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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
CP Mavragani NM Moutsopoulos HM Moutsopoulos (2006) ArticleTitleThe management of Sjögren's syndrome Nat Clin Pract Rheumatol 2 252–61 Occurrence Handle16932698 Occurrence Handle10.1038/ncprheum0165 Occurrence Handle1:CAS:528:DC%2BD28Xltlaguro%3D
RI Fox (2005) ArticleTitleSjögren's syndrome Lancet 366 321–31 Occurrence Handle16039337 Occurrence Handle10.1016/S0140-6736(05)66990-5 Occurrence Handle1:CAS:528:DC%2BD2MXmsVWkur4%3D
S Nakayamada K Saito K Nakatsuka K Nakano M Tokunaga N Sawamukai et al. (2003) ArticleTitleEfficacy of mizoribine treatment in patients with Sjögren's syndrome: An open trial Mod Rheumatol 13 339–45 Occurrence Handle10.1007/s10165-003-0247-4 Occurrence Handle1:CAS:528:DC%2BD3sXhtVSjsb3J
K Torikai (2002) ArticleTitleSpecial Issue: New topics on Sjögren's syndrome. IV. Laboratory tests: 1. Saxon test, gum test, and ophthalmologic examinations (in Japanese) Prog Med 22 43–6
SD Steinfeld P Demols T Appelboom (2002) ArticleTitleInfliximab in primary Sjögren's syndrome: One-year followup Arthritis Rheum 46 3301–3 Occurrence Handle12483735 Occurrence Handle10.1002/art.10674 Occurrence Handle1:CAS:528:DC%2BD3sXjslGhsQ%3D%3D
X Mariette P Ravaud S Steinfeld G Baron J Goetz E Hachulla et al. (2004) ArticleTitleInefficacy of infliximab in primary Sjögren's syndrome: Results of the Randomized, Controlled Trial of Remicade in Primary Sjögren's Syndrome (TRIPSS) Arthritis Rheum 50 1270–6 Occurrence Handle15077311 Occurrence Handle10.1002/art.20146 Occurrence Handle1:CAS:528:DC%2BD2cXjslGqsL4%3D
V Sankar MT Brennan MR Kok RA Leakan JA Smith J Manny et al. (2004) ArticleTitleEtanercept in Sjögren's syndrome: A twelve-week randomized, double-blind, placebo-controlled pilot clinical trial Arthritis Rheum 50 2240–5 Occurrence Handle15248223 Occurrence Handle10.1002/art.20299 Occurrence Handle1:CAS:528:DC%2BD2cXmsVansbg%3D
M Okubo X Chen K Kamata Y Masaki T Uchiyama (1986) ArticleTitleSuppressive effect of mizoribine on humoral antibody production in DBA/2 mice Transplantation 41 495–8 Occurrence Handle3485844 Occurrence Handle10.1097/00007890-198604000-00016 Occurrence Handle1:CAS:528:DyaL28Xhs1Wksro%3D
LA Turka J Dayton G Sinclair CB Thompson BS Mitchell (1991) ArticleTitleGuanine ribonucleotide depletion inhibits T cell activation J Clin Invest 87 940–8 Occurrence Handle1999502 Occurrence Handle1:CAS:528:DyaK3MXhsFKrsrg%3D Occurrence Handle10.1172/JCI115101
F Brennan C Plater-Zyberk RN Maini M Feldmann (1989) ArticleTitleCoordinate expansion of ‘fetal type’ lymphocytes (TCRγδ+T and CD5+B) in rheumatoid arthritis and primary Sjögren's syndrome Clin Exp Immunol 77 175–8 Occurrence Handle2476268 Occurrence Handle1:STN:280:DyaL1Mzns12nsQ%3D%3D
Y Shiokawa M Honma K Shichikawa T Miyamoto J Hirose T Nobunaga (1991) ArticleTitleClinical evaluation of the immunosuppressant mizoribine for treatment of rheumatoid arthritis: a multicenter double-blind placebo-controlled trial based on basal treatment(in Japanese) J Clin Expt Med 156 811–31
Author information
Authors and Affiliations
Corresponding author
About this article
Cite this article
Nakayamada, S., Saito, K., Umehara, H. et al. Efficacy and safety of mizoribine for the treatment of Sjögren's syndrome: a multicenter open-label clinical trial. Mod Rheumatol 17, 464–469 (2007). https://doi.org/10.1007/s10165-007-0627-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10165-007-0627-2