 |
|
Ustekinumab Phase 3 data show long-term improvement of chronic plaque psoriasis
February 04, 2008One-year data from a second double-blind, placebo-controlled Phase 3 study showed therapy with ustekinumab given every 12 weeks provided sustained, clinically meaningful improvement in the treatment of moderate to severe plaque psoriasis through one year. According to findings presented at the Annual Meeting of the American Academy of Dermatology, 87 percent of patients responding to ustekinumab 45 mg maintenance therapy and 91 percent of patients responding to ustekinumab 90 mg maintenance therapy sustained at least a 75 percent improvement in psoriasis through one year, as measured by the Psoriasis Area and Severity Index (PASI 75). Ustekinumab is a new human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body's regulation of immune responses and that are also believed to play a role in immune-mediated inflammatory disorders, including psoriasis.
In December 2007, Centocor announced that a Biologics License Application (BLA) had been submitted to the U.S. Food and Drug Administration (FDA) and Janssen-Cilag International NV announced its submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA).
"These findings show that ustekinumab may control plaque psoriasis with as few as four injections a year," says lead study investigator Kenneth Gordon, MD, associate professor, Feinberg School of Medicine, Northwestern University, and Head of Dermatology, Evanston Northwestern Healthcare, Skokie, IL. "We are encouraged by the results seen in clinical trials to date and the hope that ustekinumab may hold for patients and the dermatology community."
The primary endpoint of the Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) study examined the proportion of patients achieving at least a 75 percent improvement from baseline at week 12. Investigators reported findings from PHOENIX 1 that showed at week 12, after two doses, 67 percent of patients receiving 45 mg ustekinumab and 66 percent of patients receiving 90 mg ustekinumab achieved PASI 75 compared with 3 percent of patients receiving placebo (P<0.001 for each comparison versus placebo). Furthermore, 42 percent of patients in the 45 mg ustekinumab dosing group and 37 percent of patients in the 90 mg ustekinumab dosing group achieved PASI 90, or nearly complete clearance of psoriasis, compared with 2 percent of patients receiving placebo (P<0.001). Primary endpoint study findings from PHOENIX 1 were consistent with the week 12 primary endpoint findings reported at the World Congress of Dermatology in October 2007 from another study, the Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension 2 (PHOENIX 2).
In the PHOENIX 1 study, subjects who received 45 mg or 90 mg of ustekinumab and consistently achieved a 75 percent improvement from baseline were randomized at week 40 to either continue treatment or switch to placebo, with levels of response to maintenance therapy measured at week 52. Of those patients who continued treatment with ustekinumab 45 mg and ustekinumab 90 mg dosing, 87 percent and 91 percent, respectively, had a sustained PASI 75 response compared with 64 percent and 62 percent of patients switched to placebo (P≤0.001 for 45 mg comparison; P<0.001 for 90 mg comparison). Also at week 40, 66 percent and 73 percent of patients achieved PASI 90 after receiving either 45 mg ustekinumab or 90 mg ustekinumab, respectively, and response rates remained stable through week 52 with continued treatment, compared with 37 percent and 38 percent of patients switched to placebo.
"The Phase 3 efficacy and safety data for ustekinumab are extremely promising and offer hope to a patient population in need of additional therapeutic options," says Kim Papp, MD, PhD, Probity Medical Research, Waterloo, Ontario, and lead study investigator.
About the PHOENIX 1 Trial
PHOENIX 1 evaluated the efficacy and safety of ustekinumab in the treatment of 766 patients with chronic plaque psoriasis. Patients were randomized to receive subcutaneously administered ustekinumab or placebo. Patients randomized to receive ustekinumab received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of ustekinumab at weeks 12 and 16 and every 12 weeks thereafter. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to ustekinumab through week 40 were randomized to either continue treatment with ustekinumab or were switched to placebo.
Through week 12 (the placebo-controlled portion of the study) the percentages of study participants experiencing at least one adverse event (AE) were comparable between the placebo group (48 percent) and the ustekinumab 45 mg group (57 percent) and 90 mg group (51 percent). Those patients experiencing at least one serious AE were reported as follows: 1 percent and 2 percent of patients receiving 45 mg or 90 mg ustekinumab, respectively, compared with 2 percent of patients receiving placebo. After the randomization at week 40, 46 percent and 49 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, respectively, experienced at least one AE, compared with 56 and 48 percent of patients switched to placebo. Serious AEs were observed in 0 and 1 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, compared with 0 and 2 percent of patients switched to placebo.
Centocor, Inc.
The primary endpoint of the Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) study examined the proportion of patients achieving at least a 75 percent improvement from baseline at week 12. Investigators reported findings from PHOENIX 1 that showed at week 12, after two doses, 67 percent of patients receiving 45 mg ustekinumab and 66 percent of patients receiving 90 mg ustekinumab achieved PASI 75 compared with 3 percent of patients receiving placebo (P<0.001 for each comparison versus placebo). Furthermore, 42 percent of patients in the 45 mg ustekinumab dosing group and 37 percent of patients in the 90 mg ustekinumab dosing group achieved PASI 90, or nearly complete clearance of psoriasis, compared with 2 percent of patients receiving placebo (P<0.001). Primary endpoint study findings from PHOENIX 1 were consistent with the week 12 primary endpoint findings reported at the World Congress of Dermatology in October 2007 from another study, the Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension 2 (PHOENIX 2).
In the PHOENIX 1 study, subjects who received 45 mg or 90 mg of ustekinumab and consistently achieved a 75 percent improvement from baseline were randomized at week 40 to either continue treatment or switch to placebo, with levels of response to maintenance therapy measured at week 52. Of those patients who continued treatment with ustekinumab 45 mg and ustekinumab 90 mg dosing, 87 percent and 91 percent, respectively, had a sustained PASI 75 response compared with 64 percent and 62 percent of patients switched to placebo (P≤0.001 for 45 mg comparison; P<0.001 for 90 mg comparison). Also at week 40, 66 percent and 73 percent of patients achieved PASI 90 after receiving either 45 mg ustekinumab or 90 mg ustekinumab, respectively, and response rates remained stable through week 52 with continued treatment, compared with 37 percent and 38 percent of patients switched to placebo.
"The Phase 3 efficacy and safety data for ustekinumab are extremely promising and offer hope to a patient population in need of additional therapeutic options," says Kim Papp, MD, PhD, Probity Medical Research, Waterloo, Ontario, and lead study investigator.
About the PHOENIX 1 Trial
PHOENIX 1 evaluated the efficacy and safety of ustekinumab in the treatment of 766 patients with chronic plaque psoriasis. Patients were randomized to receive subcutaneously administered ustekinumab or placebo. Patients randomized to receive ustekinumab received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of ustekinumab at weeks 12 and 16 and every 12 weeks thereafter. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to ustekinumab through week 40 were randomized to either continue treatment with ustekinumab or were switched to placebo.
Through week 12 (the placebo-controlled portion of the study) the percentages of study participants experiencing at least one adverse event (AE) were comparable between the placebo group (48 percent) and the ustekinumab 45 mg group (57 percent) and 90 mg group (51 percent). Those patients experiencing at least one serious AE were reported as follows: 1 percent and 2 percent of patients receiving 45 mg or 90 mg ustekinumab, respectively, compared with 2 percent of patients receiving placebo. After the randomization at week 40, 46 percent and 49 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, respectively, experienced at least one AE, compared with 56 and 48 percent of patients switched to placebo. Serious AEs were observed in 0 and 1 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, compared with 0 and 2 percent of patients switched to placebo.
Centocor, Inc.
Psoriasis Current Events and Psoriasis News RSSCurry-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.
Home UVB therapy for psoriasis as effective and safe as hospital treatment
For patients with psoriasis, treatment with ultraviolet B (UVB) at home is as effective and as safe as conventional hospital based phototherapy, concludes a study published on bmj.com today.
More Psoriasis Current Events and Psoriasis News Articles
 |
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... |
 |
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. |
 |
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... |
 |
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. |
 |
The Psoriasis Cure: A Drug-Free Guide to Stopping and Reversing the Symptoms of Psoriasis by Lisa LeVan (Author) This book offers hope for those who suffer from this debilitating systemic disease. Beyond causing scaly red patches on the skin, psoriasis can result in aching joints, listlessness, and arthritis. Featuring a nutritional approach to treatment, this book teaches the patient to eliminate allergic reactions and to add specific supplements to the diet. |
 |
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. |
 |
Psoriasis, Healing from the Inside Out by Heather J. Ferris (Author) An important book for people with psoriasis and other conditions, who feel controlled by their diseases. This book addresses issues of the body, mind and spirit. It also provides practical techniques and opportunities to reflect on individual situations and to make the necessary changes. |
 |
Oxipor VHC Psoriasis Lotion, Coal Tar Solution, 4-Ounce Bottle by Oxipor Oxipor psoriasis lotion controls itching, and relieves redness and scaling. |
 |
Psoriasis: Everything You Need to Know (Your Personal Health) by Dr Richard G.B. Langley (Author) Helpful advice for relief of a chronic condition that affects millions. Psoriasis is a chronic inflammatory, non-contagious skin disease. Characterized by itchy, thick and raised red areas of skin covered with silvery-white scales, psoriasis affects 1 in 50 adults. This affliction makes it one of the world's most common skin disorders. Appearing at any age, it can affect relationships, the ability to work and to enjoy leisure activities. Psoriasis is a straightforward book about an all too common problem. The information is presented in clear, understandable terms for non-medical readers, covering: - Causes - Psychosocial effects - Diagnosis - Treatment options - Psoriatic arthritis - Psoriasis in children. Psoriasis includes line drawings, case studies, a... |
 |
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. |
| © 2009 BrightSurf.com |