Re: FDA Approves ACTEMRA® (tocilizumab) for the Treatment of Systemic Juvenile Idiopsults with actemra.

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Re: FDA Approves ACTEMRA® (tocilizumab) for the

> Treatment of

> > Systemic Juvenile Idiop

> >

> > Prayers answered for systemics!!!!!!! Thank you, God.

> > ( n,22, systemic for 12 years)

> >

> > Sent from my iPhone

> >

> > On Apr 15, 2011, at 6:54 PM, " YaelM " <yael_my@...> wrote:

> >

> > > April 15, 2011 6:04 PM EDT

> > > – Medicine offers a new option for children living with a

> rare and severe form

> > >of arthritis –

> > >

> > > SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a

> member of the Roche

> > >Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the

> U.S. Food and Drug

> > >Administration (FDA) approved ACTEMRA (tocilizumab) for the

> treatment of active

> > >Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two

> years of age and

> > >older. ACTEMRA can be given alone or in combination with

> methotrexate in

> > >patients with SJIA.

> > >

> > > ACTEMRA is the first medicine approved by the FDA for the

> treatment of SJIA, a

> > >rare and severe form of arthritis affecting children. SJIA

> has the worst

> > >long-term prognosis of all types of childhood arthritis.1

> > >

> > > " Today's FDA approval marks an important advance in the

> treatment of SJIA, a

> > >debilitating condition affecting children, " said Hal Barron,

> M.D., chief medical

> > >officer and head Global Product Development. " As the first

> and only approved

> > >treatment for SJIA, ACTEMRA offers a new option for this

> extremely difficult to

> > >treat disease. This approval also demonstrates our commitment

> to science and

> > >patients with high unmet medical need, including orphan

> diseases. "

> > >

> > > " The goal of treatment for children with SJIA is to reduce

> the signs and

> > >symptoms of the disease, including swelling, pain and other

> complications, " said

> > >Hermine Brunner, M.D., MSc, associate professor of pediatric

> rheumatology,

> > >University of Cincinnati College of Medicine, Cincinnati

> Children's Hospital

> > >Medical Center, scientific director of the pediatric

> rheumatology collaborative

> > >study group, and a study investigator. " We're excited about

> the results of this

> > >study which show that ACTEMRA significantly improved disease

> signs and symptoms

> > >as measured by a JIA ACR response, plus absence of fever, a

> critical validated

> > >efficacy measure of SJIA treatment. "

> > >

> > > SJIA is the rarest form of Juvenile Idiopathic Arthritis

> (JIA), also known as

> > >Juvenile Rheumatoid Arthritis (JRA).2 The disease affects

> about 10 to 20 percent

> > >of children with JIA,3 with the peak age of onset between 18

> months and two

> > >years,3,4 although the disease can persist into adulthood.

> SJIA has a two to

> > >four percent overall estimated mortality rate, and accounts

> for almost

> > >two-thirds of all deaths among children with arthritis.1 The

> severity of SJIA

> > >varies from person to person and can include symptoms ranging

> from joint

> > >inflammation accompanied by intermittent fever, skin rash,

> anemia, enlargement

> > >of the liver or spleen and inflammation of the lining of the

> heart and/or

> > >lungs.5 In the most severe cases of SJIA, up to two-thirds of

> children

> > >experience chronic arthritis, and approximately half of

> children will develop

> > >significant joint disabilities.6,7

> > >

> > > About the TENDER Study

> > > This approval was based on positive data from a Phase III

> study known as

> > >TENDER. The results showed that 85 percent (64/75) of

> children with SJIA

> > >receiving ACTEMRA experienced a 30 percent improvement (JIA

> ACR30) in the signs

> > >and symptoms of SJIA and an absence of fever after 12 weeks

> of therapy, compared

> > >with 24 percent (9/37) of children receiving placebo

> (p<0.0001).8

> > >

> > > Additional results from the TENDER study, a randomized,

> double-blind, Phase III

> > >study in 112 patients showed significantly more children who

> received ACTEMRA

> > >had improvements in SJIA signs and symptoms. In the study, 71

> percent (53/75) of

> > >children treated with ACTEMRA achieved a JIA ACR70 response

> at week 12 compared

> > >with eight percent (3/37) of those receiving placebo

> (p<0.0001).

> > >

> > > No new or unexpected safety signals were identified with

> ACTEMRA.8 The most

> > >common adverse events (at least five percent) seen in ACTEMRA

> treated patients

> > >in the 12 week controlled portion of the study were upper

> respiratory tract

> > >infection, headache, nasopharyngitis and diarrhea. The most

> commonly reported

> > >serious infections included pneumonia, gastroenteritis,

> varicella (chickenpox)

> > >and otitis media (ear infection). Sixteen percent of patients

> in the ACTEMRA

> > >treatment group and five percent of patients in the placebo

> group experienced an

> > >infusion reaction. Anaphylaxis was reported in one of the 112

> patients treated

> > >with ACTEMRA during the controlled and open-label extension

> study.

> > >

> > > This Phase III international study included 43 sites in 17

> countries. The study

> > >evaluated the efficacy and safety profile of ACTEMRA versus

> placebo over 12

> > >weeks in 112 children with SJIA. This study is the first part

> of a five-year

> > >ongoing study.

> > >

> > > Patients two to 17 years of age with active SJIA for at

> least six months

> > >(average disease duration in the study was five years) who

> could not tolerate,

> > >or did not respond well to their current therapy (NSAIDs

> and/or systemic

> > >corticosteroids) were randomized to receive ACTEMRA (8 mg/kg

> if weight ≥30

> > >kg or 12 mg/kg if weight <30 kg) or placebo every two

> weeks as a 60-minute

> > >single intravenous drip infusion for a total of 12 weeks.

> Patients continued to

> > >receive NSAIDs, corticosteroids and methotrexate if receiving

> these medicines at

> > >the start of the study. The primary endpoint was the number

> of patients treated

> > >with ACTEMRA with a JIA ACR30 response and absence of fever

> at week 12, compared

> > >with those receiving placebo.

> > >

> > > About ACTEMRA® (tocilizumab)

> > >

> > >

> >

> >