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PLAQUE PSORIASIS
Study design
Amgen offers confidence through robust clinical trial designs
AMGEVITA® has been evaluated in a large, randomised, double-blind, 52-week bioequivalence trial in plaque psoriasis, which included a switch design.1,2
Study population:
Adult patients with stable moderate-to-severe PP for ≥6 months
BSA ≥10% disease involvement
PASI score ≥12
sPGA of at least moderate severity
No known history of active tuberculosis
Previously unsuccessful systemic or phototherapy, or could
not tolerate or
receive ≥1 prior conventional systemic therapy
receive ≥1 prior conventional systemic therapy
Excluded if:
- Presenting with non-PP, drug-induced psoriasis, or skin condition able to interfere with evaluation of efficacy
- Received ≥2 biological therapies for psoriasis, Humira®, or adalimumab biosimilar.
Primary endpoint:
Percent improvement in Psoriasis Area Severity Index (PASI) score from basline to week 16.
Key secondary endpoints:
Improvement in PASI score from baseline of 50% (PASI 50) or 75% (PASI 75%), and static Physician's Global Assessment (sPGA) response of clear (0) or almost clear (1).
Safety & tolerability assessments
Treatment-emergent adverse events (TEAEs) and serious AEs, laboratory data, vital signs, and immunogenicity
AEs of interest were also assessed (eg. infections,
malignancies, hypersensitivity, demyelinating diseases) based on the Standard Medical Dictionary for Regulatory Activities (MedDRA) queries
Efficacy results
Comparable efficacy versus Humira®
At week 16, patients in the AMGEVITA® and Humira® groups achieved equivalent mean PASI score improvements (primary endpoint)1†
Comparable mean PASI score improvements were maintained throughout the trial1-3
Safety results
Comparable safety, tolerability and immunogenicity versus Humira®
Adverse events were similar between AMGEVITA® and Humira®, with no evidence of increased nasopharyngitis up to week 161
Anti-drug antibody incidence was similar between AMGEVITA® and Humira® up to week 521,2,4,5§
BSA: Body surface area; CI: Confidence interval; PASI: Psoriasis area severity index; PP: Plaque psoriasis; sPGA: Static physicians’ global assessment.
*Only week 16 PASI 50 responders were re-randomised.
†The least-square mean difference was -2.18 (95% CI: -7.39 to 3.02) and the 95% CI fell within the prespecified margin of -15 to 15, demonstrating clinical similarity between AMGEVITA® and Humira®.
‡Bowen disease occurred in a patient treated with AMGEVITA® and lentigo maligna occurred in a patient treated with Humira®.
§Anti-drug antibody status was assessed using a validated electrochemiluminescent bridging immunoassay. A two-tiered approach was conducted simultaneously to detect all anti-drug antibodies that bind to the biologic drug (binding antibodies) and confirm the specificity of the binding antibodies.
- Papp K, et al. J Am Acad Dermatol. 2017;76:1093–102.
- Papp K et al. Br J Dermatol. 2017;177:1562–74.
- ABP 501: Background information for the arthritis advisory committee. Submitted to the FDA by Amgen, July 2016.
- Chow V, et al. ECCO Vienna, Austria, 2018; Poster P404.
- Mytych DT, et al. ECCO Vienna, Austria, 2018; Poster P655.
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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.