41 results on '"Eichenfield, Lawrence F."'
Search Results
2. Diagnosis and Management of Pediatric Chronic Hand Eczema: The PeDRA CACHES Survey.
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Haft MA, Park HH, Lee SS, Sprague JM, Paller AS, Cotton CH, Thyssen JP, and Eichenfield LF
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- Humans, Child, United States, Prospective Studies, Quality of Life, Dermatology, Eczema diagnosis, Eczema drug therapy, Eczema epidemiology, Dermatitis, Atopic drug therapy
- Abstract
Background: Chronic hand eczema (CHE) significantly impacts quality of life. Published literature on pediatric CHE (P-CHE) in North America including knowledge on epidemiology and standard evaluation and management is limited., Objective: Our objective was to assess diagnostic practices when evaluating patients with P-CHE in the US and Canada, produce data on therapeutic agent prescribing practices for the disorder, and lay the foundation for future studies., Methods: We surveyed pediatric dermatologists to collect data on clinician and patient population demographics, diagnostic methods, therapeutic agent selection, among other statistics. From June 2021 to January 2022, a survey was distributed to members of the Pediatric Dermatology Research Alliance (PeDRA)., Results: Fifty PeDRA members responded stating that they would be interested in participating, and 21 surveys were completed. For patients with P-CHE, providers most often utilize the diagnoses of irritant contact dermatitis, allergic contact dermatitis, dyshidrotic hand eczema, and atopic dermatitis. Contact allergy patch testing and bacterial hand culture are the most used tests for workup. Nearly all utilize topical corticosteroids as first line therapy. Most responders report that they have treated fewer than six patients with systemic agents and prefer dupilumab as first-line systemic therapy., Conclusions: This is the first characterization of P-CHE among pediatric dermatologists in the United States and Canada. This assessment may prove useful in designing further investigations including prospective studies of P-CHE epidemiology, morphology, nomenclature, and management., (© 2023. The Author(s).)
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- 2023
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3. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies.
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Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, and Simpson EL
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- Adult, Anti-Inflammatory Agents therapeutic use, Antipruritics therapeutic use, Double-Blind Method, Emollients therapeutic use, Humans, Nitriles, Pyrazoles, Pyrimidines, Treatment Outcome, Dermatitis, Atopic diagnosis, Dermatitis, Atopic drug therapy, Eczema
- Abstract
Background: Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD)., Objective: To evaluate 8-week efficacy and safety in 2 phase 3 studies of RUX cream in patients with AD., Methods: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and ≥2-grade improvement from baseline)., Results: In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P < .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P < .05). Application site reactions were infrequent (<1%) and lower with RUX versus vehicle; none were clinically significant., Limitations: Longer-term safety data are not yet available., Conclusions: RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated., Competing Interests: Conflicts of interest Dr Papp has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or Steering Committee member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharmaceuticals, Eli Lilly, Galderma, Genentech, Gilead, GlaxoSmithKline, Incyte Corporation, InflaRx, Janssen, Kyowa Hakko Kirin, LEO, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharmaceuticals, Takeda, and UCB. Dr Szepietowski has served as an advisor for AbbVie, LEO Pharma, Novartis, Pierre Fabre, Menlo Therapeutics, and Trevi; has received speaker honoraria from AbbVie, Janssen-Cilag, LEO Pharma, Novartis, Sanofi-Genzyme, Sun Pharma, and Eli Lilly; and has received clinical trial funding from AbbVie, Almirall, Amgen, Galapagos, Holm, Incyte Corporation, InflaRX, Janssen-Cilag, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. Dr Kircik has served as an investigator, consultant, or speaker for AbbVie, Amgen, Anaptys, Arcutis, Dermavant, Eli Lilly, Glenmark, Incyte Corporation, Kamedis, LEO Pharma, L’Oréal, Menlo, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and Taro. Dr Toth has served as an investigator for AbbVie, Avillion, Amgen, Arcutis, Astellas, Astion, Boehringer Ingelheim, Celgene, Dermira, DS BioPharma, Dow Pharmaceuticals, Eli Lilly, F. Hoffmann-La Roche Ltd, Galderma, GlaxoSmithKline, Incyte Corporation, Isotechnika, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, and UCB Biopharma. Dr Eichenfield has served as an investigator, consultant, speaker, or data safety monitoring board member for AbbVie, Almirall, Arcutis, Dermira, Eli Lilly, Forte Biosciences, Galderma, Ichnos/Glenmark, Incyte Corporation, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Otsuka, Pfizer, Regeneron, and Sanofi Genzyme. Dr Leung has served as an advisor, investigator, or speaker for Incyte Corporation, LEO Pharma, Boehringer Ingelheim, Genentech, Aimmune, Novartis, Sanofi, and Regeneron. Dr Forman has received honoraria, clinical research grants, or fees as a consultant, speaker, advisory board member, and/or investigator for AbbVie, Aclaris Therapeutics, Asana BioSciences, AstraZeneca, Athenex, Celgene Corporation, Cutanea Life Sciences, Eli Lilly, Incyte Corporation, Innovaderm Research, Novartis, Pfizer, Promius Pharma, Regeneron, UCB, Valeant Pharmaceuticals North America, and XBiotech. Drs Venturanza, Sun, and Kuligowski are employees and shareholders of Incyte Corporation. Dr Simpson is an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron and is a consultant with honorarium for AbbVie, Eli Lilly, Forte Bio, Galderma, Incyte Corporation, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and Valeant., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
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- 2021
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4. Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial.
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Eichenfield LF, Flohr C, Sidbury R, Siegfried E, Szalai Z, Galus R, Yao Z, Takahashi H, Barbarot S, Feeney C, Zhang F, DiBonaventura M, Rojo R, Valdez H, and Chan G
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- Adolescent, Child, Double-Blind Method, Female, Humans, Male, Pyrimidines, Severity of Illness Index, Sulfonamides, Treatment Outcome, Dermatitis, Atopic drug therapy, Eczema drug therapy
- Abstract
Importance: Dupilumab subcutaneous injection is approved for treating moderate-to-severe atopic dermatitis (AD) in adolescents, but there has been too little research on an efficacious systemic oral treatment with a favorable benefit-risk profile for adolescents with moderate-to-severe AD., Objective: To investigate the efficacy and safety of oral abrocitinib plus topical therapy in adolescents with moderate-to-severe AD., Design, Setting, and Participants: The phase 3, randomized, double-blind, placebo-controlled study JADE TEEN was conducted in countries of the Asia-Pacific region, Europe, and North America in patients aged 12 to 17 years with moderate-to-severe AD and an inadequate response to 4 consecutive weeks or longer of topical medication or a need for systemic therapy for AD. The study was conducted between February 18, 2019, and April 8, 2020. The data were analyzed after study completion., Interventions: Patients were randomly assigned 1:1:1 to receive once-daily oral abrocitinib, 200 mg or 100 mg, or placebo for 12 weeks in combination with topical therapy., Main Outcomes and Measures: Coprimary end points were achievement of an Investigator's Global Assessment (IGA) response of clear (0) or almost clear (1) with improvement of 2 or more grades from baseline (IGA 0/1) and 75% or greater improvement from baseline in Eczema Area and Severity Index (EASI-75) response at week 12. Key secondary end points included 4-point or greater improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) at week 12. Adverse events (AEs) were monitored., Results: This study included 285 adolescents with moderate-to-severe AD (145 boys [50.9%] and 140 girls [49.1%]), of whom 160 (56.1%) were White and 94 (33.0%) were Asian; the median age was 15 years (interquartile range 13-17 years). Substantially more patients treated with abrocitinib (200 mg or 100 mg) vs placebo achieved an IGA response of 0/1 (46.2%; 41.6% vs 24.5%; P < .05 for both), EASI-75 (72.0%; 68.5% vs 41.5%; P < .05 for both), and PP-NRS4 (55.4%; 52.6% vs 29.8%; P < .01 for 200 mg vs placebo) at week 12. Adverse events were reported for 59 (62.8%), 54 (56.8%), and 50 (52.1%) patients in the 200 mg, 100 mg, and placebo groups, respectively; nausea was more common with abrocitinib, 200 mg (17 [18.1%]) and 100 mg (7 [7.4%]). Herpes-related AEs were infrequent; 1 (1.1%), 0, and 2 (2.1%) patients had serious AEs., Conclusions and Relevance: This randomized clinical trial found that oral abrocitinib combined with topical therapy was significantly more effective than placebo with topical therapy in adolescents with moderate-to-severe AD, with an acceptable safety profile., Trial Registration: ClinicalTrials.gov identifier: NCT03796676.
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- 2021
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5. Atopic Dermatitis: Evolution and Revolution in Therapy.
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Appiah MM, Haft MA, and Eichenfield LF
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- Humans, Asthma, Dermatitis, Atopic drug therapy, Eczema
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- 2021
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6. Management of Severe Atopic Dermatitis in Pediatric Patients.
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Mancuso JB, Lee SS, Paller AS, Ohya Y, and Eichenfield LF
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- Child, Humans, Immunosuppressive Agents, Pruritus therapy, Quality of Life, Dermatitis, Atopic epidemiology, Dermatitis, Atopic therapy, Eczema
- Abstract
Atopic dermatitis is a common, chronic inflammatory skin disorder, present in about 12% of children worldwide. Optimizing management of severe atopic dermatitis in pediatric patients is critical to reduce signs of inflammation, alleviate pruritus and sleep disturbance, minimize the development and/or impact of comorbidities, and improve the patient and caregiver's quality of life. Evaluating the longitudinal severity of pediatric atopic dermatitis is an important component of measuring therapeutic response and long-term management, and is different in clinical practice versus clinical trials. This article describes when and how to use different treatments for pediatric patients with severe atopic dermatitis, including topical medications, phototherapy, and systemic medical therapies (traditional immunosuppressants, biologics, and small molecule inhibitors). It also provides recommendations useful in clinical practice for nonpharmacologic interventions for pediatric patients with severe atopic dermatitis., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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7. Medical algorithm: Treatment of atopic dermatitis in early childhood (part II).
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Janmohamed SR, Ring J, Eichenfield LF, and Gutermuth J
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- Algorithms, Child, Preschool, Humans, Immunoglobulin E, Dermatitis, Atopic diagnosis, Dermatitis, Atopic epidemiology, Dermatitis, Atopic therapy, Eczema
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- 2021
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8. Medical algorithm: Diagnosis of atopic dermatitis in early childhood (part I).
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Janmohamed SR, Grosber M, Eichenfield LF, Ring J, and Gutermuth J
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- Algorithms, Child, Preschool, Humans, Dermatitis, Atopic diagnosis, Eczema, Food Hypersensitivity
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- 2021
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9. Update on pediatric atopic dermatitis.
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Tracy A, Bhatti S, and Eichenfield LF
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- Adolescent, Child, Humans, Quality of Life, Dermatitis, Atopic drug therapy, Dermatitis, Atopic epidemiology, Eczema
- Abstract
Recent studies have led to new insights into atopic dermatitis (AD) pathogenesis and epidemiology as well as its impact on the quality of life of affected children and adolescents. In addition, there are several novel topical and systemic agents recently approved and in late-stage clinical development programs. Epidemiologic insights include relative prevalence rates in different countries and studies of subsets of pediatric patients with different disease longevity and persistence. Studies on quality of life have shown tremendous impact on sleep, not only in affected individuals but in their parents/guardians. The impact of bathing regimens is discussed. Newer topical therapies are reviewed, including topical crisaborole, with a new indication for infants as young as 3 months of age. Topical Janus kinase (JAK) inhibitors are being developed, with some studies including adolescents and children. Other novel therapies include the topical aryl hydrocarbon receptor agonist tapinarof and oral JAK inhibitors; adolescents are being included in the initial clinical trials for several of these therapies. Dupilumab, the first biologic agent approved for AD, has now been well studied in patients aged 6 years and older, with expanded indication down to 6 years of age.
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- 2020
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10. Optimizing Clinical Trials for Atopic Dermatitis in Children.
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Siegfried EC, Jaworski JC, Eichenfield LF, Hebert AA, and Paller AS
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- Child, Humans, Dermatitis, Atopic, Eczema
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- 2017
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11. Natural advances in eczema care.
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Eichenfield LF, Fowler JF Jr, Rigel DS, and Taylor SC
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- Ceramides metabolism, Eczema diagnosis, Eczema metabolism, Epidermis metabolism, Filaggrin Proteins, Humans, Intermediate Filament Proteins genetics, Melanoma prevention & control, Mutation, Phytotherapy, Skin Pigmentation, Sunscreening Agents therapeutic use, Water Loss, Insensible, Eczema therapy
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Atopic dermatitis (AD) is a chronic relapsing dermatitis characterized by increased transepidermal water loss (TEWL) and subjective symptoms of pruritus, inflammation, skin sensitivity, and dryness. AD is a frequent issue for individuals of color, though it may be underrecognized. Therapy for AD is based on reducing pruritus and inflammation, and normalizing skin surface lipids, particularly ceramides. Topical corticosteroids are the gold-standard treatment for controlling disease flares, but a variety of active natural ingredients can be used adjunctively to help control itch, inflammation, and dryness. Oatmeal, particularly avenanthramides, a newly discovered oat fraction, may be of particular value in restoring the cutaneous barrier and reducing symptoms of AD. Feverfew, licorice, and dexpanthenol also have been shown to be effective in the management of inflammation. Licorice, which has some skin-lightening activity, may be helpful in patients with postinflammatory hyperpigmentation (PIH). The compromised skin barrier in AD is especially vulnerable to UV radiation exposure. Several new long-lasting photostable sunscreen ingredients provide longer durations of protection with improved cosmetic attributes.
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- 2007
12. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management
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Haft, Michael A, Park, Helen H, Lee, Stephanie S, Sprague, Jessica M, and Eichenfield, Lawrence F
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Biomedical and Clinical Sciences ,Clinical Sciences ,Pediatric AIDS ,Pediatric ,Clinical Research ,Skin ,Inflammatory and immune system ,Good Health and Well Being ,adolescent ,child ,childhood ,children ,chronic ,dermatitis ,eczema ,hand ,literature ,manus ,pediatric ,persistent ,questions ,recalcitrant ,review ,skin ,summary ,teenage ,teenager ,young - Abstract
Chronic hand eczema (CHE) is persistent inflammatory dermatitis that may significantly affect the quality of life, with psychosocial effects, impact on school, work, and leisure activities, influence on socioeconomic status, and high health care costs. Pediatric-CHE (P-CHE) has a high prevalence yet has not been extensively studied in children and adolescents. There is minimal published data on P-CHE in North America, and no specific management guidelines. Limited prevalence data show broad ranges (0.9%-4.4%) in preschool and school children, with 1 study stating up to 10.0% 1-year prevalence for ages 16 to 19 years. Atopic dermatitis and allergic contact dermatitis appear important in the pathogenesis of this disease process, although there is limited pediatric data assessing disease associations and no standardized methodology for evaluating this disorder. Given the potential life-changing consequences of P-CHE, further research into this disease process is warranted to help generate best therapeutic practices and minimize this disease process' morbidity in adulthood.
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- 2023
13. Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6–11 Years of Age with Severe Atopic Dermatitis
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Cork, Michael J., Thaçi, Diamant, Eichenfield, Lawrence F., Arkwright, Peter D., Chen, Zhen, Thomas, Ryan B., Kosloski, Matthew P., Dubost-Brama, Ariane, Prescilla, Randy, Bansal, Ashish, and Levit, Noah A.
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- 2023
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14. Therapeutic education in atopic dermatitis: A position paper from the International Eczema Council
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Eichenfield, Lawrence F, Kusari, Ayan, Han, Allison M, Barbarot, Sébastien, Deleuran, Mette, Lio, Peter, Marcoux, Danielle, Nosbaum, Audrey, and Stalder, Jean-Francois
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Prevention ,Skin ,AD ,atopic dermatitis ,EAP ,eczema action plan ,IEC ,International Eczema Council ,QOL ,quality of life ,TPE ,therapeutic patient education ,atopic dermatitis ,corticosteroids ,e-learning ,eczema ,eczema action plan ,pruritus ,quality of life ,therapeutic education ,therapeutic patient education - Abstract
BackgroundAtopic dermatitis (AD) is a chronic, inflammatory skin disease that affects as many as 12.5% of children aged 0-17 years and 3% of the adult population. In the United States, 31.6 million children and adults are estimated to be living with AD.ObjectiveTherapeutic patient education (TPE) has proven its value in the management of chronic diseases for which adherence to therapy is suboptimal. This article explores experts' opinions and treatment practices to determine if TPE is a recommended and effective method for treating AD.MethodsForty-two (51%) of 82 Councilors and Associates of the International Eczema Council (IEC), an international group with expertise in AD, responded to an electronic survey on TPE and AD.ResultsMost respondents (97.5%) agreed that TPE should play an important role in the management of AD. Many respondents (82.9%) believed that all patients with AD, regardless of disease severity, could benefit from TPE.LimitationsThe International Eczema Council survey lacks specific information on AD severity.ConclusionsPublications have shown the positive effect of TPE on the course of the disease, the prevention of complications, and the autonomy and quality of patient life. Survey respondents agreed that TPE can improve the quality of patient care and patient satisfaction with care.
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- 2021
15. International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale.
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Abuabara, Katrina, Silverberg, Jonathan I, Simpson, Eric L, Paller, Amy S, Eichenfield, Lawrence F, Bissonnette, Robert, Krueger, James, Harris, John E, Dalfonso, Laura, Watkins, Stephanie E, Crawford, Julie M, Thaçi, D, and Guttman-Yassky, Emma
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eczema ,medical history ,statistics & research methods ,therapeutics ,statistics & ,research methods ,Clinical Sciences ,Public Health and Health Services ,Other Medical and Health Sciences - Abstract
IntroductionAs new topical and systemic treatments become available for atopic dermatitis (AD), there is a need to understand how treatments are being used in routine clinical practice, their comparative effectiveness and their long-term safety in diverse clinical settings.Methods and analysisThe TARGET-DERM AD cohort is a longitudinal, observational study of patients with AD of all ages, designed to provide practical information on long-term effectiveness and safety unobtainable in traditional registration trials. Patients with physician-diagnosed AD receiving prescription treatment (topical or systemic) will be enrolled at academic and community clinical centres. Up to 3 years of retrospective medical records, 5 years of prospective medical records, and optional biological samples and patient-reported outcomes will be collected. The primary aims include characterisation of AD treatment regimens, evaluation of response to therapy, and description of adverse events.Ethics and disseminationTARGET-DERM has been approved by a central IRB (Copernicus Group IRB, 5000 Centregreen Way Suite 200, Cary, North Carolina 27513) as well as local and institutional IRBs. No additional Ethics Committee reviews. Results will be reviewed by a publications committee and submitted to peer-reviewed journals.Trial registration numberNCT03661866, pre-results.
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- 2020
16. Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families
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Simpson, Eric L, Paller, Amy S, Boguniewicz, Mark, Eichenfield, Lawrence F, Feldman, Steven R, Silverberg, Jonathan I, Chamlin, Sarah L, and Zane, Lee T
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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
17. Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases–sponsored expert panel
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Togias, Alkis, Cooper, Susan F, Acebal, Maria L, Assa'ad, Amal, Baker, James R, Beck, Lisa A, Block, Julie, Byrd-Bredbenner, Carol, Chan, Edmond S, Eichenfield, Lawrence F, Fleischer, David M, Fuchs, George J, Furuta, Glenn T, Greenhawt, Matthew J, Gupta, Ruchi S, Habich, Michele, Jones, Stacie M, Keaton, Kari, Muraro, Antonella, Plaut, Marshall, Rosenwasser, Lanny J, Rotrosen, Daniel, Sampson, Hugh A, Schneider, Lynda C, Sicherer, Scott H, Sidbury, Robert, Spergel, Jonathan, Stukus, David R, Venter, Carina, and Boyce, Joshua A
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Health Services ,Clinical Research ,Nutrition ,Food Allergies ,Pediatric ,Foodborne Illness ,Digestive Diseases ,Prevention ,Inflammatory and immune system ,Good Health and Well Being ,Allergens ,Arachis ,Eczema ,Egg Hypersensitivity ,Humans ,Immunoglobulin E ,Infant ,National Institute of Allergy and Infectious Diseases (U.S.) ,Peanut Hypersensitivity ,Skin Tests ,United States ,Food ,peanut ,allergy ,prevention ,guidelines ,Immunology ,Allergy - Abstract
BackgroundFood allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy.ObjectivesPrompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy.ResultsThe addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation.ConclusionsGuidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.
- Published
- 2017
18. Targeting the aryl hydrocarbon receptor as a strategy to expand the therapeutic armamentarium in atopic dermatitis.
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Eichenfield, Lawrence F., Silverberg, Jonathan I., Hebert, Adelaide A., and Boguniewicz, Mark
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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]
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- 2024
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19. Impact of climate change on atopic dermatitis: A review by the International Eczema Council.
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Wang, Sheng‐Pei, Stefanovic, Nicholas, Orfali, Raquel L., Aoki, Valeria, Brown, Sara J., Dhar, Sandipan, Eichenfield, Lawrence F., Flohr, Carsten, Ha, Alex, Mora, Camilo, Murase, Jenny E., Rosenbach, Misha, Srinivas, Sahana M., Thyssen, Jacob P., Wei, Maria L., Irvine, Alan D., and Abuabara, Katrina
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ATOPIC dermatitis ,GREENHOUSE gases ,CLIMATE change ,ECZEMA ,AIR pollution - Abstract
Atopic dermatitis (AD), the most burdensome skin condition worldwide, is influenced by climatic factors and air pollution; however, the impact of increasing climatic hazards on AD remains poorly characterized. Leveraging an existing framework for 10 climatic hazards related to greenhouse gas emissions, we identified 18 studies with evidence for an impact on AD through a systematic search. Most climatic hazards had evidence for aggravation of AD the impact ranged from direct effects like particulate matter‐induced AD exacerbations from wildfires to the potential for indirect effects like drought‐induced food insecurity and migration. We then created maps comparing the past, present, and future projected burden of climatic hazards to global AD prevalence data. Data are lacking, especially from those regions most likely to experience more climatic hazards. We highlight gaps important for future research: understanding the synergistic impacts of climatic hazards on AD, long‐term disease activity, the differential impact on vulnerable populations, and how basic mechanisms explain population‐level trends. [ABSTRACT FROM AUTHOR]
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- 2024
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20. Executive summary: Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies.
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Davis, Dawn M.R., Drucker, Aaron M., Alikhan, Ali, Bercovitch, Lionel, Cohen, David E., Darr, Jennifer M., Eichenfield, Lawrence F., Frazer-Green, Lindsy, Paller, Amy S., Schwarzenberger, Kathryn, Silverberg, Jonathan I., Singh, Anne Marie, Wu, Peggy A., and Sidbury, Robert
- Abstract
The summarized guidelines update the 2014 recommendations for the management of AD with phototherapy and systemic therapies. A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of the evidence and formulating and grading recommendations. The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic therapies, including biologics, oral Janus Kinase inhibitors, and other immunomodulatory medications. The evidence supported strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib and conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids. [ABSTRACT FROM AUTHOR]
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- 2024
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21. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies.
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Davis, Dawn M.R., Drucker, Aaron M., Alikhan, Ali, Bercovitch, Lionel, Cohen, David E., Darr, Jennifer M., Eichenfield, Lawrence F., Frazer-Green, Lindsy, Paller, Amy S., Schwarzenberger, Kathryn, Silverberg, Jonathan I., Singh, Anne Marie, Wu, Peggy A., and Sidbury, Robert
- Abstract
For people with atopic dermatitis (AD) refractory to topical therapies, treatment with phototherapy and systemic therapies can be considered. Multiple biologic therapies and Janus kinase (JAK)inhibitors have been approved since 2014 to treat AD. These guidelines update the 2014 recommendations for management of AD with phototherapy and systemic therapies. To provide evidence-based recommendations on the use of phototherapy and systemic therapies for AD in adults. A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of evidence and formulating and grading recommendations. The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic agents, including biologics, oral JAK inhibitors, and other immunomodulatory medications. Most randomized controlled trials of phototherapy and systemic therapies for AD are of short duration with subsequent extension studies, limiting comparative long-term efficacy and safety conclusions. We make strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib. We make conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids. [ABSTRACT FROM AUTHOR]
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- 2024
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22. A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescents, and Adult Subjects (Ages 2 Years and Older) with Mild-to-Moderate Atopic Dermatitis.
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Jacobson, Michael E., Myles, Ian A., Paller, Amy S., Eichenfield, Lawrence F., and Simpson, Eric L.
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ATOPIC dermatitis ,TERMINATION of treatment ,TEENAGERS ,ADULTS ,ECZEMA ,PREVENTIVE medicine - Abstract
Background: Atopic dermatitis is a common chronic, relapsing, and remitting inflammatory skin disorder associated with cutaneous dysbiosis. Current treatment options often fail to adequately control the disease and have unfavorable safety profiles. There is a need for new options that address these treatment shortcomings. Objective: The aim of the study was to evaluate the efficacy, safety, and tolerability of FB-401, a live therapeutic product of 3 strains of Roseomonas mucosa, compared to matching placebo applied topically 3 times per week to participants ages ≥2 years of age with mild-to-moderate atopic dermatitis. Methods: A randomized, double-blind, placebo-controlled, parallel-group study was conducted. The primary outcome was the proportion of participants with 50% improvement in Eczema Area and Severity Index score from baseline at week 16. 154 subjects aged 2 or older with a clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria with mild or moderate severity were randomized 1:1 via interactive web response system to FB-401 or placebo. Results: The proportion of subjects who achieved the primary outcome was similar between both treatment groups, with no significant treatment group differences observed at any post-baseline visit. The number of treatment-emergent adverse events and the number of subjects with at least one were similar across treatment groups. One serious adverse event not related to treatment was reported. No treatment-emergent adverse events led to treatment discontinuation or study discontinuation. Conclusions: FB-401 showed an acceptable safety profile but failed to prove superior to placebo in treating children and adults with mild-to-moderate atopic dermatitis. [ABSTRACT FROM AUTHOR]
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- 2024
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23. Clinically relevant improvements in adults and adolescents with atopic dermatitis who did not achieve Investigator's Global Assessment treatment success following 8 weeks of ruxolitinib cream monotherapy.
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Simpson, Eric L., Kircik, Leon, Blauvelt, Andrew, Kallender, Howard, Kuo, Yutzu, Ren, Haobo, Sturm, Daniel, and Eichenfield, Lawrence F.
- Abstract
Ruxolitinib cream is a topical formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and JAK2. In two phase 3 studies in adults and adolescents (aged ≥12 years) with atopic dermatitis (AD; TRuE‐AD1/TRuE‐AD2), significantly more patients who applied ruxolitinib cream versus vehicle cream achieved Investigator's Global Assessment treatment success (IGA‐TS; IGA score of 0/1 with ≥2‐point improvement from baseline) at week 8 (primary endpoint). This post hoc analysis evaluated the efficacy, safety, and disease control of ruxolitinib cream in patients with AD who did not achieve IGA‐TS at week 8. Patients in TRuE‐AD1/TRuE‐AD2 (N = 1249) were randomized 2:2:1 to apply twice‐daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks followed by a long‐term safety period in which patients applied ruxolitinib cream as needed. In this pooled analysis, clinically meaningful response thresholds included ≥50% improvement in the Eczema Area and Severity Index, ≥2‐point reduction in the Itch Numerical Rating Scale, ≥4‐point improvement in the Dermatology Life Quality Index (DLQI) or ≥6‐point improvement in Children's DLQI, and ≥1‐point reduction in IGA from baseline. Among patients who did not achieve IGA‐TS at week 8 (n = 584), significantly more patients who applied either strength ruxolitinib cream versus vehicle achieved each response threshold at week 8. A response in ≥1 clinically meaningful endpoint was achieved in significantly more patients who applied ruxolitinib cream (93.4%/90.9% for 0.75%/1.5% ruxolitinib cream, respectively) versus vehicle (69.0%, both P < 0.0001). Progressive improvements in disease control were observed, with many patients achieving IGA‐TS by week 52 (55.2%/56.3% for 0.75%/1.5% ruxolitinib cream, respectively). Ruxolitinib cream was well tolerated during the 52‐week study in this patient population. Taken together, these results demonstrate that most patients with AD who did not achieve IGA‐TS at week 8 have clinically meaningful responses to ruxolitinib cream, and continued therapy beyond 8 weeks could result in additional benefit. [ABSTRACT FROM AUTHOR]
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- 2023
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24. Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study.
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Paller, Amy S., Flohr, Carsten, Eichenfield, Lawrence F., Irvine, Alan D., Weisman, Jamie, Soung, Jennifer, Pinto Correia, Ana, Natalie, Chitra R., Rodriguez Capriles, Claudia, Pierce, Evangeline, Reifeis, Sarah, Gontijo Lima, Renata, Armengol Tubau, Clara, Laquer, Vivian, and Weidinger, Stephan
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ATOPIC dermatitis ,CLINICAL trials ,TEENAGERS ,BODY surface area ,TERMINATION of treatment ,ECZEMA ,ITCHING - Abstract
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disorder with limited treatment options for adolescents with moderate-to-severe disease. Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, demonstrated clinical benefit in previous Phase 3 trials: ADvocate1 (NCT04146363), ADvocate2 (NCT04178967), and ADhere (NCT04250337). We report 52-week safety and efficacy outcomes from ADore (NCT04250350), a Phase 3, open-label study of lebrikizumab in adolescent patients with moderate-to-severe AD. The primary endpoint was to describe the proportion of patients who discontinued from study treatment because of adverse events (AEs) through the last treatment visit. Methods: Adolescent patients (N = 206) (≥ 12 to < 18 years old, weighing ≥ 40 kg) with moderate-to-severe AD received subcutaneous lebrikizumab 500 mg loading doses at baseline and Week 2, followed by 250 mg every 2 weeks (Q2W) thereafter. Safety was monitored using reported AEs, AEs leading to treatment discontinuation, vital signs, growth assessments, and laboratory testing. Efficacy analyses included Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA), (Children's) Dermatology Life Quality Index ((C)DLQI), and Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, and PROMIS Depression. Results: 172 patients completed the treatment period. Low frequencies of SAEs (n = 5, 2.4%) and AEs leading to treatment discontinuation (n = 5, 2.4%) were reported. Overall, 134 patients (65%) reported at least one treatment-emergent AE (TEAE), most being mild or moderate in severity. In total, 62.6% achieved IGA (0,1) with ≥ 2-point improvement from baseline and 81.9% achieved EASI-75 by Week 52. The EASI mean percentage improvement from baseline to Week 52 was 86.0%. Mean BSA at baseline was 45.4%, decreasing to 8.4% by Week 52. Improvements in mean change from baseline (CFB) to Week 52 were observed in DLQI (baseline 12.3; CFB − 8.9), CDLQI (baseline 10.1; CFB − 6.5), PROMIS Anxiety (baseline 51.5; CFB − 6.3), and PROMIS Depression (baseline 49.3; CFB − 3.4) scores. Conclusions: Lebrikizumab 250 mg Q2W had a safety profile consistent with previous trials and significantly improved AD symptoms and quality of life, with meaningful responses at Week 16 increasing by Week 52. Trial registration: ClinicalTrials.gov identifier, NCT04250350. Plain Language Summary: Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis Atopic dermatitis is a chronic relapsing inflammatory skin disease that affects up to 15% of adolescents worldwide, with up to 50% suffering from moderate-to-severe disease. Signs and symptoms include dry, cracked skin; redness; itching; and painful lesions, which can negatively affect quality of life and lead to complications, including skin infections. Adolescents also report increased rates of anxiety and stress. Lebrikizumab is a novel monoclonal antibody that binds with high affinity and slow off-rate to interleukin (IL)-13, the key cytokine in atopic dermatitis, blocking the downstream effects of IL-13 with high potency. Lebrikizumab has been shown previously to improve symptoms of atopic dermatitis, including itch, skin clearance, and quality of life in ADvocate1, ADvocate2 and ADhere. The ADore study aimed to evaluate the safety and efficacy of lebrikizumab in adolescents with moderate-to-severe atopic dermatitis. Investigators recruited patients ≥ 12 to < 18 years old, weighing ≥ 40 kg, from Australia, Canada, Poland, and the US who were diagnosed with moderate-to-severe atopic dermatitis. These patients received a loading dose of 500 mg of lebrikizumab at Weeks 0 and 2, followed by 250 mg every 2 weeks for 52 weeks. The safety profile of lebrikizumab was consistent with previously published reports, with mostly mild or moderate adverse events, which did not lead to treatment discontinuation. Lebrikizumab improved skin clearance; 62.6% of patients had clear or almost clear skin by the end of the trial. Lebrikizumab also improved the patients' quality of life. These safety and efficacy results support lebrikizumab's role in treating adolescents with moderate-to-severe atopic dermatitis. D_n9HEaRPQDPZd1tfRjK-9 Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study (MP4 44681 KB) [ABSTRACT FROM AUTHOR]
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- 2023
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25. 703 - Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with moderate and/or more extensive atopic dermatitis: subgroup analysis from the TRuE-AD3 study.
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Eichenfield, Lawrence F, Armstrong, April W, Gold, Linda F Stein, Zaenglein, Andrea L, Lee, Lara Wine, Brar, Kanwaljit K, Joyce, Joel C, Holland, Kristen E, Angel, Brett, Sturm, Daniel, Li, Qian, and Simpson, Eric L
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RUXOLITINIB , *ATOPIC dermatitis , *MISSING data (Statistics) , *IMMUNOGLOBULIN A , *LOGISTIC regression analysis - Abstract
Introduction/Background Atopic dermatitis (AD) is a chronic, inflammatory skin disease with onset usually occurring in childhood. Topical therapy is the mainstay of AD treatment and is typically used prior to systemic therapy in patients with moderate disease. Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream is approved by the US Food and Drug Administration for patients aged ≥12 years with mild to moderate AD, and has demonstrated efficacy and was well tolerated in children (aged 2–11 y) with AD in TRuE-AD3 (NCT04921969), a phase 3, double-blind, randomized, vehicle-controlled study. Objectives Here we investigated the effects of ruxolitinib cream in a subset of patients from TRuE-AD3 with moderate and/or more extensive disease at baseline. Methods TRuE-AD3 included children aged 2–11 years with AD for ≥3 months, an Investigator's Global Assessment (IGA) score of 2 or 3, and an affected body surface area (BSA) of 3%–20%. Patients were randomized 2:2:1 to apply 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream twice daily for 8 weeks. Rescue treatment was not permitted. Patients from TRuE-AD3 with moderate and/or more extensive disease at baseline (defined as an IGA score of 3, ≥10% affected BSA, or a combined IGA score of 3 and ≥10% BSA) were included in this analysis. Efficacy was assessed as the proportion of patients in each treatment group who achieved IGA treatment success (IGA-TS; a score of 0 or 1 with a ≥2-grade improvement from baseline), ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75), and ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at Weeks 2, 4, and 8. Statistical significance was assessed at Week 8 using exact logistic regression. Patients with missing post-baseline data were imputed as nonresponders. Results Patients in TRuE-AD3 (N=330) had a median (range) age of 6 (2–11) years, 54.2% were girls, and 54.5% were White. The mean (SD) BSA was 10.5% (5.4%), the mean (SD) EASI was 8.6 (5.4), and 252 patients (76.4%) had a baseline IGA of 3. Among patients with an IGA of 3 at baseline, more patients who applied 1.5% ruxolitinib cream or 0.75% ruxolitinib cream versus vehicle achieved IGA-TS (40.0% and 29.1%, respectively, vs 6.1%), EASI-75 (43.0% and 38.8% vs 8.2%), and EASI-90 (17.0% and 21.4% vs 0%) at Week 2. Improvements were also observed at Week 8 (IGA-TS, 59.0% [ P <0.0001] and 37.9% [ P =0.004] vs 14.3%; EASI-75, 64.0% [ P <0.0001] and 48.5% [ P <0.0001] vs 14.3%; EASI-90, 40.0% [ P <0.0001] and 33.0% [ P =0.001] vs 8.2%), with 1.5% ruxolitinib cream consistently resulting in numerically better improvements than 0.75% ruxolitinib cream. Similar improvements were observed with ruxolitinib cream versus vehicle among patients with ≥10% affected BSA at baseline and a combined baseline IGA of 3 and ≥10% BSA. Both strengths of ruxolitinib cream were well tolerated among patients with an IGA of 3 at baseline; no serious treatment-emergent adverse events (TEAEs) were reported. Conclusions Children with moderate and/or more extensive AD in this study had substantially higher rates of clinical responses with ruxolitinib cream monotherapy versus vehicle as early as Week 2 (first assessment), with further improvement throughout the 8-week treatment period. Ruxolitinib cream was well tolerated with no serious TEAEs. [ABSTRACT FROM AUTHOR]
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- 2024
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26. 671 - Rapid and early onset of itch relief with tapinarof cream 1% once daily in two pivotal phase 3 trials in adults and children down to two years of age with atopic dermatitis.
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Simpson, Eric, Silverberg, Jonathan I, Bissonnette, Robert, Gold, Linda Stein, Armstrong, April W, Hebert, Adelaide A, Serrao, Rocco T, Jakus, Jeannette R, Brown, Philip M, Rubenstein, David S, Piscitelli, Stephen C, Tallman, Anna M, and Eichenfield, Lawrence F
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CLINICAL trials ,QUALITY of life ,BODY surface area ,ATOPIC dermatitis ,ECZEMA ,ITCHING - Abstract
Introduction Itch is the most bothersome symptom for patients with atopic dermatitis (AD), and has a significant negative impact on health-related quality of life. Rapid onset of pruritus relief with sustained efficacy is a key outcome for AD therapies. In ADORING 1 and 2, two identical pivotal phase 3, double-blind, vehicle-controlled trials, tapinarof cream 1% once daily (QD) demonstrated efficacy and was well tolerated in adults and children down to 2 years of age with AD. Objective Here, we evaluate time to onset of itch relief in the pivotal phase 3 trials. Methods In ADORING 1 and 2, patients with a Validated Investigator Global Assessment for Atopic Dermatitis
TM score of ≥3 (moderate or severe), an Eczema Area and Severity Index score of ≥6, and body surface area involvement of 5–35% were randomized 2:1 to tapinarof cream or vehicle QD for 8 weeks. Itch relief was assessed by changes in Peak Pruritus Numerical Rating Scale (PP-NRS) score, daily and by visit, from baseline through Week 8. PP-NRS considers itch over the past 24 hours; lower scores indicate less pruritus. Results 407 and 406 patients were randomized in ADORING 1 and 2. At baseline, mean PP-NRS scores were 6.7 and 6.8 in both trials, respectively. For daily evaluations of itch from baseline, greater reductions in mean PP-NRS scores for tapinarof versus vehicle were observed as early as Day 1, 24 hours after initial application in ADORING 1 (–1.2 vs –0.9), and Day 2 in ADORING 2 (–1.6 vs –1.4). Daily itch improvements continued through Week 8 in both trials. Statistically significant reductions in mean weekly PP-NRS scores occurred as early as Week 1 (earliest assessment) with tapinarof versus vehicle (–2.0 vs –1.2 [ P <0.0001]) and (–2.0 vs –1.3 [ P =0.0010]) in ADORING 1 and 2, respectively. Significantly greater reductions in mean PP-NRS scores with tapinarof versus vehicle were seen for all visits through Week 8 (–4.1 vs –2.6 and –4.1 vs –2.4 [both P<0.0001]). Conclusions Tapinarof cream 1% QD demonstrated rapid, significant, and clinically meaningful pruritus relief from 24 hours after initial application, with improvements increasing through Week 8 in both trials in adults and children down to 2 years with AD. [ABSTRACT FROM AUTHOR]- Published
- 2024
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27. A 7-month-old male presents with perioral rash and fever
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Bhatti, Safiyyah and Eichenfield, Lawrence F.
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Atopic dermatitis ,Infection ,Skin ,Rash ,Eczema ,Herpes simplex ,Common cold ,Herpes simplex virus ,Dermatitis ,Herpesvirus infections ,Health ,Health care industry - Abstract
Patients with atopic dermatitis are at risk for developing the herpes simplex virus (HSV)-related skin complication 'eczema herpeticum,' also known as Kaposi's varicelliform eruption. Eczema herpeticum is characterized by cutaneous [...]
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- 2020
28. The atopic dermatitis spectrum disorder. Recognizing the clinical heterogeneity in patients with atopic related skin conditions in order to improve therapeutic decision-making and outcomes: an expert panel consensus statement.
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Butler, Daniel C., Simpson, Eric, Guttman-Yassky, Emma, Eichenfield, Lawrence F., Golant, Alexandra K., Koo, John Y. M., Armstrong, April W., Alexis, Andrew F., Lio, Peter A., Marson, Justin W., and Lebwohl, Mark
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ATOPIC dermatitis ,ECZEMA ,HETEROGENEITY - Abstract
HT
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- 2022
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Tracy, Alexis and Eichenfield, Lawrence F.
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Neomycin ,Skin ,Dermatitis ,Eczema ,Money ,Health ,Health care industry - Abstract
Nummular dermatitis, or nummular eczema, is an inflammatory skin condition that is considered to be a distinctive form of idiopathic eczema, while the term also is used to describe lesional [...]
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- 2019
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Lio, Peter, Eichenfield, Lawrence F, Marcoux, Danielle, Lee, Wan-Ju, Teixeira, Henrique D, Raymundo, Eliza M, Gamelli, Amy E, Grada, Ayman, Hu, Xiaofei, and Irvine, Alan D
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ITCHING , *ECZEMA , *ATOPIC dermatitis , *QUALITY of life , *TEENAGERS , *CLINICAL trials , *ADULTS - Abstract
Atopic dermatitis (AD) is characterized by intense itch and symptoms that adversely impact quality of life (QoL). Upadacitinib is a selective Janus kinase-1 inhibitor approved for moderate-to-severe AD. We assessed the effect of once daily oral upadacitinib (15 or 30 mg), with or without concurrent topical corticosteroid treatment, on patient-reported outcomes for adults and adolescents with moderate-to-severe atopic dermatitis during the double-blind, placebo-controlled phase 3 clinical trials, Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422) and AD Up (NCT03568318). Assessments included itch (Worst Pruritus Numerical Rating Scale), skin pain and symptom severity (AD Symptom Scale), symptom frequency (Patient Oriented Eczema Measure) and sleep, daily activities and emotional state (AD Impact Scale). Post hoc analysis of 2240 adults and 344 adolescents randomized patients was performed. By Week 2, more patients receiving upadacitinib achieved a clinically relevant response in itch, skin pain, symptom severity, symptom frequency, sleep, daily activities and emotional state vs. placebo across studies among adults (upadacitinib 15 mg: 30.8–87.3%; upadacitinib 30 mg: 38.0–89.9%; placebo: 2.1–43.1%; nominal P < 0.001 for all comparisons) and adolescents (upadacitinib 15 mg: 19.4–82.9%; upadacitinib 30 mg: 35.3–97.6%; placebo: 0–41.0%; nominal P < 0.05 for 37/42 comparisons). These trends continued through week 16 where response rates for all outcomes improved with upadacitinib vs. placebo in adults (upadacitinib 15 mg: 42.9–80.4%; upadacitinib 30 mg: 60.9–84.6%; placebo: 10.1–38.1%; nominal P < 0.001 for all comparisons) and adolescents (upadacitinib 15 mg: 33.3–78.0%; upadacitinib 30 mg: 50.0–85.7%; placebo: 2.8–43.6%; nominal P < 0.05 for 41/42 comparisons). These findings highlight the rapid, sustained efficacy of once daily oral upadacitinib in improving symptom burden and QoL in adults and adolescents with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]
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- 2023
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Siegfried, Elaine C., Jaworski, Jennifer C., Eichenfield, Lawrence F., Paller, Amy, Hebert, Adelaide A., Simpson, Eric L., Altman, Emily, Arena, Charles, Blauvelt, Andrew, Block, Julie, Boguniewicz, Mark, Chen, Suephy, Cordoro, Kelly, Hanna, Diane, Horii, Kimberly, Hultsch, Thomas, Lee, James, Leung, Donald Y., Lio, Peter, and Milner, Joshua
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ATOPIC dermatitis treatment ,CHRONIC diseases ,SKIN disease treatment ,ADRENOCORTICAL hormones ,HORMONE therapy ,CLINICAL trials ,ANTISEPTICS - Abstract
Abstract: Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high‐level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry,
Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age) . This draft guidance has been submitted to the Food and Drug Administration based on a provision in theFederal Register (Good Guidance Practices) . [ABSTRACT FROM AUTHOR]- Published
- 2018
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Simpson, Eric L., Bruin-Weller, Marjolein, Flohr, Carsten, Ardern-Jones, Michael R., Barbarot, Sebastien, Deleuran, Mette, Bieber, Thomas, Vestergaard, Christian, Brown, Sara J., Cork, Michael J., Drucker, Aaron M., Eichenfield, Lawrence F., Foelster-Holst, Regina, Guttman-Yassky, Emma, Nosbaum, Audrey, Reynolds, Nick J., Silverberg, Jonathan I., Schmitt, Jochen, Seyger, Marieke M.B., and Spuls, Phyllis I.
- Abstract
Background: Although most patients with atopic dermatitis (AD) are effectively managed with topical medication, a significant minority require systemic therapy. Guidelines for decision making about advancement to systemic therapy are lacking.Objective: To guide those considering use of systemic therapy in AD and provide a framework for evaluation before making this therapeutic decision with the patient.Methods: A subgroup of the International Eczema Council determined aspects to consider before prescribing systemic therapy. Topics were assigned to expert reviewers who performed a topic-specific literature review, referred to guidelines when available, and provided interpretation and expert opinion.Results: We recommend a systematic and holistic approach to assess patients with severe signs and symptoms of AD and impact on quality of life before systemic therapy. Steps taken before commencing systemic therapy include considering alternate or concomitant diagnoses, avoiding trigger factors, optimizing topical therapy, ensuring adequate patient/caregiver education, treating coexistent infection, assessing the impact on quality of life, and considering phototherapy.Limitations: Our work is a consensus statement, not a systematic review.Conclusion: The decision to start systemic medication should include assessment of severity and quality of life while considering the individual's general health status, psychologic needs, and personal attitudes toward systemic therapies. [ABSTRACT FROM AUTHOR]- Published
- 2017
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Eichenfield, Lawrence F. and Gold, Linda F. Stein
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Several immunologic mediators--phosphodiesterase (PDE), interleukin (IL), small molecules, and Janus kinase--have been implicated in the pathogenesis of atopic dermatitis, and evidence has shown that blocking these mediators can help modify the disease process. Several new topical medications have been deveoped that target the enzyme PDE; crisaborole was recently approved by the US Food and Drug Administration (FDA) for the treatment of atopic dermatitis, and phase II studies have been completed on OPA-15406. The phase III clinical trial results of the systemic medication dupilumab, an inhibitor of the IL-4 receptor α subunit (which inhibits both IL-4 and IL-13 signaling), are currently being reviewed by the FDA. [ABSTRACT FROM AUTHOR]
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- 2017
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Gold, Linda F. Stein and Eichenfield, Lawrence F.
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Several risk factors have been identified that appear to be consistently and strongly associated with the development of atopic dermatitis (AD): a family history of atopy, an inherited genetic predisposition, and active and passive exposure to tobacco smoke. Recent studies also have demonstrated that a simple intervention from birth--the daily application of an emollient moisturizer--seems to protect susceptible infants from the development of AD. [ABSTRACT FROM AUTHOR]
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- 2017
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Gold, Linda F. Stein and Eichenfield, Lawrence F.
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The signs and symptoms of atopic dermatitis can be safely and effectively controlled in most patients; in many cases, the disease can be improved to the point that signs and symptoms are absent or minimal, in addition, flares can be effectively controlled and, in some cases, prevented. New topical medications, improved strategies for the use of topical corticosteroids and topical caicineurin inhibitors, and judicious use of n on ph a rm a co lo g ic regimens--including bathing, bleach baths, and early use of emollients--have led to better disease management and improved quality of life for patients and their families. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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Eichenfield, Lawrence F. and Gold, Linda F. Stein
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Atopic dermatitis (AD) has a significant, lifelong clinical impact on affected individuals and has profound effects on quality of life both for patients and their families. The diagnosis usually can be reliably established on the basis of the history and physical examination. In patients with skin of color, blanching of the skin may be helpful to detect erythema, lichenification, follicular accentuation, and hypopigmentation (all of which are more common than in lighter-skinned patients). Once the diagnosis of AD is established, an assessment of severity, persistence, and impact on the patient's and family's life is importam as a guide to treatment decisions. [ABSTRACT FROM AUTHOR]
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- 2017
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Stalder, Jean‐Francois, Bernier, Claire, Ball, Alan, De Raeve, Linda, Gieler, Uwe, Deleuran, Mette, Marcoux, Danielle, Eichenfield, Lawrence F., Lio, Peter, Lewis‐Jones, Sue, Gelmetti, Carlo, Takaoka, Roberto, Chiaverini, Christine, Misery, Laurent, and Barbarot, Sébastien
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ATOPIC dermatitis ,PATIENT education ,THERAPEUTICS ,QUALITY of life ,CHRONIC diseases ,INSURANCE companies ,ECZEMA - Abstract
Therapeutic patient education ( TPE) has proven effective in increasing treatment adherence and improving quality of life (QoL) for patients with numerous chronic diseases, especially atopic dermatitis ( AD). This study was undertaken to identify worldwide TPE experiences in AD treatment. Experts from 23 hospitals, located in 11 countries, responded to a questionnaire on 10 major items. Patients in TPE programs were mainly children and adolescents with moderate to severe AD or markedly affected QoL. Individual and collective approaches were used. Depending on the center, the number of sessions varied from one to six (corresponding to 2 to 12 hours of education), and 20 to 200 patients were followed each year. Each center's education team comprised multidisciplinary professionals (e.g., doctors, nurses, psychologists). Evaluations were based on clinical assessment, QoL, a satisfaction index, or some combination of the three. When funding was obtained, it came from regional health authorities (France), insurance companies (Germany), donations (United States), or pharmaceutical firms (Japan, Italy). The role of patient associations was always highlighted, but their involvement in the TPE process varied from one country to another. Despite the nonexhaustive approach, our findings demonstrate the increasing interest in TPE for managing individuals with AD. In spite of the cultural and financial differences between countries, there is a consensus among experts to integrate education into the treatment of eczema. [ABSTRACT FROM AUTHOR]
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- 2013
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Eichenfield, Lawrence F., Lucky, Anne W., Langley, Richard G. B., Lynde, Charles, Kaufmann, Roland, Todd, Gail, Lindsley, Linda, Barbier, Nathalie, and Felser, James M.
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SKIN inflammation , *ATOPIC dermatitis , *CYTOKINES , *IMMUNOREGULATION , *JUVENILE diseases , *ECZEMA , *PIMECROLIMUS - Abstract
Pimecrolimus cream 1%, a cell-selective inhibitor of inflammatory cytokines, has been shown to be effective in treating atopic dermatitis (AD). This report examines the effect of ethnic origin and baseline disease severity on treatment outcomes in pediatric patients with AD treated with pimecrolimus cream 1%.The analysis included 589 patients aged 3 months to 17 years from three 6-week, randomized, multicenter studies of similar design. Patients were treated with pimecrolimus cream 1% or vehicle twice daily. Efficacy, safety and tolerability in Caucasian and non-Caucasian groups were compared. In addition, the effect of baseline disease severity on treatment outcome was investigated.A total of 321 Caucasian and 268 non-Caucasian patients[Blacks, Asians and others (including Hispanics)] with mild, moderate or severe disease at baseline were included. Baseline characteristics were comparable between the pimecrolimus and vehicle control groups and between Caucasian and non-Caucasian groups. Significantly higher efficacy[measured by Investigators’ Global Assessment and Eczema Area and Severity Index (EASI) scores] was achieved in the pimecrolimus-treated group, compared with the vehicle group, irrespective of ethnic origin. Baseline disease severity had no effect on treatment outcome: patients with both mild and moderate AD responded well to pimecrolimus (absolute change from baseline in EASI score−2.60 and−5.48, respectively; bothP < 0.001). Pimecrolimus cream 1% was safe and well tolerated in all ethnic groups and at all levels of disease severity.Ethnic origin and baseline disease severity had no effect on treatment outcome with pimecrolimus cream 1% in patients with AD. [ABSTRACT FROM AUTHOR]
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- 2005
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Eichenfield, Lawrence F., Call, Robert S., Forsha, Douglass W., Jr.Fowler, Joseph, Hebert, Adelaide A., Spellman, Mary, Stein Gold, Linda F., Van Syoc, Merrie, Zane, Lee T., Tschen, Eduardo, and Fowler, Joseph Jr
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Background: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.Objective: To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302).Methods: Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed.Results: During the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs.Limitations: Long-term efficacy was not analyzed.Conclusion: Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD. [ABSTRACT FROM AUTHOR]- Published
- 2017
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Eichenfield, Lawrence F., Ahluwalia, Jusleen, Waldman, Andrea, Borok, Jenna, Udkoff, Jeremy, and Boguniewicz, Mark
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Atopic dermatitis (AD) is a chronic pruritic inflammatory disease that commonly presents in the pediatric population. Although definitions and diagnosis of AD have largely been agreed upon, allergists and dermatologists have similar and divergent approaches to the management of AD. This review facilitated integration of the American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma & Immunology Joint Task Force 2012 AD Practice Parameter and the 2014 American Academy of Dermatology guidelines to highlight the basic principles of AD management and discuss therapies and management of AD from the distinct perspectives of the allergist and dermatologist. [ABSTRACT FROM AUTHOR]
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- 2017
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Paller, Amy S., Tom, Wynnis L., Lebwohl, Mark G., Blumenthal, Robin L., Boguniewicz, Mark, Call, Robert S., Eichenfield, Lawrence F., Forsha, Douglass W., Rees, William C., Simpson, Eric L., Spellman, Mary C., Stein Gold, Linda F., Zaenglein, Andrea L., Hughes, Matilda H., Zane, Lee T., and Hebert, Adelaide A.
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Background: Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.Objective: We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).Methods: Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.Results: More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P ≤ .001). Treatment-related adverse events were infrequent and mild to moderate in severity.Limitations: Short study duration was a limitation.Conclusions: Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD. [ABSTRACT FROM AUTHOR]- Published
- 2016
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Atopic dermatitis (AD) is a condition with varied clinical presentations and heterogeneous phenotypes. While the Hanifin-Rajka criteria [[3]] improved diagnosis of AD for research, the clinical challenge has become differentiating which dermatoses are classic AD, atypical variants of AD, or distinct clinical entities unrelated to AD. Recognizing the clinical heterogeneity in patients with atopic related skin conditions in order to improve therapeutic decision-making and outcomes: an expert panel consensus statement. [Extracted from the article] 29. Nummular dermatitis
30. 413 Improvement in itch, symptoms and quality of life with upadacitinib through week 16 in adults and adolescents with atopic dermatitis: results from phase 3 studies (Measure Up 1, Measure Up 2 and AD Up).
31. Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.
32. When does atopic dermatitis warrant systemic therapy? Recommendations from an expert panel of the International Eczema Council.
33. Addressing the Immunopathogenesis of Atopic Dermatitis: Advances in Topical and Systemic Treatment.
34. Atopic Dermatitis Progression: Evaluating Intervention Strategies.
35. Nonpharmacologic Strategies and Topical Agents for Treating Atopic Dermatitis: An Update.
36. Practical Strategies for the Diagnosis and Assessment of Atopic Dermatitis.
37. Therapeutic Patient Education in Atopic Dermatitis: Worldwide Experiences.
38. Use of pimecrolimus cream 1% (Elidel®) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome.
39. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.
40. Current guidelines for the evaluation and management of atopic dermatitis: A comparison of the Joint Task Force Practice Parameter and American Academy of Dermatology guidelines.
41. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults.
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