Abstract
We compared TS-110 with a control drug, indomethacin, in a double blind study to evaluate clinical usefulness of TS-110 in rheumatoid arthritis. TS-110 (Group T) and indomethacin (Group I ) were orally administered for 6 weeks at daily doses of 12mg t.i.d. and 75mg t.i.d., respectively.
(1) Study drugs were administered to a total of 189 subjects (95 subjects in Group T and 94 in Group I ) . A total of 179 subjects (89 in Group T and 90 in Group I ) were included in ITT for efficacy, safety and usefulness.
(2) No deviations were noted in background factors except for“sex” (p=0.0560) and“use of concomitant drugs” (p=0.0312) . Influences of the deviations on the improvement rating were tested by the Mantel-Haenszel method. but no influences were noted.
(3) With respect to the final overall improvement rating, the improvement rates with“improved” or better results were 29.2% (26/89 subjects) and 16.7% (15/90 subjects) in Groups T and I, respectively, demonstrating equivalent efficacy for Groups T and I.
(4) Incidences of adverse reactions were 20.2% (18/89 subjects) and 26.7% (24/90 subjects) in Groups T and I, respectively. According to symptoms, gastrointestinal symptoms were noted in 13 and 17 subjects in Groups T and I, respectively, hypersensitivity including anthema and itchiness was noted in one subject each in Groups T and I, mental and neurological symptoms such as dizziness and headache were observed in one subject in Group T and 11 subjects in i Group I, and abnormal variations in clinical laboratory values were observed in 11 and 7 subjects in Groups T and I, respectively.
(5) Concerning overall safety rating, the safety rates with the grading of“safe”were 79.8% (71/89 subjects) and 73.3% (66/90 subjects) in Groups T and I, respectively, demonstrating equivalent safety for Groups T and I.
(6) As to utility rating, the usefulness rates with“useful”or better grading were 28.1/ (25/89 subjects) and 14.4% (13/90 subjects) in Groups T and I, respectively, showing a significantly higher result for Group T than Group I (p = 0.0256) .
(7) With respect to other secondary evaluation parameters, the patient satisfaction rate with grading of“satisfied”or better on the final day of evaluation was significantly higher in Group T than in Group I (p=0.0164) .
In light of these results. TS-110 at dose of 12 mg/day has equivalent levels of efficacy and safety as indomethacin at dose of 75 mg/day against rheumatoid arthritis, in addition, TS-110 has been judged to be a clinically highly useful drug with respect to the patient satisfaction.
