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Infliximab Approved for Psoriatic Arthritis
"The approval of Remicade is a promising development in the treatment of psoriatic arthritis," said Arthur Kavanaugh, M.D., professor of Medicine at University of California at San Diego. "Study results show that patients treated with Remicade rapidly achieved profound improvement in arthritis symptoms and dramatically improved clearance in skin disease."
Data from the Induction and Maintenance of Psoriatic Arthritis Clinical Trial 2 (IMPACT 2) served as the primary basis for the approval. Significant improvements in both ACR 20 and PASI 75 were observed in patients treated with Remicade as early as week two, with further improvements through 24 weeks. At week 14, 58 percent of patients treated with Remicade experienced at least 20 percent improvement in arthritis symptoms, according to the American College of Rheumatology scoring criteria (ACR 20) versus 11 percent of placebo-treated patients (P Importantly, patients in the Remicade group also experienced decreased symptoms of dactylitis and enthesopathy, two common disease manifestations causing pain and swelling. Dactylitis, swelling of digits in the hands or feet, and enthesopathy, inflammation of a tendon, or ligament insertion to the bone, are estimated to affect more than one-third of people with psoriatic arthritis. In the study, 40 percent of Remicade patients and 41 percent of patients in the placebo group had dactylitis in at least one digit at baseline. After 24 weeks of treatment, only 15 percent of Remicade patients continued to experience symptoms, compared to 33 percent of patients receiving placebo (P greater than or equal to 0.05). At baseline, enthesopathy was observed in 42 percent of patients in the Remicade group and 35 percent of patients receiving placebo. At week 24, only 22 percent of Remicade patients still experienced enthesopathy, compared to 36 percent in the placebo group (P = 0.004).
According to 2004 National Psoriasis Foundation surveys of more than 1000 people with psoriasis and psoriatic arthritis, approximately 85 percent of psoriatic arthritis patients reported their condition to be a problem in their everyday lives. Additionally, less than 20 percent of patients with psoriatic arthritis reported high satisfaction with their treatments.
"Our surveys show that patients have consistently noted the negative physical and emotional impact that psoriatic arthritis can have on their quality of life," said Gail Zimmerman, president and CEO, National Psoriasis Foundation. "The approval of Remicade is important because of the renewed hope that this therapy may offer for many people with psoriatic arthritis."
In September 2004, Remicade was approved in the European Union (EU), in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs).
IMPACT 2 was a Phase III randomized, double-blind, placebo-controlled study of 200 patients with active psoriatic arthritis (defined as affecting at least five joints). The study evaluated the safety and efficacy of Remicade in patients who had an inadequate response to DMARDs or nonsteroidal anti- inflammatory drugs (NSAIDs). Patients received Remicade (5mg/kg) or placebo at weeks zero, two, six and every eight weeks until week 22. In patients with > or equal to three percent body surface area (BSA) psoriasis involvement at baseline, psoriasis activity was assessed using PASI at baseline and weeks two, six, 14 and 24. Responses were achieved regardless of methotrexate use or level of joint involvement at baseline.
Patients treated with Remicade also experienced significant improvement in the physical component summary (PCS) and mental component summary (MCS) scores of the short form 36 (SF-36). The SF-36 is a 36-item questionnaire that assesses impact in eight areas, including physical functioning, pain, vitality, social functioning, psychological functioning, general health perceptions and role limitations due to physical and emotional problems. SF- 36 scores range from zero to 100, and lower scores indicate poorer functioning and well-being. At week 14, Remicade patients experienced an average increase in PCS score of 9.1 units, compared to an average 1.1-unit increase in patients receiving placebo (P Through 24 weeks, a similar number of patients experienced adverse events (AE) in each treatment group. No deaths, cases of tuberculosis or other opportunistic infections, or serious infusion reactions were reported and serious infections were uncommon. Also, with the exception of one case of basal cell carcinoma in the placebo group, no malignancies were reported. Significant laboratory abnormalities were unusual, with an elevation in liver function tests being the most common abnormality. There were more patients with serious AEs in the Remicade group (8.7 percent) than in the placebo group (6.2 percent). See Important Safety Information below.
About Psoriatic Arthritis
Psoriatic arthritis involves joint pain and swelling that can lead to debilitation coupled with inflamed, scaly, red patches of psoriasis. Symptoms may include stiffness and tenderness of the joints and surrounding tissue, reduced range of motion, nail changes and redness and pain of the eye or uveitis. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Approximately one million Americans have psoriatic arthritis, and the disease affects both men and women equally, most commonly between the ages 30 and 50.
Remicade is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both RA and Crohn's disease in North America, the EU and Japan. In the EU and in the U.S., Remicade is approved for the treatment of active ankylosing spondylitis and psoriatic arthritis.
In the U.S., 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 rheumatoid arthritis (RA). Remicade is the only biologic indicated for the treatment of patients with moderately-to-severely active Crohn's disease (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 patients with fistulizing CD. In December 2004, Remicade was approved for the treatment of active ankylosing spondylitis in the U.S.
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, CD, and PsA, Remicade is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, Remicade patients may require as few as six treatments each year. In AS, Remicade is a two-hour infusion (5 mg/kg) administered every six weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. The safety and efficacy of Remicade have been well established in clinical trials over the past 12 years and through commercial experience with over a half a million patients treated worldwide.
Source: Centocor, Inc.