The ADEQUATE study was funded by Pfizer Pharma GmbH. The Rapid Service Fee was funded by Pfizer.
Medical Writing Assistance
Medical writing support was provided by Andrea Schauenburg, PhD, of Engage Scientific Solutions and was funded by Pfizer.
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.
All authors were involved in the writing and reviewing process and have read and approved this manuscript. Additional contributions to this body of work were as follows: Eugen Feist, Xenofon Baraliakos, Frank Behrens, and Diamant Thaçi: conception/design of the study, acquisition and interpretation of data. Thilo Klopsch: acquisition of data. Anja Plenkse, Thomas Meng, and Peter-Andreas Löschmann: conception/design of the study and interpretation of data. Lisa K. Blindzellner and Pascal Klaus: interpretation of data.
List of Investigators
The full list of investigators for the ADEQUATE study is shown in Supplementary Table S7.
Data included in this manuscript have partially been presented at the following congresses: Feist E, Baraliakos X, Behrens F, Thaçi D, Klopsch T, Plenske A, Blindzellner LK, Meng T, Löschmann PA. Efficacy of Etanercept over a Period of 12 Months in the Routine Treatment of Patients with RA, AxSpA, PsA or PsO: Final Results of a German Non-Interventional, Prospective, Multicenter Study (ADEQUATE). Poster presented at the European League Against Rheumatism Congress 2019. Baraliakos X, Feist E, Behrens F, Thaçi D, Klopsch T, Plenske A, Blindzellner LK, Meng T, Löschmann PA. Nicht-interventionelle Studie zur Wirksamkeit und Sicherheit von Etanercept in der zielgerichteten Routinebehandlung von Patienten mit Rheumatoider Arthritis, axialer Spondyloarthritis, Psoriasis-Arthritis und Psoriasis (ADEQUATE). Poster presented at the congress of the German Society for Rheumatology (DGRh) 2019.
Eugen Feist received consulting/speaker fees from AbbVie, BMS, Celgene, Lilly, Novartis, Roche, Sanofi, Pfizer, and UCB. Xenofon Baraliakos received honoraria or grants from AbbVie, Amgen, Biocad, BMS, Celltrion, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz, and UCB. Frank Behrens received research grants from Bionorica, Celgene, Chugai, Janssen, Pfizer, and Roche; and consulting/speaker fees from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Chugai, Janssen, Genzyme, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, and UCB. Diamant Thaçi was consultant, investigator, speaker; and has participated in advisory boards for AbbVie, Almirall, Amgen, Biogen Idec, Bristol-Myers Squibb, Janssen-Cilag, LEO Pharma, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB; and has received research/educational grants from AbbVie, Novartis, LEO Pharma, and Sanofi. Thilo Klopsch received consulting/speaker fees from AstraZeneca, BMS, Clinuvel Pharmaceuticals, Eli Lilly, Evotec, Johnson & Johnson, Morphosys, Novartis, Novo Nordisk, Pfizer, Roche, and UCB. Anja Plenske, Lisa K. Blindzellner, Pascal Klaus, and Thomas Meng are employees and shareholders of Pfizer. Peter-Andreas Löschmann was a full-time employee of Pfizer at the time the manuscript was developed and a shareholder of Pfizer. At the time of writing, he acts as the chief correspondent and head of gesundheitspolitik.de.
Compliance with Ethics Guidelines
The final protocol and subject information and informed consent documentation were reviewed and approved by the Ethics Committee of the Faculty of Medicine of the Goethe University of Frankfurt am Main, Germany. This study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients by the treating physician or a designated person prior to patients entering the study.
Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.