Blauvelt, Andrew
Leonardi, Craig L.
Gaylis, Norman
Jauch-Lembach, Julia
Balfour, Alison
Lemke, Lena
Hachaichi, Sohaib
Brueckmann, Ines
Festini, Teodora
Wiland, Piotr
Funding for this research was provided by:
Hexal AG, a Sandoz company
Article History
Accepted: 28 January 2021
First Online: 2 March 2021
Declarations
:
: This study was funded by Hexal AG, a Sandoz company.
: Andrew Blauvelt: Received honoraria from Sandoz for scientific consulting. His company, Oregon Medical Research Center, received funds to conduct the clinical study reported herein. Also, he has served as a scientific adviser and/or clinical study investigator for Sandoz, AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Leo, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma. Craig L. Leonardi: Consultant and/or advisory board member for AbbVie, Amgen, Boehringer-Ingelheim, Dermira, Eli Lilly, Janssen, Leo, Pfizer, Sandoz, UCB and Vitae; Speaker bureau for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Ortho Dermatologies, Sun Pharmaceuticals, and UCB; Investigator for Actavis, AbbVie, Allergan, Amgen, Boehringer-Ingelheim, Celgene, Coherus, Cellceutix, Corrona, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, Leo Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, UCB and Wyeth; writing assistance received from Sandoz. Norman Gaylis: None declared. Julia Jauch Lembach: Employee of Sandoz. Alison Balfour: Employee of Sandoz. Lena Lemke: Employee of Sandoz. Sohaib Hachaichi: Employee of Sandoz. Ines Brueckmann: Employee of Sandoz. Teodora Festini: Employee of Sandoz; stock/stock options as Sandoz employee, not related to publication. Piotr Wiland: Participation in clinical trial ‘ADMYRA’, received the fee as principal investigator in his center.
: The two studies (ADACCESS and ADMYRA) were conducted in accordance with the ethical principles derived from the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practices and in compliance with local regulatory requirements. The study protocols were approved by the Independent Ethics Committee or Institutional Review Board for each center.
: All patients provided written informed consent before entering the study.
: All patients provided their consent for their data to be published.
: All data generated or analyzed in relation to PROs are included in this article and the supplementary information files. Anonymized datasets and related documents, such as the statistical analysis plan, protocol, and amendments, can be shared upon reasonable request through a data sharing agreement.
: JJL and LL contributed to the design of the studies. AB, CLL, NG, and PW contributed to the conduct of the clinical studies. JJL, LL, and AB contributed to the analysis and interpretation of the results. SH, IB, and TF discussed the results and contributed to the manuscript. All authors discussed the results and contributed to the manuscript.