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Observational Study
. 2022 Dec;10(6):e01025.
doi: 10.1002/prp2.1025.

Continuous effectiveness and safety after a hospital-wide switch to adalimumab biosimilar: An observational study in rheumatoid arthritis patients

Rianne Brouwer  1 , Peter M Ten Klooster  2 , Joost B Masselink  3 , Harald E Vonkeman  1   2
Affiliations
Observational Study

Continuous effectiveness and safety after a hospital-wide switch to adalimumab biosimilar: An observational study in rheumatoid arthritis patients

Rianne Brouwer et al. Pharmacol Res Perspect. 2022 Dec.

Abstract

The objective of this study was to examine the maintenance of effect and safety after a hospital-wide switch for economic reasons from adalimumab originator Humira® to biosimilar Amgevita® in real-world rheumatoid arthritis (RA) patients and patient satisfaction with the switch. We conducted a single-center retrospective observational study of RA patients on the course of their disease activity (DAS28, ESR, and CRP), health-related quality of life (SF-36), and functional disability (HAQ-DI) before and up to 1 year after the switch, supplemented with a cross-sectional survey on satisfaction and experienced side effects approximately 18 months after the switch. Treatment outcomes were analyzed with linear mixed modeling and generalized estimating equations. Of 52 RA patients sufficient data were available. Disease activity levels, the proportion of patients in remission, and SF-36 and HAQ-DI scores did not significantly change from before the switch. Overall, patients were satisfied with the switch. Three patients (7.9%) stopped the biosimilar due to side effects. In conclusion, switching to the adalimumab biosimilar did not result in increased disease activity or worse patient-reported outcomes. Also, there was no apparent evidence of increased side effects. Patients themselves were mostly satisfied with the switching experience.

Keywords: adalimumab; biological therapies; biosimilar; disease activity; rheumatoid arthritis; switch.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

FIGURE 1
FIGURE 1
Flowchart patient selection. DAS28, 28‐joint Disease Activity Score.
FIGURE 2
FIGURE 2
Disease activity before and after the switch. Top panel: Mean DAS28 scores over time. Bottom panel: Percentage of patients in DAS28 remission (DAS28 < 2.6) over time. Error bars are 95% Wald confidence intervals. p‐values are based on post‐hoc analyses of difference from baseline with Fisher least significant difference correction for multiple comparisons. Light gray area indicates the time of switch. DAS28, 28‐joint disease activity score.
FIGURE 3
FIGURE 3
Markers of inflammation before and after the switch. Top panel: Mean ESR values over time. Bottom panel: Percentage of patients with a normal CRP value (CRP ≤10) over time. Error bars are 95% Wald confidence intervals. p‐values are based on post‐hoc analyses of difference from baseline with Fisher least significant difference correction for multiple comparisons. Light gray area indicates the time of switch. ESR, erythrocyte sedimentation rate, CRP, C‐reactive protein.
FIGURE 4
FIGURE 4
Patient‐reported outcomes before and after the switch. Top left panel: Mean physical health‐related quality of life. Top right panel: Mean mental health‐related quality of life. Bottom left panel: Mean functional disability over time. Bottom right panel: Percentage of patients with acceptable general health (VAS‐GH ≤20). Error bars are 95% Wald confidence intervals. p‐values are based on post‐hoc analyses of difference from baseline with Fisher least significant difference correction for multiple comparisons. Light gray area indicates the time of switch. SF‐36 PCS, Short Form‐36 Physical Component Summary; SF‐36 MCS, Short Form‐36 Mental Component Summary; HAQ‐DI, Health Assessment Questionnaire Disability Index; VAS‐GH, visual analog scale of general health.
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References

    1. Curtis JR, Singh JA. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther. 2011;33(6):679‐707. doi:10.1016/j.clinthera.2011.05.044 - DOI - PMC - PubMed
    1. Klareskog L, van der Heijde D, de Jager JP, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double‐blind randomised controlled trial. Lancet. 2004;363(9410):675‐681. doi:10.1016/S0140-6736(04)15640-7 - DOI - PubMed
    1. St.Clair EW, Van Der Heijde DMFM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004;50(11):3432‐3443. doi:10.1002/art.20568 - DOI - PubMed
    1. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double‐blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26‐37. doi:10.1002/art.21519 - DOI - PubMed
    1. Kalkan A, Hallert E, Bernfort L, Husberg M, Carlsson P. Costs of rheumatoid arthritis during the period 1990‐2010: a register‐based cost‐of‐illness study in Sweden. Rheumatol (United Kingdom). 2014;53(1):153‐160. doi:10.1093/rheumatology/ket290 - DOI - PubMed

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