Trial reportAdvances in therapy2026
Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 (adalimumab-atto) and Adalimumab Reference Product in Patients with Plaque Psoriasis.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05073315 (A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira®), which is not on this map. Not yet cited in PubMed.
What it found
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The trial behind it
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A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
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Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionABP 501, now approved as AMJEVITA
methodsThis study (NCT05073315) consisted of a 12-week lead-in period where adults with moderate-to-severe plaque psoriasis received adalimumab RP subcutaneously every 2 weeks (Q2W), followed by a double-blind, two-parallel arm period in which patients were randomized to either the continued-use group (adalimumab RP Q2W, weeks 12-28) or switching group (ABP 501, weeks 12 and 14; adalimumab RP, weeks 16 and 18; ABP 501 Q2W, weeks 20-28). The primary pharmacokinetic (PK) endpoints were area under the serum concentration-time curve (AUC
resultsA total of 425 patients were enrolled across 85 centers. Adherence to dosing protocol and completion/discontinuation rates were similar between groups. The ratio of geometric least squares means (90% confidence interval; CI) between the continued-use group and switching group for AUC
conclusionThis study demonstrates PK similarity in patients with plaque psoriasis who underwent three treatment switches between adalimumab RP and ABP 501 as compared with those who received continuous treatment with adalimumab RP. Safety, immunogenicity, and efficacy profiles were comparable. Overall, results support the interchangeability designation of ABP 501 with adalimumab RP, consistent with the US Food and Drug Administration (2019) guidelines.
trial registrationThis study was registered as NCT05073315.
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