Evidence map›Paper›PMID 38734866›Full record

Trial reportInternational journal of clinical pharmacy2024

A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS).

David Young, Clare Harris, Sohail Rahmany, Inês Iria, João Gonçalves, Janet Addison, Justin Harvey, Sue Latter, Fraser Cummings

Abstract readRandomized Controlled TrialClinical Trial, Phase IV
PubMed Publisher
In one paragraph

Trial report in International journal of clinical pharmacy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Review
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

9 authors.

David YoungPharmacy Department, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK. david.young@uhs.nhs.uk.ORCID http://orcid.org/0000-0003-0102-5739
Clare HarrisFaculty of Medicine, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0002-8233-7509
Sohail RahmanyDepartment of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.ORCID http://orcid.org/0000-0003-0924-2690
Inês IriaFaculdade de Farmacia, Universidade Lisboa, Lisbon, Portugal.
João GonçalvesFaculdade de Farmacia, Universidade Lisboa, Lisbon, Portugal.
Janet AddisonBiogen UK, Maidenhead, UK.
Justin HarveyDepartment of Statistics and Actuarial Science, Stellenbosch University, Stellenbosch, South Africa.
Sue LatterSchool of Health Sciences, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0003-0973-0512
Fraser CummingsFaculty of Medicine, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0002-9659-3247

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful implementation of biosimilar medicines, little is known about the patient perspective of transition.

aimThe aim of this study was to investigate clinical outcomes and patient experience of transitioning between reference adalimumab and a biosimilar (SB5).

methodiBaSS is a phase IV single-centre, prospective, randomised, single-blind, cross-over study in adult subjects with Crohn's disease. Participants, stable on adalimumab before consent, received 24 weeks of treatment with both reference adalimumab and SB5. The primary outcome was the proportion of patients maintaining baseline clinical status throughout each treatment period, with patients' perspective of disease control and treatment satisfaction assessed as secondary outcomes.

resultsA total of 112 participants, representative of the heterogeneous patient populations encountered in routine clinical practice, were enrolled. A similar proportion of participants maintained baseline clinical status through each treatment period: 81.8% with reference adalimumab and 79.5% with SB5. Patient reported outcomes (IBD-Control questionnaire (SB5: 15.5; reference adalimumab 15) and TSQM), adverse events and therapeutic drug monitoring remained consistent through both treatment periods, although a higher median injection pain VAS score was noted with SB5 (53/100 versus 6/100 with reference adalimumab). The number of switches undertaken in the study did not impact serum drug concentration or immunogenicity.

conclusionThis study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes. CLINICAL TRIAL REGISTERED WITH EUDRACT: Number 2018-004967-30.

Indexed as

AdalimumabBiosimilar PharmaceuticalsCrohn DiseaseCross-Over StudiesPatient SatisfactionAdultAnti-Inflammatory AgentsFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresProspective StudiesSingle-Blind MethodTreatment OutcomeYoung AdultAdalimumabAnti-Inflammatory AgentsBiosimilar PharmaceuticalsAdalimumabBiosimilar pharmaceuticalsCrohn diseasePatient reported outcome measuresPatient satisfaction

Identifiers

PMID38734866

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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 OpenQuestion graph.