Healthcare Industry News: Methotrexate
News Release - January 16, 2008
New Study Shows Biologic Therapy Enbrel(R) (etanercept) Effective in Treating Psoriasis in Children and AdolescentsMAIDENHEAD, England, January 17 (HSMN NewsFeed) -- Wyeth (WYE) today announced data from a Phase 3 study which showed that Enbrel significantly reduces the symptoms and signs of plaque psoriasis in children and adolescents with the disease.(1) This study was published in the January 17, 2008, issue of The New England Journal of Medicine.
The trial - the first time any biological treatment has been tested in children and adolescents with plaque psoriasis - showed 57% of patients on etanercept for 12 weeks achieved the 'gold-standard' in improvement compared to 11% of patients who received the placebo.(1) An application for use of Enbrel in managing psoriasis in children and adolescents has been submitted by Wyeth to the European Medicines Authority and is under review.
5.1 million people have psoriasis across EU, a distressing chronic inflammatory disease.(2) Approximately 80 percent of these patients have plaque psoriasis, which is characterized by painful and itchy, red, scaly patches.(3) One third of these cases begins in childhood, and can start as young as infancy.(4) Psoriasis is frequently physically and psychologically disabling and in adults is also associated with an increased risk of obesity, type 2 diabetes, liver disease(5) and clinical depression(6).
"Biologics have dramatically improved how we manage adult psoriasis. Adult patients have benefited from treatment with Enbrel for many years and it is proven to be effective at managing this debilitating disease" said Professor Alberto Giannetti, M.D, Department of Dermatology, University of Modena and Reggio Emilia, Italy.
"The news of this study in children and adolescents is greatly welcomed - currently approved treatments are limited and many are suffering through the lack of effective therapies."
During the 48-week study, the standard Psoriasis Area and Severity Index (PASI 75), was used to evaluate the efficacy of ENBREL in patients between 4 and 17 years old. The primary efficacy endpoint was PASI 75 at week 12. There were 106 patients initially randomized to receive ENBREL and 105 patients randomized to receive placebo.
- At week 12, 57% (n equals 60) of pediatric patients treated with ENBREL achieved PASI 75, compared with 11% (n equals 12) of pediatric patients who received placebo (p less than or equal to 0.001).
- At week 36, after 24 weeks of open-label treatment during which all patients in the study received ENBREL, PASI 75 was achieved by 68% (n equals 71) of the patients initially treated with ENBREL from the start of the study and 65% (n equals 67) of those who initially received placebo from the start of the study.
- At the conclusion of the open-label treatment period (week 36), 138 patients were re-randomized to receive either ENBREL or placebo. During this period, patients who lost PASI 75 were re-treated and no patient had a rebound of psoriasis or a change in the type of their psoriasis. In addition, the ENBREL response rates were similar during re-treatment compared to the initial double-blind period.
There were no serious adverse events or serious infections during the 12-week placebo-controlled period and rates of adverse events were similar for ENBREL and placebo. During open-label treatment, three patients developed four serious adverse events, one of which (pneumonia) was deemed by investigators to be related to ENBREL. No deaths, cancers, opportunistic infections, tuberculosis or demyelination events were reported. The most common adverse events observed during the 48-week trial in patients treated with ENBREL were upper respiratory tract infection, headache, and nasopharyngitis.
Commenting on the study, Professor Alberto Giannetti noted: "Enbrel has been used for over 9 years and has an abundance of clinical efficacy and safety data - it is already approved for use in juvenile arthritis. The NEJM data adds to the vast weight of clinical evidence and shows it is an effective therapy option for the children and adolescents with plaque psoriasis. I hope to see it approved for use in this patient population across Europe in the near future".
For full study details, please access The New England Journal of Medicine online: http://content.nejm.org/
Notes to editors
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.
ENBREL is NOT currently indicated for the treatment of psoriasis in children of adolescents.
ENBREL in the EU is approved for the following indications:
Enbrel in combination with Methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including Methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to Methotrexate or when continued treatment with Methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with Methotrexate.
Enbrel, alone or in combination with Methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, Methotrexate. Enbrel has not been studied in children aged less than 4 years.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, Methotrexate or PUVA
This study was designed to assess the safety and efficacy of ENBREL therapy in children and adolescents between 4 and 17 years old with moderate to severe plaque psoriasis whose disease had been inadequately controlled with topical therapy or who received systemic therapy or phototherapy. In this 48-week study, 211 pediatric psoriasis patients were initially randomized to receive 12 once-weekly weight-based doses of ENBREL (0.8 mg/kg up to 50 mg) or placebo. After this double-blind portion, 208 patients entered a 24-week period of open-label ENBREL treatment once-weekly. At week 36, 138 patients were re-randomized to receive either ENBREL or placebo, to investigate withdrawal and re-treatment.
Wyeth is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It is also a global leader in vaccines, biotechnology and animal health care.
(1) Paller, AS et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med 2008;358:241-51
(2) Christophers E. Psoriasis - Epidemiology and Clinical Spectrum. Clin Exp Dermatol 2001;26:314-320
(3) Gottlieb, A. Psoriasis: Emerging Therapeutic Strategies, Nature Reviews volume 4, January 2005
(4) National Psoriasis Foundation. Medical facts about psoriasis in childhood. 2007. Available at: http://www.psoriasis.org/about/youth/parents/medicalfacts.php. (Accessed January 2008)
(5) Mrowietz, U et al The importance of disease associations and concomitant therapy for the long-term management of Psoriasis patients Arch Dermatol Res (2006)
(6) Rapp SR, Feldman SR, Exum ML et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999; 41:401-7
(7) Enbrel EMEA SPC
Source: Wyeth Pharmaceuticals
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