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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.

Song IH, Hermann K, Haibel H, Althoff CE, Althoff C, Listing J, Burmester G, Krause A, Bohl-Bühler M, Freundlich B, Rudwaleit M, Sieper J - Ann. Rheum. Dis. (2011)

Bottom Line: 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).This effect correlated with a good clinical response in the etanercept group.

View Article: PubMed Central - PubMed

Affiliation: Campus Benjamin Franklin, Med Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany.

ABSTRACT

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.

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Examples for MRI before and after 48 weeks of treatment with etanercept: (a) sacroiliac joints: baseline MRI, sacroiliac joint score 15.5 (A), week 48 MRI, sacroiliac joint score 0 (B); (b) spine, baseline MRI spine score 11.5 (C), week 48 MRI spine score 1 (D); (c) enthesitis of lateral condyle of femur of right knee (dorsal view), MRI baseline with enthesitis (E), week 48 without enthesitis (F).
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Figure 1: Examples for MRI before and after 48 weeks of treatment with etanercept: (a) sacroiliac joints: baseline MRI, sacroiliac joint score 15.5 (A), week 48 MRI, sacroiliac joint score 0 (B); (b) spine, baseline MRI spine score 11.5 (C), week 48 MRI spine score 1 (D); (c) enthesitis of lateral condyle of femur of right knee (dorsal view), MRI baseline with enthesitis (E), week 48 without enthesitis (F).

Mentions: In the etanercept group, there was a clear reduction of the mean sacroiliac joint score from 7.8 at baseline to 2.4 at week 48 (table 2). After adjusting for the non-significantly different baseline MRI score, this reduction remained significantly (p=0.02) larger compared with the sulfasalazine group: 5.4 and 3.5, respectively (table 2). Inflammation was thus reduced after 1 year of treatment by 69.2% in the etanercept group in comparison to 35.2% in the sulfasalazine group. The same was true when the reduction of inflammation in the spine was compared between the two groups (p=0.01) (table 2). The results of the primary outcome remained significant after taking the presence of two co-primary endpoints (MRI sacroiliac joint and spine scores) into account. In the sensitivity analysis similar significant results were found for the primary endpoints. Figure 1 shows MRI examples for the reduction of active inflammatory lesions in the sacroiliac joints, the spine and enthesitis. The improvement on the patient level is shown in the probability plots in figure 2.


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.

Song IH, Hermann K, Haibel H, Althoff CE, Althoff C, Listing J, Burmester G, Krause A, Bohl-Bühler M, Freundlich B, Rudwaleit M, Sieper J - Ann. Rheum. Dis. (2011)

Examples for MRI before and after 48 weeks of treatment with etanercept: (a) sacroiliac joints: baseline MRI, sacroiliac joint score 15.5 (A), week 48 MRI, sacroiliac joint score 0 (B); (b) spine, baseline MRI spine score 11.5 (C), week 48 MRI spine score 1 (D); (c) enthesitis of lateral condyle of femur of right knee (dorsal view), MRI baseline with enthesitis (E), week 48 without enthesitis (F).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3211465&req=5

Figure 1: Examples for MRI before and after 48 weeks of treatment with etanercept: (a) sacroiliac joints: baseline MRI, sacroiliac joint score 15.5 (A), week 48 MRI, sacroiliac joint score 0 (B); (b) spine, baseline MRI spine score 11.5 (C), week 48 MRI spine score 1 (D); (c) enthesitis of lateral condyle of femur of right knee (dorsal view), MRI baseline with enthesitis (E), week 48 without enthesitis (F).
Mentions: In the etanercept group, there was a clear reduction of the mean sacroiliac joint score from 7.8 at baseline to 2.4 at week 48 (table 2). After adjusting for the non-significantly different baseline MRI score, this reduction remained significantly (p=0.02) larger compared with the sulfasalazine group: 5.4 and 3.5, respectively (table 2). Inflammation was thus reduced after 1 year of treatment by 69.2% in the etanercept group in comparison to 35.2% in the sulfasalazine group. The same was true when the reduction of inflammation in the spine was compared between the two groups (p=0.01) (table 2). The results of the primary outcome remained significant after taking the presence of two co-primary endpoints (MRI sacroiliac joint and spine scores) into account. In the sensitivity analysis similar significant results were found for the primary endpoints. Figure 1 shows MRI examples for the reduction of active inflammatory lesions in the sacroiliac joints, the spine and enthesitis. The improvement on the patient level is shown in the probability plots in figure 2.

Bottom Line: 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).This effect correlated with a good clinical response in the etanercept group.

View Article: PubMed Central - PubMed

Affiliation: Campus Benjamin Franklin, Med Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus