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Incidence of severe COVID-19 outcomes in psoriatic patients treated with systemic therapies during the pandemic: A Biobadaderm cohort analysis

2020; Elsevier BV; Volume: 84; Issue: 2 Linguagem: Inglês

10.1016/j.jaad.2020.10.046

1097-6787

Ofelia Baniandrés, Jaime Vilar‐Alejo, R. Rivera, J.M. Carrascosa, E. Daudén, Enrique Herrera‐Acosta, Antonio Sahuquillo‐Torralba, Fran J. Gómez-García, Lula María Nieto‐Benito, P. de la Cueva, J.L. López‐Estebaranz, I. Belinchón, Marta Ferrán Farrés, M. Alsina, Lourdes Rodríguez Fernández‐Freire, G. Carretero, Carmen García‐Donoso, F. Ballescà, Mar Llamas‐Velasco, Enrique Herrera‐Ceballos, Rafael Botella‐Estrada, Diana Ruíz‐Genao, Josep Riera‐Monroig, M.Á. Descalzo, I. García‐Doval, E. Daudén, Mar Llamas‐Velasco, C. Santamaría, G. Carretero, Jaime Vilar‐Alejo, Blanca Madrid Álvarez, R. Rivera, Carmen García‐Donoso, M Gomis, Diana Cabrera, Carlos Ferrándiz, J.M. Carrascosa, F. Ballescà, P. de la Cueva, Patricia Molina Mejías, I. Belinchón, Carlos García Giner, Alfred Perez, Fran J. Gómez-García, Enrique Herrera‐Ceballos, Enrique Herrera‐Acosta, Eliseo Martínez‐García, C. García Sánchez, J.L. López‐Estebaranz, Diana Ruíz‐Genao, Elena García‐Zamora, Marta Ferrán Farrés, M. Alsina, J. Riera, Sara Pedregosa Fauste, Ofelia Baniandrés, Lula María Nieto‐Benito, Desiree Molina, José Luis Sánchez‐Carazo, Antonio Sahuquillo‐Torralba, Rafael Botella‐Estrada, Conrad Pujol Marco, Natalia Chaparro Aguilera, Verónica Massó López, Lourdes Rodríguez Fernández‐Freire, Almudena Mateu Puchades, Sergio Santos‐Alarcón, Marina Sáez Belló, Ángeles Flórez Menéndez, Laura Salgado, Beatriz González Sixto, Ma Teresa Abalde, Lucia Vilanova, Alexandra Perez Mariño, Noemí Eirís, Vicenta Prieto Marcos, I. García‐Doval, M.Á. Descalzo, Marina de Vega Martínez,

Health Systems, Economic Evaluations, Quality of Life

To the Editor: The use of systemic treatments in psoriatic patients during the pandemic has been the subject of extensive debate. In March 2020, we performed a specific study within the cohort of Biobadaderm Registry, a previously described national, multicenter, prospective cohort.1Davila-Seijo P. Dauden E. Descalzo M.A. et al.Infections in moderate to severe psoriasis patients treated with biological drugs compared to classic systemic drugs: findings from the BIOBADADERM Registry.J Invest Dermatol. 2017; 137: 313-321Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar Our primary objective was to analyze the incidence of COVID-19 infections and severe outcomes in a cohort of psoriatic patients treated with systemic therapies and to compare it with that of the general population. We reviewed all Biobadaderm patient records and contacted the patients when needed. We collected information about current comorbidities related to COVID-19 and COVID-19 outcomes in all active patients of the registry. We used the latest data updated on July 6, 2020. We estimated the age and sex standardized incidence ratio (SIR) defined as the ratio of the observed cases to the expected number of cases according to the Spanish population. The main analysis examined hospitalization, intensive care unit (ICU) admissions, and death in polymerase chain reaction (PCR)-confirmed patients included in Biobadaderm compared with PCR-confirmed cases published by the Spanish Ministry of Health.2National Epidemiology Centre-National Epidemiological Surveillance Network. Institute of Health CarlosCOVID-19 cases in Spain no 33.https://www.isciii.es/QueHacemos/Servicios/VigilanciaSaludPublicaRENAVE/EnfermedadesTransmisibles/Paginas/InformesCOVID-19.aspxDate accessed: July 6, 2020Google Scholar Also 95% confidence intervals (CI) were calculated for each SIR to compare significance between the Spanish figures and those of Biobadaderm. In our study, we found that of 2329 current active patients with systemic therapy, 73 patients (3.13%) had suffered from COVID-19, 13 patients (0.56%) required hospitalization, 1 patient (0.04%) needed ICU care, and 1 (0.04%) patient died. Patient characteristics are detailed in Table I. The profile of COVID-19 cases was similar to that of the population of origin (Biobadaderm) in age and sex,3Gisondi P. Facheris P. Dapavo P. et al.The impact of the COVID-19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience.Br J Dermatol. April 28, 2020; ([Epub ahead of print])Crossref Scopus (96) Google Scholar but with higher percentages of comorbidities like hypertension (27% vs 22%) or diabetes mellitus (16% vs 11%).Table ISARS-CoV-2 infection characteristics of patients treated with systemic therapiesCharacteristicsSARS-CoV-2 infectionPossible case,∗Possible case: febrile respiratory infection with compatible symptoms. n = 36 (%)Probable case,†Probable case: clinical criteria with an epidemiological link or any person meeting the diagnostic criteria. n = 16 (%)PCR confirmed case,‡Confirmed case: laboratory confirmation of SARS-CoV-2, irrespective of clinical signs and symptoms. n = 21 (%)Hospitalized case, n = 13 (%)ICU case, n = 1 (%)Death case, n = 1 (%)All cases, n = 73 (%)Sex Male21 (58)11 (69)11 (52)10 (77)0 (0)1 (100)43 (59) Female15 (42)5 (31)10 (48)3 (23)1 (100)0 (0)30 (41)Age (y), median (p25-p75)51.3 (38.8-59.8)49.9 (32.7-54.6)54.8 (49.6-68.3)54.8 (51.5-68.3)51.2 (NA)79.5 (NA)51.8 (39.6-60.0)Plaque psoriasis, yes35 (97)15 (94)19 (90)12 (92)1 (100)1 (100)69 (95)Psoriatic arthritis, yes2 (6)2 (13)5 (24)4 (31)1 (100)0 (0)9 (12)Treatment Anti-TNF6 (16)5 (31)2 (10)1 (8)0 (0)0 (0)13 (18) Classic systemics treatments3 (9)2 (12)4 (19)2 (15)0 (0)0 (0)9 (12) Anti-IL-12/IL-239 (25)4 (25)3 (14)4 (31)0 (0)0 (0)16 (22) Anti-IL176 (17)5 (32)2 (10)1 (8)0 (0)0 (0)13 (18) Apremilast6 (17)0 (0)6 (29)2 (15)0 (0)1 (100)12 (16) Fumarates1 (3)0 (0)0 (0)0 (0)0 (0)0 (0)1 (1) Anti-IL-23p195 (14)0 (0)4 (19)3 (23)1 (100)0 (0)9 (12)Changes in current treatment No29 (81)12 (75)20 (95)12 (92)1 (100)1 (100)61 (84) Preventive minimization3 (8)2 (13)0 (0)0 (0)0 (0)0 (0)5 (7) Preventive suspension4 (11)2 (13)1 (5)1 (8)0 (0)0 (0)7 (10) Hypertension, yes11 (31)3 (19)6 (29)5 (38)0 (0)1 (100)20 (27) Diabetes mellitus, yes7 (19)2 (13)3 (14)5 (38)0 (0)0 (0)12 (16) Cardiovascular disease, yes6 (17)2 (13)4 (19)4 (31)0 (0)1 (100)12 (16) Respiratory tract disease, yes§Few missing data.8 (22)4 (25)1 (5)3 (23)0 (0)NA13 (18) ARA II or ACE treatments, yes8 (22)3 (19)5 (24)4 (31)0 (0)1 (100)16 (22) Relative hospitalized or death by COVID-19∗Possible case: febrile respiratory infection with compatible symptoms.3 (10)2 (17)2 (22)5 (100)1 (100)NA7 (14) Time since first symptom, median (p25-p75)∗Possible case: febrile respiratory infection with compatible symptoms.20.5 (12-26)23 (15-41)18 (13.5-30)23 (13-30)30 (NA)14 (NA)20 (13-30)COVID-19 outcome Mild symptoms or asymptomatic35 (97)12 (75)11 (52)0 (0)0 (0)0 (0)58 (79) Hospitalization1 (3)4 (25)8 (38)13 (100)0 (0)0 (0)13 (18) ICU admission or similar0 (0)0 (0)1 (5)0 (0)1 (100)0 (0)1 (1) Death0 (0)0 (0)1 (5)0 (0)0 (0)1 (100)1 (1)ARA II, angiotensin II receptor antagonists; ACE, angiotensin-converting enzyme; IL, interleukin; TNF, tumor necrosis factor.∗ Possible case: febrile respiratory infection with compatible symptoms.† Probable case: clinical criteria with an epidemiological link or any person meeting the diagnostic criteria.‡ Confirmed case: laboratory confirmation of SARS-CoV-2, irrespective of clinical signs and symptoms.§ Few missing data. Open table in a new tab ARA II, angiotensin II receptor antagonists; ACE, angiotensin-converting enzyme; IL, interleukin; TNF, tumor necrosis factor. In our main analysis (Table II), the SIR for COVID-19 infection, hospitalization, ICU care, and death were slightly higher in psoriatic patients treated with systemic therapies compared with the general population of Spain, but this was not significant: 1.58 (0.98-2.41), 1.55 (0.67-3.06), 1.78 (0.05-9.93), 1.38 (0.03-7.66), respectively.Table IIAdjusted Cumulative Incidence and Standardized Incidence Ratio of psoriatic patients treated with systemic therapies and compared with equivalent definition in the general population of SpainObserved cases in BiobadadermExpected casesAdjusted cumulative incidence 9 5CI% (per 100,000 patient-years)SIR 95 CI%All PCR-confirmed cases vs Spanish-confirmed cases2113.3959.5 (593-1469)1.58 (0.98-2.41)PCR Hospitalized cases vs Spanish hospitalized cases85.2349.8 (149.4-692.6)1.55 (0.67-3.06)PCR ICU cases vs Spanish ICU cases10.633.5 (0-192)1.78 (0.05-9.93)PCR death cases vs Spanish death cases10.769.5 (0-398.3)1.38 (0.03-7.66) Open table in a new tab The results are consistent with the article published by Gisondi et al3Gisondi P. Facheris P. Dapavo P. et al.The impact of the COVID-19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience.Br J Dermatol. April 28, 2020; ([Epub ahead of print])Crossref Scopus (96) Google Scholar during the peak of the Italian pandemic that suggests that psoriatic patients receiving biologic treatments are not associated with worse outcomes. Strengths of this study are that we analyzed a prospective cohort, we know the base population, and we can calculate the incidences. This study, therefore, avoids problems of other ongoing international registries based on case notifications, which do not have a well-defined base population and likely suffer from selection bias.4Freeman E.E. McMahon D.E. Hruza G.J. et al.International collaboration and rapid harmonization across dermatologic COVID-19 registries.J Am Acad Dermatol. 2020; 83: e261-e266Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar Although the first data were reassuring at the start of the pandemic, some authors consider that it is necessary to confirm them using prospective studies of incidence with adequate denominators.5Naldi L. Cazzaniga S. More on Covid-19 in immune-mediated inflammatory diseases.N Engl J Med. July 10, 2020; ([Epub ahead of print])PubMed Google Scholar The limitations of this study include the lack of serologic or molecular confirmations for the diagnosis of COVID-19 of all possible cases, which is because in cases of mild courses of the disease, testing was often not done during the period of the study. The findings of this prospective cohort study suggest that classic systemic or biologic treatments increase neither the susceptibility nor the severity of COVID-19. This work was conducted within the BIOBADADERM Study Group. The following members participated in acquisition of data and review of the manuscript: Esteban Daudén, Mar Llamas-Velasco, Cristina Santamaría (Hospital Universitario de la Princesa); Gregorio Carretero, Jaime Vilar-Alejo, Blanca Madrid Álvarez (Hospital Universitario de Gran Canaria Dr Negrín); Raquel Rivera, Carmen García-Donoso, Ma del Mar Onteniente Gomis, Diana Batista Cabrera (Hospital Universitario 12 de Octubre); Carlos Ferrándiz, José Manuel Carrascosa, Ferrán Ballescá (Hospital Universitari Germans Trias i Pujol); Pablo de la Cueva, Patricia Molina Mejías (Hospital Universitario Infanta Leonor); Isabel Belinchón, Carlos García Giner, Alfred Perez (Hospital General Universitario de Alicante); Fran J. Gómez-García (Hospital Universitario Reina Sofía); Enrique Herrera-Ceballos, Enrique Herrera-Acosta, Eliseo Martínez-García, Cristina Sánchez (Hospital Universitario Virgen de la Victoria); José Luis López-Estebaranz, Diana Patricia Ruiz-Genao, Elena García Zamora (Fundación Hospital de Alcorcón); Marta Ferrán Farrés (Hospital del Mar, Parc de Salut Mar de Barcelona); Mercè Alsina, Josep Riera, Sara Pedregosa Fauste (Hospital Clinic de Barcelona); Ofelia Baniandrés, Lula María Nieto Benito, Desiree Molina (Hospital General Universitario Gregorio Marañón); José Luis Sánchez-Carazo (Hospital General Universitario de Valencia); Antonio Sahuquillo-Torralba, Rafael Botella-Estrada, Conrad Pujol Marco, Natalia Chaparro Aguilera, Verónica Massó López (Hospital Universitario La Fe de Valencia); Lourdes Rodríguez Fernández-Freire (Hospital Universitario Virgen del Rocío de Sevilla); Almudena Mateu Puchades, Sergio Santos, Marina Sáez Belló (Hospital Universitario Dr Peset), Ángeles Flórez Menéndez, Laura Salgado, Beatriz González Sixto, Ma Teresa Abalde, Lucia Vilanova, Alexandra Perez Mariño (Complexo Hospitalario Universitario de Pontevedra); Noemí Eiris, Vicenta Prieto Marcos (Complejo Asistencial Universitario de León); Ignacio García-Doval, Miguel Ángel Descalzo Gallego, Marina de Vega Martínez (Fundación Piel Sana AEDV).