Thoughts about RoActemra?

[Guest guest]

Is there anyone here who is in Europe or have been a part of the RoActemra

trials? Is there great success with this new RA drug, or is it about as good as

the biologics out there...in other words is it a largely YMMV kind of thing?

Also, any horrific post-market side effects that are going on. I read some of

them and they seem to be worse, on paper at least, than Rituxin.

Shandi

For those unfamiliar, here is a write up:

Roche announced that the European Committee on Human Medicinal Products (CHMP)

has given a positive recommendation for RoActemra (tocilizumab, known as Actemra

outside of the EU), in combination with methotrexate (MTX), for the treatment of

adult patients with moderate to severe rheumatoid arthritis (RA) who have either

responded inadequately to, or who were intolerant to, previous therapy with one

or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis

factor (TNF) antagonists. In these patients, RoActemra can be given as

monotherapy in cases of intolerance to methotrexate (MTX) or where continued

treatment with MTX is inappropriate. RoActemra is the first interleukin-6 (IL-6)

receptor-inhibiting monoclonal antibody developed for the treatment of RA and is

an innovative new therapy option to help tackle this serious disease.

" Today's positive opinion by the European authorities for the approval of

RoActemra for rheumatoid arthritis is an important step forward in the fight

against this debilitating disease " said M. Burns, CEO of Roche's

Pharmaceuticals Division. " Roche will work with the authorities to ensure that

this groundbreaking therapy will be available to patients as quickly as

possible. "

Rheumatoid Arthritis is a chronic, progressive inflammatory disease of the

joints and surrounding tissues that is associated with intense pain,

irreversible joint destruction and systemic complications. There are several key

cytokines, or proteins, involved in the inflammatory process including tumor

necrosis factor (TNF) alpha, interleukin-1 (IL-1) and interleukin-6 (IL-6). IL-6

has been identified as having a pivotal role in the inflammation process.

The CHMP's positive opinion on RoActemra was based on results from five

multi-national Phase III studies which demonstrated that treatment with

RoActemra alone or combination with MTX or other DMARDs significantly reduced RA

signs and symptoms, compared with current DMARDs alone. These benefits were

regardless of previous therapy or disease severity.

About RoActemra/Actemra

RoActemra (known as Actemra outside of the EU) is the result of a research

collaboration between Roche and Chugai and the drug is being co-developed

globally with Chugai. RoActemra is the first humanized interleukin-6 (IL-6)

receptor-inhibiting monoclonal antibody. An extensive clinical development

program of five Phase III trials was designed to evaluate clinical findings of

RoActemra. The five studies have reported meeting their primary endpoints. In

Japan, Actemra was launched by Chugai in June 2005 as a therapy for Castleman's

disease; in April 2008, additional indications for rheumatoid arthritis,

polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile

idiopathic arthritis were also approved in Japan.

RoActemra is generally well tolerated. The overall safety profile of RoActemra

is consistent across all global clinical studies. The serious adverse reactions

reported in RoActemra clinical studies include serious infections,

gastrointestinal perforations and hypersensitivity reactions including

anaphylaxis. The most common adverse reactions reported in clinical studies were

upper respiratory tract infection, nasopharyngitis, headache, hypertension and

increased ALT. Increases in liver enzymes (ALT and AST) were seen in patients;

these increases were generally mild and reversible, with no evidence of hepatic

injuries. Laboratory changes, including increases in lipids (total cholesterol,

LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen

in patients without association with clinical outcomes. Treatments that suppress

the immune system, such as RoActemra, may cause an increase in the risk of

malignancies.

[Guest guest]

I believe the Japanese researchers found out many people who died using this

medication. Just google using the name tocilizumab and you will find out.

Ash

From: S. Pruitt <seriouslysanibel@...>

Subject: [ ] Thoughts about RoActemra?

Date: Wednesday, April 22, 2009, 10:34 AM

Is there anyone here who is in Europe or have been a part of the RoActemra

trials? Is there great success with this new RA drug, or is it about as good as

the biologics out there...in other words is it a largely YMMV kind of thing?

Also, any horrific post-market side effects that are going on. I read some of

them and they seem to be worse, on paper at least, than Rituxin.

Shandi

For those unfamiliar, here is a write up:

Roche announced that the European Committee on Human Medicinal Products (CHMP)

has given a positive recommendation for RoActemra (tocilizumab, known as Actemra

outside of the EU), in combination with methotrexate (MTX), for the treatment of

adult patients with moderate to severe rheumatoid arthritis (RA) who have either

responded inadequately to, or who were intolerant to, previous therapy with one

or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis

factor (TNF) antagonists. In these patients, RoActemra can be given as

monotherapy in cases of intolerance to methotrexate (MTX) or where continued

treatment with MTX is inappropriate. RoActemra is the first interleukin- 6

(IL-6) receptor-inhibiting monoclonal antibody developed for the treatment of RA

and is an innovative new therapy option to help tackle this serious disease.

" Today's positive opinion by the European authorities for the approval of

RoActemra for rheumatoid arthritis is an important step forward in the fight

against this debilitating disease " said M. Burns, CEO of Roche's

Pharmaceuticals Division. " Roche will work with the authorities to ensure that

this groundbreaking therapy will be available to patients as quickly as

possible. "

Rheumatoid Arthritis is a chronic, progressive inflammatory disease of the

joints and surrounding tissues that is associated with intense pain,

irreversible joint destruction and systemic complications. There are several key

cytokines, or proteins, involved in the inflammatory process including tumor

necrosis factor (TNF) alpha, interleukin- 1 (IL-1) and interleukin- 6 (IL-6).

IL-6 has been identified as having a pivotal role in the inflammation process.

The CHMP's positive opinion on RoActemra was based on results from five

multi-national Phase III studies which demonstrated that treatment with

RoActemra alone or combination with MTX or other DMARDs significantly reduced RA

signs and symptoms, compared with current DMARDs alone. These benefits were

regardless of previous therapy or disease severity.

About RoActemra/Actemra

RoActemra (known as Actemra outside of the EU) is the result of a research

collaboration between Roche and Chugai and the drug is being co-developed

globally with Chugai. RoActemra is the first humanized interleukin- 6 (IL-6)

receptor-inhibiting monoclonal antibody. An extensive clinical development

program of five Phase III trials was designed to evaluate clinical findings of

RoActemra. The five studies have reported meeting their primary endpoints. In

Japan, Actemra was launched by Chugai in June 2005 as a therapy for Castleman's

disease; in April 2008, additional indications for rheumatoid arthritis,

polyarticular- course juvenile idiopathic arthritis and systemic-onset juvenile

idiopathic arthritis were also approved in Japan.

RoActemra is generally well tolerated. The overall safety profile of RoActemra

is consistent across all global clinical studies. The serious adverse reactions

reported in RoActemra clinical studies include serious infections,

gastrointestinal perforations and hypersensitivity reactions including

anaphylaxis. The most common adverse reactions reported in clinical studies were

upper respiratory tract infection, nasopharyngitis, headache, hypertension and

increased ALT. Increases in liver enzymes (ALT and AST) were seen in patients;

these increases were generally mild and reversible, with no evidence of hepatic

injuries. Laboratory changes, including increases in lipids (total cholesterol,

LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen

in patients without association with clinical outcomes. Treatments that suppress

the immune system, such as RoActemra, may cause an increase in the risk of

malignancies.