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THU0382 Change in sacroiliac joint structural radiographic damage after two years of etanercept therapy in comparison to a contemporary control cohort in non-radiographic axial spondyloarthritis
  1. M Dougados1,
  2. WP Maksymowych2,
  3. R Landewe3,
  4. A Molto1,
  5. P Claudepierre4,
  6. M de Hooge5,
  7. RG Lambert2,
  8. R Bonin6,
  9. JF Bukowski6,
  10. H Jones6,
  11. I Logeart7,
  12. R Pedersen6,
  13. A Szumski8,
  14. B Vlahos6,
  15. D van der Heijde5
  1. 1Paris Descartes University, Hôpital Cochin, Paris, France
  2. 2University of Alberta, Edmonton, Canada
  3. 3Amsterdam Rheumatology & Immunology Center, Amsterdam, Netherlands
  4. 4Universite Paris Est Creteil, Creteil, France
  5. 5Leiden University Medical Center, Leiden, Netherlands
  6. 6Pfizer, Collegeville, United States
  7. 7Pfizer, Paris, France
  8. 8InVentiv Health, Princeton, United States


Background Despite the well-known symptomatic and anti-inflammatory effect of TNF inhibitors in axial SpA (axSpA), demonstrating a structural effect is challenging.

Objectives To compare 2 yrs of radiographic sacroiliac joint (SIJ) changes in pts receiving etanercept (ETN) in a clinical trial to similar pts not receiving biologics in a cohort study.

Methods Pts had recent onset non-radiographic (nr)-axSpA fulfilling ASAS criteria. Study group: pts receiving ETN 50 mg once weekly for 2 yrs in EMBARK (NCT01258738). Control group: pts in an ongoing longitudinal cohort study not receiving biologics for 2 yrs (DESIR, NCT01648907). Outcome measure: change in x-ray SIJ score per mNY criteria (0–4 per SIJ). X-rays were read by 3 experienced readers unaware of image chronology and pt group. Primary endpoint: change (mean of 3 readers) in total SIJ score (-8 to +8). Binary endpoints: (1) shift from baseline (BL) mNY+ to wk-104 mNY- and vice versa; (2) change in SIJ score ≥1 (left or right SIJ); (3) change in SIJ score ≥1 in ≥1 SIJ, with change from 0 to 1 and from 1 to 0 considered no change. Treatment effect was analyzed without and with adjustment for the baseline (BL) covariates of sex, symptom duration, smoking status, HLA-B27 status, ASDAS-CRP, SPARCC MRI SIJ score, and SIJ radiography score.

Results At BL, the control (DESIR, N=197) and ETN (EMBARK, N=164) cohorts differed significantly in all covariates listed above. The difference in change in total SIJ score for control vs ETN, adjusted for covariates, was small but significant: least-squares mean (95% CI): 0.08 (-0.03, 0.20) vs -0.14 (-0.26, -0.01); p=0.008. The table presents x-ray changes. When adjusted for covariates, the mean difference between control and ETN was significant for 2 of the 3 binary endpoints (table).

Table 1.

Observed Radiographic Changes from BL to Week 104

Conclusions This analysis confirms the slow rate of radiographic SIJ progression over 2 yrs in nr-axSpA. The observed data suggest a lower rate of progression with ETN than without a TNF inhibitor.

Disclosure of Interest M. Dougados Grant/research support from: Pfizer, Abbvie, UCB, Merck, Lilly, Sanofi, Consultant for: Pfizer, Abbvie, UCB, Merck, Lilly, Sanofi, W. P. Maksymowych Grant/research support from: AbbVie, Pfizer, Sanofi, Consultant for: AbbVie, Amgen, Eli Lilly, Janssen Pharmaceutica, L.P, Novartis, Pfizer, Sanofi, UCB, R. Landewe Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, Consultant for: Abbott/Abbvie, Ablynx, Amgen, Astra-Zeneca, BMS, Celgene, Janssen (formerly Centocor), Galapagos, GSK, Novartis, Novo-Nordisk, Merck, Pfizer, Roche, Schering-plough, TiGenix, UCB, Wyeth, Employee of: Is a director of Rheumatology Consultancy BV, A. Molto Grant/research support from: Pfizer, UCB, Consultant for: Abbvie, BMS, MSD France- Merck, Pfizer, UCB, P. Claudepierre Grant/research support from: Pfizer, Roche-Chugai, MSD, Consultant for: Abbvie, BMS, Celgene, Janssen, Novartis, Merck, Pfizer, Roche, UCB, M. de Hooge: None declared, R. G. Lambert Consultant for: Bioclinica, R. Bonin Shareholder of: Pfizer, Employee of: Pfizer, J. Bukowski Shareholder of: Pfizer, Employee of: Pfizer, H. Jones Shareholder of: Pfizer, Employee of: Pfizer, I. Logeart Shareholder of: Pfizer, Employee of: Pfizer, R. Pedersen Shareholder of: Pfizer, Employee of: Pfizer, A. Szumski Employee of: InVentiv Health, B. Vlahos Shareholder of: Pfizer, Employee of: Pfizer, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB, Employee of: Director of Imaging Rheumatology bv.

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