Walter P Maksymowych1, Pascal Claudepierre2, Manouk de Hooge3,4, Robert G Lambert5, Robert Landewé6, Anna Molto7, Désirée van der Heijde4, Jack F Bukowski8, Heather Jones9, Ron Pedersen10, Annette Szumski11, Bonnie Vlahos8, Maxime Dougados7. 1. Department of Medicine, University of Alberta, 568 Heritage Medical Research Building, Edmonton, AB, T6G 2S2, Canada. walter.maksymowych@ualberta.ca. 2. Universite Paris Est Creteil, EA 7379 - EpidermE, AP-HP, Service de Rhumatologie, Hopital Henri Mondor, Creteil, France. 3. VIB Center of Inflammation Research, Ghent University, Ghent, Belgium. 4. Leiden University Medical Center, Leiden, the Netherlands. 5. Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, AB, Canada. 6. Amsterdam University Medical Center, loc. Meibergdreef 9 Amsterdam & Zuyderland MC, Heerlen, the Netherlands. 7. René Descartes University, Université de Paris, Department of Rheumatology - Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France. 8. Global Clinical Affairs, Pfizer, Collegeville, PA, USA. 9. Global Medical Affairs, Pfizer, Collegeville, PA, USA. 10. Department of Biostatistics, Pfizer, Collegeville, PA, USA. 11. Syneos Health, Princeton, NJ, USA.
Abstract
BACKGROUND: Limited information is available on the impact of treatment with a tumor necrosis factor inhibitor (TNFi) on structural lesions in patients with recent-onset axial spondyloarthritis (axSpA). We compared 2-year structural lesion changes on magnetic resonance imaging (MRI) in the sacroiliac joints (SIJ) of patients with recent-onset axSpA receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). We also evaluated the relationship between the Ankylosing Spondylitis Disease Activity Score (ASDAS) and change in MRI structural parameters. METHODS: The difference between etanercept (EMBARK) and control (DESIR) in the net percentage of patients with structural lesion change was determined using the SpondyloArthritis Research Consortium of Canada SIJ Structural Score, with and without adjustment for baseline covariates. The relationship between sustained ASDAS inactive disease, defined as the presence of ASDAS < 1.3 for at least 2 consecutive time points 6 months apart, and structural lesion change was evaluated. RESULTS: This study included 163 patients from the EMBARK trial and 76 from DESIR. The net percentage of patients with erosion decrease was significantly greater for etanercept vs control: unadjusted: 23.9% vs 5.3%; P = 0.01, adjusted: 23.1% vs 2.9%; P = 0.01. For the patients attaining sustained ASDAS inactive disease on etanercept, erosion decrease was evident in significantly more than erosion increase: 34/104 (32.7%) vs 5/104 (4.8%); P < 0.001. A higher proportion had erosion decrease and backfill increase than patients in other ASDAS status categories. However, the trend across ASDAS categories was not significant and decrease in erosion was observed even in patients without a sustained ASDAS response. CONCLUSIONS: These data show that a greater proportion of patients achieved regression of erosion with versus without etanercept. However, the link between achieving sustained ASDAS inactive disease and structural lesion change on MRI could not be clearly established. TRIAL REGISTRATION: EMBARK: ClinicalTrials.gov identifier: NCT01258738 , Registered 13 December 2010; DESIR: ClinicalTrials.gov identifier: NCT01648907 , Registered 24 July 2012.
BACKGROUND: Limited information is available on the impact of treatment with a tumor necrosis factor inhibitor (TNFi) on structural lesions in patients with recent-onset axial spondyloarthritis (axSpA). We compared 2-year structural lesion changes on magnetic resonance imaging (MRI) in the sacroiliac joints (SIJ) of patients with recent-onset axSpA receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). We also evaluated the relationship between the Ankylosing Spondylitis Disease Activity Score (ASDAS) and change in MRI structural parameters. METHODS: The difference between etanercept (EMBARK) and control (DESIR) in the net percentage of patients with structural lesion change was determined using the SpondyloArthritis Research Consortium of Canada SIJ Structural Score, with and without adjustment for baseline covariates. The relationship between sustained ASDAS inactive disease, defined as the presence of ASDAS < 1.3 for at least 2 consecutive time points 6 months apart, and structural lesion change was evaluated. RESULTS: This study included 163 patients from the EMBARK trial and 76 from DESIR. The net percentage of patients with erosion decrease was significantly greater for etanercept vs control: unadjusted: 23.9% vs 5.3%; P = 0.01, adjusted: 23.1% vs 2.9%; P = 0.01. For the patients attaining sustained ASDAS inactive disease on etanercept, erosion decrease was evident in significantly more than erosion increase: 34/104 (32.7%) vs 5/104 (4.8%); P < 0.001. A higher proportion had erosion decrease and backfill increase than patients in other ASDAS status categories. However, the trend across ASDAS categories was not significant and decrease in erosion was observed even in patients without a sustained ASDAS response. CONCLUSIONS: These data show that a greater proportion of patients achieved regression of erosion with versus without etanercept. However, the link between achieving sustained ASDAS inactive disease and structural lesion change on MRI could not be clearly established. TRIAL REGISTRATION: EMBARK: ClinicalTrials.gov identifier: NCT01258738 , Registered 13 December 2010; DESIR: ClinicalTrials.gov identifier: NCT01648907 , Registered 24 July 2012.
Authors: Maxime Dougados; Désirée van der Heijde; Joachim Sieper; Jürgen Braun; Gustavo Citera; Jan Lenaerts; Filip van den Bosch; James Cheng-Chung Wei; Ron Pedersen; Randi Bonin; Heather Jones; Lisa Marshall; Isabelle Logeart; Bonnie Vlahos; Jack F Bukowski; Walter P Maksymowych Journal: Arthritis Care Res (Hoboken) Date: 2017-08-31 Impact factor: 4.794
Authors: Denis Poddubnyy; Martin Rudwaleit; Hildrun Haibel; Joachim Listing; Elisabeth Märker-Hermann; Henning Zeidler; Jürgen Braun; Joachim Sieper Journal: Ann Rheum Dis Date: 2011-05-27 Impact factor: 19.103
Authors: Maxime Dougados; Adrien Etcheto; Anna Molto; Sandrine Alonso; Sophie Bouvet; Jean-Pierre Daurès; Paul Landais; Maria-Antonietta d'Agostino; Francis Berenbaum; Maxime Breban; Pascal Claudepierre; Bernard Combe; Bruno Fautrel; Antoine Feydy; Philippe Goupille; Pascal Richette; Thao Pham; Christian Roux; Jean-Marc Treluyer; Alain Saraux; Désirée van der Heijde; Daniel Wendling Journal: Joint Bone Spine Date: 2015-07-16 Impact factor: 4.929
Authors: Walter P Maksymowych; Stephanie Wichuk; Maxime Dougados; Heather E Jones; Ron Pedersen; Annette Szumski; Lisa Marshall; Jack F Bukowski; Robert G Lambert Journal: Ann Rheum Dis Date: 2017-09-29 Impact factor: 19.103
Authors: Maxime Dougados; Walter P Maksymowych; Robert B M Landewé; Anna Moltó; Pascal Claudepierre; Manouk de Hooge; Robert G Lambert; Randi Bonin; Jack F Bukowski; Heather E Jones; Isabelle Logeart; Ron Pedersen; Annette Szumski; Bonnie Vlahos; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2017-09-29 Impact factor: 19.103