Searched for: in-biosketch:true
person:fonacl01
Atopic dermatitis Yardstick: a new era of topical and systemic treatments
De Benedetto, Anna; Boguniewicz, Mark; Fonacier, Luz; Silverberg, Jonathan; Abuabara, Katrina; Ong, Peck Y
The atopic dermatitis (AD) Yardstick articles aim to provide an up-to-date review of AD therapy for clinicians. The first two AD Yardstick articles were published in 2018 and 2023. Since the last update, multiple medications have been added to armamentarium of AD. These include roflumilast cream, tapinarof cream, lebrikizumab and nemolizumab. In the current AD Yardstick article, we aim to provide evidence-based information on these new treatments, as well as updated information on previously reviewed therapy. A new feature of the AD Yardstick article is the addition of patient vignettes, which provide practical guide and clinical pearls for clinicians.
PMID: 42229679
ISSN: 1534-4436
CID: 6043802
The 2025 WAO Guidelines for the classification, diagnosis, and treatment of hereditary angioedema, with consideration of worldwide disparities
Vázquez, Daniel O; Giavina-Bianchi, Pedro; Josviack, Darío; Kaplan, Allen P; Martinez, Pablo A S; Fantini, Claudio; Bernstein, Jonathan A; Abbas, Shahid; Levin, Nancy Agmon; Al-Ahmad, Mona; Alandijani, Sultan; Alhashmi, Hani Abdullah; Ali, Ramzy Mohammed; Allam, Ines; Al-Nesf Al-Mansouri, Maryam; Al-Tamemi, Salem; Altrichter, Sabine; Castelló, Mirta Álvarez; Andoh, Hilary D; Aun, Marcelo Vivolo; Mapondela, Kassim Babu; Banerji, Aleena; Bara, Noémi-Anna; Barrera, Olga Melcina; Perigault, Paulo Barrera; Branco-Ferreira, Manuel; Calderón-Llosa, Oscar Manuel; Canonica, Giorgio Walter; Almarales, Raúl Castro; Cecchi, Lorenzo; Chang, Yoon-Seok; Chantaphakul, Hiroshi; Chikovani, Tinatin; Chong-Neto, Herberto Jose; Contreras-Verduzco, Francisco Alberto; Defendi, Federica; Dorsainvil, Vilbrun; Ebisawa, Motohiro; El-Sayed, Zeinab A; Fasano, Mary Beth; Fazlollahi, Mohammad Reza; Femine, Euguens; Fernandes, Fátima Rodrigues; Fiocchi, Alessandro; Fonacier, Luz; Gallego, Claudia; García Abujeta, José Luis; Gereda, José Enrique; Giordano, Erminia; Gökmen, Nihal Mete; Gómez, R Maximiliano; Gonzalez, Monica; Díaz, Sandra González; Grau, Masumi; Hakl, Roman; Hide, Michihiro; Hossny, Elham; Huilaja, Laura; Huq, Syed Rezaul; Irani, Carla; Ishchanka, Aksana; Ispayeva, Zhanat; Jamalyan, Kristina R; Kaidashev, Igor; Kamkamidze, George; Tanno, Luciana Kase; Kathuria, P C; Kessel, Aharon; Kiani-Alikhan, Sorena; Komarla, Nagendra Prasad; Kvedarienė, Violeta; Lang, David M; Lee, Yong Won; Levin, Michael; Li, Philip H; Li, Henry; Lumry, William R; Machavariani, Ketevan; Martinez-Sager, Inmaculada; Maselli, Juan P; Mikos, Nikolaos; Mitskevich, Nunu; Mobayed, Hassan M S; Monge Ortega, Olga Patricia; Morita, Hideaki; Munkhbayarlakh, Sonomjamts; Nabavi, Mohammad; Naqvi, Muhammad Raza; Ocampo, Jaime; Olivares, Margarita; Ortega-Martell, Jose Antonio; Oyuntsatsral, Batsaikhan; Papadopoulos, Nikos; Patella, Vincenzo; Pawankar, Ruby; Peter, Jonny; Psarros, Fotis; Regateiro, Frederico; Reidl, Marc; Rigalt, Ann M; Rincón Fernández, Jenny Mariel; Rivera Gómez, Maria Antonia; Rojo Gutiérrez, María Isabel; Sahiner, Ümit Murat; Sandoval-Ruballos, Mónica; Santos, Natacha; Sarrazola, Mauricio; Schrijvers, Rik; Shchurok, Iryna; Sheikh, Farrukh Rafique; Sobotkova, Marta; Soria, Angele; Stefanaki, Efthalia; Tarazona, Robin; Luján, Alejandra Valecillos; Rostan, Marylin Valentin; Valerieva, Anna; Wing-Kin Wong, Gary; Yong, Patrick F K; Zaitoun, Fares; Martin, Bryan L; Ansotegui, Ignacio J; Morais-Almeida, Mário; Craig, Timothy J
The 2025 World Allergy Organization (WAO) Guidelines for the Classification, Diagnosis, and Treatment of Hereditary Angioedema (HAE) with Consideration of Worldwide Disparities provide a comprehensive, evidence-informed, and globally applicable framework for the care of this rare and potentially life-threatening disorder. HAE is a genetic disease characterized by recurrent episodes of subcutaneous and submucosal swelling, most commonly mediated by bradykinin, and is associated with substantial morbidity, impaired quality of life, and a lifelong risk of fatal laryngeal edema. The Guidelines were developed by an international panel of 40 experts from 22 countries, with representation from all world regions, reflecting the commitment of WAO to geographic diversity, inclusiveness, and global relevance. The development process for these guidelines followed a structured and transparent methodology that integrated systematic literature review, appraisal of real-world evidence, and application of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework adapted for rare diseases, complemented by a formal Delphi consensus process. This approach was specifically designed to address the limitations of conventional evidence hierarchies in rare disorders, while ensuring clinical applicability across heterogeneous healthcare systems and resource settings. A central element of the guidelines is an updated classification of HAE based on underlying pathophysiology and disease endotypes. The traditional distinction between HAE types 1 and 2 is unified under the term HAE with C1 inhibitor deficiency (HAE-C1-INH), reflecting shared biological mechanisms and management principles. The guidelines also recognize an expanding spectrum of HAE with normal C1 inhibitor (HAE-nC1-INH), including forms associated with pathogenic variants in F12, PLG, ANGPT1, KNG1, MYOF, HS3ST6, CPN1, and DAB2IP, as well as cases with currently unidentified genetic causes. The diagnostic strategy emphasizes early clinical recognition based on characteristic features, including recurrent angioedema without urticaria, abdominal or laryngeal involvement, early symptom onset, and family history. A simplified diagnostic algorithm is proposed, prioritizing the C1 inhibitor functional assay as the preferred initial test when performed in a reliable specialized laboratory. Alternative diagnostic pathways are outlined for settings with limited access to specialized testing, including pragmatic combinations of biochemical assays and selective use of genetic testing, particularly relevant for HAE-nC1-INH and family screening. Management recommendations address on-demand treatment of acute attacks, short-term prophylaxis, and individualized long-term prophylaxis. Universal access to on-demand therapy is emphasized for all patients with confirmed HAE, including those who are asymptomatic, given the unpredictable nature of attacks and lifelong risk. Long-term prophylaxis is addressed within a treat-to-target framework aimed at achieving complete disease control and sustained improvement in health-related quality of life, with regular reassessment and shared decision-making. Empowering patients and caregivers through structured education, access to appropriate medications, and integration with specialized referral centers is associated with earlier treatment, reduced healthcare utilization, and improved equity of care and reduced avoidable morbidity and mortality worldwide. The 2025 WAO Guidelines for Hereditary Angioedema establish an evidence-informed, patient-centered, and forward-looking framework for the classification, diagnosis, and management of HAE. By integrating advances in pathophysiology, diagnostics, and therapeutics with global expert consensus and real-world considerations, the guidelines aim to support consistent, equitable, and high-quality care for patients with HAE across regions and healthcare systems.
PMCID:13184495
PMID: 42165046
ISSN: 1939-4551
CID: 6038462
Clinical remission in allergy and clinical immunology practice: State of the art and World Allergy Organization (WAO) call to action
Morais-Almeida, Mário; Canonica, Giorgio Walter; Giavina-Bianchi, Pedro; Arasi, Stefania; Caminati, Marco; Fiocchi, Alessandro; Fonacier, Luz S; Giavina-Bianchi, Mara; Gómez, R Maximiliano; González-Diaz, Sandra N; Martin, Bryan L; Ortega Martell, José Antonio; Pitè, Helena; Rouadi, Philip; Sánchez Caraballo, Jorge; Villarreal-González, Rosalaura V; Virchow, Johann Christian; Bachert, Claus; Bernstein, Jonathan A; Cianferoni, Antonella; Dávila, Ignacio; Hanania, Nicola A; Heffler, Enrico; Nair, Parameswaran; Park, Hae-Sim; Saito, Hirohisa; Varricchi, Gilda; Yáñez, Anahí; Ansotegui, Ignacio J
Recent advances in biological therapies, small molecules and allergen-specific immunotherapy are reshaping the management of immunoallergic diseases, progressively shifting therapeutic goals from short-term disease control toward the possibility of achieving sustained clinical remission. Despite increasing evidence across multiple conditions, a universally accepted and disease-transversal definition of clinical remission (CR) remains lacking. In this review we propose a comprehensive framework for defining clinical remission across a broad spectrum of immune-mediated diseases traditionally managed in Allergy and Clinical Immunology practice, including asthma, allergic rhinitis, chronic rhinosinusitis with nasal polyps, chronic urticaria, atopic dermatitis, mastocytosis, food allergy, and eosinophilic esophagitis. Clinical remission is defined as a sustained state of absence of clinically relevant disease manifestations, independently of underlying biological activity; suppression of inflammatory pathways and normalization of biomarkers define biological remission, which may coexist with, but is not required for, clinical remission. We introduce the 3D-CR model, a pragmatic, disease-adaptable framework integrating 3 complementary domains - clinical, biological, and functional - to characterize remission states as complete, partial, or absent. Building on this model, we propose the Allergic Disease Remission Score (ADReS) as a modular tool designed to support standardized assessment, longitudinal follow-up, and cross-disease comparison in clinical trials and real-world settings. These tools are intended as conceptual and research instruments rather than prescriptive algorithms for individual therapeutic decision-making. Finally, we outline a World Allergy Organization call to action advocating for a harmonized global approach to defining, measuring, and implementing clinical remission as a meaningful treatment target. Establishing standardized remission endpoints has the potential to improve patient outcomes, facilitate precision medicine strategies, enhance comparability across studies, and reduce heterogeneity in clinical research and practice worldwide.
PMCID:13122681
PMID: 42058161
ISSN: 1939-4551
CID: 6029502
The International Guideline for the Definition, Classification, Diagnosis and Management of Urticaria
Zuberbier, T; Abdul Hameed Ansari, Z; Abdul Latiff, A H; Abuzakouk, M M; Agcaoili-De Jesus, M S; Agondi, R C; Al-Ahmad, M; Alangari, A A; Alhameli, H; Alonso Bello, C D; Alshareef, S; Al-Tamemi, S; Altrichter, S; Al Wahshi, H; Aquilina, S; Araújo, M; Arnaout, R; Asero, R; Ballmer-Weber, B; Bangert, C; Bauer, A; Ben-Shoshan, M; Bernstein, J; Bindslev-Jensen, C; Bizjak, M; Boccon-Gibod, I; Bonnekoh, H; Bouillet, L; Brockow, K; Brzoza, Z; Bulatović Ćalasan, M; Bulkhi, A; Buttgereit, T; Bygum, A; Caballero, T; Calderon, O; Campos, R; Cancian, M; Carne, E; Castor, M A; Cerecedo, I; Çetinarslan, T; Cherrez-Ojeda, I; Chkhikvadze, N; Chong-Neto, H J; Choo, K; Christoff, G; Chu, C-Y; Ciupka, K; Conlon, N; Costa, C; Craig, T; Criado, P; Danilycheva, I; Darlenski, R; De Arruda Chaves, E; de Montjoye, L; Doutre, M S; Du-Thanh, A; Ebo, D; Elkhalifa, S; Elmariah, S; El-Shanawany, T; Ensina, L F; Ertaş, R; Fachini Jardim Criado, R; Ferrer, M; Ferrucci, S; Fok, J S; Fomina, D; Fonacier, L; Fouda, G; Francescantonio, I; Fukunaga, A; Galvan Calle, C A; Garcia, E; Gáspár, K; Gelincik, A; Geng, S; Godse, K; Gonçalo, M; Gotua, M; Grattan, C; Grosber, M; Guidos Fogelbach, G; Guilarte, M; Guillod, R; Hamelmann, E; Hawkes, J; Hayama, K; Heuer, R; Hide, M; Hoetzenecker, W; Inomata, N; Kang, H-R; Kaplan, A; Kapp, A; Karam, M; Kasperska-Zajac, A; Katelaris, C H; Kessel, A; Khoshkhui, M; Kim, B; Kinaciyan, T; Kocatürk, E; Kolacinska-Flont, M; Kolkhir, P; Konstantinou, G N; Kosnik, M; Krasowska, D; Kulthanan, K; Kumaran, M S; Kuprys-Lipinska, I; Labrador, M; Larco, J I; Larenas-Linnemann, D; Latysheva, E; Lazaridou, E; Li, P H; Lima, H; Lippert, U; Magerl, M; Makris, M; Alves Marcelino, J; Marzano, A V; Medina, I; Meshkova, R; Micallef, D; Mohammed Ali, R; Mortz, C G; Munoz, M; Oude Elberink, H N G; Nakonechna, A; Nasr, I; Nast, A; Netchiporouk, E; Nettis, E; Nieto, S; Ogueta Canales, I; Okas, T-L; Orfali, R L; Özkaya, E; Parisi, C; Pennitz, A; Pawankar, R; Pereira, M P; Peter, J; Petkova, E; Pigatto, P D; Podder, I; Popov, T; Porebski, G; Pyatilova, P; Ramon, G D; Ratti Sisa, H A; Recto, M; Ress, K; Ridge, K; Riedl, M; Ritchie, C; Rosario Filho, N; Rosmaninho, I; Rudenko, M; Rukhadze, M; Rutkowski, K; Sabato, V; Sahiner, U M; Saini, S; Saleh Al Sabbagh, F; Salman, A; Salvo, F; Sanchez, J; Santucci, A; Schliemann, S; Schmid-Grendelmeier, P; Sekerel, B E; Serpa, F; Sheikh, F; Sheikh, J; Shendi, H; Siebenhaar, F; Sonomjamts, M; Soria, A; Sousa Pinto, B; Staevska, M; Staubach, P; Stephan, M; Stevanovic, K; Stingeni, L; Stobiecki, M; Su Küçük, Ö; Sussman, G; Szegedi, A; Takahagi, S; Tanaka, A; Teovska Mitrevska, N; Thomsen, S F; Toubi, E; Tsatsou, F; Turk, M; Vadasz, Z; Valerieva, A; Valle, S; Doorn, M V; Veleiro Perez, B; Vera Ayala, C E; Vestergaard, C; Vieira, R J; Maruta, C W; Wedi, B; Werner, R N; Yap, E W Y; Xepapadaki, P; Xiang, Y; Ye, Y-M; Yong, P; Yosipovitch, G; Zalewska-Janowska, A Z J; Zeyen, C; Zhao, Z; Metz, M; Giménez-Arnau, A M
This update and revision of the international guideline for urticaria was developed in accordance with the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. It is an initiative of the Global Allergy and Asthma Excellence Network (GA2LEN) and its Urticaria and Angioedema Centers of Reference and Excellence (UCAREs and ACAREs), with the participation of 210 delegates from 107 national and international societies, from 59 countries. The consensus conference was held on December 6th, 2024. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell-driven disease, defined by a rapid appearance of wheals, angioedema, or both. The lifetime prevalence of acute urticaria is estimated to be approximately 20%. Chronic urticaria, categorized as either chronic spontaneous urticaria or chronic inducible urticaria, is disabling, impairs quality of life, and affects performance at work and school, however, novel therapies are available. This updated version of the international guideline for urticaria covers the definition and classification of urticaria and outlines expert-guided and evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria.
PMID: 41649409
ISSN: 1398-9995
CID: 6000592
Global disparities in adrenaline access: A World Allergy Organization call for equity in anaphylaxis care [Editorial]
Morais-Almeida, Mário; Martin, Bryan L; Turner, Paul J; Fiocchi, Alessandro; Ebisawa, Motohiro; Wing-Kin Wong, Gary; Ansotegui, Ignacio J; Al-Nesf Al-Mansouri, Maryam Ali; Bernstein, Jonathan A; Chantaphakul, Hiroshi; Chikovani, Tinatin; Fasano, Mary Beth; Fonacier, Luz; Giavina-Bianchi, Pedro; Gómez, René Maximiliano; González-Díaz, Sandra N; Hossny, Elham; Lang, David M; Morita, Hideaki; Ortegal Martell, José Antonio; Papadopoulos, Nikolaos G; Tanno, Luciana Kase
PMCID:12702309
PMID: 41399690
ISSN: 1939-4551
CID: 5979182
Atopic Dermatitis With Comorbid Skin Diseases: Recognition and Successful Treatment
Sani, Sonam; Flohr, Carsten; Abuabara, Katrina; Singh, Anne Marie; Yip, Alphonsus; Mackenzie, Madelynn; Fonacier, Luz
Atopic dermatitis (AD) is a common, chronic inflammatory skin disease that affects both children and adults. Atopic dermatitis is characterized by pruritus, erythema, induration, and scale, which can present with other conditions that may mimic or complicate AD; often leading to diagnostic challenges. Differential diagnoses include seborrheic dermatitis, contact dermatitis, psoriasis, infections, inflammatory/autoimmune disorders, cutaneous T-cell lymphoma, and immunodeficiency-related dermatoses; to name a few. This review article focuses on AD and its associated cutaneous comorbid diseases. Familiarity with the spectrum of these diseases and their distinguishing features is crucial for diagnostic accuracy and to optimize patient management.
PMID: 40571248
ISSN: 2213-2201
CID: 5904632
Correction: Complete/Near-Complete Itch Response Observed in Patients with Moderate-to-Severe Atopic Dermatitis Initiating Dupilumab: 3-Year, Real-World, Interim Data from the PROSE Registry
Bhatia, Neal; Lynde, Charles W; Fonacier, Luz; Shao, Liyang; Bosman, Kwinten; Korotzer, Andrew
PMID: 40691414
ISSN: 2193-8210
CID: 5901302
Contact Dermatitis and Patch Testing Education: A Workgroup Report from the Allergic Skin Diseases Committee of the AAAAI
Steele, Ryan; Pacheco, Karin; Sher, Ellen; Ross, Jacqueline; Tanzer, Ray; Fonacier, Luz; Aquino, Marcella R
Allergic Contact dermatitis (ACD) is effectively diagnosed and treated through the identification of causative allergens via patch testing (PT). Selection of allergens, along with the application and interpretation of PT results, necessitates specialized education and training. Our objective was to investigate the extent to which contact dermatitis (CD) education and PT training are components of the curriculum in Allergy and Immunology (A/I) training programs in the United States, and to assess where knowledge gaps may exist. A voluntary 16 item survey was sent to Program and Associate Program Directors (PDs) in A/I associated with the American Academy of Allergy, Asthma, and Immunology (AAAAI) in 2021. A total of 23 out of 84 (27%) A/I training programs responded. Of the responding programs, 22% did not have a faculty member who performs PT and 25% do not have fellows perform PT. However, programs that performed more patch tests tended to use custom and expanded series, used the patient's personal products, and provided patients with a personal avoidance plan (loadings > 0.65). With respect to scholarly activity, 30% of programs had published an article on CD in the last 3 years. In conclusion, the key findings of our survey include that programs that perform PT are more likely to provide expanded and customized panels, provide patients with an individualized avoidance plan, and present scholarly activity on the topic. Given the importance of CD in allergy practices, our results indicate that more instruction in this topic is needed in A&I fellowship programs.
PMID: 40381990
ISSN: 2213-2201
CID: 5852632
Complete/Near-Complete Itch Response Observed in Patients with Moderate-to-Severe Atopic Dermatitis Initiating Dupilumab: 3-Year, Real-World, Interim Data from the PROSE Registry
Bhatia, Neal; Lynde, Charles W; Fonacier, Luz; Shao, Liyang; Korotzer, Andrew; Bosman, Kwinten
INTRODUCTION/BACKGROUND:Atopic dermatitis (AD) is a chronic, relapsing disease that can start at any age and has a significant negative impact on quality of life, including a significant itch burden. Here we report the proportion of patients in a real-world study achieving a complete/almost complete resolution of itch, as measured by the Peak Pruritus Numeric Rating Scale (PP-NRS) and improvement in overall disease severity score (ODS), in patients aged ≥ 12 years with moderate-to-severe AD up to 3 years after commencing dupilumab treatment. METHODS:PROSE is an ongoing, prospective, observational, multicenter registry in the USA and Canada, collecting real-world data from patients aged ≥ 12 years with moderate-to-severe AD who initiated dupilumab in accordance with country-specific prescribing information. Assessments include patient-reported PP-NRS (range 0-10) and clinician-measured ODS score (range 0-4). RESULTS:A total of 857 patients were enrolled, of whom 42% were male and 6.4% were adolescents aged ≥ 12 to < 18 years. The mean [standard deviation (SD)] age was 40.1 (17.9) years, and the duration of AD was 17.4 (16.2) years. The subsequent mean (SD) duration of dupilumab treatment was 23.1 (13.7) months. The proportion of patients achieving complete/almost complete itch resolution (PP-NRS score of 0 or 1) improved consistently over time, from 2.7% (17/622) of patients at baseline to 56.3% (58/103) at 3 years. Additionally, by year 3, 65.1% (54/83) of patients had an ODS score of no/minimal disease (score of 0 or 1), versus 2.2% (19/852) at baseline. CONCLUSIONS:In this real-world setting of the PROSE registry, adult and adolescent patients with moderate-to-severe AD followed up for up to 3 years after the initiation of dupilumab treatment experienced sustained and substantial improvement in pruritus and ODS, using the stringent endpoints of PP-NRS 0 or 1 and ODS 0 or 1. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov identifier: NCT03428646.
PMID: 40234297
ISSN: 2193-8210
CID: 5827852
Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type
Alexis, Andrew F; Silverberg, Jonathan I; Rice, Zakiya P; Armstrong, April W; Desai, Seemal R; Fonacier, Luz; Kabashima, Kenji; Biswas, Pinaki; Cella, Ricardo Rojo; Chan, Gary L; Levenberg, Mark
BACKGROUND:Response to abrocitinib treatment for moderate-to-severe atopic dermatitis (AD) has not been evaluated across racial and ethnic subpopulations. OBJECTIVE:To assess the efficacy and safety of abrocitinib on the basis of patient race, ethnicity, and Fitzpatrick skin type (FST). METHODS:Data were pooled post hoc from patients treated with abrocitinib 200 mg, 100 mg, or placebo in 3 monotherapy trials (NCT02780167, NCT03349060, and NCT03575871). Race and ethnicity were self-reported; FST was determined by study investigators. Evaluations through Week 12 include the following: (1) Investigator's Global Assessment of clear or almost-clear skin; (2) greater than or equal to 75% improvement in Eczema Area and Severity Index or SCORing AD; (3) a greater-than-or-equal-to 4-point improvement in Peak Pruritus Numerical Rating Scale score; (4) least squares mean changes in Dermatology Life Quality Index and Patient-Oriented Eczema Measure scores; and (5) treatment-emergent adverse events. RESULTS:The sample comprised 628 White, 204 Asian, and 83 Black patients; 37 were Hispanic or Latino; 624 had FST I to III and 320 had FST IV to VI. Treatment with either abrocitinib dose was associated with greater proportions of patients achieving Investigator's Global Assessment of clear or almost-clear skin, ≥ 75% improvement in Eczema Area and Severity Index, ≥ 75% improvement in SCORing AD, and a ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale, or greater score changes from baseline in Dermatology Life Quality Index and Patient-Oriented Eczema Measure vs placebo regardless of race, ethnicity, or FST. Dose-response was most prominent in White patients. In Black patients, the effects of the 2 doses were similar. Treatment-emergent adverse events were more common in White and Black than in Asian patients. CONCLUSION:Abrocitinib was more efficacious than placebo across the racial and ethnic groups and ranges of phototypes analyzed. Studies with increased representation of populations of color are warranted to elucidate potential variations in response across diverse populations. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT02780167 (phase 2b), NCT03349060 (phase 3 MONO-1), and NCT03575871 (phase 3 MONO-2).
PMID: 37949351
ISSN: 1534-4436
CID: 5722942