Data From Registry of Nearly 6,000 Patients Confirm Long-Term Safety of Remicade® in Crohn's Disease

Main Category: Crohn's / IBD
Article Date: 29 Sep 2004 - 11:00 PDT


Results from TREAT Patient Registry, Largest Registry of Its Kind, Presented at United European Gastroenterology Week

PRAGUE, 28 SEPTEMBER, 2004 - Data from a prospective analysis of 5,807 "real-world" patients affirm the safety of REMICADE® (infliximab) in the treatment of Crohn's disease (CD), a chronic inflammatory bowel disorder. New analyses show that there was not an increased risk of serious infections within three months of REMICADE treatment, and the rate of mortality at three months following treatment with REMICADE was lower than in patients who had not had an infusion within three months. REMICADE (infliximab) was not an independent predictor of serious infections (RR=1.09, CI=0.58-2.05). The only drug independently associated with serious infection was prednisone (RR=2.32, CI=1.28-4.37). The results were presented today at the 12th United European Gastroenterology Week.

"These findings are important because they further support the established safety profile of REMICADE in Crohn's disease patients," said Gary R. Lichtenstein, MD, Professor of Medicine and Director, IBD Center, University of Pennsylvania School of Medicine, and study author. "This unique registry and its ongoing analysis should provide clinicians with the confidence they need to continue their patients on REMICADE therapy over extended periods," added Dr. Lichtenstein.

About TREAT

Data was collected from the Crohn's Therapy, Resource, Evaluation and Assessment Tool (TREAT), a patient registry established to study long-term safety of REMICADE in CD. At the time of this analysis, August 2003, the registry included 5,807 adult patients with CD from community and academic practices enrolled with a mean follow-up of approximately one year. Nearly half (2,850) of patients in the registry received REMICADE and 2,957 did not. At the time of enrollment, more REMICADE patients had moderate-to-severe disease, more had been hospitalized and more were being treated with other therapies including prednisone and immunomodulators.

REMICADE was well-tolerated: of 11,504 infusions of REMICADE, 5.4 percent of infusions resulted in an infusion reaction of any type, while 0.16 percent of infusions resulted in severe reactions.

REMICADE was not shown to be an independent predictor of serious infection when adjusted for other factors (including other concomitant medications) used in the model (RR=1.09, CI=0.58-2.05). The incidence of serious infections was 1.27 per 100 patient-years within three months of treatment with REMICADE compared to 0.85 in patients not treated with REMICADE in the past three months (RR=1.51, 95%; CI=0.86-2.65, p=0.11). In this analysis, use of corticosteroids (OR=2.32, 95% CI=1.56-6.06), use of narcotic analgesics (OR=3.08, 95% CI=1.23-4.37), and female gender (OR=2.21, 95% CI=1.10-4.45) were shown to be associated with a higher risk of serious infection. There was also a strong but not significant trend toward more severe CD being associated with serious infections (OR=2.21, 95% CI=0.95-7.46).

Additionally, the analysis showed no evidence of an increased risk of malignancy associated with REMICADE. The incidence of malignancies was 0.53 events per 100 patient-years in the REMICADE group vs. 0.49 in the patients who received other treatments (OR=1.05, 95% CI=0.53-2.08). Patient follow-up in the TREAT registry is ongoing and will be the subject of future reports.

About Crohn's disease

CD is a chronic inflammatory bowel disorder that commonly affects the lower part of the small intestine and the large intestine and typically begins in late childhood or early adulthood. The disease causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. It is estimated that 500,000 Americans and more than 400,000 people in Europe and Canada suffer from this gastrointestinal disorder.

About REMICADE®

REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in CD, rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriasis, and may also be important in a wide range of other immune- mediated inflammatory disorders. 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 under supervision and monitoring of specialized physicians. In RA and CD patients, REMICADE is administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. AS patients receive REMICADE every six to eight weeks, following a standard induction regimen consisting of infusions at weeks 0, 2, and 6. As a result, REMICADE patients may require as few as six treatments each year. The safety and efficacy of REMICADE have been well established in clinical trials conducted over the past 10 years and through commercial experience with more than 500,000 patients treated worldwide.

REMICADE is the only biologic indicated for the treatment of both RA and CD. In the EU, REMICADE is also approved for the treatment of AS, a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine.

In CD patients, 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 is also 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, 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 the EU, 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 treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

Important Information Regarding Labeling for REMICADE

People with heart failure should not take REMICADE. Prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor immediately if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of feet). There are reports of serious infections associated with REMICADE therapy, 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. 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 immediately. Patients should also tell their doctor 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 U.S. prescribing information at http://www.remicade.com. For complete REMICADE EU prescribing information, call Schering-Plough Corporation at +1 908-298-7616.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" information including the market potential for REMICADE under expanded labeling. The extent that REMICADE will be prescribed will determined by market forces and the market viability of REMICADE is subject to substantial risks and uncertainties. In addition, the forward-looking statements may also be adversely affected by many factors, including competitive product development, product availability, the extent of market acceptance of new indications for products, current and future branded, generic or over-the-counter competition, federal and state regulations and legislation, manufacturing issues, trade buying patterns and patent positions. For further details about these factors and other risks and uncertainties, see the company's past and future Securities and Exchange Commission filings, including the company's second quarter 2004 10-Q and future SEC filings.

About S-P Europe

Schering-Plough Europe, based in Brussels, Belgium, is part of Schering-Plough Corporation (NYSE: SGP). Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

CONTACTS: Denise K. Foy
S-P Europe
+1 908 298 7616
Cell: +1 908 338 0134
S-P Investors
Janet M. Barth
Alex Kelly
+ 1 908 298 7436

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