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

[Guest guest]

He really didn't. This was a very recent conversation I had with him. I will try

to guess though. As you know, Kineret hurts. So I wonder how many children stop

it because of the pain. Or the pain of giving it to a toddler. That would be

very, very hard.

Sent from my iPhone

On Apr 16, 2011, at 8:02 PM, " nn " <rosannwinn@...> wrote:

> , Did your doc explain why he'd prescribe this over Kineret? Thanks,

nn

>

>

> > >

> > > > 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

& #8805;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)

> > > >

> > > >

> > >

> > >