Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lu, Xiaoqin; Hu, Rui; Lin, Peng; Liu, MengSi; Sun, Zhenliang

doi:10.3389/fimmu.2021.638444

Cited by 24 publications

(13 citation statements)

References 39 publications

(72 reference statements)

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“…RA often requires treatment with anti-inflammatory drugs that may affect the correlation between RA and risk of PD. Drugs commonly used in RA patients are non-steroidal anti-inflammatory drugs (NSAIDs) and immunosuppressive drugs including traditional disease-modifying anti-rheumatic drugs (DMARDs) (such as methotrexate, hydroxychloroquine, cyclosporine, azathioprine, and leflunomide) and biologic DMARDs (such as adalimumab, rituximab, etanercept, abatacept, golimumab, and tocilizumab) ( 27 , 28 ). Some epidemiological studies have suggested that NSAIDs may be protective against the development of PD ( 29 , 30 ), and basic experiments also showed that NSAIDs could reduce the formation of neurotoxic molecules and inhibit dopaminergic neurotoxicity, thereby exerting neuroprotective effects ( 31 – 33 ).…”

Section: Discussionmentioning

confidence: 99%

Association Between Rheumatoid Arthritis and Risk of Parkinson's Disease: A Meta-Analysis and Systematic Review

Hong

Chen

2022

Front. Neurol.

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BackgroundRheumatoid arthritis (RA) and Parkinson's disease (PD) are two common chronic diseases worldwide, and any potential link between the two would significantly impact public health practice. Considering the current inconsistent evidence, we conducted a meta-analysis and systematic review to examine the risk of PD in patients with RA.MethodsTwo investigators (DL and XH) conducted a comprehensive search of PubMed, Embase, and Web of Science using medical subject headings terms combined with free words to identify relevant papers published from inception through December 31, 2021. All studies that explored the relationship between RA and PD were included for quantitative analysis and qualitative review. Random- and fixed-effects models were used to pool the risk ratios (RRs) of PD in patients with RA. The Newcastle-Ottawa scale was used to assess the quality of included studies. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guideline.ResultsFour population-based studies involving 353,246 patients and one Mendelian randomized study were included in our study. The pooled result showed a significantly reduced risk of PD in patients with RA than in the general population (RR = 0.74, 95% CI: 0.56-0.98, P = 0.034). No apparent effects of gender, age, region, follow-up time, or study design on PD risk were observed. Sensitivity analysis showed that pooled results were relatively stable, and no publication bias was detected. The Mendelian randomization study indicated a significant inverse association between RA and PD (genetic correlation: −0.10, P = 0.0033) and that each one standard deviation increase in the risk of RA was significantly associated with a lower risk of PD. Of note, the current study is limited by the relatively small number of included studies and unmeasured confounding factors, especially for RA-related anti-inflammatory agents.ConclusionsThis study supports that people with RA had a lower PD risk than those without RA. Further studies are needed to explore the underlying molecular mechanisms of the interaction between the two diseases.

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Section: Discussionmentioning

confidence: 99%

Association Between Rheumatoid Arthritis and Risk of Parkinson's Disease: A Meta-Analysis and Systematic Review

Hong

Chen

2022

Front. Neurol.

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“…This is an anti-TNF-α monoclonal antibody approved by Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and hidradenitis suppurativa [13]. Its rare side effects include worsening or initiation of congestive heart failure, lupus-like syndrome, lymphoma, cytopenias, worsening or initiation of multiple sclerosis/neurological diseases, pancytopenia, and increased liver transaminases [14].…”

Section: Adalimumabmentioning

confidence: 99%

Towards Drug Repurposing in Cancer Cachexia: Potential Targets and Candidates

et al. 2021

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As a multifactorial and multiorgan syndrome, cancer cachexia is associated with decreased tolerance to antitumor treatments and increased morbidity and mortality rates. The current approaches for the treatment of this syndrome are not always effective and well established. Drug repurposing or repositioning consists of the investigation of pharmacological components that are already available or in clinical trials for certain diseases and explores if they can be used for new indications. Its advantages comparing to de novo drugs development are the reduced amount of time spent and costs. In this paper, we selected drugs already available or in clinical trials for non-cachexia indications and that are related to the pathways and molecular components involved in the different phenotypes of cancer cachexia syndrome. Thus, we introduce known drugs as possible candidates for drug repurposing in the treatment of cancer-induced cachexia.

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“…The tumor necrosis factor (TNF) inhibitor adalimumab (ADA) was the first fully human monoclonal antibody approved for use in RA (AbbVie Inc., Humira ®, Europe, 2003 [ 6 ], USA, 200 [ 7 ]). Since the originator product patent expired in 2016 (USA; Europe, 2018) [ 8 ], seven ADA biosimilars have been approved for use in RA [ 9 , 10 ]. Biosimilars are biotherapeutic products that are highly similar in pharmacokinetic, safety, immunogenic, and efficacy profiles to the licensed biotherapeutic reference product (bio-originator), and could reduce the treatment cost, thereby improving access to optimal therapy [ 9 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

“…Switching trials have shown that switching from the ADA bio-originator to a currently approved biosimilar does not significantly impact safety, immunogenicity, or efficacy [ 10 ]. Subtle differences were considered to be due to methodological differences rather than the biosimilar properties [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Outcomes Following Adalimumab Bio-originator to Biosimilar Switch—A Comparison Using Real-world Patient- and Physician-Reported Data in European Countries

et al. 2023

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Introduction The aim of this work is to compare real-world outcomes of patients with rheumatoid arthritis (RA) receiving adalimumab (ADA) bio-originator (non-switchers) to those who had switched from ADA bio-originator to an ADA biosimilar (switchers) on the basis of the hypothesis that these outcomes would differ. Methods Data were drawn from the Adelphi RA Disease Specific Programme™, a point-in-time survey of physicians and their patients in Europe (France, Germany, Italy, Spain, UK) in 2020. Physicians completed a questionnaire for their next ten adult patients with RA, followed by four additional patients who had switched from ADA bio-originator to an ADA biosimilar (switchers). Physician- and patient-reported outcomes (PROs) for switchers and non-switchers were compared by propensity score matching. Results Three hundred and three rheumatologists provided data for 160 non-switchers and 225 switchers, 140 patients provided data; 51 non-switchers, 89 switchers. According to physician-reported disease activity, non-switchers were more likely to improve on their current ADA treatment than switchers (68%, n = 108 vs. 26%, n = 59 p < 0.001) and less likely to worsen (1%, n = 2 vs. 9%, n = 20; p < 0.01). Physician-reported patient adherence was significantly lower amongst switchers versus non-switchers (0.66 vs. 0.78, respectively; p = 0.04). More non-switchers than switchers were reported by their physicians to be consistent in taking their RA medicine ( p < 0.001). Compared with non-switchers, PRO measures indicated quality of life was worse (EQ-5D Visual Analogue Scale: 62.9 vs. 71.9; p < 0.001) and activity impairment was greater (Work Productivity Activity Index: 31.0 vs. 24.4; p = 0.02) for switchers, with trends for poorer health status and greater pain. Conclusions Non-medical switching in RA treatment may lead to unforeseen outcomes that should be considered by health decision-makers. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00526-w.

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Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Cited by 24 publications

References 39 publications

Association Between Rheumatoid Arthritis and Risk of Parkinson's Disease: A Meta-Analysis and Systematic Review

Association Between Rheumatoid Arthritis and Risk of Parkinson's Disease: A Meta-Analysis and Systematic Review

Towards Drug Repurposing in Cancer Cachexia: Potential Targets and Candidates

Outcomes Following Adalimumab Bio-originator to Biosimilar Switch—A Comparison Using Real-world Patient- and Physician-Reported Data in European Countries

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