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

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Abstract

Background

Patient 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.

Aim

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

Method

iBaSS 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.

Results

A 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.

Conclusion

This 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

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Acknowledgements

The authors are grateful to all of the participants for their contribution to the trial. With thanks to PHARMExcel for supporting the management of the trial. The contribution of Ulrich Freudensprung to the development of the statistical analysis plan is acknowledged. Clinical trial registered with EudraCT (number 2018-004967-30).

Funding

This is an investigator-initiated study with financial support from Biogen Idec Ltd..

Author information

Authors and Affiliations

  1. Pharmacy Department, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK

    David Young

  2. Faculty of Medicine, University of Southampton, Southampton, UK

    David Young, Clare Harris & Fraser Cummings

  3. Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK

    Clare Harris, Sohail Rahmany & Fraser Cummings

  4. Faculdade de Farmacia, Universidade Lisboa, Lisbon, Portugal

    Inês Iria & João Gonçalves

  5. Biogen UK, Maidenhead, UK

    Janet Addison

  6. Department of Statistics and Actuarial Science, Stellenbosch University, Stellenbosch, South Africa

    Justin Harvey

  7. School of Health Sciences, University of Southampton, Southampton, UK

    Sue Latter

Authors
  1. David Young
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Corresponding author

Correspondence to David Young.

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Conflicts of interest

DY has received personal fees from Galapagos. SR has received travel grant from Celltrion Healthcare and honoraria from Celltrion Healthcare and Galapagos. JG has acted as a speaker for Sandoz, AstraZeneca, Pfizer, Samsung Bioepis, and Libbs, and has received research funding from AstraZeneca and Pfizer. JA is an employee of and may hold stocks in Biogen. FC has served as consultant, advisory board member, or speaker for AbbVie, Amgen, Celltrion, Falk, Ferring, Gilead, Galapagos, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Sandoz, Biogen, Samsung, Tillotts and Takeda. He has received research funding from Biogen, Amgen, Hospira/Pfizer, Celltrion, Takeda, Janssen, GSK and AstraZeneca. The other authors have no conflicts of interest to declare.

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Young, D., Harris, C., Rahmany, S. et al. A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS). Int J Clin Pharm (2024). https://doi.org/10.1007/s11096-024-01739-5

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