Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis

Alten, Rieke; Markland, Colin; Boyce, Malcolm; Kazuki, Kenichi; Muniz, Rafael; Genovese, Mark C.

doi:10.1111/1756-185x.13951

Cited by 8 publications

(42 citation statements)

References 22 publications

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“…Alten et al studied the long‐term immunogenicity after single and double switching. No increases were reported for positive ADA status, ADA titre, or positive neutralising ADA status through week 76 in any treatment sequence 24 …”

Section: Resultsmentioning

confidence: 86%

“…Of these, 20 were articles 11,12,[20][21][22][23][24][25][26][27][28][30][31][32][33][34][35][36][37][38] and one was an abstract. 29 In these studies, eight adalimumab biosimilars were tested: ABP501 (seven studies), 12,22,29,32,34,36,37 SB5 (five studies), 20,28,33,35,38 FKB327 (two studies), 23,24 BI695501 (one study), 21 MSB11022 (one study), 30 GP2017 (three studies), 11,25,31 PF-061410293 (one study) 26 and CT-P17 (one study). 27 In all cases switching was performed after receiving treatment with reference adalimumab (Humira ® ).…”

Section: Search Resultsmentioning

confidence: 99%

“…Table S2 in the Supporting Information shows the characteristics of the 21 studies that were finally included. Of these, 20 were articles 11,12,[20][21][22][23][24][25][26][27][28][30][31][32][33][34][35][36][37][38] and one was an abstract. 29 In these studies, eight adalimumab biosimilars were tested: ABP501 (seven studies), 12,22,29,32,34,36,37 SB5 (five studies), 20,28,33,35,38 FKB327 (two studies), 23,24 BI695501 (one study), 21 MSB11022 (one study), 30 GP2017 (three studies), 11,25,31 PF-061410293 (one study) 26 and CT-P17 (one study).…”

Section: Search Resultsmentioning

confidence: 99%

“…We conducted a full reading of 34 articles. Finally, a total of 21 studies were included 11,12,20–38 . The result of the search strategies is shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

“…Data collection points ranged from 10 to 100 weeks. In 11 of the studies, anti‐drug antibodies (ADAs) were detected by a validated assay on an electrochemiluminescence platform 11,20–24,26,27,29,33 . In three studies, ADAs were measured by enzymatic immunoassay 33,35,38 .…”

Section: Resultsmentioning

confidence: 99%

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Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

García-Beloso

Altabás-González

Samartín-Ucha

et al. 2021

Brit J Clinical Pharma

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Adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there is an increasing number of adalimumab biosimilars. To assume the acceptability of interchangeability between reference adalimumab and biosimilars, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European UnionMember States. The aim of this study is to systematically review the evidence on the efficacy, safety and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases.Methods: Studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1 January 2004 to 30 June 2021.Results: A total of 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), one miscellaneous rheumatic disease, six psoriasis (PSO) and six inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups.Conclusions: Switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases such as psoriatic arthritis and ankylosing spondylitis.

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Section: Resultsmentioning

confidence: 86%

Section: Search Resultsmentioning

confidence: 99%

Section: Search Resultsmentioning

confidence: 99%

“…We conducted a full reading of 34 articles. Finally, a total of 21 studies were included 11,12,20–38 . The result of the search strategies is shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

García-Beloso

Altabás-González

Samartín-Ucha

et al. 2021

Brit J Clinical Pharma

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Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

et al. 2023

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ImportanceBiosimilar drugs are potentially lower-cost versions of biologics that may improve access to therapy. However, there is a lack of adequate systematic reviews demonstrating equivalence between these drugs for the treatment of rheumatoid arthritis (RA).ObjectivesTo assess the efficacy, safety, and immunogenicity associated with biosimilars of adalimumab, etanercept, and infliximab compared with their reference biologics in patients with RA.Data SourcesMEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS databases were searched from inception to September 2021.Study SelectionHead-to-head randomized clinical trials (RCTs) of biosimilars of adalimumab, etanercept, and infliximab and their biologic reference drugs for RA were assessed.Data Extraction and SynthesisTwo authors independently abstracted all data. Meta-analysis was conducted with bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences (SMDs) for continuous outcomes, with 95% credible intervals (CrIs) and trial sequential analysis. Specific domains were assessed for the risk of bias in equivalence and noninferiority trials. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline.Main Outcomes and MeasuresEquivalence was tested using prespecified margins for the American College of Rheumatology criteria, with at least 20% improvement in the core set measures (ACR20) (ie, RR, 0.94 to 1.06), and for the Health Assessment Questionnaire–Disability Index (HAQ-DI) (ie, SMD, −0.22 to 0.22). Secondary outcomes included 14 items measuring safety and immunogenicity.ResultsA total of 25 head-to-head trials provided data on 10 642 randomized patients with moderate to severe RA. Biosimilars met equivalence with reference biologics in terms of ACR20 response (24 RCTs with 10 259 patients; RR, 1.01; 95% CrI, 0.98 to 1.04; τ2 = 0.000) and change of HAQ-DI scores (14 RCTs with 5579 patients; SMD, −0.04; 95% CrI, −0.11 to 0.02; τ2 = 0.002) considering prespecified margins of equivalence. Trial sequential analysis found evidence for equivalence for ACR20 since 2017 and HAQ-DI since 2016. Overall, biosimilars were associated with similar safety and immunogenicity profiles compared with reference biologics.Conclusion and RelevanceIn this systematic review and meta-analysis, biosimilars of adalimumab, infliximab, and etanercept were associated with clinically equivalent treatment effects compared with their reference biologics for the treatment of RA.

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Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers

Dokoupilová,

Vetchý,

Pavloková

et al. 2024

International Journal of Pharmaceutics: X

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Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis

Cited by 8 publications

References 22 publications

Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers

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