Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study.

"Declarations Ethics approval and consent to participateThe study was conducted according to the International Council for Harmonisation guidelines, local regulations and guidelines governing clinical study conduct, and the Declaration of Helsinki. All patients provided written informed consent, and the study protocol and consent forms were approved by an institutional review board or independent ethics committee at each study site. Consent for publicationNot applicable. Competing interestsXB has received grant/research support from AbbVie and Novartis; consulting fees from AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB; speakers’ bureau fees from AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB; and is an editorial board member of the Annals of Rheumatic Diseases. DvdH has received consulting fees from AbbVie, Bayer, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB Pharma; and is the director of Imaging Rheumatology BV. JS has received grant/research support from AbbVie, Merck, and UCB; has been a consultant for AbbVie, Merck, Novartis, and UCB; and has served on the speakers’ bureau for AbbVie, Merck, and Novartis. RDI has received grant/research support from AbbVie, Amgen, Janssen, and Novartis; and has been a consultant for AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, and Sandoz. HK has received grant/research support from AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Eisai, and Mitsubishi-Tanabe; consulting fees from AbbVie, Janssen, Lilly, Novartis, Sanofi, and UCB; and received speakers’ bureau fees from AbbVie, Asahi-Kasei, BMS, Chugai, Eisai, Janssen, Lilly, Mitsubishi-Tanabe, Novartis, and Pfizer. YL, XB, AS, and PW are full-time, salaried employees of AbbVie Inc. and own AbbVie stock or stock options. I-HS is a full-time, salaried employee of AbbVie, owns AbbVie stock or stock options, and is an inventor on a patent application. AD has received grant/research support from AbbVie, BMS, Celgene, GSK, Lilly, Novartis, Pfizer, and UCB; and honoraria or consultation fees from AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB. Competing interests XB has received grant/research support from AbbVie and Novartis; consulting fees from AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB; speakers’ bureau fees from AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB; and is an editorial board member of the Annals of Rheumatic Diseases. DvdH has received consulting fees from AbbVie, Bayer, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB Pharma; and is the director of Imaging Rheumatology BV. JS has received grant/research support from AbbVie, Merck, and UCB; has been a consultant for AbbVie, Merck, Novartis, and UCB; and has served on the speakers’ bureau for AbbVie, Merck, and Novartis. RDI has received grant/research support from AbbVie, Amgen, Janssen, and Novartis; and has been a consultant for AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, and Sandoz. HK has received grant/research support from AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Eisai, and Mitsubishi-Tanabe; consulting fees from AbbVie, Janssen, Lilly, Novartis, Sanofi, and UCB; and received speakers’ bureau fees from AbbVie, Asahi-Kasei, BMS, Chugai, Eisai, Janssen, Lilly, Mitsubishi-Tanabe, Novartis, and Pfizer. YL, XB, AS, and PW are full-time, salaried employees of AbbVie Inc. and own AbbVie stock or stock options. I-HS is a full-time, salaried employee of AbbVie, owns AbbVie stock or stock options, and is an inventor on a patent application. AD has received grant/research support from AbbVie, BMS, Celgene, GSK, Lilly, Novartis, Pfizer, and UCB; and honoraria or consultation fees from AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB."

"Funding AbbVie funded this trial and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship."

"Trial registration NCT02049138."