ORLANDO – Older black women with postmenopausal osteoporosis had significantly higher mortality rates, were more likely to be placed in a long-term nursing facility, and were more likely to become newly eligible for Medicaid after a major fragility fracture event, compared with their white counterparts, according to a findings presented at the annual meeting of the American Society for Bone and Mineral Research.

Previous studies have examined racial differences in mortality and outcomes after fracture, but the data from those studies are older or limited to a certain region or health system, Nicole C. Wright, PhD, MPH, of the department of epidemiology at the University of Alabama at Birmingham, said in her presentation.

“To our knowledge, this is the first comprehensive evaluation of fractures and outcomes post fracture by race, particularly in black women,” she said.

Using Medicare data from between 2010 and 2016, Dr. Wright and colleagues performed a cohort-based, descriptive study of 400,479 white women and 11,563 black women with postmenopausal osteoporosis, who were covered by Medicare Parts A, B, C and D and had a hip, pelvis, femur, radius/ulna, humerus, or clinical vertebral fractures. Fractures were identified by way of a validated algorithm that used inpatient and outpatient claims, outpatient physical evaluations, and management claims, together with fracture repair codes (positive predictive value range, 90.9%-98.6%; from Wright N et al. J Bone Min Res. 2019 Jun 6. doi: 10.1002/jbmr.3807).

The groups had similar proportions of patients in each age group (65-75 years, 75-84 years, 85 years and older), with a slightly higher percentage of younger black patients than younger white patients (25.0% vs. 22.4%, respectively). Black patients were more likely than white patients to be from the South (58.6% vs. 39.7%) and have a Charlson Comorbidity Index score of 2 or higher (62.9% vs. 45.4%). White patients were more likely than black patients to have a Charlson score of 0 (42.0% vs. 24.1%).

The three identifying outcomes were: death/mortality, which was determined using the date in the Medicare vital status; debility, a term used for patients newly placed in a long-term nursing facility; and destitution, used to describe patients who became newly eligible for Medicaid after a major fragility fracture.

The results showed that the most common fracture types were hip and clinical vertebral fractures, with black women having a significantly lower rate of clinical vertebral fractures (29.0% vs. 34.1%, respectively) but a significantly higher rate of femur fractures (9.1% vs. 3.8%). Black women also had a significantly higher mortality rate after a fracture (19.6% vs. 15.4%), and a significantly higher composite outcome of all three identifying outcome measurements (24.6% vs. 20.2%). However, rates of debility and destitution were similar between the groups.

When measured by fracture type, black women had significantly different 1-year postfracture outcomes, compared with white women, with a 38.0% higher incidence of mortality, 40.2% higher rate of debility, 185.0% higher rate of destitution, and 35.4% higher composite outcome for hip fracture. For radius/ulna fractures, black women also had a 59.7% higher rate of death, 8.5% higher rate of debility, 164.7% higher rate of destitution, and 43.0% higher composite outcomes; and for clinical vertebral fractures, they had 11.4% higher rate of death, 10.8% higher rate of debility, 130.6% higher rate of destitution, and 13.6% higher composite outcome, compared with white women.

Overall, black women had higher incidence risk ratios for death (IRR, 1.24; 95% confidence interval, 1.15-1.33), debility (IRR, 1.19; 95% CI, 1.06-1.33), and destitution (IRR, 2.45; 95% CI, 2.20-2.73) for fractures of the hip; higher IRRs for death (IRR, 1.48; 95% CI, 1.33-1.66), debility (IRR, 1.02; 95% CI, 0.87-1.20), and destitution (IRR, 2.70; 95% CI, 2.33-3.13) for fractures of the radius or ulna; and higher IRRs for death (IRR, 1.07; 95% CI, 0.98-1.17) and destitution (IRR, 2.40; 95% CI, 2.15-2.67) for clinical vertebral fractures.

“These data show that we need to develop interventions and/or programs to mitigate and reduce disparities in fracture outcomes,” said Dr. Wright.

She noted that the study results were limited because of its observational nature, and results cannot be generalized beyond older women with postmenopausal osteoporosis with Medicare coverage. In addition, the algorithm used to determine fracture status also had a potentially low sensitivity, which may have affected the study results, she said.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Wright reported receiving grants from Amgen and serving as an expert witness for the law firm Norton Rose Fulbright and Pfizer. Dr. Chen reported receiving grants from Amgen. Dr. Curtis reported receiving grants from, and is a consultant for, Amgen, Eli Lilly, and Radius. Dr. Saag reported receiving grants from Amgen and is a consultant for Gilead and Radius.

SOURCE: Wright NC et al. ASBMR 2019, Abstract 1125.

ORLANDO – Older black women with postmenopausal osteoporosis had significantly higher mortality rates, were more likely to be placed in a long-term nursing facility, and were more likely to become newly eligible for Medicaid after a major fragility fracture event, compared with their white counterparts, according to a findings presented at the annual meeting of the American Society for Bone and Mineral Research.

Previous studies have examined racial differences in mortality and outcomes after fracture, but the data from those studies are older or limited to a certain region or health system, Nicole C. Wright, PhD, MPH, of the department of epidemiology at the University of Alabama at Birmingham, said in her presentation.

“To our knowledge, this is the first comprehensive evaluation of fractures and outcomes post fracture by race, particularly in black women,” she said.

Using Medicare data from between 2010 and 2016, Dr. Wright and colleagues performed a cohort-based, descriptive study of 400,479 white women and 11,563 black women with postmenopausal osteoporosis, who were covered by Medicare Parts A, B, C and D and had a hip, pelvis, femur, radius/ulna, humerus, or clinical vertebral fractures. Fractures were identified by way of a validated algorithm that used inpatient and outpatient claims, outpatient physical evaluations, and management claims, together with fracture repair codes (positive predictive value range, 90.9%-98.6%; from Wright N et al. J Bone Min Res. 2019 Jun 6. doi: 10.1002/jbmr.3807).

The groups had similar proportions of patients in each age group (65-75 years, 75-84 years, 85 years and older), with a slightly higher percentage of younger black patients than younger white patients (25.0% vs. 22.4%, respectively). Black patients were more likely than white patients to be from the South (58.6% vs. 39.7%) and have a Charlson Comorbidity Index score of 2 or higher (62.9% vs. 45.4%). White patients were more likely than black patients to have a Charlson score of 0 (42.0% vs. 24.1%).

The three identifying outcomes were: death/mortality, which was determined using the date in the Medicare vital status; debility, a term used for patients newly placed in a long-term nursing facility; and destitution, used to describe patients who became newly eligible for Medicaid after a major fragility fracture.

The results showed that the most common fracture types were hip and clinical vertebral fractures, with black women having a significantly lower rate of clinical vertebral fractures (29.0% vs. 34.1%, respectively) but a significantly higher rate of femur fractures (9.1% vs. 3.8%). Black women also had a significantly higher mortality rate after a fracture (19.6% vs. 15.4%), and a significantly higher composite outcome of all three identifying outcome measurements (24.6% vs. 20.2%). However, rates of debility and destitution were similar between the groups.

When measured by fracture type, black women had significantly different 1-year postfracture outcomes, compared with white women, with a 38.0% higher incidence of mortality, 40.2% higher rate of debility, 185.0% higher rate of destitution, and 35.4% higher composite outcome for hip fracture. For radius/ulna fractures, black women also had a 59.7% higher rate of death, 8.5% higher rate of debility, 164.7% higher rate of destitution, and 43.0% higher composite outcomes; and for clinical vertebral fractures, they had 11.4% higher rate of death, 10.8% higher rate of debility, 130.6% higher rate of destitution, and 13.6% higher composite outcome, compared with white women.

Overall, black women had higher incidence risk ratios for death (IRR, 1.24; 95% confidence interval, 1.15-1.33), debility (IRR, 1.19; 95% CI, 1.06-1.33), and destitution (IRR, 2.45; 95% CI, 2.20-2.73) for fractures of the hip; higher IRRs for death (IRR, 1.48; 95% CI, 1.33-1.66), debility (IRR, 1.02; 95% CI, 0.87-1.20), and destitution (IRR, 2.70; 95% CI, 2.33-3.13) for fractures of the radius or ulna; and higher IRRs for death (IRR, 1.07; 95% CI, 0.98-1.17) and destitution (IRR, 2.40; 95% CI, 2.15-2.67) for clinical vertebral fractures.

“These data show that we need to develop interventions and/or programs to mitigate and reduce disparities in fracture outcomes,” said Dr. Wright.

She noted that the study results were limited because of its observational nature, and results cannot be generalized beyond older women with postmenopausal osteoporosis with Medicare coverage. In addition, the algorithm used to determine fracture status also had a potentially low sensitivity, which may have affected the study results, she said.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Wright reported receiving grants from Amgen and serving as an expert witness for the law firm Norton Rose Fulbright and Pfizer. Dr. Chen reported receiving grants from Amgen. Dr. Curtis reported receiving grants from, and is a consultant for, Amgen, Eli Lilly, and Radius. Dr. Saag reported receiving grants from Amgen and is a consultant for Gilead and Radius.

SOURCE: Wright NC et al. ASBMR 2019, Abstract 1125.

ORLANDO – Older black women with postmenopausal osteoporosis had significantly higher mortality rates, were more likely to be placed in a long-term nursing facility, and were more likely to become newly eligible for Medicaid after a major fragility fracture event, compared with their white counterparts, according to a findings presented at the annual meeting of the American Society for Bone and Mineral Research.

Previous studies have examined racial differences in mortality and outcomes after fracture, but the data from those studies are older or limited to a certain region or health system, Nicole C. Wright, PhD, MPH, of the department of epidemiology at the University of Alabama at Birmingham, said in her presentation.

“To our knowledge, this is the first comprehensive evaluation of fractures and outcomes post fracture by race, particularly in black women,” she said.

Using Medicare data from between 2010 and 2016, Dr. Wright and colleagues performed a cohort-based, descriptive study of 400,479 white women and 11,563 black women with postmenopausal osteoporosis, who were covered by Medicare Parts A, B, C and D and had a hip, pelvis, femur, radius/ulna, humerus, or clinical vertebral fractures. Fractures were identified by way of a validated algorithm that used inpatient and outpatient claims, outpatient physical evaluations, and management claims, together with fracture repair codes (positive predictive value range, 90.9%-98.6%; from Wright N et al. J Bone Min Res. 2019 Jun 6. doi: 10.1002/jbmr.3807).

The groups had similar proportions of patients in each age group (65-75 years, 75-84 years, 85 years and older), with a slightly higher percentage of younger black patients than younger white patients (25.0% vs. 22.4%, respectively). Black patients were more likely than white patients to be from the South (58.6% vs. 39.7%) and have a Charlson Comorbidity Index score of 2 or higher (62.9% vs. 45.4%). White patients were more likely than black patients to have a Charlson score of 0 (42.0% vs. 24.1%).

The three identifying outcomes were: death/mortality, which was determined using the date in the Medicare vital status; debility, a term used for patients newly placed in a long-term nursing facility; and destitution, used to describe patients who became newly eligible for Medicaid after a major fragility fracture.

The results showed that the most common fracture types were hip and clinical vertebral fractures, with black women having a significantly lower rate of clinical vertebral fractures (29.0% vs. 34.1%, respectively) but a significantly higher rate of femur fractures (9.1% vs. 3.8%). Black women also had a significantly higher mortality rate after a fracture (19.6% vs. 15.4%), and a significantly higher composite outcome of all three identifying outcome measurements (24.6% vs. 20.2%). However, rates of debility and destitution were similar between the groups.

When measured by fracture type, black women had significantly different 1-year postfracture outcomes, compared with white women, with a 38.0% higher incidence of mortality, 40.2% higher rate of debility, 185.0% higher rate of destitution, and 35.4% higher composite outcome for hip fracture. For radius/ulna fractures, black women also had a 59.7% higher rate of death, 8.5% higher rate of debility, 164.7% higher rate of destitution, and 43.0% higher composite outcomes; and for clinical vertebral fractures, they had 11.4% higher rate of death, 10.8% higher rate of debility, 130.6% higher rate of destitution, and 13.6% higher composite outcome, compared with white women.

Overall, black women had higher incidence risk ratios for death (IRR, 1.24; 95% confidence interval, 1.15-1.33), debility (IRR, 1.19; 95% CI, 1.06-1.33), and destitution (IRR, 2.45; 95% CI, 2.20-2.73) for fractures of the hip; higher IRRs for death (IRR, 1.48; 95% CI, 1.33-1.66), debility (IRR, 1.02; 95% CI, 0.87-1.20), and destitution (IRR, 2.70; 95% CI, 2.33-3.13) for fractures of the radius or ulna; and higher IRRs for death (IRR, 1.07; 95% CI, 0.98-1.17) and destitution (IRR, 2.40; 95% CI, 2.15-2.67) for clinical vertebral fractures.

“These data show that we need to develop interventions and/or programs to mitigate and reduce disparities in fracture outcomes,” said Dr. Wright.

She noted that the study results were limited because of its observational nature, and results cannot be generalized beyond older women with postmenopausal osteoporosis with Medicare coverage. In addition, the algorithm used to determine fracture status also had a potentially low sensitivity, which may have affected the study results, she said.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Wright reported receiving grants from Amgen and serving as an expert witness for the law firm Norton Rose Fulbright and Pfizer. Dr. Chen reported receiving grants from Amgen. Dr. Curtis reported receiving grants from, and is a consultant for, Amgen, Eli Lilly, and Radius. Dr. Saag reported receiving grants from Amgen and is a consultant for Gilead and Radius.

SOURCE: Wright NC et al. ASBMR 2019, Abstract 1125.

Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.¹There are several unique needs of trans patients that extend into obstetrics and may be addressed as early as the first gender transition visit. Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.

Stuart Jenner/Thinkstock

The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.² Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.³ A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.²

If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.² When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).

Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.² If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.

The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.⁴ Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.

The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.

In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.¹ We found only one case report of induced lactation in a nonpuerperal transfeminine patient.⁵ In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.

Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].

References

1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.

2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.

3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.

4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.

5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.

Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.¹There are several unique needs of trans patients that extend into obstetrics and may be addressed as early as the first gender transition visit. Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.

Stuart Jenner/Thinkstock

The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.² Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.³ A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.²

If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.² When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).

Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.² If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.

The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.⁴ Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.

The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.

In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.¹ We found only one case report of induced lactation in a nonpuerperal transfeminine patient.⁵ In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.

Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].

References

1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.

2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.

3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.

4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.

5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.

Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.¹There are several unique needs of trans patients that extend into obstetrics and may be addressed as early as the first gender transition visit. Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.

Stuart Jenner/Thinkstock

The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.² Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.³ A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.²

If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.² When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).

Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.² If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.

The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.⁴ Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.

The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.

In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.¹ We found only one case report of induced lactation in a nonpuerperal transfeminine patient.⁵ In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.

Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].

References

1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.

2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.

3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.

4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.

5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

According to a study on patients undergoing revision knee replacement, a delay of more than 24 hours between hospital admission and total knee arthroplasty (TKA) for periprosthetic fracture (PPF) led to increased odds of complications such as surgical site and urinary tract infections.

gorodenkoff/iStock/Getty Images

“Although this association is an important finding, the confounding factors that cause delay to surgery must be elucidated in non-database studies,” wrote Venkat Boddapati, MD, of Columbia University Medical Center, New York, and coauthors. The study was published in Arthroplasty Today.

To assess the best time for revision TKA after PPF of the knee, the researchers analyzed data from 484 patients who underwent another TKA from 2005 to 2016. Of those patients, 377 (78%) had expedited surgery – defined as less than or equal to 24 hours from hospital admission – and 107 (22%) had non-expedited surgery. Non-expedited patients averaged 3.2 days from admission to surgery.

After multivariate analysis, non-expedited patients had more complications overall, compared with expedited patients (odds ratio 2.35, P = .037). They also had comparative increases in surgical site infections (OR 12.87, P = .029), urinary tract infections (OR 10.46, P = .048), non-home discharge (OR 4.27, P less than .001), and blood transfusions (OR 4.53, P less than .001). The two groups saw no statistical difference in mortality.

The authors noted their study’s limitations, including an inability to assess complications beyond 30 days after surgery, which may affect tracking longer-term outcomes such as mortality. In addition, they were only able to classify surgery as expedited or non-expedited based on when the patient was admitted to the hospital, not the time since their injury. Finally, they lacked “relevant variables that may have contributed to this analysis,” including the type of fracture and the revision implants used.

Three authors reported being paid consultants for, and receiving research support from, several medical companies. The others reported no conflicts of interest.

SOURCE: Boddapati V et al. Arthroplast Today. 2019 Sep 1. doi: 10.1016/j.artd.2019.05.002.

Most children who develop alopecia areata before age 4 years have mild disease with less than 50% hair loss, and present between ages 2 and 4, according to a retrospective chart review of 125 children.

Almost 90% of the children presented between aged 2 and 4 years, compared with 11.9% between ages 1 and 2 years, and 1.6% aged under 1 year, “in keeping with the existing literature,” the study authors reported in Pediatric Dermatology. “A high percentage of patients continued to have mild, patchy alopecia at their follow‐up visits,” they added.

Epidemiologic studies of children with alopecia areata are few and have not focused on the youngest patients, said Sneha Rangu, of the section of dermatology at Children’s Hospital of Philadelphia, and coauthors. They performed a retrospective chart review of 125 patients, who initially presented at the hospital with alopecia areata between Jan. 1, 2016, and June 1, 2018, when they were younger than 4 years. Patients who received systemic therapy or topical JAK inhibitors for alopecia were excluded. Severity was measured with the Severity of Alopecia Tool (SALT) score, to monitor progression of hair loss, analyzing scores at the initial presentation, at 3-6 months, at 1 year, and at 2 or more years.

Almost 70% were female, which the authors said was similar to other studies that have found alopecia areata is more prevalent in females; and 86.6% were between ages 2 and 4 years when they first presented. The initial diagnosis was alopecia areata in 72.0%, alopecia totalis in 8.8%, and alopecia universalis in 19.2%. Of the 41 boys, 39% had alopecia totalis or alopecia universalis, as did 22% of the girls, which suggested that boys presenting under aged 4 years were more likely to have more severe disease, or that “guardians of boys are more likely to present for therapy when disease is more severe,” the authors wrote.

About 40% of the children presented with a history of atopic dermatitis, and 4% had an autoimmune disease (vitiligo, celiac disease, or type 1 diabetes). Twenty-eight percent of patients had a family history of alopecia areata, 27.2% had a family history of other autoimmune diseases, and 32% had a family history of hypothyroidism.

At the first visit, 57.6% had patch‐stage alopecia and SALT scores in the mild range (0%‐24% hair loss), which was present in a high proportion of these patients at follow-up: 49.4% at 3-6 months, 39.5% at 1 year, and 42.9% at two or more years.

At the first visit, 28% had high SALT scores (50%-100% hair loss), increasing to 36% at 3-6 months, 41.8% at 1 year, and 46.4% at 2 or more years. They calculated that for those with more than 50% hair loss at the initial presentation, the likelihood of being in a high category of hair loss, as measured by increasing SALT scores, was significantly higher at 1 year (odds ratio, 1.85, P =.033) and at 2 or more years (OR, 2.29, P = .038).

“While there is a likelihood of increasing disease severity, those with higher severity at initial presentation are likely to stay severe after one or 2 years,” the authors noted.

They concluded that their results add to the understanding of the epidemiology of alopecia areata in children “and perhaps can provide clinicians and families with a better sense of prognosis for progression in the youngest patients presenting with alopecia areata.”

They said the retrospective design and small sample size were among the study’s limitations. They had no conflicts of interest to disclose.

[email protected]

SOURCE: Rangu S et al. Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990.

Most children who develop alopecia areata before age 4 years have mild disease with less than 50% hair loss, and present between ages 2 and 4, according to a retrospective chart review of 125 children.

Almost 90% of the children presented between aged 2 and 4 years, compared with 11.9% between ages 1 and 2 years, and 1.6% aged under 1 year, “in keeping with the existing literature,” the study authors reported in Pediatric Dermatology. “A high percentage of patients continued to have mild, patchy alopecia at their follow‐up visits,” they added.

Epidemiologic studies of children with alopecia areata are few and have not focused on the youngest patients, said Sneha Rangu, of the section of dermatology at Children’s Hospital of Philadelphia, and coauthors. They performed a retrospective chart review of 125 patients, who initially presented at the hospital with alopecia areata between Jan. 1, 2016, and June 1, 2018, when they were younger than 4 years. Patients who received systemic therapy or topical JAK inhibitors for alopecia were excluded. Severity was measured with the Severity of Alopecia Tool (SALT) score, to monitor progression of hair loss, analyzing scores at the initial presentation, at 3-6 months, at 1 year, and at 2 or more years.

Almost 70% were female, which the authors said was similar to other studies that have found alopecia areata is more prevalent in females; and 86.6% were between ages 2 and 4 years when they first presented. The initial diagnosis was alopecia areata in 72.0%, alopecia totalis in 8.8%, and alopecia universalis in 19.2%. Of the 41 boys, 39% had alopecia totalis or alopecia universalis, as did 22% of the girls, which suggested that boys presenting under aged 4 years were more likely to have more severe disease, or that “guardians of boys are more likely to present for therapy when disease is more severe,” the authors wrote.

About 40% of the children presented with a history of atopic dermatitis, and 4% had an autoimmune disease (vitiligo, celiac disease, or type 1 diabetes). Twenty-eight percent of patients had a family history of alopecia areata, 27.2% had a family history of other autoimmune diseases, and 32% had a family history of hypothyroidism.

At the first visit, 57.6% had patch‐stage alopecia and SALT scores in the mild range (0%‐24% hair loss), which was present in a high proportion of these patients at follow-up: 49.4% at 3-6 months, 39.5% at 1 year, and 42.9% at two or more years.

At the first visit, 28% had high SALT scores (50%-100% hair loss), increasing to 36% at 3-6 months, 41.8% at 1 year, and 46.4% at 2 or more years. They calculated that for those with more than 50% hair loss at the initial presentation, the likelihood of being in a high category of hair loss, as measured by increasing SALT scores, was significantly higher at 1 year (odds ratio, 1.85, P =.033) and at 2 or more years (OR, 2.29, P = .038).

“While there is a likelihood of increasing disease severity, those with higher severity at initial presentation are likely to stay severe after one or 2 years,” the authors noted.

They concluded that their results add to the understanding of the epidemiology of alopecia areata in children “and perhaps can provide clinicians and families with a better sense of prognosis for progression in the youngest patients presenting with alopecia areata.”

They said the retrospective design and small sample size were among the study’s limitations. They had no conflicts of interest to disclose.

[email protected]

SOURCE: Rangu S et al. Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990.

Most children who develop alopecia areata before age 4 years have mild disease with less than 50% hair loss, and present between ages 2 and 4, according to a retrospective chart review of 125 children.

Almost 90% of the children presented between aged 2 and 4 years, compared with 11.9% between ages 1 and 2 years, and 1.6% aged under 1 year, “in keeping with the existing literature,” the study authors reported in Pediatric Dermatology. “A high percentage of patients continued to have mild, patchy alopecia at their follow‐up visits,” they added.

Epidemiologic studies of children with alopecia areata are few and have not focused on the youngest patients, said Sneha Rangu, of the section of dermatology at Children’s Hospital of Philadelphia, and coauthors. They performed a retrospective chart review of 125 patients, who initially presented at the hospital with alopecia areata between Jan. 1, 2016, and June 1, 2018, when they were younger than 4 years. Patients who received systemic therapy or topical JAK inhibitors for alopecia were excluded. Severity was measured with the Severity of Alopecia Tool (SALT) score, to monitor progression of hair loss, analyzing scores at the initial presentation, at 3-6 months, at 1 year, and at 2 or more years.

Almost 70% were female, which the authors said was similar to other studies that have found alopecia areata is more prevalent in females; and 86.6% were between ages 2 and 4 years when they first presented. The initial diagnosis was alopecia areata in 72.0%, alopecia totalis in 8.8%, and alopecia universalis in 19.2%. Of the 41 boys, 39% had alopecia totalis or alopecia universalis, as did 22% of the girls, which suggested that boys presenting under aged 4 years were more likely to have more severe disease, or that “guardians of boys are more likely to present for therapy when disease is more severe,” the authors wrote.

About 40% of the children presented with a history of atopic dermatitis, and 4% had an autoimmune disease (vitiligo, celiac disease, or type 1 diabetes). Twenty-eight percent of patients had a family history of alopecia areata, 27.2% had a family history of other autoimmune diseases, and 32% had a family history of hypothyroidism.

At the first visit, 57.6% had patch‐stage alopecia and SALT scores in the mild range (0%‐24% hair loss), which was present in a high proportion of these patients at follow-up: 49.4% at 3-6 months, 39.5% at 1 year, and 42.9% at two or more years.

At the first visit, 28% had high SALT scores (50%-100% hair loss), increasing to 36% at 3-6 months, 41.8% at 1 year, and 46.4% at 2 or more years. They calculated that for those with more than 50% hair loss at the initial presentation, the likelihood of being in a high category of hair loss, as measured by increasing SALT scores, was significantly higher at 1 year (odds ratio, 1.85, P =.033) and at 2 or more years (OR, 2.29, P = .038).

“While there is a likelihood of increasing disease severity, those with higher severity at initial presentation are likely to stay severe after one or 2 years,” the authors noted.

They concluded that their results add to the understanding of the epidemiology of alopecia areata in children “and perhaps can provide clinicians and families with a better sense of prognosis for progression in the youngest patients presenting with alopecia areata.”

They said the retrospective design and small sample size were among the study’s limitations. They had no conflicts of interest to disclose.

[email protected]

SOURCE: Rangu S et al. Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Elevated serum levels of circulating sex hormones were found to be associated with lower odds of asthma in women, possibly explaining in part the different prevalence of asthma in men and women, according to the findings of a large cross-sectional population based study.

Yueh-Ying Han, PhD, of the Children’s Hospital of Pittsburgh and colleagues investigated the role of free testosterone and estradiol levels and current asthma among adults. The impact of obesity on that association was also examined. The investigators analyzed data from 7,615 adults (3,953 men and 3,662 women) who participated in the 2013-2014 and 2015-2016 U.S. National Health and Nutrition Examination Survey. The data included health interviews, examination components, and laboratory tests on each patient. Serum samples were analyzed by the division of laboratory sciences of the Centers for Disease Control and Prevention. Logistic regression was used for the multivariable analysis of sex hormone levels (as quartiles) and current asthma, and the analysis was done separately on men and women. Pregnant women were excluded, in addition to individuals with incomplete data. The exclusions tended to be Hispanic, former smokers, lower income, and lacking private insurance. The overall prevalence of current asthma in the sample was 9% (6% in men and 13% in women).

Three models were generated based on serum levels in women and in men.

For model 1 (unadjusted for estradiol), women whose serum testosterone levels were in the second and fourth quartiles had 30%-45% significantly lower odds of having current asthma than those whose serum testosterone level was in the lowest quartile. Among men, those whose serum testosterone levels were in the second and fourth quartiles had 12%-13% lower odds for current asthma.

For model 2 (unadjusted for free testosterone), women whose serum estradiol levels were in the third quartile had 34% significantly lower odds of having current asthma than those whose estradiol levels were in the lowest quartile. The findings were similar for men, that is, those whose serum estradiol levels were in the third quartile had 30% lower odds for having asthma, compared with those with in the lowest quartile.

For model 3 (a multivariable model including serum levels of both estradiol and free testosterone), women whose serum testosterone levels were in the second and fourth quartiles had 30% and 44% lower odds of current asthma than those whose serum testosterone levels were in the lowest quartile. But in this multivariable model, the association between serum estradiol and current asthma was not significant. Among men (models 1-3), the magnitude of the estimated effect of serum testosterone and serum estradiol on current asthma was similar to that observed in female participants, but neither serum testosterone nor serum estradiol was significantly associated with current asthma.

The investigators then analyzed the impact of obesity on the relationship between serum hormone levels and obesity. Obesity was defined as body mass index equal to or greater than 30 kg/m². A total of 1,370 men and 1,653 women were included in this analysis. In multivariable analyses of the obese participants, adjustment without (model 1) and with (model 3) serum estradiol, serum free-testosterone levels in the highest (fourth) quartile were significantly associated with reduced odds of asthma in obese women. In multivariable analyses without (model 2) and with (model 3), serum estradiol levels above the first quartile were significantly associated with reduced odds of current asthma in obese women.

In contrast to the results in obese women, neither serum free testosterone nor serum estradiol was significantly associated with current asthma in obese men or nonobese women.

Dr. Han and coauthors suggested a possible mechanism of the role of sex hormones in asthma. “Androgens such as testosterone may reduce innate and adaptive immune responses, while estrogen and progesterone may enhance T-helper cell type 2 allergic airway inflammation.”

They concluded: “We found that elevated serum levels of both free testosterone and estradiol were significantly associated with reduced odds of asthma in obese women, and that elevated levels of serum estradiol were significantly associated with reduced odds of asthma in nonobese men. Our findings further suggest that sex steroid hormones play a role in known sex differences in asthma among adults.”

One coauthor has received research materials from Merck and GlaxoSmithKline (inhaled steroids), as well as Pharmavite (vitamin D and placebo capsules), to provide medications free of cost to participants in National Institutes for Health–funded studies, unrelated to the current work. The other authors reported no conflicts of interest.

[email protected]

SOURCE: Han Y-Y et al. J Respir Crit Care Med. 2019 Sep 16. doi: 10.1164/rccm.201905-0996OC.

Elevated serum levels of circulating sex hormones were found to be associated with lower odds of asthma in women, possibly explaining in part the different prevalence of asthma in men and women, according to the findings of a large cross-sectional population based study.

Yueh-Ying Han, PhD, of the Children’s Hospital of Pittsburgh and colleagues investigated the role of free testosterone and estradiol levels and current asthma among adults. The impact of obesity on that association was also examined. The investigators analyzed data from 7,615 adults (3,953 men and 3,662 women) who participated in the 2013-2014 and 2015-2016 U.S. National Health and Nutrition Examination Survey. The data included health interviews, examination components, and laboratory tests on each patient. Serum samples were analyzed by the division of laboratory sciences of the Centers for Disease Control and Prevention. Logistic regression was used for the multivariable analysis of sex hormone levels (as quartiles) and current asthma, and the analysis was done separately on men and women. Pregnant women were excluded, in addition to individuals with incomplete data. The exclusions tended to be Hispanic, former smokers, lower income, and lacking private insurance. The overall prevalence of current asthma in the sample was 9% (6% in men and 13% in women).

Three models were generated based on serum levels in women and in men.

For model 1 (unadjusted for estradiol), women whose serum testosterone levels were in the second and fourth quartiles had 30%-45% significantly lower odds of having current asthma than those whose serum testosterone level was in the lowest quartile. Among men, those whose serum testosterone levels were in the second and fourth quartiles had 12%-13% lower odds for current asthma.

For model 2 (unadjusted for free testosterone), women whose serum estradiol levels were in the third quartile had 34% significantly lower odds of having current asthma than those whose estradiol levels were in the lowest quartile. The findings were similar for men, that is, those whose serum estradiol levels were in the third quartile had 30% lower odds for having asthma, compared with those with in the lowest quartile.

For model 3 (a multivariable model including serum levels of both estradiol and free testosterone), women whose serum testosterone levels were in the second and fourth quartiles had 30% and 44% lower odds of current asthma than those whose serum testosterone levels were in the lowest quartile. But in this multivariable model, the association between serum estradiol and current asthma was not significant. Among men (models 1-3), the magnitude of the estimated effect of serum testosterone and serum estradiol on current asthma was similar to that observed in female participants, but neither serum testosterone nor serum estradiol was significantly associated with current asthma.

The investigators then analyzed the impact of obesity on the relationship between serum hormone levels and obesity. Obesity was defined as body mass index equal to or greater than 30 kg/m². A total of 1,370 men and 1,653 women were included in this analysis. In multivariable analyses of the obese participants, adjustment without (model 1) and with (model 3) serum estradiol, serum free-testosterone levels in the highest (fourth) quartile were significantly associated with reduced odds of asthma in obese women. In multivariable analyses without (model 2) and with (model 3), serum estradiol levels above the first quartile were significantly associated with reduced odds of current asthma in obese women.

In contrast to the results in obese women, neither serum free testosterone nor serum estradiol was significantly associated with current asthma in obese men or nonobese women.

Dr. Han and coauthors suggested a possible mechanism of the role of sex hormones in asthma. “Androgens such as testosterone may reduce innate and adaptive immune responses, while estrogen and progesterone may enhance T-helper cell type 2 allergic airway inflammation.”

They concluded: “We found that elevated serum levels of both free testosterone and estradiol were significantly associated with reduced odds of asthma in obese women, and that elevated levels of serum estradiol were significantly associated with reduced odds of asthma in nonobese men. Our findings further suggest that sex steroid hormones play a role in known sex differences in asthma among adults.”

One coauthor has received research materials from Merck and GlaxoSmithKline (inhaled steroids), as well as Pharmavite (vitamin D and placebo capsules), to provide medications free of cost to participants in National Institutes for Health–funded studies, unrelated to the current work. The other authors reported no conflicts of interest.

[email protected]

SOURCE: Han Y-Y et al. J Respir Crit Care Med. 2019 Sep 16. doi: 10.1164/rccm.201905-0996OC.

Elevated serum levels of circulating sex hormones were found to be associated with lower odds of asthma in women, possibly explaining in part the different prevalence of asthma in men and women, according to the findings of a large cross-sectional population based study.

Yueh-Ying Han, PhD, of the Children’s Hospital of Pittsburgh and colleagues investigated the role of free testosterone and estradiol levels and current asthma among adults. The impact of obesity on that association was also examined. The investigators analyzed data from 7,615 adults (3,953 men and 3,662 women) who participated in the 2013-2014 and 2015-2016 U.S. National Health and Nutrition Examination Survey. The data included health interviews, examination components, and laboratory tests on each patient. Serum samples were analyzed by the division of laboratory sciences of the Centers for Disease Control and Prevention. Logistic regression was used for the multivariable analysis of sex hormone levels (as quartiles) and current asthma, and the analysis was done separately on men and women. Pregnant women were excluded, in addition to individuals with incomplete data. The exclusions tended to be Hispanic, former smokers, lower income, and lacking private insurance. The overall prevalence of current asthma in the sample was 9% (6% in men and 13% in women).

Three models were generated based on serum levels in women and in men.

For model 1 (unadjusted for estradiol), women whose serum testosterone levels were in the second and fourth quartiles had 30%-45% significantly lower odds of having current asthma than those whose serum testosterone level was in the lowest quartile. Among men, those whose serum testosterone levels were in the second and fourth quartiles had 12%-13% lower odds for current asthma.

For model 2 (unadjusted for free testosterone), women whose serum estradiol levels were in the third quartile had 34% significantly lower odds of having current asthma than those whose estradiol levels were in the lowest quartile. The findings were similar for men, that is, those whose serum estradiol levels were in the third quartile had 30% lower odds for having asthma, compared with those with in the lowest quartile.

For model 3 (a multivariable model including serum levels of both estradiol and free testosterone), women whose serum testosterone levels were in the second and fourth quartiles had 30% and 44% lower odds of current asthma than those whose serum testosterone levels were in the lowest quartile. But in this multivariable model, the association between serum estradiol and current asthma was not significant. Among men (models 1-3), the magnitude of the estimated effect of serum testosterone and serum estradiol on current asthma was similar to that observed in female participants, but neither serum testosterone nor serum estradiol was significantly associated with current asthma.

The investigators then analyzed the impact of obesity on the relationship between serum hormone levels and obesity. Obesity was defined as body mass index equal to or greater than 30 kg/m². A total of 1,370 men and 1,653 women were included in this analysis. In multivariable analyses of the obese participants, adjustment without (model 1) and with (model 3) serum estradiol, serum free-testosterone levels in the highest (fourth) quartile were significantly associated with reduced odds of asthma in obese women. In multivariable analyses without (model 2) and with (model 3), serum estradiol levels above the first quartile were significantly associated with reduced odds of current asthma in obese women.

In contrast to the results in obese women, neither serum free testosterone nor serum estradiol was significantly associated with current asthma in obese men or nonobese women.

Dr. Han and coauthors suggested a possible mechanism of the role of sex hormones in asthma. “Androgens such as testosterone may reduce innate and adaptive immune responses, while estrogen and progesterone may enhance T-helper cell type 2 allergic airway inflammation.”

They concluded: “We found that elevated serum levels of both free testosterone and estradiol were significantly associated with reduced odds of asthma in obese women, and that elevated levels of serum estradiol were significantly associated with reduced odds of asthma in nonobese men. Our findings further suggest that sex steroid hormones play a role in known sex differences in asthma among adults.”

One coauthor has received research materials from Merck and GlaxoSmithKline (inhaled steroids), as well as Pharmavite (vitamin D and placebo capsules), to provide medications free of cost to participants in National Institutes for Health–funded studies, unrelated to the current work. The other authors reported no conflicts of interest.

[email protected]

SOURCE: Han Y-Y et al. J Respir Crit Care Med. 2019 Sep 16. doi: 10.1164/rccm.201905-0996OC.

Iron deficiency anemia (IDA) is a serious health problem that affects millions of women globally. Heavy menstrual bleeding (HMB) is one of the most common causes of IDA in women in North America.

In this supplement to OBG Management, the authors describe the signs, symptoms, and laboratory evaluation for HMB and IDA, including a comprehensive diagnostic and treatment algorithm for the practicing physician. The authors also discuss the characteristics of iron-repletion therapies currently available in the United States to help you make the best choice for your patient.

Click here to read the supplement

Iron deficiency anemia (IDA) is a serious health problem that affects millions of women globally. Heavy menstrual bleeding (HMB) is one of the most common causes of IDA in women in North America.

In this supplement to OBG Management, the authors describe the signs, symptoms, and laboratory evaluation for HMB and IDA, including a comprehensive diagnostic and treatment algorithm for the practicing physician. The authors also discuss the characteristics of iron-repletion therapies currently available in the United States to help you make the best choice for your patient.

Click here to read the supplement

Iron deficiency anemia (IDA) is a serious health problem that affects millions of women globally. Heavy menstrual bleeding (HMB) is one of the most common causes of IDA in women in North America.

In this supplement to OBG Management, the authors describe the signs, symptoms, and laboratory evaluation for HMB and IDA, including a comprehensive diagnostic and treatment algorithm for the practicing physician. The authors also discuss the characteristics of iron-repletion therapies currently available in the United States to help you make the best choice for your patient.

Click here to read the supplement

The use of a grass-based allergy immunotherapy (AIT) lowered the risk of progression from milder to more severe asthma, according to the results of a large, real-world, industry-sponsored, observational study.

Photo courtesy Oak Ridge National Laboratory

The researchers analyzed a cohort of 1,739,440 patients aged 12 years and older using 2005-2014 data from a statutory health insurance database in Germany. From this population, 39,167 individuals aged 14 years or older were classified as having incident asthma during the observation period and were included in the study.

The severity of asthma was classified according to the treatment steps recommended by the Global Initiative for Asthma (GINA).

Among these, 4,111 patients (10.5%) received AIT. AIT use was associated with a significantly decreased likelihood of asthma progression from GINA step 1 to step 3 (hazard ratio, 0.87; 95% confidence interval, 0.80‐0.95) and GINA step 3 to step 4 (HR, 0.66; 95% CI, 0.60‐0.74).

Medications for GINA step 2 (3.5%) and GINA step 5 (0.03%) were rarely prescribed, so the researchers could not analyze the transition between GINA steps 1 and 2, step 2 and 3, and step 4 and 5.

A total of 8,726 patients had at least one transition between GINA steps 1, 3, or 4, and 1,085 had two transitions, though not all 39,167 patients were under risk of severity progression into all GINA steps, according to the authors.

The findings are consistent with earlier studies that indicate grass-based immunotherapy can effectively treat asthma symptoms and potentially asthma progression (J Allergy Clin Immuno. 2012;129[3];717-25; J Allergy Clin Immunol. 2018;141[2]:529‐38).

“This study indicates that AIT may modify the course of asthma. Our study supports the assumption that treatment with AIT may prevent the progression from mild to more severe asthma,” the authors concluded.

The study was financially supported by ALK‐Abelló; several of the authors were also employees of or received funding from the company.

[email protected]

SOURCE: Schmitt J et al. Allergy. 2019. doi: 10.1111/all.14020.

The use of a grass-based allergy immunotherapy (AIT) lowered the risk of progression from milder to more severe asthma, according to the results of a large, real-world, industry-sponsored, observational study.

Photo courtesy Oak Ridge National Laboratory

The researchers analyzed a cohort of 1,739,440 patients aged 12 years and older using 2005-2014 data from a statutory health insurance database in Germany. From this population, 39,167 individuals aged 14 years or older were classified as having incident asthma during the observation period and were included in the study.

The severity of asthma was classified according to the treatment steps recommended by the Global Initiative for Asthma (GINA).

Among these, 4,111 patients (10.5%) received AIT. AIT use was associated with a significantly decreased likelihood of asthma progression from GINA step 1 to step 3 (hazard ratio, 0.87; 95% confidence interval, 0.80‐0.95) and GINA step 3 to step 4 (HR, 0.66; 95% CI, 0.60‐0.74).

Medications for GINA step 2 (3.5%) and GINA step 5 (0.03%) were rarely prescribed, so the researchers could not analyze the transition between GINA steps 1 and 2, step 2 and 3, and step 4 and 5.

A total of 8,726 patients had at least one transition between GINA steps 1, 3, or 4, and 1,085 had two transitions, though not all 39,167 patients were under risk of severity progression into all GINA steps, according to the authors.

The findings are consistent with earlier studies that indicate grass-based immunotherapy can effectively treat asthma symptoms and potentially asthma progression (J Allergy Clin Immuno. 2012;129[3];717-25; J Allergy Clin Immunol. 2018;141[2]:529‐38).

“This study indicates that AIT may modify the course of asthma. Our study supports the assumption that treatment with AIT may prevent the progression from mild to more severe asthma,” the authors concluded.

The study was financially supported by ALK‐Abelló; several of the authors were also employees of or received funding from the company.

[email protected]

SOURCE: Schmitt J et al. Allergy. 2019. doi: 10.1111/all.14020.

The use of a grass-based allergy immunotherapy (AIT) lowered the risk of progression from milder to more severe asthma, according to the results of a large, real-world, industry-sponsored, observational study.

Photo courtesy Oak Ridge National Laboratory

The researchers analyzed a cohort of 1,739,440 patients aged 12 years and older using 2005-2014 data from a statutory health insurance database in Germany. From this population, 39,167 individuals aged 14 years or older were classified as having incident asthma during the observation period and were included in the study.

The severity of asthma was classified according to the treatment steps recommended by the Global Initiative for Asthma (GINA).

Among these, 4,111 patients (10.5%) received AIT. AIT use was associated with a significantly decreased likelihood of asthma progression from GINA step 1 to step 3 (hazard ratio, 0.87; 95% confidence interval, 0.80‐0.95) and GINA step 3 to step 4 (HR, 0.66; 95% CI, 0.60‐0.74).

Medications for GINA step 2 (3.5%) and GINA step 5 (0.03%) were rarely prescribed, so the researchers could not analyze the transition between GINA steps 1 and 2, step 2 and 3, and step 4 and 5.

A total of 8,726 patients had at least one transition between GINA steps 1, 3, or 4, and 1,085 had two transitions, though not all 39,167 patients were under risk of severity progression into all GINA steps, according to the authors.

The findings are consistent with earlier studies that indicate grass-based immunotherapy can effectively treat asthma symptoms and potentially asthma progression (J Allergy Clin Immuno. 2012;129[3];717-25; J Allergy Clin Immunol. 2018;141[2]:529‐38).

“This study indicates that AIT may modify the course of asthma. Our study supports the assumption that treatment with AIT may prevent the progression from mild to more severe asthma,” the authors concluded.

The study was financially supported by ALK‐Abelló; several of the authors were also employees of or received funding from the company.

[email protected]

SOURCE: Schmitt J et al. Allergy. 2019. doi: 10.1111/all.14020.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

EDINBURGH – Consolidation therapy with obinutuzumab after chemoimmunotherapy for B-cell chronic lymphocytic leukemia (B-CLL) was highly effective for eradicating minimal residual disease (MRD) within 6 months following randomization in the seamless phase 2/3 GALACTIC trial.

Of 14 patients who were MRD positive after chemoimmunotherapy and randomized to consolidation with the type II monoclonal antibody targeting the CD20 antigen, 10 achieved MRD negativity in the bone marrow by 6 months, and 13 achieved MRD negativity in the peripheral blood by 6 months, Talha Munir, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

“And that translated into [progression-free survival] improvement in the consolidation arm,” said Dr. Munir of St. James’s University, Leeds, England.

The median progression-free survival in that arm was not reached, whereas progression-free survival in 15 MRD-positive patients randomized to the nonconsolidation arm was 16.6 months, he said.

Further, no difference was seen in median progression-free survival, overall survival, or MRD duration between the consolidation arm and 19 patients who were not randomized because of MRD negativity after chemoimmunotherapy, he noted.

Achieving MRD negativity in CLL confers a survival advantage, and obinutuzumab has shown greater efficacy with respect to MRD in CLL when compared with previous anti-CD20 antibodies, and it is less immune suppressive than the anti-CD52 antibody alemtuzumab, he explained.

The GALACTIC trial was designed to assess the safety and efficacy of obinutuzumab consolidation for eradicating MRD and whether its effects would prolong progression-free survival in patients with B-CLL who recently responded to chemoimmunotherapy. Those achieving complete response or partial response at 3-24 months after chemoimmunotherapy, and who remained MRD-positive, were eligible for randomization.

The planned sample size was 188 patients, but the trial was closed early in February 2017 because of poor recruitment; a total of 48 patients were enrolled, including the 19 nonrandomized, MRD-negative patients.

Patients randomized to consolidation received 1,000 mg of obinutuzumab weekly for the first four doses, and then every other week for four additional doses.

Obinutuzumab was well tolerated with minimal infusion-related reactions and toxicity, Dr. Munir said.

Despite the low recruitment, both the phase 2 and 3 endpoints were assessed as positive, because the consolidation strategy was so efficacious, Dr. Munir noted, concluding that the findings provide further evidence of the value of MRD negativity for improving outcomes in CLL.

The GALACTIC trial was developed by the GALACTIC Trial Management Group with the support of the UKCLL/NCRI CLL Clinical Trials Subgroup. The trial is funded by Cancer Research UK and Roche and sponsored by the University of Leeds. Dr. Munir reported having no disclosures.

[email protected]

EDINBURGH – Consolidation therapy with obinutuzumab after chemoimmunotherapy for B-cell chronic lymphocytic leukemia (B-CLL) was highly effective for eradicating minimal residual disease (MRD) within 6 months following randomization in the seamless phase 2/3 GALACTIC trial.

Of 14 patients who were MRD positive after chemoimmunotherapy and randomized to consolidation with the type II monoclonal antibody targeting the CD20 antigen, 10 achieved MRD negativity in the bone marrow by 6 months, and 13 achieved MRD negativity in the peripheral blood by 6 months, Talha Munir, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

“And that translated into [progression-free survival] improvement in the consolidation arm,” said Dr. Munir of St. James’s University, Leeds, England.

The median progression-free survival in that arm was not reached, whereas progression-free survival in 15 MRD-positive patients randomized to the nonconsolidation arm was 16.6 months, he said.

Further, no difference was seen in median progression-free survival, overall survival, or MRD duration between the consolidation arm and 19 patients who were not randomized because of MRD negativity after chemoimmunotherapy, he noted.

Achieving MRD negativity in CLL confers a survival advantage, and obinutuzumab has shown greater efficacy with respect to MRD in CLL when compared with previous anti-CD20 antibodies, and it is less immune suppressive than the anti-CD52 antibody alemtuzumab, he explained.

The GALACTIC trial was designed to assess the safety and efficacy of obinutuzumab consolidation for eradicating MRD and whether its effects would prolong progression-free survival in patients with B-CLL who recently responded to chemoimmunotherapy. Those achieving complete response or partial response at 3-24 months after chemoimmunotherapy, and who remained MRD-positive, were eligible for randomization.

The planned sample size was 188 patients, but the trial was closed early in February 2017 because of poor recruitment; a total of 48 patients were enrolled, including the 19 nonrandomized, MRD-negative patients.

Patients randomized to consolidation received 1,000 mg of obinutuzumab weekly for the first four doses, and then every other week for four additional doses.

Obinutuzumab was well tolerated with minimal infusion-related reactions and toxicity, Dr. Munir said.

Despite the low recruitment, both the phase 2 and 3 endpoints were assessed as positive, because the consolidation strategy was so efficacious, Dr. Munir noted, concluding that the findings provide further evidence of the value of MRD negativity for improving outcomes in CLL.

The GALACTIC trial was developed by the GALACTIC Trial Management Group with the support of the UKCLL/NCRI CLL Clinical Trials Subgroup. The trial is funded by Cancer Research UK and Roche and sponsored by the University of Leeds. Dr. Munir reported having no disclosures.

[email protected]

EDINBURGH – Consolidation therapy with obinutuzumab after chemoimmunotherapy for B-cell chronic lymphocytic leukemia (B-CLL) was highly effective for eradicating minimal residual disease (MRD) within 6 months following randomization in the seamless phase 2/3 GALACTIC trial.

Of 14 patients who were MRD positive after chemoimmunotherapy and randomized to consolidation with the type II monoclonal antibody targeting the CD20 antigen, 10 achieved MRD negativity in the bone marrow by 6 months, and 13 achieved MRD negativity in the peripheral blood by 6 months, Talha Munir, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

“And that translated into [progression-free survival] improvement in the consolidation arm,” said Dr. Munir of St. James’s University, Leeds, England.

The median progression-free survival in that arm was not reached, whereas progression-free survival in 15 MRD-positive patients randomized to the nonconsolidation arm was 16.6 months, he said.

Further, no difference was seen in median progression-free survival, overall survival, or MRD duration between the consolidation arm and 19 patients who were not randomized because of MRD negativity after chemoimmunotherapy, he noted.

Achieving MRD negativity in CLL confers a survival advantage, and obinutuzumab has shown greater efficacy with respect to MRD in CLL when compared with previous anti-CD20 antibodies, and it is less immune suppressive than the anti-CD52 antibody alemtuzumab, he explained.

The GALACTIC trial was designed to assess the safety and efficacy of obinutuzumab consolidation for eradicating MRD and whether its effects would prolong progression-free survival in patients with B-CLL who recently responded to chemoimmunotherapy. Those achieving complete response or partial response at 3-24 months after chemoimmunotherapy, and who remained MRD-positive, were eligible for randomization.

The planned sample size was 188 patients, but the trial was closed early in February 2017 because of poor recruitment; a total of 48 patients were enrolled, including the 19 nonrandomized, MRD-negative patients.

Patients randomized to consolidation received 1,000 mg of obinutuzumab weekly for the first four doses, and then every other week for four additional doses.

Obinutuzumab was well tolerated with minimal infusion-related reactions and toxicity, Dr. Munir said.

Despite the low recruitment, both the phase 2 and 3 endpoints were assessed as positive, because the consolidation strategy was so efficacious, Dr. Munir noted, concluding that the findings provide further evidence of the value of MRD negativity for improving outcomes in CLL.

The GALACTIC trial was developed by the GALACTIC Trial Management Group with the support of the UKCLL/NCRI CLL Clinical Trials Subgroup. The trial is funded by Cancer Research UK and Roche and sponsored by the University of Leeds. Dr. Munir reported having no disclosures.

[email protected]