Effects of etanercept versus sulfasalazine in early axial spondyloarthritis on active inflammatory lesions as detected by whole-body MRI (ESTHER): a 48-week randomised controlled trial
- I-H Song1,
- KG Hermann2,
- H Haibel1,
- CE Althoff2,
- J Listing3,
- GR Burmester4,
- A Krause5,
- M Bohl-Bühler6,
- B Freundlich7,
- M Rudwaleit1,
- J Sieper1
- 1Department of Rheumatology, Charité Medical University, Campus Benjamin Franklin, Berlin, Germany
- 2Department of Radiology, Charité Medical University, Campus Charité Mitte, Berlin, Germany
- 3German Rheumatism Research Center, Berlin, Germany
- 4Department of Rheumatology, Charité Medical University, Campus Charité Mitte, Berlin, Germany
- 5Department of Rheumatology, Charité Medical University, Campus Buch, Berlin, Germany
- 6Private Practice, Potsdam, Germany
- 7Division of Rheumatology, University of Pennsylvania, Philadelphia, USA
- Correspondence to Dr Joachim Sieper, Charité, Campus Benjamin Franklin, Med Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany;
- Accepted 1 November 2010
Purpose To evaluate the potential of etanercept versus sulfasalazine to reduce active inflammatory lesions on whole-body MRI in active axial spondyloarthritis with a symptom duration of less than 5 years.
Methods Patients were randomly assigned to etanercept (n=40) or sulfasalazine (n=36) treatment over 48 weeks. All patients showed active inflammatory lesions (bone marrow oedema) on MRI in either the sacroiliac joints or the spine. MRI was performed at weeks 0, 24 and 48 and was scored for active inflammatory lesions in sacroiliac joints and the spine including posterior segments and peripheral enthesitis by two radiologists, blinded for treatment arm and MRI time point.
Results In the etanercept group, the reduction of the sacroiliac joint score from 7.7 at baseline to 2.0 at week 48 was significantly (p=0.02) larger compared with the sulfasalazine group from 5.4 at baseline to 3.5 at week 48. A similar difference in the reduction of inflammation was found in the spine from 2.2 to 1.0 in the etanercept group versus from 1.4 to 1.3 in the sulfasalazine group between baseline and week 48, respectively (p=0.01). The number of enthesitic sites also improved significantly from 26 to 11 in the etanercept group versus 24 to 26 in the sulfasalazine group (p=0.04 for difference). 50% of patients reached clinical remission in the etanercept group versus 19% in the sulfasalazine group at week 48.
Conclusion In patients with early axial spondyloarthritis active inflammatory lesions detected by whole-body MRI improved significantly more in etanercept versus sulfasalazine-treated patients. This effect correlated with a good clinical response in the etanercept group.
Funding This study was supported by an unrestricted grant from by Wyeth, which was acquired by Pfizer Inc in October 2009.
Competing interests IS and HH: Wyeth Pharmaceuticals, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals: consulting fees or other remuneration. GB, MR and JS: Wyeth Pharmaceuticals, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals, UCB: consulting fees or other remuneration. AK: Wyeth Pharmaceuticals, Schering Plough, Abbott Immunology Pharmaceuticals: consulting fees or other remuneration. MB: Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals: consulting fees or other remuneration. BF: Former employee of Pfizer/Wyeth. KGH, CA and JL: none.
Patient consent Obtained.
Ethics approval This study was conducted with the approval of the Landesamt für Gesundheit und Soziales, Geschäftsstelle der Ethik-Kommission des Landes Berlin, Sächsische Strasse 28, 10707 Berlin, Germany.
Provenance and peer review Not commissioned; externally peer reviewed.
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