ArticleEULAR rheumatology open2025
Comparison of the PK, PD, safety, tolerability, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab in healthy Japanese males: a phase 1, randomised, crossover study.
Article in EULAR rheumatology open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: RGB-19 is a proposed biosimilar to tocilizumab. This phase 1 study assessed the equivalence in pharmacokinetics (PKs) and compared the pharmacodynamics (PDs), safety, and immunogenicity of a single subcutaneous administration of RGB-19 and tocilizumab. Methods: Healthy Japanese males aged 20 to 40 years were included in this 2-period, 2-sequence crossover study. Participants were randomised 1:1 to RGB-19 162 mg or tocilizumab 162 mg in period 1 (day -1 to day 42), before crossing over treatment in period 2 (day 42 to day 85). The primary objective was to assess equivalence between treatments in the maximum serum drug concentration ( Results: In period 1, 110 participants were included, followed by 102 participants in period 2. PK equivalence was demonstrated between treatments for Conclusions: This study demonstrated equivalence in PK and similarity in PD, immunogenicity, and safety of RGB-19 and tocilizumab. These data suggest RGB-19 provides a similar therapeutic benefit to tocilizumab.
Identifiers
What Socratic holds
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.