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5. A systematic review and expert Delphi Consensus recommendation on the use of vaccines in patients receiving dupilumab: A position paper of the American College of Allergy, Asthma and Immunology

Author

Lieberman, Jay A., Chu, Derek K., Ahmed, Tasnuva, Dribin, Timothy E., Abrams, Elissa M., Anagnostou, Aikaterini, Blumenthal, Kimberly G., Boguniewicz, Mark, Chase, Nicole M., Golden, David B.K., Hartog, Nicholas L., Heimall, Jennifer R., Ho, Tina, Lawrence, Monica G., Khan, David A., Minniear, Timothy Dean, Mustafa, S. Shahzad, Oppenheimer, John J., Phillips, Elizabeth J., Ramsey, Allison, Rider, Nicholas L., Schneider, Lynda, Shaker, Marcus S., Spergel, Jonathan M., Stone, Cosby A., Jr, Stukus, David R., Wang, Julie, and Greenhawt, Matthew J.

Published
2024
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8. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE– and Institute of Medicine–based recommendations

Author

Chu, Derek K., Schneider, Lynda, Asiniwasis, Rachel Netahe, Boguniewicz, Mark, De Benedetto, Anna, Ellison, Kathy, Frazier, Winfred T., Greenhawt, Matthew, Huynh, Joey, Kim, Elaine, LeBovidge, Jennifer, Lind, Mary Laura, Lio, Peter, Martin, Stephen A., O'Brien, Monica, Ong, Peck Y., Silverberg, Jonathan I., Spergel, Jonathan M., Wang, Julie, Wheeler, Kathryn E., Guyatt, Gordon H., Capozza, Korey, Begolka, Wendy Smith, Chu, Alexandro W.L., Zhao, Irene X., Chen, Lina, Oykhman, Paul, Bakaa, Layla, Golden, David, Shaker, Marcus, Bernstein, Jonathan A., Horner, Caroline C., Lieberman, Jay, Stukus, David, Rank, Matthew A., Ellis, Anne, Abrams, Elissa, and Ledford, Dennis

Published
2024
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11. Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials

Author

Chu, Derek K., Chu, Alexandro W.L., Rayner, Daniel G., Guyatt, Gordon H., Yepes-Nuñez, Juan José, Gomez-Escobar, Luis, Pérez-Herrera, Lucia C., Díaz Martinez, Juan Pablo, Brignardello-Petersen, Romina, Sadeghirad, Behnam, Wong, Melanie M., Ceccacci, Renata, Zhao, Irene X., Basmaji, John, MacDonald, Margaret, Chu, Xiajing, Islam, Nazmul, Gao, Ya, Izcovich, Ariel, Asiniwasis, Rachel N., Boguniewicz, Mark, De Benedetto, Anna, Capozza, Korey, Chen, Lina, Ellison, Kathy, Frazier, Winfred T., Greenhawt, Matthew, Huynh, Joey, LeBovidge, Jennifer, Lio, Peter A., Martin, Stephen A., O’Brien, Monica, Ong, Peck Y., Silverberg, Jonathan I., Spergel, Jonathan M., Smith Begolka, Wendy, Wang, Julie, Wheeler, Kathryn E., Gardner, Donna D., and Schneider, Lynda

Published
2023
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12. Systemic treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials

Author

Chu, Alexandro W.L., Wong, Melanie M., Rayner, Daniel G., Guyatt, Gordon H., Díaz Martinez, Juan Pablo, Ceccacci, Renata, Zhao, Irene X., McMullen, Eric, Srivastava, Archita, Wang, Jason, Wen, Aaron, Wang, Fang Chi, Brignardello-Petersen, Romina, Izcovich, Ariel, Oykhman, Paul, Wheeler, Kathryn E., Wang, Julie, Spergel, Jonathan M., Singh, Jasvinder A., Silverberg, Jonathan I., Ong, Peck Y., O’Brien, Monica, Martin, Stephen A., Lio, Peter A., Lind, Mary Laura, LeBovidge, Jennifer, Kim, Elaine, Huynh, Joey, Greenhawt, Matthew, Gardner, Donna D., Frazier, Winfred T., Ellison, Kathy, Chen, Lina, Capozza, Korey, De Benedetto, Anna, Boguniewicz, Mark, Smith Begolka, Wendy, Asiniwasis, Rachel N., Schneider, Lynda C., and Chu, Derek K.

Published
2023
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14. Rapid reduction in Staphylococcus aureus in atopic dermatitis subjects following dupilumab treatment

Author

Simpson, Eric L., Schlievert, Patrick M., Yoshida, Takeshi, Lussier, Stephanie, Boguniewicz, Mark, Hata, Tissa, Fuxench, Zelma, De Benedetto, Anna, Ong, Peck Y., Ko, Justin, Calatroni, Agustin, Rudman Spergel, Amanda K., Plaut, Marshall, Quataert, Sally A., Kilgore, Samuel H., Peterson, Liam, Gill, Ann L., David, Gloria, Mosmann, Tim, Gill, Steven R., Leung, Donald Y.M., and Beck, Lisa A.

Published
2023
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20. Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families

Author

Simpson, Eric L, Paller, Amy S, Boguniewicz, Mark, Eichenfield, Lawrence F, Feldman, Steven R, Silverberg, Jonathan I, Chamlin, Sarah L, and Zane, Lee T

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Neurodegenerative, Clinical Research, Atopic dermatitis, Crisaborole, Eczema, PDE4, Phosphodiesterase 4, Quality of life, Topical treatment, Clinical sciences
Abstract

IntroductionThe impact of crisaborole ointment, a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD), on quality of life (QoL) was assessed in two identically designed phase 3 studies (AD-301: NCT02118766; AD-302: NCT02118792, both at http://www.clinicaltrials.gov ).MethodsIn both studies, patients aged ≥ 2 years with mild to moderate AD per the Investigator's Static Global Assessment were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. QoL was assessed using the Children's Dermatology Life Quality Index (CDLQI) (2-15 years), the Dermatology Life Quality Index (DLQI) (≥ 16 years), and the Dermatitis Family Impact Questionnaire (DFI) (parents/caregivers/family of patients aged 2-17 years). Established QoL score severity bands provided clinical context.ResultsGreater mean improvement in QoL was observed in crisaborole-treated patients than in vehicle-treated patients at day 29 [mean change from baseline (∆BL), CDLQI: - 4.6 vs. - 3.0; P < 0.001; DLQI: - 5.2 vs. - 3.5; P = 0.015]. At baseline, more than half the patients had a "moderate effect" or higher of AD on QoL. At day 29, there was a trend toward more crisaborole- than vehicle-treated patients having "small effect" to "no effect", The QoL of parents/caregivers/family improved more for crisaborole-treated than for vehicle-treated patients (∆BL, DFI: - 3.7 vs. - 2.7; P = 0.003).ConclusionCrisaborole treatment results in clinically meaningful improvement in QoL for patients and their parents/caregivers/families.Trial registrationAD-301: http://www.clinicaltrials.gov , NCT02118766; AD-302: http://www.clinicaltrials.gov , NCT02118792.FundingAnacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY.

Published
2018

21. Dietary Elimination for the Treatment of Atopic Dermatitis: A Systematic Review and Meta-Analysis

Author

Oykhman, Paul, Dookie, Jared, Al-Rammahy, Husam, de Benedetto, Anna, Asiniwasis, Rachel N., LeBovidge, Jennifer, Wang, Julie, Ong, Peck Y., Lio, Peter, Gutierrez, Alvin, Capozza, Korey, Martin, Stephen A., Frazier, Winfred, Wheeler, Kathryn, Boguniewicz, Mark, Spergel, Jonathan M., Greenhawt, Matthew, Silverberg, Jonathan I., Schneider, Lynda, and Chu, Derek K.

Published
2022
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22. Bleach baths for atopic dermatitis: A systematic review and meta-analysis including unpublished data, Bayesian interpretation, and GRADE

Author

Bakaa, Layla, Pernica, Jeffrey M., Couban, Rachel J., Tackett, Kelly Jo, Burkhart, Craig N., Leins, Liz, Smart, Joanne, Garcia-Romero, Maria Teresa, Elizalde-Jiménez, Itzel Guadalupe, Herd, Michael, Asiniwasis, Rachel Netahe, Boguniewicz, Mark, De Benedetto, Anna, Chen, Lina, Ellison, Kathy, Frazier, Winfred, Greenhawt, Matthew, Huynh, Joey, LeBovidge, Jennifer, Lind, Mary Laura, Lio, Peter, O'Brien, Monica, Ong, Peck Y., Silverberg, Jonathan I., Spergel, Jonathan M., Wang, Julie, Begolka, Wendy Smith, Schneider, Lynda, and Chu, Derek K.

Published
2022
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24. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis

Author

Boguniewicz, Mark, Beck, Lisa A., Sher, Lawrence, Guttman-Yassky, Emma, Thaçi, Diamant, Blauvelt, Andrew, Worm, Margitta, Corren, Jonathan, Soong, Weily, Lio, Peter, Rossi, Ana B., Lu, Yufang, Chao, Jingdong, Eckert, Laurent, Gadkari, Abhijit, Hultsch, Thomas, Ruddy, Marcella, Mannent, Leda P., Graham, Neil M.H., Pirozzi, Gianluca, Chen, Zhen, and Ardeleanu, Marius

Published
2021
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25. Targeting the aryl hydrocarbon receptor as a strategy to expand the therapeutic armamentarium in atopic dermatitis.

Author

Eichenfield, Lawrence F., Silverberg, Jonathan I., Hebert, Adelaide A., and Boguniewicz, Mark

Subjects
ARYL hydrocarbon receptors, ATOPIC dermatitis, ECZEMA, COUGH, HERPES simplex
Abstract

This article discusses the burden of atopic dermatitis (AD), a chronic inflammatory skin disease that affects both children and adults. The incidence of AD is increasing globally, and it has a significant impact on quality of life. Current treatments have limitations, and there is a need for improved topical medications. Tapinarof, a nonsteroidal topical medication, has shown promise in clinical trials for patients with AD, including children as young as 2 years old. Targeting the aryl hydrocarbon receptor (AhR) may offer a novel therapeutic strategy for AD. The document provides a list of references and citations for further research on atopic dermatitis, covering various topics related to the condition and its treatment. [Extracted from the article]

Published
2024
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29. Study of the Atopic March: Development of Atopic Comorbidities

Author

Schneider, Lynda, Hanifin, Jon, Boguniewicz, Mark, Eichenfield, Lawrence F, Spergel, Jonathan M, Dakovic, Rada, and Paller, Amy S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Asthma, Clinical Trials and Supportive Activities, Lung, Food Allergies, Patient Safety, Eczema / Atopic Dermatitis, Digestive Diseases, Pediatric, Skin, Inflammatory and immune system, Comorbidity, Dermatitis, Atopic, Dermatologic Agents, Double-Blind Method, Humans, Infant, Longitudinal Studies, Rhinitis, Allergic, Severity of Illness Index, Tacrolimus, Treatment Outcome, Paediatrics and Reproductive Medicine, Dermatology & Venereal Diseases, Clinical sciences, Paediatrics
Abstract

BackgroundAtopic dermatitis (AD) is often the first step in the atopic march leading to the development of asthma or allergic rhinitis. The goal of this study was to determine whether early intervention with pimecrolimus limits the atopic march in infants with AD and to evaluate its efficacy and safety.MethodsThis was a 3-year double-blind study in which patients were randomized to pimecrolimus or vehicle and then open-label pimecrolimus for a planned further 3 years. Rescue topical corticosteroid was permitted if 3 days of study medication led to no improvement; investigators made decisions on rescue medication until week 14 and caregivers thereafter. Efficacy assessments included disease-free days, Eczema Area and Severity Index, and body surface area affected.ResultsInfants ages 3 to 18 months with recent-onset AD (≤3 months) were observed for a mean of 2.8 years (N = 1,091). No significant differences between pimecrolimus- and placebo-treated groups were found in the percentage of patients with AD who developed asthma (10.7%) or other allergic conditions (allergic rhinitis, 22.4%; food allergy, 15.9%; allergic conjunctivitis, 14.1%; one or more atopic comorbidities, 37.0%) by study end. Allergic rhinitis, food allergy, and having one or more atopic comorbidities (but not asthma or allergic conjunctivitis alone) developed significantly more often in infants with greater AD severity at baseline. Pimecrolimus was significantly more effective than vehicle for AD treatment at week 14. Adverse event incidences were similar.ConclusionsThis longitudinal observation of infants with AD provides evidence of the atopic march. Pimecrolimus was safe and effective in infants with mild to moderate AD.

Published
2016

30. Clinically Meaningful Responses to Dupilumab in Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis: Post-hoc Analyses from a Randomized Clinical Trial

Author

Paller, Amy S., Bansal, Ashish, Simpson, Eric L., Boguniewicz, Mark, Blauvelt, Andrew, Siegfried, Elaine C., Guttman-Yassky, Emma, Hultsch, Thomas, Chen, Zhen, Mina-Osorio, Paola, Lu, Yufang, Rossi, Ana B., He, Xinyi, Kamal, Mohamed, Graham, Neil M. H., Pirozzi, Gianluca, Ruddy, Marcella, Eckert, Laurent, and Gadkari, Abhijit

Published
2020
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31. 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

36. Report from the National Institute of Allergy and Infectious Diseases workshop on “Atopic dermatitis and the atopic march: Mechanisms and interventions”

Author

Davidson, Wendy F., Leung, Donald Y.M., Beck, Lisa A., Berin, Cecilia M., Boguniewicz, Mark, Busse, William W., Chatila, Talal A., Geha, Raif S., Gern, James E., Guttman-Yassky, Emma, Irvine, Alan D., Kim, Brian S., Kong, Heidi H., Lack, Gideon, Nadeau, Kari C., Schwaninger, Julie, Simpson, Angela, Simpson, Eric L., Spergel, Jonathan M., Togias, Alkis, Wahn, Ulrich, Wood, Robert A., Woodfolk, Judith A., Ziegler, Steven F., and Plaut, Marshall

Published
2019
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41. 680 - Efficacy of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis by age of onset: analysis of two phase 3 clinical trials.

Author

Zirwas, Matthew J, Boguniewicz, Mark, Rosmarin, David, Fuxench, Zelma Chiesa, Warren, Richard B, Torres, Tiago, Bruin-Weller, Marjolein de, Dawson, Zach, Atwater, Amber Reck, Elmaraghy, Hany, Pierce, Evangeline, Bardolet, Laia, Zhong, Jinglin, and Armstrong, April W

Subjects
*CLINICAL trials, *GENETIC profile, *AGE of onset, *ATOPIC dermatitis, *LOGISTIC regression analysis
Abstract

Introduction/Background Atopic dermatitis (AD) has different clinical presentations, pathophysiology, comorbidity frequencies, and genetic profiles in adult-onset vs childhood-onset disease. Based on these differences, it is plausible that treatment response would also be different between adult- and childhood-onset AD. Lebrikizumab, a novel, high affinity monoclonal antibody, selectively targeting IL-13 with high affinity and slow dissociation rate, has been approved in the EU, UK, and Japan and is under investigation in the US and elsewhere for the treatment of moderate-to-severe AD. Objectives To evaluate the Week-16 efficacy of lebrikizumab monotherapy by age of AD onset in adults and adolescents with moderate-to-severe AD from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), identically-designed, randomized, double-blind, placebo-controlled phase 3 trials. Methods In ADvocate1 and ADvocate2, eligible patients were randomly allocated 2:1 to receive lebrikizumab 250 mg or placebo every 2 weeks. The date of AD onset was collected, and age of onset was calculated accordingly. Patients were stratified by age of AD-onset as ≤2, >2-to-<18, and ≥18 years. Efficacy was assessed at Week 16 with the proportion of patients with Investigator's Global Assessment score of 0 or 1 with ≥2-point improvement (IGA 0,1; the trials' primary endpoint); ≥75% (EASI 75) and ≥90% (EASI 90) improvement in the Eczema Area and Severity Index from baseline; ≥4-point Pruritus Numeric Rating Scale (NRS) improvement from baseline (with baseline score ≥4), and percentage change in total EASI from baseline. Data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders or set to baseline values. Data from patients who discontinued treatment for other reasons were set to missing and analyzed by multiple imputation. This was a post-hoc analysis conducted on the modified, pooled intent-to-treat population. Treatment-by-age subgroup interaction was assessed with logistic regression. Binary outcomes were analyzed by the Cochran-Mantel-Haenszel method, and continuous outcomes were analyzed with ANCOVA. Results At baseline, the numbers of patients treated with lebrikizumab and placebo, respectively, were 215 and 117 in the ≤2 years AD-onset subgroup, 178 and 103 in the >2-to-<18 years subgroup, and 171 and 67 in the ≥18 years subgroup. At baseline, the percentages of patients with ≥1 atopic comorbidity were 81% in the ≤2 years subgroup, 74% in the >2-to-<18 years subgroup, and 58% in the ≥18 years subgroup. At Week 16, treatment-by-age subgroup interactions were not significant at the 0.10 level for IGA 0,1; EASI 75; EASI 90; and Pruritus NRS 4-pt improvement. Within each subgroup, a higher proportion of lebrikizumab-treated compared with placebo-treated patients (p<0.001) achieved IGA 0,1 responses (≤2 years: 41% vs. 12%; >2-to-<18 years: 35% vs. 12%; ≥18 years: 38% vs. 12%), EASI 75 responses (≤2 years: 57% vs. 17%; >2-to-<18 years: 51% vs. 16%; ≥18 years: 58% vs. 20%), and EASI 90 responses (≤2 years: 38% vs. 10%; >2-to-<18 years: 32% vs. 9%; ≥18 years: 33% vs. 8%). Additionally, the least-squares mean percentage change from baseline in total EASI score for lebrikizumab and placebo, respectively, was -65% and -26% in the ≤2 years subgroup, -60% and -26% in the >2-to-<18 years subgroup, and -63% and -30% in the ≥18 years subgroup (p<0.001 for lebrikizumab vs. placebo in all subgroups). The proportion of lebrikizumab-treated patients who reported ≥4-point improvement in Pruritus NRS from baseline (baseline ≥4) was greater compared with placebo-treated patients ([N]; ≤2 years: 43% [201] vs. 11% [108]; >2-to-<18 years: 41% [161] vs. 14% [96]; ≥18 years: 45% [154] vs. 12% [60]; p<0.001). Conclusions Regardless of age of AD onset, lebrikizumab was associated with significant improvements in AD signs and symptoms compared with placebo over 16 weeks of treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Tralokinumab therapy for moderate‐to‐severe atopic dermatitis: Clinical outcomes with targeted IL‐13 inhibition.

Author

Simpson, Eric L., Guttman‐Yassky, Emma, Eichenfield, Lawrence F., Boguniewicz, Mark, Bieber, Thomas, Schneider, Shannon, Guana, Adriana, and Silverberg, Jonathan I.

Subjects
ATOPIC dermatitis, ALLERGIC conjunctivitis, CLINICAL trials, TREATMENT effectiveness, MONOCLONAL antibodies, SYMPTOMS
Abstract

Atopic dermatitis (AD) is a chronic, inflammatory, intensely pruritic skin disorder associated with significant patient burden. Interleukin (IL)‐13 is a cytokine that acts as a driver of immune dysregulation, skin‐barrier dysfunction, and microbiome dysbiosis that characterizes AD, and is consistently overexpressed in AD skin. Tralokinumab is a fully human immunoglobulin (Ig) G4 monoclonal antibody that binds specifically to IL‐13 with high affinity, thereby inhibiting subsequent downstream IL‐13 signaling. Three pivotal phase 3 clinical trials demonstrated that tralokinumab 300 mg every other week, as monotherapy or in combination with topical corticosteroids as needed, provides significant improvements in signs and symptoms of moderate‐to‐severe AD, as measured by Investigator's Global Assessment 0/1 (clear/almost clear) and Eczema Area and Severity Index‐75 at Week 16. Improvements were observed soon after tralokinumab initiation and were maintained over 52 weeks of therapy. Tralokinumab significantly improved patient‐reported outcomes such as itch and sleep, and demonstrated a safety profile comparable with placebo; conjunctivitis during tralokinumab therapy was generally mild. Similar results were observed in a phase 3 adolescent trial. The role of IL‐13 in the pathophysiology of AD justifies a targeted approach and a wealth of clinical data supports tralokinumab as a new therapeutic option for people with moderate‐to‐severe AD. [ABSTRACT FROM AUTHOR]

Published
2023
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