Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 501 · 3 trials · 2 indications
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.
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 |
|---|---|---|
| ABP 501 | EXPERIMENTAL | Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months. |
| Adalimumab | ACTIVE_COMPARATOR | Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22. |
| Name | Type | Description |
|---|---|---|
| ABP 501 | BIOLOGICAL | Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501 |
| Adalimumab | BIOLOGICAL | Solution for subcutaneous injection in pre-filled syringe |
Inclusion Criteria: * Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit Exclusion Criteria: * Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental * Subject...
ABP 501 is being developed for the treatment of rheumatoid arthritis and related arthritic conditions. It is a monoclonal antibody studied in adults with moderate to severe rheumatoid arthritis, and it has also been evaluated in healthy adult volunteers in pharmacokinetic studies. It is an investigational biosimilar candidate rather than a marketed product.
ABP 501 is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program evaluating ABP 501 in rheumatoid arthritis and in healthy volunteer pharmacokinetic studies.
ABP 501 has completed Phase 3 clinical development. Two Phase 3 trials in moderate to severe rheumatoid arthritis have been completed, along with a Phase 1 pharmacokinetic study in healthy adult Japanese participants. The program includes both active-controlled and randomized, double-blind trial designs.
ABP 501 has been studied in completed trials including NCT02114931, a Phase 3 long-term safety and efficacy study in moderate to severe rheumatoid arthritis, NCT01970475, a Phase 3 efficacy and safety study versus adalimumab in rheumatoid arthritis, and NCT05995691, a Phase 1 pharmacokinetic bioequivalence study in healthy adult Japanese participants.
Across the reported ABP 501 studies, total enrollment was 993 participants. The Phase 3 rheumatoid arthritis trials enrolled 467 and 526 subjects respectively, and the Phase 1 pharmacokinetic study in healthy adult Japanese volunteers enrolled 179 participants. All trials were randomized and double-blind, with active-controlled designs in the rheumatoid arthritis studies.