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New Analysis Shows Efficacy of REMICADE(R) in Treatment of Ulcerative Colitis in Patients with Recent Disease Onset or Long-Standing Disease

A Separate Retrospective Analysis of US Employer Claims Suggests a Benefit of Anti-Tumor Necrosis Factor Therapies on Absenteeism Among Employees with

Inflammatory Bowel Disease

SAN DIEGO, May 20 /PRNewswire/ -- Data from a new analysis of the Active Ulcerative Colitis Trials (ACT 1 and ACT 2) showed that at week 8, more than 60 percent of patients with moderately to severely active ulcerative colitis (UC) receiving REMICADE(R) (infliximab) achieved clinical response regardless of disease duration (less than three years versus at least three years). Investigators also reported that at week 30, significant improvements were maintained with nearly half of REMICADE-treated patients having a clinical response. Significant improvements in disease remission and mucosal healing were also reported at weeks 8 and 30 among patients receiving REMICADE and meeting the disease duration criteria. These findings were presented today at the annual Digestive Disease Week(R) (DDW) meeting.

"These data are encouraging because we see that REMICADE is an effective treatment option for patients with active ulcerative colitis, whether recently diagnosed or struggling with the condition for many years," said Dr. Bruce Sands, Associate Professor of Medicine at Harvard Medical School, and study investigator. "Regardless of disease duration, patients receiving REMICADE showed significant improvements in clinical response, remission and mucosal healing, all goals of therapy in the treatment of ulcerative colitis."

In the analysis of 728 patients from ACT 1 and ACT 2, 254 patients had UC for less than three years and 474 patients had UC for at least three years. Clinical response, clinical remission and mucosal healing rates at week 8 for the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were all significantly higher than the placebo group (P < 0.01) regardless of disease duration; clinical response: 62 percent versus 33 percent for subjects with disease duration less than three years, and 68 percent versus 34 percent for subjects with disease duration of at least three years; clinical remission: 28 percent versus 8 percent and 35 percent versus 12 percent, respectively; mucosal healing: 56 percent versus 29 percent and 63 percent versus 35 percent, respectively.

At week 30, clinical response, clinical remission and mucosal healing rates for the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were also significantly higher than the placebo group (P < 0.01) regardless of disease duration; clinical response: 49 percent versus 19 percent for subjects with disease duration less than three years, and 54 percent versus 34 percent for subjects with disease duration of at least three years; clinical remission: 28 percent versus 10 percent, and 35 percent versus 15 percent, respectively; mucosal healing: 47 percent versus 20 percent ,and 52 percent versus 32 percent, respectively. A Cochran-Mantel-Haenszel test stratified by baseline corticosteroid refractory status was used to compare REMICADE with placebo within each disease duration subgroup.

Ulcerative colitis is a chronic inflammatory disease of the colon and large intestine that affects approximately half a million Americans and can lead to frequent hospitalizations, surgery and loss of work productivity. Both UC and Crohn's disease are known collectively as inflammatory bowel diseases, or IBD. Approved in 1998 by the U.S. Food and Drug Administration as the first anti-tumor necrosis factor (TNF)-alpha therapy, REMICADE received its initial approval for the treatment of Crohn's disease and has since become the first and only anti-TNF-alpha therapy approved for the treatment of UC and pediatric Crohn's disease. A Phase 3 study evaluating the efficacy and safety of REMICADE for the treatment of pediatric UC is currently ongoing.

Impact of Anti-TNF Therapies on Absence from Work Among Employees with IBD

Also presented today were findings from a separate retrospective analysis using the Human Capital Management Services Research Reference Database. Containing claims from large employers in the U.S. between January 1, 2001 and September 30, 2006 showed the effect of persistence with anti-TNF therapies on work-related absences for employees with IBD (Crohn's disease or UC). Work absences of 294,983 employees without IBD and 1,380 employees with IBD were analyzed. Employees with IBD and treated for less than 48 weeks with anti-TNF therapies had more total health-related absence days (22.5) than those with at least 48 weeks of anti-TNF therapies (10.3). This was true for sick leave days (4.8 vs. 2.3; P = 0.44) and short-term disability days (17.6 vs. 8.0; P = 0.67). Investigators concluded from the analysis that persistence with anti-TNF therapies is associated with a trend toward reduced work absence, including sick leave and short-term disability, and that these indirect costs should be taken into account when considering treatment options available to patients with IBD.

About ACT 1 and ACT 2

ACT 1 and ACT 2 were multicenter, Phase 3, randomized, double-blind, placebo-controlled clinical trials conducted to evaluate the safety and efficacy of REMICADE for the treatment of adult patients with moderately to severely active UC experiencing an inadequate response to conventional therapy. A total of 728 patients with active UC unresponsive to at least one standard therapy, including corticosteroids, other immunosuppressants, or 5-ASAs, were enrolled in ACT 1 (n=364) and ACT 2 (n=364). Patients in ACT 1 and ACT 2 had endoscopic evidence of moderately to severely active UC (total Mayo score of 6 to 12) and an endoscopy sub-score of at least 2. ACT 1 patients received treatment with placebo or REMICADE 5 mg/kg or REMICADE 10 mg/kg at weeks 0, 2 and 6 and then every eight weeks through week 46 and had the last evaluation at week 54. ACT 2 patients received treatment with placebo or REMICADE 5 mg/kg or REMICADE 10 mg/kg at weeks 0, 2, and 6 and then every eight weeks through week 22 and had the last evaluation at week 30. In these studies, the primary assessments of efficacy were based on clinical response, defined as a decrease from baseline in the Mayo score by at least 30 percent and at least three points, accompanied by a decrease in the rectal bleeding subscore of at least one or a rectal bleeding subscore of 0 or 1, and clinical remission, defined as a Mayo score less than or equal to two points, with no individual subscore greater than 1. Based on this definition, patients in clinical remission will have a rectal bleeding subscore of 0 or 1.

The ACT 1 and ACT 2 studies both met their primary endpoint of clinical response at week 8. In the pooled data from the ACT 1 and ACT 2 studies, 66 percent of patients in the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were in clinical response at week 8, compared with 33 percent in the placebo treatment group (P < 0.001).

The serious adverse events reported in these trials were similar to those reported in previous REMICADE clinical trials. See "Important Safety Information" below.

About Human Capital Management Services

Human Capital Management Services (HCMS) is a research and analysis company that focuses on the Health as Human Capital analytical approach that emphasizes the shift from medical cost management to investment in health as human capital.

About Ulcerative Colitis

Ulcerative colitis (UC), a chronic inflammatory bowel disease affecting nearly 500,000 people in the U.S., is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which causes bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms often lead to unwanted weight loss, blood loss and a host of secondary complications. UC is a chronic disease, and there is no cure. Although progress has been made in IBD research, investigators do not know what causes this disease.

About Crohn's Disease

Crohn's disease, a chronic inflammatory disease of the gastrointestinal tract, affects approximately 1.4 million Americans, including approximately 150,000 pediatric patients. The cause of Crohn's disease is not known, but the disease is associated with an abnormality of the immune system that could be triggered by viral or bacterial infections, a genetic predisposition or diet. Symptoms of Crohn's disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn's disease.


REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and is first anti-TNF-alpha treatment to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE has demonstrated broad clinical utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE have been well established in clinical trials over the past 15 years and through commercial experience with more than one million patients treated worldwide.

In the U.S., REMICADE is approved for the following indications:

-- Reducing signs and symptoms, inhibiting the progression of structural

damage and improving physical function in patients with moderately to

severely active RA, when administered in combination with methotrexate.

-- Reducing signs and symptoms in patients with active AS.

-- Reducing signs and symptoms and inducing and maintaining clinical

remission in adult and pediatric patients with moderately to severely

active CD who have had an inadequate response to conventional therapy.

-- Reducing the number of draining enterocutaneous and rectovaginal

fistulas and maintaining fistula closure in adult patients with

fistulizing CD.

-- Reducing signs and symptoms, inducing and maintaining 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.

-- Reducing signs and symptoms of active arthritis, inhibiting the

progression of structural damage and improving physical function in

patients with PsA.

-- Treatment of adult patients with chronic severe plaque PsO who are

candidates for systemic therapy and when other systemic therapies are

medically less appropriate.

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. REMICADE is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), 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.

Important Safety Information

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 TB 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, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

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, psoriatic arthritis or plaque psoriasis 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. Children and young adults who have been treated for Crohn's disease with REMICADE have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6- mercaptopurine. 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 or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

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, swelling of your ankles or feet or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and 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 also have 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, visual disturbances or seizures while taking REMICADE.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE and discuss it with your doctor.

About Centocor

Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.

The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

SOURCE Centocor
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