Thursday, 17 Aug 2017

You are here

IL-6 Inhibitor Kevzara Granted FDA Approval for Rheumatoid Arthritis

The FDA has approved sarilumab (Kevzara), a new IL-6 inhibitor co-developed by Regeneron and Sanofi's, for use in adults with moderate to severe rheumatoid arthritis (RA).

Although approved in Canada in February 2017, the US submission of the sarilumabs BLA was held up by the FDA with a complete response letter and concerns about manufacturing.

Kevzara is indicated for adult patients with moderate to severe, active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to at least one DMARD. It is and anti-IL-6 receptor targeted therapy.

Sarilumab is off to a unique start with the manufacturers pricing the product 30% lower than TNF inhibitor competitors, and will carry a list price of $39,000 per year for the 200 milligram and 150 mg doses.

FDA approval is based on approximately 2,900 RA patients where it has been shown to yield significant clinical improvement and significantly less radiographic progression compared to placebo plus MTX.

The safety profile of sarilumab appears to be similar to other IL-6 inhibitors studied in RA.

The package insert (http://buff.ly/2rPpTFc) states that the drug is indicated for use as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs, at a dose of 200 mg once given subcutaneously every two weeks,  It comes with warnings about serious infection, bowel perforations, neutropenia, transaminitis and hyperlipidemia. It requires TB screening prior to use and should not be given with live virus vaccines. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

How Much Testing is Enough?

I saw a patient this past week with new onset polyarthralgia, which led me to ponder how my fellow rheumatologists would utilize laboratory testing in such a patient.

JIA Worsens Quality of Life Long into Adulthood

Adult patients with a history of juvenile idiopathic arthritis (JIA) showed poorer health-related quality of life decades later, compared with individuals who were healthy as children -- even if they were in clinical remission, reported researchers in Norway.

CDC: Outbreak of Arthrocentesis Related Septic Arthritis Cases in New Jersey

In March 2017, an outbreak of 41 cases of septic arthritis associated with intra-articular injections administered at an single outpatient practice occurred in New Jersey. A public health investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products. The intraarticular injections were done using fluoroscopic visualization. The CDC has reported the results of its investigation.

Acute Coronary Syndrome Increased in Early Rheumatoid Arthritis

It does not come as a surprise to anyone anymore that Acute Coronary Syndrome (ACS) is one of the major causes of morbidity and preterm mortality in RA. What we don’t know is what measures need to be taken to modify the risk and how effective such measures are.

This nationwide population-based cohort study addresses the issue of efficacy of treatment options and treatment algorithms in reduction of ACS in RA patients.

Linkage Between Gut and Joint Immunity in Rheumatoid Arthritis

Pianta, et al have published their findings in the Journal of Clinical Investigation showing that two novel autoantigens, GNS and FLNA, are highly expressed in synovium and share a sequence homology with gut microbesa; thereby providing a potential link between gut mucosal and joint immunity in rheumatoid arthritis.