Amgen and Pfizer Inc. announced results from a new trial that demonstrated Enbrel (etanercept) significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo. The data will be presented today at the 69th Annual American Academy of Dermatology (AAD) meeting in New Orleans, La.
“At least half of people with plaque psoriasis have involvement on their scalp, which may contribute to feelings of embarrassment associated with this condition,” said lead author Jerry Bagel, MD, medical director, Psoriasis Treatment Centre of Central New Jersey. “These data reinforce the efficacy and safety profile of Enbrel for adult patients with moderate to severe plaque psoriasis with scalp involvement.”
In this trial, patients were randomized to either 12 weeks of Enbrel 50 mg twice weekly followed by 12 weeks of Enbrel 50 mg once weekly (Group A), or 12 weeks of placebo twice weekly followed by 12 weeks of Enbrel 50 mg twice weekly (Group B). This trial met its primary endpoint of mean percent improvement from baseline in Psoriasis Scalp Severity Index (PSSI) with 87 percent PSSI improvement in Group A compared with 20 percent in Group B at week 12 (P<0.0001). The PSSI response to Enbrel for patients in Group A was maintained through 24 weeks despite patients switching to a lower dose (91 percent). Patients in Group B saw a mean percent improvement in their PSSI score of 79 percent at week 24, similar to that achieved by the Group A patients at week 12.
In addition to the improvement in scalp involvement, in an exploratory analysis, the mean percent improvement from baseline in Psoriasis Area Severity Index (PASI) was 74 percent in Group A compared with 11 percent in Group B at week 12 (P<0.0001). At week 24, the mean percent improvement from baseline was 78 percent in Group A and 68 percent in Group B.
At week 12 in this study, 75 percent of patients treated with ENBREL (n=43) were either satisfied or very satisfied with their treatment, compared with 21 percent of patients on placebo (n=11, P<0.0001).
Among the 121 patients evaluable for safety, 67.8 percent reported at least one adverse event (AE) through week 24; the most common were upper respiratory tract infections (11.6 percent), nasopharyngitis (8.3 percent), injection site reaction (5.8 percent), arthralgia (5.0 percent), and headache (5.0 percent). Three patients reported five serious AEs: cholecystitis/cholelithiasis, fall/rib fracture and metastatic malignant melanoma.
The trial was a phase IV, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Enbrel in adult patients with moderate to severe plaque psoriasis with scalp involvement. The 124 eligible patients were at least 18 years old with a PASI =10, affected body surface area =10 percent, PSSI =15, and affected scalp surface area =30 percent. Patients were randomized to either 12 weeks of Enbrel 50 mg twice weekly followed by 12 weeks of Enbrel 50 mg once weekly (Group A), or 12 weeks of placebo twice weekly followed by 12 weeks of Enbrel 50 mg twice weekly (Group B). The primary endpoint was the mean percent improvement from baseline in PSSI at week 12. Patient satisfaction with treatment was a patient-reported secondary endpoint and was determined by a 5-point scale (very dissatisfied to very satisfied).
Psoriasis affects approximately 7.5 million American adults and is a chronic disease of the immune system that causes the skin cells to grow at an accelerated rate. Although there are several types of psoriasis, approximately 80 percent of patients suffer from plaque psoriasis, which can cause painful and itchy red, scaly patches to appear on the skin.
According to the National Psoriasis Foundation, at least half of all the people who have psoriasis have scalp involvement. Scalp involvement can be very mild, with slight, fine scaling or very severe with thick, crusted plaques covering the entire scalp. Psoriasis can extend beyond the hairline onto the forehead, the back of the neck and around the ears.
Enbrel is a soluble form of a fully human Tumour Necrosis Factor (TNF) receptor with a clinical efficacy and safety profile established over 18 years of collective clinical experience. Enbrel was first approved in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with moderate to severe juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. Enbrel was approved in 2004 to treat adult chronic moderate to severe plaque psoriasis. Prescription Enbrel is given by injection.
Enbrel is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis and it can be taken with methotrexate or used alone. It is indicated for reducing signs and symptoms of moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA) in children ages 2 years and older.
Enbrel is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. It can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. It is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis and for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Enbrel is a medicine that affects your immune system. It can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking Enbrel. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before you take Enbrel and monitor you closely for TB before, during, and after Enbrel treatment, even if you have tested negative for TB.
There have been some cases of unusual cancers reported in children and teenage patients who started using Tumour Necrosis Factor (TNF) blockers before 18 years of age. Also, for children, teenagers, and adults taking TNF blockers, including Enbrel, the chances of getting lymphoma or other cancers may increase. Patients with RA or psoriasis may be more likely to get lymphoma.
Before starting Enbrel, tell your doctor if you have any existing medical conditions, taking any medicines, including herbals, think you has been treated for, has signs of, or is prone to infection. You should not start taking Enbrel if you have any kind of infection, unless your doctor says it is okay. If you has any open cuts or sores or diabetes, an immune system problem, TB or has been in close contact with someone who has had TB or were born in, lived in, or travelled to countries where there is more risk for getting TB.
Ask your doctor if you are not sure live or have lived in certain parts of the country (such as, the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for certain kinds of fungal infections, such as histoplasmosis. These infections may develop or become more severe if you take Enbrel.
If you don’t know if histoplasmosis or other fungal infections are common in the areas where you live or have lived, ask your doctor if you have or had hepatitis B or heart failure or develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking Enbrel use the medicines Kineret (anakinra), Orenciaâ (abatacept), or Cytoxan (cyclophosphamide) or has develop a serious nervous disorder, seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome or has recently received or are scheduled for any vaccines.
All vaccines should be brought up-to-date before starting Enbrel. Patients taking Enbrel should not receive live vaccines or are allergic to rubber or latex or are pregnant, planning to become pregnant, or breastfeeding or has been around someone with chicken pox.
Enbrel can cause serious side effects including: infections, including serious infections like TB; hepatitis B can become active if you already have had it; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; blood problems (some fatal); new or worsening heart failure; new or worsening psoriasis; allergic reactions; autoimmune reactions, including a lupus-like syndrome and autoimmune hepatitis. Some common side effects include: Injection site reactions, upper respiratory infections (sinus infections), and headache.
In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder. These are not all the side effects with Enbrel. Tell your doctor about any side effect that bothers you or does not go away.
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