Rheumatoid Arthritis Symptoms Show Improvement Two Days After Initial Infusion

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Rheumatoid Arthritis Symptoms Show Improvement Two Days After Initial Infusion

of Remicade (Infliximab)/Methotrexate

MALVERN, PA -- April 5, 2002 -- According to a new study published in the April

issue of The Journal of Rheumatology, patients with rheumatoid arthritis (RA)

may experience improvement in the pain and stiffness of the disease as early as

48 hours following their first in-office infusion of the biologic therapy

Remicade® (infliximab), in combination with methotrexate.

The authors also studied a shortened infusion time of one hour in a subset of

patients who tolerated their initial four Remicade treatments. Currently, the

recommended infusion period for Remicade is two hours.

" These findings are encouraging because they suggest that patients may improve

rapidly in response to Remicade, " said J. Shergy, MD, principal

investigator. " In addition, the possibility of being able to offer a one-hour

Remicade infusion to patients who tolerated their initial two-hour treatments

may enable rheumatologists to more efficiently manage their time and resources,

while also reducing infusion time for some patients to as little as six hours a

year. "

Remicade is a biologic that rapidly impacts the inflammatory process underlying

the disease. Remicade is a monoclonal antibody that specifically targets and

irreversibly binds to a key inflammatory mediator called tumor necrosis factor

alpha (TNF-alpha), which is believed to play a pivotal role in RA and other

inflammatory disorders. Recently, Remicade, in combination with methotrexate,

became the first and only therapy approved by the FDA to improve physical

function, as well as inhibit the progression of structural damage and reduce

signs and symptoms in patients with moderately to severely active RA who had an

inadequate response to methotrexate therapy alone.

Remicade is the worldwide market share leader among tumor necrosis factor alpha

(TNF-alpha) therapies and the only biologic indicated for the treatment of RA

and Crohn's disease, a potentially devastating gastrointestinal disorder.

The PROMPT (Profiling Remicade Onset with Methotrexate in a Prospective Trial)

study was conducted to evaluate the clinical benefits of Remicade two days

following initial infusion. The PROMPT study also examined the clinical benefit

and tolerability of administering Remicade (up to six infusions) in an in-office

setting. In addition, the open-label study evaluated the possibility of reducing

infusion time from two hours to one hour in a subset of patients for whom the

initial four infusions were well tolerated.

A total of 553 patients with active RA despite methotrexate therapy were

enrolled at 79 centers across the US. In the open-label study, patients were

treated with Remicade (3 mg/kg) given at weeks 0, 2, 6, and 14. Each of the four

infusions was delivered over a two-hour period. Follow-up efficacy assessments

were conducted at 48 hours and at weeks one, two, six, 14, and 16.

At 48 hours following the first infusion, improvements compared to baseline were

observed in duration of morning stiffness (34 percent mean improvement),

physician's global disease assessment score (30 percent), patient's global

disease assessment scores (25 percent), and patients pain assessment scores (30

percent). By week 16, 52 percent to 63 percent mean improvements in these four

efficacy parameters were recorded.

To evaluate the reduced infusion time of one hour, patients who met

pre-specified goals of tolerating the initial four infusions were enrolled into

a study extension. These patients (n=197) received two one-hour infusions of

Remicade (3 mg/kg) given eight weeks apart.

The most common of the adverse events associated with the infusion procedure

were headache, pruritus and urticaria. Most infusion-related reactions were mild

or moderate in nature, and frequency was similar over the two-hour and one-hour

infusion time period.

Rheumatoid arthritis affects 2.1 million Americans. It is a chronic, often

painful disease characterised by joint inflammation, usually beginning in the

hands, wrists, knees, and elbows. The disease affects women more often than men.

Initial RA symptoms include joint pain and fatigue. As the disease progresses,

joints usually become more swollen, inflamed, and stiff. When inflammation

persists or does not respond to treatment, it can destroy nearby cartilage,

bone, tendons and ligaments, leading to permanent disability.

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

patients should discuss any heart condition with their doctor. Patients should

tell their doctor right away if they develop new or worsening symptoms of heart

failure (such as shortness of breath or swelling of their feet).

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

Some of these infections have been fatal. Patients should tell their doctor if

they have had recent or past exposure to people with TB. Their doctor will

evaluate them for TB and perform a skin test. If a patient has latent (inactive)

TB, his or her doctor should begin TB treatment before starting Remicade. If a

patient is prone to or has a history of infections, currently has one, or

develops one while taking Remicade, he or she should tell his or her doctor

right away. Patients should also tell their doctor if they have lived in a

region where histoplasmosis is common, or if they have or have had a disease

that affects the nervous system, or if they experience any numbness, tingling,

or visual disturbances.

There are also reports of serious infusion reactions with hives, difficulty

breathing, and low blood pressure. In clinical studies, some people experienced

the following common side effects: upper respiratory infections, headache,

nausea, cough, sinusitis or mild reactions to the infusion such as rash or itchy

skin. Please read important information about Remicade, including full

prescribing information.

SOURCE: Centocor

http://www.pslgroup.com/dg/214ffe.htm