Trial reportAdvances in therapy2025
Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05637515 (A Multicenter, Randomized, Blinded, Parallel Group, Interchangeability Study in Moderate to Severe Chronic Plaque Psoriasis Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity Between Subjects Receiving Humira® Pre Filled Syringe), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Blinded, Parallel Group, Interchangeability Study in Moderate to Severe Chronic Plaque Psoriasis Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity Between Subjects Receiving Humira® Pre Filled Syringe (40 mg) Continuously and Subjects Undergoing Repeated Switches Between Humira® Pre Filled Syringe (40 mg) and Hulio Pre-filled Syringe (40 mg)
Who cites it
2 citing papers in PubMed.
- Article
- Tracing Five Decades of Psoriasis Pharmacotherapy: A Large-Scale Bibliometric Investigation with AI-Guided Terminology Normalization.Pharmaceuticals (Basel, Switzerland) · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis study was conducted to fulfill the FDA requirement for the designation of adalimumab-fkjp, an FDA-approved biosimilar, as an 'interchangeable' biosimilar to the reference adalimumab. The primary objective was to evaluate the interchangeability of adalimumab-fkjp (low concentration, 40 mg/0.8 mL) with reference adalimumab (high concentration, 40 mg/0.4 mL) by comparing adalimumab steady-state pharmacokinetics (PK) between switching and non-switching arms. The efficacy, safety, and immunogenicity were also evaluated.
methodsIn this randomized, double-blind, parallel-group study in patients with moderate-to-severe chronic plaque psoriasis (PPs) a total of 386 patients (134 F/252 M) with PPs for ≥ 6 months involving body surface area ≥ 10% and having a Psoriasis Area and Severity Index (PASI) ≥ 12 and static Physicians Global Assessment (sPGA) ≥ 3 (moderate) were enrolled into the run-in period to receive reference adalimumab (80 mg, Week 1; 40 mg biweekly, Weeks 2-10). At Week 12, patients with PASI ≥ 50 (n = 374) were randomized 1:1 to continue receiving reference adalimumab (n = 193; 40 mg/0.4 mL biweekly, Weeks 12-26) or undergo repeated switches between 40 mg/0.8 mL adalimumab-fkjp and 40 mg/0.4 mL reference adalimumab (n = 181; reference adalimumab-fkjp, Weeks 12 and 14; adalimumab, Weeks 16 and 18; and adalimumab-fkjp, Weeks 20, 22, 24, and 26). The assessments included PK (primary endpoints: AUC
resultsThe mean steady-state serum PK profiles were similar in both switching and non-switching arms. The 90% confidence intervals of LS mean ratios for AUC
conclusionPatients receiving adalimumab-fkjp (low concentration) and reference adalimumab (high concentration) in alternate fashion had similar PK, efficacy, safety, and immunogenicity profile. Interchangeability status has been granted to adalimumab-fkjp.
trial registrationClinicaltrial.gov identifier: NCT05637515, EudraCT No:2021-006015-29.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.