Sarilumab

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Sarilumab
Monoclonal antibody
Type Whole antibody
Source Human
Target IL-6R
Clinical data
Routes of
administration
Subcutaneous injection
ATC code
Legal status
Legal status
  • Investigational
Identifiers
CAS Number
ChemSpider
  • none
KEGG
Chemical and physical data
Formula C6388H9918N1718O1998S44
Molar mass 144.13 kg/mol
 NYesY (what is this?)  (verify)

Sarilumab (Kevzara) is a human monoclonal antibody against the interleukin-6 receptor.[1]

Regeneron and Sanofi developed the drug for the treatment of rheumatoid arthritis (RA), for which it received FDA approval on May 22, 2017.

Development in ankylosing spondylitis has been suspended after the drug failed to show clinical benefit over methotrexate in a phase II trial.[2]

Clinical trials[edit]

Rheumatoid arthritis[edit]

On May 15, 2013, both companies announced that 2 new trials were starting (COMPARE and ASCERTAIN) and the first patients had already been enrolled.[3]

In June 2015 a phase 3 trial (with methotrexate) for RA reported meeting its 3 coprimary endpoints.[4]

In Nov 2015 the SARIL-RA-TARGET trial reported good results (meeting both its coprimary end points).[5]

In Nov 2016 the MONARCH phase III trial comparing sarilimab to adalimumab (an anti-TNF) found sarilumab superior at reducing the DAS28-ESR score in patients with RA after 24 weeks.[6]

History[edit]

In October 2016 the US FDA refused approval (for RA) due to GMP violations.[6]

Side effects of subcutaneous sarilumab[edit]

The MONARCH trial suggested a significantly higher incidence of neutropenia in patients receiving 200 mg sarilumab every 2 weeks, compared to patients being treated with adalimumab (13.6% vs 0.5%). However, infection rates were similar between both groups (28.8% vs 27.7%).[6]

See also[edit]

References[edit]

  1. ^ "Statement On A Nonproprietary Name Adopted By The USAN Council: Sarilumab" (PDF). American Medical Association.  Needs subscription
  2. ^ Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis. July 2011
  3. ^ Sanofi and Regeneron Announce Patient Enrollment in Two Phase 3 Trials with Sarilumab in Rheumatoid Arthritis (RA). May 2013
  4. ^ "Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study.". Arthritis Rheumatol. 67 (6): 1424–37. 2015. PMID 25733246. doi:10.1002/art.39093. 
  5. ^ Sarilumab effective in broad range of RA patients: Study
  6. ^ a b c Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH). Nov 2016