Armstrong, April W.
Jaleel, Tarannum
Merola, Joseph F.
Gottlieb, Alice B.
Khattri, Saakshi
Helt, Cameron C. http://orcid.org/0009-0001-2203-010X
Malatestinic, William N.
Ross, Sarah E.
Ngantcha, Marcus E.
de Vlam, Kurt
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 25 January 2024
Accepted: 16 May 2024
First Online: 30 May 2024
Declarations
:
: April W. Armstrong has received grants or contracts from, and served as a consultant, speaker and/or investigator for: AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, EPI Health, Incyte, LEO Pharma, UCB, Janssen, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Sun, Sanofi, and Regeneron; has participated on data safety monitoring or advisory boards for: Boehringer Ingelheim and Parexel; and has been elected to the Board of Directors for the American Academy of Dermatology. Tarannum Jaleel has served as a consultant and/or investigator for: Eli Lilly and Company, Novartis, and UCB Pharma; and has received grants from: Dermatology Foundation, NIH K12, Pfizer-SOCS Grant, Skin of Colour Society, and UCB Pharma. Joseph F. Merola is a consultant and/or investigator for: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Regeneron, Sun Pharma, and UCB Pharma. Alice B. Gottlieb receives research/educational grants from: Highlights Therapeutics, Bristol Myers Squibb, Janssen and UCB Pharma—all of which were paid to Mount Sinai School of Medicine; and has received honoraria as an advisory board member and consultant for: Amgen, AnaptypsBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Eli Lilly and Company, Highlights Therapeutics, Janssen, Novartis, Sanofi, Teva, UCB, and Xbiotech (stock options for RA). Saakshi Khattri has received grants or contracts from, and/or served as a consultant and/or speaker for: AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Incyte, Janssen, LEO Pharma, Pfizer, Regeneron, Sanofi, Arcutis, Bristol Myers Squibb, Incyte, Takeda, Boehringer Ingelheim, Novartis and UCB Pharma. Cameron C. Helt, William N. Malatestinic, Sarah E. Ross, and Marcus E. Ngantcha are employees and shareholders of Eli Lilly and Company. Kurt de Vlam has received grant and/or research support from: Celgene; and is a consultant for: Celgene, Eli Lilly and Company, Galapagos NV, Novartis, Pfizer, and UCB Pharma.
: SPIRIT-P1 and SPIRIT-P2 were conducted in accordance with Good Clinical Practice, the principles of the Declaration of Helsinki of 1964 and its later amendments, and local laws and regulations. SPIRIT-P1 was approved by the Western Institutional Review Board (approval #1-838258-1), and SPIRIT-P2 was approved by the Bellberry Human Research Ethics Committee (Application #2015-01-049-AA). For both studies, approval was also obtained from each additional site the full lists of investigators and sites are provided in the primary manuscript supplements [, ]. All patients in both studies gave written informed consent to participate in the study.