TABLE 3.
Analysis of Secondary Endpoints at Week 24, Modified Intent-to-Treat Population
| TEPILAMIDE FUMARATE | PLACEBO (N=102) |
|||
|---|---|---|---|---|
| 400mg QD (N=101) |
400mg BID (N=102) |
600mg BID (N=101) |
||
| Total PASI mean absolute change, MI | -10.7 | -12.0 | -11.7 | -6.7 |
| LSM (SE) differences* | -4.6 (1.1) P<0.001 |
-5.3 (1.1) P<0.001 |
-5.4 (1.1) P<0.001 |
0 |
| PASI-50 response, MI | 68.8% | 75.0% | 72.6% | 40.8% |
| OR (95% CI)* | 3.6 (1.8-7.5) P<0.00001 |
4.6 (2.1-9.7) P<0.00001 |
4.0 (1.9-8.6) P<0.00001 |
|
| PASI-90 response, MI | 17.3% | 20.9% | 18.8% | 5.5% |
| OR (95% CI)* | 3.7 (1.2-11.1) P=0.019 |
3.9 (1.3-11.8) P=0.017 |
3.4 (1.1-9.8) P=0.027 |
|
| NAPSI-50 response, n/N (%), LOCF | 10/26 (38.5%) | 8/23 (34.8%) | 12/24 (50.0%) | 6/31 (19.4%) |
| OR (95% CI)* | 2.6 (0.8-8.5) P=0.118 |
2.3 (0.7-7.8) P=0.197 |
4.2 (1.3-13.8) P=0.020 |
|
| PSSI-75 response, n/N (%), MI | 33/85 (38.9%) | 37/79 (47.7%) | 43/81 (53.8%) | 20/77 (26.1%) |
| OR (95% CI)* | 1.9 (0.9-4.0) P=0.120 |
2.6 (1.2-5.6) P=0.019 |
3.1 (1.4-7.2) P=0.007 |
|
| DLQI response, n/N (%), LOCF | 38/60 (63.3%) | 41/65 (63.1%) | 47/67 (70.1%) | 29/64 (45.3%) |
| OR (95% CI)* | 2.5 (1.1-5.4) P=0.023 |
2.4 (1.1-5.2) P=0.024 |
3.5 (1.6-7.6) P=0.002 |
|
| BSA, mean % change | -40.3 | -46.3 | -48.7 | -27.2 |
| LSM (SE) differences* | -14.4 (6.2) P=0.020 |
-18.8 (6.2) P=0.003 |
-21.3 (6.2) P<0.001 |
|
BID=twice daily; DLQI=Dermatology Life Quality Index; LSM=least squares mean; MI=multiple imputation; NAPSI=Nail Psoriasis Severity Index=OR, odds ratio; PASI=Psoriasis Area and Severity Index=PSSI, Psoriasis Scalp Score Index; QD=once daily; SE=standard error.
* Treatment versus placebo.