Remicade Approved in Australia for Treatment of Early Rheumatoid Arthritis & Psoriatic Arthritis

[Guest guest]

Remicade Approved in Australia for Treatment of Early Rheumatoid Arthritis

and Psoriatic Arthritis: Expanded Indications Offer New Options for

Preventing Progression of these

Debilitating Diseases

http://www.docguide.com/news/content.nsf/news/852571020057CCF68525713A0057759D

KENILWORTH, N.J., -- March 23, 2006 -- Schering-Plough Corporation today

announced that the Therapeutic Goods Administration of the Department of

Health and Ageing in Australia has revised the indication of Remicade ®

(infliximab) to include the treatment of early rheumatoid arthritis (RA) and

approved a new indication for psoriatic arthritis (PsA).

Remicade, in combination with methotrexate, can now be prescribed as

first-line therapy for early rheumatoid arthritis. Previously patients were

required to be treated first with methotrexate alone, prior to the addition

of Remicade therapy. Additionally, Remicade is now indicated for the

treatment of signs and symptoms of active PsA in adults where previous

response to disease-modifying anti-rheumatic drugs (DMARDs) has been

inadequate.

" These approvals represent important developments in the management of early

RA and Psoriatic Arthritis in Australia. Patients will now have new

treatment options that inhibit the progression of joint structural damage in

early RA and in Psoriatic Arthritis a therapy that improves signs and

symptoms of joint disease as well as helps clear skin lesions, " said

Spiegel, MD, chief medical officer and senior vice president,

Schering-Plough. " Remicade continues to expand its proven efficacy and

safety profile and demonstrate its clinical value among biological therapies

in treating a host of immune-mediated inflammatory disorders. "

In Australia, Remicade, in combination with methotrexate, is currently

indicated for the reduction of signs and symptoms and prevention of

structural damage (joint erosions and joint space narrowing) in patients

with active rheumatoid arthritis despite treatment with methotrexate.

Remicade is also indicated for the reduction of signs and symptoms and

improvement in physical function in patients with active Ankylosing

Spondylitis.

For patients with Crohn's disease, Remicade is indicated in the treatment of

moderate to severe disease, to reduce the signs and symptoms and to induce

and maintain clinical remission in patients who have inadequate response to

conventional therapies. Remicade is also indicated for reducing the number

of draining enterocutaneous and rectovaginal fistulas and maintaining

fistula closure in patients with Crohn's disease.

Remicade in Early RA in the EU

Remicade was approved for early RA in the European Union (EU) in June 2004.

That approval was based on data from the ASPIRE (Active Controlled Study of

Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early

Onset) trial, a 54-week, randomized, double blind, active control study

involving 1,049 patients with early RA (< 3 years duration) enrolled in 125

centers in North America and Europe.

ASPIRE is the first and only trial in early RA to demonstrate the

superiority of Remicade with methotrexate versus methotrexate alone in

preventing progression of joint destruction and reducing disability as well

as increasing clinical improvement. In these patients, a significant

reduction in the rate of the progression of joint damage has been

demonstrated.

Patients in the ASPIRE study had an average of only seven months of clinical

disease duration yet more than 90% already had evidence of erosive joint

changes. At week 54, results of the ASPIRE trial met all of the primary

endpoints: demonstration of superior efficacy versus methotrexate alone in

improvement of signs and symptoms of RA, prevention of progression of

structural damage and improvement in physical function.

Importantly, in the subgroup of patients who had no joint damage at

initiation of the study, 79.7% of these patients treated with Remicade and

methotrexate continued to show no joint damage at week 54, versus 63% with

methotrexate alone.

Remicade in Psoriatic Arthritis in the EU

Additionally, Remicade was approved for PsA in the EU in October 2004. The

PsA approval was based on data from IMPACT (Infliximab Multinational

Psoriatic Arthritis Controlled Trial), a randomized, double-blind, placebo-

controlled study involving 104 patients with active PsA who had failed at

least one DMARD and were enrolled at nine centers in the United States,

Canada and Europe. Results demonstrated the safety and efficacy of Remicade

in treating this debilitating disorder.

In IMPACT, patients given Remicade (5mg/kg) experienced rapid and sustained

improvement in their joints, as measured by the ACR 20, 50 and 70 response

criteria, measurement tools used to assess disease activity and improvement.

Specifically, 34 of the 52 patients (65.4%) met the ACR 20 response

criteria -- the primary efficacy parameter -- at week 16, compared to five

of the 52 patients (9.6%) in the placebo group.

Responses were sustained through the end of the study (week 50). Results

were confirmed in the ACR 50 and ACR 70 scores among those treated with

Remicade: 24 patients (46.2%) met the ACR 50 response at week 16 with 26

patients (53.1%) meeting it at week 50; 15 patients (28.8%) met the ACR 70

response at week 16, with 19 patients (38.8%) meeting it at week 50.

Positive results were also seen among patients who qualified for evaluation

by the Psoriasis Area and Severity Index (PASI), a scale for assessing skin

involvement (psoriasis severity) and treatment effectiveness. Among patients

with a PASI score of greater than 2.5, results showed a substantial and

significant decrease from baseline in the mean PASI score among patients

treated with Remicade compared to placebo at 16 weeks.

In the Remicade group, 68% of patients achieved an improvement of at least

75% compared to none of the patients in the placebo group. Among patients

treated with Remicade, sustained improvement in psoriasis manifestations was

maintained at week 50.

About Early Rheumatoid Arthritis

RA is a chronic, progressive disease and recent research demonstrates that a

critical therapeutic window exists within the first years of disease onset

when the progressive joint damage of the disease as measured

radiographically can be " reset. " Joint damage can occur within 2 years of

disease onset in 50-70% of RA patients.

The American College of Rheumatology (ACR) suggests control of disease

progression should start as early as possible to limit joint damage in RA.

RA is associated with substantial disability and economic losses, and one

study showed that one-third of patients in the UK who were employed became

work-disabled within two years of disease onset.

About Psoriatic Arthritis

The Arthritis Research Campaign estimates 1 in 50 people have psoriasis. Of

these, about 1 in 3 will develop PsA. While PsA can develop at any age,

onset usually occurs in middle-age, typically in adults between the ages of

30 and 50. Men and women are affected equally. In approximately 75% of

patients with PsA, the appearance of skin lesions precedes arthritic

involvement.

Physical symptoms include stiffness, pain, swelling and tenderness of the

joints and surrounding soft tissue, reduced range of motion, morning

stiffness, and tiredness. Symptoms also could include nail changes,

including pitting (small indentations in the nail) or lifting of the nail.

About Remicade

Remicade is a monoclonal antibody that specifically targets TNF-alpha, which

has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis

(RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Remicade is

the global market leader among anti-tumor necrosis factor alpha (TNF-alpha)

therapies and the only agent approved for the treatment of both RA and CD in

North America, the EU and Japan.

The safety and efficacy of Remicade have been well established in clinical

trials over the past 13 years and through commercial experience with over

700,000 patients treated worldwide.

In the U.S., Remicade, in combination with methotrexate, is indicated for

reducing signs and symptoms, inhibiting the progression of structural damage

and improving physical function in patients with moderately to severely

active RA.

Remicade is the only biologic indicated for the treatment of patients with

moderately-to-severely active CD who have had an inadequate response to

conventional therapy. Remicade is also indicated for reducing the number of

draining enterocutaneous and rectovaginal fistulas and maintaining fistula

closure in patients with fistulizing CD.

In December 2004, Remicade was approved for reducing signs and symptoms in

patients with active AS. On May 13, 2005, Remicade was approved for reducing

signs and symptoms of active arthritis in patients with PsA. Additionally,

on September 15, 2005, Remicade was approved for reducing signs and

symptoms, achieving clinical remission and mucosal healing, and eliminating

corticosteroid use in patients with moderately to severely active UC who

have had an inadequate response to conventional therapy. This approval makes

Remicade the first and only biologic approved for the treatment of moderate

to severe UC.

In the EU, Remicade is indicated for the treatment of severe, active CD in

patients who have not responded despite a full and adequate course of

therapy with a corticosteroid and an immunosuppressant; or who are

intolerant to or have medical contraindications for such therapies. Remicade

also is indicated for the treatment of fistulizing, active CD in patients

who have not responded despite a full and adequate course of therapy with

conventional treatment (including antibiotics, drainage and

immunosuppressive therapy).

For RA patients in the EU, Remicade, in combination with methotrexate, is

indicated for the reduction of signs and symptoms as well as the improvement

in physical function in patients with active disease when the response to

disease-modifying drugs, including methotrexate, has been inadequate, and in

patients with severe, active and progressive disease not previously treated

with methotrexate or other DMARDs. In these patient populations, a reduction

in the rate of the progression of joint damage, as measured by X-ray, has

been demonstrated.

In the EU, Remicade is also indicated for the treatment of AS in patients

who have severe axial symptoms, elevated serological markers of inflammatory

activity and who have responded inadequately to conventional therapy.

Remicade, in combination with methotrexate, is also approved for the

treatment of active and progressive PsA in patients who have responded

inadequately to disease modifying anti-rheumatic drugs.

Additionally, in September 2005, Remicade was approved in the EU for the

treatment of moderate to severe plaque psoriasis in adults who failed to

respond to, or have a contraindication to, or are intolerant of other

systemic therapy including cyclosporine, methotrexate or psoralen plus

ultraviolet A light (PUVA). In February 2006, Remicade was approved in the

EU for the treatment of moderately to severely active ulcerative colitis

(UC) in patients who have had an inadequate response to conventional

therapy, including corticosteroids and 6-MP or AZA, or who are intolerant to

or have medical contraindications for such therapies.

Remicade is unique among available anti-TNF biologic therapies. Unlike

self-administered therapies that require patients to inject themselves

frequently, Remicade is the only anti-TNF biologic administered directly by

caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg),

PsA (5 mg/kg), and UC (5 mg/kg), Remicade is a two-hour infusion

administered every 8 weeks, following a standard induction regimen that

requires treatment at weeks 0, 2 and 6. As a result, Remicade patients may

require as few as six treatments each year. In AS (5 mg/kg), Remicade is a

two-hour infusion administered every 6 to 8 weeks, following a standard

induction regimen that requires treatment at weeks 0, 2 and 6.

Centocor discovered Remicade and has exclusive marketing rights to the

product in the United States. Schering-Plough markets Remicade in all

countries outside of the United States, except in Japan and parts of the Far

East where Tanabe Seiyaku, Ltd. markets the product and in China where Xian-

Janssen markets Remicade.

Important Safety Information

Many people with heart failure should not take Remicade; so prior to

treatment you should discuss any heart condition with your doctor. Tell your

doctor right away if you develop new or worsening symptoms of heart failure

(such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB), sepsis

and pneumonia. Some of these infections have been fatal. Tell your doctor if

you have had recent or past exposure to people with TB. Your doctor will

evaluate you for TB and perform a skin test. If you have latent (inactive)

TB, your doctor should begin TB treatment before you start Remicade.

Remicade can lower your ability to fight infections, so if you are prone to

or have a history of infections, or develop any signs of an infection such

as fever, fatigue, cough, or the flu while taking Remicade, tell your doctor

right away. Also tell your doctor if you have lived in a region where

histoplasmosis or coccidioidomycosis is common.

There have been rare cases of serious liver injury in people taking

Remicade, some fatal. Contact your doctor immediately if you develop

symptoms such as jaundice (yellow skin and eyes), dark brown urine,

right-sided abdominal pain, fever, or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you

develop possible signs of blood disorders such as persistent fever,

bruising, bleeding, or paleness while taking Remicade. Nervous system

disorders have also been reported. Tell your doctor if you have or have had

a disease that affects the nervous system, or if you experience any

numbness, weakness, tingling, or visual disturbances while taking Remicade.

Reports of a type of blood cancer called lymphoma in patients on Remicade or

other TNF blockers are rare but occur more often than expected for people in

general. People who have been treated for rheumatoid arthritis, Crohn's

disease, ankylosing spondylitis, or psoriatic arthritis for a long time,

particularly those with highly active disease may be more prone to develop

lymphoma. Cancers, other than lymphoma, have also been reported. If you take

Remicade or other TNF blockers, your risk for developing lymphoma or other

cancers may increase. You should also tell your doctor if you have had or

develop lymphoma or other cancers while you are taking Remicade.

Serious infusion reactions have been reported with Remicade, including

hives, difficulty breathing, and low blood pressure. Reactions have occurred

during or after infusions. In clinical studies, some people experienced the

following common side effects: respiratory infections (that may include

sinus infections and sore throat), coughing, and stomach pain or mild

reactions to infusion such as rash or itchy skin.

Please read important information about Remicade, including full US

prescribing information, at http://www.remicade.com. For complete EU

prescribing information, please visit http://www.emea.eu.int.