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Physicians need to take hyperhidrosis in teens seriously
ORLANDO – Not quite a fifth of teens experience excessive, uncontrollable sweating, according to the results of an online survey presented during this year’s annual American Academy of Dermatology.
Because nearly 70% of teens who reported the condition said it interferes with their activities of daily living, late-breaking research presenter, Adelaide A. Hebert, MD, chief of pediatric dermatology at the University of Texas, Houston, said it was time medical schools paid more attention to it.
For the study, Dr. Hebert and her colleagues online-surveyed 1,000 adolescents between 12 and 17 years who meet the accepted diagnostic criteria for primary focal hyperhidrosis. An analysis of the 981 surveys that were complete showed that 17.1% of respondents experienced excessive, uncontrollable sweating and that 68.6% of these reported the sweating was moderate or major, impairing their normal functioning.
The average age of onset for the condition was 11 years, although more than a quarter of respondents said their sweating began at age 10 years. Nearly all those surveyed said they sweat from at least two focal areas, with five areas being the average number of focal areas.
Adolescence is when hyperhidrosis begins for many adults with the condition, yet few if any data exist regarding the condition in this age group, according to Dr. Hebert. “We have to figure out what is going on so maybe we can make a difference later.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Not quite a fifth of teens experience excessive, uncontrollable sweating, according to the results of an online survey presented during this year’s annual American Academy of Dermatology.
Because nearly 70% of teens who reported the condition said it interferes with their activities of daily living, late-breaking research presenter, Adelaide A. Hebert, MD, chief of pediatric dermatology at the University of Texas, Houston, said it was time medical schools paid more attention to it.
For the study, Dr. Hebert and her colleagues online-surveyed 1,000 adolescents between 12 and 17 years who meet the accepted diagnostic criteria for primary focal hyperhidrosis. An analysis of the 981 surveys that were complete showed that 17.1% of respondents experienced excessive, uncontrollable sweating and that 68.6% of these reported the sweating was moderate or major, impairing their normal functioning.
The average age of onset for the condition was 11 years, although more than a quarter of respondents said their sweating began at age 10 years. Nearly all those surveyed said they sweat from at least two focal areas, with five areas being the average number of focal areas.
Adolescence is when hyperhidrosis begins for many adults with the condition, yet few if any data exist regarding the condition in this age group, according to Dr. Hebert. “We have to figure out what is going on so maybe we can make a difference later.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Not quite a fifth of teens experience excessive, uncontrollable sweating, according to the results of an online survey presented during this year’s annual American Academy of Dermatology.
Because nearly 70% of teens who reported the condition said it interferes with their activities of daily living, late-breaking research presenter, Adelaide A. Hebert, MD, chief of pediatric dermatology at the University of Texas, Houston, said it was time medical schools paid more attention to it.
For the study, Dr. Hebert and her colleagues online-surveyed 1,000 adolescents between 12 and 17 years who meet the accepted diagnostic criteria for primary focal hyperhidrosis. An analysis of the 981 surveys that were complete showed that 17.1% of respondents experienced excessive, uncontrollable sweating and that 68.6% of these reported the sweating was moderate or major, impairing their normal functioning.
The average age of onset for the condition was 11 years, although more than a quarter of respondents said their sweating began at age 10 years. Nearly all those surveyed said they sweat from at least two focal areas, with five areas being the average number of focal areas.
Adolescence is when hyperhidrosis begins for many adults with the condition, yet few if any data exist regarding the condition in this age group, according to Dr. Hebert. “We have to figure out what is going on so maybe we can make a difference later.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT AAD 17
Key clinical point:
Major finding: Hyperhidrosis is common in 17% of teens surveyed; 69% of these reported hyperhidrosis interferes with activities of daily living.
Data source: Online survey of 1,000 U.S. teens between 12 and 17 years who reported excessive, uncontrollable sweating.
Disclosures: Dr. Hebert received a grant from GlaxoSmithKline for this study. She is also a board member of the International Hyperhidrosis Society.
Teletriage app reduced skin specialty care wait times
ORLANDO – A teletriage app significantly reduced the time between triage and evaluation by a dermatologist, helping a volunteer-staffed clinic for the uninsured see more patients and improve rates of accurate diagnosis and treatment.
Peter Chansky, a medical student at the University of Pennsylvania, Philadelphia, presented the data on a study of the app during a late-breaking research session at this year’s annual meeting of the American Academy of Dermatology.
The teletriage app AccessDerm, which is free to all AAD members, uses a photo of the dermatological condition, along with basic clinical and demographic information. The investigators found that with the app, the mean time from referral to teledermatology response was 1.4 days vs. 13.4 days for waiting to be seen in the next dermatology clinic (P less than .0001). Additionally, because the app requires the referring physicians to enter a differential diagnosis and a suggested treatment plan, it was established that diagnoses improved with teledermatology. Compared with self-reported primary care provider plans, the app led to an altered course of treatment in 95% of cases.
In all, 70% of cases were triaged via teledermatology without the need for an in-person evaluation, resulting in an average of 1.4 out of 8 appointments being saved monthly. This allowed the clinic to treat 18% more patients who needed in-person care, according to Mr. Chansky.
“Teletriage can be easily implemented in an underserved clinical setting, and provides an opportunity for dermatologists to make a significant and meaningful impact on the health care and outcomes of underserved populations,” Mr. Chansky said.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – A teletriage app significantly reduced the time between triage and evaluation by a dermatologist, helping a volunteer-staffed clinic for the uninsured see more patients and improve rates of accurate diagnosis and treatment.
Peter Chansky, a medical student at the University of Pennsylvania, Philadelphia, presented the data on a study of the app during a late-breaking research session at this year’s annual meeting of the American Academy of Dermatology.
The teletriage app AccessDerm, which is free to all AAD members, uses a photo of the dermatological condition, along with basic clinical and demographic information. The investigators found that with the app, the mean time from referral to teledermatology response was 1.4 days vs. 13.4 days for waiting to be seen in the next dermatology clinic (P less than .0001). Additionally, because the app requires the referring physicians to enter a differential diagnosis and a suggested treatment plan, it was established that diagnoses improved with teledermatology. Compared with self-reported primary care provider plans, the app led to an altered course of treatment in 95% of cases.
In all, 70% of cases were triaged via teledermatology without the need for an in-person evaluation, resulting in an average of 1.4 out of 8 appointments being saved monthly. This allowed the clinic to treat 18% more patients who needed in-person care, according to Mr. Chansky.
“Teletriage can be easily implemented in an underserved clinical setting, and provides an opportunity for dermatologists to make a significant and meaningful impact on the health care and outcomes of underserved populations,” Mr. Chansky said.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – A teletriage app significantly reduced the time between triage and evaluation by a dermatologist, helping a volunteer-staffed clinic for the uninsured see more patients and improve rates of accurate diagnosis and treatment.
Peter Chansky, a medical student at the University of Pennsylvania, Philadelphia, presented the data on a study of the app during a late-breaking research session at this year’s annual meeting of the American Academy of Dermatology.
The teletriage app AccessDerm, which is free to all AAD members, uses a photo of the dermatological condition, along with basic clinical and demographic information. The investigators found that with the app, the mean time from referral to teledermatology response was 1.4 days vs. 13.4 days for waiting to be seen in the next dermatology clinic (P less than .0001). Additionally, because the app requires the referring physicians to enter a differential diagnosis and a suggested treatment plan, it was established that diagnoses improved with teledermatology. Compared with self-reported primary care provider plans, the app led to an altered course of treatment in 95% of cases.
In all, 70% of cases were triaged via teledermatology without the need for an in-person evaluation, resulting in an average of 1.4 out of 8 appointments being saved monthly. This allowed the clinic to treat 18% more patients who needed in-person care, according to Mr. Chansky.
“Teletriage can be easily implemented in an underserved clinical setting, and provides an opportunity for dermatologists to make a significant and meaningful impact on the health care and outcomes of underserved populations,” Mr. Chansky said.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT AAD 17
VIDEO: Don’t overlook psychosocial concerns of vitiligo patients
ORLANDO – There are ways to assess the psychosocial needs of your patients with vitiligo, even if you don’t believe you have the necessary skills to do a complete mental health work-up, according to Seemal R. Desai, MD.
In an interview recorded at this year’s annual meeting of the American Academy of Dermatology, Dr. Desai, an assistant clinical professor of dermatology at the University of Texas, Dallas, shares his ideas for how to have casual conversations with patients that can help reveal important clues to psychosocial stress patients with this serious medical skin condition might be facing.
“There are subtle clues to look for to know that these patients are uncomfortable with others seeing their skin,” says Dr. Desai.
In the video interview, he also covers taking a multidisciplinary approach to caring for these patients, what treatments are available to those who are suffering psychosocial stress after having failed several interventions, and how patients from many Asian and African counties are especially at risk for ostracization.
“It’s important to let your patients know that you understand this is really affecting them psychosocially, and that you care,” says Dr. Desai.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – There are ways to assess the psychosocial needs of your patients with vitiligo, even if you don’t believe you have the necessary skills to do a complete mental health work-up, according to Seemal R. Desai, MD.
In an interview recorded at this year’s annual meeting of the American Academy of Dermatology, Dr. Desai, an assistant clinical professor of dermatology at the University of Texas, Dallas, shares his ideas for how to have casual conversations with patients that can help reveal important clues to psychosocial stress patients with this serious medical skin condition might be facing.
“There are subtle clues to look for to know that these patients are uncomfortable with others seeing their skin,” says Dr. Desai.
In the video interview, he also covers taking a multidisciplinary approach to caring for these patients, what treatments are available to those who are suffering psychosocial stress after having failed several interventions, and how patients from many Asian and African counties are especially at risk for ostracization.
“It’s important to let your patients know that you understand this is really affecting them psychosocially, and that you care,” says Dr. Desai.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – There are ways to assess the psychosocial needs of your patients with vitiligo, even if you don’t believe you have the necessary skills to do a complete mental health work-up, according to Seemal R. Desai, MD.
In an interview recorded at this year’s annual meeting of the American Academy of Dermatology, Dr. Desai, an assistant clinical professor of dermatology at the University of Texas, Dallas, shares his ideas for how to have casual conversations with patients that can help reveal important clues to psychosocial stress patients with this serious medical skin condition might be facing.
“There are subtle clues to look for to know that these patients are uncomfortable with others seeing their skin,” says Dr. Desai.
In the video interview, he also covers taking a multidisciplinary approach to caring for these patients, what treatments are available to those who are suffering psychosocial stress after having failed several interventions, and how patients from many Asian and African counties are especially at risk for ostracization.
“It’s important to let your patients know that you understand this is really affecting them psychosocially, and that you care,” says Dr. Desai.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM AAD 17
Long-term peanut sublingual immunotherapy found safe
ATLANTA – Peanut sublingual immunotherapy induces clinically significant desensitization in the majority of subjects and can induce sustained unresponsiveness in a subset of children treated for 36-60 months, results from a small study suggest.
“Sublingual immunotherapy [SLIT] is an easy-to-administer treatment that appears to be safe, and with extended treatment, may provide a clinically significant amount of protection with the potential for a lasting effect,” one of the study authors, Edwin H. Kim, MD, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
To find out, the researchers treated 37 patients with 2 mg of peanut SLIT for 36-60 months and then assessed a 5,000-mg peanut oral food challenge to further assess desensitization. Those who passed the challenge discontinued SLIT for 2-4 weeks and were then re-challenged with 5,000 mg of peanut protein to assess for sustained unresponsiveness.
“Existing data suggested that about 50% of patients on oral immunotherapy develop sustained unresponsiveness, which was defined by being able to tolerate the same full amount of peanut 1 month after stopping therapy,” Dr. Kim said. “As the assumption was that SLIT would have a more modest effect, it was unclear if any patients at all on SLIT would develop sustained unresponsiveness.”
Of the 37 subjects who completed the study, 32 (86%) safely ingested more than 300 mg of peanut and 12 (32%) passed the oral food challenge at the end of SLIT therapy. The median amount of peanut tolerated was 1,750 mg (compared with 1,710 mg in the original 12-month paper). The 12 subjects who passed the oral food challenge were re-challenged with 5,000 mg of peanut 2-4 weeks after discontinuing SLIT. Of these, 10 (27%) demonstrated sustained unresponsiveness. Dr. Kim characterized the results as “better than we would have expected.”
He acknowledged certain limitations to the study, including the lack of an entry food challenge to determine a baseline reaction threshold and the lack of a placebo arm for the study’s extended maintenance phase.
Dr. Kim reported having no financial disclosures.
dbrunk@frontlinemedcom.com
ATLANTA – Peanut sublingual immunotherapy induces clinically significant desensitization in the majority of subjects and can induce sustained unresponsiveness in a subset of children treated for 36-60 months, results from a small study suggest.
“Sublingual immunotherapy [SLIT] is an easy-to-administer treatment that appears to be safe, and with extended treatment, may provide a clinically significant amount of protection with the potential for a lasting effect,” one of the study authors, Edwin H. Kim, MD, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
To find out, the researchers treated 37 patients with 2 mg of peanut SLIT for 36-60 months and then assessed a 5,000-mg peanut oral food challenge to further assess desensitization. Those who passed the challenge discontinued SLIT for 2-4 weeks and were then re-challenged with 5,000 mg of peanut protein to assess for sustained unresponsiveness.
“Existing data suggested that about 50% of patients on oral immunotherapy develop sustained unresponsiveness, which was defined by being able to tolerate the same full amount of peanut 1 month after stopping therapy,” Dr. Kim said. “As the assumption was that SLIT would have a more modest effect, it was unclear if any patients at all on SLIT would develop sustained unresponsiveness.”
Of the 37 subjects who completed the study, 32 (86%) safely ingested more than 300 mg of peanut and 12 (32%) passed the oral food challenge at the end of SLIT therapy. The median amount of peanut tolerated was 1,750 mg (compared with 1,710 mg in the original 12-month paper). The 12 subjects who passed the oral food challenge were re-challenged with 5,000 mg of peanut 2-4 weeks after discontinuing SLIT. Of these, 10 (27%) demonstrated sustained unresponsiveness. Dr. Kim characterized the results as “better than we would have expected.”
He acknowledged certain limitations to the study, including the lack of an entry food challenge to determine a baseline reaction threshold and the lack of a placebo arm for the study’s extended maintenance phase.
Dr. Kim reported having no financial disclosures.
dbrunk@frontlinemedcom.com
ATLANTA – Peanut sublingual immunotherapy induces clinically significant desensitization in the majority of subjects and can induce sustained unresponsiveness in a subset of children treated for 36-60 months, results from a small study suggest.
“Sublingual immunotherapy [SLIT] is an easy-to-administer treatment that appears to be safe, and with extended treatment, may provide a clinically significant amount of protection with the potential for a lasting effect,” one of the study authors, Edwin H. Kim, MD, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
To find out, the researchers treated 37 patients with 2 mg of peanut SLIT for 36-60 months and then assessed a 5,000-mg peanut oral food challenge to further assess desensitization. Those who passed the challenge discontinued SLIT for 2-4 weeks and were then re-challenged with 5,000 mg of peanut protein to assess for sustained unresponsiveness.
“Existing data suggested that about 50% of patients on oral immunotherapy develop sustained unresponsiveness, which was defined by being able to tolerate the same full amount of peanut 1 month after stopping therapy,” Dr. Kim said. “As the assumption was that SLIT would have a more modest effect, it was unclear if any patients at all on SLIT would develop sustained unresponsiveness.”
Of the 37 subjects who completed the study, 32 (86%) safely ingested more than 300 mg of peanut and 12 (32%) passed the oral food challenge at the end of SLIT therapy. The median amount of peanut tolerated was 1,750 mg (compared with 1,710 mg in the original 12-month paper). The 12 subjects who passed the oral food challenge were re-challenged with 5,000 mg of peanut 2-4 weeks after discontinuing SLIT. Of these, 10 (27%) demonstrated sustained unresponsiveness. Dr. Kim characterized the results as “better than we would have expected.”
He acknowledged certain limitations to the study, including the lack of an entry food challenge to determine a baseline reaction threshold and the lack of a placebo arm for the study’s extended maintenance phase.
Dr. Kim reported having no financial disclosures.
dbrunk@frontlinemedcom.com
AT THE 2017 AAAAI ANNUAL MEETING
Key clinical point:
Major finding: Of the children who completed the study, 86% safely ingested more than 300 mg of peanut and 32% passed the oral food challenge at the end of SLIT therapy.
Data source: A study of 37 patients who were treated with 2 mg of peanut SLIT for 36-60 months.
Disclosures: Dr. Kim reported having no financial disclosures.
CIMPASI-1 and -2 show certolizumab pegol benefits patients with severe plaque psoriasis
ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
ORLANDO – Results from two phase III trials indicated the tumor necrosis factor alpha inhibitor certolizumab pegol led to significant improvements in moderate to severe chronic plaque psoriasis, compared with placebo, according to an oral presentation at this year’s annual Academy of Dermatology Meeting.
Across the CIMPASI-1 and CIMPASI-2 trials, at 16 weeks, both certolizumab pegol (Cimzia) 400 mg and 200 mg, administered subcutaneously every 2 weeks in groups of patients with moderate to severe chronic plaque psoriasis, demonstrated statistically significant, clinically meaningful improvements in Psoriasis Area and Severity Index (PASI) scores, and on the Physician Global Assessment (PGA) scores, when compared with placebo. The data were presented by Alice B. Gottlieb, MD, PhD, professor of dermatology at New York Medical College, Valhalla. Certolizumab pegol currently is approved in the United States for use in psoriatic arthritis, but not for psoriasis.
In CIMPASI-1, 234 mostly white male patients in their mid-40s who had moderate to severe chronic plaque psoriasis were randomly assigned to one of three groups. There were 88 participants in the arm given 400 mg every 2 weeks at weeks 0, 2, and 4; 95 given 200 mg at weeks 0, 2, and 4; and 51 given placebo. At week 16, the percentage of patients who achieved a PASI 75 was 75.8% in the first group, 66.5% in the second, and 6.5% for placebo. A PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 57.9% for group 1, 47.0% for the second group, and 4.2% for placebo.
Also at week 16, the percentage of patients who achieved a PASI 90 was 43.6% in the 400 mg dose group, 35.8% in the 200 mg dose group, and 0.4% in the placebo group.
In CIMPASI-2, 227 mostly white patients with moderate to severe chronic plaque psoriasis, most of whom were in their mid-40s, evenly distributed across the sexes, were randomly assigned to one of three groups. There were 87 participants in the 400 mg every 2 weeks at weeks 0, 2, and 4 group; 91 in the 200 mg every 2 weeks at weeks 0, 2, and 4 arm, and 49 in the placebo group. At week 16, 82.6% of patients in the first group and 81.4% in the second group had a PASI 75, compared with 11.6% of the placebo group. Also at 16 weeks, a PGA scale improvement of at least two points over baseline toward a final score of clear or almost clear skin at week 16 was 71.6% for group 1, 66.8% for the second group, and 2.0% for placebo. At week 16, 55.4% of patients receiving the 400 mg dose had a PASI 90, as did 52.6% of patients receiving the 200 mg dose every 2 weeks, compared with only 4.5% of the placebo group.
Additionally, Dr. Gottlieb said that at week 16, patients in the 400-mg and 200-mg groups showed significant improvements over baseline Dermatology Life Quality Index (DLQI) average scores, compared with placebo: a 10.2 decrease in the 400-mg group and a 9.3 decrease in the 200-mg group, compared with a 3.3 decrease in the placebo arm (P less than .001) in the CIMPASI-1 study. In the CIMPASI-2 study at week 16, there was a drop of 10.0 DLQI in average scores in the 400-mg group, 10.4 in the 200-mg group, and an average drop of only 3.8 in controls (P less than .001).
Dr. Gottlieb, who disclosed that her mother suffers from severe plaque psoriasis, told the audience that the patient improvements were on par with those seen with infliximab, which she said was “the best anti–TNF alpha in the pack to date, and that’s an intravenous drug. These are impressive drops in the DLQI.”
Adverse events were, said Dr. Gottlieb, “a whole lot of nothing. There’s nothing that stands out.” She said there were no cases of tuberculosis, one case of vulvovaginal candidiasis, and equal distribution of herpes zoster across the study.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT AAD 17
Key clinical point:
Major finding: In CIMPASI-1, at week 16, the response rate for patients who achieved a PASI 75 was 75.8% in the 400-mg group, 66.5% in the 200-mg group, and 6.5% in the placebo group.
Data source: 461 adults with moderate to severe plaque arthritis randomly assigned to either 400 mg certolizumab pegol, 200 mg of the treatment, or placebo every other week at weeks 0, 2, and 4.
Disclosures: Dr. Gottlieb had relevant disclosures, including with Dermira and UCB, the sponsors of this trial.
Uptick found in severe allergy shot reactions
ATLANTA – Systemic reactions against subcutaneous allergen immunotherapy have trended down overall in recent years, but there has been an uptick in reports of severe grade 4 reactions for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.
The data come from annual surveys of members of the American Academy of Allergy, Asthma, and Immunology and of the American College of Allergy, Asthma, and Immunology, of whom 27%-51% responded each year.
However, on surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions (SRs) for 2014-2015 occurred in asthmatics. Among the three fatalities directly linked to allergy shots since 2008, all of them occurred in adults; two patients had asthma. The findings highlight the need for good asthma control before shots begin, with a forced expiratory volume of at least 70% in 1 second (J Allergy Clin Immunol. 2017 Feb;139[2]:AB377).
“Asthma remains a major risk factor for severe SRs... [It’s something] allergists need to be vigilant about,” said lead investigator Tolly Epstein, MD, an assistant professor of immunology at the University of Cincinnati.
It’s unclear if there has been a true increase in severe reactions, or simply better reporting of them since the reaction grading system started being used a few years ago. “I was surprised a little bit to see the uptick in severe systemic reactions, but I am not sure if it’s real yet,” Dr. Epstein said. She and her colleagues are collecting more data on the reports of severe reactions.
Dr. Epstein and her colleagues found in previous work that higher maintenance doses may increase the risk of SRs. The right balance between efficacy and safety is still being worked out, she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The surveys started collecting data on infections from allergy shots in 2014, amid concerns about contaminants in compounded medications. The fact that none were reported probably isn’t a surprise to allergists, but it might be news to others who have raised concerns about the possibility, Dr. Epstein said.
Overall safety was good for sublingual allergen immunotherapy, first approved by the Food and Drug Administration in 2014. One of the grade 3 reactions was pharyngeal edema; the other involved throat tightening and lower respiratory symptoms.
One of the asthma patients who died was morbidly obese and under treatment for weed allergies during pollen season, and died from overwhelming laryngeal edema. The patient’s weight made IV access difficult. The other asthma patient had severe disease, and was on the maximum dose of fluticasone/salmeterol. He was on an accelerated buildup for dust mites, pollen, mold, and other allergies, and apparently died of asthma complications triggered by the shots. There were no known risk factors in the third death.
Mortalities are lower than they used to be in the past with allergy shots, Dr. Epstein said.
She said she had no relevant disclosures.
aotto@frontlinemedcom.com
ATLANTA – Systemic reactions against subcutaneous allergen immunotherapy have trended down overall in recent years, but there has been an uptick in reports of severe grade 4 reactions for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.
The data come from annual surveys of members of the American Academy of Allergy, Asthma, and Immunology and of the American College of Allergy, Asthma, and Immunology, of whom 27%-51% responded each year.
However, on surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions (SRs) for 2014-2015 occurred in asthmatics. Among the three fatalities directly linked to allergy shots since 2008, all of them occurred in adults; two patients had asthma. The findings highlight the need for good asthma control before shots begin, with a forced expiratory volume of at least 70% in 1 second (J Allergy Clin Immunol. 2017 Feb;139[2]:AB377).
“Asthma remains a major risk factor for severe SRs... [It’s something] allergists need to be vigilant about,” said lead investigator Tolly Epstein, MD, an assistant professor of immunology at the University of Cincinnati.
It’s unclear if there has been a true increase in severe reactions, or simply better reporting of them since the reaction grading system started being used a few years ago. “I was surprised a little bit to see the uptick in severe systemic reactions, but I am not sure if it’s real yet,” Dr. Epstein said. She and her colleagues are collecting more data on the reports of severe reactions.
Dr. Epstein and her colleagues found in previous work that higher maintenance doses may increase the risk of SRs. The right balance between efficacy and safety is still being worked out, she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The surveys started collecting data on infections from allergy shots in 2014, amid concerns about contaminants in compounded medications. The fact that none were reported probably isn’t a surprise to allergists, but it might be news to others who have raised concerns about the possibility, Dr. Epstein said.
Overall safety was good for sublingual allergen immunotherapy, first approved by the Food and Drug Administration in 2014. One of the grade 3 reactions was pharyngeal edema; the other involved throat tightening and lower respiratory symptoms.
One of the asthma patients who died was morbidly obese and under treatment for weed allergies during pollen season, and died from overwhelming laryngeal edema. The patient’s weight made IV access difficult. The other asthma patient had severe disease, and was on the maximum dose of fluticasone/salmeterol. He was on an accelerated buildup for dust mites, pollen, mold, and other allergies, and apparently died of asthma complications triggered by the shots. There were no known risk factors in the third death.
Mortalities are lower than they used to be in the past with allergy shots, Dr. Epstein said.
She said she had no relevant disclosures.
aotto@frontlinemedcom.com
ATLANTA – Systemic reactions against subcutaneous allergen immunotherapy have trended down overall in recent years, but there has been an uptick in reports of severe grade 4 reactions for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.
The data come from annual surveys of members of the American Academy of Allergy, Asthma, and Immunology and of the American College of Allergy, Asthma, and Immunology, of whom 27%-51% responded each year.
However, on surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions (SRs) for 2014-2015 occurred in asthmatics. Among the three fatalities directly linked to allergy shots since 2008, all of them occurred in adults; two patients had asthma. The findings highlight the need for good asthma control before shots begin, with a forced expiratory volume of at least 70% in 1 second (J Allergy Clin Immunol. 2017 Feb;139[2]:AB377).
“Asthma remains a major risk factor for severe SRs... [It’s something] allergists need to be vigilant about,” said lead investigator Tolly Epstein, MD, an assistant professor of immunology at the University of Cincinnati.
It’s unclear if there has been a true increase in severe reactions, or simply better reporting of them since the reaction grading system started being used a few years ago. “I was surprised a little bit to see the uptick in severe systemic reactions, but I am not sure if it’s real yet,” Dr. Epstein said. She and her colleagues are collecting more data on the reports of severe reactions.
Dr. Epstein and her colleagues found in previous work that higher maintenance doses may increase the risk of SRs. The right balance between efficacy and safety is still being worked out, she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The surveys started collecting data on infections from allergy shots in 2014, amid concerns about contaminants in compounded medications. The fact that none were reported probably isn’t a surprise to allergists, but it might be news to others who have raised concerns about the possibility, Dr. Epstein said.
Overall safety was good for sublingual allergen immunotherapy, first approved by the Food and Drug Administration in 2014. One of the grade 3 reactions was pharyngeal edema; the other involved throat tightening and lower respiratory symptoms.
One of the asthma patients who died was morbidly obese and under treatment for weed allergies during pollen season, and died from overwhelming laryngeal edema. The patient’s weight made IV access difficult. The other asthma patient had severe disease, and was on the maximum dose of fluticasone/salmeterol. He was on an accelerated buildup for dust mites, pollen, mold, and other allergies, and apparently died of asthma complications triggered by the shots. There were no known risk factors in the third death.
Mortalities are lower than they used to be in the past with allergy shots, Dr. Epstein said.
She said she had no relevant disclosures.
aotto@frontlinemedcom.com
AT THE 2017 AAAAI ANNUAL MEETING
Key clinical point: for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.
Major finding: On surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions for 2014-2015 occurred in patients with asthma.
Data source: Allergist surveys from 2008 to 2015.
Disclosures: The lead investigator said she had no relevant disclosures.
VIDEO: Despite promises of abstinence, isotretinoin-exposed pregnancies still occur
ORLANDO – Pregnancy prevention remains a challenge when prescribing isotretinoin to women of childbearing years with acne, Megha M. Tollefson, MD, said at the annual meeting of the American Academy of Dermatology.
Like so many promises having to do with love, a promise of sexual abstinence, however earnest, may at some point fall by the wayside, said Dr. Tollefson of the Mayo Clinic, Rochester, Minn., in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Despite the promises, the education, and the allegiance to the iPLEDGE program, exposed pregnancies still occur. iPLEDGE, with a 2.67 rate of fetal exposure over 1,000 treatment courses, was no more effective than its predecessor, SMART, with a 3.11 exposure rate. Altogether, there are still about 150 exposed pregnancies every year; 18 babies were exposed to the drug during SMART and 11 during iPLEDGE.
An anonymous survey of 75 iPLEDGE participants disclosed that 19% of those who chose abstinence were not, and that 34% of those who were sexually active did not comply with the promise to use two forms of birth control.
For some patients, Dr. Tollefson said, the best choice is a patient-independent form of birth control. That’s not an easy conversation to have sometimes, especially when parents are involved, but it’s an important one to have.
Dr. Tollefson had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – Pregnancy prevention remains a challenge when prescribing isotretinoin to women of childbearing years with acne, Megha M. Tollefson, MD, said at the annual meeting of the American Academy of Dermatology.
Like so many promises having to do with love, a promise of sexual abstinence, however earnest, may at some point fall by the wayside, said Dr. Tollefson of the Mayo Clinic, Rochester, Minn., in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Despite the promises, the education, and the allegiance to the iPLEDGE program, exposed pregnancies still occur. iPLEDGE, with a 2.67 rate of fetal exposure over 1,000 treatment courses, was no more effective than its predecessor, SMART, with a 3.11 exposure rate. Altogether, there are still about 150 exposed pregnancies every year; 18 babies were exposed to the drug during SMART and 11 during iPLEDGE.
An anonymous survey of 75 iPLEDGE participants disclosed that 19% of those who chose abstinence were not, and that 34% of those who were sexually active did not comply with the promise to use two forms of birth control.
For some patients, Dr. Tollefson said, the best choice is a patient-independent form of birth control. That’s not an easy conversation to have sometimes, especially when parents are involved, but it’s an important one to have.
Dr. Tollefson had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – Pregnancy prevention remains a challenge when prescribing isotretinoin to women of childbearing years with acne, Megha M. Tollefson, MD, said at the annual meeting of the American Academy of Dermatology.
Like so many promises having to do with love, a promise of sexual abstinence, however earnest, may at some point fall by the wayside, said Dr. Tollefson of the Mayo Clinic, Rochester, Minn., in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Despite the promises, the education, and the allegiance to the iPLEDGE program, exposed pregnancies still occur. iPLEDGE, with a 2.67 rate of fetal exposure over 1,000 treatment courses, was no more effective than its predecessor, SMART, with a 3.11 exposure rate. Altogether, there are still about 150 exposed pregnancies every year; 18 babies were exposed to the drug during SMART and 11 during iPLEDGE.
An anonymous survey of 75 iPLEDGE participants disclosed that 19% of those who chose abstinence were not, and that 34% of those who were sexually active did not comply with the promise to use two forms of birth control.
For some patients, Dr. Tollefson said, the best choice is a patient-independent form of birth control. That’s not an easy conversation to have sometimes, especially when parents are involved, but it’s an important one to have.
Dr. Tollefson had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT AAD 17
VIDEO: Gold nanoparticles target laser acne therapy
ORLANDO – There may soon be a new gold standard in acne therapy – gold nanoparticles.
Evidence is mounting that the combination of a laser and a topical suspension of gold- or silver-coated silica nanoparticles can ablate the inner lining of the pilosebaceous unit, dramatically reducing or eliminating acne.
The system is still investigational in the United States, but shows great promise, Gilly Munavalli, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Munavalli, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas, Charlotte, N.C., described how the system works, and some of the evidence supporting it.
“Basically what we’re doing is creating a chromophore for the laser to target,” he said. Just as a laser won’t work on light hair, it can’t target the colorless sebum inside the gland. The colored particles absorb the laser energy, vibrate, and create the locally destructive heat.
The particles are about 150 nm in diameter. They are designed to absorb infrared and near-infrared irradiation. A nanoparticle solution is applied to the affected area. Dr. Munavalli uses an ultrasound paddle to drive the particles into the sebaceous gland, and then removes any solution left on the skin.
He passes a hand-held, 800-nm laser over the skin. The laser activates the particles, generating heat that disrupts the lining of the pilosebaceous unit.
In 2014, Sebacia (Duluth, Ga.), which is developing the technology, reported positive results from two small European trials enrolling a total of 97 patients with acne. The patients were randomized to the gold nanoparticles or to a control group of, in the first study, an over-the-counter face wash and later, the vehicle solution minus the gold nanoparticles.
At 12 weeks’ follow-up, there was a significant reduction in inflammatory lesions and in the Investigator’s Global Assessment score. Treatment was well tolerated and results were durable at 6 months. At that time, the inflammatory lesion count was still 60% below baseline. Side effects were transient erythema and mild edema.
Dr. Munavalli serves as a scientific advisor for Sebacia.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – There may soon be a new gold standard in acne therapy – gold nanoparticles.
Evidence is mounting that the combination of a laser and a topical suspension of gold- or silver-coated silica nanoparticles can ablate the inner lining of the pilosebaceous unit, dramatically reducing or eliminating acne.
The system is still investigational in the United States, but shows great promise, Gilly Munavalli, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Munavalli, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas, Charlotte, N.C., described how the system works, and some of the evidence supporting it.
“Basically what we’re doing is creating a chromophore for the laser to target,” he said. Just as a laser won’t work on light hair, it can’t target the colorless sebum inside the gland. The colored particles absorb the laser energy, vibrate, and create the locally destructive heat.
The particles are about 150 nm in diameter. They are designed to absorb infrared and near-infrared irradiation. A nanoparticle solution is applied to the affected area. Dr. Munavalli uses an ultrasound paddle to drive the particles into the sebaceous gland, and then removes any solution left on the skin.
He passes a hand-held, 800-nm laser over the skin. The laser activates the particles, generating heat that disrupts the lining of the pilosebaceous unit.
In 2014, Sebacia (Duluth, Ga.), which is developing the technology, reported positive results from two small European trials enrolling a total of 97 patients with acne. The patients were randomized to the gold nanoparticles or to a control group of, in the first study, an over-the-counter face wash and later, the vehicle solution minus the gold nanoparticles.
At 12 weeks’ follow-up, there was a significant reduction in inflammatory lesions and in the Investigator’s Global Assessment score. Treatment was well tolerated and results were durable at 6 months. At that time, the inflammatory lesion count was still 60% below baseline. Side effects were transient erythema and mild edema.
Dr. Munavalli serves as a scientific advisor for Sebacia.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – There may soon be a new gold standard in acne therapy – gold nanoparticles.
Evidence is mounting that the combination of a laser and a topical suspension of gold- or silver-coated silica nanoparticles can ablate the inner lining of the pilosebaceous unit, dramatically reducing or eliminating acne.
The system is still investigational in the United States, but shows great promise, Gilly Munavalli, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Munavalli, medical director and founder of Dermatology, Laser, and Vein Specialists of the Carolinas, Charlotte, N.C., described how the system works, and some of the evidence supporting it.
“Basically what we’re doing is creating a chromophore for the laser to target,” he said. Just as a laser won’t work on light hair, it can’t target the colorless sebum inside the gland. The colored particles absorb the laser energy, vibrate, and create the locally destructive heat.
The particles are about 150 nm in diameter. They are designed to absorb infrared and near-infrared irradiation. A nanoparticle solution is applied to the affected area. Dr. Munavalli uses an ultrasound paddle to drive the particles into the sebaceous gland, and then removes any solution left on the skin.
He passes a hand-held, 800-nm laser over the skin. The laser activates the particles, generating heat that disrupts the lining of the pilosebaceous unit.
In 2014, Sebacia (Duluth, Ga.), which is developing the technology, reported positive results from two small European trials enrolling a total of 97 patients with acne. The patients were randomized to the gold nanoparticles or to a control group of, in the first study, an over-the-counter face wash and later, the vehicle solution minus the gold nanoparticles.
At 12 weeks’ follow-up, there was a significant reduction in inflammatory lesions and in the Investigator’s Global Assessment score. Treatment was well tolerated and results were durable at 6 months. At that time, the inflammatory lesion count was still 60% below baseline. Side effects were transient erythema and mild edema.
Dr. Munavalli serves as a scientific advisor for Sebacia.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT AAD 17
VIDEO: Updating the rule of threes for melanoma gene testing
ORLANDO – The rule of threes that has been used to identify patients at risk of hereditary melanoma who may be candidates for genetic testing may be modified soon, according to Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, Oregon Health and Science University, Portland.
Dr. Leachman was the author of a 2009 study that listed three factors as criteria for identifying melanoma: a personal history of at least three invasive melanomas, a combination of at least three melanomas in the individual and in first-degree and second-degree blood relatives – or, in first- or second-degree relatives, a total of at least three diagnoses of melanoma or pancreatic cancer or astrocytoma, which also have been associated with a known susceptibility gene, p16 (J Am Acad Dermatol. 2009 Oct;61[4]:677.e1-14).
But with more genetic testing, it is becoming clear that there are other cancers associated with an increased risk of hereditary melanoma, she explained in a video interview at the annual meeting of the American Academy of Dermatology. “The genes are a little bit different, but if you could identify those patients, you could potentially then screen them for those other cancers,” said Dr. Leachman, who is also director of the melanoma research program at Knight Cancer Institute at OHSU.
In the interview, she discussed a soon-to-be-published literature review that builds upon the rule of threes and suggests a strategy for deciding which patients should be considered for genetic testing, and includes “a suggested list of genes” that should be used in these different subsets of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Leachman had no relevant disclosures.
ORLANDO – The rule of threes that has been used to identify patients at risk of hereditary melanoma who may be candidates for genetic testing may be modified soon, according to Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, Oregon Health and Science University, Portland.
Dr. Leachman was the author of a 2009 study that listed three factors as criteria for identifying melanoma: a personal history of at least three invasive melanomas, a combination of at least three melanomas in the individual and in first-degree and second-degree blood relatives – or, in first- or second-degree relatives, a total of at least three diagnoses of melanoma or pancreatic cancer or astrocytoma, which also have been associated with a known susceptibility gene, p16 (J Am Acad Dermatol. 2009 Oct;61[4]:677.e1-14).
But with more genetic testing, it is becoming clear that there are other cancers associated with an increased risk of hereditary melanoma, she explained in a video interview at the annual meeting of the American Academy of Dermatology. “The genes are a little bit different, but if you could identify those patients, you could potentially then screen them for those other cancers,” said Dr. Leachman, who is also director of the melanoma research program at Knight Cancer Institute at OHSU.
In the interview, she discussed a soon-to-be-published literature review that builds upon the rule of threes and suggests a strategy for deciding which patients should be considered for genetic testing, and includes “a suggested list of genes” that should be used in these different subsets of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Leachman had no relevant disclosures.
ORLANDO – The rule of threes that has been used to identify patients at risk of hereditary melanoma who may be candidates for genetic testing may be modified soon, according to Sancy Leachman, MD, PhD, professor and chair of the department of dermatology, Oregon Health and Science University, Portland.
Dr. Leachman was the author of a 2009 study that listed three factors as criteria for identifying melanoma: a personal history of at least three invasive melanomas, a combination of at least three melanomas in the individual and in first-degree and second-degree blood relatives – or, in first- or second-degree relatives, a total of at least three diagnoses of melanoma or pancreatic cancer or astrocytoma, which also have been associated with a known susceptibility gene, p16 (J Am Acad Dermatol. 2009 Oct;61[4]:677.e1-14).
But with more genetic testing, it is becoming clear that there are other cancers associated with an increased risk of hereditary melanoma, she explained in a video interview at the annual meeting of the American Academy of Dermatology. “The genes are a little bit different, but if you could identify those patients, you could potentially then screen them for those other cancers,” said Dr. Leachman, who is also director of the melanoma research program at Knight Cancer Institute at OHSU.
In the interview, she discussed a soon-to-be-published literature review that builds upon the rule of threes and suggests a strategy for deciding which patients should be considered for genetic testing, and includes “a suggested list of genes” that should be used in these different subsets of patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Leachman had no relevant disclosures.
AT AAD 17
Blinatumomab bests chemo in rel/ref B-ALL
Blinatumomab proved more effective than chemotherapy in a phase 3 trial of adults with Ph-negative, relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL).
Blinatumomab produced higher remission rates and nearly doubled overall survival (OS) when compared to standard care, which encompassed 4 different chemotherapy regimens (investigator’s choice).
The incidence of grade 3 or higher adverse events (AEs) was higher for patients who received chemotherapy, but the incidence of serious AEs was higher in the blinatumomab arm.
These results were published in NEJM. The trial, known as TOWER, was sponsored by Amgen, the company developing blinatumomab.
“Results from the TOWER study reinforce the potential of this single-agent, bispecific T-cell engager immunotherapy, which helped a higher percentage of patients achieve minimal residual disease response versus standard of care chemotherapy, highlighting the depth and quality of remissions achieved,” said study author Hagop M. Kantarjian, MD, of The University of Texas MD Anderson Cancer Center in Houston.
Treatment
TOWER enrolled 405 patients with Ph-negative, relapsed/refractory B-ALL, 376 of whom ultimately received treatment.
The patients received blinatumomab (n=267) or investigator’s choice of 1 of 4 protocol-defined standard chemotherapy regimens (n=109):
- FLAG (fludarabine, high-dose cytarabine arabinoside, and granulocyte-colony stimulating factor), with or without an anthracycline (n=49, 45%)
- A high-dose cytarabine arabinoside-based regimen (n=19, 17%)
- A high-dose methotrexate-based regimen (n=22, 20%)
- A clofarabine-based regimen (n=19, 17%).
Patients who received blinatumomab received it as a continuous infusion, 4 weeks on and 2 weeks off, at 9 µg/day for 7 days, then 28 µg/day on weeks 2-4. They received 2 cycles of induction, which was followed by 3 cycles of consolidation if they had ≤5% blasts.
If patients still had ≤5% blasts after consolidation, they received up to 12 months of blinatumomab maintenance. Maintenance was a continuous infusion, 4 weeks on and 8 weeks off, at 28 µg/day.
Patients in the blinatumomab arm received a median of 2 cycles of therapy (range, 1-9). And patients in the chemotherapy arm received a median of 1 cycle (range, 1 to 4).
Thirty-two percent of patients in the blinatumomab arm received consolidation, as did 3% of patients in the chemotherapy arm.
Patients
Patient characteristics were similar between the treatment arms. The mean age was 41 in both arms (range, 18-80). Nearly 60% of patients in both arms were male.
About 40% of patients in the blinatumomab arm and 50% in the chemotherapy arm had not received any prior salvage regimens.
Thirty-five percent of patients in the blinatumomab arm and 34% in the chemotherapy arm had an allogeneic hematopoietic stem cell transplant (allo-HSCT) prior to study enrollment. Seventeen percent and 20%, respectively, relapsed after HSCT.
Forty-two percent and 40%, respectively, were refractory to primary or salvage therapy. Twenty-eight percent of patients in both arms were in their first relapse, and their first remission had lasted less than 12 months. Twelve percent of patients in both arms had an untreated second or greater relapse.
Remission
Within 12 weeks of treatment initiation, complete remission (CR) rates were significantly higher in the blinatumomab arm than the chemotherapy arm. (This was in the intent-to-treat population, which included 271 patients in the blinatumomab arm and 134 patients in the chemotherapy arm.)
The rate of CR with full hematologic recovery was 34% in the blinatumomab arm and 16% in the chemotherapy arm (P<0.001). The rate of CR with full, partial, or incomplete hematologic recovery was 44% and 25%, respectively (P<0.001).
Among patients who achieved a CR with full, partial, or incomplete hematologic recovery, 76% of those in the blinatumomab arm and 48% of those in the chemotherapy arm were negative for minimal residual disease.
Survival
At a median follow-up of 11.7 months for the blinatumomab arm and 11.8 months for the chemotherapy arm, the OS was significantly longer in the blinatumomab arm.
The median OS was 7.7 months and 4.0 months, respectively (hazard ratio for death=0.71, P=0.01).
The improvement in OS with blinatumomab was consistent across subgroups, regardless of age, prior salvage therapy, or prior allo-HSCT.
The investigators also considered the effect that post-treatment allo-HSCT might have on OS. Sixty-five patients in the blinatumomab arm and 32 in the chemotherapy arm went on to receive an allo-HSCT (24% of patients in both arms).
When the investigators censored for post-treatment allo-HSCT, the median OS was 6.9 months in the blinatumomab arm and 3.9 months in the chemotherapy arm (hazard ratio=0.66, P=0.004).
Safety
Nearly all patients in both arms (99%) experienced AEs. Grade 3 or higher AEs occurred in 87% of patients in the blinatumomab arm and 92% of those in the chemotherapy arm. Serious AEs occurred in 62% and 45%, respectively.
Grade 3 or higher AEs of interest, according to the researchers, were infection (34% with blinatumomab and 52% with chemotherapy), neutropenia (38% and 58%, respectively), elevated liver enzymes (13% and 15%, respectively), neurologic events (9% and 8%, respectively), cytokine release syndrome (5% and 0%, respectively), infusion reactions (3% and 1%, respectively), and lymphopenia (2% and 4%, respectively).
Fatal AEs occurred in 19% of patients in the blinatumomab arm and 17% of those in the chemotherapy arm.
Fatal AEs that occurred in at least 1% of patients in either arm (blinatumomab and chemotherapy, respectively) were sepsis (3% and 4%), septic shock (2% and 0%), multiorgan failure (1% and 0%), respiratory failure (<1% and 2%), and bacteremia (0% and 2%).
Blinatumomab proved more effective than chemotherapy in a phase 3 trial of adults with Ph-negative, relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL).
Blinatumomab produced higher remission rates and nearly doubled overall survival (OS) when compared to standard care, which encompassed 4 different chemotherapy regimens (investigator’s choice).
The incidence of grade 3 or higher adverse events (AEs) was higher for patients who received chemotherapy, but the incidence of serious AEs was higher in the blinatumomab arm.
These results were published in NEJM. The trial, known as TOWER, was sponsored by Amgen, the company developing blinatumomab.
“Results from the TOWER study reinforce the potential of this single-agent, bispecific T-cell engager immunotherapy, which helped a higher percentage of patients achieve minimal residual disease response versus standard of care chemotherapy, highlighting the depth and quality of remissions achieved,” said study author Hagop M. Kantarjian, MD, of The University of Texas MD Anderson Cancer Center in Houston.
Treatment
TOWER enrolled 405 patients with Ph-negative, relapsed/refractory B-ALL, 376 of whom ultimately received treatment.
The patients received blinatumomab (n=267) or investigator’s choice of 1 of 4 protocol-defined standard chemotherapy regimens (n=109):
- FLAG (fludarabine, high-dose cytarabine arabinoside, and granulocyte-colony stimulating factor), with or without an anthracycline (n=49, 45%)
- A high-dose cytarabine arabinoside-based regimen (n=19, 17%)
- A high-dose methotrexate-based regimen (n=22, 20%)
- A clofarabine-based regimen (n=19, 17%).
Patients who received blinatumomab received it as a continuous infusion, 4 weeks on and 2 weeks off, at 9 µg/day for 7 days, then 28 µg/day on weeks 2-4. They received 2 cycles of induction, which was followed by 3 cycles of consolidation if they had ≤5% blasts.
If patients still had ≤5% blasts after consolidation, they received up to 12 months of blinatumomab maintenance. Maintenance was a continuous infusion, 4 weeks on and 8 weeks off, at 28 µg/day.
Patients in the blinatumomab arm received a median of 2 cycles of therapy (range, 1-9). And patients in the chemotherapy arm received a median of 1 cycle (range, 1 to 4).
Thirty-two percent of patients in the blinatumomab arm received consolidation, as did 3% of patients in the chemotherapy arm.
Patients
Patient characteristics were similar between the treatment arms. The mean age was 41 in both arms (range, 18-80). Nearly 60% of patients in both arms were male.
About 40% of patients in the blinatumomab arm and 50% in the chemotherapy arm had not received any prior salvage regimens.
Thirty-five percent of patients in the blinatumomab arm and 34% in the chemotherapy arm had an allogeneic hematopoietic stem cell transplant (allo-HSCT) prior to study enrollment. Seventeen percent and 20%, respectively, relapsed after HSCT.
Forty-two percent and 40%, respectively, were refractory to primary or salvage therapy. Twenty-eight percent of patients in both arms were in their first relapse, and their first remission had lasted less than 12 months. Twelve percent of patients in both arms had an untreated second or greater relapse.
Remission
Within 12 weeks of treatment initiation, complete remission (CR) rates were significantly higher in the blinatumomab arm than the chemotherapy arm. (This was in the intent-to-treat population, which included 271 patients in the blinatumomab arm and 134 patients in the chemotherapy arm.)
The rate of CR with full hematologic recovery was 34% in the blinatumomab arm and 16% in the chemotherapy arm (P<0.001). The rate of CR with full, partial, or incomplete hematologic recovery was 44% and 25%, respectively (P<0.001).
Among patients who achieved a CR with full, partial, or incomplete hematologic recovery, 76% of those in the blinatumomab arm and 48% of those in the chemotherapy arm were negative for minimal residual disease.
Survival
At a median follow-up of 11.7 months for the blinatumomab arm and 11.8 months for the chemotherapy arm, the OS was significantly longer in the blinatumomab arm.
The median OS was 7.7 months and 4.0 months, respectively (hazard ratio for death=0.71, P=0.01).
The improvement in OS with blinatumomab was consistent across subgroups, regardless of age, prior salvage therapy, or prior allo-HSCT.
The investigators also considered the effect that post-treatment allo-HSCT might have on OS. Sixty-five patients in the blinatumomab arm and 32 in the chemotherapy arm went on to receive an allo-HSCT (24% of patients in both arms).
When the investigators censored for post-treatment allo-HSCT, the median OS was 6.9 months in the blinatumomab arm and 3.9 months in the chemotherapy arm (hazard ratio=0.66, P=0.004).
Safety
Nearly all patients in both arms (99%) experienced AEs. Grade 3 or higher AEs occurred in 87% of patients in the blinatumomab arm and 92% of those in the chemotherapy arm. Serious AEs occurred in 62% and 45%, respectively.
Grade 3 or higher AEs of interest, according to the researchers, were infection (34% with blinatumomab and 52% with chemotherapy), neutropenia (38% and 58%, respectively), elevated liver enzymes (13% and 15%, respectively), neurologic events (9% and 8%, respectively), cytokine release syndrome (5% and 0%, respectively), infusion reactions (3% and 1%, respectively), and lymphopenia (2% and 4%, respectively).
Fatal AEs occurred in 19% of patients in the blinatumomab arm and 17% of those in the chemotherapy arm.
Fatal AEs that occurred in at least 1% of patients in either arm (blinatumomab and chemotherapy, respectively) were sepsis (3% and 4%), septic shock (2% and 0%), multiorgan failure (1% and 0%), respiratory failure (<1% and 2%), and bacteremia (0% and 2%).
Blinatumomab proved more effective than chemotherapy in a phase 3 trial of adults with Ph-negative, relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL).
Blinatumomab produced higher remission rates and nearly doubled overall survival (OS) when compared to standard care, which encompassed 4 different chemotherapy regimens (investigator’s choice).
The incidence of grade 3 or higher adverse events (AEs) was higher for patients who received chemotherapy, but the incidence of serious AEs was higher in the blinatumomab arm.
These results were published in NEJM. The trial, known as TOWER, was sponsored by Amgen, the company developing blinatumomab.
“Results from the TOWER study reinforce the potential of this single-agent, bispecific T-cell engager immunotherapy, which helped a higher percentage of patients achieve minimal residual disease response versus standard of care chemotherapy, highlighting the depth and quality of remissions achieved,” said study author Hagop M. Kantarjian, MD, of The University of Texas MD Anderson Cancer Center in Houston.
Treatment
TOWER enrolled 405 patients with Ph-negative, relapsed/refractory B-ALL, 376 of whom ultimately received treatment.
The patients received blinatumomab (n=267) or investigator’s choice of 1 of 4 protocol-defined standard chemotherapy regimens (n=109):
- FLAG (fludarabine, high-dose cytarabine arabinoside, and granulocyte-colony stimulating factor), with or without an anthracycline (n=49, 45%)
- A high-dose cytarabine arabinoside-based regimen (n=19, 17%)
- A high-dose methotrexate-based regimen (n=22, 20%)
- A clofarabine-based regimen (n=19, 17%).
Patients who received blinatumomab received it as a continuous infusion, 4 weeks on and 2 weeks off, at 9 µg/day for 7 days, then 28 µg/day on weeks 2-4. They received 2 cycles of induction, which was followed by 3 cycles of consolidation if they had ≤5% blasts.
If patients still had ≤5% blasts after consolidation, they received up to 12 months of blinatumomab maintenance. Maintenance was a continuous infusion, 4 weeks on and 8 weeks off, at 28 µg/day.
Patients in the blinatumomab arm received a median of 2 cycles of therapy (range, 1-9). And patients in the chemotherapy arm received a median of 1 cycle (range, 1 to 4).
Thirty-two percent of patients in the blinatumomab arm received consolidation, as did 3% of patients in the chemotherapy arm.
Patients
Patient characteristics were similar between the treatment arms. The mean age was 41 in both arms (range, 18-80). Nearly 60% of patients in both arms were male.
About 40% of patients in the blinatumomab arm and 50% in the chemotherapy arm had not received any prior salvage regimens.
Thirty-five percent of patients in the blinatumomab arm and 34% in the chemotherapy arm had an allogeneic hematopoietic stem cell transplant (allo-HSCT) prior to study enrollment. Seventeen percent and 20%, respectively, relapsed after HSCT.
Forty-two percent and 40%, respectively, were refractory to primary or salvage therapy. Twenty-eight percent of patients in both arms were in their first relapse, and their first remission had lasted less than 12 months. Twelve percent of patients in both arms had an untreated second or greater relapse.
Remission
Within 12 weeks of treatment initiation, complete remission (CR) rates were significantly higher in the blinatumomab arm than the chemotherapy arm. (This was in the intent-to-treat population, which included 271 patients in the blinatumomab arm and 134 patients in the chemotherapy arm.)
The rate of CR with full hematologic recovery was 34% in the blinatumomab arm and 16% in the chemotherapy arm (P<0.001). The rate of CR with full, partial, or incomplete hematologic recovery was 44% and 25%, respectively (P<0.001).
Among patients who achieved a CR with full, partial, or incomplete hematologic recovery, 76% of those in the blinatumomab arm and 48% of those in the chemotherapy arm were negative for minimal residual disease.
Survival
At a median follow-up of 11.7 months for the blinatumomab arm and 11.8 months for the chemotherapy arm, the OS was significantly longer in the blinatumomab arm.
The median OS was 7.7 months and 4.0 months, respectively (hazard ratio for death=0.71, P=0.01).
The improvement in OS with blinatumomab was consistent across subgroups, regardless of age, prior salvage therapy, or prior allo-HSCT.
The investigators also considered the effect that post-treatment allo-HSCT might have on OS. Sixty-five patients in the blinatumomab arm and 32 in the chemotherapy arm went on to receive an allo-HSCT (24% of patients in both arms).
When the investigators censored for post-treatment allo-HSCT, the median OS was 6.9 months in the blinatumomab arm and 3.9 months in the chemotherapy arm (hazard ratio=0.66, P=0.004).
Safety
Nearly all patients in both arms (99%) experienced AEs. Grade 3 or higher AEs occurred in 87% of patients in the blinatumomab arm and 92% of those in the chemotherapy arm. Serious AEs occurred in 62% and 45%, respectively.
Grade 3 or higher AEs of interest, according to the researchers, were infection (34% with blinatumomab and 52% with chemotherapy), neutropenia (38% and 58%, respectively), elevated liver enzymes (13% and 15%, respectively), neurologic events (9% and 8%, respectively), cytokine release syndrome (5% and 0%, respectively), infusion reactions (3% and 1%, respectively), and lymphopenia (2% and 4%, respectively).
Fatal AEs occurred in 19% of patients in the blinatumomab arm and 17% of those in the chemotherapy arm.
Fatal AEs that occurred in at least 1% of patients in either arm (blinatumomab and chemotherapy, respectively) were sepsis (3% and 4%), septic shock (2% and 0%), multiorgan failure (1% and 0%), respiratory failure (<1% and 2%), and bacteremia (0% and 2%).