Abstract
A six-month, double-blind, controlled study to compare mizoribine (MZR) with lobenzarit disodium was conducted in Japan, and this is the first Japanese study that has demonstrated an inhibitory effect of MZR on joint destruction. In order to observe this effect over a longer period, we performed a two-year, open-label study using MZR and an oral gold compound, auranofin (AUF), as a comparator from September 1993 to July 1997. Thirty-five medical institutions in Japan participated in this study. A total of 166 patients were enrolled in the study, and of these participants, 87 and 79 received MZR and AUF, respectively. The joints were assessed in 31 MZR patients and 28 AUF patients who met the joint evaluation criteria. In AUF patients, damage scores for the hands showed significant increases of 104.55±11.13%, 107.57±17.96%, and 107.03±15.07% at 6 months, 1 year, and 2 years, respectively. However, MZR patients had a score increase only at two years (104.05±18.26%). One of the characteristics of this effect is found in the fact that MZR has inhibited joint destruction in patients with or without clinical improvement, whereas AUF exerts such an effect only in symptomatically improved patients.
