Evidence mapPaperPMID 41874604Full record

ArticleDrug delivery2026

Performance evaluation of an adalimumab biosimilar autoinjector and its reference device: comparative use human factors study in patients with rheumatoid arthritis and juvenile idiopathic arthritis.

Sam Moses K, Suryaprakash Konda Ramachary Subramanian

Abstract readMulticenter StudyComparative Study
In one paragraph

Article in Drug delivery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Sam Moses KDevices R&D, Biocon Biologics Limited, Bengaluru, India.ORCID 0009-0008-0981-439X
Suryaprakash Konda Ramachary SubramanianDevices R&D, Biocon Biologics Limited, Bengaluru, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A Comparative Use Human Factors study was conducted to assess whether the injection success rate (SR) with biosimilar adalimumab-fkjp (Bios-ADA) autoinjector (Hulio®) is comparable to reference adalimumab (Ref-ADA) autoinjector (Humira®), accounting for design differences, including the absence of an activation button, to evaluate usability in the target patient population. A counterbalanced, multicenter study was conducted under simulated conditions, with patients completing multiple steps to administer the medication (40 mg Bios-ADA or Ref-ADA) into an injection pad using both devices. The endpoint was the overall SR for completing critical delivery system tasks with each device. A total of 55 patients (50 adults with rheumatoid arthritis and five patients with juvenile idiopathic arthritis and/or pediatric Crohn's disease) were enrolled. The overall SR for patients using the Bios-ADA autoinjector and the Ref-ADA was 92.7% (51/55) and 87.3% (48/55), respectively. Four and seven use errors were observed with the Bios-ADA and Ref-ADA autoinjectors, respectively. Bios-ADA autoinjector was non-inferior to Ref-ADA autoinjector, and design differences did not introduce clinically significant use-related risks. The Bios-ADA autoinjector can be used as a practical alternative to the Ref-ADA autoinjector from a usability perspective, with comparable overall performance during self-administration.

Indexed as

AdalimumabAntirheumatic AgentsArthritis, JuvenileArthritis, RheumatoidBiosimilar PharmaceuticalsAdolescentAdultAgedChildFemaleHumansMaleMiddle AgedYoung AdultAdalimumabAntirheumatic AgentsBiosimilar PharmaceuticalsAdalimumabautoinjectorbiosimilarCUHFrheumatoid arthritis

Identifiers

PMID41874604
PMCPMC13015018

What Socratic holds

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LicenceCC BY-NC
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Registered trials

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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.