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M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.
Gender affirmation surgery has become more common
, and private insurers and Medicare and Medicaid are covering more of them, according to a review of the National Inpatient Sample from 2000 to 2014.
“As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them,” said investigators led by Joseph Canner, MHS, of Johns Hopkins University, Baltimore (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).
The team sought to correct a glaring lack of demographic, hospital, and surgical data on transgender people, a problem due mainly to “the absence of routine, standardized collection and reporting of gender identity in health care settings,” the investigators said.
The Affordable Care Act banned gender identity discrimination, and state and federal governments – as well as private insurers – are expanding coverage of gender affirmation surgery and care. Given the trend, it’s essential that quality improvement agencies begin to “focus on adopting a new set of patient-centered measures to better monitor transgender care and identify opportunities for advancing transition-related services,” the researchers said.
The team identified 37,827 hospital encounters in the national database that had ICD-9 diagnosis codes of transsexualism or gender identity disorder that were listed in the National Inpatient Sample. The rate of those codes increased from 3.87/100,000 patients in 2000 to 14.22 /100,000 patients in 2014.
Mental health was the leading cause of hospitalization, accounting for 40.5% of admissions, a finding that “is consistent with the high prevalence of depression, anxiety, and suicidal ideation in this population,” the investigators said.
Patients were a median age of 38 years old; 57.1% identified as white; and 54.3% were categorized as male, 38.3% as female, and most of the rest as “inconsistent,” meaning their sex in the medical record did not match their procedures.
Almost 11% were hospitalized for gender affirmation surgery, including penile or vaginal construction. From 2000 to 2005, 72% of patients who underwent affirmation procedures had genital surgery; the number increased to 83.9% from 2006 to 2011. More than half of the patients weren’t covered by insurance, but the number covered by Medicare or Medicaid increased from 25 patients in 2012-2013 to 70 in 2014. Meanwhile, no one died in the hospital from gender reassignment surgery, and the median stay was 4 days.
“Our data suggest that genital surgery is the most common type of inpatient gender-affirming surgery; however, these data do not include gender-affirming surgical procedures performed in outpatient settings, which likely include most chest, breast, and facial surgery,” the investigators wrote.
Surgery patients in high-volume centers (performing more than 50 gender-affirming procedures per year) were mostly self-pay, while those admitted to low-volume centers were not. “It is possible that self-paying patients may be getting higher-quality care at high-volume centers, as has been observed in other types of surgery,” according to the investigators. There is a need for national clinical and patient-reported outcomes data to assess and improve the quality of gender-affirming surgery. Gender identity information should be a part of all electronic health records and reported back to national data repositories, they said.
The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
SOURCE: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
The study is thought provoking and suggests many areas for future study.
Gender-affirming surgery is the final step in a spectrum of treatments for gender identity disorders or transsexualism, including psychological counseling, hormonal therapies, and pubertal hormone blockers. Referrals for these treatments are increasing, and likely the demand for surgical treatment will also continue to increase.
A comprehensive database or other prospective tool to assess the comparative efficacy of these treatments, create quality metrics, and address long-term health or psychiatric outcomes should be pursued.
Future research must address cost effectiveness and cost burdens, given increased public funding for gender affirmation surgeries. Most longitudinal studies of patients who have undergone gender affirmation procedures have found high satisfaction rates with low rates of regret (less than 5%). However, when regret occurs, it can be surgically challenging and costly to reverse these procedures.
Marie Crandall , MD, is a professor of surgery at the University of Florida, Jacksonville. She made her comments in an editorial and had no industry disclosures (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6232).
The study is thought provoking and suggests many areas for future study.
Gender-affirming surgery is the final step in a spectrum of treatments for gender identity disorders or transsexualism, including psychological counseling, hormonal therapies, and pubertal hormone blockers. Referrals for these treatments are increasing, and likely the demand for surgical treatment will also continue to increase.
A comprehensive database or other prospective tool to assess the comparative efficacy of these treatments, create quality metrics, and address long-term health or psychiatric outcomes should be pursued.
Future research must address cost effectiveness and cost burdens, given increased public funding for gender affirmation surgeries. Most longitudinal studies of patients who have undergone gender affirmation procedures have found high satisfaction rates with low rates of regret (less than 5%). However, when regret occurs, it can be surgically challenging and costly to reverse these procedures.
Marie Crandall , MD, is a professor of surgery at the University of Florida, Jacksonville. She made her comments in an editorial and had no industry disclosures (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6232).
The study is thought provoking and suggests many areas for future study.
Gender-affirming surgery is the final step in a spectrum of treatments for gender identity disorders or transsexualism, including psychological counseling, hormonal therapies, and pubertal hormone blockers. Referrals for these treatments are increasing, and likely the demand for surgical treatment will also continue to increase.
A comprehensive database or other prospective tool to assess the comparative efficacy of these treatments, create quality metrics, and address long-term health or psychiatric outcomes should be pursued.
Future research must address cost effectiveness and cost burdens, given increased public funding for gender affirmation surgeries. Most longitudinal studies of patients who have undergone gender affirmation procedures have found high satisfaction rates with low rates of regret (less than 5%). However, when regret occurs, it can be surgically challenging and costly to reverse these procedures.
Marie Crandall , MD, is a professor of surgery at the University of Florida, Jacksonville. She made her comments in an editorial and had no industry disclosures (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6232).
, and private insurers and Medicare and Medicaid are covering more of them, according to a review of the National Inpatient Sample from 2000 to 2014.
“As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them,” said investigators led by Joseph Canner, MHS, of Johns Hopkins University, Baltimore (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).
The team sought to correct a glaring lack of demographic, hospital, and surgical data on transgender people, a problem due mainly to “the absence of routine, standardized collection and reporting of gender identity in health care settings,” the investigators said.
The Affordable Care Act banned gender identity discrimination, and state and federal governments – as well as private insurers – are expanding coverage of gender affirmation surgery and care. Given the trend, it’s essential that quality improvement agencies begin to “focus on adopting a new set of patient-centered measures to better monitor transgender care and identify opportunities for advancing transition-related services,” the researchers said.
The team identified 37,827 hospital encounters in the national database that had ICD-9 diagnosis codes of transsexualism or gender identity disorder that were listed in the National Inpatient Sample. The rate of those codes increased from 3.87/100,000 patients in 2000 to 14.22 /100,000 patients in 2014.
Mental health was the leading cause of hospitalization, accounting for 40.5% of admissions, a finding that “is consistent with the high prevalence of depression, anxiety, and suicidal ideation in this population,” the investigators said.
Patients were a median age of 38 years old; 57.1% identified as white; and 54.3% were categorized as male, 38.3% as female, and most of the rest as “inconsistent,” meaning their sex in the medical record did not match their procedures.
Almost 11% were hospitalized for gender affirmation surgery, including penile or vaginal construction. From 2000 to 2005, 72% of patients who underwent affirmation procedures had genital surgery; the number increased to 83.9% from 2006 to 2011. More than half of the patients weren’t covered by insurance, but the number covered by Medicare or Medicaid increased from 25 patients in 2012-2013 to 70 in 2014. Meanwhile, no one died in the hospital from gender reassignment surgery, and the median stay was 4 days.
“Our data suggest that genital surgery is the most common type of inpatient gender-affirming surgery; however, these data do not include gender-affirming surgical procedures performed in outpatient settings, which likely include most chest, breast, and facial surgery,” the investigators wrote.
Surgery patients in high-volume centers (performing more than 50 gender-affirming procedures per year) were mostly self-pay, while those admitted to low-volume centers were not. “It is possible that self-paying patients may be getting higher-quality care at high-volume centers, as has been observed in other types of surgery,” according to the investigators. There is a need for national clinical and patient-reported outcomes data to assess and improve the quality of gender-affirming surgery. Gender identity information should be a part of all electronic health records and reported back to national data repositories, they said.
The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
SOURCE: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
, and private insurers and Medicare and Medicaid are covering more of them, according to a review of the National Inpatient Sample from 2000 to 2014.
“As coverage for these procedures increases, likely so will demand for qualified surgeons to perform them,” said investigators led by Joseph Canner, MHS, of Johns Hopkins University, Baltimore (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).
The team sought to correct a glaring lack of demographic, hospital, and surgical data on transgender people, a problem due mainly to “the absence of routine, standardized collection and reporting of gender identity in health care settings,” the investigators said.
The Affordable Care Act banned gender identity discrimination, and state and federal governments – as well as private insurers – are expanding coverage of gender affirmation surgery and care. Given the trend, it’s essential that quality improvement agencies begin to “focus on adopting a new set of patient-centered measures to better monitor transgender care and identify opportunities for advancing transition-related services,” the researchers said.
The team identified 37,827 hospital encounters in the national database that had ICD-9 diagnosis codes of transsexualism or gender identity disorder that were listed in the National Inpatient Sample. The rate of those codes increased from 3.87/100,000 patients in 2000 to 14.22 /100,000 patients in 2014.
Mental health was the leading cause of hospitalization, accounting for 40.5% of admissions, a finding that “is consistent with the high prevalence of depression, anxiety, and suicidal ideation in this population,” the investigators said.
Patients were a median age of 38 years old; 57.1% identified as white; and 54.3% were categorized as male, 38.3% as female, and most of the rest as “inconsistent,” meaning their sex in the medical record did not match their procedures.
Almost 11% were hospitalized for gender affirmation surgery, including penile or vaginal construction. From 2000 to 2005, 72% of patients who underwent affirmation procedures had genital surgery; the number increased to 83.9% from 2006 to 2011. More than half of the patients weren’t covered by insurance, but the number covered by Medicare or Medicaid increased from 25 patients in 2012-2013 to 70 in 2014. Meanwhile, no one died in the hospital from gender reassignment surgery, and the median stay was 4 days.
“Our data suggest that genital surgery is the most common type of inpatient gender-affirming surgery; however, these data do not include gender-affirming surgical procedures performed in outpatient settings, which likely include most chest, breast, and facial surgery,” the investigators wrote.
Surgery patients in high-volume centers (performing more than 50 gender-affirming procedures per year) were mostly self-pay, while those admitted to low-volume centers were not. “It is possible that self-paying patients may be getting higher-quality care at high-volume centers, as has been observed in other types of surgery,” according to the investigators. There is a need for national clinical and patient-reported outcomes data to assess and improve the quality of gender-affirming surgery. Gender identity information should be a part of all electronic health records and reported back to national data repositories, they said.
The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
SOURCE: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
FROM JAMA SURGERY
Key clinical point: With gender affirmation surgeries on the rise in the United States, it’s time for a more rigorous system to track outcomes.
Major finding: The rate of transsexual and gender identity disorder codes in the National Inpatient Sample increased from 3.87/100,000 patients in 2000 to 14.22/100,000 patients in 2014.
Study details: A review of 37,827 hospital encounters reported in the National Inpatient Sample.
Disclosures: The investigators are supported by the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, and the National Institutes of Health, among others. They had no industry disclosures.
Source: Canner JK et al. JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231.
Baseline stress signals need for psychological help in CLL
, according to a prospective study of 152 patients.
“These findings suggest that integration of psychological intervention for patients who have high cancer-specific stress at baseline might be appropriate for this population,” wrote investigators led by Neha G. Goyal, PhD, a research fellow at Wake Forest University, Winston-Salem, N.C.
The subjects all had relapsed/refractory chronic lymphocytic leukemia (CLL). They filled out mental and physical function questionnaires at baseline, then at months 1, 2, and 5 during a nonrandomized phase 2 trial of ibrutinib (Imbruvica). The findings were published in the Annals of Behavioral Medicine.
Cancer-specific stress – essentially traumatic stress associated with cancer diagnosis, recurrence, and treatment – was assessed by the Impact of Event Scale, a common cancer research tool in which patients rate the intensity of intrusive thoughts and avoidant thoughts and behaviors. A score of 8 – out of a range of 0-64 – was the cut point used to separate patients with low versus high stress; higher scores mean worse symptoms.
“At treatment initiation, cancer-specific stress was associated with higher levels of cognitive-affective depressive symptoms, negative mood, fatigue interference, and sleep problems, and lower mental health quality of life. While patients with higher cancer-specific stress at baseline improved more rapidly on these outcomes ... higher cancer-specific stress at baseline was still associated with poorer psychological outcomes, but not physical outcomes, at 5 months,” the investigators said (Ann Behav Med. 2018 Feb 9. doi: 10.1093/abm/kax004).
For instance, high-stress patients started the trial with mean scores of about 4.5 on the 42-point cognitive-affective subscale of the Beck Depression Inventory; scores improved to about 2.5 after 5 months of treatment. Low-stress patients, however, started and ended the study with scores of about 1.5.
Cancer-specific stress has been associated with poorer outcomes in previous cancer studies, but its impact on CLL hasn’t been clear until now. It might be a particularly bad problem in CLL, because the disease is incurable and patients go through multiple relapses and treatment cycles.
“There has been a call to screen cancer patients to determine those who may be at risk for poor outcomes, and assessment of cancer-specific stress may have clinical utility as an individual difference predictor of psychological responses,” the team noted.
The mean age in the study was 64.1 years; 71% of the subjects were men. The majority were educated beyond high school, and almost all reported significant, supportive relationships. Patients had a median of three prior therapies, but one patients had been through 16.
Dr. Goyal reported having no financial disclosures. One author disclosed ties to Pharmacyclics and Janssen, marketers of ibrutinib. The work was supported by the National Cancer Institute and Pharmacyclics, among others.
, according to a prospective study of 152 patients.
“These findings suggest that integration of psychological intervention for patients who have high cancer-specific stress at baseline might be appropriate for this population,” wrote investigators led by Neha G. Goyal, PhD, a research fellow at Wake Forest University, Winston-Salem, N.C.
The subjects all had relapsed/refractory chronic lymphocytic leukemia (CLL). They filled out mental and physical function questionnaires at baseline, then at months 1, 2, and 5 during a nonrandomized phase 2 trial of ibrutinib (Imbruvica). The findings were published in the Annals of Behavioral Medicine.
Cancer-specific stress – essentially traumatic stress associated with cancer diagnosis, recurrence, and treatment – was assessed by the Impact of Event Scale, a common cancer research tool in which patients rate the intensity of intrusive thoughts and avoidant thoughts and behaviors. A score of 8 – out of a range of 0-64 – was the cut point used to separate patients with low versus high stress; higher scores mean worse symptoms.
“At treatment initiation, cancer-specific stress was associated with higher levels of cognitive-affective depressive symptoms, negative mood, fatigue interference, and sleep problems, and lower mental health quality of life. While patients with higher cancer-specific stress at baseline improved more rapidly on these outcomes ... higher cancer-specific stress at baseline was still associated with poorer psychological outcomes, but not physical outcomes, at 5 months,” the investigators said (Ann Behav Med. 2018 Feb 9. doi: 10.1093/abm/kax004).
For instance, high-stress patients started the trial with mean scores of about 4.5 on the 42-point cognitive-affective subscale of the Beck Depression Inventory; scores improved to about 2.5 after 5 months of treatment. Low-stress patients, however, started and ended the study with scores of about 1.5.
Cancer-specific stress has been associated with poorer outcomes in previous cancer studies, but its impact on CLL hasn’t been clear until now. It might be a particularly bad problem in CLL, because the disease is incurable and patients go through multiple relapses and treatment cycles.
“There has been a call to screen cancer patients to determine those who may be at risk for poor outcomes, and assessment of cancer-specific stress may have clinical utility as an individual difference predictor of psychological responses,” the team noted.
The mean age in the study was 64.1 years; 71% of the subjects were men. The majority were educated beyond high school, and almost all reported significant, supportive relationships. Patients had a median of three prior therapies, but one patients had been through 16.
Dr. Goyal reported having no financial disclosures. One author disclosed ties to Pharmacyclics and Janssen, marketers of ibrutinib. The work was supported by the National Cancer Institute and Pharmacyclics, among others.
, according to a prospective study of 152 patients.
“These findings suggest that integration of psychological intervention for patients who have high cancer-specific stress at baseline might be appropriate for this population,” wrote investigators led by Neha G. Goyal, PhD, a research fellow at Wake Forest University, Winston-Salem, N.C.
The subjects all had relapsed/refractory chronic lymphocytic leukemia (CLL). They filled out mental and physical function questionnaires at baseline, then at months 1, 2, and 5 during a nonrandomized phase 2 trial of ibrutinib (Imbruvica). The findings were published in the Annals of Behavioral Medicine.
Cancer-specific stress – essentially traumatic stress associated with cancer diagnosis, recurrence, and treatment – was assessed by the Impact of Event Scale, a common cancer research tool in which patients rate the intensity of intrusive thoughts and avoidant thoughts and behaviors. A score of 8 – out of a range of 0-64 – was the cut point used to separate patients with low versus high stress; higher scores mean worse symptoms.
“At treatment initiation, cancer-specific stress was associated with higher levels of cognitive-affective depressive symptoms, negative mood, fatigue interference, and sleep problems, and lower mental health quality of life. While patients with higher cancer-specific stress at baseline improved more rapidly on these outcomes ... higher cancer-specific stress at baseline was still associated with poorer psychological outcomes, but not physical outcomes, at 5 months,” the investigators said (Ann Behav Med. 2018 Feb 9. doi: 10.1093/abm/kax004).
For instance, high-stress patients started the trial with mean scores of about 4.5 on the 42-point cognitive-affective subscale of the Beck Depression Inventory; scores improved to about 2.5 after 5 months of treatment. Low-stress patients, however, started and ended the study with scores of about 1.5.
Cancer-specific stress has been associated with poorer outcomes in previous cancer studies, but its impact on CLL hasn’t been clear until now. It might be a particularly bad problem in CLL, because the disease is incurable and patients go through multiple relapses and treatment cycles.
“There has been a call to screen cancer patients to determine those who may be at risk for poor outcomes, and assessment of cancer-specific stress may have clinical utility as an individual difference predictor of psychological responses,” the team noted.
The mean age in the study was 64.1 years; 71% of the subjects were men. The majority were educated beyond high school, and almost all reported significant, supportive relationships. Patients had a median of three prior therapies, but one patients had been through 16.
Dr. Goyal reported having no financial disclosures. One author disclosed ties to Pharmacyclics and Janssen, marketers of ibrutinib. The work was supported by the National Cancer Institute and Pharmacyclics, among others.
FROM ANNALS OF BEHAVIORAL MEDICINE
MMWR: Current flu vaccine does not protect elderly
, according to the Feb. 16 issue of Morbidity and Mortality Weekly Report.
The elderly are not among them. Although the vaccine was somewhat protective in children and adults up to 49 years old, “no statistically significant protection was observed in other age groups,” including people 65 years and older, reported investigators led by Brendan Flannery, PhD, of the Centers for Disease Control and Prevention influenza division.
They also reported that the cumulative hospitalization rate attributed to laboratory-confirmed influenza for the week ending Feb. 3, 2018 (59.9/100,000), exceeded the rate for the same week in 2014-2015 (50.9/100,000), an A(H3N2) virus–predominant season, and is the highest rate observed for this week since the system expanded to include adults during the 2005-2006 season.
This year’s overall effectiveness rating was in contrast to the 2016-2017 seasonal effectiveness of 48% (MMWR. 2017 Feb 17;66[6];167-71).
The CDC noted that influenza is going to be active for several more weeks, so “vaccination is still recommended,” but “treatment with influenza antiviral medications, where appropriate, is especially important this season.” Meanwhile, “influenza vaccines with improved effectiveness are needed,” the CDC said.
The estimates are based on 4,562 patients 6 months to over 65 years old presenting with acute respiratory illness in 2018 from Nov. 2 to Feb. 3 at five outpatient medical clinics scattered across the United States. Nasal and oropharyngeal swabs were tested with reverse transcription polymerase chain reaction for the presence of influenza viruses; 413 subjects were 65 years or older.
Vaccine effectiveness against the less common virus A(H1N1)pdm09 was 67%, and 42% against the even rarer influenza B viruses. Estimates were adjusted for a range of confounders, including study site, age, general health, and week of illness. Vaccination rates ranged from 45% to 59% across the study sites; 38% of the subjects tested positive for influenza, most for type A viruses. The shot didn’t work too well: 43% of the influenza cases had gotten it.
The 25% effectiveness against A(H3N2) is a bit higher than recent reports of 17% from Canada and 10% from Australia, but similar to the 32% efficacy reported in the United States for the 2016-2017 season.
“These interim estimates reflect ongoing challenges with the A(H3N2) vaccine component since the 2011-12 season,” the investigators wrote. “Multiple factors might be contributing to the reported [vaccine effectiveness] against A(H3N2) viruses this season. … Genetic changes in the vaccine virus hemagglutinin protein that arise during passage in eggs might result in a vaccine immune response that is less effective against circulating viruses.”
On a related note, on Feb. 18, Senators Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), and Amy Klobuchar (D-Minn.) held a press conference to announce they were introducing the Flu Vaccine Bill to dedicate $1 billion over a 5-year period in order to develop a flu vaccine that could provide lifetime protection.
The investigators had no conflicts of interest.
SOURCE: Flannery B. et al. MMWR. 2018 Feb 16;67(6):180-5; Budd A. et al. MMWR. 2018 Feb 16;67(6):169-79.
, according to the Feb. 16 issue of Morbidity and Mortality Weekly Report.
The elderly are not among them. Although the vaccine was somewhat protective in children and adults up to 49 years old, “no statistically significant protection was observed in other age groups,” including people 65 years and older, reported investigators led by Brendan Flannery, PhD, of the Centers for Disease Control and Prevention influenza division.
They also reported that the cumulative hospitalization rate attributed to laboratory-confirmed influenza for the week ending Feb. 3, 2018 (59.9/100,000), exceeded the rate for the same week in 2014-2015 (50.9/100,000), an A(H3N2) virus–predominant season, and is the highest rate observed for this week since the system expanded to include adults during the 2005-2006 season.
This year’s overall effectiveness rating was in contrast to the 2016-2017 seasonal effectiveness of 48% (MMWR. 2017 Feb 17;66[6];167-71).
The CDC noted that influenza is going to be active for several more weeks, so “vaccination is still recommended,” but “treatment with influenza antiviral medications, where appropriate, is especially important this season.” Meanwhile, “influenza vaccines with improved effectiveness are needed,” the CDC said.
The estimates are based on 4,562 patients 6 months to over 65 years old presenting with acute respiratory illness in 2018 from Nov. 2 to Feb. 3 at five outpatient medical clinics scattered across the United States. Nasal and oropharyngeal swabs were tested with reverse transcription polymerase chain reaction for the presence of influenza viruses; 413 subjects were 65 years or older.
Vaccine effectiveness against the less common virus A(H1N1)pdm09 was 67%, and 42% against the even rarer influenza B viruses. Estimates were adjusted for a range of confounders, including study site, age, general health, and week of illness. Vaccination rates ranged from 45% to 59% across the study sites; 38% of the subjects tested positive for influenza, most for type A viruses. The shot didn’t work too well: 43% of the influenza cases had gotten it.
The 25% effectiveness against A(H3N2) is a bit higher than recent reports of 17% from Canada and 10% from Australia, but similar to the 32% efficacy reported in the United States for the 2016-2017 season.
“These interim estimates reflect ongoing challenges with the A(H3N2) vaccine component since the 2011-12 season,” the investigators wrote. “Multiple factors might be contributing to the reported [vaccine effectiveness] against A(H3N2) viruses this season. … Genetic changes in the vaccine virus hemagglutinin protein that arise during passage in eggs might result in a vaccine immune response that is less effective against circulating viruses.”
On a related note, on Feb. 18, Senators Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), and Amy Klobuchar (D-Minn.) held a press conference to announce they were introducing the Flu Vaccine Bill to dedicate $1 billion over a 5-year period in order to develop a flu vaccine that could provide lifetime protection.
The investigators had no conflicts of interest.
SOURCE: Flannery B. et al. MMWR. 2018 Feb 16;67(6):180-5; Budd A. et al. MMWR. 2018 Feb 16;67(6):169-79.
, according to the Feb. 16 issue of Morbidity and Mortality Weekly Report.
The elderly are not among them. Although the vaccine was somewhat protective in children and adults up to 49 years old, “no statistically significant protection was observed in other age groups,” including people 65 years and older, reported investigators led by Brendan Flannery, PhD, of the Centers for Disease Control and Prevention influenza division.
They also reported that the cumulative hospitalization rate attributed to laboratory-confirmed influenza for the week ending Feb. 3, 2018 (59.9/100,000), exceeded the rate for the same week in 2014-2015 (50.9/100,000), an A(H3N2) virus–predominant season, and is the highest rate observed for this week since the system expanded to include adults during the 2005-2006 season.
This year’s overall effectiveness rating was in contrast to the 2016-2017 seasonal effectiveness of 48% (MMWR. 2017 Feb 17;66[6];167-71).
The CDC noted that influenza is going to be active for several more weeks, so “vaccination is still recommended,” but “treatment with influenza antiviral medications, where appropriate, is especially important this season.” Meanwhile, “influenza vaccines with improved effectiveness are needed,” the CDC said.
The estimates are based on 4,562 patients 6 months to over 65 years old presenting with acute respiratory illness in 2018 from Nov. 2 to Feb. 3 at five outpatient medical clinics scattered across the United States. Nasal and oropharyngeal swabs were tested with reverse transcription polymerase chain reaction for the presence of influenza viruses; 413 subjects were 65 years or older.
Vaccine effectiveness against the less common virus A(H1N1)pdm09 was 67%, and 42% against the even rarer influenza B viruses. Estimates were adjusted for a range of confounders, including study site, age, general health, and week of illness. Vaccination rates ranged from 45% to 59% across the study sites; 38% of the subjects tested positive for influenza, most for type A viruses. The shot didn’t work too well: 43% of the influenza cases had gotten it.
The 25% effectiveness against A(H3N2) is a bit higher than recent reports of 17% from Canada and 10% from Australia, but similar to the 32% efficacy reported in the United States for the 2016-2017 season.
“These interim estimates reflect ongoing challenges with the A(H3N2) vaccine component since the 2011-12 season,” the investigators wrote. “Multiple factors might be contributing to the reported [vaccine effectiveness] against A(H3N2) viruses this season. … Genetic changes in the vaccine virus hemagglutinin protein that arise during passage in eggs might result in a vaccine immune response that is less effective against circulating viruses.”
On a related note, on Feb. 18, Senators Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), and Amy Klobuchar (D-Minn.) held a press conference to announce they were introducing the Flu Vaccine Bill to dedicate $1 billion over a 5-year period in order to develop a flu vaccine that could provide lifetime protection.
The investigators had no conflicts of interest.
SOURCE: Flannery B. et al. MMWR. 2018 Feb 16;67(6):180-5; Budd A. et al. MMWR. 2018 Feb 16;67(6):169-79.
FROM MORBIDITY AND MORTALITY WEEKLY REPORT
VIDEO: With tinea capitis, don’t be fooled by a Wood’s lamp
KAUAI, HAWAII – When it comes to diagnosing tinea capitis, you really can’t rely on a Wood’s lamp, according to pediatric dermatologist Robert Silverman, MD.
The Wood’s lamp generally misses the most common cause of tinea capitis in urban and suburban environments today, Trichophyton tonsurans, said Dr. Silverman, a pediatric dermatologist and clinical associate professor in the department of pediatrics at Georgetown University, Washington.
The dermatoscope, which “will allow you to see what is called the black dots of tinea capitis very, very closely,” is far better, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation
He explained the limitations of the Wood’s lamp in this setting, and what to look for with a dermatoscope. He had other tips to share, too, from years of experience treating the condition, including how to differentiate tinea capitis on exam from its most common mimics, why it’s best to include a counter stain when using potassium hydroxide, and how to motivate parents to wash their child’s hair more frequently to reduce spores on the hair and scalp.
Dr. Silverman disclosed relationships with Pierre Fabre, Pfizer, and Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – When it comes to diagnosing tinea capitis, you really can’t rely on a Wood’s lamp, according to pediatric dermatologist Robert Silverman, MD.
The Wood’s lamp generally misses the most common cause of tinea capitis in urban and suburban environments today, Trichophyton tonsurans, said Dr. Silverman, a pediatric dermatologist and clinical associate professor in the department of pediatrics at Georgetown University, Washington.
The dermatoscope, which “will allow you to see what is called the black dots of tinea capitis very, very closely,” is far better, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation
He explained the limitations of the Wood’s lamp in this setting, and what to look for with a dermatoscope. He had other tips to share, too, from years of experience treating the condition, including how to differentiate tinea capitis on exam from its most common mimics, why it’s best to include a counter stain when using potassium hydroxide, and how to motivate parents to wash their child’s hair more frequently to reduce spores on the hair and scalp.
Dr. Silverman disclosed relationships with Pierre Fabre, Pfizer, and Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – When it comes to diagnosing tinea capitis, you really can’t rely on a Wood’s lamp, according to pediatric dermatologist Robert Silverman, MD.
The Wood’s lamp generally misses the most common cause of tinea capitis in urban and suburban environments today, Trichophyton tonsurans, said Dr. Silverman, a pediatric dermatologist and clinical associate professor in the department of pediatrics at Georgetown University, Washington.
The dermatoscope, which “will allow you to see what is called the black dots of tinea capitis very, very closely,” is far better, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation
He explained the limitations of the Wood’s lamp in this setting, and what to look for with a dermatoscope. He had other tips to share, too, from years of experience treating the condition, including how to differentiate tinea capitis on exam from its most common mimics, why it’s best to include a counter stain when using potassium hydroxide, and how to motivate parents to wash their child’s hair more frequently to reduce spores on the hair and scalp.
Dr. Silverman disclosed relationships with Pierre Fabre, Pfizer, and Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Off-label dupilumab finding a home in pediatric AD
KAUAI, HAWAII – Pediatric dermatologists aren’t waiting for Food and Drug Administration approval to try dupilumab (Dupixent) for their patients with severe atopic dermatitis.
It’s not approved in children, but the possibility of good control without the side effects of cyclosporine and other alternatives is too much to resist. A phase 2, company-sponsored study reported Eczema Area and Severity Index score improvements of up to 76% in pediatric patients treated with dupilumab, an interleukin-4 and IL-13 signaling blocker approved in 2017 for moderate to severe AD in adults.
Large pediatric trials are pending, but with results like that, “many of us just feel if it was our own kid, and we could get dupilumab, we would like to do that first,” said Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego.
It’s not just dupilumab that’s causing excitement. With almost 20 biologics in the pipeline, eczema seems poised to undergo a revolution in treatment much like psoriasis has in recent years.
Dr. Eichenfield explained (Eucrisa), a topical nonsteroidal phosphodiesterase-4 inhibitor approved for mild to moderate AD for children and adults ages two and older in December 2016, which doesn’t seem to have the duration limits of steroids, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Treatment of pediatric AD is “going to be a very different picture over the next few years,” he said.
Dr. Eichenfield is a consultant or investigator for many companies, including Regeneron/Sanofi, Genentech, Novartis, Pfizer, Lilly, and Allergan.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Pediatric dermatologists aren’t waiting for Food and Drug Administration approval to try dupilumab (Dupixent) for their patients with severe atopic dermatitis.
It’s not approved in children, but the possibility of good control without the side effects of cyclosporine and other alternatives is too much to resist. A phase 2, company-sponsored study reported Eczema Area and Severity Index score improvements of up to 76% in pediatric patients treated with dupilumab, an interleukin-4 and IL-13 signaling blocker approved in 2017 for moderate to severe AD in adults.
Large pediatric trials are pending, but with results like that, “many of us just feel if it was our own kid, and we could get dupilumab, we would like to do that first,” said Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego.
It’s not just dupilumab that’s causing excitement. With almost 20 biologics in the pipeline, eczema seems poised to undergo a revolution in treatment much like psoriasis has in recent years.
Dr. Eichenfield explained (Eucrisa), a topical nonsteroidal phosphodiesterase-4 inhibitor approved for mild to moderate AD for children and adults ages two and older in December 2016, which doesn’t seem to have the duration limits of steroids, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Treatment of pediatric AD is “going to be a very different picture over the next few years,” he said.
Dr. Eichenfield is a consultant or investigator for many companies, including Regeneron/Sanofi, Genentech, Novartis, Pfizer, Lilly, and Allergan.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Pediatric dermatologists aren’t waiting for Food and Drug Administration approval to try dupilumab (Dupixent) for their patients with severe atopic dermatitis.
It’s not approved in children, but the possibility of good control without the side effects of cyclosporine and other alternatives is too much to resist. A phase 2, company-sponsored study reported Eczema Area and Severity Index score improvements of up to 76% in pediatric patients treated with dupilumab, an interleukin-4 and IL-13 signaling blocker approved in 2017 for moderate to severe AD in adults.
Large pediatric trials are pending, but with results like that, “many of us just feel if it was our own kid, and we could get dupilumab, we would like to do that first,” said Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego.
It’s not just dupilumab that’s causing excitement. With almost 20 biologics in the pipeline, eczema seems poised to undergo a revolution in treatment much like psoriasis has in recent years.
Dr. Eichenfield explained (Eucrisa), a topical nonsteroidal phosphodiesterase-4 inhibitor approved for mild to moderate AD for children and adults ages two and older in December 2016, which doesn’t seem to have the duration limits of steroids, he said in an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Treatment of pediatric AD is “going to be a very different picture over the next few years,” he said.
Dr. Eichenfield is a consultant or investigator for many companies, including Regeneron/Sanofi, Genentech, Novartis, Pfizer, Lilly, and Allergan.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: The skinny on patch testing
KAUAI, HAWAII – .
That’s sometimes the assumption, but it’s incorrect, according to Mark Davis, MD, chair of the department of dermatology at the Mayo Clinic, Rochester, Minn. Tixocortol is the marker for topical steroid allergy in many series of patch tests, but there is research showing that it is a marker for one class of topical steroids, and “there’s substantial literature saying that if you’re only reacting to tixocortol pivalate, it should be safe to use other classes of topical steroids,” he said.
It’s also important to remember that skin patch tests need to be checked on day 5, not just day 3; it’s the only way to differentiate a true skin allergy from mere skin irritation, and it does matter.
Dr. Davis explained those issues and more – including what to do with minor reactions and how to use the T.R.U.E. TEST kit – in an interview filled with pearls at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Meanwhile, during a presentation at the meeting, he noted two newer options to help allergic patients find skin care products they won’t react to: the Mayo Clinic’s SkinSAFE database and the Contact Allergen Management Program from the American Contact Dermatitis Society.
Dr. Davis had no disclosures.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – .
That’s sometimes the assumption, but it’s incorrect, according to Mark Davis, MD, chair of the department of dermatology at the Mayo Clinic, Rochester, Minn. Tixocortol is the marker for topical steroid allergy in many series of patch tests, but there is research showing that it is a marker for one class of topical steroids, and “there’s substantial literature saying that if you’re only reacting to tixocortol pivalate, it should be safe to use other classes of topical steroids,” he said.
It’s also important to remember that skin patch tests need to be checked on day 5, not just day 3; it’s the only way to differentiate a true skin allergy from mere skin irritation, and it does matter.
Dr. Davis explained those issues and more – including what to do with minor reactions and how to use the T.R.U.E. TEST kit – in an interview filled with pearls at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Meanwhile, during a presentation at the meeting, he noted two newer options to help allergic patients find skin care products they won’t react to: the Mayo Clinic’s SkinSAFE database and the Contact Allergen Management Program from the American Contact Dermatitis Society.
Dr. Davis had no disclosures.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – .
That’s sometimes the assumption, but it’s incorrect, according to Mark Davis, MD, chair of the department of dermatology at the Mayo Clinic, Rochester, Minn. Tixocortol is the marker for topical steroid allergy in many series of patch tests, but there is research showing that it is a marker for one class of topical steroids, and “there’s substantial literature saying that if you’re only reacting to tixocortol pivalate, it should be safe to use other classes of topical steroids,” he said.
It’s also important to remember that skin patch tests need to be checked on day 5, not just day 3; it’s the only way to differentiate a true skin allergy from mere skin irritation, and it does matter.
Dr. Davis explained those issues and more – including what to do with minor reactions and how to use the T.R.U.E. TEST kit – in an interview filled with pearls at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Meanwhile, during a presentation at the meeting, he noted two newer options to help allergic patients find skin care products they won’t react to: the Mayo Clinic’s SkinSAFE database and the Contact Allergen Management Program from the American Contact Dermatitis Society.
Dr. Davis had no disclosures.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Painless PDT and other AK tricks
KAUAI, HAWAII – Imiquimod on the lip can be extremely painful, but it works wonders for actinic cheilitis, sometimes with only a few treatments.
Also, and how long patients stay under the lamp, advised Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
These are just a few of the tips Dr. Rosen shared in a presentation about AKs at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
In a video interview after his talk, he went into detail about the use of imiquimod for actinic cheilitis – AKs of the lip – and painless PDT, as well as how to discuss AKs with patients – and a quick, clever way to help distinguish AKs from squamous cell carcinoma.
Dr. Rosen is an adviser to Aclaris, Cipher, Pfizer, and Valeant.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Imiquimod on the lip can be extremely painful, but it works wonders for actinic cheilitis, sometimes with only a few treatments.
Also, and how long patients stay under the lamp, advised Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
These are just a few of the tips Dr. Rosen shared in a presentation about AKs at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
In a video interview after his talk, he went into detail about the use of imiquimod for actinic cheilitis – AKs of the lip – and painless PDT, as well as how to discuss AKs with patients – and a quick, clever way to help distinguish AKs from squamous cell carcinoma.
Dr. Rosen is an adviser to Aclaris, Cipher, Pfizer, and Valeant.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Imiquimod on the lip can be extremely painful, but it works wonders for actinic cheilitis, sometimes with only a few treatments.
Also, and how long patients stay under the lamp, advised Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
These are just a few of the tips Dr. Rosen shared in a presentation about AKs at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
In a video interview after his talk, he went into detail about the use of imiquimod for actinic cheilitis – AKs of the lip – and painless PDT, as well as how to discuss AKs with patients – and a quick, clever way to help distinguish AKs from squamous cell carcinoma.
Dr. Rosen is an adviser to Aclaris, Cipher, Pfizer, and Valeant.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: What to monitor during isotretinoin treatment
KAUAI, HAWAII – Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center, Morristown, N.J., recently changed how she monitors patients on isotretinoin.
The latest research indicates that ongoing CBCs really aren’t necessary, and that GGT (gamma-glutamyl transferase), which is liver specific, is a far better option than ALT/AST to keep tabs on the liver. Creatine kinase can’t be ignored, either, especially in young, athletic patients, because of the risk of rhabdomyolysis.
In a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Baldwin explained the thinking behind her new approach, plus what else needs to be monitored and for how long – and the level of creatine kinase that should raise a red flag for clinicians.
Dr. Baldwin is a speaker, advisor, and/or investigator for a number of companies, including Allergan, Galderma, and La Roche Posay.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center, Morristown, N.J., recently changed how she monitors patients on isotretinoin.
The latest research indicates that ongoing CBCs really aren’t necessary, and that GGT (gamma-glutamyl transferase), which is liver specific, is a far better option than ALT/AST to keep tabs on the liver. Creatine kinase can’t be ignored, either, especially in young, athletic patients, because of the risk of rhabdomyolysis.
In a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Baldwin explained the thinking behind her new approach, plus what else needs to be monitored and for how long – and the level of creatine kinase that should raise a red flag for clinicians.
Dr. Baldwin is a speaker, advisor, and/or investigator for a number of companies, including Allergan, Galderma, and La Roche Posay.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center, Morristown, N.J., recently changed how she monitors patients on isotretinoin.
The latest research indicates that ongoing CBCs really aren’t necessary, and that GGT (gamma-glutamyl transferase), which is liver specific, is a far better option than ALT/AST to keep tabs on the liver. Creatine kinase can’t be ignored, either, especially in young, athletic patients, because of the risk of rhabdomyolysis.
In a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Baldwin explained the thinking behind her new approach, plus what else needs to be monitored and for how long – and the level of creatine kinase that should raise a red flag for clinicians.
Dr. Baldwin is a speaker, advisor, and/or investigator for a number of companies, including Allergan, Galderma, and La Roche Posay.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Dupilumab or cyclosporine for treating atopic dermatitis?
KAUAI, HAWAII – Sometimes, older is better, according to Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland.
Dr. Simpson was a key investigator in trials that were the basis of dupilumab’s approval in 2017 for adults with moderate to severe atopic dermatitis (AD), but there’s still a role for cyclosporine and other old standbys, he said in a video interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
He said he’s asked all the time how to pick a systemic treatment for AD when topicals aren’t doing the trick. In the interview, he explained how dupilumab (Dupixent) fits into the picture, and how to select the right systemic therapy for the right patient. There are not a lot of data yet pointing to one option over the others for first-line treatment; a lot of it comes down to clinical smarts and patient preference.
Dr. Simpson is a consultant and/or investigator for a number of companies, including Eli Lilly, Pfizer, Novartis, and dupilumab manufacturer, Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Sometimes, older is better, according to Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland.
Dr. Simpson was a key investigator in trials that were the basis of dupilumab’s approval in 2017 for adults with moderate to severe atopic dermatitis (AD), but there’s still a role for cyclosporine and other old standbys, he said in a video interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
He said he’s asked all the time how to pick a systemic treatment for AD when topicals aren’t doing the trick. In the interview, he explained how dupilumab (Dupixent) fits into the picture, and how to select the right systemic therapy for the right patient. There are not a lot of data yet pointing to one option over the others for first-line treatment; a lot of it comes down to clinical smarts and patient preference.
Dr. Simpson is a consultant and/or investigator for a number of companies, including Eli Lilly, Pfizer, Novartis, and dupilumab manufacturer, Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Sometimes, older is better, according to Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland.
Dr. Simpson was a key investigator in trials that were the basis of dupilumab’s approval in 2017 for adults with moderate to severe atopic dermatitis (AD), but there’s still a role for cyclosporine and other old standbys, he said in a video interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
He said he’s asked all the time how to pick a systemic treatment for AD when topicals aren’t doing the trick. In the interview, he explained how dupilumab (Dupixent) fits into the picture, and how to select the right systemic therapy for the right patient. There are not a lot of data yet pointing to one option over the others for first-line treatment; a lot of it comes down to clinical smarts and patient preference.
Dr. Simpson is a consultant and/or investigator for a number of companies, including Eli Lilly, Pfizer, Novartis, and dupilumab manufacturer, Regeneron.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
Triple therapy ups response in refractory mantle cell lymphoma
A combination of ibrutinib, lenalidomide, and rituximab produced an overall response rate of 76% at 17.8 months median follow-up among 50 adults with relapsed or refractory mantle cell lymphoma, according to an open-label, single-arm, phase 2 trial.
There were complete responses in 28 patients (56%) and partial responses in 10 (20%). Median progression-free survival was 16 months and median overall survival was 22 months. Similar proportions of patients, with and without TP53 mutations, had overall and complete responses, suggesting that triple therapy might be particularly useful in patients with high-risk genetic features.
“Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomized controlled trial,” wrote Mats Jerkeman, MD, of Lund University, Sweden, and colleagues. The report was published in The Lancet Haematology.
“Addition of lenalidomide to ibrutinib and rituximab might increase the proportion of patients who have complete remission ... Previous studies reported complete responses in 44% of patients on ibrutinib and rituximab, in 36% of patients on rituximab and lenalidomide, and in 19% of patients on ibrutinib alone,” they wrote.
Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only, given until disease progression or unacceptable toxicity. All the patients had previously been treated with at least one rituximab-containing regimen.
Janssen and Celgene funded the work. Dr. Jerkeman reported ties to Janssen and Celgene, as well as AbbVie and Gilead.
SOURCE: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.
A combination of ibrutinib, lenalidomide, and rituximab produced an overall response rate of 76% at 17.8 months median follow-up among 50 adults with relapsed or refractory mantle cell lymphoma, according to an open-label, single-arm, phase 2 trial.
There were complete responses in 28 patients (56%) and partial responses in 10 (20%). Median progression-free survival was 16 months and median overall survival was 22 months. Similar proportions of patients, with and without TP53 mutations, had overall and complete responses, suggesting that triple therapy might be particularly useful in patients with high-risk genetic features.
“Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomized controlled trial,” wrote Mats Jerkeman, MD, of Lund University, Sweden, and colleagues. The report was published in The Lancet Haematology.
“Addition of lenalidomide to ibrutinib and rituximab might increase the proportion of patients who have complete remission ... Previous studies reported complete responses in 44% of patients on ibrutinib and rituximab, in 36% of patients on rituximab and lenalidomide, and in 19% of patients on ibrutinib alone,” they wrote.
Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only, given until disease progression or unacceptable toxicity. All the patients had previously been treated with at least one rituximab-containing regimen.
Janssen and Celgene funded the work. Dr. Jerkeman reported ties to Janssen and Celgene, as well as AbbVie and Gilead.
SOURCE: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.
A combination of ibrutinib, lenalidomide, and rituximab produced an overall response rate of 76% at 17.8 months median follow-up among 50 adults with relapsed or refractory mantle cell lymphoma, according to an open-label, single-arm, phase 2 trial.
There were complete responses in 28 patients (56%) and partial responses in 10 (20%). Median progression-free survival was 16 months and median overall survival was 22 months. Similar proportions of patients, with and without TP53 mutations, had overall and complete responses, suggesting that triple therapy might be particularly useful in patients with high-risk genetic features.
“Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomized controlled trial,” wrote Mats Jerkeman, MD, of Lund University, Sweden, and colleagues. The report was published in The Lancet Haematology.
“Addition of lenalidomide to ibrutinib and rituximab might increase the proportion of patients who have complete remission ... Previous studies reported complete responses in 44% of patients on ibrutinib and rituximab, in 36% of patients on rituximab and lenalidomide, and in 19% of patients on ibrutinib alone,” they wrote.
Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only, given until disease progression or unacceptable toxicity. All the patients had previously been treated with at least one rituximab-containing regimen.
Janssen and Celgene funded the work. Dr. Jerkeman reported ties to Janssen and Celgene, as well as AbbVie and Gilead.
SOURCE: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.
FROM THE LANCET HAEMATOLOGY
Key clinical point:
Major finding: The overall response from for the combination of the three drugs was 76% at 17.8 months median follow-up.
Study details: An open-label, single-arm, phase 2 trial of 50 adults with relapsed/refractory MCL.
Disclosures: Janssen and Celgene funded the work. Dr. Jerkeman reported ties to Janssen and Celgene, as well as AbbVie and Gilead.
Source: Jerkeman M et al. Lancet Haematol. 2018 Jan 29. doi: 10.1016/S2352-3026(18)30018-8.