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New analyses reinforce efficacy of Remicade in treatment of severe psoriasis
February 05, 2007Findings from an integrated analysis of data from three pivotal, randomized, placebo-controlled trials showed that at week 10 more than three-quarters of patients with severe psoriasis receiving REMICADE® (infliximab) 3 mg/kg or 5 mg/kg achieved a 75 percent improvement in the chronic, inflammatory skin disease as measured by the Psoriasis Area Severity Index (PASI 75). In addition, in a separate analysis, investigators presented findings from a Phase 3 study, which showed that patients treated with REMICADE experienced significant and progressive improvements in psoriasis affecting the nails. Nail disease occurs in up to 50 percent of people with psoriasis. These findings were presented today at the 65th Annual Meeting of the American Academy of Dermatology.
"The integrated data show the substantial efficacy of REMICADE and present great hope for patients with severe psoriasis, particularly those patients burdened with this chronic disease who previously failed phototherapy or systemic therapy," said Alan Menter, MD, dermatologist, Baylor Research Institute, Dallas, and lead study investigator.
In the analysis of 1462 randomized patients, 991 patients (68 percent) met criteria for severe disease as defined by a body surface area (BSA) of at least 20 percent. Out of the 991 patients, 73 percent and 69 percent of study patients had received previous phototherapy or systemic therapy, respectively. At week 10, among patients with severe psoriasis treated with REMICADE (combined 3 mg/kg and 5 mg/kg groups), 79 percent of patients who had received prior phototherapy and 76 percent who had been previously treated with one or more systemic agents achieved PASI 75, compared with three percent and one percent, respectively, of placebo patients (P < 0.001, for both). In a separate analysis from the Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II), among patients with severe psoriasis who were either dissatisfied with or were intolerant to phototherapy, 73 percent of those treated with REMICADE achieved PASI 75 at week 10, compared with two percent of patients receiving placebo (P < 0.001). Sixty-nine percent of patients who were dissatisfied with or were intolerant to one or more systemic therapies prior to starting REMICADE achieved PASI 75 at week 10, compared with zero patients in the placebo group (P < 0.001).
A separate analysis from the European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS) trial showed that among study patients with psoriasis affecting the nails at baseline who were treated with REMICADE 5 mg/kg, seven percent, 26 percent and 45 percent had clearance of nail psoriasis at weeks 10, 24 and 50, respectively, compared with 5 percent of patients in the placebo group at week 24 (P = 0.0002). In addition, at weeks 10 and 24, the mean percent improvements in the Nail Psoriasis Severity Index (NAPSI) scores were 27 percent and 57 percent, respectively, among patients in the REMICADE 5 mg/kg group compared with disease worsening observed among patients receiving placebo with increases in NAPSI scores of eight percent and four percent, respectively (P < 0.001, for both).
"These data are promising because the results demonstrate the efficacy of REMICADE in psoriasis patients whose disease is affecting the nails, a difficult-to-treat and chronic manifestation that can affect a large proportion of patients with psoriasis," said Phoebe Rich, MD, associate professor of dermatology, Oregon Health Sciences University. "Symptoms associated with nail disease may include deep holes in the nails or separation of the nails from the nail beds, which often result in pain and discomfort and may affect an individual's ability to perform daily activities. Given the nature of these symptoms, effectively treating both skin disease and nail disease, may greatly lessen the patients' overall burden of disease."
The progressive improvements in nail psoriasis observed in patients receiving REMICADE 5 mg/kg were consistent with normal nail growth rates, and the improvement was sustained over time. Treatment also resulted in significant improvements in nail matrix and nail bed signs of the disease, as measured by the NAPSI scoring system, including lunular red spots and splinter hemorrhages (small areas of bleeding under the nails), which completely resolved in two-thirds of REMICADE-treated patients at 10 weeks. The NAPSI scoring system evaluates nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit and assesses eight characteristic features of psoriatic nail involvement, including pitting, leukonychia (discoloration), nail plate crumbling, red spots in the lunula (crescent-shaped area at bottom of nail), onycholysis (separation of nail from nail bed), nail bed hyperkeratosis (thickening of skin), splinter hemorrhages and oil drop discoloration.
In September 2006, REMICADE was approved in the U.S. 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.
About EXPRESS
The European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE induction and maintenance therapy in 378 adult patients with chronic, stable plaque psoriasis involving at least 10 percent body surface area (BSA), a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients received either REMICADE 5 mg/kg or placebo administered at weeks 0, 2 and 6, followed by maintenance treatment every eight weeks. The REMICADE group continued on maintenance treatments every eight weeks. Patients in the placebo group were crossed over at week 24 to receive REMICADE 5 mg/kg at weeks 24, 26 and 30, then every eight weeks through week 46.
In EXPRESS, through week 24, adverse events (AEs) occurred at a higher incidence in the REMICADE group (82 percent) compared with the placebo group (71 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzyme tests. There were more serious AEs (six percent), including one fatal infection, in the REMICADE group than in the placebo group (three percent). AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.
About EXPRESS II
The Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE in 835 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of REMICADE 3 mg/kg or 5 mg/kg or placebo at weeks 0, 2 and 6. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as-needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group were crossed over at week 16 to receive REMICADE 5 mg/kg at weeks 16, 18 and 22, then every eight weeks through week 46.
In EXPRESS II, through week 14 (the placebo-controlled period), AEs occurred at a higher incidence in the REMICADE groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzyme tests. Serious AEs occurred at rates of two percent in the placebo group, three percent in the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.
About SPIRIT
Study of Psoriasis with Infliximab [REMICADE] Induction Therapy (SPIRIT) was a Phase 2, multi-center, double-blind, placebo-controlled study evaluating the use of REMICADE induction therapy in 249 people with severe plaque psoriasis who had previously received psoralen plus ultraviolet light A (PUVA) or systemic therapy for psoriasis. Trial participants were randomized to receive REMICADE 3 mg/kg, REMICADE 5 mg/kg or placebo at weeks 0, 2, and 6 and were assessed biweekly for 10 weeks. At week 26, 114 patients whose Physician Global Assessment (PGA) score indicated moderate to severe disease were eligible for one additional infusion of their assigned treatment to assess the safety of re-treatment after a 20-week treatment-free period.
In the SPIRIT trial, the percentage of patients with one or more AE was higher in the REMICADE groups compared with placebo. Through week 30 of the SPIRIT trial, 63 percent, 78 percent and 79 percent of patients in the placebo, REMICADE 3 mg/kg and 5 mg/kg groups, respectively, reported one or more AE. The most commonly reported side effects versus placebo were upper respiratory tract infection (15 percent versus 14 percent), headache (15 percent versus 8 percent) and itching (12 percent versus 0 percent). A total of six percent of REMICADE-treated patients reported serious AEs, compared with zero patients in the placebo group. Overall, the AEs were consistent with those seen in previous trials. Please see "Important Safety Information" below.
About Psoriasis
Psoriasis is a chronic, immune-mediated disease, which results from inflammation in the skin and overproduction of skin cells that accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven in part by tumor necrosis factor alpha, or TNF-alpha, a cytokine involved in the body's normal immune response. TNF-alpha is found at increased levels in psoriatic plaques and plays a crucial part in their formation and continued existence. It is estimated that two percent of the U.S. population has psoriasis, and about 30 percent of people with psoriasis have cases that are considered moderate to severe.
Centocor, Inc.
A separate analysis from the European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS) trial showed that among study patients with psoriasis affecting the nails at baseline who were treated with REMICADE 5 mg/kg, seven percent, 26 percent and 45 percent had clearance of nail psoriasis at weeks 10, 24 and 50, respectively, compared with 5 percent of patients in the placebo group at week 24 (P = 0.0002). In addition, at weeks 10 and 24, the mean percent improvements in the Nail Psoriasis Severity Index (NAPSI) scores were 27 percent and 57 percent, respectively, among patients in the REMICADE 5 mg/kg group compared with disease worsening observed among patients receiving placebo with increases in NAPSI scores of eight percent and four percent, respectively (P < 0.001, for both).
"These data are promising because the results demonstrate the efficacy of REMICADE in psoriasis patients whose disease is affecting the nails, a difficult-to-treat and chronic manifestation that can affect a large proportion of patients with psoriasis," said Phoebe Rich, MD, associate professor of dermatology, Oregon Health Sciences University. "Symptoms associated with nail disease may include deep holes in the nails or separation of the nails from the nail beds, which often result in pain and discomfort and may affect an individual's ability to perform daily activities. Given the nature of these symptoms, effectively treating both skin disease and nail disease, may greatly lessen the patients' overall burden of disease."
The progressive improvements in nail psoriasis observed in patients receiving REMICADE 5 mg/kg were consistent with normal nail growth rates, and the improvement was sustained over time. Treatment also resulted in significant improvements in nail matrix and nail bed signs of the disease, as measured by the NAPSI scoring system, including lunular red spots and splinter hemorrhages (small areas of bleeding under the nails), which completely resolved in two-thirds of REMICADE-treated patients at 10 weeks. The NAPSI scoring system evaluates nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit and assesses eight characteristic features of psoriatic nail involvement, including pitting, leukonychia (discoloration), nail plate crumbling, red spots in the lunula (crescent-shaped area at bottom of nail), onycholysis (separation of nail from nail bed), nail bed hyperkeratosis (thickening of skin), splinter hemorrhages and oil drop discoloration.
In September 2006, REMICADE was approved in the U.S. 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.
About EXPRESS
The European Infliximab for Psoriasis [REMICADE] Efficacy and Safety Study (EXPRESS) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE induction and maintenance therapy in 378 adult patients with chronic, stable plaque psoriasis involving at least 10 percent body surface area (BSA), a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients received either REMICADE 5 mg/kg or placebo administered at weeks 0, 2 and 6, followed by maintenance treatment every eight weeks. The REMICADE group continued on maintenance treatments every eight weeks. Patients in the placebo group were crossed over at week 24 to receive REMICADE 5 mg/kg at weeks 24, 26 and 30, then every eight weeks through week 46.
In EXPRESS, through week 24, adverse events (AEs) occurred at a higher incidence in the REMICADE group (82 percent) compared with the placebo group (71 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzyme tests. There were more serious AEs (six percent), including one fatal infection, in the REMICADE group than in the placebo group (three percent). AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.
About EXPRESS II
The Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE in 835 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of REMICADE 3 mg/kg or 5 mg/kg or placebo at weeks 0, 2 and 6. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as-needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group were crossed over at week 16 to receive REMICADE 5 mg/kg at weeks 16, 18 and 22, then every eight weeks through week 46.
In EXPRESS II, through week 14 (the placebo-controlled period), AEs occurred at a higher incidence in the REMICADE groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzyme tests. Serious AEs occurred at rates of two percent in the placebo group, three percent in the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.
About SPIRIT
Study of Psoriasis with Infliximab [REMICADE] Induction Therapy (SPIRIT) was a Phase 2, multi-center, double-blind, placebo-controlled study evaluating the use of REMICADE induction therapy in 249 people with severe plaque psoriasis who had previously received psoralen plus ultraviolet light A (PUVA) or systemic therapy for psoriasis. Trial participants were randomized to receive REMICADE 3 mg/kg, REMICADE 5 mg/kg or placebo at weeks 0, 2, and 6 and were assessed biweekly for 10 weeks. At week 26, 114 patients whose Physician Global Assessment (PGA) score indicated moderate to severe disease were eligible for one additional infusion of their assigned treatment to assess the safety of re-treatment after a 20-week treatment-free period.
In the SPIRIT trial, the percentage of patients with one or more AE was higher in the REMICADE groups compared with placebo. Through week 30 of the SPIRIT trial, 63 percent, 78 percent and 79 percent of patients in the placebo, REMICADE 3 mg/kg and 5 mg/kg groups, respectively, reported one or more AE. The most commonly reported side effects versus placebo were upper respiratory tract infection (15 percent versus 14 percent), headache (15 percent versus 8 percent) and itching (12 percent versus 0 percent). A total of six percent of REMICADE-treated patients reported serious AEs, compared with zero patients in the placebo group. Overall, the AEs were consistent with those seen in previous trials. Please see "Important Safety Information" below.
About Psoriasis
Psoriasis is a chronic, immune-mediated disease, which results from inflammation in the skin and overproduction of skin cells that accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven in part by tumor necrosis factor alpha, or TNF-alpha, a cytokine involved in the body's normal immune response. TNF-alpha is found at increased levels in psoriatic plaques and plays a crucial part in their formation and continued existence. It is estimated that two percent of the U.S. population has psoriasis, and about 30 percent of people with psoriasis have cases that are considered moderate to severe.
Centocor, Inc.
Psoriasis Current Events and Psoriasis News RSSMultiple health concerns surface as winter, vitamin D deficiences arrive
A string of recent discoveries about the multiple health benefits of vitamin D has renewed interest in this multi-purpose nutrient, increased awareness of the huge numbers of people who are deficient in it, spurred research and even led to an appreciation of it as "nature's antibiotic."
Curry-cure? Spicing up the effectiveness of a potential disease-fighter
Scientists are reporting development of a nano-size capsule that boosts the body's uptake of curcumin, an ingredient in yellow curry now being evaluated in clinical trials for treatment of several diseases.
Skin-disease patients show brain immunity to faces of disgust
People with psoriasis - an often distressing dermatological condition that causes lesions and red scaly patches on the skin - are less likely to react to looks of disgust by others than people without the condition, new research has found.
Gene variation is 'major genetic determinant of psoriasis'
A specific genetic region that has been increasingly identified as the strongest genetic link to psoriasis has an even more significant role in the chronic skin disease than has been suspected, University of Utah medical researchers show in a new study.
Drug rescues memory lost to Alzheimer's disease
A drug similar to one used in clinical trials for treatment of rheumatoid arthritis and psoriasis has been found to rescue memory in mice exhibiting Alzheimer's symptoms.
Post-transplant combo can replace toxic immune-suppressing drugs in monkeys
Transplant patients rely on drugs to prevent graft rejection, but at the cost of serious side effects.
Psoriasis associated with cardiovascular disease and increased mortality
The skin disease psoriasis is associated with atherosclerosis (a buildup of plaque in the arteries) characterized by an increased prevalence of ischemic heart disease, cerebrovascular disease, peripheral artery disease and an increased risk of death.
Scientists discover new genetic immune disorder in children
Your immune system plays an important function in your health-it protects you against viruses, bacteria, and other toxins that can cause disease.
Study finds unexpected bacterial diversity on human skin
The health of our skin - one of the body's first lines of defense against illness and injury - depends upon the delicate balance between our own cells and the millions of bacteria and other one-celled microbes that live on its surface.
Vitamin D may halt lung function decline in asthma and COPD
Vitamin D may slow the progressive decline in the ability to breathe that can occur in people with asthma as a result of human airway smooth muscle (HASM) proliferation, according to researchers at the University of Pennsylvania.
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Healing Psoriasis: The Natural Alternative by John Pagano (Author) A leading researcher shares natural remedies for psoriasis According to the National Psoriasis Foundation, at least seven million people in the U.S. and more than 100 million worldwide suffer from this chronic skin disease. This book outlines Dr. Pagano's natural, drug-free treatment regimen that can alleviate, control, and even heal psoriasis without steroid creams, tar baths, injections, or ultraviolet treatments. Healing Psoriasis outlines a healthy diet and lifestyle and includes case histories, photos, recipes, and a chapter on eczema. John O. A. Pagano, DC (Englewood Cliffs, NJ), is a chiropractic physician who has conducted psoriasis research for more than 40 years. He has been a featured guest on CNBC, ABC, and Health Talk with Dr. Ronald Hoffman, and... |
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Loma Lux Homeopathic Medicine, Psoriasis, 8 fl oz (237 ml) by Loma Lux For relief from the scaling, itching and redness of Psoriasis and Seborrhea. Take orally. 2% Alcohol. Dermatologist Steven A. Smith, MD, developed the Loma Lux Psoriasis formula & has proven its effectiveness in treating thousands of patients for psoriasis and seborrheic dermatitis. Get relief from scaling, flaking, redness, pain and itching with Loma Lux Psoriasis. I spent hundreds of dollars on creams from the doctor; nothing worked. A miracle came in Loma Lux Psoriasis! before the first month was up I noticed a big difference in my psoriasis. My skin cleared with continued use. Loma Lux is dedicated to promote worldwide health and wholeness using natural, low dose, low side effect treatments, bringing freedom from chronic diseases. |
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Psoriasis Healing from the Inside Out by Heather J. Ferris (Author) "At last a beautifully written book on how to manage this difficult external condition by internal means. I will recommend this book to all my patients with psoriasis." Dr Stephen Falkner MB., Ch.B. Psoriasis Healing from the Inside Out is an important book for people with psoriasis and other conditions, who feel controlled by their diseases. The author Heather Ferris shares her own profound (and simple) experiences with healing addressing issues of body, mind and spirit. She provides practical techniques and opportunities to reflect on individual situations. The author's warm and caring style is evident as she invites us to experience a more peaceful inner environment. Reading this book reminds us to live full, healthy lives. |
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Adovia Natural Dead Sea Mud Soap - Great for Eczema, Psoriasis or Acne! by Adovia Mineral Skin Care Our All Natural Black Mud Soap contains a unique combination of Dead Sea minerals derived from Dead Sea Mud. This effective mud soap removes dirt and cleanses your skin, while simultaneously infusing it with minerals essential to keeping your skin hydrated and moisturized. Our Dead Sea mud soap is enriched with century old Dead Sea mud, leaving your skin cleansed and nourished. As more people are learning about the healing and beauty effects of black mud from The Dead Sea, this soap is becoming a very popular choice for skin care conscious people. |
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Your Healing Diet: A Quick Guide to Reversing Psoriasis and Chronic Diseases with Healing Foods by Deirdre Earls RD LD (Author) 'Your Healing Diet: A Quick Guide to Reversing Psoriasis and Chronic Diseases with Healing Foods' is a handbook written by Deirdre Earls, RD, LD, to make it faster and easier to eat in a way that enables the body to heal itself. A short guidebook which was designed to be very user-friendly, it also explains how food can create and reverse disease. In essense, the book distills common threads of success amongst several healing diets like Macrobiotics, Raw Foods, Alkalizing, Cancer and Heart Disease Prevention, Anti-Aging and Anti-inflammatory Diets. Then it demonstrates how you can easily incorporate healing habits into your busy lifestyle. Special segments discuss healing principles and what to expect when healing naturally. Whether or not you're an Austinite, you'll also find... |
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Oxipor VHC Psoriasis Lotion, Coal Tar Solution, 4-Ounce Bottle by Oxipor Oxipor psoriasis lotion controls itching, and relieves redness and scaling. |
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Mg 217 Intensive Strength Medicated Tar Ointment for Psoriasis - 3.8 Oz by Mg 217 Mg 217 Intensive Strength Medicated Tar Ointment for Psoriasis is specially formulated to control the itching, redness and scaling from skin psoriasis. |
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Psoriasis: The Real Way Out: A Self-Education Guide to Complete Natural Healing by Jerry G. Scott R.N.C. (Author) This is a book for the determined, not for the quick fix crowd. A clear understanding of the underlying causes of psoriasis is presented, one that flies in the face of current drug-oriented treatments, nevertheless one that recognizes the causes and alleviation of psoriasis that have been known for decades. Leading edge strategies are also revealed, and resources are listed. The book is blunt, and does not coddle the reader. Rather, it requires participation if the reader is to be healed of the condition, and very specific solutions are offered in a comprehensive plan of action. Uniquely, the author offers his personal help when readers are registered through links that are provided in the book. |
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