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1. Practical Management of the JAK1 Inhibitor Abrocitinib for Atopic Dermatitis in Clinical Practice: Special Safety Considerations.

Author

Gooderham, Melinda, de Bruin-Weller, Marjolein, Weidinger, Stephan, Cork, Michael, Eichenfield, Lawrence, Simpson, Eric, Tsianakas, Athanasios, Kerkmann, Urs, Feeney, Claire, and Romero, William

Subjects
Abrocitinib, Atopic dermatitis, JAK1-selective inhibitor, Monitoring, Safety
Abstract

Abrocitinib, an oral, once-daily, Janus kinase (JAK) 1-selective inhibitor, is approved for the treatment of adults and adolescents with moderate-to-severe atopic dermatitis (AD). Abrocitinib has shown rapid and sustained efficacy in phase 3 trials and a consistent, manageable safety profile in long-term studies. Rapid itch relief and skin clearance are more likely to be achieved with a 200-mg daily dose of abrocitinib than with dupilumab. All oral JAK inhibitors are associated with adverse events of special interest and laboratory changes, and initial risk assessment and follow-up monitoring are important. Appropriate selection of patients and adequate monitoring are key for the safe use of JAK inhibitors. Here, we review the practical use of abrocitinib and discuss characteristics of patients who are candidates for abrocitinib therapy. In general, abrocitinib may be used in all appropriate patients with moderate-to-severe AD in need of systemic therapy, provided there are no contraindications, e.g., in patients with active serious systemic infections and those with severe hepatic impairment, as well as pregnant or breastfeeding women. For patients aged ≥ 65 years, current long-time or past long-time smokers, and those with risk factors for venous thromboembolism, major adverse cardiovascular events, or malignancies, a meticulous benefit-risk assessment is recommended, and it is advised to start with the 100-mg dose, when abrocitinib is the selected treatment option.

Published
2024

2. 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

6. 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

7. 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

15. 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

17. 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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19. 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

20. 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

21. 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

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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25. 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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28. 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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33. 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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34. A prospective observational cohort study comparing the treatment effectiveness and safety of ciclosporin, dupilumab and methotrexate in adult and paediatric patients with atopic dermatitis: results from the UK–Irish A-STAR register.

Author

Alexander, Helen, Malek, Rayka, Prieto-Merino, David, Gribaleva, Elizaveta, Baden, Manisha, Beattie, Paula, Brown, Sara, Burton, Tim, Cameron, Shona, Coker, Bola, Cork, Michael J, Hearn, Ross, Ingram, John R, Irvine, Alan D, Johnston, Graham A, Lambert, Alice, Lunt, Mark, Man, Irene, Newell, Louise, and Ogg, Graham

Abstract

Background The main conventional systemic treatments for atopic dermatitis (AD) are methotrexate (MTX) and ciclosporin (CyA). Dupilumab was the first novel systemic agent to enter routine clinical practice. There are no head-to-head randomized controlled trials or real-world studies comparing these agents directly. Network meta-analyses provide indirect comparative efficacy and safety data and have shown strong evidence for dupilumab and CyA. Objectives To compare the real-world clinical effectiveness and safety of CyA, dupilumab and MTX in AD. Methods We compared the effectiveness and safety of these systemic agents in a prospective observational cohort study of adult and paediatric patients recruited into the UK–Irish Atopic eczema Systemic TherApy Register (A-STAR). Treatment effectiveness measures included Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS), Dermatology Life Quality Index (DLQI) and children's DLQI (cDLQI). The minimum duration of treatment was 28 days and follow-up was 12 months. Adjusted Cox-regression analysis was used to compare the hazard ratios of achieving EASI-50, EASI-75 and EASI-90 over time, and linear mixed-effects models were used to estimate changes in efficacy scores. Treatment safety was assessed by examining adverse events (AEs) at follow-up visits. Results We included 488 patients (311 adults and 177 children/adolescents) on dupilumab (n = 282), MTX (n = 149) or CyA (n = 57). CyA and MTX were primarily used as the first-line treatment, while dupilumab was mainly a second-line systemic treatment as per UK National Institute of Clinical and Care Excellence (NICE) recommendations. EASI-50, EASI-75 and EASI-90 were achieved more rapidly in the dupilumab and CyA groups compared with MTX. After adjustment for previous severity, the reduction in EASI, POEM, PP-NRS and DLQI was greater for patients treated with dupilumab compared with MTX. In patients with severe disease the reduction in EASI, POEM and PP-NRS was even greater with CyA. The incidence rates of AEs were similar across groups (734, 654 and 594 per 10 000 person-month on CyA, dupilumab and MTX, respectively). Conclusions This real-world comparison of CyA, dupilumab and MTX in AD suggests that dupilumab is consistently more effective than MTX and that CyA is most effective in very severe disease within 1 year of follow-up. [ABSTRACT FROM AUTHOR]

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

Subjects
TACROLIMUS, RANDOMIZED controlled trials, VITILIGO, BODY surface area, CHILD patients
Abstract

Objective: This study aims to assess the efficacy and safety of combining the 308-nm Excimer lamp with Tacrolimus 0.1% ointment, compared to Tacrolimus 0.1% ointment monotherapy, for treating pediatric vitiligo involving less than 10% of the body surface area. Methods: Fifty pediatric patients with vitiligo were randomly assigned to two groups. Group A received Tacrolimus 0.1% ointment twice daily and Excimer light at 308-nm twice weekly, while Group B received Tacrolimus 0.1% ointment alone, administered twice daily. Repigmentation percentages were evaluated after 30, 90, and 180days using the rule of nine. Results: Group A exhibited a significant improvement in repigmentation, increasing from 10% after one month to 65% after six months. In contrast, Group B observed an increase from 10% to 30% over the same timeframe. The efficacy of the treatment was significantly higher in Group A at both the 3-month and 6-month follow-up points (p-value < .001). Moreover, Group A achieved notably higher repigmentation rates in the face, trunk, and lower limbs. Conclusion: The combination of Tacrolimus and the 308-nm excimer lamp yielded superior repigmentation results compared to Tacrolimus monotherapy in pediatric vitiligo patients. This combined approach may offer an effective new treatment protocol for pediatric vitiligo. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Practical Management of the JAK1 Inhibitor Abrocitinib for Atopic Dermatitis in Clinical Practice: Special Safety Considerations

Author

MS Dermatologie/Allergologie, Infection & Immunity, Gooderham, Melinda J., de Bruin-Weller, Marjolein, Weidinger, Stephan, Cork, Michael J., Eichenfield, Lawrence F., Simpson, Eric L., Tsianakas, Athanasios, Kerkmann, Urs, Feeney, Claire, Romero, William, MS Dermatologie/Allergologie, Infection & Immunity, Gooderham, Melinda J., de Bruin-Weller, Marjolein, Weidinger, Stephan, Cork, Michael J., Eichenfield, Lawrence F., Simpson, Eric L., Tsianakas, Athanasios, Kerkmann, Urs, Feeney, Claire, and Romero, William

Published
2024

37. Dupilumab Treatment in Pediatric Patients Aged 6–11 Years with Severe Atopic Dermatitis Whose Disease Is Not Adequately Controlled: A Review

Author

Cork,Michael, Danby,Simon, Rossi,Ana B, Bansal,Ashish, Cork,Michael, Danby,Simon, Rossi,Ana B, and Bansal,Ashish

Abstract

Michael J Cork,1,2 Simon G Danby,1,2 Ana B Rossi,3 Ashish Bansal4 1Sheffield Dermatology Research, University of Sheffield, Sheffield, UK; 2Sheffield Children’s Hospital, Sheffield, UK; 3Sanofi, Cambridge, MA, USA; 4Regeneron Pharmaceuticals Inc., Tarrytown, NY, USACorrespondence: Michael J Cork, Sheffield Dermatology Research, Department of Infection and Immunity, The University of Sheffield, K Floor, The Medical School (RHH tower), Beech Hill, Sheffield, S10 2RX, UK, Email m.j.cork@sheffield.ac.ukAbstract: Atopic dermatitis (AD) is the most common inflammatory skin disease in children. Children with severe AD have a multidimensional disease burden characterized by skin lesions, itching, frequent infections, sleep deprivation, and a high rate of comorbidities. These impact the mental health and overall quality of life of not only the children but also of their parents and caregivers. There are few effective available treatment options for young children with severe AD that are suitable for long-term use. Due to their adverse effects, practice guidelines consider systemic agents inappropriate for this age group, although they are still used off-label in extreme cases. The biologic dupilumab has recently been approved for children aged 6– 11 years with severe (EU) and moderate-to-severe (USA) AD, offering hope to this population of patients with a high unmet clinical need. The purpose of this review is to describe the unmet needs of AD patients aged 6– 11 years prior to dupilumab approval and to summarize existing clinical data supporting dupilumab’s safety and efficacy in these children.Keywords: atopic dermatitis, children, dupilumab, pediatric, severe

Published
2024

38. Pharmacokinetics and pharmacodynamics of itepekimab in adults with moderate‐to‐severe atopic dermatitis: Results from two terminated phase II trials.

Author

Kosloski, Matthew P., Guttman‐Yassky, Emma, Cork, Michael J., Worm, Margitta, Nahm, Dong‐Ho, Zhu, Xiaoping, Ruddy, Marcella K., Harel, Sivan, Kamal, Mohamed A., Goulaouic, Hélène, Xu, Christine R., Avetisova, Elena, Davis, John D., Nivens, Michael C., Shabbir, Arsalan, and Radin, Allen

Subjects
CHRONIC obstructive pulmonary disease, EPITHELIUM, ATOPIC dermatitis, EPITHELIAL cells, DUPILUMAB
Abstract

Interleukin‐33 (IL‐33) is a proinflammatory alarmin cytokine released by damaged epithelial tissue cells that initiates and amplifies both type 1 and type 2 inflammatory cascades. A role for IL‐33 in atopic dermatitis (AD; a chronic, relapsing type 2 inflammatory disease of the skin) has been proposed. Itepekimab is a novel human IgG4P monoclonal antibody against IL‐33, currently in clinical development for chronic obstructive pulmonary disease (COPD). Two global phase II studies—a dose‐ranging itepekimab monotherapy study (NCT03738423) and a proof‐of‐concept study of itepekimab alone and in combination with dupilumab (NCT03736967)—were conducted in patients with moderate‐to‐severe AD to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy; both studies were terminated following an interim analysis of the proof‐of‐concept study, which failed to demonstrate the efficacy of itepekimab. In these two studies, itepekimab exhibited linear and dose‐proportional pharmacokinetics. Pharmacodynamics of total IL‐33 indicated that itepekimab saturated binding to the target in serum at 300 mg q2w and q4w doses, and decreased blood eosinophil counts. Concentration–time profiles of itepekimab and total IL‐33 were similar for itepekimab with or without dupilumab, and between East Asian and non‐East Asian subgroups. Itepekimab was generally well tolerated, both alone and in combination with dupilumab. The lack of clinical efficacy for itepekimab observed in these studies suggests that IL‐33 may not be a key pathogenic driver in moderate‐to‐severe AD. [ABSTRACT FROM AUTHOR]

Published
2024
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41. 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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42. 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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44. 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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45. 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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47. 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

48. 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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49. 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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