Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345–60.
Article CAS PubMed Google Scholar
Barbarot S, Auziere S, Gadkari A, Girolomoni G, Puig L, Simpson EL, et al. Epidemiology of atopic dermatitis in adults: results from an international survey. Allergy. 2018;73(6):1284–93.
Article CAS PubMed Google Scholar
Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(Suppl 1):8–16.
Article CAS PubMed Google Scholar
Bergqvist C, Ezzedine K. Vitiligo: a review. Dermatology. 2020;236(6):571–92.
Bibeau K, Pandya AG, Ezzedine K, Jones H, Gao J, Lindley A, et al. Vitiligo prevalence and quality of life among adults in Europe, Japan, and the USA. J Eur Acad Dermatol Venereol. 2022;36(10):1831–44.
Article CAS PubMed PubMed Central Google Scholar
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116–32.
Article PubMed PubMed Central Google Scholar
Eleftheriadou V, Atkar R, Batchelor J, McDonald B, Novakovic L, Patel JV, et al. British Association of Dermatologists guidelines for the management of people with vitiligo 2021. Br J Dermatol. 2022;186(1):18–29.
Article CAS PubMed Google Scholar
Rosmarin D, Pandya AG, Lebwohl M, Grimes P, Hamzavi I, Gottlieb AB, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(10244):110–20.
Article CAS PubMed Google Scholar
Simpson EL, Bruin-Weller M, Flohr C, Ardern-Jones MR, Barbarot S, Deleuran M, et al. When does atopic dermatitis warrant systemic therapy? Recommendations from an expert panel of the International Eczema Council. J Am Acad Dermatol. 2017;77(4):623–33.
Rashighi M, Harris JE. Interfering with the IFN-γ/CXCL10 pathway to develop new targeted treatments for vitiligo. Ann Transl Med. 2015;3(21):343.
PubMed PubMed Central Google Scholar
Bao L, Zhang H, Chan LS. The involvement of the JAK-STAT signaling pathway in chronic inflammatory skin disease atopic dermatitis. JAKSTAT. 2013;2(3): e24137.
PubMed PubMed Central Google Scholar
Oetjen LK, Mack MR, Feng J, Whelan TM, Niu H, Guo CJ, et al. Sensory neurons co-opt classical immune signaling pathways to mediate chronic itch. Cell. 2017;171(1):217–28.
Article CAS PubMed PubMed Central Google Scholar
Howell MD, Kuo FI, Smith PA. Targeting the Janus kinase family in autoimmune skin diseases. Front Immunol. 2019;10:2342.
Article CAS PubMed PubMed Central Google Scholar
Quintás-Cardama A, Vaddi K, Liu P, Manshouri T, Li J, Scherle PA, et al. Preclinical characterization of the selective JAK1/2 inhibitor INCB018424: therapeutic implications for the treatment of myeloproliferative neoplasms. Blood. 2010;115(15):3109–17.
Article PubMed PubMed Central Google Scholar
Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield L, Leung DY, et al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from two phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021;85(4):863–72.
Article CAS PubMed Google Scholar
Opzelura™ (ruxolitinib cream). Full Prescribing Information. Wilmington: Incyte Corporation; 2023.
Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Forman SB, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. J Am Acad Dermatol. 2023;88(5):1008–16.
Article CAS PubMed Google Scholar
Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, et al. Two phase 3, randomized, controlled trials of ruxolitinib cream for vitiligo. N Engl J Med. 2022;387:1445–55.
Article CAS PubMed Google Scholar
Lucas S, Ailani J, Smith TR, Abdrabboh A, Xue F, Navetta MS. Pharmacovigilance: reporting requirements throughout a product’s lifecycle. Ther Adv Drug Saf. 2022;13:20420986221125006.
Article PubMed PubMed Central Google Scholar
US FDA. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for Industry. 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment. Accessed 12 Jun 2023.
Delong C, Preuss CV. Black box warning. StatPearls. Treasure Island, FL: StatPearls Publishing; 2023.
US FDA. Prescribing Information Resources: For Industry. 2023. https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/prescribing-information-resources#:~:text=What%20is%20the%20Prescribing%20Information,the%20labeled%20conditions%20of%20use. Accessed 8 Jun 2023.
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316–26.
Article CAS PubMed Google Scholar
Kragstrup TW, Glintborg B, Svensson AL, McMaster C, Robinson PC, Deleuran B, et al. Waiting for JAK inhibitor safety data. RMD Open. 2022;8(1): e002236.
Article PubMed PubMed Central Google Scholar
US FDA. Postmarketing Adverse Event Reporting Compliance Program. https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-program. Accessed 29 Sep 2023.
US FDA. What Is a Serious Adverse Event? 2023. https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event. Accessed 9 Jun 2023.
European Medicines Agency. Inclusion/exclusion criteria for the "Important Medical Events" list. European Medicines Agency. 2021. https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf. Accessed 29 Sep 2023.
Brabete AC, Greaves L, Maximos M, Huber E, Li A, Le ML. A sex- and gender-based analysis of adverse drug reactions: a scoping review of pharmacovigilance databases. Pharmaceuticals (Basel). 2022;15(3):298.
Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, et al. Pharmacokinetics of ruxolitinib in patients with atopic dermatitis treated with ruxolitinib cream: data from phase II and III studies. Am J Clin Dermatol. 2021;22(4):555–66.
Article PubMed PubMed Central Google Scholar
Opzelura™ (ruxolitinib cream). Summary of Product Characteristics. Amsterdam: Incyte Biosciences Distribution B.V.; 2023.
Jensen AO, Svaerke C, Körmendiné Farkas D, Olesen AB, Kragballe K, Sørensen HT. Atopic dermatitis and risk of skin cancer: a Danish nationwide cohort study (1977–2006). Am J Clin Dermatol. 2012;13(1):29–36.
Apalla Z, Lallas A, Sotiriou E, Lazaridou E, Ioannides D. Epidemiological trends in skin cancer. Dermatol Pract Concept. 2017;7(2):1–6.
Article PubMed PubMed Central Google Scholar
Prepoudis A, Koechlin L, Nestelberger T, Boeddinghaus J, Lopez-Ayala P, Wussler D, et al. Incidence, clinical presentation, management, and outcome of acute pericarditis and myopericarditis. Eur Heart J Acute Cardiovasc Care. 2022;11(2):137–47.
Weycker D, Hanau A, Hatfield M, Wu H, Sharma A, Bensink ME, et al. Primary immune thrombocytopenia in US clinical practice: incidence and healthcare burden in first 12 months following diagnosis. J Med Econ. 2020;23(2):184–92.
Institute of Medicine of the National Academies. Challenges for the FDA: The Future of Drug Safety. Workshop Summary. Washington, DC: Institute of Medicine Forum on Drug Discovery, Development, and Translation; 2007.
Kavitha D. Adverse drug reaction (ADR) monitoring and pharmacovigilance. J Pharm Res Health Care. 2010;2(1):127–34.
留言 (0)