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

[Guest guest]

Yes. I think it is given at two week intervals at first, then extended to once a

month. Our doc has been very excited about this med. He said he would prescribe

it over Kineret. I know one Oregon boy has had fantastic results.

Sent from my iPhone

On Apr 16, 2011, at 5:45 PM, <lisa_michael@...> wrote:

> Is Actemra the once a month infusion?

>

> ________________________________

> From: Price <bc.price@...>

> " " < >

> Sent: Sat, April 16, 2011 1:23:34 PM

> Subject: 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

& #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)

> >

> >

>

>

[Guest guest]

, 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)

> > >

> > >

> >

> >