key: cord-338597-aq80vius authors: Baniandrés-Rodríguez, O.; Vilar-Alejo, J.; Rivera, R.; Carrascosa, J. M.; Daudén, E.; Herrera-Acosta, E.; Sahuquillo-Torralba, A.; Gómez-García, F. J.; Nieto-Benito, L. M.; de la Cueva, P.; López-Estebaranz, J. L.; Belinchón, I.; Ferrán, M.; Alsina, M.; Rodriguez, L.; Carretero, G.; García-Donoso, C.; Ballescá, F.; Llamas-Velasco, M.; Herrera-Ceballos, E.; Botella-Estrada, R.; Ruiz-Genao, D. P.; Riera-Monroig, J.; Descalzo, M. A.; García-Doval, I. title: Incidence of severe COVID-19 outcomes in psoriatic patients treated with systemic therapies during the pandemic: a Biobadaderm cohort analysis date: 2020-10-26 journal: J Am Acad Dermatol DOI: 10.1016/j.jaad.2020.10.046 sha: doc_id: 338597 cord_uid: aq80vius nan The BIOBADADERM project is promoted by the Fundación Piel Sana Academia Española de Dermatología y Venereología, which receives financial support from the Spanish Medicines and Health Products Agency (Agencia Española de Medicamentos y Productos Sanitarios) and from pharmaceutical companies (Abbott/Abbvie, Almirall, Janssen, Leo Pharma, Lilly, Novartis and UCB). The following companies have also collaborated in the past (MSD and Pfizer). Collaborating pharmaceutical companies were not involved in the design and conduct of the study; collection, management, analysis and interpretation of data; preparation, review, or approval of the manuscript; decision to submit the manuscript for publication. • Dr Baniandrés-Rodríguez acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, Pfizer, Novartis, Lilly, Celgene, Leo Pharma and Almirall. • Dr Vilar-Alejo participated as AB from Janssen, Novartis, AbbVie, Almirall and Celgene. • Dr Rivera acted as consultant and/or speaker for and/or participated in clinical trials as IP for Abbvie, Almirall, Celgene, Janssen, Leo Pharma, Lilly, Novartis, MSD and Pfizer-Wyeth. • Dr Carrascosa has participated as speaker and/or advisor for Celgene, Janssen, Lilly, Novartis, Leo Pharma, Pfizer, MSD, Abbvie, Biogen Amgen. • Dr Dauden acted as consultant for Abbott, Amgen, Astellas, Centocor Ortho Biotech Inc, Galderma, Glaxo, Jansenn-Cilag, Leo Pharma, Novartis, Pfizer, MSD and Celgene, received honoraria form Abbott, Amgen, Janssen-Cilag, Leo Pharma, Novartis, Pfizer, MSD, Celgene, participated in a speakers bureau for Abbott, Pfizer, MSD and Janssen and received grants from Pfizer, Abbott, Janssen and MSD. • Dr Herrera-Acosta has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene y Abbvie. • Dr Sahuquillo has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis and Pfizer. • Dr de la Cueva acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Biogen, Celgene, Amgen, Sandoz, Sanofi and Leo-Pharma. • Dr López-Estebaranz participated as AB and received educational grants from Janssen, Abbvie, MSD, Lilly, Novartis, LeoPharma, Pfizer. • Dr Belinchón acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, J o u r n a l P r e -p r o o f 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 [1] . 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 to the general population. We reviewed all Biobadaderm patient records and contacted the patients when needed. We collected information about current comorbidities related to outcomes in all active patients of the registry. We used the latest data updated on 6 July 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, ICU and death in PCR-confirmed patients included in Biobadaderm as compared to PCR-confirmed cases published by the Spanish Ministry of Health [2] . Also 95% CI were calculated for each SIR to compare significance between the Spanish figures and Biobadaderm. In our study, we found that out 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 and 1 (0.04%) patient died. Patient characteristics are detailed in Table 1 . The profile of COVID-19 cases was similar to that of the population of origin (Biobadaderm) in age and sex [3] , but with higher percentages of comorbidities like hypertension (27% vs 22%) or diabetes mellitus (16% vs 11%). In our main analysis ( [3] that suggests that psoriatic patients receiving biologic treatments are not associated with worse outcomes. A strength of this study is that we analyzed a prospective cohort, that we know the base population and that we can calculate the incidences. This study therefore avoids problems of other ongoing international registries based on case notifications, which do not have a welldefined base population and likely suffer from selection bias [4] . 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 [5] . The limitations of this study include the lack of serological 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. In conclusion, this prospective cohort study suggests that classic systemic or biologic treatments increase neither the susceptibility nor the severity of COVID-19. (97) 15 (94) 19 (90) 12 (92) 1 (100) 1 (100) 69 (95) Psoriatic arthritis, yes 2 (6) 2 (13) 5 (24) 4 (31) 1 (100) 0 (0) 9 (12) Treatment Anti-TNF 6 (16) 5 (31) 2 (10) ( The BIOBADADERM project is promoted by the Fundación Piel Sana Academia Española de Dermatología y Venereología, which receives financial support from the Spanish Medicines and Health Products Agency (Agencia Española de Medicamentos y Productos Sanitarios) and from pharmaceutical companies (Abbott/Abbvie, Almirall, Janssen, Leo Pharma, Lilly, Novartis and UCB). The following companies have also collaborated in the past (MSD and Pfizer). Collaborating pharmaceutical companies were not involved in the design and conduct of the study; collection, management, analysis and interpretation of data; preparation, review, or approval of the manuscript; decision to submit the manuscript for publication. 1 (8) 0 (0) 0 (0) 13 (18) Classic Systemics Treatments 3 (9) 2 (12) 4 (19) 2 (15) 0 (0) 0 (0) 9 (12) Anti-IL-12/IL-23 9 (25) 4 (25) 3 (14) 4 (31) 0 (0) 0 (0) 16 (22) Anti-IL17 6 (17) 5 (32) 2 (10) 1 (8) 0 (0) 0 (0) 13 (18) Apremilast 6 (17) 0 (0) 6 (29) 2 (15) 0 (0) 1 (100) 12 (16) Fumarates 1 (3) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (1) Anti-IL-23p19 5 (14) 0 (0) 4( 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 [1] . 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 to the general population. We reviewed all Biobadaderm patient records and contacted the patients when needed. We collected information about current comorbidities related to outcomes in all active patients of the registry. We used the latest data updated on 6 July 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, ICU and death in PCR-confirmed patients included in Biobadaderm as compared to PCR-confirmed cases published by the Spanish Ministry of Health [2] . Also 95% CI were calculated for each SIR to compare significance between the Spanish figures and Biobadaderm. In our study, we found that out 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 and 1 (0.04%) patient died. Patient characteristics are detailed in Table 1 . The profile of COVID-19 cases was similar to that of the population of origin (Biobadaderm) in age and sex [3] , but with higher percentages of comorbidities like hypertension (27% vs 22%) or diabetes mellitus (16% vs 11%). In our main analysis ( The results are consistent with the article published by Gisondi et al. during the peak of the Italian pandemic [3] that suggests that psoriatic patients receiving biologic treatments are not associated with worse outcomes. A strength of this study is that we analyzed a prospective cohort, that we know the base population and that we can calculate the incidences. This study therefore avoids problems of other ongoing international registries based on case notifications, which do not have a welldefined base population and likely suffer from selection bias [4] . 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 [5] . The limitations of this study include the lack of serological 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. In conclusion, this prospective cohort study suggests that classic systemic or biologic treatments increase neither the susceptibility nor the severity of COVID-19. 13 (100) 0 (0) 0 (0) 13 (18) ICU admission or similar 0 (0) 0 (0) 1 (5) 0 (0) 1 (100) 0 (0) 1 (1) Death 0 (0) 0 (0) 1 (5) 0 (0) 0 (0) 1 (100) 1 (1) • Dr Herrera-Ceballos has served as a consultant and/or speaker for and/or participated in clinical trials as IP and sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Janssen-Cilag, LEO Pharma, Lilly, Novartis and Pfizer. • Dr Botella-Estrada has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis Verónica Massó López Marina Sáez Belló (Hospital Universitario Dr. Peset), Ángeles Flórez Menéndez Miguel Ángel Descalzo Gallego Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry • Dr Carretero has been reimbursed by Janssen, Abbvie, Novartis, Pfizer, MSD and Celgene for advisory service and conference. • Dr García-Donoso participated as AB from AbbVie, Almirall and speaker for Janssen, Lilly and Celgene. • Dr Llamas-Velasco acted as a consultant and speaker and participated in clinical trials for Janssen-Cilag Verónica Massó López Marina Sáez Belló (Hospital Universitario Dr. Peset), Ángeles Flórez Menéndez Miguel Ángel Descalzo Gallego Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry Institute of Health Carlos. COVID-19 cases in Spain nº 33 The impact of the COVID-19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience International collaboration and rapid harmonization across dermatologic COVID-19 registries More on Covid-19 in Immune-Mediated Inflammatory Diseases 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