FDA Approves REMICADE(R) for Treatment of Chronic Severe Plaque Psoriasis: Marks Major Milestone for Patients With High Disease Burden
Nearly Eight Out of 10 REMICADE-Treated Patients Achieved 75 Percent Improvement in Psoriasis at Week 10
HORSHAM, Pa., Sept. 27 /PRNewswire/ — Centocor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE(R) (infliximab) for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter. In the Phase 3 clinical trial EXPRESS, eight out of 10 patients receiving REMICADE 5 mg/kg induction therapy achieved 75 percent improvement in psoriasis as measured by Psoriasis Area Severity Index (PASI 75) by week 10. Similar results were seen with EXPRESS II, the second Phase 3 study. These results were maintained by every eight-week REMICADE 5 mg/kg maintenance infusions at six months.
The majority of patients who continued on this regimen achieved PASI 75 at week 50, the last visit in both studies. More than 1200 patients participated in the two Phase 3 clinical trials. “The rapidity and consistency with which REMICADE can improve clearance of patients’ skin is a major step forward for a patient population where persisting unmet needs in treatment exist,” said Alice B. Gottlieb, MD, PhD, Dermatologist-in-Chief, Professor of Dermatology, Tufts-New England Medical Center, and pivotal U.S. study investigator. “As a researcher involved in the clinical investigation of REMICADE for the treatment of psoriasis, I’ve seen first-hand its significant results in improving psoriasis in the majority of patients treated.” Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and emotional distress.
It is estimated that as many as 7.5 million people in the U.S. have psoriasis(1), which can present in various forms and can range from mild to severe and disabling. Centocor will expand its educational programs to help dermatologists and their patients achieve the benefits of REMICADE and to help manage and minimize the potential risks of biologic therapies, like REMICADE. Data from two multi-center, randomized, double-blind, placebo-controlled trials - EXPRESS and EXPRESS II - served as the primary basis for approval. Both EXPRESS and EXPRESS II showed that a majority of REMICADE-treated patients achieved clinically significant levels of skin clearance with induction and every-eight-week maintenance therapy. At week 10 in EXPRESS, 80 percent of patients receiving REMICADE 5 mg/kg achieved PASI 75 versus three percent of patients receiving placebo (P < 0.001). Atweek 10 in EXPRESS II, 75 percent of patients receiving REMICADE 5 mg/kgachieved PASI 75 versus two percent of patients receiving placebo (P <0.001).
During the controlled periods in EXPRESS and EXPRESS II, adverse events(AEs) occurred at a higher incidence in the REMICADE groups compared withthe placebo groups. In the EXPRESS study, there were more serious AEs,including one fatal infection, in the REMICADE group compared with placebogroup. In the EXPRESS II study, serious AE rates were similar in theREMICADE 5 mg/kg and placebo groups. The only clinically significantlaboratory abnormalities that occurred more frequently in the REMICADEgroups compared with the placebo groups were elevated liver enzyme tests.AEs observed in these studies were generally consistent with thosedescribed in the prescribing information, including the risk of seriousinfections. Please see "Important Safety Information" below.
"New biologic treatment options are needed in our struggle to moreeffectively manage all patients with this lifelong chronic condition,particularly those that have severe disease," said Alan Menter, MD,Chairman, Division of Dermatology, Baylor University Medical Center, andlead U.S. study investigator. "The approval of REMICADE offersdermatologists a treatment option that has been clinically proven torapidly and dramatically clear the skin of patients with a high diseaseburden."
Psoriasis is most commonly diagnosed between the ages of 20 and 30,striking in the prime of people's lives, and the extent of skin involvementvaries from mild to severe and disabling. People with severe psoriasis mayhave large areas of their body covered by lesions, which may crack andbleed. The pain and embarrassment associated with such skin lesions mayprevent people from participating in social and work-related activities,and the physical and mental effects of psoriasis have been compared tothose of other chronic illnesses such as rheumatoid arthritis,hypertension, heart disease, diabetes and depression. Skin lesionsassociated with psoriasis often result in feelings of sadness, despair,guilt and anger, as well as in low self- esteem. A person's sense ofself-worth can be affected, and in some cases, this emotional turmoil canlead to depression.
"Psoriasis is a serious disease that is often misunderstood. There'sphysical pain such as itching and cracking of lesions, as well as theemotional hurt of being stared at or having to explain several times a daywhat psoriasis is and that it's not contagious. These are things that somepatients must contend with each day," said Gail Zimmerman, President andCEO, National Psoriasis Foundation. "The approval of REMICADE is amuch-needed addition for patients living with severe psoriasis." REMICADE is the first and only anti-TNF-alpha treatment to receive 13FDA approvals across inflammatory diseases in gastroenterology,rheumatology and dermatology, and has now been used to treat more than800,000 patients worldwide, more than all other anti-TNF agents combined.REMICADE is an advanced biologic treatment for chronic severe plaquepsoriasis, requiring as few as six treatments a year after an initial three treatments.
New treatments being released and approved is always encouraging — it’s good to see research moving forward toward the eventual cure of psoriasis and the release from the prison of embarassment and shame…
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