REMICADE Reduces Incidence Of Bowel Surgeries In UC Patients, Shown By Clinical Studies

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REMICADE

Reduces Incidence Of Bowel Surgeries In Ulcerative

Colitis Patients, Shown By Clinical Studies

Article Date: 17 Oct 2007 - 2:00 PDT

 Seperate analysis reveals colectomy increases healthcare

utilization and costs

Clinical data presented at the annual meeting of the American College of

Gastroenterology (ACG) show that REMICADE significantly reduces the incidence

of colectomy surgeries for patients with moderately to severely active

ulcerative colitis (UC). According to a primary

analysis of long-term extension data from the Active Ulcerative Colitis 1 and

2 trials (ACT trials), there is a 41 percent reduction in the incidence of

colectomy, the surgical removal of the colon, in patients receiving REMICADE

through 54 weeks, compared to those receiving placebo (p=0.015). REMICADE is the first and only biologic approved for the

treatment of ulcerative colitis.

The analysis of the ACT extension trials included 728 patients from

the initial ACT 1 and 2 trials, of whom 630 (86 percent) had complete

follow-up through 54 weeks to ascertain whether they underwent colectomy

surgery.

" These data illustrate that treatment with REMICADE significantly

reduces the need for life-altering colectomy in patients with refractory

ulcerative colitis, " said Rutgeerts,

M.D., Ph.D., University Hospital Gasthuisberg,

University of Leuven; Leuven,

Belgium. " REMICADE may offer patients who fail

other therapies the possibility of avoiding costly surgeries and

hospitalizations while managing the symptoms of this debilitating disease

long-term. "

Separate data also presented at ACG today show the significant impact

of colectomy on ulcerative colitis patients' use of healthcare services,

including inpatient and outpatient hospital procedures, emergency room and

physician visits, and laboratory and drug costs. A

retrospective analysis of 411 patients, identified from the U.S. PharMetrics database as having UC and a colectomy between

January 1, 2000, and June 30,

2005,

found that total utilization of healthcare services increased significantly

in the 12 months following colectomy, including inpatient and outpatient

procedures (P < 0.05).

" These diseases are devastating to patients and their loved ones

and we are excited to see more and better therapies become available to ease

their suffering, " said J. Geswell,

President, Crohn's & Colitis Foundation of America.

About the ACT Long-Term Extension

Patients with moderate to severe UC, defined as a baseline Mayo score ¡Ý 6

and ¡Ü 12, who were unresponsive to or intolerant to at least one standard

therapy, including corticosteroids, immunosuppressants

or 5ASAs, were enrolled in ACT 1 (n=364) or ACT 2 (n=364). The

728 patients were randomized to receive REMICADE 5 mg/kg, REMICADE 10 mg/kg

or placebo at weeks 0, 2, 6 and every subsequent 8 weeks through week 22 (ACT

2) or week 46 (ACT 1). Patients were allowed to

continue to receive conventional therapy.

Patients who completed treatment through the final infusion visit and

who, in the opinion of the investigator, could benefit from continued

treatment with REMICADE could enroll in the extension trials. Across multiple sites, one hundred and eighteen (118)

patients were entered into the ACT 1 extension and 111 patients were entered

into the ACT 2 extension.

During the extension, patients continued to receive the study drug to

which they were originally randomized (REMICADE 5 mg/kg, REMICADE 10 mg/kg or

placebo) every 8 weeks. Patients in the extension

trials were assessed using the Physician¡¯s Global

Assessment (PGA), which is 1 of 4 measures of disease activity included in

the Mayo score. Of the 229 patients who entered the

extension, 181 have been followed through one year, and 92 have completed two

years. Patients who had responded to placebo also

enrolled in the extension to maintain the blind and continued to receive

placebo every 8 weeks.

Overall, REMICADE was generally well tolerated in the long-term

extensions, with less than five percent of patients discontinuing therapy due

to an adverse event (AE). As previously reported,

other notable serious adverse events (SAEs)

included: prostate cancer, breast cancer, pneumonia, sarcoidosis,

abscess and a death following Histoplasmosis

pneumonia. (See Important Safety Information below.)

About the PharMetrics

Analysis

This retrospective analysis examined medical and pharmacy claims from the PharMetrics Patient Centric database to determine

healthcare resource utilization among patients with UC before and after a

colectomy. The PharMetrics

database contains enrollment data, pharmacy and medial claims from

approximately 82 different managed care organizations, consisting of more

than 46 million patients in the United States. It is considered representative of the

insured population of the United States. Patient data was collected from January

1, 2000

through June 30, 2005, for any patient with a previous diagnosis of UC

who had two distinct claims for treatment of UC and had a Current Procedural

Terminology (CPT) code indicating colectomy.

A total of 411 patients were included in the analysis, and researchers

collected data for each patient both 12 months prior to the colectomy and 12

months following colectomy. The researchers focused

on the levels of inpatient, outpatient, emergency room, physician, laboratory

and drug costs of care and found that healthcare utilization increased during

the 12 months following colectomy. The increases

were primarily driven by inpatient and outpatient visits.

The data showed that inpatient encounters increased during the 12

months after colectomy, compared with the number of encounters during the 12

months before colectomy (1.8 vs. 0.9). There were

also increases in outpatient visits (19.4 vs. 8.7), emergency room visits

(0.9 vs. 0.8), physician visits (14.9 vs. 13.9) and laboratory visits (2.2

vs. 2.1) during the post-colectomy period, compared with the pre-colectomy

period.

About Ulcerative Colitis

UC is a chronic inflammatory bowel disease affecting nearly 500,000 people in

the U.S. The disease is characterized by

inflammation and ulceration of the colonic mucosa, or innermost lining of the

intestine, which causes bloody stools and severe diarrhea. Tiny

open sores, or ulcers, form on the surface of the intestinal 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. The cause of UC is not known and there is no cure.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis factor alpha

(TNF-alpha) therapies and is the only anti-TNF-alpha treatment 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 14 years

and with more than 925,000 patients treated worldwide through commercial

experience.

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 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. REMICADE is also indicated for reducing the

number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in

adult patients with fistulizing CD. In December 2004, REMICADE was approved for reducing

signs and symptoms in patients with active AS. In

May 2005, REMICADE was approved for reducing signs and symptoms of active

arthritis in patients with PsA. Additionally,

in September 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 addition, on May

19, 2006,

REMICADE was approved for reducing signs and symptoms and inducing and

maintaining clinical remission in pediatric patients with moderately to

severely active CD who have had an inadequate response to conventional

therapy. This approval establishes REMICADE as the

first and only biologic therapy approved for the treatment of pediatric CD. In August 2006, REMICADE received the expanded

indication for inhibiting the progression of structural damage and improving

physical function in patients with psoriatic arthritis. In

September 2006, REMICADE was approved for the treatment of adult patients

with chronic severe plaque psoriasis. In October

2006, REMICADE was approved for maintaining clinical remission and mucosal

healing in patients with moderately to severely active UC, who have had an

inadequate response to conventional therapy.

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), UC (5 mg/kg), PCD (5 mg/kg), and PsO (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 weeks, following a standard induction

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