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OBJECTIVE: To investigate the clinical response and to evaluate by magnetic resonance imaging (MRI) the inflammatory tissue changes in patients with refractory rheumatoid arthritis (RA) treated with adalimumab. METHODS: Thirteen patients with refractory RA who were treated with adalimumab (40 mg every 2 weeks subcutaneously) were examined with MRI of the dominant affected wrist and hand before treatment and one year after therapy. The volume of the enhanced inflammatory tissue (VEIT) was evaluated in fat-suppressed contrast-enhanced T1-weighted MRI images using the Analyse 4.0 software. Disease activity was evaluated using the Disease Activity Score 28-joint (DAS-28). Clinical improvement was evaluated according to the American College of Rheumatology 20% response criteria (ACR20%). RESULTS: We studied 12 women and one man, with mean age 52.0 +/- 10.9 years and mean disease duration 13.0 +/- 8.5 years. Eight patients had positive IgM rheumatoid factor. One year after treatment, 11 (84.6%) patients showed a decrease of the VEIT. Moreover the values of C-reactive protein (CRP; 4.3 +/- 6.6 mg/l), the erythrocyte sedimentation rate (ESR; 26.3 +/- 19.5 mm/h), the DAS-28 (3.5 +/- 1.1), and the VEIT (21.6 +/- 10.7 cm3) after treatment were significantly lower compared to the corresponding values before treatment (CRP 41.6 +/- 39.2), (ESR 54.3 +/- 28.6) (DAS-28 5.8 +/- 0.8), and (VEIT 36.9 +/- 16.8) (p < 0.01). All but 3 (76.9%) patients with RA achieved the ACR20% response, while 7 (53.8%) and 5 (38.5%) patients achieved ACR50% and ACR70% response, respectively. A positive correlation between VEIT, swollen joint count, and ESR was found before treatment (r = 0.59, r = 0.64, respectively; p < 0.05). CONCLUSION: In patients with refractory RA, treatment with adalimumab resulted in improvement of clinical, laboratory, and MRI findings. MRI assessment of the VEIT may represent an additional tool for investigation of joint disease activity and responsiveness to treatment.