmente la expansión del virus. Durante 2021 se comercializaron los primeros test de antígenos para autodiagnóstico, de dispensación en farmacias comunitarias, y desde julio de ese año se permitió su dispensación sin receta médica. La red de farmacias comunitarias jugó un papel fundamental, no solo por la dispensación informada de dichos test, sino participando activamente en la realización, en la supervisión de su realización y en la notificación de resultados a las autoridades sanitarias, e incluso en la emisión de certificados digitales. Se ha realizado una recopilación de todos los datos disponibles al respecto, fijando como límite temporal la semana del 13 de febrero de 2022, por considerarse como el final de la sexta ola de la epidemia en España. El presente artículo revela los resultados derivados de la actuación de las farmacias de doce comunidades autónomas, que participaron de una forma u otra en dichas iniciativas mediante la realización o supervisión de un total de 1.043.800 pruebas, a partir de las cuales se detectaron 109.570 casos positivos (un 10,5% del total), que fueron comunicados al Sistema Nacional de Salud. Los resultados son provisionales, pues muchos de los programas continúan vigentes, pero son una muestra inequívoca del potencial que las farmacias comunitarias pueden desempeñar en tareas de Salud Pública.
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Background: The pandemic of coronavirus disease 2019 has led to a health crisis situation in which all healthcare sector have set up information mechanisms aimed at their own professionals, as well as the population. Among them, the General Pharmaceutical Council of Spain has carried out different actions to improve knowledge of the pandemic. Purpose(s): Ensuring that the General Council conveys the information to pharmacists, other health professionals and patients. Method(s): The General Council has set up a specific information centre on COVID-19, aimed at centralising the information activities carried out in this area, such as direct resolution of queries from professionals and the general public, publication of technical reports, creation of an information website, issuance of official communications or production of information videos. Result(s): Since the outbreak of the crisis, a total of 198 queries have been received;35% were from Provincial Pharmacists' Chambers, 51% from pharmacists, and 14% from other professionals and citizens. The most consulted topics were about prevention of contagion through hydroalcoholic solutions, use of masks and action procedure in community pharmacy. Conclusion(s): The General Council has positioned itself as an information reference for this health crisis management. The implementation of a landline for telephone queries and real concerns allowed the information issued to be tailored to the demands of health professionals and citizens.
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SARS-CoV-2 infection was an unprecedented pandemic with unprecedented global health and socio-economic impact. More than 13 million cases had been confirmed in Spain by August 2022, and diagnostic testing to detect cases of infection in the country has helped to partially mitigate the spread of the virus. In 2021, the first self-testing antigen tests were marketed for dispensing in community pharmacies, and over-the-counter dispensing was allowed from July of that year. The network of community pharmacies played a key role, not only in the informed dispensing of these tests, but also in actively participating in the performance, supervision and reporting of results to the health authorities, and even in the issuing of digital certificates. A compilation has been made of all the available data on the subject, with a deadline of 13 February 2022, which is considered to be the end of the sixth wave of the epidemic in Spain. The results of the action taken by community pharmacies in twelve Autonomous Communities, which somehow participated in these initiatives by carrying out or supervising a total of 1,043,800 tests, from which 109,570 positive cases (10.5% of the total) were detected and reported to the National Health System, are presented in this article. Although the results are provisional, because many of the programmes are still ongoing, they are a clear demonstration of the potential that community pharmacies can play in Public Health work.
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Background: Patients with immune-mediated rheumatic diseases (IMRD) are commonly treated with immunosuppressors and prone to infections. Recently introduced mRNA SARS-Cov2 vaccines have demonstrated extraordinary efficacy across all ages. Immunosuppressed patients were excluded from phase III trials with SARS-Cov2 mRNA vaccines. Objectives: To fully characterize B and T cell immune responses elicited by mRNA SARS-Cov2 vaccines in patients with rheumatic diseases under immunotherapies, and to identify which drugs reduce vaccinés immunogenicity. Methods: Humoral, CD4 and CD8 immune-responses were investigated in 100 SARS-Cov2-naïve patients with selected rheumatic diseases under immunosup-pression after a two-dose regimen of SARS-Cov2 mRNA vaccine. Responses were compared with age, gender, and disease-matched IMRD patients not receiving immunosuppressors and with healthy controls. Results: IMRD patients showed decreased seroconversion rates (80% vs 100%, p= 0.03) and cellular immune responses (75% vs 100%, p= 0.02). Patients on methotrexate achieved seroconversion in 62% of cases and cellular responses in 80% of cases. Abatacept decreased humoral and cellular responses. Rituximab (31% responders) and belimumab (50% responders) showed impaired humoral responses, but cellular responses were often preserved. Antibody titers were reduced with mycophenolate and azathioprine but preserved with lefunomide and anticytokines. Conclusion: IMRD patients exhibit impaired SARS-CoV-2 vaccine-immuno-genicity, variably reduced with immunosuppressors. Among commonly used therapies, abatacept and B-cell depleting therapies show deleterious effects, while anticytokines preserved immunogenicity. The effects of cumulative meth-otrexate and glucocorticoid doses on immunogenicity should be considered. Humoral and cellular responses are weakly correlated, but CD4 and CD8 tightly correlate. Seroconversion alone might not refect the vaccine's immunogenicity.