Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
No Progression of Chronic Sacroiliac Changes in Patients with Active, Non-Radiographic Axial Spondyloarthritis Treated with Adalimumab Over 52 Weeks
Haibel1, Hildrun, Rios2, Valeria, Hermann3, Kay-Geert, Althoff4, Christian, Rudwaleit5, Martin, Kupper6, Hartmut, Braun7, J.
Department of Rheumatology, Charité CBF, Berlin, Germany,
Department of Rheumatology, Bellvitge University Hospital, Barcelona, Spain,
Charité Medical School, Berlin, Germany,
CharitéUniversity Medicine Berlin, Berlin, Germany,
Charité - Campus Benjamin Franklin, Berlin, Germany,
Abbott GmbH & Co. KG, Ludwigshafen, Germany,
Rheumazentrum Ruhrgebiet, Herne, Germany,
Charite - Campus Benjamin Franklin, Berlin, Germany
To evaluate the progression of chronic changes, as observed in T1 sequences on MRI, over 52 weeks in a 12-week, placebo-controlled study of adalimumab with a 40-week, open-label extension in the treatment of patients with active axial spondyloarthritis (SpA) not yet fulfilling the modified New York Criteria who had previously demonstrated good clinical response.1
T1 sequences of MRIs of the sacroiliac joints (SIJ) were obtained at baseline, at Week 12 (placebo phase), and at Week 52 (40 weeks of open-label extension) in patients treated with adalimumab. MRIs were read in 1 batch blinded for both sequence and therapy regimen by 2 assessors employing a recently developed score for chronic changes. Fatty lesions were scored (08), sclerosis was read for each joint (02), and erosions were counted for each joint (024).
Nine pairs each of MRIs for both the placebo and adalimumab groups were available at baseline and Week 12. In addition, 12 pairs of MRIs for the former placebo group and 14 pairs for the adalimumab group were available at baseline and Week 52. No changes were observed after 40 weeks (former placebo group) or 52 weeks of adalimumab treatment regarding fatty lesions, sclerosis, or erosions in the SI joints. Through analysis of the 12-week placebo-controlled data, significant reductions of fatty lesions were found in the adalimumab-treated patients vs. the placebo-treated patients (p=0.042). No significant changes and no differences between the two groups were found for erosions and sclerosis.
Mean Scores for Chronic Changes in T1 sequences by MRIs of Sacroiliac Joints
|Baseline to Week 12Placebo Group n=9||Baseline to Week 12Adalimumab Group n=9||Baseline to Week 52All Patients n=26|
|BL||Wk 12||BL||Wk 12||BL||Wk 52|
This was the first study analysing chronic SI-joint changes by MRI in patients treated with a TNF antagonist. These data indicate that fatty degeneration and erosions might be stopped. These findings need to be confirmed by longer observation periods. Furthermore, it has yet to be determined how and whether this affects also new bone formation.
To cite this abstract, please use the following information:
Haibel, Hildrun, Rios, Valeria, Hermann, Kay-Geert, Althoff, Christian, Rudwaleit, Martin, Kupper, Hartmut, et al; No Progression of Chronic Sacroiliac Changes in Patients with Active, Non-Radiographic Axial Spondyloarthritis Treated with Adalimumab Over 52 Weeks [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1798