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Sirukumab ELISA Kit

Catalog #:   KDC15803 Specific References (50) DATASHEET
Applications: Used for the quantitative determination of Sirukumab concentration in serum and plasma.
Sample type: Plasma, Serum
Sensitivity: 1.58 ng/mL
Range: 2.06 - 500 ng/mL
Overview

Catalog No.

KDC15803

Description

PRINCIPLE OF THE ASSAY This assay employs the quantitative indirect enzyme immunoassay technique. Human IL6 has been pre-coated onto a microplate. Standards or samples are pipetted into the wells and any Sirukumab present is bound by the immobilized protein. After washing away any unbound substances, a biotin-labeled Mouse Anti-Human IgG antibody is added to the wells. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in proportion to the amount of Sirukumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Applications

Used for the quantitative determination of Sirukumab concentration in serum and plasma.

Detection method

Colorimetric

Sample type

Plasma, Serum

Assay type

Quantitative

Range

2.06 - 500 ng/mL

Sensitivity

1.58 ng/mL

Precision

Intra-Assay Precision (Precision within an assay): <10%

Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.

Inter-Assay Precision (Precision between assays): <15%

Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

Intra-Assay Precision

Inter-Assay Precision

Sample

1

2

3

1

2

3

n

16

16

16

24

24

24

Mean (ng/mL)

162.5

50.3

14.9

184.7

45.9

14.0

Standard deviation

15.4

4.7

1.5

25.5

6.5

2.0

CV (%)

9.5

9.3

10.1

13.8

14.2

14.0

Recovery

80-120%

Shipping

2-8 ℃

Stability and Storage

When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.

Alternative Names

CNTO 136, CAS: 1194585-53-9

Background

Sirukumab (developmental code name CNTO-136) is a human monoclonal antibody (mAb) designed for the treatment of rheumatoid arthritis (RA). It acts against the proinflammatory cytokine interleukin (IL) -6 (IL-6). Sirukumab was evaluated in five Phase 3 studies of patients with RA. In September 2016, Janssen submitted a biologics license application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active RA, but they announced in September 2017 that they received a complete response letter from the Food and Drug Administration (FDA) indicating additional clinical data were needed to further evaluate the safety of sirukumab in that patient population. Janssen subsequently decided not to pursue global approvals of sirukumab for the treatment of moderately to severely active RA. Sirukumab was being evaluated in a Phase 3 study (NCT02531633) of another inflammatory disease, giant cell arteritis. This study, sponsored by GlaxoSmithKline (GSK), was terminated in November 2017 due to GSK’s decision to return rights to sirukumab to Janssen and discontinue sirukumab development in giant cell arteritis. Also, in November 2017, a Phase 3 study (NCT02899026) sponsored by GSK of sirukumab in patients with polymyalgia rheumatica, an inflammatory disorder that causes muscle pain and stiffness, was withdrawn prior to enrollment.

Note

For Research Use Only.

Data Image
  • Experiment Example
    CALCULATION OF RESULTS
    Average the duplicate readings for each standard and sample. Construct a standard curve by plotting the mean absorbance for each standard on the Y-axis against the concentration on the X-axis and draw a best fit curve through the points on the graph. The data may be linearized by plotting the log of the Sirukumab concentrations versus the log of the O.D. and the best fit line can be determined by regression analysis. This procedure will produce an adequate but less precise fit of the data.
    If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
References

Sirukumab: A Potential Treatment for Mood Disorders?, PMID:27913990

Antibodies to watch in 2017., PMID:27960628

Absolute Bioavailability and Pharmacokinetic Comparability of Sirukumab Following Subcutaneous Administration by a Prefilled Syringe or an Autoinjector., PMID:28052588

Therapeutic Potential of Targeting the Th17/Treg Axis in Autoimmune Disorders., PMID:28098832

From mechanism to therapies in systemic lupus erythematosus., PMID:28118202

Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study., PMID:28215362

Rheumatoid Arthritis: Sirukumab effective in patients refractory to anti-TNF therapy., PMID:28250460

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update., PMID:28264816

Sirukumab: a promising therapy for rheumatoid arthritis., PMID:28374627

Profile of sarilumab and its potential in the treatment of rheumatoid arthritis., PMID:28579757

The effects of interleukin-6 neutralizing antibodies on symptoms of depressed mood and anhedonia in patients with rheumatoid arthritis and multicentric Castleman's disease., PMID:28676350

[Anti-IL-6 : new therapeutic trends]., PMID:28703549

Insulin Degludec/Liraglutide., PMID:28804155

Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study., PMID:28855173

Neuroendocrine and neurophysiological effects of interleukin 6 in rheumatoid arthritis., PMID:29186541

Efficacy and safety of sirukumab in Japanese patients with moderate to severe rheumatoid arthritis inadequately controlled by disease modifying anti-rheumatic drugs: Subgroup analysis of a phase 3 study., PMID:29336187

Comparison of the efficacy and tolerability of tocilizumab, sarilumab, and sirukumab in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials., PMID:29404725

Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naïve patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study., PMID:29483080

Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients., PMID:29514712

Efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis who were refractory or intolerant to anti-tumor necrosis factor therapy: Subgroup analysis of a randomized, double-blind, multicenter, phase 3 study (SIRROUND-T)., PMID:29532734

Confirmatory Population Pharmacokinetic Analysis for Sirukumab, a Human Monoclonal Antibody Targeting Interleukin-6, in Patients With Moderately to Severely Active Rheumatoid Arthritis., PMID:29578578

Rheumatoid arthritis: new monoclonal antibodies., PMID:29771256

Exposure-Response Modeling Analyses for Sirukumab, a Human Monoclonal Antibody Targeting Interleukin 6, in Patients With Moderately to Severely Active Rheumatoid Arthritis., PMID:29901815

Sirukumab for the treatment of rheumatoid arthritis: update on sirukumab, 2018., PMID:29925278

Joint longitudinal model development: application to exposure-response modeling of ACR and DAS scores in rheumatoid arthritis patients treated with sirukumab., PMID:29961161

Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review., PMID:30128641

The significant role of interleukin-6 and its signaling pathway in the immunopathogenesis and treatment of breast cancer., PMID:30372844

Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What's the Difference?, PMID:30488231

Investigating sirukumab for rheumatoid arthritis: 2-year results from the phase III SIRROUND-D study., PMID:30564449

Sirukumab and adalimumab reduce power Doppler ultrasound signal in patients with rheumatoid arthritis by 4 weeks in a phase III trial., PMID:31018960

Interleukin-6 inhibition in the management of non-infectious uveitis and beyond., PMID:31523783

Late-Stage Failures of Monoclonal Antibody Drugs: A Retrospective Case Study Analysis., PMID:31910414

Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis., PMID:32033937

Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis., PMID:32453485

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis., PMID:32844378

Safety and efficacy of newer biologics DMARDs in the management of rheumatoid arthritis: A systematic review., PMID:36474893

Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE)., PMID:33526709

Comparative effectiveness and safety of non-tumour necrosis factor biologics and Janus kinase inhibitors in patients with active rheumatoid arthritis showing insufficient response to tumour necrosis factor inhibitors: A Bayesian network meta-analysis of randomized controlled trials., PMID:33600008

Impact of Interferons and Biological Drug Inhibitors of IL-2 and IL-6 on Small-Molecule Drug Metabolism Through the Cytochrome P450 System., PMID:34078115

Comparison of the efficacy and safety of tocilizumab, sarilumab, and sirukumab in comparison with adalimumab as monotherapy in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials., PMID:34281633

Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: A network meta-analysis., PMID:34398007

Comparative efficacy and safety of biologic agents in patients with active rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitors: A Bayesian network meta-analysis of randomized controlled trials., PMID:34622767

A glance into the future of myositis therapy., PMID:35634354

Role of IL-6 and IL-6 targeted therapy in systemic lupus erythematosus., PMID:37594751

Drug Repurposing Analysis for Colorectal Cancer through Network Medicine Framework: Novel Candidate Drugs and Small Molecules., PMID:37682113

Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?, PMID:37989892

Immune-Targeted Therapies for Depression: Current Evidence for Antidepressant Effects of Monoclonal Antibodies., PMID:38959503

The IL-6 hypothesis in COVID-19: A phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of free IL-6 sequestration by the monoclonal antibody sirukumab in severe and critical COVID-19., PMID:39182655

Pharmacodynamic, prognostic, and predictive biomarkers in severe and critical COVID-19 patients treated with sirukumab., PMID:39362933

Corrigendum to "The IL-6 hypothesis in COVID-19: A phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of free IL-6 sequestration by the monoclonal antibody sirukumab in severe and critical COVID-19" [J Infect 89 (2024) 106241]., PMID:39541804

Datasheet

Document Download

Sirukumab ELISA Kit.pdf

 

$ 1128
Product specifications
96 T 1128

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