Background: Abrocitinib has demonstrated long-term efficacy (48 weeks) and safety (~4 years) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This analysis evaluated abrocitinib efficacy in adolescents through 112 weeks, and safety of up to 4.6 years of exposure.
Methods: Data were from adolescents in JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), REGIMEN (NCT03627767; safety analysis only), and the ongoing phase 3 extension trial, EXTEND (NCT03422822; data cutoff: September 5, 2022). Efficacy assessments included proportions of patients achieving an Investigator's Global Assessment score of 0 or 1 (IGA 0/1) and ≥ 75%/≥ 90% improvement in Eczema Area and Severity Index (EASI-75/-90). Treatment-emergent adverse events (TEAEs) and AEs of special interest were reported as incidence rate/100 patient-years. A substudy of JADE TEEN assessed immune response to vaccination.
Results: Efficacy was assessed in 170 and 187 patients in the abrocitinib 200-mg and 100-mg arms, respectively; median exposure was 971.0 and 899.0 days. At Week 112, comparable proportions of patients treated with abrocitinib (200, 100 mg) achieved EASI-75 (85%, 83%), EASI-90 (62%, 60%), and IGA 0/1 (57%, 57%). Safety was assessed in 289 and 201 patients in the abrocitinib 200- and 100-mg arms, respectively; median exposure was 882.0 and 863.0 days. Incidence rates were numerically higher with abrocitinib 200 mg versus 100 mg, with overlapping confidence intervals for serious TEAEs (IR [95% CI]; 5.47 [3.69-7.80] vs. 3.45 [1.89-5.80]) and TEAEs leading to discontinuation (6.78 [4.80-9.31] vs. 5.39 [3.38-8.16]).
Conclusions: Efficacy and safety results support long-term abrocitinib use in adolescent patients.
Trail Registration: ClinicalTrials.gov Identifiers NCT03349060, NCT03575871, NCT03796676, NCT03627767, NCT03422822.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1111/all.16512 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Fecal microbiota transplantation for vancomycin-resistant Clostridium innocuum infection in inflammatory bowel disease: A pilot study evaluating safety and clinical and microbiota outcome.
J Microbiol Immunol Infect
March 2025
Chang Gung Microbiota Therapy Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan; Molecular Infectious Disease Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan; Division of Pediatric Infectious Diseases, Department of Pediatrics, Chang Gung Memorial Hospital, Taoyuan, Taiwan. Electronic address:
Background: Clostridium innocuum is a vancomycin-resistant pathobiome associated with poor clinical outcomes in inflammatory bowel disease (IBD). In ulcerative colitis (UC), it correlates with reduced remission rates, while in Crohn's disease (CD), it is linked to creeping fat formation and intestinal strictures. Notably, some patients experience refractory or recurrent C.
View Article and Find Full Text PDFEfficacy of Acoramidis on All-Cause Mortality and Cardiovascular Hospitalization in Transthyretin Amyloid Cardiomyopathy.
J Am Coll Cardiol
March 2025
National Amyloidosis Centre, University College London, Royal Free Hospital, London, United Kingdom.
Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed chronic disease associated with progressive heart failure that results in impaired quality of life, repeated hospitalizations, and premature death. Acoramidis is a selective, oral transthyretin stabilizer recently approved by the U.S.
View Article and Find Full Text PDFMulti-epitope-based vaccine models prioritization against Astrovirus MLB1 using immunoinformatics and reverse vaccinology approaches.
J Genet Eng Biotechnol
March 2025
Department of Dermatovenereology, Kazakhstan Medical University, Almaty, Kazakhstan, 050016. Electronic address:
Astrovirus MLB1 (HAstV-MLB1) is non-enveloped RNA virus that cause acute gastroenteritis infection. Despite research progress about infection and pathogenesis of HAstV-MLB1, Currently, no vaccine has been developed to effectively combat this pathogen. The current study is based on immunoinformatics and reverse vaccinology approaches to design next-generation, multi-epitope-based vaccine models against HAstV-MLB1.
View Article and Find Full Text PDFRecanalization for Symptomatic Non-acute Intracranial Large Vessel Occlusion: An Observational Study.
J Atheroscler Thromb
March 2025
Department of Neurology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital.
Aim: This study investigated the efficacy and safety of endovascular revascularization for symptomatic non-acute atherosclerotic intracranial LVO.
Methods: For non-acute atherosclerotic intracranial large vessel occlusion (LVO), despite aggressive medical treatment, recurrent ischemic stroke or transient ischemic attack related to the occluded artery still occurs repeatedly. This retrospective cohort study included stroke patients with intracranial LVO who received endovascular treatment (EVT), categorized by successful recanalization and the time interval from symptom onset to revascularization (＜30 days vs.
Early Mobilization of Patients in the Intensive Care Unit: A Quality Improvement Evidence-Based Project.
J Dr Nurs Pract
March 2025
Department of Nursing, Aspen University, Denver, CO, USA
At an urban public acute care hospital, a gap existed in the safety and efficacy of early mobilization (EM) of intensive care unit (ICU) patients, with the need for an evidence-based intervention. A literature review revealed that a nurse-driven mobility protocol could safely achieve early mobility in ICU patients. This quality improvement project aims to utilize a nurse-driven mobility protocol to determine its effects on EM of ICU patients.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!