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Doctoral Thesis Effectiveness of Tumor Necrosis Factor Inhibitors in Patients

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Doctoral Thesis Effectiveness of Tumor Necrosis Factor Inhibitors in Patients Bente Glintborg 2018 Glintborg Bente UNIVERSITY OF COPENHAGEN FACULTY OF HEALTH AND MEDICAL SCIENCES Effectiveness of Effectiveness Doctoral thesis Doctoral thesis Bente Glintborg, 2018 Bente Glintborg, 2018 tumor Effectiveness of tumor necrosis factor inhibitors in patients necrosis factor inhibitors in patients with psoriatic arthritis and arthritiswithaxial psoriatic inhibitorsin patients factor necrosis with psoriatic arthritis and axial spondyloarthritis – treatment response, drug retention and predictors thereof Results from the nationwide DANBIO registry Copenhagen Center for Arthritis Research (COPECARE) Center for Rheumatology and Spine Diseases Centre of Head and Orthopaedics Rigshospitalet, Glostrup spondyloarthritis ISBN 978-87-970989-0-5 Doctoral thesis Effectiveness of tumor necrosis factor inhibitors in patients with psoriatic arthritis and axial spondyloarthritis – treatment response, drug retention and predictors thereof Results from the nationwide DANBIO registry Bente Glintborg, MD, PhD 2018 The DANBIO registry and Copenhagen Center for Arthritis Research, COPECARE Center for Rheumatology and Spine Diseases Centre of Head and Orthopedics Rigshospitalet 1 © Bente Glintborg 2018 ISBN 978-87-970989-0-5 All rights reserved. No parts of this publication may be reproduced or transmitted, in any form or by any means, without permission The Faculty of Health and Medical Sciences at the University of Copenhagen has accepted this dissertation, which consists of the already published dissertations listed below, for public defence for the doctoral degree in Medicine. Copenhagen, 17 October 2018. Ulla Wewer, Head of Faculty The defence will take place at Rigshospitalet, Glostrup, Auditorium C, 23 November 2018 2 List of contents List of contents .................................................................................................................................................. 3 Preface ............................................................................................................................................................... 6 Abbreviations..................................................................................................................................................... 8 Publications ..................................................................................................................................................... 10 1. Introduction ................................................................................................................................................. 13 2. Aims ............................................................................................................................................................. 14 2.1. Overall aim ............................................................................................................................................ 14 2.2. Specific aims ......................................................................................................................................... 14 3. Background .................................................................................................................................................. 15 3.1. Spondyloarthritis .................................................................................................................................. 15 3.1.1. PsA, disease manifestations and classification criteria ................................................................. 16 3.1.2. PsA, outcome measures and response criteria ............................................................................. 16 3.1.3. AxSpA, classification criteria and disease manifestations ............................................................. 17 3.1.4. AxSpA, outcome measures and response criteria ......................................................................... 17 3.1.5. Treatment strategies in PsA and AxSpA ........................................................................................ 18 3.2. How to study bDMARD treatment outcomes, efficacy versus effectiveness ...................................... 19 3.3. Predictors of treatment effectiveness in PsA and axSpA ..................................................................... 20 3.4. Real world registries ............................................................................................................................. 21 4. Patients and methods .................................................................................................................................. 23 4.1. Cohorts and study design ..................................................................................................................... 23 4.1.1. Patient inclusion ............................................................................................................................ 23 4.1.2. Patient exclusion ........................................................................................................................... 26 4.2. Validation of data in DANBIO ............................................................................................................... 26 4.3. Baseline characteristics, measures of disease activity and outcomes ................................................. 27 4.4. Comorbidities ....................................................................................................................................... 29 3 4.5. Ethics..................................................................................................................................................... 30 4.6. Statistical analysis ................................................................................................................................. 30 5. Summary of results ...................................................................................................................................... 33 5.1. Baseline demographics of study cohorts .............................................................................................. 33 5.2. Summary of results and discussion according to specific aims ............................................................ 35 5.2.1. Treatment response, treatment retention, and predictors thereof during the first TNFi treatment course in PsA (Specific aim 1, Paper 1) .................................................................................................... 35 5.2.2. Treatment response, treatment retention, and predictors thereof among PsA patients switching to a subsequent bDMARD (Specific aim 2, Paper 2)................................................................................ 37 5.2.3. Impact of different infliximab dose regimens on treatment response and treatment retention during the first TNFi treatment course in PsA (Specific aim 3, Paper 3) ................................................. 38 5.2.4. The impact of smoking on baseline disease activity and outcomes during the first TNFi treatment course in PsA (Specific aim 4, Paper 4) .................................................................................................... 41 5.2.5. Treatment response, treatment retention, and predictors thereof during the first TNFi treatment course in patients with AS (Specific aim 5, paper 5) ............................................................................... 42 5.2.6. Treatment response, treatment retention, and predictors thereof among AS patients switching to a subsequent bDMARD (Specific aim 6, paper 6) ............................................................................... 43 5.2.7. The impact of smoking on baseline disease activity and outcomes during the first TNFi treatment course in patients with AS (Specific aim 7, paper 7) ............................................................................... 45 5.2.8. The impact of axSpA sub-diagnosis (AS versus non-radiographic axial SpA (nr-axSpA)) on treatment response and treatment retention during the first TNFi treatment course in patients with AxSpA (Specific aim 8, paper 8) ............................................................................................................... 46 5.2.9. The impact of switch from originator to biosimilar infliximab on disease activity and one-year treatment retention (Specific aim 9, paper 9) ......................................................................................... 49 6. Methodological considerations ................................................................................................................... 51 6.1. Data quality and interpretation ............................................................................................................ 51 6.2. Confounders included in multivariable analyses .................................................................................. 54 6.3. Other methodological considerations .................................................................................................. 58 7. Discussion of future perspectives ................................................................................................................ 59 4 7.1. Data enrichment ................................................................................................................................... 59 7.2. Collaboration across countries ............................................................................................................. 60 7.3. Important research questions for future
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