| . | TK-98 (n = 24) . | Placebo (n = 23) . | P-value . |
|---|---|---|---|
| Age at diagnosis, years [mean (s.d.)] | 57.1 (11.9) | 52.3 (9.2) | 0.124 |
| Disease duration, days [mean (s.d.)] | 212.2 (259.6) | 169.8 (107.4) | 0.472 |
| Gender, male/female (n) | 6/18 | 5/18 | 0.792 |
| Classification criteria (n) | |||
| Probable/definite | 2/22 | 2/21 | 0.965 |
| PM/DM | 12/12 | 11/12 | 0.882 |
| Baseline MMT score [n (%)] | |||
| 6≦, <7 | 4 (16.7) | 5 (21.7) | |
| 7≦, <8 | 8 (33.3) | 7 (30.4) | 0.676 |
| 8≦, <9.5 | 12 (50.0) | 11 (47.8) | |
| Interstitial lung disease [n (%)] | 11 (45.8) | 10 (43.5) | 0.871 |
| Initial dose of PSL, mg/kg/day [mean (s.d.)] | 0.98 (0.066) | 0.97 (0.11) | 0.662 |
| Concomitant immuno-suppressant [n (%)] | |||
| MTX | 2 (8.3) | 6 (26.1) | |
| AZA | 3 (12.5) | 1 (4.3) | |
| Tacrolimus | 11 (45.8) | 11 (47.8) | |
| CSA | 0 (0.0) | 0 (0.0) | |
| CYC | 1 (4.2) | 2 (8.7) |
| . | TK-98 (n = 24) . | Placebo (n = 23) . | P-value . |
|---|---|---|---|
| Age at diagnosis, years [mean (s.d.)] | 57.1 (11.9) | 52.3 (9.2) | 0.124 |
| Disease duration, days [mean (s.d.)] | 212.2 (259.6) | 169.8 (107.4) | 0.472 |
| Gender, male/female (n) | 6/18 | 5/18 | 0.792 |
| Classification criteria (n) | |||
| Probable/definite | 2/22 | 2/21 | 0.965 |
| PM/DM | 12/12 | 11/12 | 0.882 |
| Baseline MMT score [n (%)] | |||
| 6≦, <7 | 4 (16.7) | 5 (21.7) | |
| 7≦, <8 | 8 (33.3) | 7 (30.4) | 0.676 |
| 8≦, <9.5 | 12 (50.0) | 11 (47.8) | |
| Interstitial lung disease [n (%)] | 11 (45.8) | 10 (43.5) | 0.871 |
| Initial dose of PSL, mg/kg/day [mean (s.d.)] | 0.98 (0.066) | 0.97 (0.11) | 0.662 |
| Concomitant immuno-suppressant [n (%)] | |||
| MTX | 2 (8.3) | 6 (26.1) | |
| AZA | 3 (12.5) | 1 (4.3) | |
| Tacrolimus | 11 (45.8) | 11 (47.8) | |
| CSA | 0 (0.0) | 0 (0.0) | |
| CYC | 1 (4.2) | 2 (8.7) |
PSL: prednisolone.
| . | TK-98 (n = 24) . | Placebo (n = 23) . | P-value . |
|---|---|---|---|
| Age at diagnosis, years [mean (s.d.)] | 57.1 (11.9) | 52.3 (9.2) | 0.124 |
| Disease duration, days [mean (s.d.)] | 212.2 (259.6) | 169.8 (107.4) | 0.472 |
| Gender, male/female (n) | 6/18 | 5/18 | 0.792 |
| Classification criteria (n) | |||
| Probable/definite | 2/22 | 2/21 | 0.965 |
| PM/DM | 12/12 | 11/12 | 0.882 |
| Baseline MMT score [n (%)] | |||
| 6≦, <7 | 4 (16.7) | 5 (21.7) | |
| 7≦, <8 | 8 (33.3) | 7 (30.4) | 0.676 |
| 8≦, <9.5 | 12 (50.0) | 11 (47.8) | |
| Interstitial lung disease [n (%)] | 11 (45.8) | 10 (43.5) | 0.871 |
| Initial dose of PSL, mg/kg/day [mean (s.d.)] | 0.98 (0.066) | 0.97 (0.11) | 0.662 |
| Concomitant immuno-suppressant [n (%)] | |||
| MTX | 2 (8.3) | 6 (26.1) | |
| AZA | 3 (12.5) | 1 (4.3) | |
| Tacrolimus | 11 (45.8) | 11 (47.8) | |
| CSA | 0 (0.0) | 0 (0.0) | |
| CYC | 1 (4.2) | 2 (8.7) |
| . | TK-98 (n = 24) . | Placebo (n = 23) . | P-value . |
|---|---|---|---|
| Age at diagnosis, years [mean (s.d.)] | 57.1 (11.9) | 52.3 (9.2) | 0.124 |
| Disease duration, days [mean (s.d.)] | 212.2 (259.6) | 169.8 (107.4) | 0.472 |
| Gender, male/female (n) | 6/18 | 5/18 | 0.792 |
| Classification criteria (n) | |||
| Probable/definite | 2/22 | 2/21 | 0.965 |
| PM/DM | 12/12 | 11/12 | 0.882 |
| Baseline MMT score [n (%)] | |||
| 6≦, <7 | 4 (16.7) | 5 (21.7) | |
| 7≦, <8 | 8 (33.3) | 7 (30.4) | 0.676 |
| 8≦, <9.5 | 12 (50.0) | 11 (47.8) | |
| Interstitial lung disease [n (%)] | 11 (45.8) | 10 (43.5) | 0.871 |
| Initial dose of PSL, mg/kg/day [mean (s.d.)] | 0.98 (0.066) | 0.97 (0.11) | 0.662 |
| Concomitant immuno-suppressant [n (%)] | |||
| MTX | 2 (8.3) | 6 (26.1) | |
| AZA | 3 (12.5) | 1 (4.3) | |
| Tacrolimus | 11 (45.8) | 11 (47.8) | |
| CSA | 0 (0.0) | 0 (0.0) | |
| CYC | 1 (4.2) | 2 (8.7) |
PSL: prednisolone.
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