scholarly journals Faculty Opinions recommendation of Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis.

2019 ◽  
Author(s):  
Tonia Vincent
Keyword(s):  
Variable Domain ◽  
Interleukin 1Β ◽  
Hand Osteoarthritis ◽  
Dual Variable ◽  
Randomised Study ◽  
Erosive Hand Osteoarthritis ◽  
Interleukin 1Α

scholarly journals Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis

2018 ◽  
Vol 78 (3) ◽  
pp. 413-420 ◽  
Author(s):  
Margreet Kloppenburg ◽  
Charles Peterfy ◽  
Ida K Haugen ◽  
Féline Kroon ◽  
Su Chen ◽  
...  
Keyword(s):  
Study Drug ◽  
High Sensitivity ◽  
Variable Domain ◽  
Analysis Of Covariance ◽  
Hand Osteoarthritis ◽  
Dual Variable ◽  
Randomised Study ◽  
Protein Levels ◽  
Blood Neutrophils ◽  
Erosive Hand Osteoarthritis

ObjectiveTo assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA).MethodsPatients with ≥1 erosive and ≥3 tender and/or swollen hand joints were randomised to placebo or lutikizumab 200 mg subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score from baseline to 16 weeks. At baseline and week 26, subjects had bilateral hand radiographs and MRI of the hand with the greatest number of baseline tender and/or swollen joints. Continuous endpoints were assessed using analysis of covariance models, with treatment and country as main factors and baseline measurements as covariates.ResultsOf 132 randomised subjects, 1 received no study drug and 110 completed the study (placebo, 61/67 (91%); lutikizumab, 49/64 (77%)). AUSCAN pain was not different among subjects treated with lutikizumab versus placebo at week 16 (least squares mean difference, 1.5 (95% CI –1.9 to 5.0)). Other clinical and imaging endpoints were not different between lutikizumab and placebo. Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils. Lutikizumab pharmacokinetics were consistent with phase I studies and not affected by antidrug antibodies. Injection site reactions and neutropaenia were more common in the lutikizumab group; discontinuations because of adverse events occurred more frequently with lutikizumab (4/64) versus placebo (1/67).ConclusionDespite adequate blockade of IL-1, lutikizumab did not improve pain or imaging outcomes in erosive HOA compared with placebo.

scholarly journals Is Lutikizumab, an Anti–Interleukin-1α/β Dual Variable Domain Immunoglobulin, efficacious for Osteoarthritis? Results from a bayesian network meta-analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Ziqin Cao ◽  
Yajia Li ◽  
Wanchun Wang ◽  
Shuo Jie ◽  
Xuantao Hu ◽  
...  
Keyword(s):  
Pain Relief ◽  
Bayesian Network ◽  
Meta Analysis ◽  
Variable Domain ◽  
Dual Variable ◽  
Efficacy And Safety ◽  
Study Results ◽  
Interleukin 1Α ◽  
Cox 2 ◽  
Cox 2 Inhibitors

Objective. Most guidelines recommend the use of nonsteroidal anti-inflammatory drugs (NSAIDs), duloxetine, and tramadol for the nonoperative treatment of osteoarthritis (OA), but the use of them is limited by the tolerability and safety concerns. Lutikizumab is a novel anti–IL-1α/β dual variable domain immunoglobulin that can simultaneously bind and inhibit IL-1α and IL-1β to relieve the pain and dysfunction symptoms. We conducted this network meta-analysis to comprehensively compare the clinical efficacy and safety of lutikizumab with other drugs recommended by guidelines. Methods. We conducted a Bayesian network and conventional meta-analyses to compare the efficacy and safety of lutikizumab with other traditional drugs. All eligible randomized clinical trials, in PubMed, CNKI, EMBASE, and Web of Science databases, from January 2000 to January 2020, were included. The Cochrane risk of the bias assessment tool was used for quality assessment. Pain relief, function improvement, and risk of adverse effects (AEs) were compared in this study. Results. 24 articles with 11858 patients were included. Duloxetine (DUL) had the largest effect for pain relief (4.76, 95% CI [2.35 to 7.17]), and selective cox-2 inhibitors (SCI) were the most efficacious treatment for physical function improvement (SMD 3.94, 95% CI [2.48 to 5.40]). Lutikizumab showed no benefit compared with placebo for both pain relief (SMD 1.11, 95% CI [-2.29 to 4.52]) and function improvement (SMD 0.992, 95% CI [-0.433 to 4.25]). Lutikizumab and all other drugs are of favorable tolerance for patients in the treatment of OA compared with placebo. Conclusions. Lutikizumab, the new anti–Interleukin-1α/β dual variable domain immunoglobulin, showed no improvement in pain or function when compared with placebo. Selective cox-2 inhibitors and duloxetine remain the most effective and safest treatment for OA. More high-quality trials are still needed to reconfirm the findings of this study.

scholarly journals A Phase II Trial of Lutikizumab, an Anti–Interleukin‐1α/β Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis

2019 ◽  
Vol 71 (7) ◽  
pp. 1056-1069 ◽  
Author(s):  
Roy M. Fleischmann ◽  
Henning Bliddal ◽  
Francisco J. Blanco ◽  
Thomas J. Schnitzer ◽  
Charles Peterfy ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Variable Domain ◽  
Dual Variable ◽  
Interleukin 1Α

scholarly journals Is Lutikizumab, an Anti–Interleukin-1α/β Dual Variable Domain Immunoglobulin, efficacious for Osteoarthritis? Results from a bayesian network meta-analysis

2020 ◽  
Author(s):  
Ziqin Cao ◽  
Xutao Hu ◽  
Jian Zhou ◽  
Tong Wu ◽  
Dilihumaer Aili ◽  
...  
Keyword(s):  
Pain Relief ◽  
Bayesian Network ◽  
Meta Analysis ◽  
Variable Domain ◽  
Joint Disease ◽  
Knee Joints ◽  
Dual Variable ◽  
Interleukin 1Α ◽  
Meta Analyses ◽  
And Function

Abstract OBJECTIVEOsteoarthritis (OA) is the most common form of joint disease which usually affects load-bearing joints such as hip and knee joints. Most guidelines recommend the use non-steroidal anti-inflammatory drugs (NSAIDs), duloxetine and tramadol for the non-operative treatment of OA, the use of them is limited by the tolerability and safety concerns. Lutikizumab is a novel anti–IL-1α/β dual variable domain immunoglobulin that can simultaneously binds and inhibits IL-1α and IL-1β to relieve the pain and dysfunction symptoms. We conducted this network meta-analysis to comprehensively compare the clinical efficacy and safety of lutikizumab with other drugs recommended by guidelines.DESIGNSystematic review and Bayesian network meta-analysis.DATA SOURCESAll eligible studies in PubMed, CKNI, EMBASE and Web of Science databases, from January 2000 to January 2020.METHODSBayesian network and conventional meta-analyses were conducted. Pain relief, function improvement and risk of adverse effects (AEs) were assessed.RESULTS24 articles with 11858 patients were included. Lutikizumab showed no benifit compared with placebo for both pain relief (SMD 1.11, 95% CI [-2.29 to 4.52]) and function improvement (SMD 0.992, 95% CI [-0.433 to 4.25]). Lutikizumab and all other drugs are of favorable tolerance for patients in treatment of OA compared with placebo.CONCLUSIONSThe results show that lutikizumab, the new anti–Interleukin-1α/β dual variable domain immunoglobulin, did not improve pain or function in the comparison with placebo. Selective cox-2 inhibitors remain the most effective and safest treatment for osteoarthritis. More high-quality trials are still needed to reconfirm the findings of this study.

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