The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel® (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis
MAIDENHEAD, England | November 21, 2008 | The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel® (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis. If approved by the European Commission, following the Committee’s recommendation, Enbrel will become the first biologic treatment indicated for severe psoriasis in children and adolescents. Enbrel is currently approved in the European Union for the treatment of moderate-to-severe plaque psoriasis in adults, as well as for ankylosing spondylitis, psoriatic arthritis, moderate to severe rheumatoid arthritis (RA) in adults, and polyarticular juvenile idiopathic arthritis (JIA) in children.(1)
"Psoriasis can be a distressing disease at any age," said Stevo Knezevic, MD, PhD, Chief Medical Officer of Wyeth Europa. "A third of psoriasis patients first see signs of the disease well before the age of 16 and there are currently limited effective treatment options available with approved dosing regimens for children and adolescents. We are, therefore, encouraged by the positive recommendation from the CHMP for the approval of Enbrel® for use in the paediatric population."
The recommendation by the CHMP is based on results from the first randomised placebo-controlled trial of a biologic treatment in children aged 17 and under (study 211). Results from the study showed that patients treated with Enbrel experienced a significant improvement of their plaque psoriasis compared to those treated with placebo. 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.
Impact of Psoriasis
Across Europe, 5.1 million people are estimated to have psoriasis(2), a distressing chronic inflammatory disease. Approximately 80 per cent of these patients have plaque psoriasis, which is characterised by red, scaly patches.(3) Psoriasis can be extremely distressing, and may have a significant impact on patients’ quality of life. It is a condition which is frequently physically and psychologically disabling.(4)
Currently, treatments for children and adolescents with psoriasis are mainly limited to topical medications that are applied directly to the skin. Whilst these treatments may be effective at reducing the visible skin lesions and associated symptoms, they are generally used for mild and moderate forms of paediatric psoriasis.
Enbrel is an innovative drug that works by reducing the chronic inflammation that leads to plaque psoriasis.
To access further media information relating to this press release, additional information on Enbrel and future media announcements, please register on the media centre at http://www.wyeth.eu. If you subscribe to receive our emails you will get updates as soon as new content added to the site. Please note you will be able to unsubscribe at any time and we will not pass your details to any third party.
"The 211 study: Enbrel® in children and adolescents(5)
The 48 week study involved 211 patients with moderate-to-severe psoriasis aged four to 17 years. During the first 12 weeks of the trial, patients received once weekly injections of either placebo or 0.8 mg of Enbrel per kilogram of body weight up to a maximum of 50 mg. For the next 24 consecutive weeks, all patients went on to receive Enbrel. The 138 patients still participating at week 36 were then re-randomised to receive either placebo or Enbrel in order to investigate whether stopping treatment would lead to any rebound.
At week 12, almost two-thirds of patients (57%) achieved a 75% improvement in the psoriasis area-and-severity index (PASI 75), compared to 11% of patients receiving placebo. At week 36, after 24 weeks of open-label Enbrel, 68% of patients in the Enbrel-Enbrel group and 65% of patients in the placebo-Enbrel group achieved PASI 75. During the treatment withdrawal period, 42% of patients receiving placebo instead of Enbrel, lost their response to treatment. There were no cases of rebound or change in psoriasis morphology from plaque to, for example, guttate or pustular psoriasis).
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. 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. After allowing for the greater length of time Enbrel was administered, the rates were seen to be numerically lower that those when the patients were on placebo injections."
About Enbrel
Enbrel is a fully human soluble tumour 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 in the EU is approved for the following indications:
Rheumatoid arthritis
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.
Psoriatic arthritis
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.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Plaque psoriasis
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
About Wyeth:
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.
References
1. Enbrel EMEA SPC. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-en.pdf
2. Christophers E. Psoriasis – Epidemiology and Clinical Spectrum. Clin Exp Dermatol 2001;26:314-320
3. National Psoriasis Fund. Plaque Psoriasis. http://www.psoriasis.org/about/psoriasis/plaque.php . Accessed October 2008
4. Mrowietz, U et al. The importance of disease associations and concomitant therapy for the long-term management of Psoriasis patients Arch Dermatol Res (2006)
5. Paller, AS et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med 2008;358:241-51
SOURCE: Wyeth Pharmaceuticals Limited
Post Views: 48
The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel® (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis
MAIDENHEAD, England | November 21, 2008 | The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel® (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis. If approved by the European Commission, following the Committee’s recommendation, Enbrel will become the first biologic treatment indicated for severe psoriasis in children and adolescents. Enbrel is currently approved in the European Union for the treatment of moderate-to-severe plaque psoriasis in adults, as well as for ankylosing spondylitis, psoriatic arthritis, moderate to severe rheumatoid arthritis (RA) in adults, and polyarticular juvenile idiopathic arthritis (JIA) in children.(1)
"Psoriasis can be a distressing disease at any age," said Stevo Knezevic, MD, PhD, Chief Medical Officer of Wyeth Europa. "A third of psoriasis patients first see signs of the disease well before the age of 16 and there are currently limited effective treatment options available with approved dosing regimens for children and adolescents. We are, therefore, encouraged by the positive recommendation from the CHMP for the approval of Enbrel® for use in the paediatric population."
The recommendation by the CHMP is based on results from the first randomised placebo-controlled trial of a biologic treatment in children aged 17 and under (study 211). Results from the study showed that patients treated with Enbrel experienced a significant improvement of their plaque psoriasis compared to those treated with placebo. 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.
Impact of Psoriasis
Across Europe, 5.1 million people are estimated to have psoriasis(2), a distressing chronic inflammatory disease. Approximately 80 per cent of these patients have plaque psoriasis, which is characterised by red, scaly patches.(3) Psoriasis can be extremely distressing, and may have a significant impact on patients’ quality of life. It is a condition which is frequently physically and psychologically disabling.(4)
Currently, treatments for children and adolescents with psoriasis are mainly limited to topical medications that are applied directly to the skin. Whilst these treatments may be effective at reducing the visible skin lesions and associated symptoms, they are generally used for mild and moderate forms of paediatric psoriasis.
Enbrel is an innovative drug that works by reducing the chronic inflammation that leads to plaque psoriasis.
To access further media information relating to this press release, additional information on Enbrel and future media announcements, please register on the media centre at http://www.wyeth.eu. If you subscribe to receive our emails you will get updates as soon as new content added to the site. Please note you will be able to unsubscribe at any time and we will not pass your details to any third party.
"The 211 study: Enbrel® in children and adolescents(5)
The 48 week study involved 211 patients with moderate-to-severe psoriasis aged four to 17 years. During the first 12 weeks of the trial, patients received once weekly injections of either placebo or 0.8 mg of Enbrel per kilogram of body weight up to a maximum of 50 mg. For the next 24 consecutive weeks, all patients went on to receive Enbrel. The 138 patients still participating at week 36 were then re-randomised to receive either placebo or Enbrel in order to investigate whether stopping treatment would lead to any rebound.
At week 12, almost two-thirds of patients (57%) achieved a 75% improvement in the psoriasis area-and-severity index (PASI 75), compared to 11% of patients receiving placebo. At week 36, after 24 weeks of open-label Enbrel, 68% of patients in the Enbrel-Enbrel group and 65% of patients in the placebo-Enbrel group achieved PASI 75. During the treatment withdrawal period, 42% of patients receiving placebo instead of Enbrel, lost their response to treatment. There were no cases of rebound or change in psoriasis morphology from plaque to, for example, guttate or pustular psoriasis).
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. 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. After allowing for the greater length of time Enbrel was administered, the rates were seen to be numerically lower that those when the patients were on placebo injections."
About Enbrel
Enbrel is a fully human soluble tumour 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 in the EU is approved for the following indications:
Rheumatoid arthritis
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.
Psoriatic arthritis
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.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Plaque psoriasis
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
About Wyeth:
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.
References
1. Enbrel EMEA SPC. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-en.pdf
2. Christophers E. Psoriasis – Epidemiology and Clinical Spectrum. Clin Exp Dermatol 2001;26:314-320
3. National Psoriasis Fund. Plaque Psoriasis. http://www.psoriasis.org/about/psoriasis/plaque.php . Accessed October 2008
4. Mrowietz, U et al. The importance of disease associations and concomitant therapy for the long-term management of Psoriasis patients Arch Dermatol Res (2006)
5. Paller, AS et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med 2008;358:241-51
SOURCE: Wyeth Pharmaceuticals Limited
Post Views: 48
