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.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 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.2 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,3 but with higher percentages of comorbidities like hypertension (27% vs 22%) or diabetes mellitus (16% vs 11%).
Table I.
SARS-CoV-2 infection characteristics of patients treated with systemic therapies
| Characteristics | SARS-CoV-2 infection |
||||||
|---|---|---|---|---|---|---|---|
| Possible case,∗ n = 36 (%) | Probable case,† n = 16 (%) | PCR confirmed case,‡ n = 21 (%) | Hospitalized case, n = 13 (%) | ICU case, n = 1 (%) | Death case, n = 1 (%) | All cases, n = 73 (%) | |
| Sex | |||||||
| Male | 21 (58) | 11 (69) | 11 (52) | 10 (77) | 0 (0) | 1 (100) | 43 (59) |
| Female | 15 (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, yes | 35 (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) | 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 (19) | 3 (23) | 1 (100) | 0 (0) | 9 (12) |
| Changes in current treatment | |||||||
| No | 29 (81) | 12 (75) | 20 (95) | 12 (92) | 1 (100) | 1 (100) | 61 (84) |
| Preventive minimization | 3 (8) | 2 (13) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 5 (7) |
| Preventive suspension | 4 (11) | 2 (13) | 1 (5) | 1 (8) | 0 (0) | 0 (0) | 7 (10) |
| Hypertension, yes | 11 (31) | 3 (19) | 6 (29) | 5 (38) | 0 (0) | 1 (100) | 20 (27) |
| Diabetes mellitus, yes | 7 (19) | 2 (13) | 3 (14) | 5 (38) | 0 (0) | 0 (0) | 12 (16) |
| Cardiovascular disease, yes | 6 (17) | 2 (13) | 4 (19) | 4 (31) | 0 (0) | 1 (100) | 12 (16) |
| Respiratory tract disease, yes§ | 8 (22) | 4 (25) | 1 (5) | 3 (23) | 0 (0) | NA | 13 (18) |
| ARA II or ACE treatments, yes | 8 (22) | 3 (19) | 5 (24) | 4 (31) | 0 (0) | 1 (100) | 16 (22) |
| Relative hospitalized or death by COVID-19∗ | 3 (10) | 2 (17) | 2 (22) | 5 (100) | 1 (100) | NA | 7 (14) |
| Time since first symptom, median (p25-p75)∗ | 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 asymptomatic | 35 (97) | 12 (75) | 11 (52) | 0 (0) | 0 (0) | 0 (0) | 58 (79) |
| Hospitalization | 1 (3) | 4 (25) | 8 (38) | 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) |
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.
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 II.
Adjusted Cumulative Incidence and Standardized Incidence Ratio of psoriatic patients treated with systemic therapies and compared with equivalent definition in the general population of Spain
| Observed cases in Biobadaderm | Expected cases | Adjusted cumulative incidence 9 5CI% (per 100,000 patient-years) | SIR 95 CI% | |
|---|---|---|---|---|
| All PCR-confirmed cases vs Spanish-confirmed cases | 21 | 13.3 | 959.5 (593-1469) | 1.58 (0.98-2.41) |
| PCR Hospitalized cases vs Spanish hospitalized cases | 8 | 5.2 | 349.8 (149.4-692.6) | 1.55 (0.67-3.06) |
| PCR ICU cases vs Spanish ICU cases | 1 | 0.6 | 33.5 (0-192) | 1.78 (0.05-9.93) |
| PCR death cases vs Spanish death cases | 1 | 0.7 | 69.5 (0-398.3) | 1.38 (0.03-7.66) |
The results are consistent with the article published by Gisondi et al3 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.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 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.
Acknowledgments
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).
Footnotes
Funding sources: 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.
Conflicts of interest: 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, and 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, and 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, and 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, and 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, including Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, Leo-Pharma, UCB, Pfizer-Wyeth, and MSD. Dr Ferran-Farrés has participated as speaker and/or advisor for Janssen, Lilly, Novartis, Pfizer, MSD, Abbvie Celgene, and Almirall. Dr Alsina gave expert testimony for Merck-Schering Plough, Pfizer, Janssen, Novartis, Lilly, and Abbott and has participated as speaker for Almirall, Janssen, and Gebro Pharma. Dr Rodriguez Fernandez-Freire acted as a consultant and speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, Celgene, and Leo-Pharma. 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 and 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, AbbVie, Celgene, Pfizer, Novartis, Lilly, Almirall, and Leo-Pharma. 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, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis, and Pfizer. Dr Ruiz-Genao has been reimbursed by Pfizer, Janssen, Celgene, Abbvie, Novartis, and LeoPharma for advisory services and conferences. Dr Riera-Monroig received travel grants for congresses from Abbvie, Almirall, Janssen, LEO-Pharma, and Novartis. Dr Garcia-Doval received travel grants for congresses from Abbvie, MSD, and Pfizer. None of the other authors has any conflicting interests to disclose.
IRB status: Observational study. Approved (Biobadaderm: Hospital Universitario 12 de Octubre (216/07).
Reprints not available from the authors.
Contributor Information
BIOBADADERM Study Group:
Esteban Daudén, Mar Llamas-Velasco, Cristina Santamaría, Gregorio Carretero, Jaime Vilar-Alejo, Blanca Madrid Álvarez, Raquel Rivera, Carmen García-Donoso, Ma del Mar Onteniente Gomis, Diana Batista Cabrera, Carlos Ferrándiz, José Manuel Carrascosa, Ferrán Ballescá, Pablo de la Cueva, Patricia Molina Mejías, Isabel Belinchón, Carlos García Giner, Alfred Perez, Fran J. Gómez-García, Enrique Herrera-Ceballos, Enrique Herrera-Acosta, Eliseo Martínez-García, Cristina Sánchez, José Luis López-Estebaranz, Diana Patricia Ruiz-Genao, Elena García Zamora, Marta Ferrán Farrés, Mercè Alsina, Josep 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, Marina Sáez Belló, Ángeles Flórez Menéndez, Laura Salgado, Beatriz González Sixto, Ma Teresa Abalde, Lucia Vilanova, Alexandra Perez Mariño, Noemí Eiris, Vicenta Prieto Marcos, Ignacio García-Doval, Miguel Ángel Descalzo Gallego, and Marina de Vega Martínez
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