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Leflunomide use in pregnancy shows little impact on newborns
Leflunomide, prescribed in Canada to treat active rheumatoid arthritis, was previously classified as a category X pregnancy medication because it is embryotoxic and teratogenic in rats and rabbits in doses similar to those used in humans, wrote Anick Bérard, MD, of CHU Sainte Justine, Montreal, and her colleagues, in a study published in Annals of the Rheumatic Diseases.
However, data on the impact of leflunomide on a developing human embryo are limited, so the researchers analyzed the Quebec Pregnancy Cohort, an ongoing study of all pregnancies in Quebec, Canada, between Jan. 1, 1998, and Dec. 31, 2015.
The findings are consistent with those from previous studies and suggest that continued caution is warranted for women of childbearing age who are taking or considering leflunomide, the researchers concluded.
They also examined the potential impact of several categories of other antirheumatic drugs to account for indication bias: other conventional disease-modifying antirheumatic drugs, biologic agents, nonsteroidal anti-inflammatory drugs, oral corticosteroids, and gold salts. Oral corticosteroid use in the first trimester was associated with an increased risk of major congenital malformations (aOR 1.31; 95% CI, 1.06-1.61), and the risk of prematurity also was significant with their use in the second or third trimester (aOR 1.32; 95% CI, 1.09 to 1.60). The risk of major congenital malformations was significantly higher with the use of NSAIDs in the first trimester (aOR 1.15; 95% CI, 1.03-1.29). Any use of disease-modifying antirheumatic drugs overall between the first day of gestation and the index date increased the odds for spontaneous abortion (aOR, 1.54; 95% CI, 1.06-2.22).
Cholestyramine may lower the blood level of the active metabolite of leflunomide to a safe level, the researchers noted, but the study population showed no evidence of cholestyramine or charcoal use for leflunomide washout, and any cholestyramine exposures during pregnancy were not concurrent with leflunomide exposure. “In three first-trimester leflunomide-exposed pregnancies, cholestyramine was introduced in monotherapy in the third trimester,” they wrote.
The results were limited by the small number of women exposed to leflunomide, despite the population-based study being the largest of its kind published to date, the researchers said.
The study was supported in part by the Fonds de la Recherche du Québec-Santé and by Sanofi. Two authors are employees of Sanofi.
SOURCE: Bérard A et al., Ann Rheum Dis. 2017 Dec 8. doi: 10.1136/annrheumdis-2017-212078
Leflunomide, prescribed in Canada to treat active rheumatoid arthritis, was previously classified as a category X pregnancy medication because it is embryotoxic and teratogenic in rats and rabbits in doses similar to those used in humans, wrote Anick Bérard, MD, of CHU Sainte Justine, Montreal, and her colleagues, in a study published in Annals of the Rheumatic Diseases.
However, data on the impact of leflunomide on a developing human embryo are limited, so the researchers analyzed the Quebec Pregnancy Cohort, an ongoing study of all pregnancies in Quebec, Canada, between Jan. 1, 1998, and Dec. 31, 2015.
The findings are consistent with those from previous studies and suggest that continued caution is warranted for women of childbearing age who are taking or considering leflunomide, the researchers concluded.
They also examined the potential impact of several categories of other antirheumatic drugs to account for indication bias: other conventional disease-modifying antirheumatic drugs, biologic agents, nonsteroidal anti-inflammatory drugs, oral corticosteroids, and gold salts. Oral corticosteroid use in the first trimester was associated with an increased risk of major congenital malformations (aOR 1.31; 95% CI, 1.06-1.61), and the risk of prematurity also was significant with their use in the second or third trimester (aOR 1.32; 95% CI, 1.09 to 1.60). The risk of major congenital malformations was significantly higher with the use of NSAIDs in the first trimester (aOR 1.15; 95% CI, 1.03-1.29). Any use of disease-modifying antirheumatic drugs overall between the first day of gestation and the index date increased the odds for spontaneous abortion (aOR, 1.54; 95% CI, 1.06-2.22).
Cholestyramine may lower the blood level of the active metabolite of leflunomide to a safe level, the researchers noted, but the study population showed no evidence of cholestyramine or charcoal use for leflunomide washout, and any cholestyramine exposures during pregnancy were not concurrent with leflunomide exposure. “In three first-trimester leflunomide-exposed pregnancies, cholestyramine was introduced in monotherapy in the third trimester,” they wrote.
The results were limited by the small number of women exposed to leflunomide, despite the population-based study being the largest of its kind published to date, the researchers said.
The study was supported in part by the Fonds de la Recherche du Québec-Santé and by Sanofi. Two authors are employees of Sanofi.
SOURCE: Bérard A et al., Ann Rheum Dis. 2017 Dec 8. doi: 10.1136/annrheumdis-2017-212078
Leflunomide, prescribed in Canada to treat active rheumatoid arthritis, was previously classified as a category X pregnancy medication because it is embryotoxic and teratogenic in rats and rabbits in doses similar to those used in humans, wrote Anick Bérard, MD, of CHU Sainte Justine, Montreal, and her colleagues, in a study published in Annals of the Rheumatic Diseases.
However, data on the impact of leflunomide on a developing human embryo are limited, so the researchers analyzed the Quebec Pregnancy Cohort, an ongoing study of all pregnancies in Quebec, Canada, between Jan. 1, 1998, and Dec. 31, 2015.
The findings are consistent with those from previous studies and suggest that continued caution is warranted for women of childbearing age who are taking or considering leflunomide, the researchers concluded.
They also examined the potential impact of several categories of other antirheumatic drugs to account for indication bias: other conventional disease-modifying antirheumatic drugs, biologic agents, nonsteroidal anti-inflammatory drugs, oral corticosteroids, and gold salts. Oral corticosteroid use in the first trimester was associated with an increased risk of major congenital malformations (aOR 1.31; 95% CI, 1.06-1.61), and the risk of prematurity also was significant with their use in the second or third trimester (aOR 1.32; 95% CI, 1.09 to 1.60). The risk of major congenital malformations was significantly higher with the use of NSAIDs in the first trimester (aOR 1.15; 95% CI, 1.03-1.29). Any use of disease-modifying antirheumatic drugs overall between the first day of gestation and the index date increased the odds for spontaneous abortion (aOR, 1.54; 95% CI, 1.06-2.22).
Cholestyramine may lower the blood level of the active metabolite of leflunomide to a safe level, the researchers noted, but the study population showed no evidence of cholestyramine or charcoal use for leflunomide washout, and any cholestyramine exposures during pregnancy were not concurrent with leflunomide exposure. “In three first-trimester leflunomide-exposed pregnancies, cholestyramine was introduced in monotherapy in the third trimester,” they wrote.
The results were limited by the small number of women exposed to leflunomide, despite the population-based study being the largest of its kind published to date, the researchers said.
The study was supported in part by the Fonds de la Recherche du Québec-Santé and by Sanofi. Two authors are employees of Sanofi.
SOURCE: Bérard A et al., Ann Rheum Dis. 2017 Dec 8. doi: 10.1136/annrheumdis-2017-212078
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: Exposure to leflunomide during pregnancy was not associated with significantly increased risk of major congenital malformations, low birth weight, premature birth, or spontaneous abortions.
Major finding: No significant association was seen between leflunomide use in the first trimester and an increased risk of major congenital malformations based on five cases (adjusted odds ratio, 0.97).
Data source: A population-based cohort study of 289,688 pregnancies in Canada between 1998 and 2015.
Disclosures: The study was supported in part by the Fonds de la Recherche du Québec-Santé and by Sanofi. Two authors are employees of Sanofi.
Source: Bérard A et al., Ann Rheum Dis. 2017 Dec 8. doi: 10.1136/annrheumdis-2017-212078
Surgery residents cite time challenges to robotics training
Although a majority of surgical residents plan to incorporate robotics in practice, 80% cited time commitment as a barrier to completing a nonmandatory robotics curriculum, according to a survey published online in the American Journal of Surgery.
Most surgery residents agree that robotics training is important, but most academic institutions have not yet established a mandatory training program, wrote Vernissia Tam, MD, of the University of Pittsburgh and her colleagues (Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051).
To determine resident attitudes about robotics and the impact of a robotics curriculum, the researchers surveyed 48 general surgery residents in 2014-2015 and 49 residents in 2016-2017 at a single academic center. Overall, 98% and 96% of the two groups, respectively, reported high interest improving robotic skills, and more than two-thirds reported plans to use robotics in their practices.
The introduction of a voluntary, structured robotics program yielded significant improvements in the percentage of residents using both a robotic backpack simulator (from 18% to 39%) and an inanimate box trainer (increased from 20% to 41%).
However, of 60 unique residents between the two survey time points, only 24 began the robotics curriculum (40%) and only 11 (18%) completed it. In a follow-up survey of residents who had not yet completed the robotics training, 80% said that “time away from clinical responsibilities and/or research was the most commonly cited barrier to curriculum completion,” Dr. Tam and her associates noted.
The study was limited in part by the use of data from a single center over a short period of time, but “we believe these results provide a broad needs assessment for a structured robotics program and identify barriers to implementing a novel curriculum,” the researchers wrote. Many health professionals argue that a competence-based program, rather than time-based, would be more effective and accessible to students, so “development of an inanimate deliberate practice system with weekly opportunities is a viable avenue to increase technical skills and learn surgical procedures,” they said.
The researchers had no financial conflicts to disclose. The study was supported in part by an Intuitive Surgical Education Grant.
SOURCE: Tam V et al. Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051.
Although a majority of surgical residents plan to incorporate robotics in practice, 80% cited time commitment as a barrier to completing a nonmandatory robotics curriculum, according to a survey published online in the American Journal of Surgery.
Most surgery residents agree that robotics training is important, but most academic institutions have not yet established a mandatory training program, wrote Vernissia Tam, MD, of the University of Pittsburgh and her colleagues (Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051).
To determine resident attitudes about robotics and the impact of a robotics curriculum, the researchers surveyed 48 general surgery residents in 2014-2015 and 49 residents in 2016-2017 at a single academic center. Overall, 98% and 96% of the two groups, respectively, reported high interest improving robotic skills, and more than two-thirds reported plans to use robotics in their practices.
The introduction of a voluntary, structured robotics program yielded significant improvements in the percentage of residents using both a robotic backpack simulator (from 18% to 39%) and an inanimate box trainer (increased from 20% to 41%).
However, of 60 unique residents between the two survey time points, only 24 began the robotics curriculum (40%) and only 11 (18%) completed it. In a follow-up survey of residents who had not yet completed the robotics training, 80% said that “time away from clinical responsibilities and/or research was the most commonly cited barrier to curriculum completion,” Dr. Tam and her associates noted.
The study was limited in part by the use of data from a single center over a short period of time, but “we believe these results provide a broad needs assessment for a structured robotics program and identify barriers to implementing a novel curriculum,” the researchers wrote. Many health professionals argue that a competence-based program, rather than time-based, would be more effective and accessible to students, so “development of an inanimate deliberate practice system with weekly opportunities is a viable avenue to increase technical skills and learn surgical procedures,” they said.
The researchers had no financial conflicts to disclose. The study was supported in part by an Intuitive Surgical Education Grant.
SOURCE: Tam V et al. Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051.
Although a majority of surgical residents plan to incorporate robotics in practice, 80% cited time commitment as a barrier to completing a nonmandatory robotics curriculum, according to a survey published online in the American Journal of Surgery.
Most surgery residents agree that robotics training is important, but most academic institutions have not yet established a mandatory training program, wrote Vernissia Tam, MD, of the University of Pittsburgh and her colleagues (Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051).
To determine resident attitudes about robotics and the impact of a robotics curriculum, the researchers surveyed 48 general surgery residents in 2014-2015 and 49 residents in 2016-2017 at a single academic center. Overall, 98% and 96% of the two groups, respectively, reported high interest improving robotic skills, and more than two-thirds reported plans to use robotics in their practices.
The introduction of a voluntary, structured robotics program yielded significant improvements in the percentage of residents using both a robotic backpack simulator (from 18% to 39%) and an inanimate box trainer (increased from 20% to 41%).
However, of 60 unique residents between the two survey time points, only 24 began the robotics curriculum (40%) and only 11 (18%) completed it. In a follow-up survey of residents who had not yet completed the robotics training, 80% said that “time away from clinical responsibilities and/or research was the most commonly cited barrier to curriculum completion,” Dr. Tam and her associates noted.
The study was limited in part by the use of data from a single center over a short period of time, but “we believe these results provide a broad needs assessment for a structured robotics program and identify barriers to implementing a novel curriculum,” the researchers wrote. Many health professionals argue that a competence-based program, rather than time-based, would be more effective and accessible to students, so “development of an inanimate deliberate practice system with weekly opportunities is a viable avenue to increase technical skills and learn surgical procedures,” they said.
The researchers had no financial conflicts to disclose. The study was supported in part by an Intuitive Surgical Education Grant.
SOURCE: Tam V et al. Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051.
FROM THE AMERICAN JOURNAL OF SURGERY
Key clinical point: .
Major finding: 80% of surgical residents said that the length of time needed to complete a robotics curriculum was a barrier to doing so.
Data source: Survey of 97 general surgery residents conducted in 2014-2015 and 2016-2017.
Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by an Intuitive Surgical Education Grant.
Source: Tam V et al. Am J Surg. 2017. doi: 10.1016/j.amjsurg.2017.08.051.
Counseling parents may curb nonmedical vaccine exemptions
Nonmedical vaccine exemptions for children in Washington State decreased by 40% after the implementation of a law requiring parent counseling and a signed form from a medical provider, based on data from a regression analysis of kindergarten students during time periods before and after the law took effect.
The Washington State Senate Bill 5005 (SB5005), implemented in 2011, requires parents seeking exemptions to file a certificate of exemption (COE) signed by a Washington-licensed health care provider. It documents that the parents have discussed “the benefits and risks of immunizations” with the provider, the researchers wrote.
The researchers examined the effect of the parent counseling and signature requirement on exemption rates by reviewing data on kindergarten students.
Overall, the significant relative decrease of 40% translated to a significant absolute reduction of 2.9% in immunization exemption rates, and vaccine coverage increased or remained the same across all vaccines required for school. The greatest decline in exemption rates occurred in geographic areas with historically high rates before the bill was passed, the researchers said.
Based on the Washington findings, “states in the United States and jurisdictions in other countries should consider adding parental counseling as a requirement for obtaining exemptions to vaccination requirements,” they concluded.
Dr. Omer had no financial conflicts to disclose. One of the coauthors disclosed ties to vaccine manufacturers, and another’s organization had such ties. The study was supported by the Robert Wood Johnson Foundation.
Restoring community immunity requires diligence on the part of medical professionals, policymakers, and parents, wrote California state senator Richard J. Pan, MD, MPH, in an accompanying editorial.
Laws requiring that children be vaccinated before starting school are designed to protect the vaccinated children and the community at large, wrote Dr. Pan, but the passage of certain laws resulted in nonmedical exemptions that can reduce the effectiveness of childhood vaccinations on community health. In the past, parents rarely chose nonmedical exemptions because they recognized the dangers of diseases such as polio and measles and acknowledged the safety and effectiveness of the vaccines to protect against them, said Dr. Pan.
“However, some saw the opportunity to exploit these circumstances for personal gain by spreading vaccine misinformation over the Internet and social media to fuel parental anxiety and promote sales of their supplements and books, leading to increased use of nonmedical exemptions,” he said.
In Dr. Pan’s view, community immunity can be restored by creating stricter policies for vaccination and eliminating nonmedical exemptions. He authored a bill in California to abolish these exemptions, and the vaccination rate was 96% among kindergartners in California during the first year the policy was in place.
But antivaccine groups are well organized. One study found that “half of all Twitter posts about vaccines contain antivaccine beliefs. Just this year [2017] in Minnesota, antivaccine groups targeted a community, causing a significant drop in vaccination rates. The resulting measles outbreak exposed more than 8,000 people, sickened 79 (of which 73 were less than 10 years old), and hospitalized 22,” Dr. Pan said.
Pediatricians and other child health advocates must continue to work to address medical exemptions as well and to define the standards for what constitutes a medical exemption, Dr. Pan said. By educating and working with parents, legislators, and other health care professionals, “pediatricians need to build the political will to pass effective vaccine policy,” he said.
Dr. Pan is a California state senator in Sacramento. He had no financial conflicts to disclose. He commented in an editorial accompanying the study by Omer et al. (Pediatrics. 2017 Dec 18;141[1]:e20173449).
Restoring community immunity requires diligence on the part of medical professionals, policymakers, and parents, wrote California state senator Richard J. Pan, MD, MPH, in an accompanying editorial.
Laws requiring that children be vaccinated before starting school are designed to protect the vaccinated children and the community at large, wrote Dr. Pan, but the passage of certain laws resulted in nonmedical exemptions that can reduce the effectiveness of childhood vaccinations on community health. In the past, parents rarely chose nonmedical exemptions because they recognized the dangers of diseases such as polio and measles and acknowledged the safety and effectiveness of the vaccines to protect against them, said Dr. Pan.
“However, some saw the opportunity to exploit these circumstances for personal gain by spreading vaccine misinformation over the Internet and social media to fuel parental anxiety and promote sales of their supplements and books, leading to increased use of nonmedical exemptions,” he said.
In Dr. Pan’s view, community immunity can be restored by creating stricter policies for vaccination and eliminating nonmedical exemptions. He authored a bill in California to abolish these exemptions, and the vaccination rate was 96% among kindergartners in California during the first year the policy was in place.
But antivaccine groups are well organized. One study found that “half of all Twitter posts about vaccines contain antivaccine beliefs. Just this year [2017] in Minnesota, antivaccine groups targeted a community, causing a significant drop in vaccination rates. The resulting measles outbreak exposed more than 8,000 people, sickened 79 (of which 73 were less than 10 years old), and hospitalized 22,” Dr. Pan said.
Pediatricians and other child health advocates must continue to work to address medical exemptions as well and to define the standards for what constitutes a medical exemption, Dr. Pan said. By educating and working with parents, legislators, and other health care professionals, “pediatricians need to build the political will to pass effective vaccine policy,” he said.
Dr. Pan is a California state senator in Sacramento. He had no financial conflicts to disclose. He commented in an editorial accompanying the study by Omer et al. (Pediatrics. 2017 Dec 18;141[1]:e20173449).
Restoring community immunity requires diligence on the part of medical professionals, policymakers, and parents, wrote California state senator Richard J. Pan, MD, MPH, in an accompanying editorial.
Laws requiring that children be vaccinated before starting school are designed to protect the vaccinated children and the community at large, wrote Dr. Pan, but the passage of certain laws resulted in nonmedical exemptions that can reduce the effectiveness of childhood vaccinations on community health. In the past, parents rarely chose nonmedical exemptions because they recognized the dangers of diseases such as polio and measles and acknowledged the safety and effectiveness of the vaccines to protect against them, said Dr. Pan.
“However, some saw the opportunity to exploit these circumstances for personal gain by spreading vaccine misinformation over the Internet and social media to fuel parental anxiety and promote sales of their supplements and books, leading to increased use of nonmedical exemptions,” he said.
In Dr. Pan’s view, community immunity can be restored by creating stricter policies for vaccination and eliminating nonmedical exemptions. He authored a bill in California to abolish these exemptions, and the vaccination rate was 96% among kindergartners in California during the first year the policy was in place.
But antivaccine groups are well organized. One study found that “half of all Twitter posts about vaccines contain antivaccine beliefs. Just this year [2017] in Minnesota, antivaccine groups targeted a community, causing a significant drop in vaccination rates. The resulting measles outbreak exposed more than 8,000 people, sickened 79 (of which 73 were less than 10 years old), and hospitalized 22,” Dr. Pan said.
Pediatricians and other child health advocates must continue to work to address medical exemptions as well and to define the standards for what constitutes a medical exemption, Dr. Pan said. By educating and working with parents, legislators, and other health care professionals, “pediatricians need to build the political will to pass effective vaccine policy,” he said.
Dr. Pan is a California state senator in Sacramento. He had no financial conflicts to disclose. He commented in an editorial accompanying the study by Omer et al. (Pediatrics. 2017 Dec 18;141[1]:e20173449).
Nonmedical vaccine exemptions for children in Washington State decreased by 40% after the implementation of a law requiring parent counseling and a signed form from a medical provider, based on data from a regression analysis of kindergarten students during time periods before and after the law took effect.
The Washington State Senate Bill 5005 (SB5005), implemented in 2011, requires parents seeking exemptions to file a certificate of exemption (COE) signed by a Washington-licensed health care provider. It documents that the parents have discussed “the benefits and risks of immunizations” with the provider, the researchers wrote.
The researchers examined the effect of the parent counseling and signature requirement on exemption rates by reviewing data on kindergarten students.
Overall, the significant relative decrease of 40% translated to a significant absolute reduction of 2.9% in immunization exemption rates, and vaccine coverage increased or remained the same across all vaccines required for school. The greatest decline in exemption rates occurred in geographic areas with historically high rates before the bill was passed, the researchers said.
Based on the Washington findings, “states in the United States and jurisdictions in other countries should consider adding parental counseling as a requirement for obtaining exemptions to vaccination requirements,” they concluded.
Dr. Omer had no financial conflicts to disclose. One of the coauthors disclosed ties to vaccine manufacturers, and another’s organization had such ties. The study was supported by the Robert Wood Johnson Foundation.
Nonmedical vaccine exemptions for children in Washington State decreased by 40% after the implementation of a law requiring parent counseling and a signed form from a medical provider, based on data from a regression analysis of kindergarten students during time periods before and after the law took effect.
The Washington State Senate Bill 5005 (SB5005), implemented in 2011, requires parents seeking exemptions to file a certificate of exemption (COE) signed by a Washington-licensed health care provider. It documents that the parents have discussed “the benefits and risks of immunizations” with the provider, the researchers wrote.
The researchers examined the effect of the parent counseling and signature requirement on exemption rates by reviewing data on kindergarten students.
Overall, the significant relative decrease of 40% translated to a significant absolute reduction of 2.9% in immunization exemption rates, and vaccine coverage increased or remained the same across all vaccines required for school. The greatest decline in exemption rates occurred in geographic areas with historically high rates before the bill was passed, the researchers said.
Based on the Washington findings, “states in the United States and jurisdictions in other countries should consider adding parental counseling as a requirement for obtaining exemptions to vaccination requirements,” they concluded.
Dr. Omer had no financial conflicts to disclose. One of the coauthors disclosed ties to vaccine manufacturers, and another’s organization had such ties. The study was supported by the Robert Wood Johnson Foundation.
FROM PEDIATRICS
Key clinical point:
Major finding: After the implementation of SB5005 in Washington State, the rate of exemptions decreased by 40%.
Data source: The data come from a regression analysis of immunization coverage and exemption rates in Washington State for the school years 1997-1998 through 2013-2014.
Disclosures: Dr. Omer had no financial conflicts to disclose. One of the coauthors disclosed ties to vaccine manufacturers, and another’s organization had such ties. The study was supported by the Robert Wood Johnson Foundation.
Source: Omer SB et al. Pediatrics. 2018;141(1):e20172364.
Intrauterine exposure to methylphenidate tied to increased cardiac risk
The use of methylphenidate by pregnant women is associated with a small increased risk of congenital cardiac malformations in newborns. However, a comparable increased risk is not found with intrauterine exposure to stimulants, according to a population-based cohort study published Dec. 13.
Krista F. Huybrechts, PhD, and her associates analyzed data from more than 1 million pregnancies in the United States. They found that the overall incidence of congenital malformations among the 1,813,894 pregnancies was 35 per 1,000 control infants, compared with 45.9 per 1,000 infants whose mothers used methylphenidate and 45.4 per 1,000 infants whose mothers used amphetamines. 
For the subset of infants with cardiac malformations, the risk per 1,000 infants was 12.7 for controls, 18.8 for methylphenidate exposure, and 15.4 for amphetamine exposure. The researchers identified an adjusted relative risk of 1.11 for overall congenital abnormalities and 1.28 for cardiac abnormalities with methylphenidate exposure, compared with a relative risk of 1.05 for overall congenital abnormalities and 0.96 for cardiac abnormalities with stimulant exposure.
An analysis among 2,560,069 pregnancies in Denmark, Finland, Iceland, Norway, and Sweden yielded a similarly significant relative risk of 1.28 for cardiac malformations associated with methylphenidate exposure (JAMA Psychiatry 2017. doi: 10.1001/jamapsychiatry.2017.3644).
“We found a 28% increased prevalence of cardiac malformations after first-trimester exposure to methylphenidate,” wrote Dr. Huybrechts of Brigham and Women’s Hospital, Boston, and her associates. “Although the absolute risk is small, it is nevertheless important evidence to consider when weighing the potential risks and benefits of different treatment strategies for [attention-deficit/hyperactivity disorder] in young women of reproductive age and in pregnant women.”
The researchers had no financial conflicts to disclose. The study was supported in part by grants from the National Institutes of Mental Health, the Eunice Kennedy Shriver National Institute for Child Health & Human Development, and the Söderström König Foundation.
The use of methylphenidate by pregnant women is associated with a small increased risk of congenital cardiac malformations in newborns. However, a comparable increased risk is not found with intrauterine exposure to stimulants, according to a population-based cohort study published Dec. 13.
Krista F. Huybrechts, PhD, and her associates analyzed data from more than 1 million pregnancies in the United States. They found that the overall incidence of congenital malformations among the 1,813,894 pregnancies was 35 per 1,000 control infants, compared with 45.9 per 1,000 infants whose mothers used methylphenidate and 45.4 per 1,000 infants whose mothers used amphetamines.
For the subset of infants with cardiac malformations, the risk per 1,000 infants was 12.7 for controls, 18.8 for methylphenidate exposure, and 15.4 for amphetamine exposure. The researchers identified an adjusted relative risk of 1.11 for overall congenital abnormalities and 1.28 for cardiac abnormalities with methylphenidate exposure, compared with a relative risk of 1.05 for overall congenital abnormalities and 0.96 for cardiac abnormalities with stimulant exposure.
An analysis among 2,560,069 pregnancies in Denmark, Finland, Iceland, Norway, and Sweden yielded a similarly significant relative risk of 1.28 for cardiac malformations associated with methylphenidate exposure (JAMA Psychiatry 2017. doi: 10.1001/jamapsychiatry.2017.3644).
“We found a 28% increased prevalence of cardiac malformations after first-trimester exposure to methylphenidate,” wrote Dr. Huybrechts of Brigham and Women’s Hospital, Boston, and her associates. “Although the absolute risk is small, it is nevertheless important evidence to consider when weighing the potential risks and benefits of different treatment strategies for [attention-deficit/hyperactivity disorder] in young women of reproductive age and in pregnant women.”
The researchers had no financial conflicts to disclose. The study was supported in part by grants from the National Institutes of Mental Health, the Eunice Kennedy Shriver National Institute for Child Health & Human Development, and the Söderström König Foundation.
The use of methylphenidate by pregnant women is associated with a small increased risk of congenital cardiac malformations in newborns. However, a comparable increased risk is not found with intrauterine exposure to stimulants, according to a population-based cohort study published Dec. 13.
Krista F. Huybrechts, PhD, and her associates analyzed data from more than 1 million pregnancies in the United States. They found that the overall incidence of congenital malformations among the 1,813,894 pregnancies was 35 per 1,000 control infants, compared with 45.9 per 1,000 infants whose mothers used methylphenidate and 45.4 per 1,000 infants whose mothers used amphetamines.
For the subset of infants with cardiac malformations, the risk per 1,000 infants was 12.7 for controls, 18.8 for methylphenidate exposure, and 15.4 for amphetamine exposure. The researchers identified an adjusted relative risk of 1.11 for overall congenital abnormalities and 1.28 for cardiac abnormalities with methylphenidate exposure, compared with a relative risk of 1.05 for overall congenital abnormalities and 0.96 for cardiac abnormalities with stimulant exposure.
An analysis among 2,560,069 pregnancies in Denmark, Finland, Iceland, Norway, and Sweden yielded a similarly significant relative risk of 1.28 for cardiac malformations associated with methylphenidate exposure (JAMA Psychiatry 2017. doi: 10.1001/jamapsychiatry.2017.3644).
“We found a 28% increased prevalence of cardiac malformations after first-trimester exposure to methylphenidate,” wrote Dr. Huybrechts of Brigham and Women’s Hospital, Boston, and her associates. “Although the absolute risk is small, it is nevertheless important evidence to consider when weighing the potential risks and benefits of different treatment strategies for [attention-deficit/hyperactivity disorder] in young women of reproductive age and in pregnant women.”
The researchers had no financial conflicts to disclose. The study was supported in part by grants from the National Institutes of Mental Health, the Eunice Kennedy Shriver National Institute for Child Health & Human Development, and the Söderström König Foundation.
FROM JAMA PSYCHIATRY
Don’t choose hormones to protect postmenopausal women
Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.
In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”
In response to public comments, the USPSTF team made several changes including adjusting the language to clarify that the recommendations apply only to postmenopausal women, and adding tables showing estimates of increased or decreased risk of various outcomes for postmenopausal women receiving different hormone therapies.
Approximately 40,000 women aged 53-79 years were included in an evidence report from Gerald Gartlehner, MD, of the University of North Carolina, Chapel Hill, and his colleagues that accompanied the recommendations (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.16952).
The researchers found that women taking estrogen alone had significantly lower risk of breast cancer, diabetes, and osteoporotic fractures, but significantly higher risk of gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo. In addition, women using a combination of estrogen and progestin had significantly lower risk of colorectal cancer, diabetes, and osteoporotic fractures, but significantly higher risk of breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo.
“Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms,” and the current evidence for the risks and benefits of hormone therapy is inconclusive, the researchers said.
The final recommendation remains consistent with the USPSTF draft statement issued earlier in 2017 and with the final recommendation statements issued in 2012.
The researchers had no relevant financial conflicts to disclose.
Twenty-five years ago, the U.S. Preventive Services Task Force advised clinicians to consider hormone therapy for the prevention of disease in all women, particularly those at risk for coronary heart disease, Deborah Grady, MD, wrote in an editorial (JAMA Intern Med. 2017 Dec 12. doi: 10.1001/jamainternmed.2017.7861). Dr. Grady was one of the coauthors of a literature review supporting the American College of Physicians’ recommendation to counsel asymptomatic postmenopausal women about hormone therapy based on data from observational studies. “No randomized trials with clinical outcomes had been conducted,” Dr. Grady said. By 2002, data from three large randomized trials told a different story, and the Task Force recommended against using estrogen alone as a strategy to prevent chronic conditions in postmenopausal women, she noted.
“I believe that the fear of hormone therapy is overblown,” Dr. Grady wrote. “When adequately informed, women with moderate to severe symptoms and without contraindications should be able to take such small risks if hormone therapy improves symptoms and quality of life,” she said.
In fact, professional societies, including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society support hormone therapy for symptomatic women who are recently menopausal, said Dr. Grady. However, a key lesson learned from the ongoing research on hormone therapy is the importance of conducting clinical trials that are large enough to identify serious adverse effects, she added.
Dr. Grady is affiliated with the University of California, San Francisco. She had no financial conflicts to disclose.
Twenty-five years ago, the U.S. Preventive Services Task Force advised clinicians to consider hormone therapy for the prevention of disease in all women, particularly those at risk for coronary heart disease, Deborah Grady, MD, wrote in an editorial (JAMA Intern Med. 2017 Dec 12. doi: 10.1001/jamainternmed.2017.7861). Dr. Grady was one of the coauthors of a literature review supporting the American College of Physicians’ recommendation to counsel asymptomatic postmenopausal women about hormone therapy based on data from observational studies. “No randomized trials with clinical outcomes had been conducted,” Dr. Grady said. By 2002, data from three large randomized trials told a different story, and the Task Force recommended against using estrogen alone as a strategy to prevent chronic conditions in postmenopausal women, she noted.
“I believe that the fear of hormone therapy is overblown,” Dr. Grady wrote. “When adequately informed, women with moderate to severe symptoms and without contraindications should be able to take such small risks if hormone therapy improves symptoms and quality of life,” she said.
In fact, professional societies, including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society support hormone therapy for symptomatic women who are recently menopausal, said Dr. Grady. However, a key lesson learned from the ongoing research on hormone therapy is the importance of conducting clinical trials that are large enough to identify serious adverse effects, she added.
Dr. Grady is affiliated with the University of California, San Francisco. She had no financial conflicts to disclose.
Twenty-five years ago, the U.S. Preventive Services Task Force advised clinicians to consider hormone therapy for the prevention of disease in all women, particularly those at risk for coronary heart disease, Deborah Grady, MD, wrote in an editorial (JAMA Intern Med. 2017 Dec 12. doi: 10.1001/jamainternmed.2017.7861). Dr. Grady was one of the coauthors of a literature review supporting the American College of Physicians’ recommendation to counsel asymptomatic postmenopausal women about hormone therapy based on data from observational studies. “No randomized trials with clinical outcomes had been conducted,” Dr. Grady said. By 2002, data from three large randomized trials told a different story, and the Task Force recommended against using estrogen alone as a strategy to prevent chronic conditions in postmenopausal women, she noted.
“I believe that the fear of hormone therapy is overblown,” Dr. Grady wrote. “When adequately informed, women with moderate to severe symptoms and without contraindications should be able to take such small risks if hormone therapy improves symptoms and quality of life,” she said.
In fact, professional societies, including the North American Menopause Society, the American College of Obstetricians and Gynecologists, and the Endocrine Society support hormone therapy for symptomatic women who are recently menopausal, said Dr. Grady. However, a key lesson learned from the ongoing research on hormone therapy is the importance of conducting clinical trials that are large enough to identify serious adverse effects, she added.
Dr. Grady is affiliated with the University of California, San Francisco. She had no financial conflicts to disclose.
Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.
In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”
In response to public comments, the USPSTF team made several changes including adjusting the language to clarify that the recommendations apply only to postmenopausal women, and adding tables showing estimates of increased or decreased risk of various outcomes for postmenopausal women receiving different hormone therapies.
Approximately 40,000 women aged 53-79 years were included in an evidence report from Gerald Gartlehner, MD, of the University of North Carolina, Chapel Hill, and his colleagues that accompanied the recommendations (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.16952).
The researchers found that women taking estrogen alone had significantly lower risk of breast cancer, diabetes, and osteoporotic fractures, but significantly higher risk of gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo. In addition, women using a combination of estrogen and progestin had significantly lower risk of colorectal cancer, diabetes, and osteoporotic fractures, but significantly higher risk of breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo.
“Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms,” and the current evidence for the risks and benefits of hormone therapy is inconclusive, the researchers said.
The final recommendation remains consistent with the USPSTF draft statement issued earlier in 2017 and with the final recommendation statements issued in 2012.
The researchers had no relevant financial conflicts to disclose.
Hormone therapy should not be used to prevent chronic conditions in postmenopausal women, according to updated recommendations from the U.S. Preventive Services Task Force. The recommendations were published online Dec. 12 in JAMA.
In the latest recommendation statement, the USPSTF issued D recommendations against using combination estrogen and progestin to prevent chronic conditions in postmenopausal women and against using estrogen only to prevent chronic conditions in postmenopausal women who have undergone hysterectomies (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.18261). A grade D recommendation is defined as “The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”
In response to public comments, the USPSTF team made several changes including adjusting the language to clarify that the recommendations apply only to postmenopausal women, and adding tables showing estimates of increased or decreased risk of various outcomes for postmenopausal women receiving different hormone therapies.
Approximately 40,000 women aged 53-79 years were included in an evidence report from Gerald Gartlehner, MD, of the University of North Carolina, Chapel Hill, and his colleagues that accompanied the recommendations (JAMA. 2017 Dec 12. doi: 10.1001/jama.2017.16952).
The researchers found that women taking estrogen alone had significantly lower risk of breast cancer, diabetes, and osteoporotic fractures, but significantly higher risk of gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo. In addition, women using a combination of estrogen and progestin had significantly lower risk of colorectal cancer, diabetes, and osteoporotic fractures, but significantly higher risk of breast cancer, probable dementia, gallbladder disease, stroke, urinary incontinence, and venous thromboembolism, compared with women taking placebo.
“Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms,” and the current evidence for the risks and benefits of hormone therapy is inconclusive, the researchers said.
The final recommendation remains consistent with the USPSTF draft statement issued earlier in 2017 and with the final recommendation statements issued in 2012.
The researchers had no relevant financial conflicts to disclose.
FROM JAMA
Early weight change has no special effect on mortality in RA
Weight loss at the time of rheumatoid arthritis diagnosis had the same impact on mortality in patients with and without RA, according to research trying to solve the so-called obesity paradox in RA, which has been related to prior observations of a protective effect of obesity on mortality in RA patients.
The finding indicates that clinicians can continue to encourage patients with rheumatoid arthritis to follow healthy weight-loss strategies, according to first author of the study, Jeffrey Sparks, MD, of Brigham and Women’s Hospital in Boston.
Dr. Sparks and his colleagues examined the impact of weight change and mortality in RA patients based on data from the Nurses’ Health Study.
“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years,” Dr. Sparks noted.
By examining changes in weight near the time of RA diagnosis, Dr. Sparks and his colleagues said that they hoped to extract information about RA-specific processes rather than the underlying pathologies that might cause weight changes near the end of life.
In the study published in Arthritis & Rheumatology, the researchers compared women diagnosed with RA during follow-up to women without RA during the same index time period of 1976-2016. The study population included 121,701 women. Of these, 902 developed incident RA and were matched with 7,884 non-RA controls.
During an average of 18 years of follow-up, 41% of the RA cohort and 29% of the controls died. The risk of death was approximately twice as high (hazard ratio, 2.78; 95% confidence interval, 1.58-4.89) among those with weight loss greater than 30 pounds at the time of RA diagnosis, compared with those whose weight remained stable. However, the risk for mortality was similarly increased (HR, 2.16; 95% CI, 1.61-2.88) among the controls with weight loss greater than 30 pounds, compared with those with stable weight. No association with mortality was noted in either group among women who gained more than 30 pounds at the time of RA diagnosis.
Dr. Sparks said he was somewhat surprised by the findings.
“We expected severe, pathologic weight loss to be associated with increased risk of death among patients with RA and comparators. It was somewhat surprising that the risks in both groups were similar,” he said. “Conversely, prior studies suggested that weight gain might have been associated with increased risk of death. However, we found no association of weight gain with risk of death,” he noted.
In addition, “Our findings argue that there is not an RA-specific mortality risk based on either weight loss or gain,” he said. “While we found that weight loss was associated with increased mortality, this was most pronounced in the severe weight loss group, so was likely due to unintentional weight loss.”
Joshua F. Baker, MD, of the University of Pennsylvania, Philadelphia, and his colleagues identified an association between weight change and risk of death in RA patients in a study first published online in Arthritis & Rheumatology in 2015 (Arthritis Rheumatol. 2015 Jul;67[7]:1711-17). That study addressed the so-called obesity paradox in RA, and Dr. Baker and his colleagues noted that weight loss associated with the development of chronic illness is a significant confounder that may explain the observed protective effect of obesity on mortality.
“It is not clear how best to monitor changes in weight, when exactly to become concerned, and what to do when changes are observed,” Dr. Baker noted. “RA patients may lose weight for a number of reasons, not all related to their arthritis, and it is unlikely that there is a ‘one size fits all’ approach,” he said.
The study was limited in part by the women-only study population, so the results might not be generalizable to men, Dr. Sparks said. “The reason for weight change was unavailable,” he added. Directions for further research include investigation of how factors such as physical activity, diet, and weight loss may affect the risk of death among individuals with and without RA, he said.
Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
SOURCE: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
Weight loss at the time of rheumatoid arthritis diagnosis had the same impact on mortality in patients with and without RA, according to research trying to solve the so-called obesity paradox in RA, which has been related to prior observations of a protective effect of obesity on mortality in RA patients.
The finding indicates that clinicians can continue to encourage patients with rheumatoid arthritis to follow healthy weight-loss strategies, according to first author of the study, Jeffrey Sparks, MD, of Brigham and Women’s Hospital in Boston.
Dr. Sparks and his colleagues examined the impact of weight change and mortality in RA patients based on data from the Nurses’ Health Study.
“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years,” Dr. Sparks noted.
By examining changes in weight near the time of RA diagnosis, Dr. Sparks and his colleagues said that they hoped to extract information about RA-specific processes rather than the underlying pathologies that might cause weight changes near the end of life.
In the study published in Arthritis & Rheumatology, the researchers compared women diagnosed with RA during follow-up to women without RA during the same index time period of 1976-2016. The study population included 121,701 women. Of these, 902 developed incident RA and were matched with 7,884 non-RA controls.
During an average of 18 years of follow-up, 41% of the RA cohort and 29% of the controls died. The risk of death was approximately twice as high (hazard ratio, 2.78; 95% confidence interval, 1.58-4.89) among those with weight loss greater than 30 pounds at the time of RA diagnosis, compared with those whose weight remained stable. However, the risk for mortality was similarly increased (HR, 2.16; 95% CI, 1.61-2.88) among the controls with weight loss greater than 30 pounds, compared with those with stable weight. No association with mortality was noted in either group among women who gained more than 30 pounds at the time of RA diagnosis.
Dr. Sparks said he was somewhat surprised by the findings.
“We expected severe, pathologic weight loss to be associated with increased risk of death among patients with RA and comparators. It was somewhat surprising that the risks in both groups were similar,” he said. “Conversely, prior studies suggested that weight gain might have been associated with increased risk of death. However, we found no association of weight gain with risk of death,” he noted.
In addition, “Our findings argue that there is not an RA-specific mortality risk based on either weight loss or gain,” he said. “While we found that weight loss was associated with increased mortality, this was most pronounced in the severe weight loss group, so was likely due to unintentional weight loss.”
Joshua F. Baker, MD, of the University of Pennsylvania, Philadelphia, and his colleagues identified an association between weight change and risk of death in RA patients in a study first published online in Arthritis & Rheumatology in 2015 (Arthritis Rheumatol. 2015 Jul;67[7]:1711-17). That study addressed the so-called obesity paradox in RA, and Dr. Baker and his colleagues noted that weight loss associated with the development of chronic illness is a significant confounder that may explain the observed protective effect of obesity on mortality.
“It is not clear how best to monitor changes in weight, when exactly to become concerned, and what to do when changes are observed,” Dr. Baker noted. “RA patients may lose weight for a number of reasons, not all related to their arthritis, and it is unlikely that there is a ‘one size fits all’ approach,” he said.
The study was limited in part by the women-only study population, so the results might not be generalizable to men, Dr. Sparks said. “The reason for weight change was unavailable,” he added. Directions for further research include investigation of how factors such as physical activity, diet, and weight loss may affect the risk of death among individuals with and without RA, he said.
Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
SOURCE: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
Weight loss at the time of rheumatoid arthritis diagnosis had the same impact on mortality in patients with and without RA, according to research trying to solve the so-called obesity paradox in RA, which has been related to prior observations of a protective effect of obesity on mortality in RA patients.
The finding indicates that clinicians can continue to encourage patients with rheumatoid arthritis to follow healthy weight-loss strategies, according to first author of the study, Jeffrey Sparks, MD, of Brigham and Women’s Hospital in Boston.
Dr. Sparks and his colleagues examined the impact of weight change and mortality in RA patients based on data from the Nurses’ Health Study.
“Our study is the first to focus on weight change around RA diagnosis and risk of death, rather than weight change in patients who had RA for many years,” Dr. Sparks noted.
By examining changes in weight near the time of RA diagnosis, Dr. Sparks and his colleagues said that they hoped to extract information about RA-specific processes rather than the underlying pathologies that might cause weight changes near the end of life.
In the study published in Arthritis & Rheumatology, the researchers compared women diagnosed with RA during follow-up to women without RA during the same index time period of 1976-2016. The study population included 121,701 women. Of these, 902 developed incident RA and were matched with 7,884 non-RA controls.
During an average of 18 years of follow-up, 41% of the RA cohort and 29% of the controls died. The risk of death was approximately twice as high (hazard ratio, 2.78; 95% confidence interval, 1.58-4.89) among those with weight loss greater than 30 pounds at the time of RA diagnosis, compared with those whose weight remained stable. However, the risk for mortality was similarly increased (HR, 2.16; 95% CI, 1.61-2.88) among the controls with weight loss greater than 30 pounds, compared with those with stable weight. No association with mortality was noted in either group among women who gained more than 30 pounds at the time of RA diagnosis.
Dr. Sparks said he was somewhat surprised by the findings.
“We expected severe, pathologic weight loss to be associated with increased risk of death among patients with RA and comparators. It was somewhat surprising that the risks in both groups were similar,” he said. “Conversely, prior studies suggested that weight gain might have been associated with increased risk of death. However, we found no association of weight gain with risk of death,” he noted.
In addition, “Our findings argue that there is not an RA-specific mortality risk based on either weight loss or gain,” he said. “While we found that weight loss was associated with increased mortality, this was most pronounced in the severe weight loss group, so was likely due to unintentional weight loss.”
Joshua F. Baker, MD, of the University of Pennsylvania, Philadelphia, and his colleagues identified an association between weight change and risk of death in RA patients in a study first published online in Arthritis & Rheumatology in 2015 (Arthritis Rheumatol. 2015 Jul;67[7]:1711-17). That study addressed the so-called obesity paradox in RA, and Dr. Baker and his colleagues noted that weight loss associated with the development of chronic illness is a significant confounder that may explain the observed protective effect of obesity on mortality.
“It is not clear how best to monitor changes in weight, when exactly to become concerned, and what to do when changes are observed,” Dr. Baker noted. “RA patients may lose weight for a number of reasons, not all related to their arthritis, and it is unlikely that there is a ‘one size fits all’ approach,” he said.
The study was limited in part by the women-only study population, so the results might not be generalizable to men, Dr. Sparks said. “The reason for weight change was unavailable,” he added. Directions for further research include investigation of how factors such as physical activity, diet, and weight loss may affect the risk of death among individuals with and without RA, he said.
Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
SOURCE: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point:
Major finding: The risk of death was approximately twice as high among women with weight loss greater than 30 pounds both for those diagnosed around the same time with RA (hazard ratio, 2.78) and for controls (HR, 2.16), compared with those whose weight remained stable.
Study details: A case-control study of 8,786 participants in the Nurses’ Health Study during 1976-2016.
Disclosures: Dr. Sparks had no financial conflicts to disclose. The study was supported in part by the National Institutes of Health and the Rheumatology Research Foundation’s Disease-Targeted Innovative Award and Scientist Development Awards.
Source: Sparks J et al. Arthritis Rheumatol. 2017 Nov 30. doi: 10.1002/art.40346.
Elevated antiphospholipid antibodies in celiac disease unrelated to gluten
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
FROM DIGESTIVE AND LIVER DISEASE
Key clinical point: Antiphospholipid antibodies are elevated in celiac patients, and highest in those on a gluten-free diet.
Major finding: Levels among celiac patients vs. controls were 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin.
Data source: Study of 179 adults with confirmed celiac disease and 91 controls.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Pulmonary hypertension treatment gets under the skin
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
FROM CHEST
Key clinical point: An implantable drug delivery system was successfully placed in 100% of adult PAH patients with no serious complications.
Major finding: The most common complaints among patients who received an implant system to deliver treprostinil were implant site pain (83%) and bruising (17%).
Data source: A multicenter, prospective study of 60 adults with pulmonary arterial hypertension who received implantable pumps to deliver treprostinil.
Disclosures: Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Biosimilars and sources show mostly parallel safety profiles
Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.
“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.
In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).
Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.
Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).
For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity
The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.
The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.
The researchers had no financial conflicts to disclose.
Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.
“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.
In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).
Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.
Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).
For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity
The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.
The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.
The researchers had no financial conflicts to disclose.
Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.
“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.
In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).
Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.
Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).
For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity
The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.
The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.
The researchers had no financial conflicts to disclose.
FROM THE BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Key clinical point: Most biosimilars show safety profiles comparable to their originators.
Major finding: Infliximab biosimilars demonstrated three more general safety concerns than the originator.
Data source: The data come from a cross-sectional analysis 19 biosimilars and 6 originators.
Disclosures: The researchers had no financial conflicts to disclose.
Emerging treatments tackling hair loss challenges include light therapies
according to Maria Hordinsky, MD.
“Although the precise mechanism remains unclear, it has been postulated that photobiomodulation acts through oxidative metabolism and transcription factor stimulation,” Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She referred to one trial, which found that men with androgenetic alopecia who used the HairMax Lasercomb showed an increase in mean hair density at 26 weeks of daily use, compared with a group that used a sham device.
Photobiomodulation devices use either laser light or light-emitting diodes. Comparing the two types is a challenge, and the question of which is more effective remains unanswered, Dr. Hordinsky said.
Other issues to be addressed in future research include finding the optimal wavelength to use for different indications for light-based treatments, determining whether pulse or continuous wave is more effective, and evaluating the potential for systemic side effects of these therapies, she noted.
No treatment for alopecia areata is currently approved by the Food and Drug Administration, but factors to consider when choosing a treatment include the patient’s age, location and extent of hair loss, and the presence of other medical problems, as well as a scalp biopsy report with information on the hair cycle and inflammation. Patients and/or their parents should understand the risks and benefits associated with various treatments to make an informed decision, Dr. Hordinsky said.
Patients and their families “have heard the ‘buzz’ about potential new treatments for alopecia areata, and the discussion needs to include a conversation about ongoing and future clinical research opportunities, as well as off-label use of Janus kinase inhibitors,” particularly oral tofacitinib, she said.
Approximately two-thirds of patients in recent studies of oral tofacitinib have had clinically acceptable hair regrowth after 6 months, Dr. Hordinsky said. Ruxolitinib is also being studied. However, “until clinical research studies are completed, there will be ongoing debate regarding the risks and benefits, cost, and sustainability” of JAK inhibitors or other new treatments, she said.
Dr. Hordinsky disclosed that she is a consultant for companies including Procter & Gamble and Concert, and has received grant/research support from Incyte, Allergan, and the National Alopecia Areata Foundation.
SDEF and this news organization are owned by Frontline Medical Communications.
according to Maria Hordinsky, MD.
“Although the precise mechanism remains unclear, it has been postulated that photobiomodulation acts through oxidative metabolism and transcription factor stimulation,” Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She referred to one trial, which found that men with androgenetic alopecia who used the HairMax Lasercomb showed an increase in mean hair density at 26 weeks of daily use, compared with a group that used a sham device.
Photobiomodulation devices use either laser light or light-emitting diodes. Comparing the two types is a challenge, and the question of which is more effective remains unanswered, Dr. Hordinsky said.
Other issues to be addressed in future research include finding the optimal wavelength to use for different indications for light-based treatments, determining whether pulse or continuous wave is more effective, and evaluating the potential for systemic side effects of these therapies, she noted.
No treatment for alopecia areata is currently approved by the Food and Drug Administration, but factors to consider when choosing a treatment include the patient’s age, location and extent of hair loss, and the presence of other medical problems, as well as a scalp biopsy report with information on the hair cycle and inflammation. Patients and/or their parents should understand the risks and benefits associated with various treatments to make an informed decision, Dr. Hordinsky said.
Patients and their families “have heard the ‘buzz’ about potential new treatments for alopecia areata, and the discussion needs to include a conversation about ongoing and future clinical research opportunities, as well as off-label use of Janus kinase inhibitors,” particularly oral tofacitinib, she said.
Approximately two-thirds of patients in recent studies of oral tofacitinib have had clinically acceptable hair regrowth after 6 months, Dr. Hordinsky said. Ruxolitinib is also being studied. However, “until clinical research studies are completed, there will be ongoing debate regarding the risks and benefits, cost, and sustainability” of JAK inhibitors or other new treatments, she said.
Dr. Hordinsky disclosed that she is a consultant for companies including Procter & Gamble and Concert, and has received grant/research support from Incyte, Allergan, and the National Alopecia Areata Foundation.
SDEF and this news organization are owned by Frontline Medical Communications.
according to Maria Hordinsky, MD.
“Although the precise mechanism remains unclear, it has been postulated that photobiomodulation acts through oxidative metabolism and transcription factor stimulation,” Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She referred to one trial, which found that men with androgenetic alopecia who used the HairMax Lasercomb showed an increase in mean hair density at 26 weeks of daily use, compared with a group that used a sham device.
Photobiomodulation devices use either laser light or light-emitting diodes. Comparing the two types is a challenge, and the question of which is more effective remains unanswered, Dr. Hordinsky said.
Other issues to be addressed in future research include finding the optimal wavelength to use for different indications for light-based treatments, determining whether pulse or continuous wave is more effective, and evaluating the potential for systemic side effects of these therapies, she noted.
No treatment for alopecia areata is currently approved by the Food and Drug Administration, but factors to consider when choosing a treatment include the patient’s age, location and extent of hair loss, and the presence of other medical problems, as well as a scalp biopsy report with information on the hair cycle and inflammation. Patients and/or their parents should understand the risks and benefits associated with various treatments to make an informed decision, Dr. Hordinsky said.
Patients and their families “have heard the ‘buzz’ about potential new treatments for alopecia areata, and the discussion needs to include a conversation about ongoing and future clinical research opportunities, as well as off-label use of Janus kinase inhibitors,” particularly oral tofacitinib, she said.
Approximately two-thirds of patients in recent studies of oral tofacitinib have had clinically acceptable hair regrowth after 6 months, Dr. Hordinsky said. Ruxolitinib is also being studied. However, “until clinical research studies are completed, there will be ongoing debate regarding the risks and benefits, cost, and sustainability” of JAK inhibitors or other new treatments, she said.
Dr. Hordinsky disclosed that she is a consultant for companies including Procter & Gamble and Concert, and has received grant/research support from Incyte, Allergan, and the National Alopecia Areata Foundation.
SDEF and this news organization are owned by Frontline Medical Communications.
FROM SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR