The FDA has granted an additional indication for infliximab (Remicade) for inhibiting the progression of structural damage and improving physical function in patients who have psoriatic arthritis. This indication is in addition to Remicade’s already approved indication in dermatology for reducing the signs and symptoms of active arthritis in patients who have psoriatic arthritis. The expanded indication is based on data from the double-blind placebo-controlled IMPACT and IMPACT 2 trials. Here are the key findings from those trials upon which approval was based:
• IMPACT 2 — an analysis of 1 year of radiographs revealed that patients treated with Remicade experienced significant inhibition of the progression of structural damage as compared with patients who received placebo, according to their van der Heijde-Sharp scores.
• IMPACT — By week 16 in this trial, patients who received Remicade experienced significant improvement in functional status with a median improvement of 50% in their scores on the Health Assessment Questionnaire-Disability Index, as compared to a 2% improvement in this score for study participants in the placebo group. These scores were typically the same throughout the nearly 2-year study.
• Improved Skin Symptoms — In addition to the above findings, 64% of patients in the IMPACT study achieved a 75% improvement from baseline in their psoriasis symptoms. These improvements also were maintained throughout the nearly 2-year study.Remicade is administered in a dose of 5 mg/kg every 8 weeks during a 2-hour infusion.
Wednesday, September 27, 2006
Monday, September 25, 2006
Aims And Purposes Of World Psoriasis Day, October 29th
World Psoriasis Day is an evolving project with more and more individuals, experts and patient associations from around the world getting involved over time.
The aims for WPD were defined by the Steering Committee as follows:
1. Raise awareness about psoriasis: World Psoriasis Day communication and activities should for example explain that psoriasis is a non contagious skin condition that can affect anybody and that people with psoriasis are really no different inside from anyone else. The World Psoriasis Day project should also aim to dispel myths about the condition.
2. Encourage healthcare decision makers to give psoriasis suffers better access to the most appropriate therapies for their condition: World Psoriasis Day should aim to encourage healthcare decision makers for example governments, physicians, carers and all those responsible for psoriasis care/ medicines to allow psoriasis sufferers access to all the most appropriate therapies. For too long psoriasis has not been seen as a priority with patients not always getting access to the most appropriate therapies for their condition.
3. Deliver relevant information and knowledge to interested parties: World Psoriasis Day should aim to provide information and knowledge to those who are affected by psoriasis/ psoriatic arthritis as well as the general public, in order that people can be better informed about the condition, develop a better understanding, enabling them to be more confident to speak about it.
4. Provide a patient voice platform: World Psoriasis Day should provide a platform from which the 'patient voice' can be heard and from which people with psoriasis can be encouraged to speak out about their needs and wants.www.worldpsoriasisday.com
The aims for WPD were defined by the Steering Committee as follows:
1. Raise awareness about psoriasis: World Psoriasis Day communication and activities should for example explain that psoriasis is a non contagious skin condition that can affect anybody and that people with psoriasis are really no different inside from anyone else. The World Psoriasis Day project should also aim to dispel myths about the condition.
2. Encourage healthcare decision makers to give psoriasis suffers better access to the most appropriate therapies for their condition: World Psoriasis Day should aim to encourage healthcare decision makers for example governments, physicians, carers and all those responsible for psoriasis care/ medicines to allow psoriasis sufferers access to all the most appropriate therapies. For too long psoriasis has not been seen as a priority with patients not always getting access to the most appropriate therapies for their condition.
3. Deliver relevant information and knowledge to interested parties: World Psoriasis Day should aim to provide information and knowledge to those who are affected by psoriasis/ psoriatic arthritis as well as the general public, in order that people can be better informed about the condition, develop a better understanding, enabling them to be more confident to speak about it.
4. Provide a patient voice platform: World Psoriasis Day should provide a platform from which the 'patient voice' can be heard and from which people with psoriasis can be encouraged to speak out about their needs and wants.www.worldpsoriasisday.com
Friday, September 15, 2006
Humira Exceeds Expectations In Treating Psoriasis
Recently revealed data show a study of Abbott Laboratories (ABT) drug Humira and its ability to treat the skin disease psoriasis exceeded expectations and topped results in an earlier trial, an Abbott official said Tuesday.
Results from the Phase 3 trial have not yet been publicly released and will be presented at a conference early next month. But data in the trial were recently "unblinded," and Humira showed "significantly better efficacy than approved biologics" in psoriasis treatment, said Thomas Freyman, Abbott's chief financial officer.
Freyman spoke at a Bear Stearns conference that was broadcast on the Internet.
The recent trial looked at Humira, a placebo and methotrexate - a standard drug used for years to treat psoriasis - to see which treatment scored best after 16 weeks on a standard scale of psoriasis treatment. The recently revealed data showed that the trial was better than expected and better than a Phase 2 trial, Freyman said.
An Abbott spokeswoman confirmed that the latest trial met its primary endpoint, or goal. Safety information from the trial will be released, along with more specific trial data, at October's European Academy of Dermatology and Venereology conference in Rhodes, Greece.
Humira, which posted $1.4 billion in global sales last year, is currently approved to treat rheumatoid arthritis, arthritis of the spine and psoriatic arthritis - but not psoriasis itself. Abbott plans to file with the U.S. Food and Drug Administration for psoriasis-treatment approval in the first half of 2007.
The skin disease is one of multiple indications that could significantly expand Humira's reach and revenue-generating potential if the treatment is approved.
Abbott announced last week that it has filed with U.S. and European regulators seeking approval to market Humira for the treatment of moderate to severe Crohn's disease, a serious and chronic intestinal inflammatory disorder.
Abbott also plans to file with the FDA next year, seeking approval to use Humira to treat juvenile rheumatoid arthritis and ulcerative colitis, another intestinal inflammatory disease.
Freyman said Abbott continues to target Humira sales of more than $1.9 billion this year, and noted that his company has said that the new indications alone represent a multibillion-dollar opportunity.
"Humira continues to meet or exceed our expectations," he said at the Bear Stearns conference.
"This is a product that's got legs," he added.
Humira is part of a class of treatments called tumor necrosis factor antagonists, or anti-TNF. TNF is a substance believed to play a role in inflammatory conditions.
article by Jon Kamp
Results from the Phase 3 trial have not yet been publicly released and will be presented at a conference early next month. But data in the trial were recently "unblinded," and Humira showed "significantly better efficacy than approved biologics" in psoriasis treatment, said Thomas Freyman, Abbott's chief financial officer.
Freyman spoke at a Bear Stearns conference that was broadcast on the Internet.
The recent trial looked at Humira, a placebo and methotrexate - a standard drug used for years to treat psoriasis - to see which treatment scored best after 16 weeks on a standard scale of psoriasis treatment. The recently revealed data showed that the trial was better than expected and better than a Phase 2 trial, Freyman said.
An Abbott spokeswoman confirmed that the latest trial met its primary endpoint, or goal. Safety information from the trial will be released, along with more specific trial data, at October's European Academy of Dermatology and Venereology conference in Rhodes, Greece.
Humira, which posted $1.4 billion in global sales last year, is currently approved to treat rheumatoid arthritis, arthritis of the spine and psoriatic arthritis - but not psoriasis itself. Abbott plans to file with the U.S. Food and Drug Administration for psoriasis-treatment approval in the first half of 2007.
The skin disease is one of multiple indications that could significantly expand Humira's reach and revenue-generating potential if the treatment is approved.
Abbott announced last week that it has filed with U.S. and European regulators seeking approval to market Humira for the treatment of moderate to severe Crohn's disease, a serious and chronic intestinal inflammatory disorder.
Abbott also plans to file with the FDA next year, seeking approval to use Humira to treat juvenile rheumatoid arthritis and ulcerative colitis, another intestinal inflammatory disease.
Freyman said Abbott continues to target Humira sales of more than $1.9 billion this year, and noted that his company has said that the new indications alone represent a multibillion-dollar opportunity.
"Humira continues to meet or exceed our expectations," he said at the Bear Stearns conference.
"This is a product that's got legs," he added.
Humira is part of a class of treatments called tumor necrosis factor antagonists, or anti-TNF. TNF is a substance believed to play a role in inflammatory conditions.
article by Jon Kamp
Thursday, September 07, 2006
Improving Your Psoriasis
Dermatitis-Ltd is a blend of soothing, beneficial minerals specially formulated to work synergistically with your skin to improve the appearance of psoriasis and psoriasis-related conditions.
Individuals with psoriasis experience skin conditions such as itching, cracking, stinging, burning, or bleeding (ICN Pharmaceuticals, Inc.). These symptoms are usually worse in the winter months due to the lack of sunlight and low indoor humidity (Hall 132). The skin is most likely to crack at the joints where the body bends or in areas where the individual fails to refrain from scratching. Scratching can also lead to bleeding and infection, which is why it should be avoided at all costs. This skin condition has also been known to affect fingernails and toenails by causing pits or dents in them. There is also the possibility that the soft tissue inside the mouth and genitalia can be affected. In some cases, individuals experience joint inflammation, which can lead to the development of arthritis symptoms. This condition is known as psoriatic arthritis.
Individuals with psoriasis experience skin conditions such as itching, cracking, stinging, burning, or bleeding (ICN Pharmaceuticals, Inc.). These symptoms are usually worse in the winter months due to the lack of sunlight and low indoor humidity (Hall 132). The skin is most likely to crack at the joints where the body bends or in areas where the individual fails to refrain from scratching. Scratching can also lead to bleeding and infection, which is why it should be avoided at all costs. This skin condition has also been known to affect fingernails and toenails by causing pits or dents in them. There is also the possibility that the soft tissue inside the mouth and genitalia can be affected. In some cases, individuals experience joint inflammation, which can lead to the development of arthritis symptoms. This condition is known as psoriatic arthritis.
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