Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 501 · 5 trials · 4 indications
Participants analyzed according to actual treatment received.
Participants analyzed according to treatment received.
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening (places the subject at immediate risk of death) * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal.
Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies. Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study.
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).
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
| 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 ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months. |
| 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...
ABP 501 is a monoclonal antibody being developed by Amgen for the treatment of moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis. It has been studied in clinical trials for these conditions, as well as in healthy volunteers for pharmacokinetic bioequivalence studies.
ABP 501 is a monoclonal antibody that targets tumor necrosis factor (TNF). By binding to TNF, it is designed to block its activity, which is involved in inflammatory processes. This mechanism is relevant to its use in autoimmune conditions like rheumatoid arthritis and plaque psoriasis.
ABP 501 is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen has conducted multiple clinical trials to evaluate the safety and efficacy of ABP 501 in patients with rheumatoid arthritis and plaque psoriasis.
ABP 501 has completed Phase 3 clinical trials for rheumatoid arthritis and plaque psoriasis. These trials were active-controlled, randomized, and double-blind, comparing ABP 501 to adalimumab. The drug is investigational and not yet approved, as it remains in clinical development.
ABP 501 has been studied in several completed trials, including NCT01970475 and NCT02114931 for rheumatoid arthritis, NCT01970488 for plaque psoriasis, and NCT05995691 for healthy volunteers. These trials assessed efficacy, safety, and pharmacokinetic bioequivalence compared to adalimumab.
ABP 501 is not the same as adalimumab, but it is a biosimilar candidate designed to be highly similar to adalimumab (Humira). Clinical trials have compared ABP 501 directly to adalimumab to evaluate its efficacy, safety, and pharmacokinetic equivalence in treating rheumatoid arthritis and plaque psoriasis.