ackground : SA96 is a new antirheumatic drug which was developed in Japan. A
number of clinical studies has been demonstrated that SA96 is effective and safe in the
treatment of rheumatoid anthritis (RA) with mild adverse reactions. However, there has
beeen no experience is SA96 on RA outside of Japan. This study was performed to evaluate
the clincal efficacy and safety of SA96 in patients with RA in Korea.
Methods ; 30 patients with RA who fulfilled 1987 revised criteria of American College of
Rheumatology (ACR) were selected and were given 300 mg/day of SA96 for 16 weeks or
longer by the non double blind method. And the daily dosage was allowed to chage within
the range between 100 and 600 mg depending on patients' compliances. Every patient was
allowed to take nonsteroidal antiinflammatory drun (NSAID) and/ or steroid (less than 7.5
mg/day of prednisole), provided that the dosage was kept constant for the duration of this
clinical trial.
Results ; In the clinical evaluation items, it showed statistically significant improvements
in Ritchie index, the number of painful joints, the number of swollen joints, morning stiffness,
15 m walking time and ESR by the 8the week of drug administration.
1) Final global improvement
4 patients (13%) were assessed as "markedly improved", 9(30%) as "moderately improved",
9(30%) as "slightly improved" and 8 (27%) as "unchanged". An rating of "slightly improved
or better" was seen in 22 patients (73%).
2) Overall safety
Adverse reactions were experienced in 14 patients (47%), mild adverse reactions in 10
(33%), moderate adverse reactions in 2 (7%) and severe adverse reactions in 2(7%).
3) Usefulness
Considering final global improvement and overall safety, 3 patients (10%) revealed
"markedly useful", 7(24%) "moderately useful", 6(20%) "slightly useful", 9(30%) "indecisive",
3(10%) "slightly unfavorable", 1 (3%) "moderately unfavorable" and 1 (3%) "markedly
unfavorable". 54% (16 out of 30) revealed "mild or better useful".
Conclusion : SA96 is expected to be one of the useful DMARDs in the treatment of RA.
However, further large scale, long-term follow up clinical trials are required.
|