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Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

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Abstract

Objective

SB5 showed comparable efficacy and safety profile in respect to adalimumab originator (ADA) in randomized clinical trials of rheumatoid arthritis (RA) and psoriasis. We aimed to describe the efficacy and safety of SB5 after switching from ADA in RA, axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and juvenile idiopathic arthritis (JIA) patients.

Method

Adult RA, PsA, axSpA, JIA patients treated with ADA for at least 6 months, switched to SB5 in stable clinical conditions, were eligible. Data on safety, activity indexes and patient-reported outcomes were collected at baseline, 3 and 6 months after switching.

Results

Eighty-two patients (19 RA, 28 PsA, 32 axSpA and 3 JIA; 45 females, mean age 54 ± 14 years, disease duration 13 ± 7 years, ADA duration 6 ± 3 years) were enrolled. RA patients showed stable conditions, while PsA patients showed an increase in both HAQ, DAS28(CRP) and DAPSA and axSpA patients an increase in VAS pain, VAS patient disease activity and ASDAS, both at 3 months. There were changes in the concomitant medications profile, with regression of activity indexes increases at 6 months. Adverse events were reported by 33.7% patients at 3 months and 16.6% patients at 6 months, mostly disease flares and infectious events. Two patients stopped SB5.

Conclusions

Despite temporary changes in the concomitant medication profile for mild disease flares, our real-life data replicate the safety profile of switching from ADA to SB5 in RA, with additional data for its applicability in PsA and axSpA patients, further supporting switching to biosimilars in treating inflammatory rheumatic conditions.

Key Points

• Switching from adalimumab originator to SB5 is feasible in real life rheumatic inflammatory joint diseases.

• Mild disease flares can present after switching from originator adalimumab to SB5, in particular in axial spondyloarthritis and psoriatic arthritis.

• Changes in concomitant medications profile allows the control of minor disease flares presenting after switching from adalimumab originator to SB5.

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank the patients who participated to the study.

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Authors and Affiliations

  1. Department of Experimental and Clinical Medicine, Division of Rheumatology, University of Firenze, Via delle Oblate 4, 50141, Florence, Italy

    Cosimo Bruni, Roberta Bitti, Francesca Nacci, Laura Cometi, Lorenzo Tofani & Marco Matucci-Cerinic

  2. Department of Geriatric Medicine, Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, Via delle Oblate 4, 50141, Florence, Italy

    Francesca Bartoli, Ginevra Fiori & Marco Matucci-Cerinic

Authors
  1. Cosimo Bruni
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  2. Roberta Bitti
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  3. Francesca Nacci
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  4. Laura Cometi
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  5. Lorenzo Tofani
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  8. Marco Matucci-Cerinic
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by CB, RB, FN, LC, LT. The first draft of the manuscript was written by CB and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Cosimo Bruni.

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Conflict of interest

CB received honoraria from Actelion and Eli-Lilly; RB, FN, LC, LT, FB, GF: none. MMC reports receipt of grant/research support and/or speaker’s bureau attendance from Actelion, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, Bayer - MSD, Biogen, Eli Lilly.

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Obtained from Comitato Etico Area Vasta Toscana Centro.

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Bruni, C., Bitti, R., Nacci, F. et al. Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases. Clin Rheumatol 40, 85–91 (2021). https://doi.org/10.1007/s10067-020-05199-w

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  • DOI: https://doi.org/10.1007/s10067-020-05199-w

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