Abstract
Clinical usefulness of TS-110 against rheumatoid arthritis in long-term administration was evaluated in an open study.
1. A total of 134 subjects were included; 108 subjects (80.6%) were treated for 12 weeks or more, 82 subjects (61.2%) for 24 weeks or more, and 30 subjects (22.4%) for 48 weeks.
2. In the examination of the clinical evaluation items at final observation, there were significant improvement for number of painful and swallen joints, joint score, pain score and activities of daily living (upper limb), comparing at baseline.
3. In the patients' satisfaction rating, the rate of “satisfied” or better was found in 16.2% (12/74 cases) after 24 weeks, almost constant value of more than 20% was seen after 32 or more weeks, and the rate was 26.7% (8/30 cases) after 48 weeks.
According to evaluation of symptom-improvement by physicians, the rate of “improved” or better results was found in 33.3% (25/75 cases) after 24 weeks, more than 30% thereafter and 37.9% (11/29 cases) after 48 weeks.
4. With respect to the global improvement rating, the rate of “improved” or better results was found in 33.8% (25/74 cases) at the time after 24 weeks of administration and 40.0% (12/30 cases) after 48 weeks of administration. The final global improvement rate was 30.5% (36/118 cases) .
5. Sixty-four episodes of adverse drug reactions were found in 41 of 133 patents (30.8%), and every case was mild or moderate. Every abnormal change of clinical laboratory value of which causal relation to the trial drug could not be denied was handled as adverse drug reactions.
The incidence did not rise and the types of adverse drug reactions were not different with prolonging administration period.
6. Conerning the overall safety rating, the safety rate with “safe” was found in 85.3% (64/75 cases) at the time after 24 weeks of administration and 90.0% (27/30 cases) after 48 weeks of administration. The final overall safety rate was 69.2% (92/133 cases) .
7. As to the utility rating, the usefulness rate with “useful” or better was found in 36.5% (27/74 cases) at the time after 24 weeks of administration and 43.3% (13/34 cases) after 48 weeks of administration. The final usefulness rate was 26.8% (34/127 cases) .
In conclusion, TS-110 exhibited good efficacy and safety in a long-term administration against rheumatoid arthritis, and therefore, is considered to be a useful drug clinically.
