{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T17:41:04Z","timestamp":1789062064429,"version":"build-2803163510"},"reference-count":34,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T00:00:00Z","timestamp":1617753600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T00:00:00Z","timestamp":1617753600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Am J Clin Dermatol"],"published-print":{"date-parts":[[2021,5]]},"DOI":"10.1007\/s40257-021-00602-x","type":"journal-article","created":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T04:02:46Z","timestamp":1617768166000},"page":"395-405","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials"],"prefix":"10.1007","volume":"22","clinical-trial-number":[{"clinical-trial-number":"nct02576938","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03334396","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03334422","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03428100","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03435081","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03733301","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03334435","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03559270","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Brett","family":"King","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Maari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Lain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan I.","family":"Silverberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maher","family":"Issa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrin","family":"Holzwarth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Brinker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy","family":"Cardillo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio P.","family":"Nunes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric L.","family":"Simpson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,4,7]]},"reference":[{"issue":"4s","key":"602_CR1","doi-asserted-by":"publisher","first-page":"S65","DOI":"10.1016\/j.jaci.2017.01.011","volume":"139","author":"PM Brunner","year":"2017","unstructured":"Brunner PM, Guttman-Yassky E, Leung DY. The immunology of atopic dermatitis and its reversibility with broad-spectrum and targeted therapies. J Allergy Clin Immunol. 2017;139(4s):S65-76. https:\/\/doi.org\/10.1016\/j.jaci.2017.01.011.","journal-title":"J Allergy Clin Immunol."},{"issue":"1","key":"602_CR2","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1016\/j.anai.2017.10.039","volume":"120","author":"M Boguniewicz","year":"2018","unstructured":"Boguniewicz M, Fonacier L, Guttman-Yassky E, Ong PY, Silverberg J, Farrar JR. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10-22.e2. https:\/\/doi.org\/10.1016\/j.anai.2017.10.039.","journal-title":"Ann Allergy Asthma Immunol."},{"issue":"1","key":"602_CR3","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jaci.2018.10.032","volume":"143","author":"T Czarnowicki","year":"2019","unstructured":"Czarnowicki T, He H, Krueger JG, Guttman-Yassky E. Atopic dermatitis endotypes and implications for targeted therapeutics. J Allergy Clin Immunol. 2019;143(1):1\u201311. https:\/\/doi.org\/10.1016\/j.jaci.2018.10.032.","journal-title":"J Allergy Clin Immunol."},{"issue":"3","key":"602_CR4","doi-asserted-by":"publisher","first-page":"329","DOI":"10.1007\/s12016-016-8548-5","volume":"51","author":"PY Ong","year":"2016","unstructured":"Ong PY, Leung DY. Bacterial and viral infections in atopic dermatitis: a comprehensive review. Clin Rev Allergy Immunol. 2016;51(3):329\u201337. https:\/\/doi.org\/10.1007\/s12016-016-8548-5.","journal-title":"Clin Rev Allergy Immunol."},{"issue":"6","key":"602_CR5","doi-asserted-by":"publisher","first-page":"1375","DOI":"10.1016\/j.jid.2017.01.030","volume":"137","author":"SM Langan","year":"2017","unstructured":"Langan SM, Abuabara K, Henrickson SE, Hoffstad O, Margolis DJ. Increased risk of cutaneous and systemic infections in atopic dermatitis: a cohort study. J Invest Dermatol. 2017;137(6):1375\u20137. https:\/\/doi.org\/10.1016\/j.jid.2017.01.030.","journal-title":"J Invest Dermatol."},{"issue":"1","key":"602_CR6","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1016\/j.anai.2017.10.019","volume":"120","author":"S Narla","year":"2018","unstructured":"Narla S, Silverberg JI. Association between atopic dermatitis and serious cutaneous, multiorgan and systemic infections in US adults. Ann Allergy Asthma Immunol. 2018;120(1):66-72.e11. https:\/\/doi.org\/10.1016\/j.anai.2017.10.019.","journal-title":"Ann Allergy Asthma Immunol."},{"issue":"12","key":"602_CR7","doi-asserted-by":"publisher","first-page":"843","DOI":"10.1038\/nrd.2017.201","volume":"16","author":"DM Schwartz","year":"2017","unstructured":"Schwartz DM, Kanno Y, Villarino A, Ward M, Gadina M, O\u2019Shea JJ. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017;16(12):843\u201362. https:\/\/doi.org\/10.1038\/nrd.2017.201.","journal-title":"Nat Rev Drug Discov."},{"issue":"4","key":"602_CR8","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1016\/j.anai.2018.02.012","volume":"120","author":"MD Howell","year":"2018","unstructured":"Howell MD, Fitzsimons C, Smith PA. JAK\/STAT inhibitors and other small molecule cytokine antagonists for the treatment of allergic disease. Ann Allergy Asthma Immunol. 2018;120(4):367\u201375. https:\/\/doi.org\/10.1016\/j.anai.2018.02.012.","journal-title":"Ann Allergy Asthma Immunol."},{"issue":"1","key":"602_CR9","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1016\/j.anai.2019.10.005","volume":"124","author":"Y Renert-Yuval","year":"2020","unstructured":"Renert-Yuval Y, Guttman-Yassky E. New treatments for atopic dermatitis targeting beyond IL-4\/IL-13 cytokines. Ann Allergy Asthma Immunol. 2020;124(1):28\u201335. https:\/\/doi.org\/10.1016\/j.anai.2019.10.005.","journal-title":"Ann Allergy Asthma Immunol."},{"issue":"9","key":"602_CR10","doi-asserted-by":"publisher","first-page":"5298","DOI":"10.4049\/jimmunol.0902819","volume":"184","author":"JS Fridman","year":"2010","unstructured":"Fridman JS, Scherle PA, Collins R, Burn TC, Li Y, Li J, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol. 2010;184(9):5298\u2013307. https:\/\/doi.org\/10.4049\/jimmunol.0902819.","journal-title":"J Immunol."},{"key":"602_CR11","unstructured":"ClinicalTrials.gov. A study of baricitinib (LY3009104) in participants with severe or very severe alopecia areata (BRAVE-AA1). 2018. Identifier (NCT03570749). https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03570749. Accessed 26 Feb 2021."},{"key":"602_CR12","unstructured":"ClinicalTrials.gov. A study of baricitinib (LY3009104) in adults with severe or very severe alopecia areata (BRAVE-AA2). 2019. Identifier (NCT03899259). https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03899259. Accessed 26 Feb 2021."},{"issue":"5","key":"602_CR13","doi-asserted-by":"publisher","first-page":"320","DOI":"10.1038\/nrrheum.2017.51","volume":"13","author":"KL Winthrop","year":"2017","unstructured":"Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(5):320. https:\/\/doi.org\/10.1038\/nrrheum.2017.51.","journal-title":"Nat Rev Rheumatol."},{"issue":"1","key":"602_CR14","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1136\/annrheumdis-2020-218398","volume":"80","author":"P Nash","year":"2021","unstructured":"Nash P, Kerschbaumer A, D\u00f6rner T, Dougados M, Fleischmann RM, Geissler K, et al. Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement. Ann Rheum Dis. 2021;80(1):71\u201387. https:\/\/doi.org\/10.1136\/annrheumdis-2020-218398.","journal-title":"Ann Rheum Dis."},{"issue":"4","key":"602_CR15","doi-asserted-by":"publisher","first-page":"913","DOI":"10.1016\/j.jaad.2018.01.018","volume":"80","author":"E Guttman-Yassky","year":"2019","unstructured":"Guttman-Yassky E, Silverberg JI, Nemoto O, Forman SB, Wilke A, Prescilla R, et al. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: a phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study. J Am Acad Dermatol. 2019;80(4):913-21.e9. https:\/\/doi.org\/10.1016\/j.jaad.2018.01.018.","journal-title":"J Am Acad Dermatol."},{"issue":"2","key":"602_CR16","doi-asserted-by":"publisher","first-page":"242","DOI":"10.1111\/bjd.18898","volume":"183","author":"EL Simpson","year":"2020","unstructured":"Simpson EL, Lacour JP, Spelman L, Galimberti R, Eichenfield LF, Bissonnette R, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020;183(2):242\u201355. https:\/\/doi.org\/10.1111\/bjd.18898.","journal-title":"Br J Dermatol."},{"key":"602_CR17","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2020.3260","author":"K Reich","year":"2020","unstructured":"Reich K, Kabashima K, Peris K, Silverberg JI, Eichenfield LF, Bieber T, et al. Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020. https:\/\/doi.org\/10.1001\/jamadermatol.2020.3260.","journal-title":"JAMA Dermatol."},{"issue":"21","key":"602_CR18","doi-asserted-by":"publisher","first-page":"00353","DOI":"10.1016\/j.jaad.2021.02.028","volume":"S0190\u20139622","author":"EL Simpson","year":"2021","unstructured":"Simpson EL, Forman S, Silverberg JI, Zirwas M, Maverakis E, Han G, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis: results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5). J Am Acad Dermatol. 2021;S0190\u20139622(21):00353\u20134. https:\/\/doi.org\/10.1016\/j.jaad.2021.02.028.","journal-title":"J Am Acad Dermatol."},{"issue":"2","key":"602_CR19","doi-asserted-by":"publisher","first-page":"476","DOI":"10.1111\/jdv.16948","volume":"35","author":"T Bieber","year":"2021","unstructured":"Bieber T, Thyssen JP, Reich K, Simpson EL, Katoh N, Torrelo A, et al. Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. J Eur Acad Dermatol Venereol. 2021;35(2):476\u201385. https:\/\/doi.org\/10.1111\/jdv.16948.","journal-title":"J Eur Acad Dermatol Venereol."},{"key":"602_CR20","unstructured":"Eli Lilly and Company. Olumiant: Australian product information. ARTG ID 277905. 2021. https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2018-PI-01225-1. Accessed 25 Mar 2021."},{"key":"602_CR21","unstructured":"Eli Lilly and Company. Olumiant: European Union summary of product characteristics. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/olumiant-epar-product-information_en.pdf. Accessed 23 Mar 2021."},{"key":"602_CR22","unstructured":"Eli Lilly and Company. Olumiant: Japan product information. https:\/\/www.info.pmda.go.jp\/go\/pdf\/530471_3999043F1020_1_07. Accessed 25 Mar 2021."},{"key":"602_CR23","unstructured":"Eli Lilly and Company. Olumiant: U.S. prescribing information. Reference ID: 4271150. 2018. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/207924s000lbl.pdf. Accessed 28 Mar 2020."},{"issue":"10","key":"602_CR24","doi-asserted-by":"publisher","first-page":"1960","DOI":"10.1002\/art.40189","volume":"69","author":"KL Winthrop","year":"2017","unstructured":"Winthrop KL, Curtis JR, Lindsey S, Tanaka Y, Yamaoka K, Valdez H, et al. Herpes zoster and tofacitinib: clinical outcomes and the risk of concomitant therapy. Arthritis Rheumatol. 2017;69(10):1960\u20138. https:\/\/doi.org\/10.1002\/art.40189.","journal-title":"Arthritis Rheumatol."},{"issue":"10","key":"602_CR25","doi-asserted-by":"publisher","first-page":"1843","DOI":"10.1136\/annrheumdis-2016-209131","volume":"75","author":"JR Curtis","year":"2016","unstructured":"Curtis JR, Xie F, Yun H, Bernatsky S, Winthrop KL. Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis. Ann Rheum Dis. 2016;75(10):1843\u20137. https:\/\/doi.org\/10.1136\/annrheumdis-2016-209131.","journal-title":"Ann Rheum Dis."},{"key":"602_CR26","unstructured":"AbbVie. Rinvoq: prescribing information. Reference ID: 4478363. 2019. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/211675s000lbl.pdf. Accessed 29 Nov 2020."},{"key":"602_CR27","doi-asserted-by":"publisher","first-page":"k1786","DOI":"10.1136\/bmj.k1786","volume":"361","author":"RJ Silverwood","year":"2018","unstructured":"Silverwood RJ, Forbes HJ, Abuabara K, Ascott A, Schmidt M, Schmidt SAJ, et al. Severe and predominantly active atopic eczema in adulthood and long term risk of cardiovascular disease: population based cohort study. BMJ. 2018;361:k1786. https:\/\/doi.org\/10.1136\/bmj.k1786.","journal-title":"BMJ"},{"issue":"49","key":"602_CR28","doi-asserted-by":"publisher","first-page":"e13512","DOI":"10.1097\/md.0000000000013512","volume":"97","author":"M Yuan","year":"2018","unstructured":"Yuan M, Cao WF, Xie XF, Zhou HY, Wu XM. Relationship of atopic dermatitis with stroke and myocardial infarction: a meta-analysis. Medicine (Baltimore). 2018;97(49):e13512. https:\/\/doi.org\/10.1097\/md.0000000000013512.","journal-title":"Medicine (Baltimore)"},{"issue":"1","key":"602_CR29","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1016\/j.jaci.2016.01.015","volume":"138","author":"YMF Andersen","year":"2016","unstructured":"Andersen YMF, Egeberg A, Gislason GH, Hansen PR, Skov L, Thyssen JP. Risk of myocardial infarction, ischemic stroke, and cardiovascular death in patients with atopic dermatitis. J Allergy Clin Immunol. 2016;138(1):310-2.e3. https:\/\/doi.org\/10.1016\/j.jaci.2016.01.015.","journal-title":"J Allergy Clin Immunol."},{"issue":"7","key":"602_CR30","doi-asserted-by":"publisher","first-page":"645","DOI":"10.1007\/s40264-018-0651-5","volume":"41","author":"IC Scott","year":"2018","unstructured":"Scott IC, Hider SL, Scott DL. Thromboembolism with Janus kinase (JAK) inhibitors for rheumatoid arthritis: how real is the risk? Drug Saf. 2018;41(7):645\u201353. https:\/\/doi.org\/10.1007\/s40264-018-0651-5.","journal-title":"Drug Saf."},{"issue":"4","key":"602_CR31","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1007\/s40264-017-0622-2","volume":"41","author":"A Verden","year":"2018","unstructured":"Verden A, Dimbil M, Kyle R, Overstreet B, Hoffman KB. Analysis of spontaneous postmarket case reports submitted to the FDA regarding thromboembolic adverse events and JAK inhibitors. Drug Saf. 2018;41(4):357\u201361. https:\/\/doi.org\/10.1007\/s40264-017-0622-2.","journal-title":"Drug Saf."},{"issue":"2","key":"602_CR32","doi-asserted-by":"publisher","first-page":"280","DOI":"10.1016\/j.jaad.2017.03.003","volume":"77","author":"JP Thyssen","year":"2017","unstructured":"Thyssen JP, Toft PB, Halling-Overgaard AS, Gislason GH, Skov L, Egeberg A. Incidence, prevalence, and risk of selected ocular disease in adults with atopic dermatitis. J Am Acad Dermatol. 2017;77(2):280-6.e1. https:\/\/doi.org\/10.1016\/j.jaad.2017.03.003.","journal-title":"J Am Acad Dermatol."},{"issue":"3","key":"602_CR33","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1111\/bjd.17869","volume":"181","author":"B Akinlade","year":"2019","unstructured":"Akinlade B, Guttman-Yassky E, de Bruin-Weller M, Simpson EL, Blauvelt A, Cork MJ, et al. Conjunctivitis in dupilumab clinical trials. Br J Dermatol. 2019;181(3):459\u201373. https:\/\/doi.org\/10.1111\/bjd.17869.","journal-title":"Br J Dermatol."},{"issue":"2","key":"602_CR34","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1056\/NEJMra1202117","volume":"368","author":"JJ O'Shea","year":"2013","unstructured":"O\u2019Shea JJ, Holland SM, Staudt LM. JAKs and STATs in immunity, immunodeficiency, and cancer. N Engl J Med. 2013;368(2):161\u201370. https:\/\/doi.org\/10.1056\/NEJMra1202117.","journal-title":"N Engl J Med."}],"container-title":["American Journal of Clinical Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40257-021-00602-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40257-021-00602-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40257-021-00602-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T17:39:12Z","timestamp":1628617152000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40257-021-00602-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,7]]},"references-count":34,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,5]]}},"alternative-id":["602"],"URL":"https:\/\/doi.org\/10.1007\/s40257-021-00602-x","relation":{},"ISSN":["1175-0561","1179-1888"],"issn-type":[{"value":"1175-0561","type":"print"},{"value":"1179-1888","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4,7]]},"assertion":[{"value":"26 March 2021","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 April 2021","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was sponsored by Eli Lilly and Company, under license from Incyte Corporation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Brett King served as a consultant for Eli Lilly and Company. Catherine Maari served as an advisory board member, investigator, and\/or speaker for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galderma, GSK Stiefel, Janssen, Novartis, and Pfizer. Edward Lain served as an advisory board member, investigator, speaker and\/or consultant for AbbVie, Allergan, Almirall, Amgen, Arcutis, Athenex, Brickell Biotech, Bristol-Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Galderma, Johnson & Johnson, Kiniksa, L\u2019Oreal, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, Pierre-Fabre, Pulse Biosciences, Regeneron\/Sanofi Genzyme, Sebacia, UCB Pharma, and Vyne Therapeutics.\u00a0Jonathan I. Silverberg served as a consultant and\/or advisory board member for AbbVie, Arena, Asana, Bluefin, Boehringer-Ingelheim, Dermavant, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, Leo, Luna, Novartis, Pfizer, RAPT, Regeneron, Sanofi, receiving honoraria; served as a speaker for Regeneron-Sanofi; and received research grants from Galderma. Maher Issa, Katrin Holzwarth, Dennis Brinker, and Tracy Cardillo are employees and shareholders of Eli Lilly and Company. Fabio P. Nunes is a former employee of Eli Lilly and Company and is a current employee and shareholder of Janssen. Eric L. Simpson received grants and fees for participation as a consultant and principal investigator from Eli Lilly and Company, LEO Pharma, Pfizer, and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co.; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi Genzyme.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/Competing interests"}},{"value":"Trials were conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines and approved by the ethics committee or institutional review board of each center.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at .","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, were involved in drafting the article or revising it critically for important intellectual content, and have given their approval for this version to be published. Study conception and design: MI, DB, TC, FPN. Acquisition of data: EL, JIS, MI, DB. Analysis and interpretation of data: BK, CM, EL, JIS, MI, KH, DB, FPN, ELS.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}