* Trial combined sarilumab and methotrexate
* Sarilumab met all three co-primary endpoints
* Most reported adverse events were infections
PARIS, Nov 22 An experimental drug for
rheumatoid arthritis developed by French drugmaker Sanofi
and Regeneron, when combined with
methotrexate, improved symptoms and physical function and slowed
progression of the disease in a late-stage clinical trial.
Rheumatoid arthritis is an autoimmune disease in which the
body's immune system mistakenly attacks healthy tissue, causing
inflammation and pain in the joints.
Sanofi and Regeneron's drug, called sarilumab, is an
injectable antibody that works by blocking an
inflammation-causing protein called interleukin 6. It is similar
to Actemra, Roche's fast-growing treatment approved in
The success of the trial pushes the new drug one step closer
to the production line, although it still to pass further
long-term trials and the approval process in particular markets.
The 52 week SARIL-RA-MOBILITY Phase 3 trial enrolled some
1,200 patients with active, moderate-to-severe rheumatoid
arthritis, who have not benefited from or been able to tolerate
the standard oral treatment, methotrexate, whose side effects
can include nausea and liver damage.
Patients given a 200 mg dose of sarilumab every other week
on top of methotrexate saw a 66 percent improvement in signs and
symptoms of rheumatoid arthritis after six months, Sanofi and
Regeneron said in a statement on Friday.
Those given a 150 mg dose saw a 58 percent improvement,
while those given a placebo alongside methotrexate saw a 33
Sarilumab met the other two primary endpoints of the study,
improving physical function at week 16 and inhibiting
progression of joint damage after one year, the companies said.
Infections were the most frequently reported adverse side
effects, as well as increases in "bad" LDL cholesterol and
transaminases, they added.
Sarilumab, alongside cholesterol drug alirocumab, is one of
the promising products Sanofi is developing under its
partnership with U.S. biotech Regeneron to offset the loss of
patents on once top-selling drugs like blood thinner Plavix.