Barker, J.

Bosma, A.

Capon, F.

Coker, B.

Dand, N.

Di Meglio, P.

Fletcher, G.

Flohr, C.

Griffiths, C.E.M.

Irvine, A.D.

Iversen, L.

Langan, S.M.

Mahil, S.K.

Mason, K.J.

Musters, A.H.

Prieto‐Merino, D.

Smith, C.H.

Spuls, P.I.

Tsakok, T.

Wall, D.

Warren, R.B.

Yiu, Z.Z.N.

Keele Research Repository

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bjd.19161 This article is protected by copyright. All rights reservedGlobal reporting of cases of COVID-19 in psoriasis and atopic dermatitis: an opportunity to inform care during a pandemicS.K. Mahil,1* Z.Z.N. Yiu,2* K.J. Mason,2 N. Dand,3 B. Coker,4 D. Wall,5,6 G. Fletcher,6 A. Bosma,7 F. Capon,3 L. Iversen,8 S.M. Langan,1,9 P. Di Meglio,3 A. Musters,7 D. Prieto-Merino,9 T. Tsakok,1 R.B. Warren,2 C. Flohr,1 P. Spuls,7 C.E.M. Griffiths,2 J. Barker,1 A.D Irvine10 and C.H. Smith1 on behalf of the Secure-AD and PsoPROTECT study groups*Joint first authors1St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, London SE1 9RT, UK2Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester M13 9PT, UK3Department of Medical and Molecular Genetics, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK4NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust, London SE1 9RT, UK5Hair Restoration Blackrock, Dublin, Ireland6National and International Skin Registry Solutions (NISR), Charles Institute of Dermatology, Dublin, Ireland7Department of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.8Department of Dermatology, Aarhus University Hospital, Aarhus C, Denmark.9Faculty of Epidemiology, and Population Health, London School of Hygiene and Tropical Medicine, London, UK10St. James's Hospital, James's Street, Dublin, Ireland.Corresponding author: Catherine SmithEmail: catherine.smith@kcl.ac.ukAccepted ArticleThis article is protected by copyright. All rights reservedTo the Editor,We wish to bring your attention to the PsoPROTECT (Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of Covid-19 infecTion) and SECURE-AD (Surveillance Epidemiology of Coronavirus Under Research Exclusion-Atopic Dermatitis) registries; two urgent global initiatives that address an unmet need for delineating the determinants of COVID-19 outcomes in the common cutaneous immune-mediated inflammatory diseases (IMIDs) psoriasis and atopic dermatitis. The highly transmissible coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has created an unprecedented global public health emergency. The pandemic has placed an immense strain on healthcare systems and societal infrastructure worldwide. Most patients exhibit mild-to-moderate symptoms and recover without sequelae, however around 15% develop severe pneumonia and 5% progress to acute respiratory distress syndrome, septic shock and/or multiple organ failure, associated with high mortality1. There is an urgent need to better delineate the risk factors leading to poorer outcomes, with emerging data suggesting the elderly and those with pre-existing comorbid conditions such as cardiovascular disease, poorly controlled asthma and diabetes are at highest risk2. Although the precise mechanisms by which SARS-CoV-2 causes severe illness are not known, exaggerated innate inflammatory and impaired adaptive immune responses have been observed1. Given the immunopathogenesis and treatment paradigm of IMIDs, this group of conditions poses a particular management challenge in the pandemic, and also a potential opportunity to gain insight into the host immune response to the virus. Both psoriasis and atopic dermatitis are associated with multimorbidity and typified by innate and adaptive immune dysregulation, which is targeted by immunomodulatory therapies3,4. In the context of COVID-19, the broad immune-suppression conferred by conventional systemic agents, such as methotrexate, may downregulate protective host antiviral immune responses. On the other hand, should treatment need to be paused in the pandemic, the longer half-life and particular pharmacokinetics of biological therapies will limit the speed of their systemic clearance. Although real-world observational data suggest an increased risk of serious infections with some agents5,6, their relative safety in relation to COVID-19 is unknown7. Conversely, there is a theoretical protective role of immunomodulators in attenuating a severe systemic inflammatory response to infection. JAK inhibitors (which have demonstrated efficacy in psoriasis and atopic dermatitis in clinical trials) and interleukin-1 inhibitors are being explored as treatments for COVID-198. Finally, genome-wide association studies have uncovered a Accepted ArticleThis article is protected by copyright. All rights reservedpotential pathogenic role for upregulated innate antiviral immune responses in psoriasis3, however, it is unclear whether this has implications for risk or outcome of COVID-19.   To address these gaps, the international clinical, scientific and public health dermatological communities have rapidly connected with the common aim of gathering observational data on COVID-19 outcomes in psoriasis and atopic dermatitis on a global scale. PsoPROTECT (www.psoprotect.org) and SECURE-AD (www.covidderm.org) are web-based registries for clinicians to report COVID-19 outcomes in psoriasis and atopic dermatitis, respectively. They have received robust support from major international dermatological professional and patient organisations, and wide participation of clinicians is now vital.  Global case reporting in PsoPROTECT and SECURE-ADClinicians worldwide are invited to complete the short web-based PsoPROTECT and SECURE-AD case report forms for any cases of confirmed or suspected COVID-19 in psoriasis and atopic dermatitis. The forms collect patient demographics, comorbidities, change in psoriasis/atopic dermatitis severity during COVID-19, immunomodulator medications (including drug exposure prior to/during the illness), and COVID-19 symptoms, management and outcome. The rapid adoption of virtual care models in the current pandemic has transformed the landscape of dermatological practice and is highly conducive to reporting cases of COVID-19 via PsoPROTECT and SECURE-AD. Data are collected online and processed solely for the purpose of medical research undertaken in the public interest. No patient identifiers are collected, and the data are housed on secure servers. Scope of new knowledge and data sharingThe accumulating prospective observational clinical datasets in PsoPROTECT and SECURE-AD, alongside emerging data in the scientific literature, may help to guide clinical decision making during the pandemic. A key objective is to identify predictors (e.g. immunomodulator medications, comorbidities, demographic variables) of COVID-19 outcomes in psoriasis and atopic dermatitis and to characterise patients in whom it may be beneficial to pause, continue or initiate systemic treatment. Regular open-access summaries of aggregated data will be published online for the benefit of the global clinical and patient community. Researchers are also actively encouraged to apply to utilise the registry data.Importantly, these data have the potential to generate hypotheses on the underlying immunological basis for COVID-19 outcomes, which may inform the development of life-saving treatments and vaccines. The Accepted ArticleThis article is protected by copyright. All rights reservedscientific basis and mode of action of immunomodulators in psoriasis and atopic dermatitis has been rigorously evaluated3,4, so any emerging novel associations of these therapies or disease-specific characteristics with COVID-19 outcomes may provide insight into pathomechanisms of the infection beyond these conditions and dermatology. Cross-disease collaborationSubsets of patients will be compared to determine the impacts on COVID-19 outcomes of specific immunomodulators/drug classes, disease severity and demographic variables such as age, sex, ethnicity and geographical regions. Cross-IMID comparisons are also important, since individual diseases may confer differential risks on COVID-19 outcome. The data fields in PsoPROTECT and SECURE-AD case report forms are therefore aligned with those of similar global efforts in rheumatology (https://rheum-covid.org/) and inflammatory bowel disease (https://covidibd.org/). Since treatments such as TNF-antagonists are shared across IMIDs, greater power to infer impact of specific immunomodulators on outcomes may be afforded by combining disease datasets. Limitations and mitigation strategiesAny preliminary data should be interpreted with caution, particularly where case numbers are limited. An observational design is necessary for the capture of real-world outcomes in the registries, however there is inevitable potential for bias and incomplete data capture. For instance, clinicians may be more likely to report, and in more severe/complex skin disease, in better-resourced health care systems. In the context of a global case collection, cross-national differences in public health strategies will also need to be accounted for when interpreting outcome data.A limitation of registries relying on spontaneous reporting is a lack of denominator data for each treatment. To help to mitigate this, data from PsoPROTECT and SECURE-AD can be used to enrich existing large-scale pharmacovigilance registries. Subsequent meta-analyses may give more precise estimates of the risks associated with each drug/variable. Patient-reported outcomes of COVID-19, patient experiences and health behaviours during the pandemic are also key considerations for informing clinical care. Therefore, patient-led collections of data will be pursued, with the data fields of the patient case report forms closely matched to those of PsoPROTECT Accepted ArticleThis article is protected by copyright. All rights reservedand SECURE-AD. This will enable inclusion of individuals with milder psoriasis and atopic dermatitis, and also less severe COVID-19 infections, reducing the risk of selection bias. ConclusionClose international collaboration between clinicians, scientists and patients in the current pandemic is essential to fulfil PsoPROTECT and SECURE-AD’s exciting potential to rapidly accrue large-scale datasets with high translational value. The knowledge gained from these efforts will be vital for guiding treatment choices and counselling patients on how to mitigate the potential risk of COVID-19.  Please help to inform our common clinical practice in the coming weeks and months by reporting your cases of COVID-19 today.AcknowledgementsThe PsoPROTECT study team is thankful to Engine Group UK for their generous creative input and website expertise. We acknowledge financial support from the Department of Health via the National Institute for Health Research (NIHR) Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, and The Psoriasis Association. References1. Cao, X. COVID-19: immunopathology and its implications for therapy. Nat. Rev. Immunol. (2020) doi:10.1038/s41577-020-0308-3.2. Wu, Z. & McGoogan, J. M. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA (2020) doi:10.1001/jama.2020.2648.3. Mahil, S. K., Capon, F. & Barker, J. N. Update on psoriasis immunopathogenesis and targeted immunotherapy. Semin Immunopathol 38, 11–27 (2016).4. Weidinger, S., Beck, L. A., Bieber, T., Kabashima, K. & Irvine, A. D. Atopic dermatitis. Nat Rev Dis Primers 4, 1 (2018).Accepted ArticleThis article is protected by copyright. All rights reserved5. Kalb, R. E. et al. Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol 151, 961–969 (2015).6. Schneeweiss, M. C., Perez-Chada, L. & Merola, J. F. Comparative Safety of Systemic Immuno-modulatory Medications in Adults with Atopic Dermatitis. J. Am. Acad. Dermatol. (2019) doi:10.1016/j.jaad.2019.05.073.7. Wollenberg, A. et al. European Task Force on Atopic Dermatitis (ETFAD) statement on severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)-infection and atopic dermatitis. J Eur Acad Dermatol Venereol (2020) doi:10.1111/jdv.16411.8. Favalli, E. G., Biggioggero, M., Maioli, G. & Caporali, R. Baricitinib for COVID-19: a suitable treatment? Lancet Infect Dis (2020) doi:10.1016/S1473-3099(20)30262-0.Accepted Article

Global reporting of cases of COVID-19 in psoriasis and atopic dermatitis: an opportunity to inform care during a pandemic.

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Global reporting of cases of COVID-19 in psoriasis and atopic dermatitis: an opportunity to inform care during a pandemic.

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