To evaluate the safety and efficacy of etanercept (ETN) plus methotrexate (MTX) in patients with rhupus without using corticosteroids.
Twenty rhupus patients [meeting the criteria for both rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)] who had never been treated with corticosteroids, DMARDs, or biological agents with a 28-joint Disease Activity Score (DAS28) >3.2 and lupus nephritis determined from histopathological specimens were enrolled. All patients were treated with MTX plus ETN, and monitored for 24 weeks of treatment. Clinical efficacy was evaluated using the DAS28 and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Demographic characteristics, clinical parameters, and treatment data were analyzed at baseline (BL) and after 4, 8, 16, and 24 weeks of treatment. The incidence of adverse events (AEs) was evaluated.
The 20 patients had a mean age of 44.3±8 years and a disease duration of 5.4±3.1 years. At week 24, treatment with ETN plus MTX resulted in a significant improvement in DAS28 (3.3±0.1 vs. 6.0±0.1 /BL; p<0.001), tender joint count (2.9±0.2 vs. 10.75±0.8/BL; p<0.001), swollen joint count (2.7±0.2 vs. 8.5±0.5/BL; p<0.001), Visual Analog Scale for pain (27.0±2.6 mm vs. 66.5±3.1 mm/BL; p<0.001), and SLEDAI-2K (6.30±0.36 vs. 13.7±0.48/BL; p<0.001). During the study, the most frequent AEs were upper respiratory tract infections (10%), injection site reactions (10%), and cutaneous rashes (5%); there were no serious AEs. No deaths, malignancies, or tuberculosis or other serious infections were reported.
Without corticosteroids, combination therapy of ETN plus MTX was relatively safe and effective in rhupus patients, which indicates efficacy of non-corticosteroid treatment for rhupus.