PMID- 29466690 OWN - NLM STAT- MEDLINE DCOM- 20180927 LR - 20180927 IS - 1944-7930 (Electronic) IS - 1539-6509 (Linking) VI - 25 IP - 135 DP - 2018 Jan TI - Safety and efficacy of etanercept-methotrexate combination therapy in patients with rhupus: an observational study of non-glucocorticoid treatment for rheumatic diseases. PG - 14-20 AB - OBJECTIVES: To evaluate the safety and efficacy of etanercept (ETN) plus methotrexate (MTX) in patients with rhupus without using corticosteroids. METHODS: 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. RESULTS: 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. CONCLUSION: 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. FAU - Yang, Bei-Bei AU - Yang BB AD - Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China. AD - These authors contributed equally to this article. FAU - Xiao, Hua AU - Xiao H AD - Department of Rheumatology, the First People's Hospital of Chenzhou, Chenzhou, Hunan 423000, China. AD - These authors contributed equally to this article. FAU - Li, Xiao-Jie AU - Li XJ AD - Department of Rheumatology, the First People's Hospital of Chenzhou, Chenzhou, Hunan 423000, China. FAU - Zheng, Min AU - Zheng M AD - Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China. LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Observational Study PL - United States TA - Discov Med JT - Discovery medicine JID - 101250006 RN - OP401G7OJC (Etanercept) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Drug Therapy, Combination MH - Etanercept/*administration & dosage/adverse effects MH - Female MH - Humans MH - Lupus Erythematosus, Systemic/complications/*drug therapy/pathology MH - Male MH - Methotrexate/*administration & dosage/adverse effects MH - Middle Aged MH - Rheumatic Fever/complications/*drug therapy/pathology EDAT- 2018/02/22 06:00 MHDA- 2018/09/28 06:00 CRDT- 2018/02/22 06:00 PHST- 2018/02/22 06:00 [entrez] PHST- 2018/02/22 06:00 [pubmed] PHST- 2018/09/28 06:00 [medline] PST - ppublish SO - Discov Med. 2018 Jan;25(135):14-20.