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1. Infections in Children Aged 6 Months to 5 Years Treated with Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis.

Author

Paller, Amy, Siegfried, Elaine, Cork, Michael, Arkwright, Peter, Ramien, Michele, Khokhar, Faisal, Chen, Zhen, Zhang, Annie, Cyr, Sonya, and Eichenfield, Lawrence

Subjects
Child, Child, Preschool, Humans, Dermatitis, Atopic, Antibodies, Monoclonal, Treatment Outcome, Injections, Subcutaneous, Severity of Illness Index, Double-Blind Method, Bacterial Infections, Antibodies, Monoclonal, Humanized
Abstract

BACKGROUND: Patients with atopic dermatitis (AD), particularly infants and young children, are at greater risk of developing skin infections. In this study, we assessed infection rates in AD patients aged 6 months to 5 years treated with dupilumab. METHODS: In LIBERTY AD PRESCHOOL, a double-blind, placebo-controlled, phase III clinical trial, children aged 6 months to 5 years with moderate-to-severe AD were randomized 1:1 to subcutaneous dupilumab or placebo, with concomitant low-potency topical corticosteroids, every 4 weeks for 16 weeks. Exposure-adjusted infection rates were used to compare treatment groups. RESULTS: The analysis included 162 patients, of whom 83 received dupilumab and 79 received placebo. Total infection rates were not significantly different between the dupilumab and placebo groups (rate ratio [RR] 0.75, 95% CI 0.48-1.19; p = 0.223). Non-herpetic adjudicated skin infections and bacterial infections were significantly less frequent with dupilumab versus placebo (non-herpetic skin infections: RR 0.46, 95% CI 0.21-0.99; p = 0.047; bacterial infections: RR 0.09, 95% CI 0.01-0.67; p = 0.019), and the number of patients using systemic anti-infective medication was significantly lower in the dupilumab group (RR 0.52, 95% CI 0.30-0.89; p = 0.019). There were no significant differences in the number of herpetic infections between the dupilumab and placebo groups (RR 1.17, 95% CI 0.31-4.35; p = 0.817). The number of patients with two or more infection events was significantly higher in the placebo group (RR 0.29, 95% CI 0.12-0.68; p = 0.004), and no severe or serious infections (including eczema herpeticum) were observed among patients receiving dupilumab. CONCLUSIONS: These data suggest that dupilumab treatment in infants and children younger than 6 years with AD does not increase overall risk of infections and is associated with a reduced risk of bacterial and non-herpetic skin infections compared with placebo, resulting in a reduced need for anti-infective medication. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov with ID number NCT03346434 on November 17, 2017. INFOGRAPHIC.

Published
2024

5. Methods for Estimating the Exposure-Response Curve to Inform the New Safety Standards for Fine Particulate Matter

Author

Cork, Michael, Mork, Daniel, and Dominici, Francesca

Subjects
Statistics - Applications
Abstract

Exposure to fine particulate matter ($PM_{2.5}$) poses significant health risks and accurately determining the shape of the relationship between $PM_{2.5}$ and health outcomes has crucial policy ramifications. While various statistical methods exist to estimate this exposure-response curve (ERC), few studies have compared their performance under plausible data-generating scenarios. This study compares seven commonly used ERC estimators across 72 exposure-response and confounding scenarios via simulation. Additionally, we apply these methods to estimate the ERC between long-term $PM_{2.5}$ exposure and all-cause mortality using data from over 68 million Medicare beneficiaries in the United States. Our simulation indicates that regression methods not placed within a causal inference framework are unsuitable when anticipating heterogeneous exposure effects. Under the setting of a large sample size and unknown ERC functional form, we recommend utilizing causal inference methods that allow for nonlinear ERCs. In our data application, we observe a nonlinear relationship between annual average $PM_{2.5}$ and all-cause mortality in the Medicare population, with a sharp increase in relative mortality at low PM2.5 concentrations. Our findings suggest that stricter $PM_{2.5}$ limits could avert numerous premature deaths. To facilitate the utilization of our results, we provide publicly available, reproducible code on Github for every step of the analysis.

Published
2023

6. Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age with Severe Atopic Dermatitis.

Author

Cork, Michael, Thaçi, Diamant, Arkwright, Peter, Chen, Zhen, Thomas, Ryan, Kosloski, Matthew, Dubost-Brama, Ariane, Prescilla, Randy, Bansal, Ashish, Levit, Noah, and Eichenfield, Lawrence

Subjects
Atopic dermatitis, Children, Dupilumab, Eczema, Efficacy, Long-term, Open-label, Pediatric, Quality of life, Safety
Abstract

BACKGROUND: For children aged 6-11 years with uncontrolled severe atopic dermatitis (AD), 16 weeks of treatment with dupilumab resulted in substantial clinical benefit compared with placebo with an acceptable safety profile. However, longer-term safety and efficacy data are important to inform longitudinal AD management. OBJECTIVES: This analysis of data from an open-label extension study (LIBERTY AD PED-OLE, NCT02612454) reports the long-term safety, efficacy, and pharmacokinetics of dupilumab in children with severe AD who had participated in the pivotal dupilumab LIBERTY AD PEDS study (NCT03345914). METHODS: Enrolled patients initially received subcutaneous dupilumab 300 mg every 4 weeks (q4w). The q4w regimen could be uptitrated to dupilumab dose regimens of 200 or 300 mg every 2 weeks (q2w; for body weight

Published
2023

13. Mapping age- and sex-specific HIV prevalence in adults in sub-Saharan Africa, 2000–2018

Author

Haeuser, Emily, Serfes, Audrey L, Cork, Michael A, Yang, Mingyou, Abbastabar, Hedayat, Abhilash, ES, Adabi, Maryam, Adebayo, Oladimeji M, Adekanmbi, Victor, Adeyinka, Daniel Adedayo, Afzal, Saira, Ahinkorah, Bright Opoku, Ahmadi, Keivan, Ahmed, Muktar Beshir, Akalu, Yonas, Akinyemi, Rufus Olusola, Akunna, Chisom Joyqueenet, Alahdab, Fares, Alanezi, Fahad Mashhour, Alanzi, Turki M, Alene, Kefyalew Addis, Alhassan, Robert Kaba, Alipour, Vahid, Almasi-Hashiani, Amir, Alvis-Guzman, Nelson, Ameyaw, Edward Kwabena, Amini, Saeed, Amugsi, Dickson A, Ancuceanu, Robert, Anvari, Davood, Appiah, Seth Christopher Yaw, Arabloo, Jalal, Aremu, Olatunde, Asemahagn, Mulusew A, Jafarabadi, Mohammad Asghari, Awedew, Atalel Fentahun, Quintanilla, Beatriz Paulina Ayala, Ayanore, Martin Amogre, Aynalem, Yared Asmare, Azari, Samad, Azene, Zelalem Nigussie, Darshan, BB, Babalola, Tesleem Kayode, Baig, Atif Amin, Banach, Maciej, Bärnighausen, Till Winfried, Bell, Arielle Wilder, Bhagavathula, Akshaya Srikanth, Bhardwaj, Nikha, Bhardwaj, Pankaj, Bhattacharyya, Krittika, Bijani, Ali, Bitew, Zebenay Workneh, Bohlouli, Somayeh, Bolarinwa, Obasanjo Afolabi, Boloor, Archith, Bozicevic, Ivana, Butt, Zahid A, Cárdenas, Rosario, Carvalho, Felix, Charan, Jaykaran, Chattu, Vijay Kumar, Chowdhury, Mohiuddin Ahsanul Kabir, Chu, Dinh-Toi, Cowden, Richard G, Dahlawi, Saad MA, Damiani, Giovanni, Darteh, Eugene Kofuor Maafo, Darwesh, Aso Mohammad, das Neves, José, Weaver, Nicole Davis, De Leo, Diego, De Neve, Jan-Walter, Deribe, Kebede, Deuba, Keshab, Dharmaratne, Samath, Dianatinasab, Mostafa, Diaz, Daniel, Didarloo, Alireza, Djalalinia, Shirin, Dorostkar, Fariba, Dubljanin, Eleonora, Duko, Bereket, El Tantawi, Maha, El-Jaafary, Shaimaa I, Eshrati, Babak, Eskandarieh, Sharareh, Eyawo, Oghenowede, Ezeonwumelu, Ifeanyi Jude, Ezzikouri, Sayeh, Farzadfar, Farshad, Fattahi, Nazir, Fauk, Nelsensius Klau, Fernandes, Eduarda, Filip, Irina, Fischer, Florian, Foigt, Nataliya A, Foroutan, Masoud, Fukumoto, Takeshi, and Gad, Mohamed M

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Clinical Sciences, HIV/AIDS, Infectious Diseases, Prevention, Pediatric, Clinical Research, 2.4 Surveillance and distribution, Aetiology, Infection, Good Health and Well Being, Male, Female, Adult, Humans, Pregnancy, Adolescent, Young Adult, Middle Aged, HIV, Acquired Immunodeficiency Syndrome, Prevalence, Seroepidemiologic Studies, HIV Infections, Africa South of the Sahara, Mapping, Africa, Geostatistics, Spatial statistics, HIV prevalence, Demographics, Local Burden of Disease sub-Saharan Africa HIV Prevalence Collaborators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundHuman immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS) is still among the leading causes of disease burden and mortality in sub-Saharan Africa (SSA), and the world is not on track to meet targets set for ending the epidemic by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the United Nations Sustainable Development Goals (SDGs). Precise HIV burden information is critical for effective geographic and epidemiological targeting of prevention and treatment interventions. Age- and sex-specific HIV prevalence estimates are widely available at the national level, and region-wide local estimates were recently published for adults overall. We add further dimensionality to previous analyses by estimating HIV prevalence at local scales, stratified into sex-specific 5-year age groups for adults ages 15-59 years across SSA.MethodsWe analyzed data from 91 seroprevalence surveys and sentinel surveillance among antenatal care clinic (ANC) attendees using model-based geostatistical methods to produce estimates of HIV prevalence across 43 countries in SSA, from years 2000 to 2018, at a 5 × 5-km resolution and presented among second administrative level (typically districts or counties) units.ResultsWe found substantial variation in HIV prevalence across localities, ages, and sexes that have been masked in earlier analyses. Within-country variation in prevalence in 2018 was a median 3.5 times greater across ages and sexes, compared to for all adults combined. We note large within-district prevalence differences between age groups: for men, 50% of districts displayed at least a 14-fold difference between age groups with the highest and lowest prevalence, and at least a 9-fold difference for women. Prevalence trends also varied over time; between 2000 and 2018, 70% of all districts saw a reduction in prevalence greater than five percentage points in at least one sex and age group. Meanwhile, over 30% of all districts saw at least a five percentage point prevalence increase in one or more sex and age group.ConclusionsAs the HIV epidemic persists and evolves in SSA, geographic and demographic shifts in prevention and treatment efforts are necessary. These estimates offer epidemiologically informative detail to better guide more targeted interventions, vital for combating HIV in SSA.

Published
2022

14. Long-Term Exposure to Low-Level P[M.sub.2.5] and Mortality: Investigation of Heterogeneity by Harmonizing Analyses in Large Cohort Studies in Canada, United States, and Europe

Author

Chen, Jie, Braun, Danielle, Christidis, Tanya, Cork, Michael, Rodopoulou, Sophia, Samoli, Evangelia, Stafoggia, Massimo, Wolf, Kathrin, Wu, Xiao, Yuchi, Weiran, Andersen, Zorana J., Atkinson, Richard, Bauwelinck, Mariska, de Hoogh, Kees, Janssen, Nicole A.H., Katsouyanni, Klea, Klompmaker, Jochem O., Kristoffersen, Doris Tove, Lim, Youn-Hee, Oftedal, Bente, Strak, Maciej, Vienneau, Danielle, Zhang, Jiawei, Burnett, Richard T., Hoek, Gerard, Dominici, Francesca, Brauer, Michael, and Brunekreef, Bert

Subjects
Mortality -- Statistics -- Environmental aspects -- Health aspects -- Europe -- Canada -- United States, Air pollution -- Statistics -- Health aspects, Particles -- Statistics -- Health aspects, Environmental issues, Health
Abstract

BACKGROUND: Studies across the globe generally reported increased mortality risks associated with particulate matter with aerodynamic diameter [less than or equal to]2.5 [micro]m (P[M.sub.2.5]) exposure with large heterogeneity in the magnitude of reported associations and the shape of concentration-response functions (CRFs). We aimed to evaluate the impact of key study design factors (including confounders, applied exposure model, population age, and outcome definition) on P[M.sub.2.5] effect estimates by harmonizing analyses on three previously published large studies in Canada [Mortality-Air Pollution Associations in Low Exposure Environments (MAPLE), 1991-2016], the United States (Medicare, 2000-2016), and Europe [Effects of Low-Level Air Pollution: A Study in Europe (ELAPSE), 2000-2016] as much as possible. METHODS: We harmonized the study populations to individuals 65+ years of age, applied the same satellite-derived P[M.sub.2.5] exposure estimates, and selected the same sets of potential confounders and the same outcome. We evaluated whether differences in previously published effect estimates across cohorts were reduced after harmonization among these factors. Additional analyses were conducted to assess the influence of key design features on estimated risks, including adjusted covariates and exposure assessment method. A combined CRF was assessed with meta-analysis based on the extended shape-constrained health impact function (eSCHIF). RESULTS: More than 81 million participants were included, contributing 692 million person-years of follow-up. Hazard ratios and 95% confidence intervals (CIs) for all-cause mortality associated with a 5-[micro]g/[m.sup.3] increase in P[M.sub.2.5] were 1.039 (1.032, 1.046) in MAPLE, 1.025 (1.021, 1.029) in Medicare, and 1.041 (1.014, 1.069) in ELAPSE. Applying a harmonized analytical approach marginally reduced difference in the observed associations across the three studies. Magnitude of the association was affected by the adjusted covariates, exposure assessment methodology, age of the population, and marginally by outcome definition. Shape of the CRFs differed across cohorts but generally showed associations down to the lowest observed P[M.sub.2.5] levels. A common CRF suggested a monotonically increased risk down to the lowest exposure level. https://doi.org/10.1289/EHP12141, Introduction Ambient particulate matter (PM) pollution has been identified as a leading risk factor for global disease burden. (1) Evaluating the risks attributable to PM with aerodynamic diameter [less than [...]

Published
2023
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17. Mapping local patterns of childhood overweight and wasting in low- and middle-income countries between 2000 and 2017

Author

Kinyoki, Damaris K, Ross, Jennifer M, Lazzar-Atwood, Alice, Munro, Sandra B, Schaeffer, Lauren E, Bhattacharjee, Natalia V, Collison, Michael L, Cork, Michael A, Cormier, Natalie, Weaver, Nicole Davis, Deshpande, Aniruddha, Dharmaratne, Samath Dhamminda, Earl, Lucas, Henry, Nathaniel J, Hollerich, Gillian, Johnson, Kimberly B, Kassebaum, Nicholas J, Krohn, Kris J, Letourneau, Ian D, Marczak, Laurie B, Mayala, Benjamin K, Mokdad, Ali H, Mosser, Jonathan F, Murray, Christopher JL, Naghavi, Mohsen, Osgood-Zimmerman, Aaron E, Pickering, Brandon V, Pigott, David M, Ray, Sarah E, Sbarra, Alyssa N, Schipp, Megan F, VanderHeide, John, Wang, Haidong, Wiens, Kirsten E, Afshin, Ashkan, Hay, Simon I, Sartorius, Benn, Khalil, Ibrahim A, Abbasalizad-Farhangi, Mahdieh M, Hasankhani, Milad, Abbasi, Masoumeh, Farzam, Hossein, Moradi, Masoud, Rezaeian, Shahab, Abbastabar, Hedayat, Abdelalim, Ahmed, El-Jaafary, Shaimaa I, Shehata, Hatem Samir, Abdoli, Amir, Abdollahi, Mohammad, Abdollahpour, Ibrahim, Abdulkader, Rizwan Suliankatchi, Abebe, Nebiyu Dereje, Deribe, Kebede, Abebo, Teshome Abuka, Abegaz, Kedir Hussein, Abolhassani, Hassan, Rezaei, Nima, Abreu, Lucas Guimaraes, Abrigo, Michael RM, Abushouk, Abdelrahman I, Accrombessi, Manfred Mario Kokou, Acharya, Dilaram, Adabi, Maryam, Adebiyi, Akindele Olupelumi, Ilesanmi, Olayinka Stephen, Adedeji, Isaac Akinkunmi, Adekanmbi, Victor, Adeoye, Abiodun Moshood, Adetokunboh, Olatunji O, Mahasha, Phetole Walter, Ndwandwe, Duduzile Edith, Nnaji, Chukwudi A, Sambala, Evanson Zondani, Adham, Davoud, Aduroja, Posi Emmanuel, Dipeolu, Isaac Oluwafemi, Ibitoye, Segun Emmanuel, John-Akinola, Yetunde O, Oluwasanu, Mojisola Morenike, Advani, Shailesh M, Afarideh, Mohsen, Esteghamati, Alireza, Ghajar, Alireza, Heidari, Behnam, Sayyah, Mehdi, Aghaali, Mohammad, Agrawal, Anurag, Ahmad, Tauseef, Ahmadi, Keivan, Ahmadi, Sepideh, Ahmed, Muktar Beshir, Gebrehiwot, Tsegaye Tewelde, Gesesew, Hailay Abrha, Ahmed, Rushdia, Das Gupta, Rajat, Ajumobi, Olufemi, Akal, Chalachew Genet, Demeke, Feleke Mekonnen, and Melese, Addisu

Subjects
Nutrition, Pediatric, Clinical Research, Prevention, Patient Safety, Zero Hunger, Child, Child, Preschool, Demography, Developing Countries, Female, Geographic Mapping, Humans, Income, Infant, Infant, Newborn, Male, Malnutrition, Nutritional Status, Overweight, Pediatric Obesity, Poverty, Prevalence, Social Class, Wasting Syndrome, LBD Double Burden of Malnutrition Collaborators, Medical and Health Sciences, Immunology
Abstract

A double burden of malnutrition occurs when individuals, household members or communities experience both undernutrition and overweight. Here, we show geospatial estimates of overweight and wasting prevalence among children under 5 years of age in 105 low- and middle-income countries (LMICs) from 2000 to 2017 and aggregate these to policy-relevant administrative units. Wasting decreased overall across LMICs between 2000 and 2017, from 8.4% (62.3 (55.1-70.8) million) to 6.4% (58.3 (47.6-70.7) million), but is predicted to remain above the World Health Organization's Global Nutrition Target of

Published
2020

18. Mapping disparities in education across low- and middle-income countries

Author

Graetz, Nicholas, Woyczynski, Lauren, Wilson, Katherine F, Hall, Jason B, Abate, Kalkidan Hassen, Abd-Allah, Foad, Adebayo, Oladimeji M, Adekanmbi, Victor, Afshari, Mahdi, Ajumobi, Olufemi, Akinyemiju, Tomi, Alahdab, Fares, Al-Aly, Ziyad, Alcalde Rabanal, Jacqueline Elizabeth, Alijanzadeh, Mehran, Alipour, Vahid, Altirkawi, Khalid, Amiresmaili, Mohammadreza, Anber, Nahla Hamed, Andrei, Catalina Liliana, Anjomshoa, Mina, Antonio, Carl Abelardo T, Arabloo, Jalal, Aremu, Olatunde, Aryal, Krishna K, Asadi-Aliabadi, Mehran, Atique, Suleman, Ausloos, Marcel, Awasthi, Ashish, Ayala Quintanilla, Beatriz Paulina, Azari, Samad, Badawi, Alaa, Banoub, Joseph Adel Mattar, Barker-Collo, Suzanne Lyn, Barnett, Anthony, Bedi, Neeraj, Bennett, Derrick A, Bhattacharjee, Natalia V, Bhattacharyya, Krittika, Bhattarai, Suraj, Bhutta, Zulfiqar A, Bijani, Ali, Bikbov, Boris, Britton, Gabrielle, Burstein, Roy, Butt, Zahid A, Cardenas, Rosario, Carvalho, Felix, Castaneda-Orjuela, Carlos A, Castro, Franz, Cerin, Ester, Chang, Jung-Chen, Collison, Michael L, Cooper, Cyrus, Cork, Michael A, Daoud, Farah, Das Gupta, Rajat, Weaver, Nicole Davis, De Neve, Jan-Walter, Deribe, Kebede, Desalegn, Beruk Berhanu, Deshpande, Aniruddha, Desta, Melaku, Dhimal, Meghnath, Diaz, Daniel, Dinberu, Mesfin Tadese, Djalalinia, Shirin, Dubey, Manisha, Dubljanin, Eleonora, Duraes, Andre R, Dwyer-Lindgren, Laura, Earl, Lucas, Kalan, Mohammad Ebrahimi, El-Khatib, Ziad, Eshrati, Babak, Faramarzi, Mahbobeh, Fareed, Mohammad, Faro, Andre, Fereshtehnejad, Seyed-Mohammad, Fernandes, Eduarda, Filip, Irina, Fischer, Florian, Fukumoto, Takeshi, Garcia, Jose A, Gill, Paramjit Singh, Gill, Tiffany K, Gona, Philimon N, Gopalani, Sameer Vali, Grada, Ayman, Guo, Yuming, Gupta, Rajeev, Gupta, Vipin, Haj-Mirzaian, Arvin, Haj-Mirzaian, Arya, Hamadeh, Randah R, Hamidi, Samer, Hasan, Mehedi, Hassen, Hamid Yimam, Hendrie, Delia, and Henok, Andualem

Subjects
Pediatric, Aetiology, 2.3 Psychological, social and economic factors, Good Health and Well Being, Bayes Theorem, Developing Countries, Education, Female, Health Status, Humans, Male, Socioeconomic Factors, Local Burden of Disease Educational Attainment Collaborators, General Science & Technology
Abstract

Educational attainment is an important social determinant of maternal, newborn, and child health1-3. As a tool for promoting gender equity, it has gained increasing traction in popular media, international aid strategies, and global agenda-setting4-6. The global health agenda is increasingly focused on evidence of precision public health, which illustrates the subnational distribution of disease and illness7,8; however, an agenda focused on future equity must integrate comparable evidence on the distribution of social determinants of health9-11. Here we expand on the available precision SDG evidence by estimating the subnational distribution of educational attainment, including the proportions of individuals who have completed key levels of schooling, across all low- and middle-income countries from 2000 to 2017. Previous analyses have focused on geographical disparities in average attainment across Africa or for specific countries, but-to our knowledge-no analysis has examined the subnational proportions of individuals who completed specific levels of education across all low- and middle-income countries12-14. By geolocating subnational data for more than 184 million person-years across 528 data sources, we precisely identify inequalities across geography as well as within populations.

Published
2020

19. Diaper dermatitis prevalence and severity: Global perspective on the impact of caregiver behavior

Author

Carr, Andrew N, DeWitt, Thomas, Cork, Michael J, Eichenfield, Lawrence F, Fölster‐Holst, Regina, Hohl, Daniel, Lane, Alfred T, Paller, Amy, Pickering, Larry, Taieb, Alain, Cui, Tao Y, Xu, Zi G, Wang, Xeumin, Brink, Susanna, Niu, Yeuqing, Ogle, Julie, Odio, Mauricio, and Gibb, Roger D

Subjects
Pediatric, Clinical Research, Skin, Buttocks, Caregivers, China, Cross-Sectional Studies, Diaper Rash, Diapers, Infant, Female, Germany, Humans, Hydrogen-Ion Concentration, Infant, Infant Care, Male, Prevalence, Surveys and Questionnaires, United States, diaper dermatitis, neonatal, skin barrier, Paediatrics and Reproductive Medicine, Dermatology & Venereal Diseases
Abstract

ObjectivesTo compare prevalence and severity of diaper dermatitis (DD) in infants and toddlers (babies) across three countries (China, USA, and Germany), including diapered skin measures and caregiver practices.MethodsA cross-sectional study of 1791 babies (~600 from each country) was recruited at each clinical site. Based on regional toilet-training habits, exclusively diaper-wearing infants were recruited between ages 2-8 months in China and 2-18 months in the USA and Germany. DD was measured, as well as skin pH, transepidermal water loss (TEWL), and relative humidity (RH) in the diapered region. Caregiver habits were collected via a questionnaire and included information on hygienic practices.ResultsDiaper dermatitis was highest in the perianal area, followed by the intertriginous, genital, and buttock regions. In general, DD was significantly lower in babies in China, highest in Germany, and intermediate in the USA. This rank ordering of DD by geography was also observed in baby age 2-8 months. The lower DD observed in China was associated with lower skin pH and TEWL on diapered skin and decreased RH in the diaper. Chinese caregivers had the highest rate of prophylactic topical product usage, the most robust cleaning of the diapered area, lack of cleansing after urine-only diaper changes, and Chinese infants spent the least time in an overnight diaper.ConclusionsThese data suggest caregiver behaviors including prophylactic use of topical products, thorough cleaning after stooling and reduced time in an overnight diaper are associated with less DD, lower superficial skin pH, and enhanced skin barrier.

Published
2020

20. Integrated Safety Analysis of Abrocitinib in 635 Adolescent Patients With Moderate-To-Severe Atopic Dermatitis With Over 1000 Patient-Years of Exposure

Author

Paller, Amy, primary, Eichenfield, Lawrence, additional, Silverberg, Jonathan, additional, Cork, Michael, additional, Bangert, Christine, additional, Irvine, Alan, additional, Weidinger, Stephan, additional, Barbarot, Sebastien, additional, Fan, Haiyun, additional, Alderfer, Justine, additional, Koppensteiner, Herwig, additional, and Chittuluru, Kanti, additional

Published
2024
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22. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE)

Author

Blauvelt, Andrew, Guttman-Yassky, Emma, Paller, Amy S., Simpson, Eric L., Cork, Michael J., Weisman, Jamie, Browning, John, Soong, Weily, Sun, Xian, Chen, Zhen, Kosloski, Matthew P., Kamal, Mohamed A., Delevry, Dimittri, Chuang, Chien-Chia, O’Malley, John T., and Bansal, Ashish

Published
2022
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23. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Pepper, Amber, Paller, Amy S, Lockshin, Benjamin, Cohen, David, Pariser, David, Siegfried, Elaine C, Simpson, Eric L, Leflein, Jeffrey, Weinberg, Jeffrey, Browning, John, Teng, Joyce, Wine Lee, Lara, Sher, Lawrence, Diaz, Lucia, Schneider, Lynda, Gonzalez, Mercedes E, Rupp, Ned, Ong, Peck, Cartwright, Robert, Sidbury, Robert, Soong, Weily, Pinter, Andreas, Wollenberg, Andreas, Schnopp, Christina, Cork, Michael J, Arkwright, Peter D, Korkosz, Anna, Bystrzanowska, Dorota, Sygula, Ewa, Zdybski, Jacek, Padlewska, Kamila, Schneider, Lynda C, Meltzer, Steven, Wang, Zhixiao, Mannent, Leda P, Amin, Nikhil, Sun, Yiping, Laws, Elizabeth, Akinlade, Bolanle, Dillon, Myles, Kosloski, Matthew P, Kamal, Mohamed A, Dubost-Brama, Ariane, Patel, Naimish, Weinreich, David M, Yancopoulos, George D, O’Malley, John T, and Bansal, Ashish

Published
2022
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31. 549 - Laboratory parameters in adolescent patients aged 12–17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to week 52: results from the phase 3 ECZTRA 6 trial

Author

Paller, Amy, primary, Cork, Michael, additional, Hong, Chih-ho, additional, Soong, Weily, additional, Schneider, Shannon, additional, Lo, Hannah, additional, Pedersen, Line Rosendahl Meldgaard, additional, Vacko, Emilia, additional, and Wollenberg, Andreas, additional

Published
2024
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32. Dupilumab Improves Skin Lipid Barrier in Pediatric Patients With Moderate-to-Severe Atopic Dermatitis

Author

Bronova, Irina, primary, Berdyshev, Evgeny, additional, Goleva, Elena, additional, Danby, Simon, additional, Bronoff, Anna Sofia, additional, Richers, Brittany, additional, Garcia, Shannon, additional, Gama, Marco Ramirez, additional, Taylor, Patricia, additional, Zahn, Joseph, additional, Agueusop, Inoncent, additional, Bafna, Shantanu, additional, Boguniewicz, Mark, additional, Ong, Peck, additional, Zhang, Annie, additional, Cork, Michael, additional, and Leung, Donald, additional

Published
2024
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34. Laboratory Parameters in Adolescent Patients Aged 12–17 with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52: Results from the Phase 3 ECZTRA 6 Trial

Author

Paller, Amy, primary, Cork, Michael, additional, Hong, Chih-ho, additional, Soong, Weilly, additional, Schneider, Shannon, additional, Lo, Hannah, additional, Pedersen, Line Rosendahl Meldgaard, additional, Vacko, Emilia, additional, and Wollenberg, Andreas, additional

Published
2024
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35. Efficacy and safety of 308-nm Excimer lamp combined with Tacrolimus 0.1% ointment vs Tacrolimus 0.1% ointment as monotherapy in treating children with limited vitiligo: a randomized controlled trial

Author

Alshiyab, Diala, primary, Ba-shammakh, Saleh A., additional, Al-Fakih, Abdulqudos, additional, Tashman, Osama, additional, Sarakbi, Danyah, additional, Al-qarqaz, Firas, additional, Muhaidat, Jihan, additional, Atwan, Ausama, additional, and Cork, Michael J., additional

Published
2023
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37. Subnational mapping of HIV incidence and mortality among individuals aged 15–49 years in sub-Saharan Africa, 2000–18: a modelling study

Author

Sartorius, Benn, VanderHeide, John D, Yang, Mingyou, Goosmann, Erik A, Hon, Julia, Haeuser, Emily, Cork, Michael A, Perkins, Samantha, Jahagirdar, Deepa, Schaeffer, Lauren E, Serfes, Audrey L, LeGrand, Kate E, Abbastabar, Hedayat, Abebo, Zeleke Hailemariam, Abosetugn, Akine Eshete, Abu-Gharbieh, Eman, Accrombessi, Manfred Mario Kokou, Adebayo, Oladimeji M, Adegbosin, Adeyinka Emmanuel, Adekanmbi, Victor, Adetokunboh, Olatunji O, Adeyinka, Daniel Adedayo, Ahinkorah, Bright Opoku, Ahmadi, Keivan, Ahmed, Muktar Beshir, Akalu, Yonas, Akinyemi, Oluwaseun Oladapo, Akinyemi, Rufus Olusola, Aklilu, Addis, Akunna, Chisom Joyqueenet, Alahdab, Fares, Al-Aly, Ziyad, Alam, Noore, Alamneh, Alehegn Aderaw, Alanzi, Turki M, Alemu, Biresaw Wassihun, Alhassan, Robert Kaba, Ali, Tilahun, Alipour, Vahid, Amini, Saeed, Ancuceanu, Robert, Ansari, Fereshteh, Anteneh, Zelalem Alamrew, Anvari, Davood, Anwer, Razique, Appiah, Seth Christopher Yaw, Arabloo, Jalal, Asemahagn, Mulusew A, Asghari Jafarabadi, Mohammad, Asmare, Wondwossen Niguse, Atnafu, Desta Debalkie, Atout, Maha Moh'd Wahbi, Atreya, Alok, Ausloos, Marcel, Awedew, Atalel Fentahun, Ayala Quintanilla, Beatriz Paulina, Ayanore, Martin Amogre, Aynalem, Yared Asmare, Ayza, Muluken Altaye, Azari, Samad, Azene, Zelalem Nigussie, Babar, Zaheer-Ud-Din, Baig, Atif Amin, Balakrishnan, Senthilkumar, Banach, Maciej, Bärnighausen, Till Winfried, Basu, Sanjay, Bayati, Mohsen, Bedi, Neeraj, Bekuma, Tariku Tesfaye, Bezabhe, Woldesellassie M Mequanint, Bhagavathula, Akshaya Srikanth, Bhardwaj, Pankaj, Bhattacharyya, Krittika, Bhutta, Zulfiqar A, Bibi, Sadia, Bikbov, Boris, Birhan, Tsegaye Adane, Bitew, Zebenay Workneh, Bockarie, Moses John, Boloor, Archith, Brady, Oliver J, Bragazzi, Nicola Luigi, Briko, Andrey Nikolaevich, Briko, Nikolay Ivanovich, Burugina Nagaraja, Sharath, Butt, Zahid A, Cárdenas, Rosario, Carvalho, Felix, Charan, Jaykaran, Chatterjee, Souranshu, Chattu, Soosanna Kumary, Chattu, Vijay Kumar, Chowdhury, Mohiuddin Ahsanul Kabir, Chu, Dinh-Toi, Cook, Aubrey J, Cormier, Natalie Maria, Cowden, Richard G, Culquichicon, Carlos, Dagnew, Baye, Dahlawi, Saad M A, Damiani, Giovanni, Daneshpajouhnejad, Parnaz, Daoud, Farah, Daryani, Ahmad, das Neves, José, Davis Weaver, Nicole, Derbew Molla, Meseret, Deribe, Kebede, Desta, Abebaw Alemayehu, Deuba, Keshab, Dharmaratne, Samath Dhamminda, Dhungana, Govinda Prasad, Diaz, Daniel, Djalalinia, Shirin, Doku, Paul Narh, Dubljanin, Eleonora, Duko, Bereket, Eagan, Arielle Wilder, Earl, Lucas, Eaton, Jeffrey W, Effiong, Andem, El Sayed Zaki, Maysaa, El Tantawi, Maha, Elayedath, Rajesh, El-Jaafary, Shaimaa I, Elsharkawy, Aisha, Eskandarieh, Sharareh, Eyawo, Oghenowede, Ezzikouri, Sayeh, Fasanmi, Abidemi Omolara, Fasil, Alebachew, Fauk, Nelsensius Klau, Feigin, Valery L, Ferede, Tomas Y, Fernandes, Eduarda, Fischer, Florian, Foigt, Nataliya A, Folayan, Morenike Oluwatoyin, Foroutan, Masoud, Francis, Joel Msafiri, Fukumoto, Takeshi, Gad, Mohamed M, Geberemariyam, Biniyam Sahiledengle, Gebregiorgis, Birhan Gebresillassie, Gebremichael, Berhe, Gesesew, Hailay Abrha, Getacher, Lemma, Ghadiri, Keyghobad, Ghashghaee, Ahmad, Gilani, Syed Amir, Ginindza, Themba G, Glagn, Mustefa, Golechha, Mahaveer, Gona, Philimon N, Gubari, Mohammed Ibrahim Mohialdeen, Gugnani, Harish Chander, Guido, Davide, Guled, Rashid Abdi, Hall, Brian J, Hamidi, Samer, Handiso, Demelash Woldeyohannes, Hargono, Arief, Hashi, Abdiwahab, Hassanipour, Soheil, Hassankhani, Hadi, Hayat, Khezar, Herteliu, Claudiu, Hidru, Hagos Degefa de, Holla, Ramesh, Hosgood, H Dean, Hossain, Naznin, Hosseini, Mostafa, Hosseinzadeh, Mehdi, Househ, Mowafa, Hwang, Bing-Fang, Ibitoye, Segun Emmanuel, Ilesanmi, Olayinka Stephen, Ilic, Irena M, Ilic, Milena D, Irvani, Seyed Sina Naghibi, Iwu, Chidozie C D, Iwu, Chinwe Juliana, Iyamu, Ihoghosa Osamuyi, Jain, Vardhmaan, Jakovljevic, Mihajlo, Jalilian, Farzad, Jha, Ravi Prakash, Johnson, Kimberly B, Joshua, Vasna, Joukar, Farahnaz, Jozwiak, Jacek Jerzy, Kabir, Ali, Kalankesh, Leila R, Kalhor, Rohollah, Kamath, Ashwin, Kamyari, Naser, Kanchan, Tanuj, Karami Matin, Behzad, Karch, André, Karimi, Salah Eddin, Kasa, Ayele Semachew, Kassahun, Getinet, Kayode, Gbenga A, Kazemi Karyani, Ali, Keiyoro, Peter Njenga, Kelkay, Bayew, Khalid, Nauman, Khan, Gulfaraz, Khan, Junaid, Khan, Md Nuruzzaman, Khatab, Khaled, Khazaei, Salman, Kim, Yun Jin, Kisa, Adnan, Kisa, Sezer, Kochhar, Sonali, Kopec, Jacek A, Kosen, Soewarta, Koulmane Laxminarayana, Sindhura Lakshmi, Koyanagi, Ai, Krishan, Kewal, Kuate Defo, Barthelemy, Kugbey, Nuworza, Kulkarni, Vaman, Kumar, Manasi, Kumar, Nithin, Kurmi, Om P, Kusuma, Dian, Kuupiel, Desmond, Kyu, Hmwe Hmwe, La Vecchia, Carlo, Lal, Dharmesh Kumar, Lam, Jennifer O, Landires, Iván, Lasrado, Savita, Lazarus, Jeffrey V, Lazzar-Atwood, Alice, Lee, Paul H, Leshargie, Cheru Tesema, Li, Bingyu, Liu, Xuefeng, Lopukhov, Platon D, M. Amin, Hawraz Ibrahim, Madi, Deepak, Mahasha, Phetole Walter, Majeed, Azeem, Maleki, Afshin, Maleki, Shokofeh, Mamun, Abdullah A, Manafi, Navid, Mansournia, Mohammad Ali, Martins-Melo, Francisco Rogerlândio, Masoumi, Seyedeh Zahra, Mayala, Benjamin K, Meharie, Birhanu Geta, Meheretu, Hailemariam Abiy Alemu, Meles, Hagazi Gebre, Melku, Mulugeta, Mendoza, Walter, Mengesha, Endalkachew Worku, Meretoja, Tuomo J, Mersha, Abera M, Mestrovic, Tomislav, Miller, Ted R, Mirica, Andreea, Mirzaei-Alavijeh, Mehdi, Mohamad, Osama, Mohammad, Yousef, Mohammadian-Hafshejani, Abdollah, Mohammed, Jemal Abdu, Mohammed, Salahuddin, Mohammed, Shafiu, Mokdad, Ali H, Mokonnon, Taklu Marama, Molokhia, Mariam, Moradi, Masoud, Moradi, Yousef, Moradzadeh, Rahmatollah, Moraga, Paula, Mosser, Jonathan F, Munro, Sandra B, Mustafa, Ghulam, Muthupandian, Saravanan, Naderi, Mehdi, Nagarajan, Ahamarshan Jayaraman, Naghavi, Mohsen, Naveed, Muhammad, Nayak, Vinod C, Nazari, Javad, Ndejjo, Rawlance, Nepal, Samata, Netsere, Henok Biresaw, Ngalesoni, Frida N, Nguefack-Tsague, Georges, Ngunjiri, Josephine W, Nigatu, Yeshambel T, Nigussie, Samuel Negash, Nnaji, Chukwudi A, Noubiap, Jean Jacques, Nuñez-Samudio, Virginia, Oancea, Bogdan, Odukoya, Oluwakemi Ololade, Ogbo, Felix Akpojene, Oladimeji, Olanrewaju, Olagunju, Andrew T, Olusanya, Bolajoko Olubukunola, Olusanya, Jacob Olusegun, Omer, Muktar Omer, Omonisi, Abidemi E Emmanuel, Onwujekwe, Obinna E, Orisakwe, Orish Ebere, Otstavnov, Nikita, Owolabi, Mayowa O, P A, Mahesh, Padubidri, Jagadish Rao, Pakhale, Smita, Pana, Adrian, Pandi-Perumal, Seithikurippu R, Patel, Urvish K, Pathak, Mona, Patton, George C, Pawar, Shrikant, Peprah, Emmanuel K, Pokhrel, Khem Narayan, Postma, Maarten J, Pottoo, Faheem Hyder, Pourjafar, Hadi, Pribadi, Dimas Ria Angga, Quazi Syed, Zahiruddin, Rafiei, Alireza, Rahim, Fakher, Rahman, Mohammad Hifz Ur, Rahmani, Amir Masoud, Ram, Pradhum, Rana, Juwel, Ranabhat, Chhabi Lal, Rao, Satish, Rao, Sowmya J, Rathi, Priya, Rawaf, David Laith, Rawaf, Salman, Rawassizadeh, Reza, Renjith, Vishnu, Reta, Melese Abate, Rezaei, Nima, Rezapour, Aziz, Ribeiro, Ana Isabel, Ross, Jennifer M, Rumisha, Susan Fred, Sagar, Rajesh, Sahu, Maitreyi, Sajadi, S. Mohammad, Salem, Marwa Rashad, Samy, Abdallah M, Sathian, Brijesh, Schutte, Aletta Elisabeth, Seidu, Abdul-Aziz, Sha, Feng, Shafaat, Omid, Shahbaz, Mohammad, Shaikh, Masood Ali, Shaka, Mohammed Feyisso, Sheikh, Aziz, Shibuya, Kenji, Shin, Jae Il, Shivakumar, K M, Sidemo, Negussie Boti, Singh, Jasvinder A, Skryabin, Valentin Yurievich, Skryabina, Anna Aleksandrovna, Soheili, Amin, Soltani, Shahin, Somefun, Oluwaseyi Dolapo, Sorrie, Muluken Bekele, Spurlock, Emma Elizabeth, Sufiyan, Mu'awiyyah Babale, Taddele, Biruk Wogayehu, Tadesse, Eyayou Girma, Tamir, Zemenu, Tamiru, Animut Tagele, Tanser, Frank C, Taveira, Nuno, Tehrani-Banihashemi, Arash, Tekalegn, Yohannes, Tesfay, Fisaha Haile, Tessema, Belay, Tessema, Zemenu Tadesse, Thakur, Bhaskar, Tolani, Musliu Adetola, Topor-Madry, Roman, Torrado, Marco, Tovani-Palone, Marcos Roberto, Traini, Eugenio, Tsai, Alexander C, Tsegaye, Gebiyaw Wudie, Ullah, Irfan, Ullah, Saif, Umeokonkwo, Chukwuma David, Unnikrishnan, Bhaskaran, Vardavas, Constantine, Violante, Francesco S, Vo, Bay, Wado, Yohannes Dibaba, Waheed, Yasir, Wamai, Richard G, Wang, Yanzhong, Ward, Paul, Werdecker, Andrea, Wickramasinghe, Nuwan Darshana, Wijeratne, Tissa, Wiysonge, Charles Shey, Wondmeneh, Temesgen Gebeyehu, Yamada, Tomohide, Yaya, Sanni, Yeshaw, Yigizie, Yeshitila, Yordanos Gizachew, Yilma, Mekdes Tigistu, Yip, Paul, Yonemoto, Naohiro, Yosef, Tewodros, Yusefzadeh, Hasan, Zaidi, Syed Saoud, Zaki, Leila, Zamanian, Maryam, Zastrozhin, Mikhail Sergeevich, Zastrozhina, Anasthasia, Zewdie, Dejene Tesfaye, Zhang, Yunquan, Zhang, Zhi-Jiang, Ziapour, Arash, Hay, Simon I, and Dwyer-Lindgren, Laura

Published
2021
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38. Characterization of skin barrier defects using infrared spectroscopy in patients with atopic dermatitis.

Author

Williams, Samuel F, Wan, Helen, Chittock, John, Brown, Kirsty, Wigley, Andrew, Cork, Michael J, and Danby, Simon G

Subjects
INFRARED spectroscopy, ATOPIC dermatitis, FOURIER transforms, MEASURING instruments, FUNCTIONAL groups
Abstract

Background Atopic dermatitis (AD) is characterized by skin barrier defects that are often measured by biophysical tools that observe the functional properties of the stratum corneum (SC). Objectives To employ in vivo infrared spectroscopy alongside biophysical measurements to analyse changes in the chemical composition of the SC in relation to AD severity. Methods We conducted an observational cross-sectional cohort study where attenuated total reflection Fourier transform infrared (ATR-FTIR) spectroscopy measurements were collected on the forearm alongside surface pH, capacitance, erythema and transepidermal water loss (TEWL), combined with tape stripping, in a cohort of 75 participants (55 patients with AD stratified by phenotypic severity and 20 healthy controls). Common FLG variant alleles were genotyped. Results Reduced hydration, elevated TEWL and redness were all associated with greater AD severity. Spectral analysis showed a reduction in 1465 cm–1 (full width half maximum) and 1340 cm–1 peak areas, indicative of less orthorhombic lipid ordering and reduced carboxylate functional groups, which correlated with clinical severity (lipid structure r = –0.59, carboxylate peak area r = –0.50). Conclusions ATR-FTIR spectroscopy is a suitable tool for the characterization of structural skin barrier defects in AD and has potential as a clinical tool for directing individual treatment based on chemical structural deficiencies. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): a multicentre, parallel group, assessor-blinded clinical trial

Author

Flohr, Carsten, primary, Rosala-Hallas, Anna, additional, Jones, Ashley P, additional, Beattie, Paula, additional, Baron, Susannah, additional, Browne, Fiona, additional, Brown, Sara J, additional, Gach, Joanna E, additional, Greenblatt, Danielle, additional, Hearn, Ross, additional, Hilger, Eva, additional, Esdaile, Ben, additional, Cork, Michael J, additional, Howard, Emma, additional, Lovgren, Marie-Louise, additional, August, Suzannah, additional, Ashoor, Farhiya, additional, Williamson, Paula R, additional, McPherson, Tess, additional, O’Kane, Donal, additional, Ravenscroft, Jane, additional, Shaw, Lindsay, additional, Sinha, Manish D, additional, Spowart, Catherine, additional, Taams, Leonie S, additional, Thomas, Bjorn R, additional, Wan, Mandy, additional, Sach, Tracey H, additional, and Irvine, Alan D, additional

Published
2023
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43. A concept for integrated care pathways for atopic dermatitis—A GA2LEN ADCARE initiative

Author

Zuberbier, Torsten, primary, Abdul Latiff, Amir, additional, Aggelidis, Xenofon, additional, Augustin, Matthias, additional, Balan, Radu‐Gheorghe, additional, Bangert, Christine, additional, Beck, Lisa, additional, Bieber, Thomas, additional, Bernstein, Jonathan A., additional, Bertolin Colilla, Marta, additional, Berardi, Alejandro, additional, Bedbrook, Anna, additional, Bindslev‐Jensen, Carsten, additional, Bousquet, Jean, additional, de Bruin‐Weller, Marjolein, additional, Bruscky, Dayanne, additional, Buyuktiryaki, Betul, additional, Canonica, Giorgio Walter, additional, Castro, Carla, additional, Chanturidze, Natia, additional, Chong‐Neto, Herberto Jose, additional, Chu, Chia‐Yu, additional, Chularojanamontri, Leena, additional, Cork, Michael, additional, Criado, Roberta F. J., additional, Barredo, Laia Curto, additional, Custovic, Adnan, additional, Darsow, Ulf, additional, Emurlai, Arben, additional, de Pablo, Ana, additional, Del Giacco, Stefano, additional, Girolomoni, Giampiero, additional, Deleva Jovanova, Tanja, additional, Deleuran, Mette, additional, Douladiris, Nikolaos, additional, Duarte, Bruno, additional, Dubakiene, Ruta, additional, Eller, Esben, additional, Engel‐Yeger, Batya, additional, Ensina, Luis Felipe, additional, Filho, Nelson Rosario, additional, Flohr, Carsten, additional, Fomina, Daria, additional, Francuzik, Wojciech, additional, Galimberti, Maria Laura, additional, Giménez‐Arnau, Ana M., additional, Godse, Kiran, additional, Mortz, Charlotte Gotthard, additional, Gotua, Maia, additional, Hide, Michihiro, additional, Hoetzenecker, Wolfram, additional, Hunzelmann, Nicolas, additional, Irvine, Alan, additional, Jack, Carolyn, additional, Kanavarou, Ioanna, additional, Katoh, Norito, additional, Kinaciyan, Tamar, additional, Kocatürk, Emek, additional, Kulthanan, Kanokvalai, additional, Lapeere, Hilde, additional, Lau, Susanne, additional, Machado Forti Nastri, Mariana, additional, Makris, Michael, additional, Mansour, Eli, additional, Marsland, Alexander, additional, Morelo Rocha Felix, Mara, additional, Moschione Castro, Ana Paula, additional, Nettis, Eustachio, additional, Nicolas, J. F., additional, Nosbaum, Audrey, additional, Odemyr, Mikaela, additional, Papapostolou, Niki, additional, Parisi, Claudio A. S., additional, Paudel, Sushil, additional, Peter, Jonny, additional, Pokharel, Prakash, additional, Puig, Luis, additional, Quint, Tamara, additional, Ramon, German Dario, additional, Regateiro, Frederico, additional, Ricci, Giampaolo, additional, Rosario, Cristine, additional, Sackesen, Cansin, additional, Schmid‐Grendelmeier, Peter, additional, Serra‐Baldrich, Esther, additional, Siemens, Kristina, additional, Smith, Cathrine, additional, Staubach, Petra, additional, Stevanovic, Katarina, additional, Su‐Kücük, Özlem, additional, Sussman, Gordon, additional, Tavecchio, Simona, additional, Teovska Mitrevska, Natasa, additional, Thaci, Diamant, additional, Toubi, Elias, additional, Traidl‐Hoffmann, Claudia, additional, Treudler, Regina, additional, Vadasz, Zahava, additional, van Hofman, Ingrid, additional, Ventura, Maria Teresa, additional, Wang, Zhao, additional, Werfel, Thomas, additional, Wollenberg, Andreas, additional, Yang, Ariana, additional, Weng Yew, Yik, additional, Zhao, Zuotao, additional, Zwiener, Ricardo, additional, and Worm, Margitta, additional

Published
2023
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45. Pimecrolimus in atopic dermatitis: Consensus on safety and the need to allow use in infants

Author

Luger, Thomas, Boguniewicz, Mark, Carr, Warner, Cork, Michael, Deleuran, Mette, Eichenfield, Lawrence, Eigenmann, Philippe, Fölster-Holst, Regina, Gelmetti, Carlo, Gollnick, Harald, Hamelmann, Eckard, Hebert, Adelaide A, Muraro, Antonella, Oranje, Arnold P, Paller, Amy S, Paul, Carle, Puig, Luis, Ring, Johannes, Siegfried, Elaine, Spergel, Jonathan M, Stingl, Georg, Taieb, Alain, Torrelo, Antonio, Werfel, Thomas, and Wahn, Ulrich

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Aging, Pediatric, Skin, Anti-Inflammatory Agents, Non-Steroidal, Child, Preschool, Consensus, Dermatitis, Atopic, Humans, Infant, Practice Guidelines as Topic, Tacrolimus, atopic dermatitis, eczema, infants, paediatric, pimecrolimus, safety, tacrolimus, topical calcineurin inhibitors, topical corticosteroids, Immunology, Paediatrics and Reproductive Medicine, Public Health and Health Services, Allergy, Paediatrics
Abstract

Atopic dermatitis (AD) is a distressing dermatological disease, which is highly prevalent during infancy, can persist into later life and requires long-term management with anti-inflammatory compounds. The introduction of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, more than 10 yr ago was a major breakthrough for the topical anti-inflammatory treatment of AD. Pimecrolimus 1% is approved for second-line use in children (≥2 yr old) and adults with mild-to-moderate AD. The age restriction was emphasized in a boxed warning added by the FDA in January 2006, which also highlights the lack of long-term safety data and the theoretical risk of skin malignancy and lymphoma. Since then, pimecrolimus has been extensively investigated in short- and long-term studies including over 4000 infants (

Published
2015

46. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials

Author

Silverberg, Jonathan I., Simpson, Eric L., Guttman-Yassky, Emma, Cork, Michael J., de Bruin-Weller, Marjolein, Yosipovitch, Gil, Eckert, Laurent, Chen, Zhen, Ardeleanu, Marius, Shumel, Brad, Hultsch, Thomas, Rossi, Ana B., Hamilton, Jennifer D., Orengo, Jamie M., Ruddy, Marcella, Graham, Neil M. H., Pirozzi, Gianluca, and Gadkari, Abhijit

Published
2021
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47. Long-Term Exposure to Low-Level PM2.5 and Mortality: Investigation of Heterogeneity by Harmonizing Analyses in Large Cohort Studies in Canada, United States, and Europe.

Author

Jie Chen, Braun, Danielle, Christidis, Tanya, Cork, Michael, Rodopoulou, Sophia, Samoli, Evangelia, Stafoggia, Massimo, Wolf, Kathrin, Xiao Wu, Weiran Yuchi, Andersen, Zorana J., Atkinson, Richard, Bauwelinck, Mariska, de Hoogh, Kees, Janssen, Nicole A. H., Katsouyanni, Klea, Klompmaker, Jochem O., Kristoffersen, Doris Tove, Youn-Hee Lim, and Oftedal, Bente

Subjects
MORTALITY risk factors, PARTICULATE matter, AERODYNAMICS, RELATIVE medical risk, CONFIDENCE intervals, NOSOLOGY, META-analysis, RISK assessment, SOCIAL classes, DESCRIPTIVE statistics, DATA analysis software, ENVIRONMENTAL exposure, LONGITUDINAL method, PROPORTIONAL hazards models, MEDICARE, POISSON distribution
Abstract

BACKGROUND: Studies across the globe generally reported increased mortality risks associated with particulate matter with aerodynamic diameter ≤2.5 μm (PM2.5) exposure with large heterogeneity in the magnitude of reported associations and the shape of concentration-response functions (CRFs). We aimed to evaluate the impact of key study design factors (including confounders, applied exposure model, population age, and outcome definition) on PM2.5 effect estimates by harmonizing analyses on three previously published large studies in Canada [Mortality-Air Pollution Associations in Low Exposure Environments (MAPLE), 1991-2016], the United States (Medicare, 2000-2016), and Europe [Effects of Low-Level Air Pollution: A Study in Europe (ELAPSE), 2000-2016] as much as possible. METHODS: We harmonized the study populations to individuals 65+ years of age, applied the same satellite-derived PM2.5 exposure estimates, and selected the same sets of potential confounders and the same outcome. We evaluated whether differences in previously published effect estimates across cohorts were reduced after harmonization among these factors. Additional analyses were conducted to assess the influence of key design features on estimated risks, including adjusted covariates and exposure assessment method. A combined CRF was assessed with meta-analysis based on the extended shape-constrained health impact function (eSCHIF). RESULTS: More than 81 million participants were included, contributing 692 million person-years of follow-up. Hazard ratios and 95% confidence intervals (CIs) for all-cause mortality associated with a 5-μg/m³ increase in PM2.5 were 1.039 (1.032, 1.046) in MAPLE, 1.025 (1.021, 1.029) in Medicare, and 1.041 (1.014, 1.069) in ELAPSE. Applying a harmonized analytical approach marginally reduced difference in the observed associations across the three studies. Magnitude of the association was affected by the adjusted covariates, exposure assessment methodology, age of the population, and marginally by outcome definition. Shape of the CRFs differed across cohorts but generally showed associations down to the lowest observed PM2.5 levels. A common CRF suggested a monotonically increased risk down to the lowest exposure level. [ABSTRACT FROM AUTHOR]

Published
2023
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48. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomised placebo-controlled trial

Author

Weidinger, Stephan, primary, Bieber, Thomas, additional, Cork, Michael J, additional, Reich, Adam, additional, Wilson, Rosamund, additional, Quaratino, Sonia, additional, Stebegg, Marisa, additional, Brennan, Nuala, additional, Gilbert, Sally, additional, O’Malley, John T, additional, and Porter-Brown, Ben, additional

Published
2023
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