WebMD Medical News
Michael W. Smith, MD
March 20, 2008 -- Actemra, an experimental biologic drug, shows promise in
treating rheumatoid arthritis
and juvenile idiopathic arthritis (formerly called juvenile
rheumatoid arthritis, or JRA).
That news comes from the drug's phase III trials, which test safety and
Biologic drugs, such as Actemra, target specific parts of the immune system
that lead the inflammation that causes joint
damage in RA. Current biologic drugs used to treat RA include Enbrel,
Humira, Orencia, Remicade, and Rituxan.
Actemra is not yet available. It works on a different area of the immune
system than the other biologic drugs.
One trial covered rheumatoid
arthritis; the other focused on juvenile idiopathic arthritis. Results for
both trials appear in the March 22 edition of The Lancet.
A related editorial voices "cautious optimism" but calls for more
studies on Actemra's possible effects on cholesterol, and for head-to-head comparisons of Actemra
and other biologic arthritis drugs.
The rheumatoid arthritis study included 621 patients with moderate to severe
rheumatoid arthritis who had already tried the drug methotrexate for their RA.
The patients got injections of a higher dose of Actemra, a lower dose of
Actemra, or a placebo every four weeks for six months.
At the end of the study, 59% of the patients who got the higher Actemra
dose, 48% of those taking the lower Actemra dose, and 26% of those who got the
placebo had at least a 20% improvement in their signs and symptoms of RA, which
is considered significant improvement.
Upper respiratory tract infections were the most common side effects seen in
the Actemra group. Liver enzyme levels also rose for some Actemra patients, but
those were typically one-time events and weren't linked to symptoms of liver
disease, according to the researchers.
Total cholesterol and LDL ("bad") cholesterol levels rose in the Actemra users. The reason
for that isn't clear. Major heart "events" -- such as heart attacks --
weren't more common with Actemra use, but the study only lasted for six months,
which may not have been long enough to detect cardiovascular risk.
WebMD reported on the study
last June, when researcher Josef Smolen, MD, of Austria's Medical
University of Vienna, presented the findings in Barcelona, Spain, at the
European League Against Rheumatism's annual meeting.
The study, which didn't look at the drug's long-term safety, was funded by
Hoffmann-La Roche and Japan's Chugai Pharmaceutical Co., which are developing
The juvenile idiopathic arthritis trial included 56 children in Japan who
had tried other drugs to treat their arthritis.
First, all of the children got three doses of Actemra every two weeks for
six weeks. Then 43 kids whose arthritis had improved with Actemra treatment
kept getting Actemra; all in all, they took Actemra for four months.
Actemra trumped the placebo and "might be a suitable treatment in the
control of this disorder, which has so far been difficult to manage," write
Yokohama City University's Shumpei Yokota, MD, and colleagues.
Adverse events were typical of other biologic drugs and included upper
respiratory-tract infections and stomach flu. Anaphylactic allergic reactions
and increases in liver enzyme levels were rarer.
The study was funded by Chugai Pharmaceutical Co.
Editorialist Tim Bongartz, MD, who works at the Mayo Clinic College of
Medicine in Rochester, Minn., writes that he is "excited about the ongoing
expansion of therapeutic options for rheumatoid arthritis and, especially,
systemic [juvenile idiopathic arthritis]."
But he cautions that the evidence doesn't show how Actemra's risks and
benefits stack up against other treatment choices.
"In an ideal world, comparative trials of new drugs with other effective
treatments, powered to detect important safety and efficacy endpoints, would
provide this information, which I regard as essential," writes
"It is not clear that these trials will be available before the likely
approval of tocolizumab [Actemra], and it may be up to investigators to
initiate the head-to-head comparisons needed to address these issues," adds
SOURCES:Smolen, J. The Lancet, March 22, 2008; vol 371: pp 987-997.WebMD Medical News:
"New RA Drugs Show Promise."Yokota, S. The Lancet, March 22, 2008; vol 371: pp 998-1006.Bongartz, T. The Lancet, March 22, 2008; vol 371: pp 961-963.News release, The Lancet.
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