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
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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.
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