REMICADE(reg) Psoriatic New Level of Benefit in Reducing Signs and Symptoms of Both Joint and Skin Components of Arthritis

Main Category: Arthritis / Rheumatology
Article Date: 11 Jun 2004 - 9:00 PDT


REMICADE(reg) Psoriatic Arthritis Clinical Trial Demonstrates New Level of Benefit in Reducing Signs and Symptoms of Both Joint and Skin Components of the Disease than in Previously Reported.

Studies Results From Phase III Multinational IMPACT 2 Study Presented at EULAR and IPS

Berlin, Germany (June 10, 2004) - Data released from a phase III trial with REMICADE(reg) (infliximab) showed improvement in both the arthritis and psoriasis associated with psoriatic arthritis (PsA). In this trial, REMICADE(reg) provided a 70 percent improvement (as measured by ACR 70) in symptoms of arthritis in nearly one-third of patients, compared with only two percent of patients on placebo at 24 weeks.

In patients with psoriasis that involved three percent or more of their body surface area (BSA), treatment with REMICADE(reg) resulted in an impressive improvement with over 40 percent of patients achieving a 90 percent or more improvement in PASI score and 21 percent of patients achieving 100 percent improvement in PASI score as early as week 14 with response maintained throughout the study. In addition, REMICADE(reg) was efficacious in the treatment of dactylitis and enthesopathies, two common manifestations of PsA causing pain and swelling.

These findings from the IMPACT 2 Psoriatic Arthritis phase III trial are being presented at two major medical meetings: the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology and the International Psoriasis Symposium (IPS).

"Patients with psoriatic arthritis require treatments that address the dual challenges of this disorder," said Christian Antoni, M.D., Friedrich-Alexander-University, Erlangen, Germany. "The results of IMPACT are compelling as they support the potential of REMICADE(reg) in alleviating both the skin and joint symptoms of this condition."

"The results of IMPACT 2 are exciting and promising for both physicians and patients," remarked Kim Papp, M.D., Ph.D., Associate Clinical Professor, University of Western Ontario and one of the study's lead investigators. "In this study, a significant number of patients achieved total or almost total clearance of their psoriatic skin disease."

"These data are important to rheumatologists because they suggest that it is possible to rapidly achieve relief from the signs and symptoms of arthritis for a substantial number of patients with this potentially debilitating disease," said Arthur Kavanaugh, M.D., professor of Medicine, Center for Innovative Therapy, UCSD, Division of Rheumatology, Allergy and Immunology, and one of the lead investigators in the trial.

IMPACT 2 is a phase III, multi-center, randomized, double-blind, placebo-controlled trial initiated to evaluate the safety and efficacy of REMICADE(reg) in patients with active PsA who had an inadequate response to disease modifying antirheumatic drugs (DMARD) or nonsteroidal anti-inflammatory drugs (NSAID) therapy. IMPACT 2 reinforces the findings of an earlier study, IMPACT, which showed that REMICADE(reg) significantly improved the signs and symptoms of PsA, including psoriasis in 104 patients who failed treatment with at least one DMARD.

The primary endpoint for IMPACT 2 was a 20 percent improvement in American College of Rheumatology criteria (ACR 20) at week 14. The proportion of patients achieving ACR 20 response in the REMICADE(reg) group was significantly greater than placebo (p<0.001) both at week 14 (58.0 percent and 11.0 percent, respectively) and week 24 (54.0 percent and 16.0 percent, respectively). Centocor, Inc., plans to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) later this year to request approval for this new use.

REMICADE(reg) is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-alpha) on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in RA and CD and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE(reg) is currently being studied.

About IMPACT 2

Two hundred PsA patients were enrolled in IMPACT 2 who had the disease for at least six months and an inadequate response to NSAIDs or DMARDs. Patients were required to have active PsA, defined as five or more swollen and tender joints and also had to have at least one plaque of psoriasis. The primary endpoint for signs and symptoms was 20 percent improvement in ACR 20 at week 14. Secondary endpoints included at least a 75 percent improvement in PASI (Psoriasis Area and Severity Index) at week 14, Psoriatic Arthritis Response Criteria (PsARC) at week 14 and ACR 20 response at week 24.

Patients were randomized to receive infusions of placebo or REMICADE(reg) 5 mg/kg at weeks zero, two, six, 14 and 22. The proportion of patients achieving ACR 20 response in the REMICADE(reg) group was significantly greater than placebo (p<0.001) both at week 14 (58.0 percent and 11.0 percent, respectively) and week 24 (54.0 percent and 16.0 percent, respectively).

The proportion of patients with three percent or greater BSA at baseline achieving at least a 75 percent improvement in PASI at week 14 was 63.9 percent and 2.3 percent in the REMICADE(reg) and placebo groups, respectively (p<0.001). At week 14, 77 percent of REMICADE(reg) patients achieved PsARC compared with 27 percent of placebo patients (p<0.001). Dactylitis and enthesopathy improved significantly with REMICADE(reg) compared with placebo. Arthritis and psoriasis responses were maintained through week 24.

REMICADE(reg) was generally well tolerated in this study, with similar numbers of patients experiencing adverse events in each group. No deaths, malignancies, cases of tuberculosis or other opportunistic infections were reported and serious infections were uncommon. There was a case of basal cell carcinoma of the skin in one placebo patient. Six patients treated with REMICADE(reg) discontinued treatment as a result of an adverse event compared to two patients in the placebo group. Overall, adverse events and severe adverse events were similar between the REMICADE(reg) and placebo treatment groups.

About Psoriatic Arthritis

Psoriatic arthritis affects men and women equally and can develop at any age, although it most commonly appears between the ages of 30 and 50. In most instances, psoriasis symptoms, such as scaly rashes, occur as long as 10 years before the patient begins to suffer from arthritis. Symptoms of PsA include stiffness, pain, swelling and tenderness of the joints and the soft tissue around them; reduced range of motion; morning stiffness and tiredness; nail changes; and redness and pain of the eye. Joints commonly affected by PsA are the hands, wrists, knees, ankles, feet, lower back and neck.

About REMICADE(reg)

REMICADE(reg) is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both Rheumatoid Arthritis (RA) and Crohn's disease (CD). In the European Union, REMICADE(reg) is also approved for the treatment of Ankylosing Spondylitis. In most countries, REMICADE(reg), in combination with methotrexate, is indicated for the treatment of patients with moderately to severely active RA who have had an inadequate response to methotrexate alone.

REMICADE(reg) 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(reg) is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD.

With more than 500,000 patients treated, twice as many patients treated versus other anti-TNF therapies, and over ten years of clinical experience, REMICADE(reg) is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies with approvals in 72 countries and is the only biologic drug indicated for the treatment of both RA and CD in three major world areas, North America, the European Union and Japan.

Important Information

Many people with heart failure should not take REMICADE(reg); 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 the ankles and 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(reg). If a patient is prone to or has a history of infections, currently has one, or develops one while taking REMICADE(reg), 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 or coccidioidomycosis is common or if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, 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: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to the infusion such as rash or itchy skin. Please read important information about REMICADE(reg), including full prescribing information at http://www.remicade.com. For prescribing information for the European Union, call Schering-Plough Corporation at +1-908-298-7616.

About Centocor, Inc.

Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and the health care community. The company is dedicated to the research and development of treatments for a wide range of diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.) such as arthritis and inflammatory skin diseases. Centocor's products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.

Centocor, Inc., has exclusive marketing rights to REMICADE(reg) in the United States. Schering-Plough Corporation has rights to market REMICADE(reg) in all other countries throughout the world, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd., markets the product.

Johnson & Johnson Disclosure Notice

This press release contains "forward- looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2003. Copies of this Form 10-K are available online at www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

• Additional
• References
• Citations