sarilumab

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sarilumab

GtoPdb Ligand ID: 7999

Synonyms: Kevzara® | REGN88 | SAR153191

sarilumab is an approved drug (EMA & FDA (2017))

Comment: Sarilumab is a monoclonal antibody directed against the interleukin 6 receptor (IL6R).
Peptide sequence and structural information for this antibody are available from its IMGT/mAb-db record. Peptide sequence BLAST search using the heavy and light chain variable regions of sarilumab provides 100% matches to sequences covered by patent US7582298 [4], and to the antibody with designation VQ8F11-21.

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Summary of Clinical Use
Sarilumab was granted FDA approval as a treatment for moderate to severe active RA in May 2017 (with EMA approval granted in June 2017), following evaluation in several clinical trials, either as a monotherapy (eg NCT02121210) or in combination with other drugs such as etanercept, methotrexate, tocilizumab and adalimumab. Click here to link to ClinicalTrials.gov's listing of Phase 3 sarilumab trials. A Phase 2 study for non-infectious uveitis (NCT01900431) has been completed, whereas a Phase 2 extension study (NCT01118728) for ankylosing spondylitis was terminated. SARS-CoV-2 and COVID-19: Sarilumab has been evaluated for potential to reduce exaggerated inflammation in hospitalised patients with COVID-19. The Phase 2/3 clinical trial (NCT04315298) did not meet its primary or secondary endpoints in these patients and the trial was terminated. An Italian trial also failed to find mortality benefit [3]. However, early in 2021, data was reported from a small cohort of severely ill, mechanically ventilated COVID-19 patients in the REMAP-CAP trial ( NCT02735707) who received sarilumab. The information released (data not yet published) suggested that sarilumab (compared to standard care) significantly reduced mortality and that patients treated with this mAb were able to leave intensive care 7-10 days earlier than those who didn't receive the drug. Similar efficacy was observed in patients who received the alternative anti-IL-6R mAb tocilizumab. The effects of mAb therapy appeared to be in addition to the benefit provided by dexamethasone.

Summary of Clinical Use

Sarilumab was granted FDA approval as a treatment for moderate to severe active RA in May 2017 (with EMA approval granted in June 2017), following evaluation in several clinical trials, either as a monotherapy (eg NCT02121210) or in combination with other drugs such as etanercept, methotrexate, tocilizumab and adalimumab.
Click here to link to ClinicalTrials.gov's listing of Phase 3 sarilumab trials. A Phase 2 study for non-infectious uveitis (NCT01900431) has been completed, whereas a Phase 2 extension study (NCT01118728) for ankylosing spondylitis was terminated.

SARS-CoV-2 and COVID-19: Sarilumab has been evaluated for potential to reduce exaggerated inflammation in hospitalised patients with COVID-19. The Phase 2/3 clinical trial (NCT04315298) did not meet its primary or secondary endpoints in these patients and the trial was terminated. An Italian trial also failed to find mortality benefit [3]. However, early in 2021, data was reported from a small cohort of severely ill, mechanically ventilated COVID-19 patients in the REMAP-CAP trial ( NCT02735707) who received sarilumab. The information released (data not yet published) suggested that sarilumab (compared to standard care) significantly reduced mortality and that patients treated with this mAb were able to leave intensive care 7-10 days earlier than those who didn't receive the drug. Similar efficacy was observed in patients who received the alternative anti-IL-6R mAb tocilizumab. The effects of mAb therapy appeared to be in addition to the benefit provided by dexamethasone.

Mechanism Of Action and Pharmacodynamic Effects
Interleukin 6 (IL6) is a potent pleiotropic cytokine that regulates cell growth and differentiation and plays an important role in the immune response. Dysregulated production of IL6 and its receptor are implicated in the pathogenesis of autoimmune diseases such as RA. Sarilumab blocks the abberant IL6R signalling associated with RA, thereby modulating pathological symptoms.

Mechanism Of Action and Pharmacodynamic Effects

Interleukin 6 (IL6) is a potent pleiotropic cytokine that regulates cell growth and differentiation and plays an important role in the immune response. Dysregulated production of IL6 and its receptor are implicated in the pathogenesis of autoimmune diseases such as RA. Sarilumab blocks the abberant IL6R signalling associated with RA, thereby modulating pathological symptoms.