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Label indication HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid a rthritis . FDA label
Also known as HUMIRA
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 ...
Adalimumab every other week is a subcutaneous dosing regimen of adalimumab studied in plaque psoriasis and rheumatoid arthritis. It is a monoclonal antibody that inhibits TNF. The regimen has been evaluated in Phase 3 clinical trials, including a long-term roll-over study in rheumatoid arthritis and a study in plaque psoriasis patients who had an unsatisfactory response to etanercept.
Adalimumab every other week works by inhibiting TNF, a molecular target involved in inflammatory processes. As a monoclonal antibody, it binds to TNF and neutralizes its activity. This mechanism is intended to reduce inflammation associated with plaque psoriasis and rheumatoid arthritis. The every other week schedule refers to the dosing frequency of subcutaneous administration.
Adalimumab every other week is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott Laboratories is the sponsor of the clinical trials investigating this dosing regimen in plaque psoriasis and rheumatoid arthritis.
Adalimumab every other week is in Phase 3 clinical development. The Phase 3 trials for this regimen have been completed. It is an investigational dosing schedule and is not described as approved in the available information.
Adalimumab every other week has been studied in two completed Phase 3 trials. NCT00927069 evaluated safety and efficacy in plaque psoriasis patients who showed an unsatisfactory response to etanercept, enrolling 85 participants in Canada. NCT00233571 was a long-term roll-over study in rheumatoid arthritis, enrolling 796 participants. Both trials are completed.