Breast Cancer ICYMI

A former associate professor at Purdue University faked data in two published papers and hundreds of images in 16 grant applications, according to a U.S. government research watchdog. 

Alice C. Chang, PhD, whose publications and grants listed her name as Chun-Ju Chang, received nearly $700,000 in funding from the National Institutes of Health through grant applications that the U.S. Office of Research Integrity said contained fake data. She will be banned from receiving federal grants for a decade – a more severe sanction than ORI has typically imposed in recent years.

In its findings, ORI said Dr. Chang, who was an associate professor of basic medical sciences at Purdue’s College of Veterinary Medicine, West Lafayette, Ind., “knowingly, intentionally, or recklessly falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments in three hundred eighty-four (384) figure panels in sixteen (16) grant applications.”

Two of the grant applications were funded. Dr. Chang received $688,196 from the National Cancer Institute, a division of NIH, from 2018 to 2019 for “Targeting metformin-directed stem cell fate in triple negative breast cancer.” The other grant ORI says was submitted in 2014 and funded, “Targeting cell polarity machinery to exhaust breast cancer stem cell pool,” does not show up in NIH RePorter. The rest of the grants were not approved. 

We found a Chun-Ju Chang who is dean of the College of Life Sciences at China Medical University in Taiwan and has published papers with a group that Chun-Ju Chang at Purdue also published with. She did not immediately respond to our request for comment. 

ORI’s finding also stated Dr. Chang faked data in two papers supported by government funding by reusing figures reporting gene expression in mice and cells after drug treatments, relabeling them to say they showed the results of different experiments. According to the agency, she has agreed to request corrections for the papers: 

“Leptin–STAT3–G9a Signaling Promotes Obesity-Mediated Breast Cancer Progression,” published in May 2015 in Cancer Research and cited 83 times, according to Clarivate’s Web of Science. 

“Retinoic acid directs breast cancer cell state changes through regulation of TET2-PKC-zeta pathway,” published in February 2017 in Oncogene and cited 26 times. 

Between the two papers and 15 of the grant applications, ORI said that Dr. Chang reused gene expression data, sometimes with manipulation, in 119 figure panels. She reused other types of data and images in hundreds of figures across multiple grant applications, ORI found. 

As well as correcting the two papers, Dr. Chang agreed to a 10-year ban from all federal contracting, including grant funding. She also agreed not to serve in any advisory or consulting role with the U.S. Public Health Service, which includes the NIH, for that time period.

A version of this article first appeared on Retraction Watch.

A former associate professor at Purdue University faked data in two published papers and hundreds of images in 16 grant applications, according to a U.S. government research watchdog. 

Alice C. Chang, PhD, whose publications and grants listed her name as Chun-Ju Chang, received nearly $700,000 in funding from the National Institutes of Health through grant applications that the U.S. Office of Research Integrity said contained fake data. She will be banned from receiving federal grants for a decade – a more severe sanction than ORI has typically imposed in recent years.

In its findings, ORI said Dr. Chang, who was an associate professor of basic medical sciences at Purdue’s College of Veterinary Medicine, West Lafayette, Ind., “knowingly, intentionally, or recklessly falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments in three hundred eighty-four (384) figure panels in sixteen (16) grant applications.”

Two of the grant applications were funded. Dr. Chang received $688,196 from the National Cancer Institute, a division of NIH, from 2018 to 2019 for “Targeting metformin-directed stem cell fate in triple negative breast cancer.” The other grant ORI says was submitted in 2014 and funded, “Targeting cell polarity machinery to exhaust breast cancer stem cell pool,” does not show up in NIH RePorter. The rest of the grants were not approved. 

We found a Chun-Ju Chang who is dean of the College of Life Sciences at China Medical University in Taiwan and has published papers with a group that Chun-Ju Chang at Purdue also published with. She did not immediately respond to our request for comment. 

ORI’s finding also stated Dr. Chang faked data in two papers supported by government funding by reusing figures reporting gene expression in mice and cells after drug treatments, relabeling them to say they showed the results of different experiments. According to the agency, she has agreed to request corrections for the papers: 

“Leptin–STAT3–G9a Signaling Promotes Obesity-Mediated Breast Cancer Progression,” published in May 2015 in Cancer Research and cited 83 times, according to Clarivate’s Web of Science. 

“Retinoic acid directs breast cancer cell state changes through regulation of TET2-PKC-zeta pathway,” published in February 2017 in Oncogene and cited 26 times. 

Between the two papers and 15 of the grant applications, ORI said that Dr. Chang reused gene expression data, sometimes with manipulation, in 119 figure panels. She reused other types of data and images in hundreds of figures across multiple grant applications, ORI found. 

As well as correcting the two papers, Dr. Chang agreed to a 10-year ban from all federal contracting, including grant funding. She also agreed not to serve in any advisory or consulting role with the U.S. Public Health Service, which includes the NIH, for that time period.

A version of this article first appeared on Retraction Watch.

A former associate professor at Purdue University faked data in two published papers and hundreds of images in 16 grant applications, according to a U.S. government research watchdog. 

Alice C. Chang, PhD, whose publications and grants listed her name as Chun-Ju Chang, received nearly $700,000 in funding from the National Institutes of Health through grant applications that the U.S. Office of Research Integrity said contained fake data. She will be banned from receiving federal grants for a decade – a more severe sanction than ORI has typically imposed in recent years.

In its findings, ORI said Dr. Chang, who was an associate professor of basic medical sciences at Purdue’s College of Veterinary Medicine, West Lafayette, Ind., “knowingly, intentionally, or recklessly falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments in three hundred eighty-four (384) figure panels in sixteen (16) grant applications.”

Two of the grant applications were funded. Dr. Chang received $688,196 from the National Cancer Institute, a division of NIH, from 2018 to 2019 for “Targeting metformin-directed stem cell fate in triple negative breast cancer.” The other grant ORI says was submitted in 2014 and funded, “Targeting cell polarity machinery to exhaust breast cancer stem cell pool,” does not show up in NIH RePorter. The rest of the grants were not approved. 

We found a Chun-Ju Chang who is dean of the College of Life Sciences at China Medical University in Taiwan and has published papers with a group that Chun-Ju Chang at Purdue also published with. She did not immediately respond to our request for comment. 

ORI’s finding also stated Dr. Chang faked data in two papers supported by government funding by reusing figures reporting gene expression in mice and cells after drug treatments, relabeling them to say they showed the results of different experiments. According to the agency, she has agreed to request corrections for the papers: 

“Leptin–STAT3–G9a Signaling Promotes Obesity-Mediated Breast Cancer Progression,” published in May 2015 in Cancer Research and cited 83 times, according to Clarivate’s Web of Science. 

“Retinoic acid directs breast cancer cell state changes through regulation of TET2-PKC-zeta pathway,” published in February 2017 in Oncogene and cited 26 times. 

Between the two papers and 15 of the grant applications, ORI said that Dr. Chang reused gene expression data, sometimes with manipulation, in 119 figure panels. She reused other types of data and images in hundreds of figures across multiple grant applications, ORI found. 

As well as correcting the two papers, Dr. Chang agreed to a 10-year ban from all federal contracting, including grant funding. She also agreed not to serve in any advisory or consulting role with the U.S. Public Health Service, which includes the NIH, for that time period.

A version of this article first appeared on Retraction Watch.

Women who have survived hormone receptor–positive (HR+) breast cancer can interrupt their endocrine therapy for up to 2 years to pursue pregnancy without affecting their short-term disease outcomes, suggest results from the prospective POSITIVE trial.

The study involved more than 500 premenopausal women from 20 countries who had received at least 18 months of endocrine therapy for HR+ breast cancer. After a 3-month washout, they were given 2 years to conceive, deliver, and breastfeed a baby before resuming treatment.

Crucially, taking a treatment break had no impact on recurrence rates, with the 3-year breast cancer–free interval (BCFI) failure rate of nearly 9% comparing favorably with historical controls.

Moreover, almost three-quarters of women achieved at least one pregnancy, the majority within 2 years, and the vast majority had resumed endocrine therapy by the end of the study period.

The research was presented at the San Antonio Breast Cancer Symposium.

“These data stress the need to incorporate patient-centered reproductive health care, treatments, and choices in the treatment and follow-up of our young women with breast cancer so that they can not only survive, but thrive in their survivorship,” said study presenter Ann Partridge, MD, MPH, vice chair of medical oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, both in Boston.

She noted, however, that the results so far are from a 3-year follow-up. The team now plans on following the women for “at least a decade ... to monitor for independent therapy resumption, and disease outcomes, because of course there is great concern about the late return” of HR+ breast cancer.

This point was also raised by Marleen I. Meyers, MD, a medical oncologist New York University Langone Perlmutter Cancer Center, who was not involved in the study. While she praised the study as offering the “first real evidence” that treatment can be interrupted safely, she said she would be “cautious, as the follow-up is short and we know that hormone positive breast cancer can recur within 10 years of diagnosis and beyond.”

Meyer also emphasized that “the potential loss of fertility and ability to have biologic children ... [is] one of the most devastating results for young women with breast cancer.”

“We have come a long way with fertility preservation,” Dr. Meyers continued, but waiting to complete the recommended 5-10 years of endocrine therapy “makes the possibility of carrying a child less realistic.”

“This study offers hope for some women with hormone receptor–positive breast cancer to be able to interrupt cancer treatment and still have good outcomes,” she said.

Dr. Partridge said that “women are often discouraged” from becoming pregnant, in addition to which giving adjuvant endocrine therapy for the standard 5-10 years “compromises conception” in women with HR+ disease.

POSITIVE was a single-arm trial involving premenopausal women aged up to 42 years at study entry. They were required to have undergone at least 18 months and no more than 30 months of adjuvant endocrine therapy for stage I-III HR+ breast cancer, with no clinical evidence of recurrence. The women could also have undergone prior neoadjuvant chemotherapy with or without fertility preservation.

Women halted endocrine therapy within 1 month of trial enrollment and then underwent a 3-month washout period before having up to 2 years to attempt pregnancy, and to conceive, give birth to, and breastfeed a baby. They were then “strongly recommended” to resume endocrine therapy to complete the planned 5-10 years of treatment, with follow-up planned for up to 10 years.

In all, 518 women were enrolled at 116 centers in 20 countries on four continents, of whom 516 were available for the primary efficacy analysis. The median time from breast cancer diagnosis to enrollment was 29 months.

The median age of the participants at enrollment was 37 years, and 75% had no prior births. Stage I or II disease was diagnosed in 93%. The median duration of endocrine therapy prior to enrollment was 23.4 months.

Selective estrogen receptor modulators were given alone in 42% of patients, while 36% had a SERM plus ovarian function suppression. A further 16% of women received an aromatase inhibitor alongside ovarian function suppression. The majority (62%) of women had received prior neoadjuvant chemotherapy.

The primary endpoint of 3-year BCFI was measured after a median follow-up of 41 months. There were 44 events, with a 3-year BCFI failure rate of 8.9%. The 3-year distant recurrence–free interval (DRFI) failure rate was calculated at 4.5%, with 22 events.

To provide an external control, the researchers examined data from the SOFT and TEXT trials to assemble a cohort of 1,499 women balanced for patient, disease, and treatment characteristics.

This revealed no significant differences in BCFI between the two groups (hazard ratio, 0.81; 95% confidence interval, 0.57-1.15) and a difference in BCFI rates at 3 years of 0.2% between the SOFT, TEXT, and POSITIVE trials.

There was also no significant difference in DRFI rates (HR, 0.70; 95% CI, 0.44-1.12), with a 3-year rate difference of 1.4%.

For the secondary endpoint analysis, the team included 497 women from the POSITIVE cohort, of whom 368 (74%) had at least one pregnancy, giving a total of 507 pregnancies. At least one live birth was recorded in 64% of the women, or 86% of those who became pregnant.

Dr. Partridge noted that around 43% of women used some form of assisted reproductive technology at some point during the study period.

Pregnancy complications were observed in 11% of pregnancies, the most common of which were hypertension/preeclampsia in 3%, and diabetes in 2%.

There were a total of 350 live births in 317 women, including 335 singleton births and 15 sets of twins. Only 8% of the offspring had a low birth weight, and 2% had a birth defect. Breastfeeding was reported by 62% of women.

Conducting an 18-month landmark analysis, the team found that pregnancy did not increase BCFI rates, at an HR versus nonpregnant women of 0.53 after controlling for age, body mass index, lymph node status, prior chemotherapy, and prior aromatase inhibitor therapy.

At 48 months of follow-up, 76% of women had resumed endocrine therapy. A further 8% of women had cancer recurrence or death before they could restart therapy, while 15% had not yet resumed treatment for other reasons.

Among disease-free women who had not resumed endocrine therapy, 79% reported at their most recent follow-up continuing to pursue pregnancy, having an active or recent pregnancy, or continuing to breastfeed as the reason.

Commenting on the study, Jennifer K. Litton, MD, vice president of clinical research at University of Texas MD Anderson Cancer Center, Houston, said that this was a “challenging study to design and execute.”

“It gives us really a first look into the safety of a practice that was already happening,” she commented, and emphasized that the interruption of treatment to pursue pregnancy remains “an exceptionally individual decision.”

Dr. Litton also underlined that these results apply only to endocrine therapy and not to women on other therapies such as abemaciclib, for example, for which the course should be “fully completed” before considering any treatment interruptions.

She added more generally that “we need to continue to improve discussing fertility concerns with our breast cancer patients who want future pregnancies.”

The study was sponsored and conducted by the International Breast Cancer Study Group, a division of ETOP IBCSG Partners Foundation, and by the Alliance for Clinical Trials in Oncology in North America, in collaboration with the Breast International Group. Dr. Partridge and Dr. Litton reported no relevant relationships.

A version of this article first appeared on Medscape.com.

Women who have survived hormone receptor–positive (HR+) breast cancer can interrupt their endocrine therapy for up to 2 years to pursue pregnancy without affecting their short-term disease outcomes, suggest results from the prospective POSITIVE trial.

The study involved more than 500 premenopausal women from 20 countries who had received at least 18 months of endocrine therapy for HR+ breast cancer. After a 3-month washout, they were given 2 years to conceive, deliver, and breastfeed a baby before resuming treatment.

Crucially, taking a treatment break had no impact on recurrence rates, with the 3-year breast cancer–free interval (BCFI) failure rate of nearly 9% comparing favorably with historical controls.

Moreover, almost three-quarters of women achieved at least one pregnancy, the majority within 2 years, and the vast majority had resumed endocrine therapy by the end of the study period.

The research was presented at the San Antonio Breast Cancer Symposium.

“These data stress the need to incorporate patient-centered reproductive health care, treatments, and choices in the treatment and follow-up of our young women with breast cancer so that they can not only survive, but thrive in their survivorship,” said study presenter Ann Partridge, MD, MPH, vice chair of medical oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, both in Boston.

She noted, however, that the results so far are from a 3-year follow-up. The team now plans on following the women for “at least a decade ... to monitor for independent therapy resumption, and disease outcomes, because of course there is great concern about the late return” of HR+ breast cancer.

This point was also raised by Marleen I. Meyers, MD, a medical oncologist New York University Langone Perlmutter Cancer Center, who was not involved in the study. While she praised the study as offering the “first real evidence” that treatment can be interrupted safely, she said she would be “cautious, as the follow-up is short and we know that hormone positive breast cancer can recur within 10 years of diagnosis and beyond.”

Meyer also emphasized that “the potential loss of fertility and ability to have biologic children ... [is] one of the most devastating results for young women with breast cancer.”

“We have come a long way with fertility preservation,” Dr. Meyers continued, but waiting to complete the recommended 5-10 years of endocrine therapy “makes the possibility of carrying a child less realistic.”

“This study offers hope for some women with hormone receptor–positive breast cancer to be able to interrupt cancer treatment and still have good outcomes,” she said.

Dr. Partridge said that “women are often discouraged” from becoming pregnant, in addition to which giving adjuvant endocrine therapy for the standard 5-10 years “compromises conception” in women with HR+ disease.

POSITIVE was a single-arm trial involving premenopausal women aged up to 42 years at study entry. They were required to have undergone at least 18 months and no more than 30 months of adjuvant endocrine therapy for stage I-III HR+ breast cancer, with no clinical evidence of recurrence. The women could also have undergone prior neoadjuvant chemotherapy with or without fertility preservation.

Women halted endocrine therapy within 1 month of trial enrollment and then underwent a 3-month washout period before having up to 2 years to attempt pregnancy, and to conceive, give birth to, and breastfeed a baby. They were then “strongly recommended” to resume endocrine therapy to complete the planned 5-10 years of treatment, with follow-up planned for up to 10 years.

In all, 518 women were enrolled at 116 centers in 20 countries on four continents, of whom 516 were available for the primary efficacy analysis. The median time from breast cancer diagnosis to enrollment was 29 months.

The median age of the participants at enrollment was 37 years, and 75% had no prior births. Stage I or II disease was diagnosed in 93%. The median duration of endocrine therapy prior to enrollment was 23.4 months.

Selective estrogen receptor modulators were given alone in 42% of patients, while 36% had a SERM plus ovarian function suppression. A further 16% of women received an aromatase inhibitor alongside ovarian function suppression. The majority (62%) of women had received prior neoadjuvant chemotherapy.

The primary endpoint of 3-year BCFI was measured after a median follow-up of 41 months. There were 44 events, with a 3-year BCFI failure rate of 8.9%. The 3-year distant recurrence–free interval (DRFI) failure rate was calculated at 4.5%, with 22 events.

To provide an external control, the researchers examined data from the SOFT and TEXT trials to assemble a cohort of 1,499 women balanced for patient, disease, and treatment characteristics.

This revealed no significant differences in BCFI between the two groups (hazard ratio, 0.81; 95% confidence interval, 0.57-1.15) and a difference in BCFI rates at 3 years of 0.2% between the SOFT, TEXT, and POSITIVE trials.

There was also no significant difference in DRFI rates (HR, 0.70; 95% CI, 0.44-1.12), with a 3-year rate difference of 1.4%.

For the secondary endpoint analysis, the team included 497 women from the POSITIVE cohort, of whom 368 (74%) had at least one pregnancy, giving a total of 507 pregnancies. At least one live birth was recorded in 64% of the women, or 86% of those who became pregnant.

Dr. Partridge noted that around 43% of women used some form of assisted reproductive technology at some point during the study period.

Pregnancy complications were observed in 11% of pregnancies, the most common of which were hypertension/preeclampsia in 3%, and diabetes in 2%.

There were a total of 350 live births in 317 women, including 335 singleton births and 15 sets of twins. Only 8% of the offspring had a low birth weight, and 2% had a birth defect. Breastfeeding was reported by 62% of women.

Conducting an 18-month landmark analysis, the team found that pregnancy did not increase BCFI rates, at an HR versus nonpregnant women of 0.53 after controlling for age, body mass index, lymph node status, prior chemotherapy, and prior aromatase inhibitor therapy.

At 48 months of follow-up, 76% of women had resumed endocrine therapy. A further 8% of women had cancer recurrence or death before they could restart therapy, while 15% had not yet resumed treatment for other reasons.

Among disease-free women who had not resumed endocrine therapy, 79% reported at their most recent follow-up continuing to pursue pregnancy, having an active or recent pregnancy, or continuing to breastfeed as the reason.

Commenting on the study, Jennifer K. Litton, MD, vice president of clinical research at University of Texas MD Anderson Cancer Center, Houston, said that this was a “challenging study to design and execute.”

“It gives us really a first look into the safety of a practice that was already happening,” she commented, and emphasized that the interruption of treatment to pursue pregnancy remains “an exceptionally individual decision.”

Dr. Litton also underlined that these results apply only to endocrine therapy and not to women on other therapies such as abemaciclib, for example, for which the course should be “fully completed” before considering any treatment interruptions.

She added more generally that “we need to continue to improve discussing fertility concerns with our breast cancer patients who want future pregnancies.”

The study was sponsored and conducted by the International Breast Cancer Study Group, a division of ETOP IBCSG Partners Foundation, and by the Alliance for Clinical Trials in Oncology in North America, in collaboration with the Breast International Group. Dr. Partridge and Dr. Litton reported no relevant relationships.

A version of this article first appeared on Medscape.com.

Women who have survived hormone receptor–positive (HR+) breast cancer can interrupt their endocrine therapy for up to 2 years to pursue pregnancy without affecting their short-term disease outcomes, suggest results from the prospective POSITIVE trial.

The study involved more than 500 premenopausal women from 20 countries who had received at least 18 months of endocrine therapy for HR+ breast cancer. After a 3-month washout, they were given 2 years to conceive, deliver, and breastfeed a baby before resuming treatment.

Crucially, taking a treatment break had no impact on recurrence rates, with the 3-year breast cancer–free interval (BCFI) failure rate of nearly 9% comparing favorably with historical controls.

Moreover, almost three-quarters of women achieved at least one pregnancy, the majority within 2 years, and the vast majority had resumed endocrine therapy by the end of the study period.

The research was presented at the San Antonio Breast Cancer Symposium.

“These data stress the need to incorporate patient-centered reproductive health care, treatments, and choices in the treatment and follow-up of our young women with breast cancer so that they can not only survive, but thrive in their survivorship,” said study presenter Ann Partridge, MD, MPH, vice chair of medical oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, both in Boston.

She noted, however, that the results so far are from a 3-year follow-up. The team now plans on following the women for “at least a decade ... to monitor for independent therapy resumption, and disease outcomes, because of course there is great concern about the late return” of HR+ breast cancer.

This point was also raised by Marleen I. Meyers, MD, a medical oncologist New York University Langone Perlmutter Cancer Center, who was not involved in the study. While she praised the study as offering the “first real evidence” that treatment can be interrupted safely, she said she would be “cautious, as the follow-up is short and we know that hormone positive breast cancer can recur within 10 years of diagnosis and beyond.”

Meyer also emphasized that “the potential loss of fertility and ability to have biologic children ... [is] one of the most devastating results for young women with breast cancer.”

“We have come a long way with fertility preservation,” Dr. Meyers continued, but waiting to complete the recommended 5-10 years of endocrine therapy “makes the possibility of carrying a child less realistic.”

“This study offers hope for some women with hormone receptor–positive breast cancer to be able to interrupt cancer treatment and still have good outcomes,” she said.

Dr. Partridge said that “women are often discouraged” from becoming pregnant, in addition to which giving adjuvant endocrine therapy for the standard 5-10 years “compromises conception” in women with HR+ disease.

POSITIVE was a single-arm trial involving premenopausal women aged up to 42 years at study entry. They were required to have undergone at least 18 months and no more than 30 months of adjuvant endocrine therapy for stage I-III HR+ breast cancer, with no clinical evidence of recurrence. The women could also have undergone prior neoadjuvant chemotherapy with or without fertility preservation.

Women halted endocrine therapy within 1 month of trial enrollment and then underwent a 3-month washout period before having up to 2 years to attempt pregnancy, and to conceive, give birth to, and breastfeed a baby. They were then “strongly recommended” to resume endocrine therapy to complete the planned 5-10 years of treatment, with follow-up planned for up to 10 years.

In all, 518 women were enrolled at 116 centers in 20 countries on four continents, of whom 516 were available for the primary efficacy analysis. The median time from breast cancer diagnosis to enrollment was 29 months.

The median age of the participants at enrollment was 37 years, and 75% had no prior births. Stage I or II disease was diagnosed in 93%. The median duration of endocrine therapy prior to enrollment was 23.4 months.

Selective estrogen receptor modulators were given alone in 42% of patients, while 36% had a SERM plus ovarian function suppression. A further 16% of women received an aromatase inhibitor alongside ovarian function suppression. The majority (62%) of women had received prior neoadjuvant chemotherapy.

The primary endpoint of 3-year BCFI was measured after a median follow-up of 41 months. There were 44 events, with a 3-year BCFI failure rate of 8.9%. The 3-year distant recurrence–free interval (DRFI) failure rate was calculated at 4.5%, with 22 events.

To provide an external control, the researchers examined data from the SOFT and TEXT trials to assemble a cohort of 1,499 women balanced for patient, disease, and treatment characteristics.

This revealed no significant differences in BCFI between the two groups (hazard ratio, 0.81; 95% confidence interval, 0.57-1.15) and a difference in BCFI rates at 3 years of 0.2% between the SOFT, TEXT, and POSITIVE trials.

There was also no significant difference in DRFI rates (HR, 0.70; 95% CI, 0.44-1.12), with a 3-year rate difference of 1.4%.

For the secondary endpoint analysis, the team included 497 women from the POSITIVE cohort, of whom 368 (74%) had at least one pregnancy, giving a total of 507 pregnancies. At least one live birth was recorded in 64% of the women, or 86% of those who became pregnant.

Dr. Partridge noted that around 43% of women used some form of assisted reproductive technology at some point during the study period.

Pregnancy complications were observed in 11% of pregnancies, the most common of which were hypertension/preeclampsia in 3%, and diabetes in 2%.

There were a total of 350 live births in 317 women, including 335 singleton births and 15 sets of twins. Only 8% of the offspring had a low birth weight, and 2% had a birth defect. Breastfeeding was reported by 62% of women.

Conducting an 18-month landmark analysis, the team found that pregnancy did not increase BCFI rates, at an HR versus nonpregnant women of 0.53 after controlling for age, body mass index, lymph node status, prior chemotherapy, and prior aromatase inhibitor therapy.

At 48 months of follow-up, 76% of women had resumed endocrine therapy. A further 8% of women had cancer recurrence or death before they could restart therapy, while 15% had not yet resumed treatment for other reasons.

Among disease-free women who had not resumed endocrine therapy, 79% reported at their most recent follow-up continuing to pursue pregnancy, having an active or recent pregnancy, or continuing to breastfeed as the reason.

Commenting on the study, Jennifer K. Litton, MD, vice president of clinical research at University of Texas MD Anderson Cancer Center, Houston, said that this was a “challenging study to design and execute.”

“It gives us really a first look into the safety of a practice that was already happening,” she commented, and emphasized that the interruption of treatment to pursue pregnancy remains “an exceptionally individual decision.”

Dr. Litton also underlined that these results apply only to endocrine therapy and not to women on other therapies such as abemaciclib, for example, for which the course should be “fully completed” before considering any treatment interruptions.

She added more generally that “we need to continue to improve discussing fertility concerns with our breast cancer patients who want future pregnancies.”

The study was sponsored and conducted by the International Breast Cancer Study Group, a division of ETOP IBCSG Partners Foundation, and by the Alliance for Clinical Trials in Oncology in North America, in collaboration with the Breast International Group. Dr. Partridge and Dr. Litton reported no relevant relationships.

A version of this article first appeared on Medscape.com.

SAN ANTONIO – While major reports on hormone receptor (HR)–positive breast cancer took center stage at the San Antonio Breast Cancer Symposium, research highlighting new findings in triple-negative breast cancer (TNBC) stood out as well.

This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Kevin Kalinsky, MD, a medical oncologist and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University in Atlanta, about the TNBC data that caught their eye and what the findings could mean for clinical practice.
 

1. Carboplatin for TNBC

Dr. Kalinsky’s first pick was a study on the impact of platinum therapy on long-term TNBC outcomes.

The phase 3 randomized controlled trial, presented in general session (GS) 5-01, explored whether adding carboplatin to sequential taxane-anthracycline neoadjuvant chemotherapy for patients with TNBC improved disease-free survival, pathologic complete response, or overall survival.

Overall, 365 patients received carboplatin, and 355 did not. At a median follow-up of 67.6 months, the 5-year disease-free survival rate was 70.6% in the carboplatin group vs. 64.5% in the control arm (hazard ratio, 0.79); the 5-year overall survival was also higher in the carboplatin group (74.0% vs. 66.7%; HR, 0.75). Pathologic complete response occurred in 55.2% of carboplatin patients, vs. 41.5% of control patients.

“These results are important,” Dr. Kalinsky said. “The results of this study suggest that there is a benefit to the TNBC population from being treated with carboplatin.”

Dr. Kalinsky cautioned, however, that despite the encouraging results, it remains unclear whether there is a specific biomarker for selecting patients who may derive the most benefit from treatment with carboplatin. “This remains an outstanding question,” he said.
 

2. Risk of contralateral breast cancer

Women with breast cancer who have germline pathogenic variants in BRCA1, BRCA2, CHEK2, or PALB2 had nearly double the risk of contralateral breast cancer in comparison with patients without those variants, according to recent data presented at the meeting (GS4-04).

Researchers estimated the risk of contralateral breast cancer in women with pathogenic variants in comparison with control patients. They found that having ATM does not increase this risk.

“The reason this study is important is that many women with these mutations want to have a bilateral mastectomy, but thus far, the data have been unclear, and the question is, are they going to benefit from having a bilateral mastectomy?” said Dr. Kaklamani. “The results of this study help shine a light on what mutations might warrant a bilateral mastectomy. Most of these patients are going to be triple negative.”

Hal Burstein, MD, also weighed in, saying the “data should allow many to avoid prophylactic mastectomy.”
 

3. Cemiplimab plus LAG-3 inhibitor in TNBC

Another session that caught Dr. Kalinsky’s attention explored results from the I-SPY2 trial (GS5-03), which evaluated the use of the checkpoint inhibitior cemiplimab in combination with LAG-3 inhibitor REGN3767 for patients with early-stage, high-risk, HER2-negative breast cancer.

Among the 73 patients with HER2-negative disease who received cemiplimab plus REGN3767, 33 had TNBC. The control group included 357 patients with HER2-negative tumors, of whom 156 had TNBC. Overall, the combination of a LAG-3 and anti-PD1 inhibitor resulted in a pathologic complete response rate of 60% for patients with TNBC and 37% for patients with HR-positive disease.

“We know that checkpoint inhibitors benefit patients with TNBC, and there has been a lot of interest in looking beyond checkpoint inhibition,” said Dr. Kalinsky, who is a coinvestigator on the I-SPY trial. “LAG-3 has been a target of interest, and this is the first study looking in the neoadjuvant setting of giving a LAG-3 inhibitor along with a checkpoint inhibitor.”
 

4. Efficacy vs. side effect profile of cemiplimab

Taking adverse events of immune checkpoint inhibitors into account is also important. Dr. Kalinsky and colleagues presented research on the efficacy as well as the side-effect profile associated with cemiplimab (PD11-01) among patients in the I-SPY trial.

Overall, cemiplimab was associated with a higher pathologic complete response rate for patients with TNBC (55%), compared with control patients who received paclitaxel followed by doxorubicin/cyclophosphamide (29%). The rate of immune-related adverse events was higher in the cemiplimab group: hypothyroidism, 3% vs. 0%; adrenal insufficiency, 6% vs. 0%; hyperthyroid, 8% vs. 0%; and thyroiditis, 3% vs. 0%. However, only one case of grade 3 adrenal insufficiency occurred in the cemiplimab arm.

“I really think the key takeaway is not just the efficacy that is seen in the HER2-negative population but also what the side-effect profile is going to be,” Dr. Kalinsky said.
 

5. Olaparib or carboplatinum?

Dr. Kaklamani highlighted data from the GeparOLA study (GS5-02), which evaluated the efficacy and safety of using olaparib instead of carboplatinum along with paclitaxel as neoadjuvant chemotherapy in early-stage HER2-negative breast cancer.

The results of the study indicate that among patients in the cohort with HER2-negative homologous recombination deficiency tumors – those with a g/tBRCA mutation – the two groups had similar pathologic complete responses. Overall, patients in the olaparib group had more invasive disease-free survival events (15 vs. 3), more distant disease-free survival events (11 vs. 2), and more deaths (6 vs. 1). However, when comparing patients with a g/tBRCA mutation, outcomes were comparable in both arms.

“The majority of these patients were triple negative, and I think the importance here is that this [study] shows us whether we should be adding olaparib in some patients who have a homologous recombination deficiency,” Dr. Kaklamani said.

A version of this article first appeared on Medscape.com.

SAN ANTONIO – While major reports on hormone receptor (HR)–positive breast cancer took center stage at the San Antonio Breast Cancer Symposium, research highlighting new findings in triple-negative breast cancer (TNBC) stood out as well.

This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Kevin Kalinsky, MD, a medical oncologist and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University in Atlanta, about the TNBC data that caught their eye and what the findings could mean for clinical practice.
 

1. Carboplatin for TNBC

Dr. Kalinsky’s first pick was a study on the impact of platinum therapy on long-term TNBC outcomes.

The phase 3 randomized controlled trial, presented in general session (GS) 5-01, explored whether adding carboplatin to sequential taxane-anthracycline neoadjuvant chemotherapy for patients with TNBC improved disease-free survival, pathologic complete response, or overall survival.

Overall, 365 patients received carboplatin, and 355 did not. At a median follow-up of 67.6 months, the 5-year disease-free survival rate was 70.6% in the carboplatin group vs. 64.5% in the control arm (hazard ratio, 0.79); the 5-year overall survival was also higher in the carboplatin group (74.0% vs. 66.7%; HR, 0.75). Pathologic complete response occurred in 55.2% of carboplatin patients, vs. 41.5% of control patients.

“These results are important,” Dr. Kalinsky said. “The results of this study suggest that there is a benefit to the TNBC population from being treated with carboplatin.”

Dr. Kalinsky cautioned, however, that despite the encouraging results, it remains unclear whether there is a specific biomarker for selecting patients who may derive the most benefit from treatment with carboplatin. “This remains an outstanding question,” he said.
 

2. Risk of contralateral breast cancer

Women with breast cancer who have germline pathogenic variants in BRCA1, BRCA2, CHEK2, or PALB2 had nearly double the risk of contralateral breast cancer in comparison with patients without those variants, according to recent data presented at the meeting (GS4-04).

Researchers estimated the risk of contralateral breast cancer in women with pathogenic variants in comparison with control patients. They found that having ATM does not increase this risk.

“The reason this study is important is that many women with these mutations want to have a bilateral mastectomy, but thus far, the data have been unclear, and the question is, are they going to benefit from having a bilateral mastectomy?” said Dr. Kaklamani. “The results of this study help shine a light on what mutations might warrant a bilateral mastectomy. Most of these patients are going to be triple negative.”

Hal Burstein, MD, also weighed in, saying the “data should allow many to avoid prophylactic mastectomy.”
 

3. Cemiplimab plus LAG-3 inhibitor in TNBC

Another session that caught Dr. Kalinsky’s attention explored results from the I-SPY2 trial (GS5-03), which evaluated the use of the checkpoint inhibitior cemiplimab in combination with LAG-3 inhibitor REGN3767 for patients with early-stage, high-risk, HER2-negative breast cancer.

Among the 73 patients with HER2-negative disease who received cemiplimab plus REGN3767, 33 had TNBC. The control group included 357 patients with HER2-negative tumors, of whom 156 had TNBC. Overall, the combination of a LAG-3 and anti-PD1 inhibitor resulted in a pathologic complete response rate of 60% for patients with TNBC and 37% for patients with HR-positive disease.

“We know that checkpoint inhibitors benefit patients with TNBC, and there has been a lot of interest in looking beyond checkpoint inhibition,” said Dr. Kalinsky, who is a coinvestigator on the I-SPY trial. “LAG-3 has been a target of interest, and this is the first study looking in the neoadjuvant setting of giving a LAG-3 inhibitor along with a checkpoint inhibitor.”
 

4. Efficacy vs. side effect profile of cemiplimab

Taking adverse events of immune checkpoint inhibitors into account is also important. Dr. Kalinsky and colleagues presented research on the efficacy as well as the side-effect profile associated with cemiplimab (PD11-01) among patients in the I-SPY trial.

Overall, cemiplimab was associated with a higher pathologic complete response rate for patients with TNBC (55%), compared with control patients who received paclitaxel followed by doxorubicin/cyclophosphamide (29%). The rate of immune-related adverse events was higher in the cemiplimab group: hypothyroidism, 3% vs. 0%; adrenal insufficiency, 6% vs. 0%; hyperthyroid, 8% vs. 0%; and thyroiditis, 3% vs. 0%. However, only one case of grade 3 adrenal insufficiency occurred in the cemiplimab arm.

“I really think the key takeaway is not just the efficacy that is seen in the HER2-negative population but also what the side-effect profile is going to be,” Dr. Kalinsky said.
 

5. Olaparib or carboplatinum?

Dr. Kaklamani highlighted data from the GeparOLA study (GS5-02), which evaluated the efficacy and safety of using olaparib instead of carboplatinum along with paclitaxel as neoadjuvant chemotherapy in early-stage HER2-negative breast cancer.

The results of the study indicate that among patients in the cohort with HER2-negative homologous recombination deficiency tumors – those with a g/tBRCA mutation – the two groups had similar pathologic complete responses. Overall, patients in the olaparib group had more invasive disease-free survival events (15 vs. 3), more distant disease-free survival events (11 vs. 2), and more deaths (6 vs. 1). However, when comparing patients with a g/tBRCA mutation, outcomes were comparable in both arms.

“The majority of these patients were triple negative, and I think the importance here is that this [study] shows us whether we should be adding olaparib in some patients who have a homologous recombination deficiency,” Dr. Kaklamani said.

A version of this article first appeared on Medscape.com.

SAN ANTONIO – While major reports on hormone receptor (HR)–positive breast cancer took center stage at the San Antonio Breast Cancer Symposium, research highlighting new findings in triple-negative breast cancer (TNBC) stood out as well.

This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Kevin Kalinsky, MD, a medical oncologist and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University in Atlanta, about the TNBC data that caught their eye and what the findings could mean for clinical practice.
 

1. Carboplatin for TNBC

Dr. Kalinsky’s first pick was a study on the impact of platinum therapy on long-term TNBC outcomes.

The phase 3 randomized controlled trial, presented in general session (GS) 5-01, explored whether adding carboplatin to sequential taxane-anthracycline neoadjuvant chemotherapy for patients with TNBC improved disease-free survival, pathologic complete response, or overall survival.

Overall, 365 patients received carboplatin, and 355 did not. At a median follow-up of 67.6 months, the 5-year disease-free survival rate was 70.6% in the carboplatin group vs. 64.5% in the control arm (hazard ratio, 0.79); the 5-year overall survival was also higher in the carboplatin group (74.0% vs. 66.7%; HR, 0.75). Pathologic complete response occurred in 55.2% of carboplatin patients, vs. 41.5% of control patients.

“These results are important,” Dr. Kalinsky said. “The results of this study suggest that there is a benefit to the TNBC population from being treated with carboplatin.”

Dr. Kalinsky cautioned, however, that despite the encouraging results, it remains unclear whether there is a specific biomarker for selecting patients who may derive the most benefit from treatment with carboplatin. “This remains an outstanding question,” he said.
 

2. Risk of contralateral breast cancer

Women with breast cancer who have germline pathogenic variants in BRCA1, BRCA2, CHEK2, or PALB2 had nearly double the risk of contralateral breast cancer in comparison with patients without those variants, according to recent data presented at the meeting (GS4-04).

Researchers estimated the risk of contralateral breast cancer in women with pathogenic variants in comparison with control patients. They found that having ATM does not increase this risk.

“The reason this study is important is that many women with these mutations want to have a bilateral mastectomy, but thus far, the data have been unclear, and the question is, are they going to benefit from having a bilateral mastectomy?” said Dr. Kaklamani. “The results of this study help shine a light on what mutations might warrant a bilateral mastectomy. Most of these patients are going to be triple negative.”

Hal Burstein, MD, also weighed in, saying the “data should allow many to avoid prophylactic mastectomy.”
 

3. Cemiplimab plus LAG-3 inhibitor in TNBC

Another session that caught Dr. Kalinsky’s attention explored results from the I-SPY2 trial (GS5-03), which evaluated the use of the checkpoint inhibitior cemiplimab in combination with LAG-3 inhibitor REGN3767 for patients with early-stage, high-risk, HER2-negative breast cancer.

Among the 73 patients with HER2-negative disease who received cemiplimab plus REGN3767, 33 had TNBC. The control group included 357 patients with HER2-negative tumors, of whom 156 had TNBC. Overall, the combination of a LAG-3 and anti-PD1 inhibitor resulted in a pathologic complete response rate of 60% for patients with TNBC and 37% for patients with HR-positive disease.

“We know that checkpoint inhibitors benefit patients with TNBC, and there has been a lot of interest in looking beyond checkpoint inhibition,” said Dr. Kalinsky, who is a coinvestigator on the I-SPY trial. “LAG-3 has been a target of interest, and this is the first study looking in the neoadjuvant setting of giving a LAG-3 inhibitor along with a checkpoint inhibitor.”
 

4. Efficacy vs. side effect profile of cemiplimab

Taking adverse events of immune checkpoint inhibitors into account is also important. Dr. Kalinsky and colleagues presented research on the efficacy as well as the side-effect profile associated with cemiplimab (PD11-01) among patients in the I-SPY trial.

Overall, cemiplimab was associated with a higher pathologic complete response rate for patients with TNBC (55%), compared with control patients who received paclitaxel followed by doxorubicin/cyclophosphamide (29%). The rate of immune-related adverse events was higher in the cemiplimab group: hypothyroidism, 3% vs. 0%; adrenal insufficiency, 6% vs. 0%; hyperthyroid, 8% vs. 0%; and thyroiditis, 3% vs. 0%. However, only one case of grade 3 adrenal insufficiency occurred in the cemiplimab arm.

“I really think the key takeaway is not just the efficacy that is seen in the HER2-negative population but also what the side-effect profile is going to be,” Dr. Kalinsky said.
 

5. Olaparib or carboplatinum?

Dr. Kaklamani highlighted data from the GeparOLA study (GS5-02), which evaluated the efficacy and safety of using olaparib instead of carboplatinum along with paclitaxel as neoadjuvant chemotherapy in early-stage HER2-negative breast cancer.

The results of the study indicate that among patients in the cohort with HER2-negative homologous recombination deficiency tumors – those with a g/tBRCA mutation – the two groups had similar pathologic complete responses. Overall, patients in the olaparib group had more invasive disease-free survival events (15 vs. 3), more distant disease-free survival events (11 vs. 2), and more deaths (6 vs. 1). However, when comparing patients with a g/tBRCA mutation, outcomes were comparable in both arms.

“The majority of these patients were triple negative, and I think the importance here is that this [study] shows us whether we should be adding olaparib in some patients who have a homologous recombination deficiency,” Dr. Kaklamani said.

A version of this article first appeared on Medscape.com.

In a small randomized controlled trial of patients with type 2 diabetes in China, close to half of those who followed a novel intermittent fasting program for 3 months had diabetes remission (A1c less than 6.5% without taking antidiabetic drugs) that persisted for 1 year.

Importantly, “this study was performed under real-life conditions, and the intervention was delivered by trained nurses in primary care rather than by specialized staff at a research institute, making it a more practical and achievable way to manage” type 2 diabetes, the authors report.

Moreover, 65% of the patients in the intervention group who achieved diabetes remission had had diabetes for more than 6 years, which “suggests the possibility of remission for patients with longer duration” of diabetes, they note.

©Thinkstock

‘Excellent outcome’

Invited to comment, Amy E. Rothberg, MD, PhD, who was not involved with the research, agreed that the study indicates that intermittent fasting works for diabetes remission.

“We know that diabetes remission is possible with calorie restriction and subsequent weight loss, and intermittent fasting is just one of the many [dietary] approaches that may be suitable, appealing, and sustainable to some individuals, and usually results in calorie restriction and therefore weight loss,” she said.

The most studied types of intermittent fasting diets are alternate-day fasting, the 5:2 diet, and time-restricted consumption, Dr. Rothberg told this news organization.

This study presented a novel type of intermittent fasting, she noted. The intervention consisted of 6 cycles (3 months) of 5 fasting days followed by 10 ad libitum days, and then 3 months of follow-up (with no fasting days).

After 3 months of the intervention plus 3 months of follow-up, 47% of the 36 patients in the intervention group achieved diabetes remission (with a mean A1c of 5.66%), compared with only 2.8% of the 36 patients in the control group.

At 12 months, 44% of patients in the intervention group had sustained diabetes remission (with a mean A1c of 6.33%).

This was “an excellent outcome,” said Dr. Rothberg, professor of nutritional sciences, School of Public Health, University of Michigan, Ann Arbor, and a co-author of an international consensus statement that defined diabetes remission.

On average, patients in the intermittent fasting group lost 5.93 kg (13.0 lb) in 3 months, which was sustained over 12 months. “The large amount of weight reduction is key to continuing to achieve diabetes remission,” she noted.

This contrasted with an average weight loss of just 0.27 kg (0.6 lb) in the control group.

Participants who were prescribed fewer antidiabetic medications were more likely to achieve diabetes remission. The researchers acknowledge that the study was not blinded, and they did not record physical activity (although participants were encouraged to maintain their usual physical activity).

This was a small study, Dr. Rothberg acknowledged. The researchers did not specify which specific antidiabetic drugs patients were taking, and they did not determine waist or hip circumference or assess lipids.

The diet was culturally sensitive, appropriate, and feasible in this Chinese population and would not be generalizable to non-Asians.

Nevertheless, a similar approach could be used in any population if the diet is tailored to the individual, according to Dr. Rothberg. Importantly, patients would need to receive guidance from a dietician to make sure their diet comprises all the necessary micronutrients, vitamins, and minerals on fasting days, and they would need to maintain a relatively balanced diet and not gorge themselves on feast days. 

“I think we should campaign widely about lifestyle approaches to achieve diabetes remission,” she urged.
 

72 patients with diabetes for an average of 6.6 years

“Despite a widespread public consensus that [type 2 diabetes] is irreversible and requires drug treatment escalation, there is some evidence of the possibility of remission,” Dr. Yang and colleagues write in their article.

They aimed to evaluate the effectiveness of intermittent fasting for diabetes remission and the durability of diabetes remission at 1 year.

Diabetes remission was defined having a stable A1c less than 6.5% for at least 3 months after discontinuing all antidiabetic medications, confirmed in at least annual A1c measurements (according to a 2021 consensus statement initiated by the American Diabetes Association).

Between 2019 and 2020, the researchers enrolled 72 participants aged 38-72 years who had had type 2 diabetes (duration 1 to 11 years) and a body mass index (BMI) of 19.1-30.4 kg/m². Patients were randomized 1:1 to the intermittent fasting group or control group.

Baseline characteristics were similar in both groups. Patients were a mean age of 53 years and roughly 60% were men. They had a mean BMI of 24 kg/m², a mean duration of diabetes of 6.6 years, and a mean A1c of 7.6%, and they were taking an average of 1.8 glucose-lowering medications.  

On fasting days, patients in the intervention group received a Chinese Medical Nutrition Therapy kit that provided approximately 840 kcal/day (46% carbohydrates, 46% fat, 8% protein). The kit included a breakfast of a fruit and vegetable gruel, lunch of a solid beverage plus a nutritional rice composite, and dinner of a solid beverage and a meal replacement biscuit, which participants reconstituted by mixing with boiling water. They were allowed to consume noncaloric beverages.

On nonfasting days, patients chose foods ad libitum based on the 2017 Dietary Guidelines for Diabetes in China, which recommend approximately 50%-65% of total energy intake from carbohydrates, 15%-20% from protein, and 20%-30% from fat, and had greater than or equal to 5 g fiber per serving.

Patients in the control group chose foods ad libitum from the dietary guidelines during the entire study.

The study received funding from the National Natural Science Foundation of China. The authors have reported no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

In a small randomized controlled trial of patients with type 2 diabetes in China, close to half of those who followed a novel intermittent fasting program for 3 months had diabetes remission (A1c less than 6.5% without taking antidiabetic drugs) that persisted for 1 year.

Importantly, “this study was performed under real-life conditions, and the intervention was delivered by trained nurses in primary care rather than by specialized staff at a research institute, making it a more practical and achievable way to manage” type 2 diabetes, the authors report.

Moreover, 65% of the patients in the intervention group who achieved diabetes remission had had diabetes for more than 6 years, which “suggests the possibility of remission for patients with longer duration” of diabetes, they note.

©Thinkstock

‘Excellent outcome’

Invited to comment, Amy E. Rothberg, MD, PhD, who was not involved with the research, agreed that the study indicates that intermittent fasting works for diabetes remission.

“We know that diabetes remission is possible with calorie restriction and subsequent weight loss, and intermittent fasting is just one of the many [dietary] approaches that may be suitable, appealing, and sustainable to some individuals, and usually results in calorie restriction and therefore weight loss,” she said.

The most studied types of intermittent fasting diets are alternate-day fasting, the 5:2 diet, and time-restricted consumption, Dr. Rothberg told this news organization.

This study presented a novel type of intermittent fasting, she noted. The intervention consisted of 6 cycles (3 months) of 5 fasting days followed by 10 ad libitum days, and then 3 months of follow-up (with no fasting days).

After 3 months of the intervention plus 3 months of follow-up, 47% of the 36 patients in the intervention group achieved diabetes remission (with a mean A1c of 5.66%), compared with only 2.8% of the 36 patients in the control group.

At 12 months, 44% of patients in the intervention group had sustained diabetes remission (with a mean A1c of 6.33%).

This was “an excellent outcome,” said Dr. Rothberg, professor of nutritional sciences, School of Public Health, University of Michigan, Ann Arbor, and a co-author of an international consensus statement that defined diabetes remission.

On average, patients in the intermittent fasting group lost 5.93 kg (13.0 lb) in 3 months, which was sustained over 12 months. “The large amount of weight reduction is key to continuing to achieve diabetes remission,” she noted.

This contrasted with an average weight loss of just 0.27 kg (0.6 lb) in the control group.

Participants who were prescribed fewer antidiabetic medications were more likely to achieve diabetes remission. The researchers acknowledge that the study was not blinded, and they did not record physical activity (although participants were encouraged to maintain their usual physical activity).

This was a small study, Dr. Rothberg acknowledged. The researchers did not specify which specific antidiabetic drugs patients were taking, and they did not determine waist or hip circumference or assess lipids.

The diet was culturally sensitive, appropriate, and feasible in this Chinese population and would not be generalizable to non-Asians.

Nevertheless, a similar approach could be used in any population if the diet is tailored to the individual, according to Dr. Rothberg. Importantly, patients would need to receive guidance from a dietician to make sure their diet comprises all the necessary micronutrients, vitamins, and minerals on fasting days, and they would need to maintain a relatively balanced diet and not gorge themselves on feast days. 

“I think we should campaign widely about lifestyle approaches to achieve diabetes remission,” she urged.
 

72 patients with diabetes for an average of 6.6 years

“Despite a widespread public consensus that [type 2 diabetes] is irreversible and requires drug treatment escalation, there is some evidence of the possibility of remission,” Dr. Yang and colleagues write in their article.

They aimed to evaluate the effectiveness of intermittent fasting for diabetes remission and the durability of diabetes remission at 1 year.

Diabetes remission was defined having a stable A1c less than 6.5% for at least 3 months after discontinuing all antidiabetic medications, confirmed in at least annual A1c measurements (according to a 2021 consensus statement initiated by the American Diabetes Association).

Between 2019 and 2020, the researchers enrolled 72 participants aged 38-72 years who had had type 2 diabetes (duration 1 to 11 years) and a body mass index (BMI) of 19.1-30.4 kg/m². Patients were randomized 1:1 to the intermittent fasting group or control group.

Baseline characteristics were similar in both groups. Patients were a mean age of 53 years and roughly 60% were men. They had a mean BMI of 24 kg/m², a mean duration of diabetes of 6.6 years, and a mean A1c of 7.6%, and they were taking an average of 1.8 glucose-lowering medications.  

On fasting days, patients in the intervention group received a Chinese Medical Nutrition Therapy kit that provided approximately 840 kcal/day (46% carbohydrates, 46% fat, 8% protein). The kit included a breakfast of a fruit and vegetable gruel, lunch of a solid beverage plus a nutritional rice composite, and dinner of a solid beverage and a meal replacement biscuit, which participants reconstituted by mixing with boiling water. They were allowed to consume noncaloric beverages.

On nonfasting days, patients chose foods ad libitum based on the 2017 Dietary Guidelines for Diabetes in China, which recommend approximately 50%-65% of total energy intake from carbohydrates, 15%-20% from protein, and 20%-30% from fat, and had greater than or equal to 5 g fiber per serving.

Patients in the control group chose foods ad libitum from the dietary guidelines during the entire study.

The study received funding from the National Natural Science Foundation of China. The authors have reported no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

In a small randomized controlled trial of patients with type 2 diabetes in China, close to half of those who followed a novel intermittent fasting program for 3 months had diabetes remission (A1c less than 6.5% without taking antidiabetic drugs) that persisted for 1 year.

Importantly, “this study was performed under real-life conditions, and the intervention was delivered by trained nurses in primary care rather than by specialized staff at a research institute, making it a more practical and achievable way to manage” type 2 diabetes, the authors report.

Moreover, 65% of the patients in the intervention group who achieved diabetes remission had had diabetes for more than 6 years, which “suggests the possibility of remission for patients with longer duration” of diabetes, they note.

©Thinkstock

‘Excellent outcome’

Invited to comment, Amy E. Rothberg, MD, PhD, who was not involved with the research, agreed that the study indicates that intermittent fasting works for diabetes remission.

“We know that diabetes remission is possible with calorie restriction and subsequent weight loss, and intermittent fasting is just one of the many [dietary] approaches that may be suitable, appealing, and sustainable to some individuals, and usually results in calorie restriction and therefore weight loss,” she said.

The most studied types of intermittent fasting diets are alternate-day fasting, the 5:2 diet, and time-restricted consumption, Dr. Rothberg told this news organization.

This study presented a novel type of intermittent fasting, she noted. The intervention consisted of 6 cycles (3 months) of 5 fasting days followed by 10 ad libitum days, and then 3 months of follow-up (with no fasting days).

After 3 months of the intervention plus 3 months of follow-up, 47% of the 36 patients in the intervention group achieved diabetes remission (with a mean A1c of 5.66%), compared with only 2.8% of the 36 patients in the control group.

At 12 months, 44% of patients in the intervention group had sustained diabetes remission (with a mean A1c of 6.33%).

This was “an excellent outcome,” said Dr. Rothberg, professor of nutritional sciences, School of Public Health, University of Michigan, Ann Arbor, and a co-author of an international consensus statement that defined diabetes remission.

On average, patients in the intermittent fasting group lost 5.93 kg (13.0 lb) in 3 months, which was sustained over 12 months. “The large amount of weight reduction is key to continuing to achieve diabetes remission,” she noted.

This contrasted with an average weight loss of just 0.27 kg (0.6 lb) in the control group.

Participants who were prescribed fewer antidiabetic medications were more likely to achieve diabetes remission. The researchers acknowledge that the study was not blinded, and they did not record physical activity (although participants were encouraged to maintain their usual physical activity).

This was a small study, Dr. Rothberg acknowledged. The researchers did not specify which specific antidiabetic drugs patients were taking, and they did not determine waist or hip circumference or assess lipids.

The diet was culturally sensitive, appropriate, and feasible in this Chinese population and would not be generalizable to non-Asians.

Nevertheless, a similar approach could be used in any population if the diet is tailored to the individual, according to Dr. Rothberg. Importantly, patients would need to receive guidance from a dietician to make sure their diet comprises all the necessary micronutrients, vitamins, and minerals on fasting days, and they would need to maintain a relatively balanced diet and not gorge themselves on feast days. 

“I think we should campaign widely about lifestyle approaches to achieve diabetes remission,” she urged.
 

72 patients with diabetes for an average of 6.6 years

“Despite a widespread public consensus that [type 2 diabetes] is irreversible and requires drug treatment escalation, there is some evidence of the possibility of remission,” Dr. Yang and colleagues write in their article.

They aimed to evaluate the effectiveness of intermittent fasting for diabetes remission and the durability of diabetes remission at 1 year.

Diabetes remission was defined having a stable A1c less than 6.5% for at least 3 months after discontinuing all antidiabetic medications, confirmed in at least annual A1c measurements (according to a 2021 consensus statement initiated by the American Diabetes Association).

Between 2019 and 2020, the researchers enrolled 72 participants aged 38-72 years who had had type 2 diabetes (duration 1 to 11 years) and a body mass index (BMI) of 19.1-30.4 kg/m². Patients were randomized 1:1 to the intermittent fasting group or control group.

Baseline characteristics were similar in both groups. Patients were a mean age of 53 years and roughly 60% were men. They had a mean BMI of 24 kg/m², a mean duration of diabetes of 6.6 years, and a mean A1c of 7.6%, and they were taking an average of 1.8 glucose-lowering medications.  

On fasting days, patients in the intervention group received a Chinese Medical Nutrition Therapy kit that provided approximately 840 kcal/day (46% carbohydrates, 46% fat, 8% protein). The kit included a breakfast of a fruit and vegetable gruel, lunch of a solid beverage plus a nutritional rice composite, and dinner of a solid beverage and a meal replacement biscuit, which participants reconstituted by mixing with boiling water. They were allowed to consume noncaloric beverages.

On nonfasting days, patients chose foods ad libitum based on the 2017 Dietary Guidelines for Diabetes in China, which recommend approximately 50%-65% of total energy intake from carbohydrates, 15%-20% from protein, and 20%-30% from fat, and had greater than or equal to 5 g fiber per serving.

Patients in the control group chose foods ad libitum from the dietary guidelines during the entire study.

The study received funding from the National Natural Science Foundation of China. The authors have reported no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

LAS VEGAS – Improving diversity in dermatology starts with education, Susan C. Taylor, MD, said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar, where she led a panel discussion on opportunities to improve diversity in the specialty.

The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.

Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.

The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.

Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.

Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.

Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.

“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.

Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.

Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.

Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.

The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Improving diversity in dermatology starts with education, Susan C. Taylor, MD, said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar, where she led a panel discussion on opportunities to improve diversity in the specialty.

The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.

Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.

The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.

Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.

Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.

Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.

“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.

Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.

Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.

Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.

The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Improving diversity in dermatology starts with education, Susan C. Taylor, MD, said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar, where she led a panel discussion on opportunities to improve diversity in the specialty.

The growing ethnic minority population in the United States “underscores the need for medical education to ensure dermatologists are prepared to provide quality care for patients of diverse racial and ethnic backgrounds,” said Dr. Taylor, the Bernett L. Johnson Jr., MD, Professor, and vice chair for diversity, equity, and inclusion in the department of dermatology at the University of Pennsylvania.

Improving education includes diversifying resource material, she said. A recent study in the Journal of the American Academy of Dermatology showed the representation of skin tones on Google searches for skin conditions was mostly light skin (91.7%), although non-Hispanic Whites account for less than two-thirds (approximately 60%) of the U.S. population, she said. Many people with darker skin tones “are not finding people who look like themselves” when they search skin conditions online, she noted.

The lack of diversity in images occurs not only on Google, “but in our textbooks, which are the foundational resources for our students,” said Nada M. Elbuluk, MD, founder and director of the Skin of Color and Pigmentary Disorders Program at the University of Southern California, Los Angeles. She also established the Dermatology Diversity and Inclusion Program at USC.

Although more than 13% of Americans are Black, only 3% of dermatologists in the United States are Black, Dr. Callender noted. Similarly, 4.2% of dermatologists in the United States are Hispanic or Latino, but these groups make up more than 18% of the general U.S. population, according to a recent study, she said.

Cheryl M. Burgess, MD, founder and medical director of the Center for Dermatology and Dermatologic Surgery in Washington, presented a roadmap of strategies for improving diversity in dermatology, starting with increasing STEM education at the high school and college levels among all populations and increasing the pipeline of underrepresented students to medical schools.

Then, faculty should work to increase interest in dermatology among underrepresented medical students and increase the numbers of underrepresented medical students in dermatology residency programs, said Dr. Burgess, assistant clinical professor of dermatology at Georgetown University and George Washington University, Washington.

“The more diversity we have in our specialty, the more we learn from each other,” and increased diversity can promote new research questions, said Andrew F. Alexis, MD, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York.

Increasing the diversity of populations in clinical trials is another important strategy to improve diversity in dermatology, he emphasized.

Mentoring is an excellent way to help underrepresented students develop and pursue a career in dermatology, the panelists agreed. Time is precious for everyone, so don’t hesitate to use Zoom and other technology to help connect with mentees, Dr. Burgess advised.

Dr. Taylor added that mentoring doesn’t have to be a huge time commitment, it can be as simple as volunteering once a year at a school career forum. “It is so gratifying to have these young people looking up to you,” she said.

The panelists disclosed relationships with multiple companies, but none were relevant to this panel discussion. MedscapeLive and this news organization are owned by the same parent company.

At least once a week, dermatologist Kelly Stankiewicz, MD, meets with patients who believe that fillers can help them achieve any lip shape. Some reach for their smartphones to show her images and say: “I want my lips to look just like this.”

Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”

During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.

Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”

Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.

Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”

Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”

Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”

Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”

Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.

Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”

Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”

Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.

At least once a week, dermatologist Kelly Stankiewicz, MD, meets with patients who believe that fillers can help them achieve any lip shape. Some reach for their smartphones to show her images and say: “I want my lips to look just like this.”

Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”

During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.

Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”

Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.

Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”

Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”

Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”

Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”

Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.

Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”

Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”

Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.

At least once a week, dermatologist Kelly Stankiewicz, MD, meets with patients who believe that fillers can help them achieve any lip shape. Some reach for their smartphones to show her images and say: “I want my lips to look just like this.”

Those images may help Dr. Stankiewicz understand patient preferences in terms of lip size and proportion, but she points out that shape is unique to each person. “I tell them: ‘All we can do is enhance that lip shape with filler. We can’t give you somebody else’s lip shape with an injection of filler.’ ”

During a virtual course on laser and aesthetic skin therapy, she and Omar A. Ibrahimi, MD, PhD, dispelled this and other false dogmas that they hear from some clinicians who practice aesthetic medicine and the patients who see them.

Wait 1 year before treating traumatic and surgical scars with vascular and fractional CO2 lasers. “I don’t think this is controversial anymore, because there is a boatload of data, which has shown that early treatment can prevent hypertrophic scarring and promote scar maturation,” said Dr. Stankiewicz, who practices dermatology in Park City, Utah. “Histology has also shown more organized dermal collagen from early treatment. Of course, there will be situations where you may want to hold off, like doing an ablative fractional [laser treatment] over the scar of a joint replacement ... where you may risk infection.” In her clinic, she routinely treats scars on the same day as suture removal, “as long as the healing looks appropriate.”

Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, Stamford, also jumps on treating scars early. For a patient with postacne erythema, for example, he will use a pulsed-dye laser, which he believes will prevent scars from becoming atrophic.

Used equipment is a better investment than new equipment. While purchasing used laser and light devices can save money, especially when starting out, be wary of potential pitfalls, including the fact that many devices have disposable tips. “If your laser isn’t certified or you’re not the authorized owner of the device, you won’t be able to buy the disposables,” Dr. Stankiewicz noted. “So, before you buy a used device, ensure that you can buy them.”

Also, consider the cost of service if the device breaks down, she advised. Some lasers are complicated to service and others have codes set by the manufacturer so that only contracted engineers can work on them. “Otherwise, third-party engineers and service providers have to figure out how to crack the code to get into the machine,” she said. “If you’re in the situation where you have to ask the manufacturer to service your device, you have to pay a lot of money to recertify your device. Then you’ve lost all the savings you thought you made by buying a used machine.” She prefers to negotiate a good deal on a new device. “Often, a very good deal on a new device can rival the offer of a used one.”

Dr. Ibrahimi recalled buying a used fractional laser that came with a 30-day guarantee, but it stopped working around day 45. “I didn’t have much recourse there,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “You can’t go back to the company [for repair] unless you pay a recertification fee.”

Avoid exercise after Botox treatment. Although inverted yoga poses and lying down should be avoided for several hours after receiving Botox, there are no other limits to other forms of exercise post treatment, Dr. Stankiewicz said. If she suspects that a patient will develop bruising on one or more injection sites, she treats the areas with a laser. “Doing this on the same day as Botox treatment doesn’t always stop or treat bruising, many times it does.”

Another myth she hears is that it is not safe to fly in an airplane after Botox treatment. “That recommendation comes from the fact that the atmospheric pressure is lower in an airplane, so we worry about the risk of Botox spread,” Dr. Stankiewicz said. “But I practice at 7,000 feet above sea level, which is the same atmospheric pressure as that in an airplane,” she added, noting Botox is administered throughout the day in her practice and she does not see increased complications or worry about spread.

Clinician self-treatment is okay. In the opinion of Dr. Stankiewicz, aesthetic clinicians who treat themselves “have a fool for a patient.” She added: “Although no one is going to blame you and may not even know if you give yourself a little Botox touch-up at home, glorifying self-treatment on social media must stop. It’s dangerous and it can be ineffective.”

Self-treatment can also impair judgment and the objectivity of cosmetic therapies. “Also, when you’re pointing a laser at your own face and posting it on social media, it gives viewers the impression that this is not a serious medical treatment when it really is,” she emphasized. In addition, “when you treat yourself, you lose the ability to see the proper clinical endpoint. You also lose the ability to see the angle and the appropriate position for injection to avoid intervascular occlusion.”

Neither Dr. Stankiewicz nor Dr. Ibrahimi reported having relevant financial disclosures.

NEW ORLEANS – Patients with chronic immune thrombocytopenia (ITP) fared better on intravenous efgartigimod (Vyvgart) than a placebo, a new study found. Still, only 21.8% of subjects who received the biologic reached the primary endpoint of sustained platelet count response, an indication that most patients won’t benefit.

Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.

“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.

In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”

The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.

Treatment options include corticosteroids and intravenous immunoglobulin.

“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.

For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).

Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.

Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.

Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).

“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”

She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”

Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.

Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.

In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.

Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.

As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”

It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”

For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”

What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.

The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.

NEW ORLEANS – Patients with chronic immune thrombocytopenia (ITP) fared better on intravenous efgartigimod (Vyvgart) than a placebo, a new study found. Still, only 21.8% of subjects who received the biologic reached the primary endpoint of sustained platelet count response, an indication that most patients won’t benefit.

Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.

“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.

In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”

The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.

Treatment options include corticosteroids and intravenous immunoglobulin.

“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.

For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).

Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.

Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.

Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).

“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”

She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”

Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.

Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.

In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.

Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.

As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”

It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”

For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”

What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.

The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.

NEW ORLEANS – Patients with chronic immune thrombocytopenia (ITP) fared better on intravenous efgartigimod (Vyvgart) than a placebo, a new study found. Still, only 21.8% of subjects who received the biologic reached the primary endpoint of sustained platelet count response, an indication that most patients won’t benefit.

Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.

“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.

In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”

The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.

Treatment options include corticosteroids and intravenous immunoglobulin.

“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.

For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).

Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.

Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.

Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).

“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”

She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”

Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.

Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.

In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.

Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.

As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”

It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”

For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”

What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.

The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.

Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.

Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).

Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465

Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.

Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).

Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465

Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.

Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).

Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465

Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.

Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.

Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.

Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).

Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411

Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.

Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.

Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.

Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).

Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411

Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.

Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.

Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.

Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).

Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411

Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.

Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.

Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.

Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423

Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.

Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.

Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.

Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423

Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.

Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.

Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.

Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423