Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26–52, including a treatment switch from reference ADL to PF-06410293

Fleischmann, Roy; Alvarez, Daniel; Bock, Amy E.; Cronenberger, Carol; Vranić, Ivana; Zhang, Wuyan; Alten, Rieke

doi:10.1136/rmdopen-2021-001578

Cited by 11 publications

(56 citation statements)

References 15 publications

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“…25 T A B L E 2 Clinical safety results in the studies finally included in the systematic review Fleischmann et al reported no clinically meaningful differences between RA treatment groups in the incidences of reported TEAEs of special interest, including injection-site reactions, anaphylaxis/ angioedema/urticaria or opportunistic infections. 26 Furst et al reported safety findings in RA patients that were consistent with the known safety profile of reference adalimumab. Most TEAEs were grade 1-2 in intensity.…”

Section: Safety Resultsmentioning

confidence: 59%

“…Eighteen of the 21 articles studied the safety of the study population (Table 2). 11,12,[20][21][22][23][24][25][26][27][28][30][31][32][34][35][36]38 Overall, infection was the most often reported treatment emergent adverse event (TEAE).…”

Section: Safety Resultsmentioning

confidence: 99%

“…Nineteen of the 21 articles assessed clinical efficacy (Table 1). 11,12,20–23,25–28,30–38 Seven of them included patients diagnosed with RA, 20–23,25–27 four with PSO, 11,12,30,31 six with IBD, 33–38 one with PSO or PsA, 32 and one with RA, axSpA, PsA or JIA 28 …”

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%

“…Fleischmann et al reported no clinically meaningful differences between RA treatment groups in the incidences of reported TEAEs of special interest, including injection‐site reactions, anaphylaxis/angioedema/urticaria or opportunistic infections 26 …”

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: Safety Resultsmentioning

confidence: 59%

Section: Safety Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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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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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Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis

et al. 2022

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Introduction The aim of this sub-study was to evaluate injection success of patients with rheumatoid arthritis (RA) and their caregivers administering the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada ® /Amsparity ® /Xilbrilada ® ) by prefilled pen (PFP) during the open-label treatment period in year two (weeks 52–78) of a phase 3 multinational, double-blind, clinical study (NCT02480153) comparing ADL-PF and reference ADL (Humira ® ) sourced from the EU. Methods This sub-study included adult patients with active RA not adequately controlled by methotrexate. Patients received subcutaneous ADL-PF 40 mg by prefilled syringe (PFS) at weeks 52 and 54, then six biweekly doses (weeks 56–66) of ADL-PF 40 mg each via a single-use PFP device. Training was given on first injection at week 56; all injections were given by patients/caregivers. The primary endpoint was delivery system success rate (DSSR): the percentage of participants (i.e., actual PFP user) achieving delivery success for each of the six attempted PFP injections. Injection success was recorded by the observer (Observer Assessment Tool) and participant (Participant Assessment Tool). Results In total, 50 patients with no experience self-injecting with an autoinjector/injection pen were included (74.0% female; mean age at screening, 54.9 years; mean RA duration, 8.0 years). Of these, 49 (98.0%) completed the sub-study and 46 (92.0%) received all six PFP injections. Overall DSSR ( n = 294 injections) across visits was 100% (95% CI 92.0–100.0%). Complete injection was confirmed following inspection of 292 used and returned PFPs. A total of 47/49 (95.9%) participants who completed the sub-study elected to continue study treatment using PFP injections, rather than switching back to the PFS. Conclusions All actual PFP users could safely and effectively administer ADL-PF by PFP at each visit, and nearly all participants who completed the sub-study elected to continue study treatment using PFP injections. Trial registration ClinicalTrials.gov identifier: NCT02480153; EudraCT number: 2014-000352-29. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00439-8.

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Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26–52, including a treatment switch from reference ADL to PF-06410293

Cited by 11 publications

References 15 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

Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis

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