Women's Health

A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.

The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.

However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.

The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.

Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.

The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.

However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.

“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.

In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.

“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.

The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.

Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.

SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.

A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.

The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.

However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.

The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.

Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.

The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.

However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.

“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.

In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.

“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.

The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.

Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.

SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.

A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.

The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.

However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.

The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.

Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.

The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.

However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.

“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.

In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.

“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.

The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.

Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.

SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.

CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.

The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).

Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.

“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.

In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.

For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.

Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.

The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.

The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.

A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.

Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.

In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.

No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).

Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.

The net effect of the abbreviated protocol, said Dr. Seely, was an increase in positive predictive value without a drop in cancer detection rates. She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.

Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.

[email protected]

SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.

CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.

The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).

Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.

“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.

In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.

For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.

Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.

The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.

The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.

A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.

Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.

In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.

No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).

Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.

The net effect of the abbreviated protocol, said Dr. Seely, was an increase in positive predictive value without a drop in cancer detection rates. She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.

Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.

[email protected]

SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.

CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.

The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).

Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.

“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.

In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.

For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.

Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.

The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.

The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.

A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.

Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.

In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.

No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).

Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.

The net effect of the abbreviated protocol, said Dr. Seely, was an increase in positive predictive value without a drop in cancer detection rates. She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.

Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.

[email protected]

SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

[email protected]

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

[email protected]

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

[email protected]

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

[email protected]

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

[email protected]

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

[email protected]

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

GRAPEVINE, TEX. – Blood pressure categories created by the American College of Cardiology (ACC) and American Heart Association (AHA) in 2017 identify patients with increased risk of preeclampsia, preterm birth, and perinatal death when applied to the first 20 weeks of pregnancy, according to a retrospective study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The absolute risk increases are small, and it is unknown whether treating these patients differently would be beneficial, said study author Martha Tesfalul, MD, maternal-fetal medicine clinical fellow at University of California, San Francisco. Nevertheless, the associations suggest that patients with hypertension during the first 20 weeks may benefit from additional monitoring and counseling, Dr. Tesfalul said.

Cutoffs with unclear implications

The ACC/AHA in November 2017 reclassified blood pressure in nonpregnant adults, but “implications of these categories in pregnancy are still unclear,” Dr. Tesfalul and colleagues said. Under the guidelines, normal blood pressure is systolic blood pressure less than 120 mm Hg and diastolic blood pressure less than 80 mm Hg. Elevated blood pressure is defined as systolic blood pressure between 120 and 129 mm Hg and diastolic blood pressure less than 80 mm Hg. Stage 1 hypertension is systolic blood pressure between 130 and 139 mm Hg or diastolic blood pressure between 80 and 89 mm Hg. And stage 2 hypertension is systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg.

For the present analysis, the researchers retrospectively compared obstetric and perinatal outcomes for approximately 6,000 pregnancies at an academic center for which they had at least one blood pressure measurement prior to 20 weeks. The highest measurement was used to identify women with normal blood pressure, elevated blood pressure, or stage 1 hypertension according to the 2017 thresholds.

The researchers included singleton pregnancies with delivery between January 2014 and October 2017. They excluded patients with a prior diagnosis of chronic hypertension, autoimmune or chronic renal disease, or fetal anomalies. They examined rates of gestational hypertension, preeclampsia, preterm birth, neonatal intensive care admission, and perinatal death.

Adjusted relative risks

Dr. Tesfalul and colleagues identified about 3,500 pregnancies with normal blood pressure, more than 1,300 pregnancies with elevated blood pressure, and nearly 1,100 pregnancies with stage 1 hypertension.

After adjusting for relevant covariates – maternal age, nulliparity, race, body mass index, in vitro fertilization, tobacco use, pregestational diabetes, and aspirin use – elevated blood pressure and stage 1 hypertension were associated with a higher risk of preeclampsia and severe preeclampsia, relative to normal blood pressure. The proportion of patients with preeclampsia was 5.7% in the normal blood pressure group, 11.7% in the elevated blood pressure group (adjusted relative risk, 1.8), and 15% in the stage 1 hypertension group (adjusted RR, 2.1). The proportion with preeclampsia with severe features was 3.1% in the normal blood pressure group, 5.7% in the elevated blood pressure group (adjusted RR, 1.6), and 6.8% in the stage 1 hypertension group (adjusted RR, 1.8).

In addition, stage 1 hypertension, compared with normal blood pressure, was associated with increased odds of preterm birth at less than 37 weeks (7.9% vs. 5.1%; adjusted RR, 1.4) and perinatal death (0.7% vs. 0.4%; adjusted RR, 2.8).

“Patients with elevated blood pressure and stage 1 hypertension prior to 20 weeks are at increased risk of adverse outcomes,” the authors concluded. “Further research [is] needed to determine optimal care of patients with elevated blood pressure and stage 1 hypertension in pregnancy.”

Dr. Tesfalul receives support from the Foundation for SMFM.

[email protected]

SOURCE: Tesfalul M et al. Am J Obstet Gynecol. 2020 Jan;222(1):S92-3, Abstract 119.

GRAPEVINE, TEX. – Blood pressure categories created by the American College of Cardiology (ACC) and American Heart Association (AHA) in 2017 identify patients with increased risk of preeclampsia, preterm birth, and perinatal death when applied to the first 20 weeks of pregnancy, according to a retrospective study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The absolute risk increases are small, and it is unknown whether treating these patients differently would be beneficial, said study author Martha Tesfalul, MD, maternal-fetal medicine clinical fellow at University of California, San Francisco. Nevertheless, the associations suggest that patients with hypertension during the first 20 weeks may benefit from additional monitoring and counseling, Dr. Tesfalul said.

Cutoffs with unclear implications

The ACC/AHA in November 2017 reclassified blood pressure in nonpregnant adults, but “implications of these categories in pregnancy are still unclear,” Dr. Tesfalul and colleagues said. Under the guidelines, normal blood pressure is systolic blood pressure less than 120 mm Hg and diastolic blood pressure less than 80 mm Hg. Elevated blood pressure is defined as systolic blood pressure between 120 and 129 mm Hg and diastolic blood pressure less than 80 mm Hg. Stage 1 hypertension is systolic blood pressure between 130 and 139 mm Hg or diastolic blood pressure between 80 and 89 mm Hg. And stage 2 hypertension is systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg.

For the present analysis, the researchers retrospectively compared obstetric and perinatal outcomes for approximately 6,000 pregnancies at an academic center for which they had at least one blood pressure measurement prior to 20 weeks. The highest measurement was used to identify women with normal blood pressure, elevated blood pressure, or stage 1 hypertension according to the 2017 thresholds.

The researchers included singleton pregnancies with delivery between January 2014 and October 2017. They excluded patients with a prior diagnosis of chronic hypertension, autoimmune or chronic renal disease, or fetal anomalies. They examined rates of gestational hypertension, preeclampsia, preterm birth, neonatal intensive care admission, and perinatal death.

Adjusted relative risks

Dr. Tesfalul and colleagues identified about 3,500 pregnancies with normal blood pressure, more than 1,300 pregnancies with elevated blood pressure, and nearly 1,100 pregnancies with stage 1 hypertension.

After adjusting for relevant covariates – maternal age, nulliparity, race, body mass index, in vitro fertilization, tobacco use, pregestational diabetes, and aspirin use – elevated blood pressure and stage 1 hypertension were associated with a higher risk of preeclampsia and severe preeclampsia, relative to normal blood pressure. The proportion of patients with preeclampsia was 5.7% in the normal blood pressure group, 11.7% in the elevated blood pressure group (adjusted relative risk, 1.8), and 15% in the stage 1 hypertension group (adjusted RR, 2.1). The proportion with preeclampsia with severe features was 3.1% in the normal blood pressure group, 5.7% in the elevated blood pressure group (adjusted RR, 1.6), and 6.8% in the stage 1 hypertension group (adjusted RR, 1.8).

In addition, stage 1 hypertension, compared with normal blood pressure, was associated with increased odds of preterm birth at less than 37 weeks (7.9% vs. 5.1%; adjusted RR, 1.4) and perinatal death (0.7% vs. 0.4%; adjusted RR, 2.8).

“Patients with elevated blood pressure and stage 1 hypertension prior to 20 weeks are at increased risk of adverse outcomes,” the authors concluded. “Further research [is] needed to determine optimal care of patients with elevated blood pressure and stage 1 hypertension in pregnancy.”

Dr. Tesfalul receives support from the Foundation for SMFM.

[email protected]

SOURCE: Tesfalul M et al. Am J Obstet Gynecol. 2020 Jan;222(1):S92-3, Abstract 119.

GRAPEVINE, TEX. – Blood pressure categories created by the American College of Cardiology (ACC) and American Heart Association (AHA) in 2017 identify patients with increased risk of preeclampsia, preterm birth, and perinatal death when applied to the first 20 weeks of pregnancy, according to a retrospective study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The absolute risk increases are small, and it is unknown whether treating these patients differently would be beneficial, said study author Martha Tesfalul, MD, maternal-fetal medicine clinical fellow at University of California, San Francisco. Nevertheless, the associations suggest that patients with hypertension during the first 20 weeks may benefit from additional monitoring and counseling, Dr. Tesfalul said.

Cutoffs with unclear implications

The ACC/AHA in November 2017 reclassified blood pressure in nonpregnant adults, but “implications of these categories in pregnancy are still unclear,” Dr. Tesfalul and colleagues said. Under the guidelines, normal blood pressure is systolic blood pressure less than 120 mm Hg and diastolic blood pressure less than 80 mm Hg. Elevated blood pressure is defined as systolic blood pressure between 120 and 129 mm Hg and diastolic blood pressure less than 80 mm Hg. Stage 1 hypertension is systolic blood pressure between 130 and 139 mm Hg or diastolic blood pressure between 80 and 89 mm Hg. And stage 2 hypertension is systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg.

For the present analysis, the researchers retrospectively compared obstetric and perinatal outcomes for approximately 6,000 pregnancies at an academic center for which they had at least one blood pressure measurement prior to 20 weeks. The highest measurement was used to identify women with normal blood pressure, elevated blood pressure, or stage 1 hypertension according to the 2017 thresholds.

The researchers included singleton pregnancies with delivery between January 2014 and October 2017. They excluded patients with a prior diagnosis of chronic hypertension, autoimmune or chronic renal disease, or fetal anomalies. They examined rates of gestational hypertension, preeclampsia, preterm birth, neonatal intensive care admission, and perinatal death.

Adjusted relative risks

Dr. Tesfalul and colleagues identified about 3,500 pregnancies with normal blood pressure, more than 1,300 pregnancies with elevated blood pressure, and nearly 1,100 pregnancies with stage 1 hypertension.

After adjusting for relevant covariates – maternal age, nulliparity, race, body mass index, in vitro fertilization, tobacco use, pregestational diabetes, and aspirin use – elevated blood pressure and stage 1 hypertension were associated with a higher risk of preeclampsia and severe preeclampsia, relative to normal blood pressure. The proportion of patients with preeclampsia was 5.7% in the normal blood pressure group, 11.7% in the elevated blood pressure group (adjusted relative risk, 1.8), and 15% in the stage 1 hypertension group (adjusted RR, 2.1). The proportion with preeclampsia with severe features was 3.1% in the normal blood pressure group, 5.7% in the elevated blood pressure group (adjusted RR, 1.6), and 6.8% in the stage 1 hypertension group (adjusted RR, 1.8).

In addition, stage 1 hypertension, compared with normal blood pressure, was associated with increased odds of preterm birth at less than 37 weeks (7.9% vs. 5.1%; adjusted RR, 1.4) and perinatal death (0.7% vs. 0.4%; adjusted RR, 2.8).

“Patients with elevated blood pressure and stage 1 hypertension prior to 20 weeks are at increased risk of adverse outcomes,” the authors concluded. “Further research [is] needed to determine optimal care of patients with elevated blood pressure and stage 1 hypertension in pregnancy.”

Dr. Tesfalul receives support from the Foundation for SMFM.

[email protected]

SOURCE: Tesfalul M et al. Am J Obstet Gynecol. 2020 Jan;222(1):S92-3, Abstract 119.

GRAPEVINE, TEX.* – Pregnant women with type 2 diabetes or prediabetes had significantly less gestational weight gain if they had metformin exposure at any point in their pregnancies, with no differences in infant birth weight or postnatal infant hypoglycemia, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/MDedge News

In a retrospective single-center review of 284 women without metformin exposure and 227 with metformin exposure in pregnancy, metformin exposure at any point in pregnancy was associated with a significantly greater chance of appropriate – rather than excessive – weight gain.

The relationship held true for the 169 women who had metformin in their first trimester of pregnancy. Here, 69% of women had appropriate weight gain using Institute of Medicine and American College of Obstetricians and Gynecologists standards, compared with 54% of the 282 women who had no metformin exposure (adjusted odds ratio 1.92, P = .003). A further 22% of women receiving metformin in their first trimester of pregnancy lost weight, compared with 9% of women without metformin exposure (aOR 2.11, P = .019). There was no significant difference between the two groups in infant birth weight.

Separately, study author Jacquelyn Adams, MD, and her colleagues analyzed outcomes for the full cohort of 227 women who received metformin at any point in their pregnancy, comparing them again to the 282 women who had not received metformin. Most women (85%) were on 2 g of metformin at the time of delivery. These results again showed a greater likelihood of appropriate weight gain in the metformin group (69%; aOR 1.85; P = .002). Maternal weight loss was seen in 20% of this group (aOR 1.98, P = .018). Infant birth weights were not significantly different between these two groups.

“We found that women who had been on metformin at any point in their pregnancy had more appropriate weight gain and less excessive weight gain,” said Dr. Adams, a maternal-fetal medicine fellow at the University of Wisconsin–Madison. “Actually, some women on metformin had even had a little bit of weight loss, with no difference in their baby’s birth weight. So that’s really exciting, because our starting prepregnancy body mass index was 33-36 [kg/m²], which is considered obese,” she said in an interview.

This is an important finding, said Dr. Adams, because previous work has shown that less weight gain in pregnancy is associated with lower risk for hypertension and preeclampsia, and lower rates of fetal macrosomia.

What about infant outcomes? Dr. Adams said that there were many concerns about metformin: “Would it affect baby outcome? Were those babies more likely to be hypoglycemic? Were they more likely to be growth restricted? Were they more likely to have issues in the NICU? And the answer was really, ‘No.’ ”

“So we can both help these women have appropriate weight gain and not have any negative effects on these babies,” she added.

Specifically, Dr. Adams and her coinvestigators found no significant differences between the groups in gestational age at birth, likelihood of neonatal ICU admission, Apgar scores, neonatal hypoglycemia, respiratory distress syndrome, or fetal death. Fetal growth restriction and anomalies occurred at a low and similar rate between the groups.

Dr. Adams said that she was not surprised to see that metformin was associated with less weight gain in pregnancy, but she was surprised at how highly significant the differences were with metformin use. “Metformin is first-line for diabetes in nonpregnant individuals because it’s associated with things like weight loss, and because of ease of use and lack of hypoglycemia – so I was really hoping to see this kind of result.”

Women receiving metformin were a mean 34 years old, while those who didn’t get metformin were 32 years old, a significant difference. Prepregnancy body mass index also was higher in those receiving metformin, and they were more likely to have a type 2 diabetes diagnosis. A similar proportion of both groups – about two-thirds – were white, and about 20% were Hispanic.

The lower weight gain seen in metformin-takers also might smooth the way post partum, said Dr. Adams. “My perception is that, when these women leave us, they might not have any primary care follow-up; they might not have anybody following their diabetes; and metformin is a very viable way to help them in their life outside of pregnancy.

“Not to mention that all the weight you gain in pregnancy, you do eventually have to lose post partum,” she added, “so having less pregnancy weight gain kind of sets them up for success in their postpregnancy life as well.”

Asked whether these results inform the ongoing question of whether insulin or metformin is the most appropriate first-line treatment for gestational diabetes, Dr. Adams first noted that “there’s a lot of crossover,” pointing out that over 60% of the participants in her study eventually also required insulin.

“It’s a question I would love to address in a head-to-head trial,” she said, adding that questions about metformin’s effects on the placenta and the potential for later deleterious effects require more study.

In her practice, Dr. Adams said that patients generally are discharged with a metformin prescription, and then meet with a diabetes educator 1 week after delivery to assess blood glucose levels and adjust medical management. Following that, a warm hand-off to a primary care practice who can continue management and education is optimal, she said.

In terms of next steps, “We would really love to look at metformin in the postpartum period,” said Dr. Adams. Ideally, future work could look for outcomes that extend beyond the 6- to 8-week postpartum follow-up visit. For example, she said, there are indications that women with insulin insensitivity might benefit from metformin while breastfeeding; it’s also possible that metformin might reduce the risk of postpartum preeclampsia.

Dr. Adams reported that she had no conflicts of interest and no outside sources of funding.

[email protected]

SOURCE: Adams J et al. SMFM 2020, Abstract 335.

*This story was updated 2/10/2020.

GRAPEVINE, TEX.* – Pregnant women with type 2 diabetes or prediabetes had significantly less gestational weight gain if they had metformin exposure at any point in their pregnancies, with no differences in infant birth weight or postnatal infant hypoglycemia, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/MDedge News

In a retrospective single-center review of 284 women without metformin exposure and 227 with metformin exposure in pregnancy, metformin exposure at any point in pregnancy was associated with a significantly greater chance of appropriate – rather than excessive – weight gain.

The relationship held true for the 169 women who had metformin in their first trimester of pregnancy. Here, 69% of women had appropriate weight gain using Institute of Medicine and American College of Obstetricians and Gynecologists standards, compared with 54% of the 282 women who had no metformin exposure (adjusted odds ratio 1.92, P = .003). A further 22% of women receiving metformin in their first trimester of pregnancy lost weight, compared with 9% of women without metformin exposure (aOR 2.11, P = .019). There was no significant difference between the two groups in infant birth weight.

Separately, study author Jacquelyn Adams, MD, and her colleagues analyzed outcomes for the full cohort of 227 women who received metformin at any point in their pregnancy, comparing them again to the 282 women who had not received metformin. Most women (85%) were on 2 g of metformin at the time of delivery. These results again showed a greater likelihood of appropriate weight gain in the metformin group (69%; aOR 1.85; P = .002). Maternal weight loss was seen in 20% of this group (aOR 1.98, P = .018). Infant birth weights were not significantly different between these two groups.

“We found that women who had been on metformin at any point in their pregnancy had more appropriate weight gain and less excessive weight gain,” said Dr. Adams, a maternal-fetal medicine fellow at the University of Wisconsin–Madison. “Actually, some women on metformin had even had a little bit of weight loss, with no difference in their baby’s birth weight. So that’s really exciting, because our starting prepregnancy body mass index was 33-36 [kg/m²], which is considered obese,” she said in an interview.

This is an important finding, said Dr. Adams, because previous work has shown that less weight gain in pregnancy is associated with lower risk for hypertension and preeclampsia, and lower rates of fetal macrosomia.

What about infant outcomes? Dr. Adams said that there were many concerns about metformin: “Would it affect baby outcome? Were those babies more likely to be hypoglycemic? Were they more likely to be growth restricted? Were they more likely to have issues in the NICU? And the answer was really, ‘No.’ ”

“So we can both help these women have appropriate weight gain and not have any negative effects on these babies,” she added.

Specifically, Dr. Adams and her coinvestigators found no significant differences between the groups in gestational age at birth, likelihood of neonatal ICU admission, Apgar scores, neonatal hypoglycemia, respiratory distress syndrome, or fetal death. Fetal growth restriction and anomalies occurred at a low and similar rate between the groups.

Dr. Adams said that she was not surprised to see that metformin was associated with less weight gain in pregnancy, but she was surprised at how highly significant the differences were with metformin use. “Metformin is first-line for diabetes in nonpregnant individuals because it’s associated with things like weight loss, and because of ease of use and lack of hypoglycemia – so I was really hoping to see this kind of result.”

Women receiving metformin were a mean 34 years old, while those who didn’t get metformin were 32 years old, a significant difference. Prepregnancy body mass index also was higher in those receiving metformin, and they were more likely to have a type 2 diabetes diagnosis. A similar proportion of both groups – about two-thirds – were white, and about 20% were Hispanic.

The lower weight gain seen in metformin-takers also might smooth the way post partum, said Dr. Adams. “My perception is that, when these women leave us, they might not have any primary care follow-up; they might not have anybody following their diabetes; and metformin is a very viable way to help them in their life outside of pregnancy.

“Not to mention that all the weight you gain in pregnancy, you do eventually have to lose post partum,” she added, “so having less pregnancy weight gain kind of sets them up for success in their postpregnancy life as well.”

Asked whether these results inform the ongoing question of whether insulin or metformin is the most appropriate first-line treatment for gestational diabetes, Dr. Adams first noted that “there’s a lot of crossover,” pointing out that over 60% of the participants in her study eventually also required insulin.

“It’s a question I would love to address in a head-to-head trial,” she said, adding that questions about metformin’s effects on the placenta and the potential for later deleterious effects require more study.

In her practice, Dr. Adams said that patients generally are discharged with a metformin prescription, and then meet with a diabetes educator 1 week after delivery to assess blood glucose levels and adjust medical management. Following that, a warm hand-off to a primary care practice who can continue management and education is optimal, she said.

In terms of next steps, “We would really love to look at metformin in the postpartum period,” said Dr. Adams. Ideally, future work could look for outcomes that extend beyond the 6- to 8-week postpartum follow-up visit. For example, she said, there are indications that women with insulin insensitivity might benefit from metformin while breastfeeding; it’s also possible that metformin might reduce the risk of postpartum preeclampsia.

Dr. Adams reported that she had no conflicts of interest and no outside sources of funding.

[email protected]

SOURCE: Adams J et al. SMFM 2020, Abstract 335.

*This story was updated 2/10/2020.

GRAPEVINE, TEX.* – Pregnant women with type 2 diabetes or prediabetes had significantly less gestational weight gain if they had metformin exposure at any point in their pregnancies, with no differences in infant birth weight or postnatal infant hypoglycemia, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/MDedge News

In a retrospective single-center review of 284 women without metformin exposure and 227 with metformin exposure in pregnancy, metformin exposure at any point in pregnancy was associated with a significantly greater chance of appropriate – rather than excessive – weight gain.

The relationship held true for the 169 women who had metformin in their first trimester of pregnancy. Here, 69% of women had appropriate weight gain using Institute of Medicine and American College of Obstetricians and Gynecologists standards, compared with 54% of the 282 women who had no metformin exposure (adjusted odds ratio 1.92, P = .003). A further 22% of women receiving metformin in their first trimester of pregnancy lost weight, compared with 9% of women without metformin exposure (aOR 2.11, P = .019). There was no significant difference between the two groups in infant birth weight.

Separately, study author Jacquelyn Adams, MD, and her colleagues analyzed outcomes for the full cohort of 227 women who received metformin at any point in their pregnancy, comparing them again to the 282 women who had not received metformin. Most women (85%) were on 2 g of metformin at the time of delivery. These results again showed a greater likelihood of appropriate weight gain in the metformin group (69%; aOR 1.85; P = .002). Maternal weight loss was seen in 20% of this group (aOR 1.98, P = .018). Infant birth weights were not significantly different between these two groups.

“We found that women who had been on metformin at any point in their pregnancy had more appropriate weight gain and less excessive weight gain,” said Dr. Adams, a maternal-fetal medicine fellow at the University of Wisconsin–Madison. “Actually, some women on metformin had even had a little bit of weight loss, with no difference in their baby’s birth weight. So that’s really exciting, because our starting prepregnancy body mass index was 33-36 [kg/m²], which is considered obese,” she said in an interview.

This is an important finding, said Dr. Adams, because previous work has shown that less weight gain in pregnancy is associated with lower risk for hypertension and preeclampsia, and lower rates of fetal macrosomia.

What about infant outcomes? Dr. Adams said that there were many concerns about metformin: “Would it affect baby outcome? Were those babies more likely to be hypoglycemic? Were they more likely to be growth restricted? Were they more likely to have issues in the NICU? And the answer was really, ‘No.’ ”

“So we can both help these women have appropriate weight gain and not have any negative effects on these babies,” she added.

Specifically, Dr. Adams and her coinvestigators found no significant differences between the groups in gestational age at birth, likelihood of neonatal ICU admission, Apgar scores, neonatal hypoglycemia, respiratory distress syndrome, or fetal death. Fetal growth restriction and anomalies occurred at a low and similar rate between the groups.

Dr. Adams said that she was not surprised to see that metformin was associated with less weight gain in pregnancy, but she was surprised at how highly significant the differences were with metformin use. “Metformin is first-line for diabetes in nonpregnant individuals because it’s associated with things like weight loss, and because of ease of use and lack of hypoglycemia – so I was really hoping to see this kind of result.”

Women receiving metformin were a mean 34 years old, while those who didn’t get metformin were 32 years old, a significant difference. Prepregnancy body mass index also was higher in those receiving metformin, and they were more likely to have a type 2 diabetes diagnosis. A similar proportion of both groups – about two-thirds – were white, and about 20% were Hispanic.

The lower weight gain seen in metformin-takers also might smooth the way post partum, said Dr. Adams. “My perception is that, when these women leave us, they might not have any primary care follow-up; they might not have anybody following their diabetes; and metformin is a very viable way to help them in their life outside of pregnancy.

“Not to mention that all the weight you gain in pregnancy, you do eventually have to lose post partum,” she added, “so having less pregnancy weight gain kind of sets them up for success in their postpregnancy life as well.”

Asked whether these results inform the ongoing question of whether insulin or metformin is the most appropriate first-line treatment for gestational diabetes, Dr. Adams first noted that “there’s a lot of crossover,” pointing out that over 60% of the participants in her study eventually also required insulin.

“It’s a question I would love to address in a head-to-head trial,” she said, adding that questions about metformin’s effects on the placenta and the potential for later deleterious effects require more study.

In her practice, Dr. Adams said that patients generally are discharged with a metformin prescription, and then meet with a diabetes educator 1 week after delivery to assess blood glucose levels and adjust medical management. Following that, a warm hand-off to a primary care practice who can continue management and education is optimal, she said.

In terms of next steps, “We would really love to look at metformin in the postpartum period,” said Dr. Adams. Ideally, future work could look for outcomes that extend beyond the 6- to 8-week postpartum follow-up visit. For example, she said, there are indications that women with insulin insensitivity might benefit from metformin while breastfeeding; it’s also possible that metformin might reduce the risk of postpartum preeclampsia.

Dr. Adams reported that she had no conflicts of interest and no outside sources of funding.

[email protected]

SOURCE: Adams J et al. SMFM 2020, Abstract 335.

*This story was updated 2/10/2020.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

AUSTIN, TEX. – Patients with inflammatory bowel disease (IBD) who want to have children can benefit from better education about recent findings that disease control, laparoscopic surgery, and in vitro fertilization (IVF) have improved their chances of conceiving, according to a review of published reports presented here at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Congress Foundation and the American Gastroenterological Association.

Richard Mark Kirkner/MDedge News

“Decreased fertility in IBD is due to voluntary childlessness, which we can change with education; surgery for IBD, which we can improve with laparoscopic surgery; and increased disease activity, which we can also make a difference in,” Sonia Friedman, MD, of Harvard Medical School, Boston, said in an interview.

Dr. Friedman and coauthors last year published an analysis of the Danish National Birth Cohort, which showed women with IBD had an 28% greater relative risk of taking a year or more to get pregnant than controls without IBD, and that the relative risk was even higher in women with Crohn’s disease — 54% (Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.031). “We found that women with Crohn’s surgery had decreased fertility by 2.54 times greater relative risk,” she said.

“Fertility, pregnancy is the most important thing to patients,” Dr. Friedman said in an interview. “That’s what people ask me about the most. In the population of IBD patients, the onset is age 15-35, and these people are in the prime of their reproductive years.” Sexual function, known to be decreased in men and women with IBD, is also an overriding concern in these patients, she said. “There needs to be a lot more information out there about it.”

She said gastroenterologists should keep in mind that much of the evidence documenting reduced fertility after ileo-pouch anal anastomosis is dated and focused on open surgery, which caused profound scarring of the pelvis and fallopian tubes, thus hindering conception. Laparoscopic ileoanal J-pouch surgery (IPAA) has yielded much improved outcomes in women of child-bearing age, she said, citing a study late last year that reported women who had laparoscopic IPAA had a median time to pregnancy of 3.5 months versus 9 months for women who had open IPAA (Surgery. 2019;166:670-7).

“It’s really important to discuss the issues of fertility, especially for patients contemplating surgery,” Dr. Friedman said. “Emphasize that there are good outcomes with laparoscopic surgery, and they can have assisted reproductive technology [ART], or in vitro fertilization, if needed. Never withhold surgery based on fear of infertility.”

Her practice is to refer women with IBD in remission for IVF if they’ve tried to get pregnant every month for a year or more and to refer women with IBD surgery for IVF after trying to get pregnant for 6 months. Dr. Friedman coauthored two studies of the Danish National Birth Cohort of ART in women with Crohn’s disease and ulcerative colitis (UC) along with controls (Gut. 2016;65:767-76; Gut. 2017;66:556-58). “We found that women with Crohn’s and UC had a decreased chance of having a clinical pregnancy, but they had no problem carrying the pregnancy to term,” she said.

Those findings raised questions about the etiology of decreased fertility in IBD patients, which could include factors such as IVF technique, reproductive hormone and microbiome changes, or IBD medications. “How can we carry that forward to all women with IBD?” she said. Women with IBD have less chance of conceiving with each IVF treatment cycle than do women without IBD, she said. “The most interesting thing is that the reduced chance of live birth after IVF treatment in Crohn’s and UC is related to the stages of implantation and not to the ability to maintain the fetus throughout pregnancy,” she said.

Dr. Friedman has no financial relationships to disclose.

SOURCE: Friedman S. Crohn’s & Colitis Congress, Session Sp86.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

[email protected]

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

[email protected]

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

[email protected]

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

A study of lung cancer in younger adults (less than 50 years) has found a recent trend of higher lung cancer rates in women, compared with men. The increase is driven by cases of adenocarcinoma of the lung.

The “emerging pattern of higher lung cancer incidence in young females” is not confined to geographic areas and income levels and “is not fully explained by sex-differences in smoking prevalence,” the authors comment.

Miranda M. Fidler-Benaoudia, PhD, Cancer Control Alberta, Alberta Health Services, Calgary, and colleagues examined lung cancer cases in 40 countries from 1993 to 2012.

They found that the female-to-male incidence rate ratio (IRR) had significantly crossed over from men to women in six countries, including the United States and Canada, and had nonsignificantly crossed over in a further 23 countries.

The research was published online Feb. 5 in the International Journal of Cancer.

These findings “forewarn of a higher lung cancer burden in women than men at older ages in the decades to follow, especially in higher-income settings,” write the authors. They highlight “the need for etiologic studies.”

Historically, lung cancer higher in men

Historically, lung cancer rates have been higher among men than women, owing to the fact that men start smoking in large numbers earlier and smoke at higher rates, the researchers comment.

However, there has been a convergence in lung cancer incidence between men and women. A recent study suggests that, in the United States, the incidence in young women is higher than that in their male counterparts.

To determine the degree to which this phenomenon is occurring globally, the team used national or subnational registry data from Cancer Incidence in Five Continents, volumes VIII–XI.

These included lung and bronchial cancer cases in 40 countries from 1993 to 2012, divided into 5-year periods. Individuals were categorized into 5-year age bands.

In addition, the team used the Global Health Data Exchange to extract data from the Global Burden of Disease Study 2015 and derive country- and sex-specific daily smoking prevalence rates.

The researchers found that among young men and women, there were three patterns in the occurrence of lung cancer between the periods 1993-1997 and 2008-2012:

• A significant crossover from male to female dominance, seen in six countries.
• An insignificant crossover from male to female dominance, found in 23 countries.
• A continued male dominance, observed in 11 countries.

Higher incidence in women in six countries

The six countries with significant crossover from male to female dominance were Canada, Denmark, Germany, New Zealand, the Netherlands, and the United States.

Further analysis showed that, in general, age-specific lung cancer incidence rates decreased in successive male birth cohorts in these six countries. There was more variation across female birth cohorts.

Calculating female-to-male incidence rate ratios, the team found, for example, the IRR increased in New Zealand from 1.0 in the 1953 birth cohort to 1.6 in the 1968 birth cohort for people aged 40-44 years.

In addition, among adults aged 45-49 years in the Netherlands, the IRR rose from 0.7 in those born in the circa 1948 cohort to 1.4 in those from the circa 1958 cohort.

Overall, female-to-male IRRs increased notably among the following groups:

• Individuals aged 30-34 years in Canada, Denmark, and Germany.
• Those aged 40-44 years in Germany, the Netherlands, and the United States.
• Those aged 44-50 years in the Netherlands and the United States.
• Those aged 50-54 years in Canada, Denmark, and New Zealand.

Countries with an insignificant crossover from male to female dominance of lung cancer were located across Africa, the Americas, Asia, Europe, and Oceania.

Again, incidence rates were typically characterized by falling rates of lung cancer among men in more recent birth cohorts, and lung cancer incidence trends were more variable in women.

The team writes: “Of note, the six countries demonstrating a significant crossover are among those considered to be more advanced in the tobacco epidemic.

“Many of the countries where the crossover was insignificant or when there was no crossover are considered to be late adopters of the tobacco epidemic, with the effects of the epidemic on the burden of lung cancer and other smoking-related diseases beginning to manifest more recently, or perhaps yet to come.”

They suggest that low- and middle-resource countries may not follow the tobacco epidemic pattern of high-income countries, and so “we may not see higher lung cancer incidence rates in women than men for the foreseeable future in these countries.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A study of lung cancer in younger adults (less than 50 years) has found a recent trend of higher lung cancer rates in women, compared with men. The increase is driven by cases of adenocarcinoma of the lung.

The “emerging pattern of higher lung cancer incidence in young females” is not confined to geographic areas and income levels and “is not fully explained by sex-differences in smoking prevalence,” the authors comment.

Miranda M. Fidler-Benaoudia, PhD, Cancer Control Alberta, Alberta Health Services, Calgary, and colleagues examined lung cancer cases in 40 countries from 1993 to 2012.

They found that the female-to-male incidence rate ratio (IRR) had significantly crossed over from men to women in six countries, including the United States and Canada, and had nonsignificantly crossed over in a further 23 countries.

The research was published online Feb. 5 in the International Journal of Cancer.

These findings “forewarn of a higher lung cancer burden in women than men at older ages in the decades to follow, especially in higher-income settings,” write the authors. They highlight “the need for etiologic studies.”

Historically, lung cancer higher in men

Historically, lung cancer rates have been higher among men than women, owing to the fact that men start smoking in large numbers earlier and smoke at higher rates, the researchers comment.

However, there has been a convergence in lung cancer incidence between men and women. A recent study suggests that, in the United States, the incidence in young women is higher than that in their male counterparts.

To determine the degree to which this phenomenon is occurring globally, the team used national or subnational registry data from Cancer Incidence in Five Continents, volumes VIII–XI.

These included lung and bronchial cancer cases in 40 countries from 1993 to 2012, divided into 5-year periods. Individuals were categorized into 5-year age bands.

In addition, the team used the Global Health Data Exchange to extract data from the Global Burden of Disease Study 2015 and derive country- and sex-specific daily smoking prevalence rates.

The researchers found that among young men and women, there were three patterns in the occurrence of lung cancer between the periods 1993-1997 and 2008-2012:

• A significant crossover from male to female dominance, seen in six countries.
• An insignificant crossover from male to female dominance, found in 23 countries.
• A continued male dominance, observed in 11 countries.

Higher incidence in women in six countries

The six countries with significant crossover from male to female dominance were Canada, Denmark, Germany, New Zealand, the Netherlands, and the United States.

Further analysis showed that, in general, age-specific lung cancer incidence rates decreased in successive male birth cohorts in these six countries. There was more variation across female birth cohorts.

Calculating female-to-male incidence rate ratios, the team found, for example, the IRR increased in New Zealand from 1.0 in the 1953 birth cohort to 1.6 in the 1968 birth cohort for people aged 40-44 years.

In addition, among adults aged 45-49 years in the Netherlands, the IRR rose from 0.7 in those born in the circa 1948 cohort to 1.4 in those from the circa 1958 cohort.

Overall, female-to-male IRRs increased notably among the following groups:

• Individuals aged 30-34 years in Canada, Denmark, and Germany.
• Those aged 40-44 years in Germany, the Netherlands, and the United States.
• Those aged 44-50 years in the Netherlands and the United States.
• Those aged 50-54 years in Canada, Denmark, and New Zealand.

Countries with an insignificant crossover from male to female dominance of lung cancer were located across Africa, the Americas, Asia, Europe, and Oceania.

Again, incidence rates were typically characterized by falling rates of lung cancer among men in more recent birth cohorts, and lung cancer incidence trends were more variable in women.

The team writes: “Of note, the six countries demonstrating a significant crossover are among those considered to be more advanced in the tobacco epidemic.

“Many of the countries where the crossover was insignificant or when there was no crossover are considered to be late adopters of the tobacco epidemic, with the effects of the epidemic on the burden of lung cancer and other smoking-related diseases beginning to manifest more recently, or perhaps yet to come.”

They suggest that low- and middle-resource countries may not follow the tobacco epidemic pattern of high-income countries, and so “we may not see higher lung cancer incidence rates in women than men for the foreseeable future in these countries.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A study of lung cancer in younger adults (less than 50 years) has found a recent trend of higher lung cancer rates in women, compared with men. The increase is driven by cases of adenocarcinoma of the lung.

The “emerging pattern of higher lung cancer incidence in young females” is not confined to geographic areas and income levels and “is not fully explained by sex-differences in smoking prevalence,” the authors comment.

Miranda M. Fidler-Benaoudia, PhD, Cancer Control Alberta, Alberta Health Services, Calgary, and colleagues examined lung cancer cases in 40 countries from 1993 to 2012.

They found that the female-to-male incidence rate ratio (IRR) had significantly crossed over from men to women in six countries, including the United States and Canada, and had nonsignificantly crossed over in a further 23 countries.

The research was published online Feb. 5 in the International Journal of Cancer.

These findings “forewarn of a higher lung cancer burden in women than men at older ages in the decades to follow, especially in higher-income settings,” write the authors. They highlight “the need for etiologic studies.”

Historically, lung cancer higher in men

Historically, lung cancer rates have been higher among men than women, owing to the fact that men start smoking in large numbers earlier and smoke at higher rates, the researchers comment.

However, there has been a convergence in lung cancer incidence between men and women. A recent study suggests that, in the United States, the incidence in young women is higher than that in their male counterparts.

To determine the degree to which this phenomenon is occurring globally, the team used national or subnational registry data from Cancer Incidence in Five Continents, volumes VIII–XI.

These included lung and bronchial cancer cases in 40 countries from 1993 to 2012, divided into 5-year periods. Individuals were categorized into 5-year age bands.

In addition, the team used the Global Health Data Exchange to extract data from the Global Burden of Disease Study 2015 and derive country- and sex-specific daily smoking prevalence rates.

The researchers found that among young men and women, there were three patterns in the occurrence of lung cancer between the periods 1993-1997 and 2008-2012:

• A significant crossover from male to female dominance, seen in six countries.
• An insignificant crossover from male to female dominance, found in 23 countries.
• A continued male dominance, observed in 11 countries.

Higher incidence in women in six countries

The six countries with significant crossover from male to female dominance were Canada, Denmark, Germany, New Zealand, the Netherlands, and the United States.

Further analysis showed that, in general, age-specific lung cancer incidence rates decreased in successive male birth cohorts in these six countries. There was more variation across female birth cohorts.

Calculating female-to-male incidence rate ratios, the team found, for example, the IRR increased in New Zealand from 1.0 in the 1953 birth cohort to 1.6 in the 1968 birth cohort for people aged 40-44 years.

In addition, among adults aged 45-49 years in the Netherlands, the IRR rose from 0.7 in those born in the circa 1948 cohort to 1.4 in those from the circa 1958 cohort.

Overall, female-to-male IRRs increased notably among the following groups:

• Individuals aged 30-34 years in Canada, Denmark, and Germany.
• Those aged 40-44 years in Germany, the Netherlands, and the United States.
• Those aged 44-50 years in the Netherlands and the United States.
• Those aged 50-54 years in Canada, Denmark, and New Zealand.

Countries with an insignificant crossover from male to female dominance of lung cancer were located across Africa, the Americas, Asia, Europe, and Oceania.

Again, incidence rates were typically characterized by falling rates of lung cancer among men in more recent birth cohorts, and lung cancer incidence trends were more variable in women.

The team writes: “Of note, the six countries demonstrating a significant crossover are among those considered to be more advanced in the tobacco epidemic.

“Many of the countries where the crossover was insignificant or when there was no crossover are considered to be late adopters of the tobacco epidemic, with the effects of the epidemic on the burden of lung cancer and other smoking-related diseases beginning to manifest more recently, or perhaps yet to come.”

They suggest that low- and middle-resource countries may not follow the tobacco epidemic pattern of high-income countries, and so “we may not see higher lung cancer incidence rates in women than men for the foreseeable future in these countries.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.