Funding for this research was provided by:
Horizon Therapeutics plc
Received: 11 May 2022
Accepted: 13 July 2022
First Online: 25 August 2022
: This multicentre, open-label, efficacy and safety study (ClinicalTrials.gov: NCT03635957) was reviewed and approved for the 6 participating sites by the Western Institutional Review Board (Puyallup, WA; IRB assurance number: IRB00000533, protocol approval number 20182156). All patients provided written informed consent to participate, and all study conduct adhered to the tenants of the Declaration of Helsinki.
: Not applicable.
: JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees > 10 k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRPT has served as a consultant/advisory board member for BMS, Janssen, Lilly Pfizer, Sanofi-Genzyme, AbbVie, Aurinia, AstraZeneca, and Samumed/Biosplice. He has served as a speaker for AbbVie, Amgen, BMS, Janssen, Lilly, Pfizer, Sanofi/Genzyme, Aurinia, AstraZeneca, and GlaxoSmithKline. He has received research grants and support from AbbVie, Amgen, BMS, Boehringer Ingelheim, Genentech, Gilead, Horizon Therapeutics, Janssen, Lilly, Pfizer, Vorso, Samumed/Biosplice, Selecta, Exagen, CSL Behring, Organogenesis, SunPharma, DRL, and Emerald. RB declares that there are no competing interests. HMK has received research support from Horizon Therapeutics (study site/investigator), is an advisor and speaker for Horizon Therapeutics, and is an owner and chairman of the Board of Discus Analytics (JoinMan). KO, YS, BL, LZ, YX, and JC are employees of and own stock in Horizon Therapeutics. PMP and SR were employees of Horizon Therapeutics during the study and own stock in Horizon. MEW has received grants from Amgen, Bristol-Myers Squibb, Lilly, and Sanofi. He has received consulting fees greater than US $10,000 from Chemocentryx, Corona, and Genosco and less than US $10,000 from AbbVie, Amgen, Aclaris, Arena, Bayer, Bristol Meyer Squibb, Crescendo Myriad Genetics, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Johnson and Johnson, Eli Lilly, Novartis, Pfizer, Rani Therapeutics, Roche, Samsung, Scipher Medicine, Set Point, Tremeau, and XBiotech; he has stock options in Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso and royalties from Elsevier as co-editor for the textbook <i>Rheumatology</i>. JP has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics.