ORIGINAL ARTICLE

Efficacy and safety of mizoribine for the treatment of Sjögren's syndrome: a multicenter open-label clinical trial

Authors

Shingo Nakayamada¹, Kazuyoshi Saito¹, Hisanori Umehara², Noriyoshi Ogawa^2,10, Takayuki Sumida³, Satoshi Ito³, Seiji Minota⁴, Hiroyuki Nara⁴, Hirobumi Kondo^5,11, Jun Okada⁶, Tsuneyo Mimori⁷, Hajime Yoshifuji⁷, Hajime Sano⁸, Naoaki Hashimoto⁸, Susumu Sugai⁹ and Yoshiya Tanaka¹

1. First Department of Internal Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
2. Department of Hematology and Immunology, Kanazawa Medical University, Kahoku, Ishikawa, Japan
3. Division of Clinical Immunology, Major of Advanced Biomedical Applications, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan
4. Division of Rheumatology and Clinical Immunology, Department of Medicine, Jichi Medical School, Shimono, Japan
5. Department of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Sagamihara, Japan
6. Kitasato University Health Care Center, Sagamihara, Japan
7. Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan
8. Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
9. Kudoh Hospital, Kaga, Japan
10. Present address: Third Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan
11. Present address: Kitasato Institute Medical Center Hospital, Kitamoto, Japan

Received:

16 February 2007

Accepted:

22 June 2007

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Abstract

This multicenter clinical trial was performed to evaluate the efficacy and safety of mizoribine for the treatment of Sjögren's syndrome. Fifty-nine patients with a definite diagnosis of Sjögren's syndrome received 150^Smg of mizoribine daily for 16 weeks. The salivary secretion volume was determined at baseline, at weeks 8 and 16 after the start of the study treatment by the Saxon test, and clinical manifestations were assessed by the investigator and the patients using a 10-cm visual analog scale (VAS). Adverse drug reactions were reported in 18 patients, of whom 6 patients had to discontinue the study due to such adverse reactions; however, no serious adverse drug reactions definitely related to the study drug were noted. The salivary secretion volume, the rate of change in salivary secretion, the patients’ own assessments of dry mouth and dry eyes, the investigators’ assessment of oral sicca symptoms, and the investigators’ overall assessment improved following the treatment regimen with statistical significance at week 16 after the start of treatment in comparison to the baseline values. These results suggested that mizoribine may be effective in producing a subjective and objective amelioration of the glandular symptoms in patients with Sjögren's syndrome, without observing any serious adverse effects related to this drug.

Key words

Mizoribine - Sjögren's syndrome - Xerostomia