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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 · 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...
Adalimumab is used to treat moderate to severe plaque psoriasis, a chronic inflammatory skin condition. Amgen is developing it as a biosimilar to Humira, studied in adults 18 years and older. Its clinical program in dermatology focuses on psoriasis, with trials conducted across the United States, Canada, Europe, and Australia.
Adalimumab targets TNF, tumor necrosis factor. It is a monoclonal antibody that acts as a TNF inhibitor, binding to and neutralizing this inflammatory cytokine. By inhibiting TNF signaling, adalimumab reduces the inflammation that drives plaque psoriasis and other immune-mediated conditions.
Amgen Inc. (ticker: AMGN) is developing adalimumab as a biosimilar candidate, referenced in trials as ABP 501. The program compares it against Humira in patients with moderate to severe plaque psoriasis. Amgen is the sponsor behind the clinical studies evaluating this monoclonal antibody.
Adalimumab is in Phase 3 clinical development for plaque psoriasis. The completed Phase 3 trials include NCT05073315, which enrolled 425 participants, and NCT01970488, which enrolled 350 participants. Both were randomized, double-blind, active-controlled studies in adults with moderate to severe disease.
Adalimumab has been studied in two completed Phase 3 trials: NCT05073315, a comparative study between ABP 501 and Humira in moderate to severe plaque psoriasis with 425 participants, and NCT01970488, comparing ABP 501 and adalimumab in adults with moderate to severe plaque psoriasis with 350 participants.