Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies

Genovese, Mark C.; Fleischmann, Roy; Kivitz, Alan; Lee, Eun-Bong; Hoogstraten, Hubert van; Kimura, Takeshi; John, Gregory St; Mangan, Erin; Burmester, Gerd R

doi:10.1186/s13075-020-02194-z

Cited by 27 publications

(19 citation statements)

References 37 publications

(69 reference statements)

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“…Following evidence from BC cell line models [113], a phase I trial is currently underway to assess use of tocilizumab in combination with HER2-targeted therapy to treat trastuzumab-resistant HER2+ metastatic BC (NCT03135171). Other anti-IL6R antibodies such as sarilumab and NI-1201 are currently also in development [299,300].…”

Section: Therapeutic Targeting Of Gp130/il6st Signallingmentioning

confidence: 99%

The IL6-like Cytokine Family: Role and Biomarker Potential in Breast Cancer

Martínez-Pérez

Kay

Meehan

et al. 2021

JPM

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IL6-like cytokines are a family of regulators with a complex, pleiotropic role in both the healthy organism, where they regulate immunity and homeostasis, and in different diseases, including cancer. Here we summarise how these cytokines exert their effect through the shared signal transducer IL6ST (gp130) and we review the extensive evidence on the role that different members of this family play in breast cancer. Additionally, we discuss how the different cytokines, their related receptors and downstream effectors, as well as specific polymorphisms in these molecules, can serve as predictive or prognostic biomarkers with the potential for clinical application in breast cancer. Lastly, we also discuss how our increasing understanding of this complex signalling axis presents promising opportunities for the development or repurposing of therapeutic strategies against cancer and, specifically, breast neoplasms.

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Section: Therapeutic Targeting Of Gp130/il6st Signallingmentioning

confidence: 99%

The IL6-like Cytokine Family: Role and Biomarker Potential in Breast Cancer

Martínez-Pérez

Kay

Meehan

et al. 2021

JPM

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“…В исследованиях сарилумаба MOBILITY [23], TARGET [24], MONARCH [25] были получены аналогичные результаты. Они подтвердили возможность применения препарата в виде монотерапии [26][27][28]. Именно поэтому в международных и российских клинических рекомендациях [2,3]…”

Section: клиническая эффективностьunclassified

Interleukin 6 Receptor Inhibitor Levilimab in the Treatment of Rheumatoid Arthritis

Karateev¹,

Luchikhina²

2022

EPh

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The inhibitors of the biological effects of interleukin 6 (IL-6) are the most actively developing group of biologics for the treatment of rheumatoid arthritis (RA) due to pleiotropic effects of this most important pro-inflammatory cytokine, which stimulates a number of processes that play an important role in the pathogenesis of RA. IL-6 receptor (IL-6R) is of great importance in the implementation of these biological effects. Activation of IL-6R occurs with the participation of the glycoprotein gp130 in three variants: classical, and in trans-signaling and trans-presentation modes. The most recent representative of this group is levilimab, an IgG1 monoclonal antibody to IL-6R that binds both soluble and membrane forms of the receptor. The efficacy and safety of levilimab has been demonstrated in the Phase II AURORA and Phase III SOLAR trials. The paper presents the main statements of the resolution of the regional expert council of rheumatologists of Moscow and the Moscow Region on the topic: ‘The place of a new IL-6R inhibitor levilimab in the treatment of patients with rheumatoid arthritis’, which took place on December 18, 2021 in Moscow. The panel of experts confirmed that levilimab is recommended for widespread use in patients with active RA who fail or are intolerant to traditional synthetic DMARDs.

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“…The development of ADAs was not connected with adverse effects or loss of efficacy, although it may have an impact on sarilumab pharmacokinetics ( 346 ). A phase III multicenter, randomized, controlled studies indicated that sarilumab might be more effective in RA patients who were ACPA positive ( 311 ). Also, better clinical response to sarilumab was consistently observed among patients who were RF positive and/or CCP positive in MOBILITY and TARGET studies ( 312 ).…”

Section: Bdmards Blocking T Cells Cd20 and Il-6rmentioning

confidence: 99%

Toward Overcoming Treatment Failure in Rheumatoid Arthritis

et al. 2021

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Rheumatoid arthritis (RA) is an autoimmune disorder characterized by inflammation and bone erosion. The exact mechanism of RA is still unknown, but various immune cytokines, signaling pathways and effector cells are involved. Disease-modifying antirheumatic drugs (DMARDs) are commonly used in RA treatment and classified into different categories. Nevertheless, RA treatment is based on a “trial-and-error” approach, and a substantial proportion of patients show failed therapy for each DMARD. Over the past decades, great efforts have been made to overcome treatment failure, including identification of biomarkers, exploration of the reasons for loss of efficacy, development of sequential or combinational DMARDs strategies and approval of new DMARDs. Here, we summarize these efforts, which would provide valuable insights for accurate RA clinical medication. While gratifying, researchers realize that these efforts are still far from enough to recommend specific DMARDs for individual patients. Precision medicine is an emerging medical model that proposes a highly individualized and tailored approach for disease management. In this review, we also discuss the potential of precision medicine for overcoming RA treatment failure, with the introduction of various cutting-edge technologies and big data.

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Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies

Cited by 27 publications

References 37 publications

The IL6-like Cytokine Family: Role and Biomarker Potential in Breast Cancer

The IL6-like Cytokine Family: Role and Biomarker Potential in Breast Cancer

Interleukin 6 Receptor Inhibitor Levilimab in the Treatment of Rheumatoid Arthritis

Toward Overcoming Treatment Failure in Rheumatoid Arthritis

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