Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus® Insulin Glargine

Ilag, Leodevico L.; Costigan, Timothy M.; Deeg, Mark A.; Pollom, Robyn K.; Chang, Curtis; Konrad, Robert J.; Prince, Melvin

doi:10.1007/s13300-017-0253-8

Cited by 9 publications

(7 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Immunogenicity profiles appeared to be comparable across study groups in all studies. In two separate follow up analyses, Illag et al also supported the assessment that immunogenicity profiles were similar between LY2963016 and the respective reference product [ 44 , 45 ]. An investigation by Home et al demonstrated similar immunogenicity profile between SAR342434 and its reference product [ 46 ].…”

Section: Resultsmentioning

confidence: 87%

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review

et al. 2018

View full text Add to dashboard Cite

ImportanceFor nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017.ObjectiveTo summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products.Data sourcesWe conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018.Study selectionWe included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokinetics and pharmacodynamics of any biosimilar insulin with a reference product in adults regardless of sample size and location.Data extraction and synthesisTwo researchers independently reviewed all titles, abstracts and text; extracted data; and performed quality assessments.Main outcomes and measuresEfficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin productsResultsOf 6945 articles screened, 11 studies were included in the data synthesis. LY2963016, Basalog, Basalin, and MK-1293 were compared to Lantus while SAR342434 was compared to Humalog. Three trials enrolled healthy volunteers, five enrolled type 1 diabetics, and two enrolled type 2 diabetics. One study enrolled both healthy and type 1 diabetics. Of the eleven studies, six examined pharmacokinetic and/or pharmacodynamic parameters and five examined clinical efficacy and immunogenicity. All studies included adverse events. All PK and/or PD studies showed that comparable parameters of biosimilar and reference products were within the pre-specified equivalence margins. Clinical studies suggested similar clinical efficacy and immunogenicity. Adverse events were similar between the groups across all studies.Conclusions and relevanceFew published studies have compared biosimilar and reference insulins, though those that did suggest that the biosimilars have comparable safety and clinical efficacy as its reference product.

show abstract

Section: Resultsmentioning

confidence: 87%

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review

et al. 2018

View full text Add to dashboard Cite

show abstract

“…In an immunogenicity analysis across ELEMENT-1 and ELEMENT-2 studies, data from evaluable patients showed no significant differences between GLY and its reference product with regard to insulin antibody levels or relationship to efficacy or safety outcomes including adverse events of special interest such as allergic reactions (comparable to hypersensitivity reactions) 19 . Similarly, a post hoc analysis of ELEMENT-2 that stratified patients by age evaluated insulin antibody levels and showed no difference between GLY and its reference product overall or by age group 20 .…”

Section: Hypersensitivity Reactionsmentioning

confidence: 98%

Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study

Shingaki

Taki

Koyanagi

et al. 2020

Current Medical Research and Opinion

View full text Add to dashboard Cite

Objective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice. Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control. Results: The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulinnaive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was -1.2 (p ¼ .066) and 0.0 (p ¼ .915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was -0.5% (p < .001) and -0.9% (p < .001), respectively, and -1.5% (p < .001) in insulin-naive T2DM. Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice. ARTICLE HISTORY

show abstract

“…Studies that have evaluated biosimilar insulins against reference insulin products are very limited [10]. Lilly insulin glargine (LY IGlar; Basaglar ® , Eli Lilly and Company, Indianapolis, IN, USA, and Boehringer Ingelheim, Ingelheim am Rhein, Germany) is the first biosimilar insulin to have received approval in the highly regulated markets; it was approved in the EU and Japan in the year 2014 followed by approval as the first follow-on insulin in the USA [11]. It has recently received approval from the regulatory authorities in Korea, Taiwan, and India.…”

Section: Introductionmentioning

confidence: 99%

Lilly Insulin Glargine Versus Lantus® in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study

et al. 2019

View full text Add to dashboard Cite

Background and Objectives Lilly insulin glargine (LY IGlar; Basaglar ® ) and the reference insulin glargine product (IGlar; Lantus ® ) are basal insulin glargine analogs with identical amino acid sequence and similar pharmacological profiles. ELEMENT 5, a Phase 3, prospective, randomized, multinational, two-arm, active-controlled, open-label, parallel-design study in type 2 diabetes mellitus (T2DM) patients ( N = 493) showed similar efficacy and safety profiles with LY IGlar and IGlar. This study reports results from India ( N = 100) and East Asia ( N = 134) subpopulations. Methods Patients from India and East Asia (Korea and Taiwan) with T2DM who were insulin naïve (glycated hemoglobin (HbA1c) ≥ 7.0% and ≤ 11.0%) or on basal insulin (HbA1c ≤ 11.0%) were randomized to receive LY IGlar or IGlar along with oral antihyperglycemic medications (OAMs) for 24 weeks. Patients were instructed to self-titrate from the starting dose by 1 unit/day until fasting blood glucose (FBG) ≤ 5.6 mmol/L (100 mg/dL) was achieved. The key outcome was HbA1c change from baseline to Week 24. Results Within-group least-squares mean (LSM) decrease (baseline to Week 24) in HbA1c was similar between treatments. The upper limit of confidence interval (CI) for treatment difference was below the defined 0.4% noninferiority margin in India (LY IGlar: − 0.83%; IGlar: − 0.62%; difference [95% CI] − 0.21 [− 0.70, 0.28]) and East Asia (LY IGlar: − 1.28%; IGlar: − 1.26%; difference [95% CI] − 0.02 [− 0.34, 0.30]) subpopulations. Results of other efficacy and safety endpoints at Week 24 were similar between treatments in both subpopulations. LSM self-monitored FBG levels were similar between treatments at all visits in both subpopulations except at Week 24 in the India subpopulation (LY IGlar: 5.65 [0.10] mmol/L or 101.8 [1.86] mg/dL; IGlar: 5.18 [0.10] mmol/L or 93.3 [1.75] mg/dL; p = 0.002). Conclusion Efficacy and safety profiles of LY IGlar and IGlar, in combination with OAMs, were similar in India and East Asia subpopulations. This was consistent with the ELEMENT 5 total population. Clinical Trial Registration NCT02302716. Electronic supplementary material The online version of this article (10.1007/s40261-019-00798-1) contains supplementary material, which is available to authorized users.

show abstract

Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus® Insulin Glargine

Cited by 9 publications

References 15 publications

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review

Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study

Lilly Insulin Glargine Versus Lantus® in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study

Contact Info

Product

Resources

About