Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adalimumab · 2 trials · 2 indications
Participants analyzed according to actual treatment received.
Participants analyzed according to treatment received.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
| Arm | Type | Description |
|---|---|---|
| Continued-use Group (Adalimumab) | ACTIVE_COMPARATOR | Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28. |
| Switching Group (Adalimumab - ABP 501) | EXPERIMENTAL | Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28. |
| ABP 501 | EXPERIMENTAL | Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48. |
| Adalimumab | ACTIVE_COMPARATOR | Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48. |
| Name | Type | Description |
|---|---|---|
| Adalimumab | DRUG | Participants will receive subcutaneous (SC) injection of adalimumab |
| ABP 501 | DRUG | Participants will receive SC injection of ABP 501 |
Inclusion Criteria: * Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months * Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Ass...