News
February 2002
Roche Unveils Enhanced S.M.A.R.T. Guidelines For Accutane Patients
Accutane’s New Guidelines Are Out. Effectiveness Has Yet To Be Determined.
By Gina DiGironimo, Production Editor
Roche recently began distributing the S.M.A.R.T. program (System to Manage Accutane Related Teratogenicity), the enhanced pregnancy prevention guidelines for Accutane that we reported on in our December issue, to dermatologists, pharmacists and primary care prescribers in the United States.
The new program will be phased in over a 3-month period with an April 10 compliance deadline. In an effort to inform Accutane prescribers about the S.M.A.R.T. program, Roche Laboratories is currently circulating a letter outlining the new procedures they will be required to complete before distributing Accutane. Also, on January 2, a newly revised professional package insert on the implementation of S.M.A.R.T. became effective along with a new Medication Guide.
Patients will not be able to fill a prescription for Accutane unless they have a yellow Accutane Qualification Sticker on the prescription. Under the new procedures, “prescribers will be required to enroll in the S.M.A.R.T. program in order to receive the yellow Accutane Qualification Stickers.” Along with the letter, prescribers received a S.M.A.R.T. Guide to Best Practices and a S.M.A.R.T. Letter of Understanding. Prescribers must read the guide and sign and return the S.M.A.R.T. Letter of Understanding to Roche to ensure enrollment in the program. After these steps are completed, prescribers will receive a supply of Accutane Qualification Stickers.
In order for a prescriber to give a female patient a qualified Accutane prescription for the first time, the female patient must meet criteria “…identified in the Contraindications and Warnings (Black Box) section of the package insert.” The patient must:
- have two negative pregnancy tests;
- commit to using two forms of contraception simultaneously beginning 1 month before treatment until 1 month after treatment;
- read and sign an informed consent agreement explaining the risk of potential birth defects associated with the drug; and
- be taught about and encouraged to enroll in the Accutane Survey, a system that tracks female Accutane patients and their pregnancy prevention efforts and status.
The yellow Accutane Qualification Sticker must be affixed to all Accutane prescriptions for male and female patients and no more than a 30 day supply of Accutane may be prescribed — as noted in the December issue of Skin & Aging. For refills, female patients must come back for monthly pregnancy tests and repeat counseling regarding contraception.
According to one dermatologist who regularly prescribes Accutane, these new guidelines will not change his own Accutane prescribing techniques. Alan Fleischer, M.D., lauds the drug calling it “superb,” but believes the new requirements are a “window dressing approach that puts one more barrier in the way of practicing medicine.” He goes on to say, “the phenomenon of Accutane restriction is a symptom of the disease rather than a disease in itself.”
“The government administrators we elect feel these regulations improve public health” says Dr. Fleischer. He went on to say that he thinks the regulations will “…increase the cost borne by insurers and increase the cost of care of patients.”
Roche will monitor the progress of the new restrictions through its Accutane Survey conducted by the Slone Epidemiology Unit of Boston University School of Public Health and through an audit of pharmacies to assess the use of the yellow qualification stickers. These measures will provide a clear outcome of S.M.A.R.T.’s effectiveness and if the new policies are working. In the interim, dermatologists such as Dr. Fleischer will continue to prescribe and advocate for Accutane. Dr. Fleischer says he believes that those who only occasionally prescribe Accutane will stop all together. Will the new guidelines succeed in reducing the number of pregnancies resulting in birth defects? Time will tell.
New Patients May be Marching In
Month is dedicated to rosacea awareness.
As March approaches, be aware that you may see some new rosy faces in your practice. The National Rosacea Society has designated March “Rosacea Awareness Month.” The goal of the month is to publicize the warning signs of rosacea and to encourage sufferers to seek medical treatment for this condition. The society will conduct extensive public education activities to increase awareness of rosacea and the need for early diagnosis and treatment, in hopes that sufferers will visit your offices for help.
The symptoms can be chronic and serious, causing disruption in patients’ daily lives. The Society reports that a Gallup survey found that 78% of Americans don’t have knowledge of this disorder, which causes many people psychological and social problems because of the “acne-like” effects on personal appearance.
Recent Society surveys found:
- 70% of rosacea sufferers have lowered self-confidence and self-esteem.
-41% reported that it caused them to avoid public contact or cancel social engagements.
- 70% of those suffering from severe symptoms say rosacea has adversely affected their professional interactions.
- Almost 30% of these serious sufferers reported having to miss work because of their appearance.
The National Rosacea Society will encourage anyone over the age of 30 to visit a dermatologist for diagnosis and treatment if they suffer from one or more of the following warning signs of rosacea:
- Redness on the cheeks, nose, forehead or chin.
- Small visible blood vessels on the face.
-Bumps or pimples on the face.
-Watery or irritated eyes.
If you’d like more information on the society or Rosacea Awareness Month, please visit www.rosacea.org.
New Help for Psoriatic Arthritis Patients
Enbrel receives FDA approval.
In January, the FDA approved Enbrel (etanercept) to treat people with psoriatic arthritis, a condition about 1 million U.S. adults suffer from, according to research results recently released by the National Psoriasis Foundation (NPF). Immunex Corp. and Wyeth-Ayerst Labs claim that Enbrel is the first therapy to receive approval to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis.
According to the NPF, its benchmark study is the first research to establish the prevalence of psoriatic arthritis among U.S. adults. The survey, conducted in December 2001, included more than 27,000 adults and found that one-half of 1% said they had been diagnosed with psoriatic arthritis. This 1-million person total is about twice the number that the medical community previously suspected had the disease.
When 448 follow-up interviews were conducted with those reporting to be diagnosed with the disease, 84% said that psoriatic arthritis has a moderate to large impact of their daily lives. Seventy-five percent reported a loss of sleep or bad sleep and almost two-thirds said it has forced them to alter their daily activities.
Will Enbrel help alleviate some of their pain? A 24-week, multi-center, randomized, double-blind, placebo-controlled phase 2 study assessed the efficacy and tolerability of Enbrel (25 mg twice per week subcutaneous injections) or placebo in 205 patients suffering from psoriatic arthritis. Patient response was judged based on the American College of Rheumatology’s preliminary criteria for improvement (ACR-20), which includes tender and swollen joint counts, patient, as well as physician global assessment, patient assessment of pain, a disability index, and acute phase reactant. Also, a subset of patients was measured by improvement in the psoriasis area and severity index (PASI), which measures improvement in the amount of psoriatic plaque throughout the body and the severity of the skin disease.
Results were as follows:
- Of the 101 patients receiving Enbrel, 59% achieved an ACR 20 response as opposed to 15% of 104 patients receiving placebo, after 12 weeks of treatment.
- Of the 101 patients receiving Enbrel, 38% achieved an ACR 50 response as opposed to 4% of 104 patients receiving placebo, after 12 weeks of treatment.
- Of the 101 patients receiving Enbrel, 11% achieved an ACR 70 response as opposed to 0% of 104 patients receiving placebo, after 12 weeks of treatment.
In a subset of patients with a pre-defined severity of psoriasis, responses increased over time, and at 6 months those achieving a 50% to 75% improvement in the PASI were 47% and 23% respectively, in the Enbrel group compared to 18% and 3% respectively in the placebo group.
Results of the study were similar to earlier studies. Adverse reactions were similar as well. The most common type of infection psoriatic arthritis patients suffered from during the study was upper respiratory infection.
“In Brief”
News from Novartis…The FDA recently granted marketing approval for the first ever non-steroid prescription cream for atopic dermatitis. Manufactured by Novartis Pharmaceuticals, Elidel contains 1% pimecrolimus to combat mild to moderate atopic dermatitis patients two years and older.
Action Against Acne…Dermik Laboratories recently introduced its latest product currently available to treat moderate to severe acne vulgaris. BenzaClin Topical Gel combines 1% clindamyclin and 5% benzoyl peroxide and has a photosensitivity associated with its use. According to three clinical trials done on this gel, participants experienced a lesion reduction 2 weeks after therapy began. The research indicated that the new gel is stable for 2 months at room temperature. The study noted that patients continued to see improvement in subsequent following visits. Dermik says the aqueous gel is less drying and non oily for acne patients.
New Actinic Keratosis Therapy…As of January 2002, Bioglan Pharma, Inc. announced their latest product, Solaraze’s availability. Recently approved by the FDA, Solaraze treats patients with actinic keratosis with the NSAID diclofenac sodium in a 3% topical formulation.
Jan Marini Aids Relief Fund… In response to the terrorist attacks of September 11th, Jan Marini Skin Research has begun manufacturing American flag pins. The pins sell for $3 a piece with proceeds going toward the Families of Freedom Scholarship Fund. The fund provides educational assistance to the September 11th families of victims in financial duress. To order a pin and/or to contribute to the fund, please call the Families of Freedom Scholarship Fund at 800-347-2223.
Study Shows Acne Drug Promise….At the Interscience Conference on Antimicrobial Agents & Chemotherapy in Vancouver, Canada, researchers presented data on a drug under development to fight acne. The investigational drug, MBI 594AN is manufactured by Micrologix Biotech as the first peptide antibiotic in acne treatment. In phase 2, clinical studies conducted with the MBI 594AN treatment, it appeared to be safe and did not cause irritation to the skin.
Lumenis’ Light….Currently available outside of the U.S., the light based system, ClearLight, to treat acne has recently received FDA clearance within the United States.
Detecting Heart Trouble….A tool used by dermatologists is being tested by the Texas Diabetes Institute to see if it can spot the warning signs of cardiovascular disease. The Doppler device is used by dermatologists to study the reaction of skin to temperature changes. The American Diabetes Association has provided a grant to the institute due to the large number of diabetic patients who experience heart disease as a major complication of
diabetes.
Roche Unveils Enhanced S.M.A.R.T. Guidelines For Accutane Patients
Accutane’s New Guidelines Are Out. Effectiveness Has Yet To Be Determined.
By Gina DiGironimo, Production Editor
Roche recently began distributing the S.M.A.R.T. program (System to Manage Accutane Related Teratogenicity), the enhanced pregnancy prevention guidelines for Accutane that we reported on in our December issue, to dermatologists, pharmacists and primary care prescribers in the United States.
The new program will be phased in over a 3-month period with an April 10 compliance deadline. In an effort to inform Accutane prescribers about the S.M.A.R.T. program, Roche Laboratories is currently circulating a letter outlining the new procedures they will be required to complete before distributing Accutane. Also, on January 2, a newly revised professional package insert on the implementation of S.M.A.R.T. became effective along with a new Medication Guide.
Patients will not be able to fill a prescription for Accutane unless they have a yellow Accutane Qualification Sticker on the prescription. Under the new procedures, “prescribers will be required to enroll in the S.M.A.R.T. program in order to receive the yellow Accutane Qualification Stickers.” Along with the letter, prescribers received a S.M.A.R.T. Guide to Best Practices and a S.M.A.R.T. Letter of Understanding. Prescribers must read the guide and sign and return the S.M.A.R.T. Letter of Understanding to Roche to ensure enrollment in the program. After these steps are completed, prescribers will receive a supply of Accutane Qualification Stickers.
In order for a prescriber to give a female patient a qualified Accutane prescription for the first time, the female patient must meet criteria “…identified in the Contraindications and Warnings (Black Box) section of the package insert.” The patient must:
- have two negative pregnancy tests;
- commit to using two forms of contraception simultaneously beginning 1 month before treatment until 1 month after treatment;
- read and sign an informed consent agreement explaining the risk of potential birth defects associated with the drug; and
- be taught about and encouraged to enroll in the Accutane Survey, a system that tracks female Accutane patients and their pregnancy prevention efforts and status.
The yellow Accutane Qualification Sticker must be affixed to all Accutane prescriptions for male and female patients and no more than a 30 day supply of Accutane may be prescribed — as noted in the December issue of Skin & Aging. For refills, female patients must come back for monthly pregnancy tests and repeat counseling regarding contraception.
According to one dermatologist who regularly prescribes Accutane, these new guidelines will not change his own Accutane prescribing techniques. Alan Fleischer, M.D., lauds the drug calling it “superb,” but believes the new requirements are a “window dressing approach that puts one more barrier in the way of practicing medicine.” He goes on to say, “the phenomenon of Accutane restriction is a symptom of the disease rather than a disease in itself.”
“The government administrators we elect feel these regulations improve public health” says Dr. Fleischer. He went on to say that he thinks the regulations will “…increase the cost borne by insurers and increase the cost of care of patients.”
Roche will monitor the progress of the new restrictions through its Accutane Survey conducted by the Slone Epidemiology Unit of Boston University School of Public Health and through an audit of pharmacies to assess the use of the yellow qualification stickers. These measures will provide a clear outcome of S.M.A.R.T.’s effectiveness and if the new policies are working. In the interim, dermatologists such as Dr. Fleischer will continue to prescribe and advocate for Accutane. Dr. Fleischer says he believes that those who only occasionally prescribe Accutane will stop all together. Will the new guidelines succeed in reducing the number of pregnancies resulting in birth defects? Time will tell.
New Patients May be Marching In
Month is dedicated to rosacea awareness.
As March approaches, be aware that you may see some new rosy faces in your practice. The National Rosacea Society has designated March “Rosacea Awareness Month.” The goal of the month is to publicize the warning signs of rosacea and to encourage sufferers to seek medical treatment for this condition. The society will conduct extensive public education activities to increase awareness of rosacea and the need for early diagnosis and treatment, in hopes that sufferers will visit your offices for help.
The symptoms can be chronic and serious, causing disruption in patients’ daily lives. The Society reports that a Gallup survey found that 78% of Americans don’t have knowledge of this disorder, which causes many people psychological and social problems because of the “acne-like” effects on personal appearance.
Recent Society surveys found:
- 70% of rosacea sufferers have lowered self-confidence and self-esteem.
-41% reported that it caused them to avoid public contact or cancel social engagements.
- 70% of those suffering from severe symptoms say rosacea has adversely affected their professional interactions.
- Almost 30% of these serious sufferers reported having to miss work because of their appearance.
The National Rosacea Society will encourage anyone over the age of 30 to visit a dermatologist for diagnosis and treatment if they suffer from one or more of the following warning signs of rosacea:
- Redness on the cheeks, nose, forehead or chin.
- Small visible blood vessels on the face.
-Bumps or pimples on the face.
-Watery or irritated eyes.
If you’d like more information on the society or Rosacea Awareness Month, please visit www.rosacea.org.
New Help for Psoriatic Arthritis Patients
Enbrel receives FDA approval.
In January, the FDA approved Enbrel (etanercept) to treat people with psoriatic arthritis, a condition about 1 million U.S. adults suffer from, according to research results recently released by the National Psoriasis Foundation (NPF). Immunex Corp. and Wyeth-Ayerst Labs claim that Enbrel is the first therapy to receive approval to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis.
According to the NPF, its benchmark study is the first research to establish the prevalence of psoriatic arthritis among U.S. adults. The survey, conducted in December 2001, included more than 27,000 adults and found that one-half of 1% said they had been diagnosed with psoriatic arthritis. This 1-million person total is about twice the number that the medical community previously suspected had the disease.
When 448 follow-up interviews were conducted with those reporting to be diagnosed with the disease, 84% said that psoriatic arthritis has a moderate to large impact of their daily lives. Seventy-five percent reported a loss of sleep or bad sleep and almost two-thirds said it has forced them to alter their daily activities.
Will Enbrel help alleviate some of their pain? A 24-week, multi-center, randomized, double-blind, placebo-controlled phase 2 study assessed the efficacy and tolerability of Enbrel (25 mg twice per week subcutaneous injections) or placebo in 205 patients suffering from psoriatic arthritis. Patient response was judged based on the American College of Rheumatology’s preliminary criteria for improvement (ACR-20), which includes tender and swollen joint counts, patient, as well as physician global assessment, patient assessment of pain, a disability index, and acute phase reactant. Also, a subset of patients was measured by improvement in the psoriasis area and severity index (PASI), which measures improvement in the amount of psoriatic plaque throughout the body and the severity of the skin disease.
Results were as follows:
- Of the 101 patients receiving Enbrel, 59% achieved an ACR 20 response as opposed to 15% of 104 patients receiving placebo, after 12 weeks of treatment.
- Of the 101 patients receiving Enbrel, 38% achieved an ACR 50 response as opposed to 4% of 104 patients receiving placebo, after 12 weeks of treatment.
- Of the 101 patients receiving Enbrel, 11% achieved an ACR 70 response as opposed to 0% of 104 patients receiving placebo, after 12 weeks of treatment.
In a subset of patients with a pre-defined severity of psoriasis, responses increased over time, and at 6 months those achieving a 50% to 75% improvement in the PASI were 47% and 23% respectively, in the Enbrel group compared to 18% and 3% respectively in the placebo group.
Results of the study were similar to earlier studies. Adverse reactions were similar as well. The most common type of infection psoriatic arthritis patients suffered from during the study was upper respiratory infection.
“In Brief”
News from Novartis…The FDA recently granted marketing approval for the first ever non-steroid prescription cream for atopic dermatitis. Manufactured by Novartis Pharmaceuticals, Elidel contains 1% pimecrolimus to combat mild to moderate atopic dermatitis patients two years and older.
Action Against Acne…Dermik Laboratories recently introduced its latest product currently available to treat moderate to severe acne vulgaris. BenzaClin Topical Gel combines 1% clindamyclin and 5% benzoyl peroxide and has a photosensitivity associated with its use. According to three clinical trials done on this gel, participants experienced a lesion reduction 2 weeks after therapy began. The research indicated that the new gel is stable for 2 months at room temperature. The study noted that patients continued to see improvement in subsequent following visits. Dermik says the aqueous gel is less drying and non oily for acne patients.
New Actinic Keratosis Therapy…As of January 2002, Bioglan Pharma, Inc. announced their latest product, Solaraze’s availability. Recently approved by the FDA, Solaraze treats patients with actinic keratosis with the NSAID diclofenac sodium in a 3% topical formulation.
Jan Marini Aids Relief Fund… In response to the terrorist attacks of September 11th, Jan Marini Skin Research has begun manufacturing American flag pins. The pins sell for $3 a piece with proceeds going toward the Families of Freedom Scholarship Fund. The fund provides educational assistance to the September 11th families of victims in financial duress. To order a pin and/or to contribute to the fund, please call the Families of Freedom Scholarship Fund at 800-347-2223.
Study Shows Acne Drug Promise….At the Interscience Conference on Antimicrobial Agents & Chemotherapy in Vancouver, Canada, researchers presented data on a drug under development to fight acne. The investigational drug, MBI 594AN is manufactured by Micrologix Biotech as the first peptide antibiotic in acne treatment. In phase 2, clinical studies conducted with the MBI 594AN treatment, it appeared to be safe and did not cause irritation to the skin.
Lumenis’ Light….Currently available outside of the U.S., the light based system, ClearLight, to treat acne has recently received FDA clearance within the United States.
Detecting Heart Trouble….A tool used by dermatologists is being tested by the Texas Diabetes Institute to see if it can spot the warning signs of cardiovascular disease. The Doppler device is used by dermatologists to study the reaction of skin to temperature changes. The American Diabetes Association has provided a grant to the institute due to the large number of diabetic patients who experience heart disease as a major complication of
diabetes.
Roche Unveils Enhanced S.M.A.R.T. Guidelines For Accutane Patients
Accutane’s New Guidelines Are Out. Effectiveness Has Yet To Be Determined.
By Gina DiGironimo, Production Editor
Roche recently began distributing the S.M.A.R.T. program (System to Manage Accutane Related Teratogenicity), the enhanced pregnancy prevention guidelines for Accutane that we reported on in our December issue, to dermatologists, pharmacists and primary care prescribers in the United States.
The new program will be phased in over a 3-month period with an April 10 compliance deadline. In an effort to inform Accutane prescribers about the S.M.A.R.T. program, Roche Laboratories is currently circulating a letter outlining the new procedures they will be required to complete before distributing Accutane. Also, on January 2, a newly revised professional package insert on the implementation of S.M.A.R.T. became effective along with a new Medication Guide.
Patients will not be able to fill a prescription for Accutane unless they have a yellow Accutane Qualification Sticker on the prescription. Under the new procedures, “prescribers will be required to enroll in the S.M.A.R.T. program in order to receive the yellow Accutane Qualification Stickers.” Along with the letter, prescribers received a S.M.A.R.T. Guide to Best Practices and a S.M.A.R.T. Letter of Understanding. Prescribers must read the guide and sign and return the S.M.A.R.T. Letter of Understanding to Roche to ensure enrollment in the program. After these steps are completed, prescribers will receive a supply of Accutane Qualification Stickers.
In order for a prescriber to give a female patient a qualified Accutane prescription for the first time, the female patient must meet criteria “…identified in the Contraindications and Warnings (Black Box) section of the package insert.” The patient must:
- have two negative pregnancy tests;
- commit to using two forms of contraception simultaneously beginning 1 month before treatment until 1 month after treatment;
- read and sign an informed consent agreement explaining the risk of potential birth defects associated with the drug; and
- be taught about and encouraged to enroll in the Accutane Survey, a system that tracks female Accutane patients and their pregnancy prevention efforts and status.
The yellow Accutane Qualification Sticker must be affixed to all Accutane prescriptions for male and female patients and no more than a 30 day supply of Accutane may be prescribed — as noted in the December issue of Skin & Aging. For refills, female patients must come back for monthly pregnancy tests and repeat counseling regarding contraception.
According to one dermatologist who regularly prescribes Accutane, these new guidelines will not change his own Accutane prescribing techniques. Alan Fleischer, M.D., lauds the drug calling it “superb,” but believes the new requirements are a “window dressing approach that puts one more barrier in the way of practicing medicine.” He goes on to say, “the phenomenon of Accutane restriction is a symptom of the disease rather than a disease in itself.”
“The government administrators we elect feel these regulations improve public health” says Dr. Fleischer. He went on to say that he thinks the regulations will “…increase the cost borne by insurers and increase the cost of care of patients.”
Roche will monitor the progress of the new restrictions through its Accutane Survey conducted by the Slone Epidemiology Unit of Boston University School of Public Health and through an audit of pharmacies to assess the use of the yellow qualification stickers. These measures will provide a clear outcome of S.M.A.R.T.’s effectiveness and if the new policies are working. In the interim, dermatologists such as Dr. Fleischer will continue to prescribe and advocate for Accutane. Dr. Fleischer says he believes that those who only occasionally prescribe Accutane will stop all together. Will the new guidelines succeed in reducing the number of pregnancies resulting in birth defects? Time will tell.
New Patients May be Marching In
Month is dedicated to rosacea awareness.
As March approaches, be aware that you may see some new rosy faces in your practice. The National Rosacea Society has designated March “Rosacea Awareness Month.” The goal of the month is to publicize the warning signs of rosacea and to encourage sufferers to seek medical treatment for this condition. The society will conduct extensive public education activities to increase awareness of rosacea and the need for early diagnosis and treatment, in hopes that sufferers will visit your offices for help.
The symptoms can be chronic and serious, causing disruption in patients’ daily lives. The Society reports that a Gallup survey found that 78% of Americans don’t have knowledge of this disorder, which causes many people psychological and social problems because of the “acne-like” effects on personal appearance.
Recent Society surveys found:
- 70% of rosacea sufferers have lowered self-confidence and self-esteem.
-41% reported that it caused them to avoid public contact or cancel social engagements.
- 70% of those suffering from severe symptoms say rosacea has adversely affected their professional interactions.
- Almost 30% of these serious sufferers reported having to miss work because of their appearance.
The National Rosacea Society will encourage anyone over the age of 30 to visit a dermatologist for diagnosis and treatment if they suffer from one or more of the following warning signs of rosacea:
- Redness on the cheeks, nose, forehead or chin.
- Small visible blood vessels on the face.
-Bumps or pimples on the face.
-Watery or irritated eyes.
If you’d like more information on the society or Rosacea Awareness Month, please visit www.rosacea.org.
New Help for Psoriatic Arthritis Patients
Enbrel receives FDA approval.
In January, the FDA approved Enbrel (etanercept) to treat people with psoriatic arthritis, a condition about 1 million U.S. adults suffer from, according to research results recently released by the National Psoriasis Foundation (NPF). Immunex Corp. and Wyeth-Ayerst Labs claim that Enbrel is the first therapy to receive approval to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis.
According to the NPF, its benchmark study is the first research to establish the prevalence of psoriatic arthritis among U.S. adults. The survey, conducted in December 2001, included more than 27,000 adults and found that one-half of 1% said they had been diagnosed with psoriatic arthritis. This 1-million person total is about twice the number that the medical community previously suspected had the disease.
When 448 follow-up interviews were conducted with those reporting to be diagnosed with the disease, 84% said that psoriatic arthritis has a moderate to large impact of their daily lives. Seventy-five percent reported a loss of sleep or bad sleep and almost two-thirds said it has forced them to alter their daily activities.
Will Enbrel help alleviate some of their pain? A 24-week, multi-center, randomized, double-blind, placebo-controlled phase 2 study assessed the efficacy and tolerability of Enbrel (25 mg twice per week subcutaneous injections) or placebo in 205 patients suffering from psoriatic arthritis. Patient response was judged based on the American College of Rheumatology’s preliminary criteria for improvement (ACR-20), which includes tender and swollen joint counts, patient, as well as physician global assessment, patient assessment of pain, a disability index, and acute phase reactant. Also, a subset of patients was measured by improvement in the psoriasis area and severity index (PASI), which measures improvement in the amount of psoriatic plaque throughout the body and the severity of the skin disease.
Results were as follows:
- Of the 101 patients receiving Enbrel, 59% achieved an ACR 20 response as opposed to 15% of 104 patients receiving placebo, after 12 weeks of treatment.
- Of the 101 patients receiving Enbrel, 38% achieved an ACR 50 response as opposed to 4% of 104 patients receiving placebo, after 12 weeks of treatment.
- Of the 101 patients receiving Enbrel, 11% achieved an ACR 70 response as opposed to 0% of 104 patients receiving placebo, after 12 weeks of treatment.
In a subset of patients with a pre-defined severity of psoriasis, responses increased over time, and at 6 months those achieving a 50% to 75% improvement in the PASI were 47% and 23% respectively, in the Enbrel group compared to 18% and 3% respectively in the placebo group.
Results of the study were similar to earlier studies. Adverse reactions were similar as well. The most common type of infection psoriatic arthritis patients suffered from during the study was upper respiratory infection.
“In Brief”
News from Novartis…The FDA recently granted marketing approval for the first ever non-steroid prescription cream for atopic dermatitis. Manufactured by Novartis Pharmaceuticals, Elidel contains 1% pimecrolimus to combat mild to moderate atopic dermatitis patients two years and older.
Action Against Acne…Dermik Laboratories recently introduced its latest product currently available to treat moderate to severe acne vulgaris. BenzaClin Topical Gel combines 1% clindamyclin and 5% benzoyl peroxide and has a photosensitivity associated with its use. According to three clinical trials done on this gel, participants experienced a lesion reduction 2 weeks after therapy began. The research indicated that the new gel is stable for 2 months at room temperature. The study noted that patients continued to see improvement in subsequent following visits. Dermik says the aqueous gel is less drying and non oily for acne patients.
New Actinic Keratosis Therapy…As of January 2002, Bioglan Pharma, Inc. announced their latest product, Solaraze’s availability. Recently approved by the FDA, Solaraze treats patients with actinic keratosis with the NSAID diclofenac sodium in a 3% topical formulation.
Jan Marini Aids Relief Fund… In response to the terrorist attacks of September 11th, Jan Marini Skin Research has begun manufacturing American flag pins. The pins sell for $3 a piece with proceeds going toward the Families of Freedom Scholarship Fund. The fund provides educational assistance to the September 11th families of victims in financial duress. To order a pin and/or to contribute to the fund, please call the Families of Freedom Scholarship Fund at 800-347-2223.
Study Shows Acne Drug Promise….At the Interscience Conference on Antimicrobial Agents & Chemotherapy in Vancouver, Canada, researchers presented data on a drug under development to fight acne. The investigational drug, MBI 594AN is manufactured by Micrologix Biotech as the first peptide antibiotic in acne treatment. In phase 2, clinical studies conducted with the MBI 594AN treatment, it appeared to be safe and did not cause irritation to the skin.
Lumenis’ Light….Currently available outside of the U.S., the light based system, ClearLight, to treat acne has recently received FDA clearance within the United States.
Detecting Heart Trouble….A tool used by dermatologists is being tested by the Texas Diabetes Institute to see if it can spot the warning signs of cardiovascular disease. The Doppler device is used by dermatologists to study the reaction of skin to temperature changes. The American Diabetes Association has provided a grant to the institute due to the large number of diabetic patients who experience heart disease as a major complication of
diabetes.
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