Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Effects of Etanercept vs. Sulfasalazine on Acute Inflammatory Lesions as Detected by Whole Body MRI in Early Axial SpondyloarthritisA 48 Week Randomized Controlled Trial.
Song2, In-Ho, Hermann4, Kay-Geert, Haibel3, Hildrun, Althoff4, Christian, Listing7, Joachim, Burmester5, Gerd-Rüdiger, Krause6, Andreas
Charite Benjamin-Franklin, Med. Clinic I, Rheumatology, Berlin, Germany
Charite Campus Benjamin, Med. Clinic I, Rheumatology, Berlin, Germany
Charite Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Berlin, Germany
Charite Campus Mitte, Radiology, Berlin, Germany
Charite Campus Mitte, Rheumatology, Berlin, Germany
Clinic Buch Rheumatologie, Berlin, Germany
German Rheumatism Research Center, Berlin, Germany
Private Practice, Rheumatology, Potsdam, Germany
To evaluate the potential of etanercept (ETA) versus sulfasalazine (SSZ) to reduce active inflammatory lesions on whole-body magnetic resonance imaging (wb-MRI) in active axial spondyloarthritis (SpA) with a symptom duration of short symptom duration.
76 patients with NSAID-refractory axial SpA were randomized to etanercept (ETA 25 mg given twice weekly subcutaneously; n= 40) or sulfasalazine (SSZ 23 g per day orally; n= 36) treatment over 48 weeks. All patients fulfilled the recently published ASAS-classification criteria for axial SpA, showed active inflammatory lesions (bone marrow edema) on whole-body MRI (wb-MRI) in either the sacroiliac joints (SIJ) or the spine and had a symptom duration of less than 5 years. All patients underwent wb-MRI at week 0, 24 and 48. MRIs were scored by two radiologists, blinded for treatment arm and MRI time point, resulting in a score for the SIJ of between 0 and 24 and for the spine between 0 and 69. The primary endpoint was the reduction of active inflammatory lesions on wb-MRI, clinical outcome parameters were secondary endpoints.
Patients' characteristics were similar for the ETA group (mean age 35, 58% male, 85% HLA-B27 positive, mean symptom duration 2.6 years), and the SSZ group (mean age 33 years, 58% male, 78% HLA-B27 positive, mean symptom duration 3.0 years). At baseline, 92% of the patients showed active inflammatory lesions in the SIJ, 41% in the spine, but only 5% in the spine but not in the SIJ. According to the early disease stage, the mean score in the SIJ with 6.6 (standard deviation SD 5.9) out of 24 was relatively higher compared to a mean score of 1.8 (SD 3.3) out of 72 for the spine. In the ETA group, the reduction of the SIJ score from 7.7 at baseline to 2.0 at week 48 was significantly (p=0.003) larger compared to the SSZ group from 5.4 at baseline to 3.5 at week 48. A similar reduction of inflammation was found in the spine: 2.2 to 1.0 in the ETA group vs. 1.4 to 1.3 in the SSZ group between baseline and week 48, respectively (p=0.0024). Enthesitis improved also significantly (p= 0.027) better in the ETA compared to the SSZ group. Inflammation on the posterior segments showed no significant difference between the two treatment groups. 50% of the patients reached ASAS clinical remission and 70% ASAS 40 response in the ETA group vs 19% and 31% in the SSZ group at week 48.
Of the 6 patients who became completely free of inflammation both in SIJ and spine in the ETA group all patients were also in clinical remission. In contrast, none of the 2 patients reaching remission on the SULFA group were free of inflammation as shown by wb-MRI.
In patients with early axial SpA active inflammatory lesions detected by wb-MRI improved significantly more in ETA- versus SSZ-treated patients. This effect correlated with a good clinical response in the ETA group.
To cite this abstract, please use the following information:
Song, In-Ho, Hermann, Kay-Geert, Haibel, Hildrun, Althoff, Christian, Listing, Joachim, Burmester, Gerd-Rüdiger, et al; Effects of Etanercept vs. Sulfasalazine on Acute Inflammatory Lesions as Detected by Whole Body MRI in Early Axial SpondyloarthritisA 48 Week Randomized Controlled Trial. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2271