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Iguratimod treatment reduces disease activity in early primary Sjögren's syndrome: An open-label pilot study.
Mod Rheumatol. 2020 Aug 03 [Online ahead of print]MR

Abstract

OBJECTIVES

To evaluate the efficacy and safety of iguratimod in patients with early primary Sjögren's syndrome (pSS).

METHODS

Twenty-seven disease-modifying antirheumatic drug-naive female patients met the revised American-European Consensus Group criteria for pSS were enrolled in this open-label pilot study. Patients were treated with iguratimod 25 mg twice a day for 24 weeks. The disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 12 and 24 weeks. Salivary and lacrimal gland function, laboratory, and subjective variables were also assessed. Generalized estimating equations were used to analyze parameters over time.

RESULTS

ESSDAI (median, 5 versus 2 versus 2, p < .01), IgG (median, 26.6 versus 22.4 versus 21.4 g/L, p < .01) and rheumatoid factor (median, 119.9 versus 94.1 versus 83.8 lU/mL, p < .01) levels decreased significantly during iguratimod treatment. ESSPRI, salivary and lacrimal gland function, fatigue and health-related quality of life did not change during treatment. One patient experienced thrombocytopenia, and no other serious adverse effects were observed.

CONCLUSION

In this study, iguratimod treatment is safe and effective for improving disease activity and laboratory parameters in early pSS patients.

Authors+Show Affiliations

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Stomatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32613869

Citation

Chen, Hua, et al. "Iguratimod Treatment Reduces Disease Activity in Early Primary Sjögren's Syndrome: an Open-label Pilot Study." Modern Rheumatology, 2020, pp. 1-5.
Chen H, Qi X, Li Y, et al. Iguratimod treatment reduces disease activity in early primary Sjögren's syndrome: An open-label pilot study. Mod Rheumatol. 2020.
Chen, H., Qi, X., Li, Y., Wu, Q., Shi, Q., Wang, L., Li, J., Zhao, L., Zhang, L., Zhou, X., Fei, Y., Liu, J., Su, J., Wu, D., Yang, Y., Jiang, H., Zeng, X., Zhang, F., & Zhao, Y. (2020). Iguratimod treatment reduces disease activity in early primary Sjögren's syndrome: An open-label pilot study. Modern Rheumatology, 1-5. https://doi.org/10.1080/14397595.2020.1789335
Chen H, et al. Iguratimod Treatment Reduces Disease Activity in Early Primary Sjögren's Syndrome: an Open-label Pilot Study. Mod Rheumatol. 2020 Aug 3;1-5. PubMed PMID: 32613869.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Iguratimod treatment reduces disease activity in early primary Sjögren's syndrome: An open-label pilot study. AU - Chen,Hua, AU - Qi,Xuan, AU - Li,Yuan, AU - Wu,Qing, AU - Shi,Qun, AU - Wang,Li, AU - Li,Jing, AU - Zhao,Lidan, AU - Zhang,Li, AU - Zhou,Xinyao, AU - Fei,Yunyun, AU - Liu,Jinjing, AU - Su,Jinmei, AU - Wu,Di, AU - Yang,Yunjiao, AU - Jiang,Hui, AU - Zeng,Xiaofeng, AU - Zhang,Fengchun, AU - Zhao,Yan, Y1 - 2020/08/03/ PY - 2020/7/3/pubmed PY - 2020/7/3/medline PY - 2020/7/3/entrez KW - Iguratimod KW - primary Sjögren's syndrome SP - 1 EP - 5 JF - Modern rheumatology JO - Mod Rheumatol N2 - OBJECTIVES: To evaluate the efficacy and safety of iguratimod in patients with early primary Sjögren's syndrome (pSS). METHODS: Twenty-seven disease-modifying antirheumatic drug-naive female patients met the revised American-European Consensus Group criteria for pSS were enrolled in this open-label pilot study. Patients were treated with iguratimod 25 mg twice a day for 24 weeks. The disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 12 and 24 weeks. Salivary and lacrimal gland function, laboratory, and subjective variables were also assessed. Generalized estimating equations were used to analyze parameters over time. RESULTS: ESSDAI (median, 5 versus 2 versus 2, p < .01), IgG (median, 26.6 versus 22.4 versus 21.4 g/L, p < .01) and rheumatoid factor (median, 119.9 versus 94.1 versus 83.8 lU/mL, p < .01) levels decreased significantly during iguratimod treatment. ESSPRI, salivary and lacrimal gland function, fatigue and health-related quality of life did not change during treatment. One patient experienced thrombocytopenia, and no other serious adverse effects were observed. CONCLUSION: In this study, iguratimod treatment is safe and effective for improving disease activity and laboratory parameters in early pSS patients. SN - 1439-7609 UR - https://www.unboundmedicine.com/medline/citation/32613869/Iguratimod_treatment_reduces_disease_activity_in_early_primary_Sjögren's_syndrome:_an_open-label_pilot_study L2 - http://www.tandfonline.com/doi/full/10.1080/14397595.2020.1789335 DB - PRIME DP - Unbound Medicine ER -
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