Patient and pharmacist

Photo by Rhoda Baer

The US Food and Drug Administration (FDA) has issued 5 draft documents related to drug compounding and repackaging that aim to help entities comply with public health provisions.

The agency said these draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted by Congress in November 2013.

It was enacted in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.

Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.

Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Descriptions of these documents follow.

Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

This draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility with information about the regulatory impact of registering.

For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.

Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

This draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.

Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.

Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)

This draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute, or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts without an approved BLA.

The draft guidance notes that a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA.

Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing the guidance to describe how it intends to address these practices.

Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

Entities registered as outsourcing facilities are required to report adverse events to the FDA. This draft guidance explains adverse event reporting for such facilities.

Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products

The draft memorandum of understanding (MOU) under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.

These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities.

The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.

Patient and pharmacist

Photo by Rhoda Baer

The US Food and Drug Administration (FDA) has issued 5 draft documents related to drug compounding and repackaging that aim to help entities comply with public health provisions.

The agency said these draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted by Congress in November 2013.

It was enacted in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.

Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.

Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Descriptions of these documents follow.

Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

This draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility with information about the regulatory impact of registering.

For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.

Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

This draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.

Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.

Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)

This draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute, or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts without an approved BLA.

The draft guidance notes that a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA.

Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing the guidance to describe how it intends to address these practices.

Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

Entities registered as outsourcing facilities are required to report adverse events to the FDA. This draft guidance explains adverse event reporting for such facilities.

Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products

The draft memorandum of understanding (MOU) under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.

These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities.

The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.

Patient and pharmacist

Photo by Rhoda Baer

The US Food and Drug Administration (FDA) has issued 5 draft documents related to drug compounding and repackaging that aim to help entities comply with public health provisions.

The agency said these draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted by Congress in November 2013.

It was enacted in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.

Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.

Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Descriptions of these documents follow.

Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

This draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility with information about the regulatory impact of registering.

For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.

Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

This draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.

Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.

Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)

This draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute, or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts without an approved BLA.

The draft guidance notes that a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA.

Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing the guidance to describe how it intends to address these practices.

Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

Entities registered as outsourcing facilities are required to report adverse events to the FDA. This draft guidance explains adverse event reporting for such facilities.

Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products

The draft memorandum of understanding (MOU) under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.

These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities.

The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.

Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.

The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.

Related: Sexual Trauma in the Military

According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”

Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.

Related: Recovering From Military Sexual Trauma

The DoD report outlines 5 initiatives to further reduce USC and PSH:

•  Establishing a forum for strategic dialogue between academies;
• Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
• Developing an educational program available anonymously to those coping with a history of sexual victimization;
• Improving sexual assault reporting; and
• Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.

“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”

Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.

The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.

Related: Sexual Trauma in the Military

According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”

Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.

Related: Recovering From Military Sexual Trauma

The DoD report outlines 5 initiatives to further reduce USC and PSH:

•  Establishing a forum for strategic dialogue between academies;
• Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
• Developing an educational program available anonymously to those coping with a history of sexual victimization;
• Improving sexual assault reporting; and
• Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.

“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”

Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.

The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.

Related: Sexual Trauma in the Military

According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”

Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.

Related: Recovering From Military Sexual Trauma

The DoD report outlines 5 initiatives to further reduce USC and PSH:

•  Establishing a forum for strategic dialogue between academies;
• Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
• Developing an educational program available anonymously to those coping with a history of sexual victimization;
• Improving sexual assault reporting; and
• Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.

“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”

Bellafill

Suneva Medical, Inc, announces US Food and Drug Administration approval of the polymethylmethacrylate collagen filler Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21 years. Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. Bellafill also is indicated for correction of nasolabial folds. For more information, visit www.bellafill.com.

Benzac

Galderma Laboratories, LP, launches Benzac Acne Solutions, an over-the-counter 3-step acne regimen consisting of a skin balancing foaming cleanser, intensive spot treatment, and blemish clearing hydrator. In addition to salicylic acid, Benzac also contains Kakadu plum (an antioxidant) to brighten the skin, lemon myrtle (an astringent) to reduce excess oil, and zinc to act as a barrier against skin moisture loss. Benzac contains pharmaceutical-grade East Indian sandalwood oil to calm and soothe the skin. For more information, visit www.benzac.com.

The Promius Promise App

Promius Pharma, LLC, marketers of Zenatane (isotretinoin capsules), launches The Promius Promise App designed to help educate and guide patients through the iPLEDGE program from the first visit to the last visit. The app is free for patients who have received a Zenatane prescription through The Promius Promise program. Patients can easily find important information, which may help with treatment compliance. The app will be useful for young adults and teenagers as well as their parents. For more information, visit www.zenatane.com/toolkit/Promius-Promise-Enrollment-Form.php.

Soolantra

Galderma Laboratories, LP, announces US Food and Drug Administration approval of Soolantra Cream 1% for the once-daily treatment of inflammatory lesions of rosacea. Ivermectin, the active ingredient in Soolantra, has both anti-inflammatory and antiparasitic activity. The basis for the cream formulation is Cetaphil Moisturizing Cream. Soolantra offers patients improvement as early as week 2 of treatment. For more information, visit www.soolantra.com/hcp.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].

Bellafill

Suneva Medical, Inc, announces US Food and Drug Administration approval of the polymethylmethacrylate collagen filler Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21 years. Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. Bellafill also is indicated for correction of nasolabial folds. For more information, visit www.bellafill.com.

Benzac

Galderma Laboratories, LP, launches Benzac Acne Solutions, an over-the-counter 3-step acne regimen consisting of a skin balancing foaming cleanser, intensive spot treatment, and blemish clearing hydrator. In addition to salicylic acid, Benzac also contains Kakadu plum (an antioxidant) to brighten the skin, lemon myrtle (an astringent) to reduce excess oil, and zinc to act as a barrier against skin moisture loss. Benzac contains pharmaceutical-grade East Indian sandalwood oil to calm and soothe the skin. For more information, visit www.benzac.com.

The Promius Promise App

Promius Pharma, LLC, marketers of Zenatane (isotretinoin capsules), launches The Promius Promise App designed to help educate and guide patients through the iPLEDGE program from the first visit to the last visit. The app is free for patients who have received a Zenatane prescription through The Promius Promise program. Patients can easily find important information, which may help with treatment compliance. The app will be useful for young adults and teenagers as well as their parents. For more information, visit www.zenatane.com/toolkit/Promius-Promise-Enrollment-Form.php.

Soolantra

Galderma Laboratories, LP, announces US Food and Drug Administration approval of Soolantra Cream 1% for the once-daily treatment of inflammatory lesions of rosacea. Ivermectin, the active ingredient in Soolantra, has both anti-inflammatory and antiparasitic activity. The basis for the cream formulation is Cetaphil Moisturizing Cream. Soolantra offers patients improvement as early as week 2 of treatment. For more information, visit www.soolantra.com/hcp.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].

Bellafill

Suneva Medical, Inc, announces US Food and Drug Administration approval of the polymethylmethacrylate collagen filler Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21 years. Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. Bellafill also is indicated for correction of nasolabial folds. For more information, visit www.bellafill.com.

Benzac

Galderma Laboratories, LP, launches Benzac Acne Solutions, an over-the-counter 3-step acne regimen consisting of a skin balancing foaming cleanser, intensive spot treatment, and blemish clearing hydrator. In addition to salicylic acid, Benzac also contains Kakadu plum (an antioxidant) to brighten the skin, lemon myrtle (an astringent) to reduce excess oil, and zinc to act as a barrier against skin moisture loss. Benzac contains pharmaceutical-grade East Indian sandalwood oil to calm and soothe the skin. For more information, visit www.benzac.com.

The Promius Promise App

Promius Pharma, LLC, marketers of Zenatane (isotretinoin capsules), launches The Promius Promise App designed to help educate and guide patients through the iPLEDGE program from the first visit to the last visit. The app is free for patients who have received a Zenatane prescription through The Promius Promise program. Patients can easily find important information, which may help with treatment compliance. The app will be useful for young adults and teenagers as well as their parents. For more information, visit www.zenatane.com/toolkit/Promius-Promise-Enrollment-Form.php.

Soolantra

Galderma Laboratories, LP, announces US Food and Drug Administration approval of Soolantra Cream 1% for the once-daily treatment of inflammatory lesions of rosacea. Ivermectin, the active ingredient in Soolantra, has both anti-inflammatory and antiparasitic activity. The basis for the cream formulation is Cetaphil Moisturizing Cream. Soolantra offers patients improvement as early as week 2 of treatment. For more information, visit www.soolantra.com/hcp.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].

In hepatitis C, people born with the IL28B CC genotype can count themselves luckier than those born with CT or TT.

To read the full article, go to the Cleveland Clinic Journal of Medicine:  http://www.ccjm.org/home/article/genetics-and-hepatitis-c-its-good-to-be-cc/0afbe8ada94cdbab08fd0663c76e460e.html.

In hepatitis C, people born with the IL28B CC genotype can count themselves luckier than those born with CT or TT.

To read the full article, go to the Cleveland Clinic Journal of Medicine:  http://www.ccjm.org/home/article/genetics-and-hepatitis-c-its-good-to-be-cc/0afbe8ada94cdbab08fd0663c76e460e.html.

In hepatitis C, people born with the IL28B CC genotype can count themselves luckier than those born with CT or TT.

To read the full article, go to the Cleveland Clinic Journal of Medicine:  http://www.ccjm.org/home/article/genetics-and-hepatitis-c-its-good-to-be-cc/0afbe8ada94cdbab08fd0663c76e460e.html.

The Centers for Disease Control and Prevention offers information to teach patients about the importance of getting sufficient sleep. “Are you getting enough sleep?” is available at http://www.cdc.gov/Features/Sleep/. It explains how many hours of sleep people need each night and describes common sleep disorders, including insomnia, narcolepsy, restless leg syndrome, and sleep apnea. The online resource also offers tools to improve the quality of sleep and tips on how to sleep through the night.

The Centers for Disease Control and Prevention offers information to teach patients about the importance of getting sufficient sleep. “Are you getting enough sleep?” is available at http://www.cdc.gov/Features/Sleep/. It explains how many hours of sleep people need each night and describes common sleep disorders, including insomnia, narcolepsy, restless leg syndrome, and sleep apnea. The online resource also offers tools to improve the quality of sleep and tips on how to sleep through the night.

The Centers for Disease Control and Prevention offers information to teach patients about the importance of getting sufficient sleep. “Are you getting enough sleep?” is available at http://www.cdc.gov/Features/Sleep/. It explains how many hours of sleep people need each night and describes common sleep disorders, including insomnia, narcolepsy, restless leg syndrome, and sleep apnea. The online resource also offers tools to improve the quality of sleep and tips on how to sleep through the night.

The phenomenon of natural (nonchemically treated) hair in individuals of African and Afro-Caribbean descent is sweeping across the United States. The ideals of beauty among this patient population have shifted from a relaxed, straightened, noncurly look to a more natural curly and/or kinky appearance. The discussion on natural hair versus straight hair has been brought to the mainstream by films such as Good Hair (2009). Furthermore, major hair care companies have increased their marketing of natural hair products to address the needs of these patients.

Popular traumatic hair care practices such as chemical relaxation and thermal straightening may lead to hair damage. Although the role of hair care practices in various scalp and hair disorders is ambiguous, traumatic practices commonly are performed by patients who are diagnosed with dermatologic conditions such as scarring alopecia.¹ Alopecia is the fourth most common dermatologic diagnosis in black patients.² Central centrifugal cicatricial alopecia is the most common form of scarring alopecia in this patient population³ and has been associated with traumatic hair care practices. As a result, many patients have switched to natural hairstyles that are less traumatic and damaging, often due to recommendations by dermatologists.

As the US population continues to become more diverse, dermatologists will be faced with many questions regarding hair disease and natural hair care in patients with skin of color. A basic understanding of hair care practices among black individuals is important to aid in the diagnosis and treatment of hair shaft and scalp disorders.⁴ When patients switch to natural hairstyles, are dermatologists prepared to answer questions that may arise during this process? This article will familiarize dermatologists with basic hair care terminology and general recommendations they can make to black patients who are transitioning to natural hairstyles.

Characteristics of Hair in the Skin of Color Population

A basic understanding of the structural properties of hair is fundamental. Human hair is categorized into 3 groups: Asian, Caucasian, and African.⁵ African hair typically is curly and, depending on the degree of the curl, is more susceptible to damage due to increased mechanical fragility. It also has a tendency to form knots and fissures along the hair shaft, which causes additional fracturing with simple manipulation. African hair grows more slowly than Asian and Caucasian hair, which can be discouraging to patients. It also has a lower water concentration and does not become coated with sebum as naturally as straightened hair.⁵ A simplified explanation of these characteristics can help patients understand how to proceed in managing and styling their natural hair.

As physicians, it is important for us to treat any underlying conditions related to the hair and scalp in black patients. Common dermatologic conditions such as seborrheic dermatitis, lupus, folliculitis, and alopecia can affect patients’ hair health. In addition to traumatic hair care practices, inflammation secondary to bacterial infections can contribute to the onset of central centrifugal cicatricial alopecia.⁶ Therefore, a detailed history and physical examination are needed to evaluate the etiology of associated symptoms. Treatment of these associated symptoms will aid in the overall care of patients.

Transitioning to Natural Hairstyles

Following evaluation and treatment of any hair or scalp conditions, how can dermatologists help black patients transition to natural hairstyles? The term transition refers to the process of switching from a chemically relaxed or thermally straightened hairstyle to a natural hairstyle. Dermatologists must understand the common terminology used to describe natural hair practices in this patient population.

There are several methods patients can use to transition from chemically treated hairstyles to natural hairstyles. Patients may consider the option of the “big chop,” or cutting off all chemically treated hair. This option typically leaves women with very short hairstyles down to the new growth, or hair that has grown since the last chemical relaxer. Other commonly used methods during the transition phase include protective styling (eg, braids, weaves, extensions) or simply growing out the chemically treated hair.

Protective styling methods such as braids, weaves, and extensions allow hair to be easily styled while the chemically treated hair grows out over time.⁷ Typically, protective styles may be worn for weeks to months, allowing hair growth without hair breakage and shedding. Hair weaving is a practice that incorporates artificial (synthetic) or human hair into one’s natural scalp hair.⁸ There are various techniques to extend hair including clip-in extensions, hair bonding and fusion with adhesives, sewing hair into braided hair, or the application of single strands of hair into a cap made of nylon mesh known as a lace front. Braided styles, weaves, and hair extensions cannot be washed as often as natural hair, but it is important to remind patients to replenish moisture as often as possible. Moisturizing or greasing the exposed scalp and proximal hair shafts can assist with water retention. It is imperative to inform patients that overuse of tight braids and glues for weaves and extensions may further damage the hair and scalp. Some of the natural ingredients commonly used in moisturizers include olive oil, jojoba oil, coconut oil, castor oil, and glycerin. These products can commonly cause pomade acne, which should be recognized and treated by dermatologists. Furthermore, long weaves and extensions can put excess weight on natural hair causing breakage. To prevent breakage, wearing an updo (a hairstyle in which the hair is pulled upward) can reduce the heavy strain on the hair.

Dermatologists should remind patients who wish to grow out chemically treated hair to frequently moisturize the hair and scalp as well as to avoid trauma to prevent hair breakage. As the natural hair grows out, the patient will experience varying hair textures from the natural curly hair to the previously processed straightened hair; as a result, the hair may tangle and become damaged. Manual detangling and detangling conditioners can help prevent damage. Patients should be advised to detangle the hair in sections first with the fingers, then with a wide-tooth comb working retrograde from the hair end to the roots.

Frequent hair trimming, ranging from every 4 to 6 weeks to every 2 to 4 months, should be recommended to patients who are experiencing breakage or wish to prevent damage. Trimming damaged hair can relieve excess weight on the natural hair and remove split ends, which promotes hair growth. Braiding and other lengthening techniques can prevent the hair from curling upon itself or tangling, causing less kinking and thereby decreasing the need for trimming.⁷ Wearing bonnets, using satin pillowcases, and wearing protective hairstyles while sleeping also can decrease hair breakage and hair loss. A commonly used hairstyle to protect the hair while sleeping is called “pineappling,” which is used to preserve and protect curls. This technique is described as gathering the hair in a high but loose ponytail at the top of the head. For patients with straightened hair, wrapping the hair underneath a bonnet or satin scarf while sleeping can prevent damage.

Managing Natural Hairstyles

An important factor in the management of natural hairstyles is the retention of hair moisture, as there is less water content in African hair compared to other hair types.⁵ Overuse of heat and harsh shampoos can strip moisture from the hair. Similar to patients with atopic dermatitis who should restore and maintain the skin barrier to prevent transepidermal water loss, it is important to remind patients with natural hairstyles to avoid using products and styling practices that may further deplete water content in the hair. Moisture is crucial to healthy hair.

A common culprit in shampoos that leads to hair dryness is sodium lauryl sulfate/sodium laureth sulfate, a detergent/surfactant used as a foaming agent. Sodium lauryl sulfate is a potent degreaser that binds dirt and excess product on the hair and scalp. It also dissolves oil in the hair, causing additional dryness and breakage.

Patients with natural hairstyles commonly use sulfate-free shampoos to prevent stripping the hair of its moisture and natural oils. Another method used to prevent hair dryness is co-washing, or washing the hair with a conditioner. Co-washing can effectively cleanse the hair while maintaining moisture. The use of cationic ingredients in conditioners aids in sealing moisture within the hair shaft. Hair consists of the negatively charged protein keratin, which binds to cationic surfactants in conditioners.⁹ The hydrophobic ends of the surfactant prevent the substance from being rinsed out and act to restore the hair barrier.

Silicone is another important ingredient in hair care products. In patients with natural hair, there are varying views on the use of products containing silicone. Silicones are added to products designed to coat the hair, adding shine, retaining moisture, and providing thermal protection. Silicones are used to provide “slip.” Slip is a term that is commonly used among patients with natural hair to describe how slippery a product is and how easily the product will help comb or detangle the hair. There are 2 basic types of silicones: water insoluble and water soluble. Water-insoluble silicones traditionally build up on the hair and require surfactant-containing shampoos to becompletely removed. Residue buildup on the hair weighs the hair down and causes damage. In contrast, water-soluble silicones do not build up and typically do not cause damage.

Silicones with the prefixes PEG- or PPG- typically are water soluble and will not build up on the hair. Dimethicone copolyol and lauryl methicone copolyol are other water-soluble silicones. In general, water-soluble silicones provide moisturizing properties without leaving residue. Other silicones such as amodimethicone and cyclomethicone are not water soluble but have properties that prevent buildup.

It is common practice for patients with natural hairstyles to avoid using water-insoluble silicones. As dermatologists, we can recommend silicone-free conditioners or conditioners containing water-soluble silicones to prevent hair dehydration and subsequent breakage. It may be advantageous to have patients try various products to determine which ones work best for their hair.

More Resources for Patients

Dermatologists have extensive knowledge of the pathophysiology of skin, hair, and nail diseases; however, despite our vast knowledge, we also need to recognize our limits. In addition to increasing your own knowledge of natural hair care practices to help your patients, it is important to recommend that your patients search for additional resources to aid in their transition to natural hairstyles. Natural hairstylists can be great resources for patients to help with hair management. In the current digital age, there also are thousands of blogs and social media forums dedicated to the topic of natural hair care. Advising patients to consult natural hair care resources can be beneficial, but as hair specialists, it also is important for us to dispel any false information that our patients may receive. As physicians, it is essential not only to manage patients who present to our offices with conditions resulting from damaging hair practices but also to help prevent such conditions from occurring. Although there may not be an overwhelming amount of evidence-based medical research to guide our decisions, we also can learn from the thousands of patients who have articulated their stories and experiences. Through observing and listening to our patients, we can incorporate this new knowledge in the management of our patients.

The phenomenon of natural (nonchemically treated) hair in individuals of African and Afro-Caribbean descent is sweeping across the United States. The ideals of beauty among this patient population have shifted from a relaxed, straightened, noncurly look to a more natural curly and/or kinky appearance. The discussion on natural hair versus straight hair has been brought to the mainstream by films such as Good Hair (2009). Furthermore, major hair care companies have increased their marketing of natural hair products to address the needs of these patients.

Popular traumatic hair care practices such as chemical relaxation and thermal straightening may lead to hair damage. Although the role of hair care practices in various scalp and hair disorders is ambiguous, traumatic practices commonly are performed by patients who are diagnosed with dermatologic conditions such as scarring alopecia.¹ Alopecia is the fourth most common dermatologic diagnosis in black patients.² Central centrifugal cicatricial alopecia is the most common form of scarring alopecia in this patient population³ and has been associated with traumatic hair care practices. As a result, many patients have switched to natural hairstyles that are less traumatic and damaging, often due to recommendations by dermatologists.

As the US population continues to become more diverse, dermatologists will be faced with many questions regarding hair disease and natural hair care in patients with skin of color. A basic understanding of hair care practices among black individuals is important to aid in the diagnosis and treatment of hair shaft and scalp disorders.⁴ When patients switch to natural hairstyles, are dermatologists prepared to answer questions that may arise during this process? This article will familiarize dermatologists with basic hair care terminology and general recommendations they can make to black patients who are transitioning to natural hairstyles.

Characteristics of Hair in the Skin of Color Population

A basic understanding of the structural properties of hair is fundamental. Human hair is categorized into 3 groups: Asian, Caucasian, and African.⁵ African hair typically is curly and, depending on the degree of the curl, is more susceptible to damage due to increased mechanical fragility. It also has a tendency to form knots and fissures along the hair shaft, which causes additional fracturing with simple manipulation. African hair grows more slowly than Asian and Caucasian hair, which can be discouraging to patients. It also has a lower water concentration and does not become coated with sebum as naturally as straightened hair.⁵ A simplified explanation of these characteristics can help patients understand how to proceed in managing and styling their natural hair.

As physicians, it is important for us to treat any underlying conditions related to the hair and scalp in black patients. Common dermatologic conditions such as seborrheic dermatitis, lupus, folliculitis, and alopecia can affect patients’ hair health. In addition to traumatic hair care practices, inflammation secondary to bacterial infections can contribute to the onset of central centrifugal cicatricial alopecia.⁶ Therefore, a detailed history and physical examination are needed to evaluate the etiology of associated symptoms. Treatment of these associated symptoms will aid in the overall care of patients.

Transitioning to Natural Hairstyles

Following evaluation and treatment of any hair or scalp conditions, how can dermatologists help black patients transition to natural hairstyles? The term transition refers to the process of switching from a chemically relaxed or thermally straightened hairstyle to a natural hairstyle. Dermatologists must understand the common terminology used to describe natural hair practices in this patient population.

There are several methods patients can use to transition from chemically treated hairstyles to natural hairstyles. Patients may consider the option of the “big chop,” or cutting off all chemically treated hair. This option typically leaves women with very short hairstyles down to the new growth, or hair that has grown since the last chemical relaxer. Other commonly used methods during the transition phase include protective styling (eg, braids, weaves, extensions) or simply growing out the chemically treated hair.

Protective styling methods such as braids, weaves, and extensions allow hair to be easily styled while the chemically treated hair grows out over time.⁷ Typically, protective styles may be worn for weeks to months, allowing hair growth without hair breakage and shedding. Hair weaving is a practice that incorporates artificial (synthetic) or human hair into one’s natural scalp hair.⁸ There are various techniques to extend hair including clip-in extensions, hair bonding and fusion with adhesives, sewing hair into braided hair, or the application of single strands of hair into a cap made of nylon mesh known as a lace front. Braided styles, weaves, and hair extensions cannot be washed as often as natural hair, but it is important to remind patients to replenish moisture as often as possible. Moisturizing or greasing the exposed scalp and proximal hair shafts can assist with water retention. It is imperative to inform patients that overuse of tight braids and glues for weaves and extensions may further damage the hair and scalp. Some of the natural ingredients commonly used in moisturizers include olive oil, jojoba oil, coconut oil, castor oil, and glycerin. These products can commonly cause pomade acne, which should be recognized and treated by dermatologists. Furthermore, long weaves and extensions can put excess weight on natural hair causing breakage. To prevent breakage, wearing an updo (a hairstyle in which the hair is pulled upward) can reduce the heavy strain on the hair.

Dermatologists should remind patients who wish to grow out chemically treated hair to frequently moisturize the hair and scalp as well as to avoid trauma to prevent hair breakage. As the natural hair grows out, the patient will experience varying hair textures from the natural curly hair to the previously processed straightened hair; as a result, the hair may tangle and become damaged. Manual detangling and detangling conditioners can help prevent damage. Patients should be advised to detangle the hair in sections first with the fingers, then with a wide-tooth comb working retrograde from the hair end to the roots.

Frequent hair trimming, ranging from every 4 to 6 weeks to every 2 to 4 months, should be recommended to patients who are experiencing breakage or wish to prevent damage. Trimming damaged hair can relieve excess weight on the natural hair and remove split ends, which promotes hair growth. Braiding and other lengthening techniques can prevent the hair from curling upon itself or tangling, causing less kinking and thereby decreasing the need for trimming.⁷ Wearing bonnets, using satin pillowcases, and wearing protective hairstyles while sleeping also can decrease hair breakage and hair loss. A commonly used hairstyle to protect the hair while sleeping is called “pineappling,” which is used to preserve and protect curls. This technique is described as gathering the hair in a high but loose ponytail at the top of the head. For patients with straightened hair, wrapping the hair underneath a bonnet or satin scarf while sleeping can prevent damage.

Managing Natural Hairstyles

An important factor in the management of natural hairstyles is the retention of hair moisture, as there is less water content in African hair compared to other hair types.⁵ Overuse of heat and harsh shampoos can strip moisture from the hair. Similar to patients with atopic dermatitis who should restore and maintain the skin barrier to prevent transepidermal water loss, it is important to remind patients with natural hairstyles to avoid using products and styling practices that may further deplete water content in the hair. Moisture is crucial to healthy hair.

A common culprit in shampoos that leads to hair dryness is sodium lauryl sulfate/sodium laureth sulfate, a detergent/surfactant used as a foaming agent. Sodium lauryl sulfate is a potent degreaser that binds dirt and excess product on the hair and scalp. It also dissolves oil in the hair, causing additional dryness and breakage.

Patients with natural hairstyles commonly use sulfate-free shampoos to prevent stripping the hair of its moisture and natural oils. Another method used to prevent hair dryness is co-washing, or washing the hair with a conditioner. Co-washing can effectively cleanse the hair while maintaining moisture. The use of cationic ingredients in conditioners aids in sealing moisture within the hair shaft. Hair consists of the negatively charged protein keratin, which binds to cationic surfactants in conditioners.⁹ The hydrophobic ends of the surfactant prevent the substance from being rinsed out and act to restore the hair barrier.

Silicone is another important ingredient in hair care products. In patients with natural hair, there are varying views on the use of products containing silicone. Silicones are added to products designed to coat the hair, adding shine, retaining moisture, and providing thermal protection. Silicones are used to provide “slip.” Slip is a term that is commonly used among patients with natural hair to describe how slippery a product is and how easily the product will help comb or detangle the hair. There are 2 basic types of silicones: water insoluble and water soluble. Water-insoluble silicones traditionally build up on the hair and require surfactant-containing shampoos to becompletely removed. Residue buildup on the hair weighs the hair down and causes damage. In contrast, water-soluble silicones do not build up and typically do not cause damage.

Silicones with the prefixes PEG- or PPG- typically are water soluble and will not build up on the hair. Dimethicone copolyol and lauryl methicone copolyol are other water-soluble silicones. In general, water-soluble silicones provide moisturizing properties without leaving residue. Other silicones such as amodimethicone and cyclomethicone are not water soluble but have properties that prevent buildup.

It is common practice for patients with natural hairstyles to avoid using water-insoluble silicones. As dermatologists, we can recommend silicone-free conditioners or conditioners containing water-soluble silicones to prevent hair dehydration and subsequent breakage. It may be advantageous to have patients try various products to determine which ones work best for their hair.

More Resources for Patients

Dermatologists have extensive knowledge of the pathophysiology of skin, hair, and nail diseases; however, despite our vast knowledge, we also need to recognize our limits. In addition to increasing your own knowledge of natural hair care practices to help your patients, it is important to recommend that your patients search for additional resources to aid in their transition to natural hairstyles. Natural hairstylists can be great resources for patients to help with hair management. In the current digital age, there also are thousands of blogs and social media forums dedicated to the topic of natural hair care. Advising patients to consult natural hair care resources can be beneficial, but as hair specialists, it also is important for us to dispel any false information that our patients may receive. As physicians, it is essential not only to manage patients who present to our offices with conditions resulting from damaging hair practices but also to help prevent such conditions from occurring. Although there may not be an overwhelming amount of evidence-based medical research to guide our decisions, we also can learn from the thousands of patients who have articulated their stories and experiences. Through observing and listening to our patients, we can incorporate this new knowledge in the management of our patients.

The phenomenon of natural (nonchemically treated) hair in individuals of African and Afro-Caribbean descent is sweeping across the United States. The ideals of beauty among this patient population have shifted from a relaxed, straightened, noncurly look to a more natural curly and/or kinky appearance. The discussion on natural hair versus straight hair has been brought to the mainstream by films such as Good Hair (2009). Furthermore, major hair care companies have increased their marketing of natural hair products to address the needs of these patients.

Popular traumatic hair care practices such as chemical relaxation and thermal straightening may lead to hair damage. Although the role of hair care practices in various scalp and hair disorders is ambiguous, traumatic practices commonly are performed by patients who are diagnosed with dermatologic conditions such as scarring alopecia.¹ Alopecia is the fourth most common dermatologic diagnosis in black patients.² Central centrifugal cicatricial alopecia is the most common form of scarring alopecia in this patient population³ and has been associated with traumatic hair care practices. As a result, many patients have switched to natural hairstyles that are less traumatic and damaging, often due to recommendations by dermatologists.

As the US population continues to become more diverse, dermatologists will be faced with many questions regarding hair disease and natural hair care in patients with skin of color. A basic understanding of hair care practices among black individuals is important to aid in the diagnosis and treatment of hair shaft and scalp disorders.⁴ When patients switch to natural hairstyles, are dermatologists prepared to answer questions that may arise during this process? This article will familiarize dermatologists with basic hair care terminology and general recommendations they can make to black patients who are transitioning to natural hairstyles.

Characteristics of Hair in the Skin of Color Population

A basic understanding of the structural properties of hair is fundamental. Human hair is categorized into 3 groups: Asian, Caucasian, and African.⁵ African hair typically is curly and, depending on the degree of the curl, is more susceptible to damage due to increased mechanical fragility. It also has a tendency to form knots and fissures along the hair shaft, which causes additional fracturing with simple manipulation. African hair grows more slowly than Asian and Caucasian hair, which can be discouraging to patients. It also has a lower water concentration and does not become coated with sebum as naturally as straightened hair.⁵ A simplified explanation of these characteristics can help patients understand how to proceed in managing and styling their natural hair.

As physicians, it is important for us to treat any underlying conditions related to the hair and scalp in black patients. Common dermatologic conditions such as seborrheic dermatitis, lupus, folliculitis, and alopecia can affect patients’ hair health. In addition to traumatic hair care practices, inflammation secondary to bacterial infections can contribute to the onset of central centrifugal cicatricial alopecia.⁶ Therefore, a detailed history and physical examination are needed to evaluate the etiology of associated symptoms. Treatment of these associated symptoms will aid in the overall care of patients.

Transitioning to Natural Hairstyles

Following evaluation and treatment of any hair or scalp conditions, how can dermatologists help black patients transition to natural hairstyles? The term transition refers to the process of switching from a chemically relaxed or thermally straightened hairstyle to a natural hairstyle. Dermatologists must understand the common terminology used to describe natural hair practices in this patient population.

There are several methods patients can use to transition from chemically treated hairstyles to natural hairstyles. Patients may consider the option of the “big chop,” or cutting off all chemically treated hair. This option typically leaves women with very short hairstyles down to the new growth, or hair that has grown since the last chemical relaxer. Other commonly used methods during the transition phase include protective styling (eg, braids, weaves, extensions) or simply growing out the chemically treated hair.

Protective styling methods such as braids, weaves, and extensions allow hair to be easily styled while the chemically treated hair grows out over time.⁷ Typically, protective styles may be worn for weeks to months, allowing hair growth without hair breakage and shedding. Hair weaving is a practice that incorporates artificial (synthetic) or human hair into one’s natural scalp hair.⁸ There are various techniques to extend hair including clip-in extensions, hair bonding and fusion with adhesives, sewing hair into braided hair, or the application of single strands of hair into a cap made of nylon mesh known as a lace front. Braided styles, weaves, and hair extensions cannot be washed as often as natural hair, but it is important to remind patients to replenish moisture as often as possible. Moisturizing or greasing the exposed scalp and proximal hair shafts can assist with water retention. It is imperative to inform patients that overuse of tight braids and glues for weaves and extensions may further damage the hair and scalp. Some of the natural ingredients commonly used in moisturizers include olive oil, jojoba oil, coconut oil, castor oil, and glycerin. These products can commonly cause pomade acne, which should be recognized and treated by dermatologists. Furthermore, long weaves and extensions can put excess weight on natural hair causing breakage. To prevent breakage, wearing an updo (a hairstyle in which the hair is pulled upward) can reduce the heavy strain on the hair.

Dermatologists should remind patients who wish to grow out chemically treated hair to frequently moisturize the hair and scalp as well as to avoid trauma to prevent hair breakage. As the natural hair grows out, the patient will experience varying hair textures from the natural curly hair to the previously processed straightened hair; as a result, the hair may tangle and become damaged. Manual detangling and detangling conditioners can help prevent damage. Patients should be advised to detangle the hair in sections first with the fingers, then with a wide-tooth comb working retrograde from the hair end to the roots.

Frequent hair trimming, ranging from every 4 to 6 weeks to every 2 to 4 months, should be recommended to patients who are experiencing breakage or wish to prevent damage. Trimming damaged hair can relieve excess weight on the natural hair and remove split ends, which promotes hair growth. Braiding and other lengthening techniques can prevent the hair from curling upon itself or tangling, causing less kinking and thereby decreasing the need for trimming.⁷ Wearing bonnets, using satin pillowcases, and wearing protective hairstyles while sleeping also can decrease hair breakage and hair loss. A commonly used hairstyle to protect the hair while sleeping is called “pineappling,” which is used to preserve and protect curls. This technique is described as gathering the hair in a high but loose ponytail at the top of the head. For patients with straightened hair, wrapping the hair underneath a bonnet or satin scarf while sleeping can prevent damage.

Managing Natural Hairstyles

An important factor in the management of natural hairstyles is the retention of hair moisture, as there is less water content in African hair compared to other hair types.⁵ Overuse of heat and harsh shampoos can strip moisture from the hair. Similar to patients with atopic dermatitis who should restore and maintain the skin barrier to prevent transepidermal water loss, it is important to remind patients with natural hairstyles to avoid using products and styling practices that may further deplete water content in the hair. Moisture is crucial to healthy hair.

A common culprit in shampoos that leads to hair dryness is sodium lauryl sulfate/sodium laureth sulfate, a detergent/surfactant used as a foaming agent. Sodium lauryl sulfate is a potent degreaser that binds dirt and excess product on the hair and scalp. It also dissolves oil in the hair, causing additional dryness and breakage.

Patients with natural hairstyles commonly use sulfate-free shampoos to prevent stripping the hair of its moisture and natural oils. Another method used to prevent hair dryness is co-washing, or washing the hair with a conditioner. Co-washing can effectively cleanse the hair while maintaining moisture. The use of cationic ingredients in conditioners aids in sealing moisture within the hair shaft. Hair consists of the negatively charged protein keratin, which binds to cationic surfactants in conditioners.⁹ The hydrophobic ends of the surfactant prevent the substance from being rinsed out and act to restore the hair barrier.

Silicone is another important ingredient in hair care products. In patients with natural hair, there are varying views on the use of products containing silicone. Silicones are added to products designed to coat the hair, adding shine, retaining moisture, and providing thermal protection. Silicones are used to provide “slip.” Slip is a term that is commonly used among patients with natural hair to describe how slippery a product is and how easily the product will help comb or detangle the hair. There are 2 basic types of silicones: water insoluble and water soluble. Water-insoluble silicones traditionally build up on the hair and require surfactant-containing shampoos to becompletely removed. Residue buildup on the hair weighs the hair down and causes damage. In contrast, water-soluble silicones do not build up and typically do not cause damage.

Silicones with the prefixes PEG- or PPG- typically are water soluble and will not build up on the hair. Dimethicone copolyol and lauryl methicone copolyol are other water-soluble silicones. In general, water-soluble silicones provide moisturizing properties without leaving residue. Other silicones such as amodimethicone and cyclomethicone are not water soluble but have properties that prevent buildup.

It is common practice for patients with natural hairstyles to avoid using water-insoluble silicones. As dermatologists, we can recommend silicone-free conditioners or conditioners containing water-soluble silicones to prevent hair dehydration and subsequent breakage. It may be advantageous to have patients try various products to determine which ones work best for their hair.

More Resources for Patients

Dermatologists have extensive knowledge of the pathophysiology of skin, hair, and nail diseases; however, despite our vast knowledge, we also need to recognize our limits. In addition to increasing your own knowledge of natural hair care practices to help your patients, it is important to recommend that your patients search for additional resources to aid in their transition to natural hairstyles. Natural hairstylists can be great resources for patients to help with hair management. In the current digital age, there also are thousands of blogs and social media forums dedicated to the topic of natural hair care. Advising patients to consult natural hair care resources can be beneficial, but as hair specialists, it also is important for us to dispel any false information that our patients may receive. As physicians, it is essential not only to manage patients who present to our offices with conditions resulting from damaging hair practices but also to help prevent such conditions from occurring. Although there may not be an overwhelming amount of evidence-based medical research to guide our decisions, we also can learn from the thousands of patients who have articulated their stories and experiences. Through observing and listening to our patients, we can incorporate this new knowledge in the management of our patients.

Two new genetic studies provide insights into the biology of obesity, according to findings reported in the journal Nature.

In a study of waist-to-hip ratios in more than 244,000 individuals, Dr. Dmitry Shungin of Umea University in Sweden and his colleagues identified 49 genetic locations associated with fat deposits, 19 of which had a stronger effect on women. In a simultaneously published study of body mass index (BMI) in nearly 340,000 patients, investigators identified 97 genetic locations associated with BMI, reported Dr. Adam E. Locke and colleagues at the University of Michigan, Ann Arbor.

“This work is the first step toward finding individual genes that play key roles in body shape and size,” said a University of Michigan statement. “The proteins these genes help produce could become targets for future drug development.”

Read the full article by Dr. Shungin here and the full article by Dr. Locke here.

Two new genetic studies provide insights into the biology of obesity, according to findings reported in the journal Nature.

In a study of waist-to-hip ratios in more than 244,000 individuals, Dr. Dmitry Shungin of Umea University in Sweden and his colleagues identified 49 genetic locations associated with fat deposits, 19 of which had a stronger effect on women. In a simultaneously published study of body mass index (BMI) in nearly 340,000 patients, investigators identified 97 genetic locations associated with BMI, reported Dr. Adam E. Locke and colleagues at the University of Michigan, Ann Arbor.

“This work is the first step toward finding individual genes that play key roles in body shape and size,” said a University of Michigan statement. “The proteins these genes help produce could become targets for future drug development.”

Read the full article by Dr. Shungin here and the full article by Dr. Locke here.

Two new genetic studies provide insights into the biology of obesity, according to findings reported in the journal Nature.

In a study of waist-to-hip ratios in more than 244,000 individuals, Dr. Dmitry Shungin of Umea University in Sweden and his colleagues identified 49 genetic locations associated with fat deposits, 19 of which had a stronger effect on women. In a simultaneously published study of body mass index (BMI) in nearly 340,000 patients, investigators identified 97 genetic locations associated with BMI, reported Dr. Adam E. Locke and colleagues at the University of Michigan, Ann Arbor.

“This work is the first step toward finding individual genes that play key roles in body shape and size,” said a University of Michigan statement. “The proteins these genes help produce could become targets for future drug development.”

Read the full article by Dr. Shungin here and the full article by Dr. Locke here.

Patients hospitalized with non–ST-segment myocardial infarction who received fondaparinux had significantly lower risk of suffering a major bleed or dying in the hospital, compared with those treated with low-molecular-weight heparin, investigators reported online Feb. 17 in JAMA.

The differences persisted 1 and 6 months after hospitalization, said Dr. Karolina Szummer at Karolinska University Hospital in Stockholm, and her associates. However, fondaparinux was not linked to lower rates of stroke or recurrent heart attack, compared with low-molecular-weight heparin (LMWH), the researchers said.

The European Society of Cardiology changed its NSTEMI guidelines in 2011, recommending fondaparinux as a first-choice anticoagulant for both patients treated either noninvasively or with PCI, spurring a “rapid switch” from LMWH to the indirect factor Xa inhibitor fondaparinux for treating non–ST-segment myocardial infarction (NSTEMI), said the investigators. (American Heart Association/American College of Cardiology guidelines, issued in 2012, do not favor fondaparinux over LMWH.) To study the effects of ESC’s change, they analyzed registry data from 40,616 patients hospitalized with NSTEMI between 2006 and 2010, of whom 36% of patients received fondaparinux and 64% received LMWH (JAMA 2015 Feb. 17;313:707-16).

Only 3.7% of the fondaparinux group suffered severe bleeding events or died in the hospital, compared with 5.5% of the heparin group (adjusted odds ratio, 0.67; 95% confidence interval, 0.58-0.78), the study found. Significant differences in bleeding and death rates persisted 30 days and 6 months after hospitalization, but rates of recurrent heart attack and stroke were similar between the treatment groups at all time points, the researchers said.

“This is not a randomized trial; therefore, residual confounding is very likely,” the investigators cautioned, adding that because the study used registry data, it probably underestimated bleeding events.

The work was funded by the Swedish Foundation for Strategic Research, the Swedish Heart and Lung Foundation, ALF Medicin, and the Swedish Medical Research Council. Dr. Szummer has received lecture fees from AstraZeneca. One coauthor reported financial relationships with GlaxoSmithKline, which markets fondaparinux. Other coauthors reported funding from numerous pharmaceutical companies.

Patients hospitalized with non–ST-segment myocardial infarction who received fondaparinux had significantly lower risk of suffering a major bleed or dying in the hospital, compared with those treated with low-molecular-weight heparin, investigators reported online Feb. 17 in JAMA.

The differences persisted 1 and 6 months after hospitalization, said Dr. Karolina Szummer at Karolinska University Hospital in Stockholm, and her associates. However, fondaparinux was not linked to lower rates of stroke or recurrent heart attack, compared with low-molecular-weight heparin (LMWH), the researchers said.

The European Society of Cardiology changed its NSTEMI guidelines in 2011, recommending fondaparinux as a first-choice anticoagulant for both patients treated either noninvasively or with PCI, spurring a “rapid switch” from LMWH to the indirect factor Xa inhibitor fondaparinux for treating non–ST-segment myocardial infarction (NSTEMI), said the investigators. (American Heart Association/American College of Cardiology guidelines, issued in 2012, do not favor fondaparinux over LMWH.) To study the effects of ESC’s change, they analyzed registry data from 40,616 patients hospitalized with NSTEMI between 2006 and 2010, of whom 36% of patients received fondaparinux and 64% received LMWH (JAMA 2015 Feb. 17;313:707-16).

Only 3.7% of the fondaparinux group suffered severe bleeding events or died in the hospital, compared with 5.5% of the heparin group (adjusted odds ratio, 0.67; 95% confidence interval, 0.58-0.78), the study found. Significant differences in bleeding and death rates persisted 30 days and 6 months after hospitalization, but rates of recurrent heart attack and stroke were similar between the treatment groups at all time points, the researchers said.

“This is not a randomized trial; therefore, residual confounding is very likely,” the investigators cautioned, adding that because the study used registry data, it probably underestimated bleeding events.

The work was funded by the Swedish Foundation for Strategic Research, the Swedish Heart and Lung Foundation, ALF Medicin, and the Swedish Medical Research Council. Dr. Szummer has received lecture fees from AstraZeneca. One coauthor reported financial relationships with GlaxoSmithKline, which markets fondaparinux. Other coauthors reported funding from numerous pharmaceutical companies.

Patients hospitalized with non–ST-segment myocardial infarction who received fondaparinux had significantly lower risk of suffering a major bleed or dying in the hospital, compared with those treated with low-molecular-weight heparin, investigators reported online Feb. 17 in JAMA.

The differences persisted 1 and 6 months after hospitalization, said Dr. Karolina Szummer at Karolinska University Hospital in Stockholm, and her associates. However, fondaparinux was not linked to lower rates of stroke or recurrent heart attack, compared with low-molecular-weight heparin (LMWH), the researchers said.

The European Society of Cardiology changed its NSTEMI guidelines in 2011, recommending fondaparinux as a first-choice anticoagulant for both patients treated either noninvasively or with PCI, spurring a “rapid switch” from LMWH to the indirect factor Xa inhibitor fondaparinux for treating non–ST-segment myocardial infarction (NSTEMI), said the investigators. (American Heart Association/American College of Cardiology guidelines, issued in 2012, do not favor fondaparinux over LMWH.) To study the effects of ESC’s change, they analyzed registry data from 40,616 patients hospitalized with NSTEMI between 2006 and 2010, of whom 36% of patients received fondaparinux and 64% received LMWH (JAMA 2015 Feb. 17;313:707-16).

Only 3.7% of the fondaparinux group suffered severe bleeding events or died in the hospital, compared with 5.5% of the heparin group (adjusted odds ratio, 0.67; 95% confidence interval, 0.58-0.78), the study found. Significant differences in bleeding and death rates persisted 30 days and 6 months after hospitalization, but rates of recurrent heart attack and stroke were similar between the treatment groups at all time points, the researchers said.

“This is not a randomized trial; therefore, residual confounding is very likely,” the investigators cautioned, adding that because the study used registry data, it probably underestimated bleeding events.

The work was funded by the Swedish Foundation for Strategic Research, the Swedish Heart and Lung Foundation, ALF Medicin, and the Swedish Medical Research Council. Dr. Szummer has received lecture fees from AstraZeneca. One coauthor reported financial relationships with GlaxoSmithKline, which markets fondaparinux. Other coauthors reported funding from numerous pharmaceutical companies.

Patient receives chemotherapy

Photo by Rhoda Baer

SAN DIGEO—A phase 3 study comparing conditioning regimens in multiple myeloma patients undergoing autologous transplant has yielded counterintuitive results.

Patients who received busulfan plus melphalan (bu-mel) had a lower complete response (CR) rate at 90 days and a higher rate of grade 3-4 non-hematologic

toxicity, compared to patients who received melphalan (mel) alone.

However, patients in the bu-mel arm enjoyed significantly longer progression-free survival (PFS).

These results suggest the rate of CR at 90 days is not a good endpoint for trials of autologous hematopoietic stem cell transplant (auto-HSCT), said Muzaffar H.

Qazilbash, MD, of The University of Texas MD Anderson Cancer Center in Houston.

Dr Qazilbash presented these and other findings at the 2015 BMT Tandem Meetings as abstract 83.*

“High-dose melphalan at 200 mg/m² is considered the standard of care for autologous stem cell transplantation for multiple myeloma,” he said. “However, most patients have disease recurrence or progression after an autologous transplant, even with the use of post-transplant maintenance.”

A recent retrospective study suggested that bu-mel might be associated with a longer PFS compared to mel alone. So Dr Qazilbash and his colleagues decided to

investigate that possibility in a randomized, phase 3 trial.

The trial included 92 patients with symptomatic multiple myeloma who had received at least 2 cycles of induction therapy. They were all within 12 months of the start of induction, and all had adequate cardiac, pulmonary, renal, and liver function.

Forty-nine patients received bu-mel—a 130 mg/m² daily infusion of busulfan for 4 days, followed by 2 daily doses of melphalan at 70 mg/m². All patients in this arm also received phenytoin for seizure prophylaxis. The 43 patients in the mel-only arm received a single dose of melphalan at 200 mg/m².

Baseline characteristics were similar between the 2 arms. The patients’ median ages were 58 in the bu-mel arm and 59 in the mel arm. At the time of transplant, 18% of patients in the bu-mel arm were in CR or near CR, as were 28% of patients in the mel arm.

Adverse events

At 100 days post-transplant, the transplant-related mortality was 0% in both arms.

“There was a significantly higher rate of grade 3-4 non-hematologic adverse events in the busulfan-plus-melphalan arm—78% vs 47% [P=0.002],” Dr Qazilbash noted. “And these adverse events were mostly infectious events.”

Grade 3 infection occurred in 71% of bu-mel-treated patients and 39% of mel-treated patients (P=0.003). Grade 2 gastrointestinal toxicities occurred in 69% and 48%, respectively (P=0.05).

There were no significant differences between the arms with regard to other adverse events. And there were no second primary malignancies in either arm.

Response

At 90 days, the CR rate was 16% in the bu-mel arm and 35% in the mel arm (P=0.05). The rates of CR plus very good partial response were 63% and 81%, respectively (P=0.06).

“The trial was stopped early, based on a prescribed rule in the trial design, because of a significantly higher CR rate in the control arm,” Dr Qazilbash said.

Still, he noted that, at 180 days, the CR rate was 26% in the bu-mel arm and 37% in the mel arm (P=0.36). And the 180-day rates of CR plus very good

partial response were 69% and 86%, respectively (P=0.65).

Maintenance

A majority of patients received maintenance therapy post-transplant—84% of patients in the bu-mel arm and 88% in the mel arm.

The median interval between auto-HSCT and maintenance was 4.6 months and 4.5 months, respectively. And the median duration of maintenance was 16 months and 14.2 months, respectively.

Maintenance largely consisted of lenalidomide. Sixty-five percent of patients in the bu-mel arm and 63% in the mel arm received the drug. Fewer patients received bortezomib—8% and 16%, respectively—or lenalidomide plus ixazomib—10% and 9%, respectively.

Survival

At a median follow-up of 19.5 months, bu-mel was associated with significantly longer PFS than mel alone (P=0.047). And a multivariate analysis showed that bu-mel was an independent predictor of PFS.

Dr Qazilbash noted that there was no significant difference in overall survival between the bu-mel and mel arms (P=0.97), but the follow-up is less than 2 years, so this is expected.

“Bu-mel was associated with a significantly lower day 90 CR rate, a significantly higher rate of grade 3-4 non-hematologic toxicity, no significant difference in transplant-related mortality . . . , and a significantly longer PFS,” Dr Qazilbash summarized.

He therefore concluded that, based on this study, day 90 CR is not an adequate endpoint for auto-HSCT trials. This trial was amended to change the primary

endpoint from day 90 CR to PFS, and accrual has been increased to 205 patients.

Dr Qazilbash and others involved in this study received research funding from Otsuka, makers of busulfan. Dr Qazilbash also reported relationships (advisory

board, honoraria) with Celgene, Millennium, and Onyx.

*Information in the abstract differs from that presented at the meeting.

Patient receives chemotherapy

Photo by Rhoda Baer

SAN DIGEO—A phase 3 study comparing conditioning regimens in multiple myeloma patients undergoing autologous transplant has yielded counterintuitive results.

Patients who received busulfan plus melphalan (bu-mel) had a lower complete response (CR) rate at 90 days and a higher rate of grade 3-4 non-hematologic

toxicity, compared to patients who received melphalan (mel) alone.

However, patients in the bu-mel arm enjoyed significantly longer progression-free survival (PFS).

These results suggest the rate of CR at 90 days is not a good endpoint for trials of autologous hematopoietic stem cell transplant (auto-HSCT), said Muzaffar H.

Qazilbash, MD, of The University of Texas MD Anderson Cancer Center in Houston.

Dr Qazilbash presented these and other findings at the 2015 BMT Tandem Meetings as abstract 83.*

“High-dose melphalan at 200 mg/m² is considered the standard of care for autologous stem cell transplantation for multiple myeloma,” he said. “However, most patients have disease recurrence or progression after an autologous transplant, even with the use of post-transplant maintenance.”

A recent retrospective study suggested that bu-mel might be associated with a longer PFS compared to mel alone. So Dr Qazilbash and his colleagues decided to

investigate that possibility in a randomized, phase 3 trial.

The trial included 92 patients with symptomatic multiple myeloma who had received at least 2 cycles of induction therapy. They were all within 12 months of the start of induction, and all had adequate cardiac, pulmonary, renal, and liver function.

Forty-nine patients received bu-mel—a 130 mg/m² daily infusion of busulfan for 4 days, followed by 2 daily doses of melphalan at 70 mg/m². All patients in this arm also received phenytoin for seizure prophylaxis. The 43 patients in the mel-only arm received a single dose of melphalan at 200 mg/m².

Baseline characteristics were similar between the 2 arms. The patients’ median ages were 58 in the bu-mel arm and 59 in the mel arm. At the time of transplant, 18% of patients in the bu-mel arm were in CR or near CR, as were 28% of patients in the mel arm.

Adverse events

At 100 days post-transplant, the transplant-related mortality was 0% in both arms.

“There was a significantly higher rate of grade 3-4 non-hematologic adverse events in the busulfan-plus-melphalan arm—78% vs 47% [P=0.002],” Dr Qazilbash noted. “And these adverse events were mostly infectious events.”

Grade 3 infection occurred in 71% of bu-mel-treated patients and 39% of mel-treated patients (P=0.003). Grade 2 gastrointestinal toxicities occurred in 69% and 48%, respectively (P=0.05).

There were no significant differences between the arms with regard to other adverse events. And there were no second primary malignancies in either arm.

Response

At 90 days, the CR rate was 16% in the bu-mel arm and 35% in the mel arm (P=0.05). The rates of CR plus very good partial response were 63% and 81%, respectively (P=0.06).

“The trial was stopped early, based on a prescribed rule in the trial design, because of a significantly higher CR rate in the control arm,” Dr Qazilbash said.

Still, he noted that, at 180 days, the CR rate was 26% in the bu-mel arm and 37% in the mel arm (P=0.36). And the 180-day rates of CR plus very good

partial response were 69% and 86%, respectively (P=0.65).

Maintenance

A majority of patients received maintenance therapy post-transplant—84% of patients in the bu-mel arm and 88% in the mel arm.

The median interval between auto-HSCT and maintenance was 4.6 months and 4.5 months, respectively. And the median duration of maintenance was 16 months and 14.2 months, respectively.

Maintenance largely consisted of lenalidomide. Sixty-five percent of patients in the bu-mel arm and 63% in the mel arm received the drug. Fewer patients received bortezomib—8% and 16%, respectively—or lenalidomide plus ixazomib—10% and 9%, respectively.

Survival

At a median follow-up of 19.5 months, bu-mel was associated with significantly longer PFS than mel alone (P=0.047). And a multivariate analysis showed that bu-mel was an independent predictor of PFS.

Dr Qazilbash noted that there was no significant difference in overall survival between the bu-mel and mel arms (P=0.97), but the follow-up is less than 2 years, so this is expected.

“Bu-mel was associated with a significantly lower day 90 CR rate, a significantly higher rate of grade 3-4 non-hematologic toxicity, no significant difference in transplant-related mortality . . . , and a significantly longer PFS,” Dr Qazilbash summarized.

He therefore concluded that, based on this study, day 90 CR is not an adequate endpoint for auto-HSCT trials. This trial was amended to change the primary

endpoint from day 90 CR to PFS, and accrual has been increased to 205 patients.

Dr Qazilbash and others involved in this study received research funding from Otsuka, makers of busulfan. Dr Qazilbash also reported relationships (advisory

board, honoraria) with Celgene, Millennium, and Onyx.

*Information in the abstract differs from that presented at the meeting.

Patient receives chemotherapy

Photo by Rhoda Baer

SAN DIGEO—A phase 3 study comparing conditioning regimens in multiple myeloma patients undergoing autologous transplant has yielded counterintuitive results.

Patients who received busulfan plus melphalan (bu-mel) had a lower complete response (CR) rate at 90 days and a higher rate of grade 3-4 non-hematologic

toxicity, compared to patients who received melphalan (mel) alone.

However, patients in the bu-mel arm enjoyed significantly longer progression-free survival (PFS).

These results suggest the rate of CR at 90 days is not a good endpoint for trials of autologous hematopoietic stem cell transplant (auto-HSCT), said Muzaffar H.

Qazilbash, MD, of The University of Texas MD Anderson Cancer Center in Houston.

Dr Qazilbash presented these and other findings at the 2015 BMT Tandem Meetings as abstract 83.*

“High-dose melphalan at 200 mg/m² is considered the standard of care for autologous stem cell transplantation for multiple myeloma,” he said. “However, most patients have disease recurrence or progression after an autologous transplant, even with the use of post-transplant maintenance.”

A recent retrospective study suggested that bu-mel might be associated with a longer PFS compared to mel alone. So Dr Qazilbash and his colleagues decided to

investigate that possibility in a randomized, phase 3 trial.

The trial included 92 patients with symptomatic multiple myeloma who had received at least 2 cycles of induction therapy. They were all within 12 months of the start of induction, and all had adequate cardiac, pulmonary, renal, and liver function.

Forty-nine patients received bu-mel—a 130 mg/m² daily infusion of busulfan for 4 days, followed by 2 daily doses of melphalan at 70 mg/m². All patients in this arm also received phenytoin for seizure prophylaxis. The 43 patients in the mel-only arm received a single dose of melphalan at 200 mg/m².

Baseline characteristics were similar between the 2 arms. The patients’ median ages were 58 in the bu-mel arm and 59 in the mel arm. At the time of transplant, 18% of patients in the bu-mel arm were in CR or near CR, as were 28% of patients in the mel arm.

Adverse events

At 100 days post-transplant, the transplant-related mortality was 0% in both arms.

“There was a significantly higher rate of grade 3-4 non-hematologic adverse events in the busulfan-plus-melphalan arm—78% vs 47% [P=0.002],” Dr Qazilbash noted. “And these adverse events were mostly infectious events.”

Grade 3 infection occurred in 71% of bu-mel-treated patients and 39% of mel-treated patients (P=0.003). Grade 2 gastrointestinal toxicities occurred in 69% and 48%, respectively (P=0.05).

There were no significant differences between the arms with regard to other adverse events. And there were no second primary malignancies in either arm.

Response

At 90 days, the CR rate was 16% in the bu-mel arm and 35% in the mel arm (P=0.05). The rates of CR plus very good partial response were 63% and 81%, respectively (P=0.06).

“The trial was stopped early, based on a prescribed rule in the trial design, because of a significantly higher CR rate in the control arm,” Dr Qazilbash said.

Still, he noted that, at 180 days, the CR rate was 26% in the bu-mel arm and 37% in the mel arm (P=0.36). And the 180-day rates of CR plus very good

partial response were 69% and 86%, respectively (P=0.65).

Maintenance

A majority of patients received maintenance therapy post-transplant—84% of patients in the bu-mel arm and 88% in the mel arm.

The median interval between auto-HSCT and maintenance was 4.6 months and 4.5 months, respectively. And the median duration of maintenance was 16 months and 14.2 months, respectively.

Maintenance largely consisted of lenalidomide. Sixty-five percent of patients in the bu-mel arm and 63% in the mel arm received the drug. Fewer patients received bortezomib—8% and 16%, respectively—or lenalidomide plus ixazomib—10% and 9%, respectively.

Survival

At a median follow-up of 19.5 months, bu-mel was associated with significantly longer PFS than mel alone (P=0.047). And a multivariate analysis showed that bu-mel was an independent predictor of PFS.

Dr Qazilbash noted that there was no significant difference in overall survival between the bu-mel and mel arms (P=0.97), but the follow-up is less than 2 years, so this is expected.

“Bu-mel was associated with a significantly lower day 90 CR rate, a significantly higher rate of grade 3-4 non-hematologic toxicity, no significant difference in transplant-related mortality . . . , and a significantly longer PFS,” Dr Qazilbash summarized.

He therefore concluded that, based on this study, day 90 CR is not an adequate endpoint for auto-HSCT trials. This trial was amended to change the primary

endpoint from day 90 CR to PFS, and accrual has been increased to 205 patients.

Dr Qazilbash and others involved in this study received research funding from Otsuka, makers of busulfan. Dr Qazilbash also reported relationships (advisory

board, honoraria) with Celgene, Millennium, and Onyx.

*Information in the abstract differs from that presented at the meeting.

Diffuse large B-cell lymphoma

Researchers say they have developed a method that simulates Epstein-Barr virus (EBV) infection, and the immune cells that are activated as a result can kill non-Hodgkin lymphoma cells efficiently.

The team made use of antibodies that exhibit a piece of viral protein. The antibodies contain binding sites that target molecules on the surface of lymphoma cells.

The researchers used genetic engineering methods to fuse protein pieces of EBV to the “rear” end of the antibody protein.

As exposure to EBV is common, many people already have memory T cells that can mount a rapid immune response upon a new encounter with this pathogen.

The antibodies attach to the cancerous B cells and are subsequently engulfed into the cell interior. There, the antibody protein is degraded, and the individual fragments are presented by molecules on the surface of the cancer cells.

As a result, the viral protein is also exhibited on the cell surface, thus making it look like an EBV infection to the immune system.

The researchers found that T cells effectively killed the “infected” lymphoma cells in vitro. In blood cells from individuals who had been infected with EBV in the past, the antigen-armed antibodies successfully activated memory T cells.

“This is a clear indication that our antigen-armed antibodies can also induce an immune response against lymphoma cells in a living organism,” said study author Henri-Jacques Delecluse, MD, PhD, of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) in Heidelberg.

To activate the immune system in as many people as possible, Dr Delecluse and his colleagues also inserted larger pieces of EBV proteins into their antibodies.

Depending on a person’s genetic makeup, the cells could then cut out various smaller protein segments and present them on their surface.

“A problem with antibody-based cancer therapies is that the tumor cells make the surface molecule targeted by the antibody disappear from their surface,” Dr Delecluse said. “To prevent this situation, we used a mixture of antibodies that target 4 different B-cell surface molecules.”

For more details, see the researchers’ article in Blood.

Diffuse large B-cell lymphoma

Researchers say they have developed a method that simulates Epstein-Barr virus (EBV) infection, and the immune cells that are activated as a result can kill non-Hodgkin lymphoma cells efficiently.

The team made use of antibodies that exhibit a piece of viral protein. The antibodies contain binding sites that target molecules on the surface of lymphoma cells.

The researchers used genetic engineering methods to fuse protein pieces of EBV to the “rear” end of the antibody protein.

As exposure to EBV is common, many people already have memory T cells that can mount a rapid immune response upon a new encounter with this pathogen.

The antibodies attach to the cancerous B cells and are subsequently engulfed into the cell interior. There, the antibody protein is degraded, and the individual fragments are presented by molecules on the surface of the cancer cells.

As a result, the viral protein is also exhibited on the cell surface, thus making it look like an EBV infection to the immune system.

The researchers found that T cells effectively killed the “infected” lymphoma cells in vitro. In blood cells from individuals who had been infected with EBV in the past, the antigen-armed antibodies successfully activated memory T cells.

“This is a clear indication that our antigen-armed antibodies can also induce an immune response against lymphoma cells in a living organism,” said study author Henri-Jacques Delecluse, MD, PhD, of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) in Heidelberg.

To activate the immune system in as many people as possible, Dr Delecluse and his colleagues also inserted larger pieces of EBV proteins into their antibodies.

Depending on a person’s genetic makeup, the cells could then cut out various smaller protein segments and present them on their surface.

“A problem with antibody-based cancer therapies is that the tumor cells make the surface molecule targeted by the antibody disappear from their surface,” Dr Delecluse said. “To prevent this situation, we used a mixture of antibodies that target 4 different B-cell surface molecules.”

For more details, see the researchers’ article in Blood.

Diffuse large B-cell lymphoma

Researchers say they have developed a method that simulates Epstein-Barr virus (EBV) infection, and the immune cells that are activated as a result can kill non-Hodgkin lymphoma cells efficiently.

The team made use of antibodies that exhibit a piece of viral protein. The antibodies contain binding sites that target molecules on the surface of lymphoma cells.

The researchers used genetic engineering methods to fuse protein pieces of EBV to the “rear” end of the antibody protein.

As exposure to EBV is common, many people already have memory T cells that can mount a rapid immune response upon a new encounter with this pathogen.

The antibodies attach to the cancerous B cells and are subsequently engulfed into the cell interior. There, the antibody protein is degraded, and the individual fragments are presented by molecules on the surface of the cancer cells.

As a result, the viral protein is also exhibited on the cell surface, thus making it look like an EBV infection to the immune system.

The researchers found that T cells effectively killed the “infected” lymphoma cells in vitro. In blood cells from individuals who had been infected with EBV in the past, the antigen-armed antibodies successfully activated memory T cells.

“This is a clear indication that our antigen-armed antibodies can also induce an immune response against lymphoma cells in a living organism,” said study author Henri-Jacques Delecluse, MD, PhD, of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) in Heidelberg.

To activate the immune system in as many people as possible, Dr Delecluse and his colleagues also inserted larger pieces of EBV proteins into their antibodies.

Depending on a person’s genetic makeup, the cells could then cut out various smaller protein segments and present them on their surface.

“A problem with antibody-based cancer therapies is that the tumor cells make the surface molecule targeted by the antibody disappear from their surface,” Dr Delecluse said. “To prevent this situation, we used a mixture of antibodies that target 4 different B-cell surface molecules.”

For more details, see the researchers’ article in Blood.