Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adalimumab every other week · 2 trials · 2 indications
Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. |
| Group B | EXPERIMENTAL | Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening. |
| Group A dose increase at Week 12 | EXPERIMENTAL | Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. |
| Group B dose increase at Week 12 | EXPERIMENTAL | Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to reach a physician's global assessment (PGA) of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks. |
| Adalimumab 40mg subcutaneous (SC) every other week (EOW) | EXPERIMENTAL | Adalimumab 40mg subcutaneous (SC) every other week (EOW) |
| Name | Type | Description |
|---|---|---|
| Adalimumab every other week | DRUG | Adalimumab 40mg injection every other week for 24 weeks |
| Adalimumab Every Week | DRUG | Adalimumab 40mg injection every week for the last 12 weeks of study. |
| Adalimumab 40 mg subcutaneous (SC) every other week (EOW) | BIOLOGICAL | - |
Inclusion Criteria: * Subject with plaque psoriasis with documentation of an unsatisfactory response to etanercept as defined by either: 1. Failure to present a PGA of clear or almost clear after at least 3 months of etanercept at 50 mg twice a week OR; 2. Failure to present a PGA of clear or ...