Funding

AbbVie and Boehringer Ingelheim funded the core study (NCT02719171) and AbbVie funded the extension study (NCT02986373). No honoraria or payments were made for authorship. AbbVie funded the journal’s Rapid Service Fee.

Medical Writing, Editorial, and Other Assistance

The authors would like to thank the participants of the study as well as Beate Berner of Boehringer Ingelheim for contributions to the core study. Medical writing support was provided by Maria Hovenden, PhD, and Janet E. Matsuura, PhD, of ICON (Blue Bell, PA, United States) and was funded by AbbVie Inc. AbbVie and Boehringer Ingelheim both contributed to its design and participated in data collection; and participated in data analysis and interpretation of the data and in writing, reviewing, and approving the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication.

Authorship

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, and have given their approval for this version to be published.

Author Contributions

Philip J. Mease, Stella Aslanyan, Steven J. Padula, Ann Eldred, and Kim A. Papp contributed to the study conception and design. Philip J. Mease, Herbert Kellner, Akimichi Morita, Alan J. Kivitz, Stella Aslanyan, Steven J. Padula, Andrew S. Topp, Ann Eldred, Frank Behrens, and Kim A. Papp contributed to acquisition of data. Substantial contributions to analysis and interpretation of data were provided by all authors, with formal analysis and investigation of the data performed by Andrew S. Topp. The first draft of the manuscript was written by Maria Hovenden and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Disclosures

Philip J. Mease has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sun Pharma, and UCB. Herbert Kellner has received research grants, consulting fees, and/or speaker’s fees from AbbVie, BMS, MSD, Novartis, Pfizer, Roche, and UCB. Akimichi Morita has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb, Eli Lilly Japan K.K., Esai, GlaxoSmithKline K. K., Janssen Pharmaceutical K. K., Kyowa Hakko Kirin Co., Ltd, Leo Pharma, Maruho Co., Ltd, Mitsubishi-Tanabe Pharma, Nichi-Iko Pharmaceutical Co., Ltd, Nippon Kayaku Co., Ltd, Novartis, Pfizer Japan Inc, Sun Pharmaceutical Industries, Ltd, Taiho Pharmaceutical Co., Ltd, Torii Pharmaceutical Co., Ltd, and UCB Japan Co., Ltd. Alan J. Kivitz has received consulting fees and/or speaker’s fees from and/or served as an advisor to AbbVie, Amgen, Bendcare, Boehringer Ingelheim, Celgene, ChemoCentryx, ECOR1, Flexion, Genentech, Gilead Sciences Inc, GlaxoSmithKline, Grünenthal, Horizon, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sanofi-Genzyme, Sun Pharma Advanced Research, and UCB and is a shareholder of Amgen, Gilead Sciences Inc, GlaxoSmithKline, Novartis, Pfizer, and Sanofi. Stella Aslanyan is a full-time salaried employee of Boehringer Ingelheim. Steven J. Padula was a full-time salaried employee of Boehringer Ingelheim at the time of this research. He has since retired from Boehringer Ingelheim. Andrew S. Topp and Ann Eldred are full-time salaried employees of AbbVie and may own stock/options. Frank Behrens has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Celgene, Chugai, Eli Lilly, Genzyme, Janssen, Novartis, Pfizer, Roche, Sandoz, and Sanofi. Kim A. Papp has received grants paid to his institution and/or personal honoraria or fees for serving on advisory boards, as a speaker, and as a consultant and grants as an investigator from AbbVie, Akros, Amgen, Anacor (institution only), Arcutis, Astellas, Avillion, Bausch Health, Baxalta (institution only), Baxter, Boehringer Ingelheim, Bristol Myers Squibb, CanFite (institution only), Celgene, Coherus, Dermavent (institution only), Dermira (institution only), Dice Pharmaceuticals (institution only), Dow Pharma (institution only), Eli Lilly, Evelo (institution only), Galapagos (institution only), Galderma, Genentech (institution only), Gilead (institution only), GlaxoSmithKline (institution only), Incyte, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune (institution only), Meiji Seika Pharma, Merck-Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Moberg Pharma (institution only), Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Genzyme, Sun Pharma (institution only), Takeda, and UCB.

Compliance with Ethics Guidelines

This study was conducted in accordance with the protocol, International Council on Harmonisation guidelines, local regulations, and the ethical principles of the Declaration of Helsinki. An independent ethics committee or institutional review board at each study site approved all study-related documents (Supplementary Table S1). All patients reviewed and signed an informed consent form before any study procedures were conducted.

Data Availability

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html