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Serious complications linked to rituximab in MS
NASHVILLE, TENN. – In a sign of the potential complications that can be spawned by B-cell–depleting therapies, a new report found that 5 of 30 patients with relapsing-remitting multiple sclerosis (RRMS) had to discontinue or interrupt long-term treatment with rituximab (Rituxan) because of serious infections such as pneumonia, septic arthritis, and sinusitis.
The findings are a “big lesson to not just focus on opportunistic infections [with Rituxan use] but also consider nonopportunistic infections that could occur,” lead study author Cindy Darius, a registered nurse with the Johns Hopkins Multiple Sclerosis Center (JHMSC), Baltimore, said in an interview. She presented the research at the annual meeting of the Consortium of Multiple Sclerosis Centers.
As Ms. Darius noted, progressive multifocal leukoencephalopathy has been the main focus of discussions about the use of rituximab in MS, as the disease has been noted in patients who have taken rituximab for other conditions.
But Ms. Darius said that the JHMSC observed a trend of patients with MS who took rituximab and developed “these weird infections that were more nonopportunistic infections. That prompted us to dig a little bit deeper: Are these infections happening sporadically, or could they have a connection with Rituxan?”
Ms. Darius and her colleagues retrospectively reviewed the records of 30 patients with MS who were prescribed rituximab by a single JHMSC physician since 2012. They found five cases of infectious complications, all in patients with RRMS:
- A woman, aged 30 years, whose rituximab regimen was interrupted after 4 years of treatment when she developed recurrent pneumonia.
- A man, aged 42 years, who took rituximab for a year then stopped after developing ringworm and two bouts of Staphylococcus aureus septic arthritis, and who had previously changed from natalizumab (Tysabri) to rituximab after seroconverting to the John Cunningham virus.
- A woman, aged 65 years, with Sjögren’s syndrome who stopped rituximab at 2 years after developing sinusitis, pneumonia, and herpes simplex virus keratitis.
- A woman, aged 38 years, who discontinued rituximab after 2 years because of recurrent urosepsis, sinusitis, and pyrexia of unknown origin.
- A woman, aged 56 years, who stopped rituximab after 2 years following intractable sinusitis and pneumonia that resulted in empyema and required a thoracotomy.
What might be causing the apparent side effects? Ms. Darius pointed out that the patients were already immunocompromised because of previous treatment with first- and/or second-line medications. She added that the complications “may be due to dosing that may be a little too high for the MS population.”
JHMSC is considering whether to give doses of the drug once a year instead of twice annually, she said. “Other providers are cutting the dose in half: Instead of 1,000 mg, they’re giving 500,” she added. “After the patient has been on the medication for a year or two, and you feel the disease process has stabilized, you may want to consider adjusting the dosage.”
Going forward, the researchers wrote that they “plan to determine the incidence of all serious infectious complications related to rituximab use among MS patients attending the JHMSC, and the influence of different dosing protocols between MS providers in this regard.”
No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.
SOURCE: Darius C et al. CMSC 2018, Abstract DX57.
NASHVILLE, TENN. – In a sign of the potential complications that can be spawned by B-cell–depleting therapies, a new report found that 5 of 30 patients with relapsing-remitting multiple sclerosis (RRMS) had to discontinue or interrupt long-term treatment with rituximab (Rituxan) because of serious infections such as pneumonia, septic arthritis, and sinusitis.
The findings are a “big lesson to not just focus on opportunistic infections [with Rituxan use] but also consider nonopportunistic infections that could occur,” lead study author Cindy Darius, a registered nurse with the Johns Hopkins Multiple Sclerosis Center (JHMSC), Baltimore, said in an interview. She presented the research at the annual meeting of the Consortium of Multiple Sclerosis Centers.
As Ms. Darius noted, progressive multifocal leukoencephalopathy has been the main focus of discussions about the use of rituximab in MS, as the disease has been noted in patients who have taken rituximab for other conditions.
But Ms. Darius said that the JHMSC observed a trend of patients with MS who took rituximab and developed “these weird infections that were more nonopportunistic infections. That prompted us to dig a little bit deeper: Are these infections happening sporadically, or could they have a connection with Rituxan?”
Ms. Darius and her colleagues retrospectively reviewed the records of 30 patients with MS who were prescribed rituximab by a single JHMSC physician since 2012. They found five cases of infectious complications, all in patients with RRMS:
- A woman, aged 30 years, whose rituximab regimen was interrupted after 4 years of treatment when she developed recurrent pneumonia.
- A man, aged 42 years, who took rituximab for a year then stopped after developing ringworm and two bouts of Staphylococcus aureus septic arthritis, and who had previously changed from natalizumab (Tysabri) to rituximab after seroconverting to the John Cunningham virus.
- A woman, aged 65 years, with Sjögren’s syndrome who stopped rituximab at 2 years after developing sinusitis, pneumonia, and herpes simplex virus keratitis.
- A woman, aged 38 years, who discontinued rituximab after 2 years because of recurrent urosepsis, sinusitis, and pyrexia of unknown origin.
- A woman, aged 56 years, who stopped rituximab after 2 years following intractable sinusitis and pneumonia that resulted in empyema and required a thoracotomy.
What might be causing the apparent side effects? Ms. Darius pointed out that the patients were already immunocompromised because of previous treatment with first- and/or second-line medications. She added that the complications “may be due to dosing that may be a little too high for the MS population.”
JHMSC is considering whether to give doses of the drug once a year instead of twice annually, she said. “Other providers are cutting the dose in half: Instead of 1,000 mg, they’re giving 500,” she added. “After the patient has been on the medication for a year or two, and you feel the disease process has stabilized, you may want to consider adjusting the dosage.”
Going forward, the researchers wrote that they “plan to determine the incidence of all serious infectious complications related to rituximab use among MS patients attending the JHMSC, and the influence of different dosing protocols between MS providers in this regard.”
No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.
SOURCE: Darius C et al. CMSC 2018, Abstract DX57.
NASHVILLE, TENN. – In a sign of the potential complications that can be spawned by B-cell–depleting therapies, a new report found that 5 of 30 patients with relapsing-remitting multiple sclerosis (RRMS) had to discontinue or interrupt long-term treatment with rituximab (Rituxan) because of serious infections such as pneumonia, septic arthritis, and sinusitis.
The findings are a “big lesson to not just focus on opportunistic infections [with Rituxan use] but also consider nonopportunistic infections that could occur,” lead study author Cindy Darius, a registered nurse with the Johns Hopkins Multiple Sclerosis Center (JHMSC), Baltimore, said in an interview. She presented the research at the annual meeting of the Consortium of Multiple Sclerosis Centers.
As Ms. Darius noted, progressive multifocal leukoencephalopathy has been the main focus of discussions about the use of rituximab in MS, as the disease has been noted in patients who have taken rituximab for other conditions.
But Ms. Darius said that the JHMSC observed a trend of patients with MS who took rituximab and developed “these weird infections that were more nonopportunistic infections. That prompted us to dig a little bit deeper: Are these infections happening sporadically, or could they have a connection with Rituxan?”
Ms. Darius and her colleagues retrospectively reviewed the records of 30 patients with MS who were prescribed rituximab by a single JHMSC physician since 2012. They found five cases of infectious complications, all in patients with RRMS:
- A woman, aged 30 years, whose rituximab regimen was interrupted after 4 years of treatment when she developed recurrent pneumonia.
- A man, aged 42 years, who took rituximab for a year then stopped after developing ringworm and two bouts of Staphylococcus aureus septic arthritis, and who had previously changed from natalizumab (Tysabri) to rituximab after seroconverting to the John Cunningham virus.
- A woman, aged 65 years, with Sjögren’s syndrome who stopped rituximab at 2 years after developing sinusitis, pneumonia, and herpes simplex virus keratitis.
- A woman, aged 38 years, who discontinued rituximab after 2 years because of recurrent urosepsis, sinusitis, and pyrexia of unknown origin.
- A woman, aged 56 years, who stopped rituximab after 2 years following intractable sinusitis and pneumonia that resulted in empyema and required a thoracotomy.
What might be causing the apparent side effects? Ms. Darius pointed out that the patients were already immunocompromised because of previous treatment with first- and/or second-line medications. She added that the complications “may be due to dosing that may be a little too high for the MS population.”
JHMSC is considering whether to give doses of the drug once a year instead of twice annually, she said. “Other providers are cutting the dose in half: Instead of 1,000 mg, they’re giving 500,” she added. “After the patient has been on the medication for a year or two, and you feel the disease process has stabilized, you may want to consider adjusting the dosage.”
Going forward, the researchers wrote that they “plan to determine the incidence of all serious infectious complications related to rituximab use among MS patients attending the JHMSC, and the influence of different dosing protocols between MS providers in this regard.”
No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.
SOURCE: Darius C et al. CMSC 2018, Abstract DX57.
REPORTING FROM THE CMSC ANNUAL MEETING
Key clinical point: Much of the attention toward side effects in rituximab as an off-label treatment for multiple sclerosis has focused on progressive multifocal leukoencephalopathy, but other infections may affect this population over the long term.
Major finding: Of 30 patients treated with rituximab for MS, 5 developed infections that required suspension or cessation of the treatment.
Study details: A retrospective analysis of 30 patients with MS treated with rituximab since 2012.
Disclosures: No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.
Source: Darius C et al. CMSC 2018, Abstract DX57.
For some SUD patients, kratom may be a self-treatment tool
SAN DIEGO – New research suggests that some patients with substance use disorder are turning to the herbal supplement kratom in an effort to reduce their use of heroin and prescription pain killers.
“Some, but not all, heroin users are utilizing kratom as an opioidlike drug with less risks, primarily as a drug substitute or to help abstain from IV heroin and prescription opiate use,” lead author Kirsten Elin Smith, a PhD student at the University of Louisville and an associate at the University of Kentucky’s Center on Drug and Alcohol Research, said in an interview. “Kratom appears as less risky due to the fact that it is not readily injectable.”
Kratom, a plant-based herbal product that’s available over the counter, produces an opioidlike effect. When the Food and Drug Administration declared in February 2018 that scientific evidence shows that kratom indeed is an opioid, the agency also warned that the drug could lead to abuse, addiction, and death. Several U.S. states and the District of Columbia have banned it, as have some cities and counties. In addition, the Drug Enforcement Administration has put kratom on its list of Drugs and Chemicals of Concern.
Nevertheless, some substance users view kratom as helpful and are open to using it, Ms. Smith and her colleagues reported in Drug and Alcohol Dependence.
“There seem to be three categories of substance-using individuals with some relationship to kratom: Those who use kratom inconsistently and as needed when there isn’t an alternative, those who tried it once and just didn’t find much benefit in it, and didn’t try it again, and those who have been using it regularly/daily as a long-term replacement for opioids, including IV heroin use,” Ms. Smith said.
For the new research, Ms. Smith and her colleagues surveyed 478 polysubstance users at five residential recovery centers in Kentucky. The average age of subjects was 35, 58% were male, 85% were white, and 48% were employed. About 85% of the participants were referred to programs by correctional facilities. Twenty-one percent reported ever using kratom, and 10% reported use within the last 12 months.
What do the findings mean? Along with anecdotal reports now being documented, they suggest the use of kratom by heroin users as a “possible harm-reduction” aid, Ms. Smith said at the meeting.
“These men and women are not necessarily getting kratom on a Friday night and saying, ‘This is going to be a great time.’ ” In the interview, she added that “this shows that substance-using individuals are, above all else, pragmatic.”
“It is unlikely that the majority of these users are consuming kratom primarily for achieving recreational ‘highs,’ ” Ms. Smith and her colleagues wrote in the article.
She added during her presentation that kratom is inexpensive and primarily legal. “If it were going to catch on as a serious drug of abuse, we would have expected to have a kratom epidemic already – but we do not.”
As for the big picture, Ms. Smith said in the interview that
Going forward, Ms. Smith said, she and a colleague plan to document the lives of regular kratom users in an effort to understand the progression from heroin and other drugs to kratom. They also want to know what the users would do if kratom is banned.
“These will be case studies in Kentucky, New Mexico, and possibly somewhere in the Northeast,” she said. “Since data will be collected locally, I think it would be helpful to try and obtain samples of kratom that the individuals report using so it can be analyzed. There may be variation between kratom purchased online vs. local vendors, which needs to be documented as well.”
Ms. Smith reported funding from the University of Louisville Graduate Student Research Fund, and another author was supported by the National Institute on Drug Abuse. The authors reported no relevant disclosures.
SOURCE: Smith KE et al. CPDD 2018. Drug and Alcohol Depend. 2017 Nov 1. 180:340-8.
SAN DIEGO – New research suggests that some patients with substance use disorder are turning to the herbal supplement kratom in an effort to reduce their use of heroin and prescription pain killers.
“Some, but not all, heroin users are utilizing kratom as an opioidlike drug with less risks, primarily as a drug substitute or to help abstain from IV heroin and prescription opiate use,” lead author Kirsten Elin Smith, a PhD student at the University of Louisville and an associate at the University of Kentucky’s Center on Drug and Alcohol Research, said in an interview. “Kratom appears as less risky due to the fact that it is not readily injectable.”
Kratom, a plant-based herbal product that’s available over the counter, produces an opioidlike effect. When the Food and Drug Administration declared in February 2018 that scientific evidence shows that kratom indeed is an opioid, the agency also warned that the drug could lead to abuse, addiction, and death. Several U.S. states and the District of Columbia have banned it, as have some cities and counties. In addition, the Drug Enforcement Administration has put kratom on its list of Drugs and Chemicals of Concern.
Nevertheless, some substance users view kratom as helpful and are open to using it, Ms. Smith and her colleagues reported in Drug and Alcohol Dependence.
“There seem to be three categories of substance-using individuals with some relationship to kratom: Those who use kratom inconsistently and as needed when there isn’t an alternative, those who tried it once and just didn’t find much benefit in it, and didn’t try it again, and those who have been using it regularly/daily as a long-term replacement for opioids, including IV heroin use,” Ms. Smith said.
For the new research, Ms. Smith and her colleagues surveyed 478 polysubstance users at five residential recovery centers in Kentucky. The average age of subjects was 35, 58% were male, 85% were white, and 48% were employed. About 85% of the participants were referred to programs by correctional facilities. Twenty-one percent reported ever using kratom, and 10% reported use within the last 12 months.
What do the findings mean? Along with anecdotal reports now being documented, they suggest the use of kratom by heroin users as a “possible harm-reduction” aid, Ms. Smith said at the meeting.
“These men and women are not necessarily getting kratom on a Friday night and saying, ‘This is going to be a great time.’ ” In the interview, she added that “this shows that substance-using individuals are, above all else, pragmatic.”
“It is unlikely that the majority of these users are consuming kratom primarily for achieving recreational ‘highs,’ ” Ms. Smith and her colleagues wrote in the article.
She added during her presentation that kratom is inexpensive and primarily legal. “If it were going to catch on as a serious drug of abuse, we would have expected to have a kratom epidemic already – but we do not.”
As for the big picture, Ms. Smith said in the interview that
Going forward, Ms. Smith said, she and a colleague plan to document the lives of regular kratom users in an effort to understand the progression from heroin and other drugs to kratom. They also want to know what the users would do if kratom is banned.
“These will be case studies in Kentucky, New Mexico, and possibly somewhere in the Northeast,” she said. “Since data will be collected locally, I think it would be helpful to try and obtain samples of kratom that the individuals report using so it can be analyzed. There may be variation between kratom purchased online vs. local vendors, which needs to be documented as well.”
Ms. Smith reported funding from the University of Louisville Graduate Student Research Fund, and another author was supported by the National Institute on Drug Abuse. The authors reported no relevant disclosures.
SOURCE: Smith KE et al. CPDD 2018. Drug and Alcohol Depend. 2017 Nov 1. 180:340-8.
SAN DIEGO – New research suggests that some patients with substance use disorder are turning to the herbal supplement kratom in an effort to reduce their use of heroin and prescription pain killers.
“Some, but not all, heroin users are utilizing kratom as an opioidlike drug with less risks, primarily as a drug substitute or to help abstain from IV heroin and prescription opiate use,” lead author Kirsten Elin Smith, a PhD student at the University of Louisville and an associate at the University of Kentucky’s Center on Drug and Alcohol Research, said in an interview. “Kratom appears as less risky due to the fact that it is not readily injectable.”
Kratom, a plant-based herbal product that’s available over the counter, produces an opioidlike effect. When the Food and Drug Administration declared in February 2018 that scientific evidence shows that kratom indeed is an opioid, the agency also warned that the drug could lead to abuse, addiction, and death. Several U.S. states and the District of Columbia have banned it, as have some cities and counties. In addition, the Drug Enforcement Administration has put kratom on its list of Drugs and Chemicals of Concern.
Nevertheless, some substance users view kratom as helpful and are open to using it, Ms. Smith and her colleagues reported in Drug and Alcohol Dependence.
“There seem to be three categories of substance-using individuals with some relationship to kratom: Those who use kratom inconsistently and as needed when there isn’t an alternative, those who tried it once and just didn’t find much benefit in it, and didn’t try it again, and those who have been using it regularly/daily as a long-term replacement for opioids, including IV heroin use,” Ms. Smith said.
For the new research, Ms. Smith and her colleagues surveyed 478 polysubstance users at five residential recovery centers in Kentucky. The average age of subjects was 35, 58% were male, 85% were white, and 48% were employed. About 85% of the participants were referred to programs by correctional facilities. Twenty-one percent reported ever using kratom, and 10% reported use within the last 12 months.
What do the findings mean? Along with anecdotal reports now being documented, they suggest the use of kratom by heroin users as a “possible harm-reduction” aid, Ms. Smith said at the meeting.
“These men and women are not necessarily getting kratom on a Friday night and saying, ‘This is going to be a great time.’ ” In the interview, she added that “this shows that substance-using individuals are, above all else, pragmatic.”
“It is unlikely that the majority of these users are consuming kratom primarily for achieving recreational ‘highs,’ ” Ms. Smith and her colleagues wrote in the article.
She added during her presentation that kratom is inexpensive and primarily legal. “If it were going to catch on as a serious drug of abuse, we would have expected to have a kratom epidemic already – but we do not.”
As for the big picture, Ms. Smith said in the interview that
Going forward, Ms. Smith said, she and a colleague plan to document the lives of regular kratom users in an effort to understand the progression from heroin and other drugs to kratom. They also want to know what the users would do if kratom is banned.
“These will be case studies in Kentucky, New Mexico, and possibly somewhere in the Northeast,” she said. “Since data will be collected locally, I think it would be helpful to try and obtain samples of kratom that the individuals report using so it can be analyzed. There may be variation between kratom purchased online vs. local vendors, which needs to be documented as well.”
Ms. Smith reported funding from the University of Louisville Graduate Student Research Fund, and another author was supported by the National Institute on Drug Abuse. The authors reported no relevant disclosures.
SOURCE: Smith KE et al. CPDD 2018. Drug and Alcohol Depend. 2017 Nov 1. 180:340-8.
REPORTING FROM CPDD 2018
Key clinical point: Some polysubstance users might be taking the herb kratom for harm reduction.
Major finding: Nearly 74% of recent kratom users also reported using the addiction drug buprenorphine on a nonprescription basis, even though few prefer it.
Study details: Survey of 478 polysubstance users at five residential recovery centers in Kentucky.
Disclosures: Ms. Smith reported individual funding from the University of Louisville Graduate Student Research Fund, and another author was supported by the National Institute on Drug Abuse. The authors reported no relevant disclosures.
Source: Smith KE et al. CPDD 2018. Drug And Alcohol Depend. 2017 Nov 1. 180:340-8.
Private Facebook chats show promise as depression, cannabis use intervention
SAN DIEGO – A pair of small studies suggest that cyber-based interventions with private online meeting areas – like those available on Facebook – could help lift depression and encourage less marijuana use in young people with cannabis use disorder.
“Even individuals who are not looking to quit their use of cannabis have some degree of ambivalence about the extent of their use of it,” said study researcher Suzette Glasner, PhD, in an interview. “When given tools to explore the consequences of their use and change if they want to, they do find reasons and effective ways to change or reduce their use – even if they don’t quit completely.”
Research shows that nearly one-third of cannabis users in 2012-2013 showed signs of cannabis use disorder (JAMA Psychiatry. 2015 Dec; 72[12]:1235-42).
For the first study, researchers recruited 26 participants who were diagnosed with major depressive disorder and cannabis use disorder (all had used marijuana on at least 40 of the previous 90 days). After a brief in-person intervention session, they received 9 therapy sessions via computer and brief weekly check-ins by clinicians over 10 weeks.
The average age of the participants was 29, and 54% were women. They reported that their average depression severity fell from 13 to 6 at 14-week follow-up, based on the Patient Health Questionnaire-9 scale. Cannabis use also declined.
For the separate Facebook study, an additional 18 participants received access to a private Facebook group that included daily posts reinforcing the program. The average age of this group was 27, and 56% were women.
The posts asked questions about topics such as “your fears about cutting back” and feelings that are “triggers” for cannabis use. One post directed users to details about mindfulness activities, and another asked users to describe on a scale of 1-10 how important it is for them to cut back.
Participants responded with praise for the private group, offering comments such as “the Facebook group is really helpful and offers a lot of support,” “it’s nice throughout the day to have uplifting Facebook notifications,” and “I like the tips, the positive feedback and the feeling that we’re in it together, not alone.”
Dr. Glasner said. “The Facebook approach enables those addicted to cannabis, for whom motivation for many things – including socializing – may be lacking, to utilize social support, without having to leave the comfort of their home or wherever they might isolate when they’re using cannabis heavily.”
She added that “this social support may be inspiring, motivating, and reassuring to them,” letting them know that they’re not alone in experiencing an addiction whose existence is sometimes doubted.
Dr. Glasner said she next plans a large randomized trial to evaluate the efficacy of the Facebook intervention and its mechanisms of action.
After her presentation at the meeting, Dr. Glasner was asked about the ongoing concerns regarding privacy on Facebook. “When I funded and started this study, it was nearly 2 years ago, and it wasn’t as large of a concern,” she said. “We may need to look to utilize a social media platform that may not be Facebook: ‘We have one to support you, but it’s not Facebook.’”
In a related presentation at the meeting, another researcher reported success using 80 interactive texts over 4 weeks to reach out to participants in an intervention programs targeting cannabis use disorder.
The National Institute on Drug Abuse funded the study. Dr. Glasner is author of The Addiction Recovery Skills Workbook: Changing Addictive Behaviors Using CBT, Mindfulness, and Motivational Interviewing Techniques (Oakland, Calif.: New Harbinger Publications, 2015). The authors reported no relevant disclosures.
SAN DIEGO – A pair of small studies suggest that cyber-based interventions with private online meeting areas – like those available on Facebook – could help lift depression and encourage less marijuana use in young people with cannabis use disorder.
“Even individuals who are not looking to quit their use of cannabis have some degree of ambivalence about the extent of their use of it,” said study researcher Suzette Glasner, PhD, in an interview. “When given tools to explore the consequences of their use and change if they want to, they do find reasons and effective ways to change or reduce their use – even if they don’t quit completely.”
Research shows that nearly one-third of cannabis users in 2012-2013 showed signs of cannabis use disorder (JAMA Psychiatry. 2015 Dec; 72[12]:1235-42).
For the first study, researchers recruited 26 participants who were diagnosed with major depressive disorder and cannabis use disorder (all had used marijuana on at least 40 of the previous 90 days). After a brief in-person intervention session, they received 9 therapy sessions via computer and brief weekly check-ins by clinicians over 10 weeks.
The average age of the participants was 29, and 54% were women. They reported that their average depression severity fell from 13 to 6 at 14-week follow-up, based on the Patient Health Questionnaire-9 scale. Cannabis use also declined.
For the separate Facebook study, an additional 18 participants received access to a private Facebook group that included daily posts reinforcing the program. The average age of this group was 27, and 56% were women.
The posts asked questions about topics such as “your fears about cutting back” and feelings that are “triggers” for cannabis use. One post directed users to details about mindfulness activities, and another asked users to describe on a scale of 1-10 how important it is for them to cut back.
Participants responded with praise for the private group, offering comments such as “the Facebook group is really helpful and offers a lot of support,” “it’s nice throughout the day to have uplifting Facebook notifications,” and “I like the tips, the positive feedback and the feeling that we’re in it together, not alone.”
Dr. Glasner said. “The Facebook approach enables those addicted to cannabis, for whom motivation for many things – including socializing – may be lacking, to utilize social support, without having to leave the comfort of their home or wherever they might isolate when they’re using cannabis heavily.”
She added that “this social support may be inspiring, motivating, and reassuring to them,” letting them know that they’re not alone in experiencing an addiction whose existence is sometimes doubted.
Dr. Glasner said she next plans a large randomized trial to evaluate the efficacy of the Facebook intervention and its mechanisms of action.
After her presentation at the meeting, Dr. Glasner was asked about the ongoing concerns regarding privacy on Facebook. “When I funded and started this study, it was nearly 2 years ago, and it wasn’t as large of a concern,” she said. “We may need to look to utilize a social media platform that may not be Facebook: ‘We have one to support you, but it’s not Facebook.’”
In a related presentation at the meeting, another researcher reported success using 80 interactive texts over 4 weeks to reach out to participants in an intervention programs targeting cannabis use disorder.
The National Institute on Drug Abuse funded the study. Dr. Glasner is author of The Addiction Recovery Skills Workbook: Changing Addictive Behaviors Using CBT, Mindfulness, and Motivational Interviewing Techniques (Oakland, Calif.: New Harbinger Publications, 2015). The authors reported no relevant disclosures.
SAN DIEGO – A pair of small studies suggest that cyber-based interventions with private online meeting areas – like those available on Facebook – could help lift depression and encourage less marijuana use in young people with cannabis use disorder.
“Even individuals who are not looking to quit their use of cannabis have some degree of ambivalence about the extent of their use of it,” said study researcher Suzette Glasner, PhD, in an interview. “When given tools to explore the consequences of their use and change if they want to, they do find reasons and effective ways to change or reduce their use – even if they don’t quit completely.”
Research shows that nearly one-third of cannabis users in 2012-2013 showed signs of cannabis use disorder (JAMA Psychiatry. 2015 Dec; 72[12]:1235-42).
For the first study, researchers recruited 26 participants who were diagnosed with major depressive disorder and cannabis use disorder (all had used marijuana on at least 40 of the previous 90 days). After a brief in-person intervention session, they received 9 therapy sessions via computer and brief weekly check-ins by clinicians over 10 weeks.
The average age of the participants was 29, and 54% were women. They reported that their average depression severity fell from 13 to 6 at 14-week follow-up, based on the Patient Health Questionnaire-9 scale. Cannabis use also declined.
For the separate Facebook study, an additional 18 participants received access to a private Facebook group that included daily posts reinforcing the program. The average age of this group was 27, and 56% were women.
The posts asked questions about topics such as “your fears about cutting back” and feelings that are “triggers” for cannabis use. One post directed users to details about mindfulness activities, and another asked users to describe on a scale of 1-10 how important it is for them to cut back.
Participants responded with praise for the private group, offering comments such as “the Facebook group is really helpful and offers a lot of support,” “it’s nice throughout the day to have uplifting Facebook notifications,” and “I like the tips, the positive feedback and the feeling that we’re in it together, not alone.”
Dr. Glasner said. “The Facebook approach enables those addicted to cannabis, for whom motivation for many things – including socializing – may be lacking, to utilize social support, without having to leave the comfort of their home or wherever they might isolate when they’re using cannabis heavily.”
She added that “this social support may be inspiring, motivating, and reassuring to them,” letting them know that they’re not alone in experiencing an addiction whose existence is sometimes doubted.
Dr. Glasner said she next plans a large randomized trial to evaluate the efficacy of the Facebook intervention and its mechanisms of action.
After her presentation at the meeting, Dr. Glasner was asked about the ongoing concerns regarding privacy on Facebook. “When I funded and started this study, it was nearly 2 years ago, and it wasn’t as large of a concern,” she said. “We may need to look to utilize a social media platform that may not be Facebook: ‘We have one to support you, but it’s not Facebook.’”
In a related presentation at the meeting, another researcher reported success using 80 interactive texts over 4 weeks to reach out to participants in an intervention programs targeting cannabis use disorder.
The National Institute on Drug Abuse funded the study. Dr. Glasner is author of The Addiction Recovery Skills Workbook: Changing Addictive Behaviors Using CBT, Mindfulness, and Motivational Interviewing Techniques (Oakland, Calif.: New Harbinger Publications, 2015). The authors reported no relevant disclosures.
REPORTING FROM CPDD 2018
Do free meals to physicians affect opioid prescribing?
SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.
A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.
The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.
Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.
The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.
According to data from the Centers for Disease Control and Prevention, a record number of people – 52,404 – died from drug overdoses in 2015, and nearly 13,000 of the deaths were attributable to prescription drugs (natural or semi-synthetic). An estimated 12.5 million people aged 12 and older in 2015, meanwhile, recently had misused prescription pain relievers.
For the new study, Dr. Hadland and his colleagues sought to understand whether opioid marketing in 2014 influenced prescribing in 2015.
The researchers retrospectively tracked 369,139 physicians in a Medicare Part D database who prescribed opioids in 2015 and found that 7% reported receiving opioid marketing – speaking fees ($6.2 million), meals ($1.8 million), travel ($731,000), consulting fees ($290,000), and education ($80,000).
Overall, received marketing.
“The effect is very subtle,” said Dr. Hadland, an addiction medicine specialist at the university. “Nine percent does not seem like a large number, but when you’re talking about hundreds of thousands of physicians, that’s a large number of opioids being prescribed.”
The study takes only Medicare Part D opioid prescriptions into account, and includes only about 42% of the active national physician workforce, he noted.
The researchers linked rising numbers of meals received in 2014 per physician – from 1 to more than 10 – to a steady increase in the number of opioid claims per physician. For example, physicians who received 1 meal made about 150 opioid claims, while those who received more than 10 made more than 700 claims.
As for physician motivations, Dr. Hadland said, he doesn’t believe “this is intentional for most physicians. If you asked the vast majority of physicians in our study, ‘Do you believe marketing is influencing your prescribing?’ most would say no.”
But the findings, he said, still raise questions.
Going forward, researchers plan to study the effect of opioid marketing on public health, he added.
Dr. Hadland reports funding from the National Institute on Drug Abuse, Society for Adolescent Health and Medicine, Thrasher Research Fund, and Academic Pediatric Association. Another author reports funding from NIDA. No additional relevant disclosures were reported.
SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.
SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.
A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.
The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.
Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.
The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.
According to data from the Centers for Disease Control and Prevention, a record number of people – 52,404 – died from drug overdoses in 2015, and nearly 13,000 of the deaths were attributable to prescription drugs (natural or semi-synthetic). An estimated 12.5 million people aged 12 and older in 2015, meanwhile, recently had misused prescription pain relievers.
For the new study, Dr. Hadland and his colleagues sought to understand whether opioid marketing in 2014 influenced prescribing in 2015.
The researchers retrospectively tracked 369,139 physicians in a Medicare Part D database who prescribed opioids in 2015 and found that 7% reported receiving opioid marketing – speaking fees ($6.2 million), meals ($1.8 million), travel ($731,000), consulting fees ($290,000), and education ($80,000).
Overall, received marketing.
“The effect is very subtle,” said Dr. Hadland, an addiction medicine specialist at the university. “Nine percent does not seem like a large number, but when you’re talking about hundreds of thousands of physicians, that’s a large number of opioids being prescribed.”
The study takes only Medicare Part D opioid prescriptions into account, and includes only about 42% of the active national physician workforce, he noted.
The researchers linked rising numbers of meals received in 2014 per physician – from 1 to more than 10 – to a steady increase in the number of opioid claims per physician. For example, physicians who received 1 meal made about 150 opioid claims, while those who received more than 10 made more than 700 claims.
As for physician motivations, Dr. Hadland said, he doesn’t believe “this is intentional for most physicians. If you asked the vast majority of physicians in our study, ‘Do you believe marketing is influencing your prescribing?’ most would say no.”
But the findings, he said, still raise questions.
Going forward, researchers plan to study the effect of opioid marketing on public health, he added.
Dr. Hadland reports funding from the National Institute on Drug Abuse, Society for Adolescent Health and Medicine, Thrasher Research Fund, and Academic Pediatric Association. Another author reports funding from NIDA. No additional relevant disclosures were reported.
SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.
SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.
A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.
The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.
Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.
The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.
According to data from the Centers for Disease Control and Prevention, a record number of people – 52,404 – died from drug overdoses in 2015, and nearly 13,000 of the deaths were attributable to prescription drugs (natural or semi-synthetic). An estimated 12.5 million people aged 12 and older in 2015, meanwhile, recently had misused prescription pain relievers.
For the new study, Dr. Hadland and his colleagues sought to understand whether opioid marketing in 2014 influenced prescribing in 2015.
The researchers retrospectively tracked 369,139 physicians in a Medicare Part D database who prescribed opioids in 2015 and found that 7% reported receiving opioid marketing – speaking fees ($6.2 million), meals ($1.8 million), travel ($731,000), consulting fees ($290,000), and education ($80,000).
Overall, received marketing.
“The effect is very subtle,” said Dr. Hadland, an addiction medicine specialist at the university. “Nine percent does not seem like a large number, but when you’re talking about hundreds of thousands of physicians, that’s a large number of opioids being prescribed.”
The study takes only Medicare Part D opioid prescriptions into account, and includes only about 42% of the active national physician workforce, he noted.
The researchers linked rising numbers of meals received in 2014 per physician – from 1 to more than 10 – to a steady increase in the number of opioid claims per physician. For example, physicians who received 1 meal made about 150 opioid claims, while those who received more than 10 made more than 700 claims.
As for physician motivations, Dr. Hadland said, he doesn’t believe “this is intentional for most physicians. If you asked the vast majority of physicians in our study, ‘Do you believe marketing is influencing your prescribing?’ most would say no.”
But the findings, he said, still raise questions.
Going forward, researchers plan to study the effect of opioid marketing on public health, he added.
Dr. Hadland reports funding from the National Institute on Drug Abuse, Society for Adolescent Health and Medicine, Thrasher Research Fund, and Academic Pediatric Association. Another author reports funding from NIDA. No additional relevant disclosures were reported.
SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.
REPORTING FROM CPDD 2018
Key clinical point: Opioid marketing appears to affect physician prescribing practices.
Major finding: Physicians who received opioid marketing payments and meals in 2014 prescribed an adjusted 9% more opioids in 2015 than did their opioid-prescribing colleagues.
Study details: Retrospective 2014-2015 analysis of 369,139 opioid-prescribing physicians in a Medicare Part D database.
Disclosures: Dr. Hadland reported funding from the National Institute on Drug Abuse, Society for Adolescent Health and Medicine, Thrasher Research Fund, and Academic Pediatric Association. Another author reported funding from NIDA. No additional relevant disclosures were reported.
Source: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.
Maternal use of pot and tobacco may boost birth defect risk
SAN DIEGO – New research suggests that pregnant users of both cannabis and tobacco may put their unborn children at higher risk of birth defects and small head circumference than if they used either alone.
Researchers also found that 13% of pregnant Medicaid recipients surveyed reported using both cannabis and tobacco within the past month.
, especially if they smoke tobacco, said study lead author Victoria H. Coleman-Cowger, PhD, of the research organization Battelle, in an interview.
In some cases, in fact, pregnant women might think that marijuana is healthier than regular cigarettes, said Dr. Coleman-Cowger. She observed this phenomenon while conducting a smoking intervention study at a prenatal clinic that largely served poor, African American women.
“I learned that many participants were also smoking cannabis and felt that there was lower risk associated with cannabis use than with tobacco use,” she said. “Some women were decreasing their use of tobacco during pregnancy but increasing their use of cannabis.”
Dr. Coleman-Cowger’s observations at the clinic inspired the new study, which reports the findings of a convenience survey of 500 pregnant women.
The mean age in the group was 28, and 71% were black. Two-thirds were employed, and 29% were college graduates.
By comparison, the 45 women in the co-user group – who reported both cannabis and tobacco use in the past month – were 93% black, 42% employed, and 7% college graduates. (An additional 39 women reported tobacco use only, and 60 reported cannabis use only.)
Co-use also was correlated with “never married, being in the first trimester of pregnancy, not wanting to be pregnant when they were, past-month other substance use, and more frequent use of both cannabis and tobacco than either exclusive group,” Dr. Coleman-Cowger said.
In adjusted models, co-users were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers. Birth defects also were more likely in the co-user group.
The study did not allow researchers to speculate on whether co-use may multiply risk vs. cannabis or tobacco use alone.
Dr. Coleman-Cowger said in light of the small sample size, the results should be interpreted with caution. One possible confounder is quantity of use, she said. “We did not assess quantity of use, but given our finding that frequency of use is higher among the co-use group, it could be that the co-use group is simply using more of each substance and thus impacting the health consequences.”
Current clinical practice guidelines do not suggest screening for cannabis use in pregnant women. But Dr. Coleman-Cowger said it’s “particularly important when tobacco use has been identified, though in states where substance use is considered child abuse, professional judgment should be utilized in terms of the legal implications of asking about use.”
More research is planned to better understand issues like quantity of use, and reasons why pregnant women co-use cannabis and tobacco, Dr. Coleman-Cowger said.
The National Institute on Drug Abuse funded the study, which Dr. Coleman-Cowger said is part of a larger project “to compare and validate screeners that assess prescription drug misuse and illicit drug use during pregnancy.” The study authors report no relevant disclosures.
SAN DIEGO – New research suggests that pregnant users of both cannabis and tobacco may put their unborn children at higher risk of birth defects and small head circumference than if they used either alone.
Researchers also found that 13% of pregnant Medicaid recipients surveyed reported using both cannabis and tobacco within the past month.
, especially if they smoke tobacco, said study lead author Victoria H. Coleman-Cowger, PhD, of the research organization Battelle, in an interview.
In some cases, in fact, pregnant women might think that marijuana is healthier than regular cigarettes, said Dr. Coleman-Cowger. She observed this phenomenon while conducting a smoking intervention study at a prenatal clinic that largely served poor, African American women.
“I learned that many participants were also smoking cannabis and felt that there was lower risk associated with cannabis use than with tobacco use,” she said. “Some women were decreasing their use of tobacco during pregnancy but increasing their use of cannabis.”
Dr. Coleman-Cowger’s observations at the clinic inspired the new study, which reports the findings of a convenience survey of 500 pregnant women.
The mean age in the group was 28, and 71% were black. Two-thirds were employed, and 29% were college graduates.
By comparison, the 45 women in the co-user group – who reported both cannabis and tobacco use in the past month – were 93% black, 42% employed, and 7% college graduates. (An additional 39 women reported tobacco use only, and 60 reported cannabis use only.)
Co-use also was correlated with “never married, being in the first trimester of pregnancy, not wanting to be pregnant when they were, past-month other substance use, and more frequent use of both cannabis and tobacco than either exclusive group,” Dr. Coleman-Cowger said.
In adjusted models, co-users were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers. Birth defects also were more likely in the co-user group.
The study did not allow researchers to speculate on whether co-use may multiply risk vs. cannabis or tobacco use alone.
Dr. Coleman-Cowger said in light of the small sample size, the results should be interpreted with caution. One possible confounder is quantity of use, she said. “We did not assess quantity of use, but given our finding that frequency of use is higher among the co-use group, it could be that the co-use group is simply using more of each substance and thus impacting the health consequences.”
Current clinical practice guidelines do not suggest screening for cannabis use in pregnant women. But Dr. Coleman-Cowger said it’s “particularly important when tobacco use has been identified, though in states where substance use is considered child abuse, professional judgment should be utilized in terms of the legal implications of asking about use.”
More research is planned to better understand issues like quantity of use, and reasons why pregnant women co-use cannabis and tobacco, Dr. Coleman-Cowger said.
The National Institute on Drug Abuse funded the study, which Dr. Coleman-Cowger said is part of a larger project “to compare and validate screeners that assess prescription drug misuse and illicit drug use during pregnancy.” The study authors report no relevant disclosures.
SAN DIEGO – New research suggests that pregnant users of both cannabis and tobacco may put their unborn children at higher risk of birth defects and small head circumference than if they used either alone.
Researchers also found that 13% of pregnant Medicaid recipients surveyed reported using both cannabis and tobacco within the past month.
, especially if they smoke tobacco, said study lead author Victoria H. Coleman-Cowger, PhD, of the research organization Battelle, in an interview.
In some cases, in fact, pregnant women might think that marijuana is healthier than regular cigarettes, said Dr. Coleman-Cowger. She observed this phenomenon while conducting a smoking intervention study at a prenatal clinic that largely served poor, African American women.
“I learned that many participants were also smoking cannabis and felt that there was lower risk associated with cannabis use than with tobacco use,” she said. “Some women were decreasing their use of tobacco during pregnancy but increasing their use of cannabis.”
Dr. Coleman-Cowger’s observations at the clinic inspired the new study, which reports the findings of a convenience survey of 500 pregnant women.
The mean age in the group was 28, and 71% were black. Two-thirds were employed, and 29% were college graduates.
By comparison, the 45 women in the co-user group – who reported both cannabis and tobacco use in the past month – were 93% black, 42% employed, and 7% college graduates. (An additional 39 women reported tobacco use only, and 60 reported cannabis use only.)
Co-use also was correlated with “never married, being in the first trimester of pregnancy, not wanting to be pregnant when they were, past-month other substance use, and more frequent use of both cannabis and tobacco than either exclusive group,” Dr. Coleman-Cowger said.
In adjusted models, co-users were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers. Birth defects also were more likely in the co-user group.
The study did not allow researchers to speculate on whether co-use may multiply risk vs. cannabis or tobacco use alone.
Dr. Coleman-Cowger said in light of the small sample size, the results should be interpreted with caution. One possible confounder is quantity of use, she said. “We did not assess quantity of use, but given our finding that frequency of use is higher among the co-use group, it could be that the co-use group is simply using more of each substance and thus impacting the health consequences.”
Current clinical practice guidelines do not suggest screening for cannabis use in pregnant women. But Dr. Coleman-Cowger said it’s “particularly important when tobacco use has been identified, though in states where substance use is considered child abuse, professional judgment should be utilized in terms of the legal implications of asking about use.”
More research is planned to better understand issues like quantity of use, and reasons why pregnant women co-use cannabis and tobacco, Dr. Coleman-Cowger said.
The National Institute on Drug Abuse funded the study, which Dr. Coleman-Cowger said is part of a larger project “to compare and validate screeners that assess prescription drug misuse and illicit drug use during pregnancy.” The study authors report no relevant disclosures.
REPORTING FROM CPDD 2018
Key clinical point: Couse of cannabis and tobacco by pregnant mothers may pose more risk to unborn children than use of either alone.
Major finding: Cousers had a higher risk of giving birth to children with birth detects and small head circumference than tobacco-only or cannabis-only users. In adjusted models, cousers were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers.
Study details: Survey of 500 pregnant Medicaid recipients.
Disclosures: The National Institute on Drug Abuse funded the study. The study authors report no relevant disclosures.
Low hyaluronidase doses may be adequate for addressing filler asymmetry
, and in some cases, slightly larger doses may move things along more rapidly, according to the authors of a small split-arm clinical trial.
“These findings offer clinicians a means to modify and fine-tune filler-associated skin contour without resorting to high-dose injections that completely remove all filler from the treatment site,” wrote the authors, led by Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology, Northwestern University, Chicago. The study was published online in JAMA Dermatology.
The study, conducted during 2013-2014, analyzed the impact of various small doses of hyaluronidase on two types of fillers that had been administered into the upper inner arms of nine women (seven white, two black; mean age, 46 years). Another participant withdrew because of a fear of needles.
In one arm in each woman, researchers injected four aliquots of Juvéderm Ultra XC (0.4 mL each). Then, at 1, 2, and 3 weeks, they administered 1.5 U, 3.0 U, or 9.0 U hyaluronidase per 0.1 mL or saline control (at a constant volume of 0.1 mL) into each site. In the other arms, researchers performed the same protocol, but with Restylane-L. A 5-point scale was used to rate detectability of each site ranging from 0 (undetectable) and 1 (faintly perceptible) to 4 (“very” perceptible).
A blinded physician visually rated the effects of saline versus hyaluronidase at 4 weeks and found a significant difference between assessments of the hyaluronidase-treated sites and saline control sites at 4 weeks, favoring the hyaluronidase sites for visual detection (mean difference, 1.15; P less than .001) and palpability (mean difference, 1.22; P less than .001). Participant self-assessments at 4 weeks produced similar results for visual detection (mean difference, 0.87; P = .006) and palpability (mean difference, 1.59; P less than .001).
Similar differences favoring hyaluronidase persisted at 4 months.
The researchers also found that 9.0-U treatments of hyaluronidase led to significantly less palpability than 1.5-U treatments at 4 weeks and 4 months. The researchers noticed a larger dose-related difference for hyaluronidase for Restylane-L sites, and they noted that all the filler nodules diminished over time regardless of the study treatment.
“The clinical relevance of these findings is clear,” they concluded. “Minor filler-associated asymmetries, nodules, and textural abnormalities may be corrected safely and effectively with low-volume, low-dose hyaluronidase. Rather than dissolving all the offending filler, waiting, and then reinjecting fresh filler weeks or months later, dermatologists may precisely sculpt already injected excess filler by titration with low-volume, low-dose hyaluronidase to the desired skin contour.”
Other types of hyaluronidase may work in different ways, the study authors noted, and larger doses may be needed to treat longer-lasting types of fillers.
In an accompanying commentary, Derek H. Jones, MD, of Skin Care and Laser Physicians of Beverly Hills, Calif., praised the study, which he wrote, “proves that smaller, less-concentrated doses of hyaluronidase are capable of removing small amounts of HA [hyaluronic acid] without removing the entire implant.”
Dr. Jones added that he uses 10 U of Vitrase (hyaluronidase) for each 0.1 cc of Juvéderm that he estimates should be removed. He also uses 5 U of Vitrase for each 0.1 cc of Restylane, and 30 U for each 0.1 cc of Juvéderm Voluma.
“When attempting to remove smaller or partial amounts of HA implant,” he added, “I often dilute Vitrase with normal saline to go from 20 U/0.1 cc to 10 U/0.1 cc or less.”
Northwestern University funded the study. Dr. Alam, the lead author, reported various disclosures, and the university disclosed that its clinical trials branch receives various government and corporate grants. The other authors reported no disclosures. Dr. Jones disclosed serving as an investigator, consultant, and/or speaker for Allergan, Merz, and Galderma.
SOURCE: Alam M et al. JAMA Dermatol. 2018 Apr 25. doi: 10.1001/jamadermatol.2018.0515.
, and in some cases, slightly larger doses may move things along more rapidly, according to the authors of a small split-arm clinical trial.
“These findings offer clinicians a means to modify and fine-tune filler-associated skin contour without resorting to high-dose injections that completely remove all filler from the treatment site,” wrote the authors, led by Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology, Northwestern University, Chicago. The study was published online in JAMA Dermatology.
The study, conducted during 2013-2014, analyzed the impact of various small doses of hyaluronidase on two types of fillers that had been administered into the upper inner arms of nine women (seven white, two black; mean age, 46 years). Another participant withdrew because of a fear of needles.
In one arm in each woman, researchers injected four aliquots of Juvéderm Ultra XC (0.4 mL each). Then, at 1, 2, and 3 weeks, they administered 1.5 U, 3.0 U, or 9.0 U hyaluronidase per 0.1 mL or saline control (at a constant volume of 0.1 mL) into each site. In the other arms, researchers performed the same protocol, but with Restylane-L. A 5-point scale was used to rate detectability of each site ranging from 0 (undetectable) and 1 (faintly perceptible) to 4 (“very” perceptible).
A blinded physician visually rated the effects of saline versus hyaluronidase at 4 weeks and found a significant difference between assessments of the hyaluronidase-treated sites and saline control sites at 4 weeks, favoring the hyaluronidase sites for visual detection (mean difference, 1.15; P less than .001) and palpability (mean difference, 1.22; P less than .001). Participant self-assessments at 4 weeks produced similar results for visual detection (mean difference, 0.87; P = .006) and palpability (mean difference, 1.59; P less than .001).
Similar differences favoring hyaluronidase persisted at 4 months.
The researchers also found that 9.0-U treatments of hyaluronidase led to significantly less palpability than 1.5-U treatments at 4 weeks and 4 months. The researchers noticed a larger dose-related difference for hyaluronidase for Restylane-L sites, and they noted that all the filler nodules diminished over time regardless of the study treatment.
“The clinical relevance of these findings is clear,” they concluded. “Minor filler-associated asymmetries, nodules, and textural abnormalities may be corrected safely and effectively with low-volume, low-dose hyaluronidase. Rather than dissolving all the offending filler, waiting, and then reinjecting fresh filler weeks or months later, dermatologists may precisely sculpt already injected excess filler by titration with low-volume, low-dose hyaluronidase to the desired skin contour.”
Other types of hyaluronidase may work in different ways, the study authors noted, and larger doses may be needed to treat longer-lasting types of fillers.
In an accompanying commentary, Derek H. Jones, MD, of Skin Care and Laser Physicians of Beverly Hills, Calif., praised the study, which he wrote, “proves that smaller, less-concentrated doses of hyaluronidase are capable of removing small amounts of HA [hyaluronic acid] without removing the entire implant.”
Dr. Jones added that he uses 10 U of Vitrase (hyaluronidase) for each 0.1 cc of Juvéderm that he estimates should be removed. He also uses 5 U of Vitrase for each 0.1 cc of Restylane, and 30 U for each 0.1 cc of Juvéderm Voluma.
“When attempting to remove smaller or partial amounts of HA implant,” he added, “I often dilute Vitrase with normal saline to go from 20 U/0.1 cc to 10 U/0.1 cc or less.”
Northwestern University funded the study. Dr. Alam, the lead author, reported various disclosures, and the university disclosed that its clinical trials branch receives various government and corporate grants. The other authors reported no disclosures. Dr. Jones disclosed serving as an investigator, consultant, and/or speaker for Allergan, Merz, and Galderma.
SOURCE: Alam M et al. JAMA Dermatol. 2018 Apr 25. doi: 10.1001/jamadermatol.2018.0515.
, and in some cases, slightly larger doses may move things along more rapidly, according to the authors of a small split-arm clinical trial.
“These findings offer clinicians a means to modify and fine-tune filler-associated skin contour without resorting to high-dose injections that completely remove all filler from the treatment site,” wrote the authors, led by Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology, Northwestern University, Chicago. The study was published online in JAMA Dermatology.
The study, conducted during 2013-2014, analyzed the impact of various small doses of hyaluronidase on two types of fillers that had been administered into the upper inner arms of nine women (seven white, two black; mean age, 46 years). Another participant withdrew because of a fear of needles.
In one arm in each woman, researchers injected four aliquots of Juvéderm Ultra XC (0.4 mL each). Then, at 1, 2, and 3 weeks, they administered 1.5 U, 3.0 U, or 9.0 U hyaluronidase per 0.1 mL or saline control (at a constant volume of 0.1 mL) into each site. In the other arms, researchers performed the same protocol, but with Restylane-L. A 5-point scale was used to rate detectability of each site ranging from 0 (undetectable) and 1 (faintly perceptible) to 4 (“very” perceptible).
A blinded physician visually rated the effects of saline versus hyaluronidase at 4 weeks and found a significant difference between assessments of the hyaluronidase-treated sites and saline control sites at 4 weeks, favoring the hyaluronidase sites for visual detection (mean difference, 1.15; P less than .001) and palpability (mean difference, 1.22; P less than .001). Participant self-assessments at 4 weeks produced similar results for visual detection (mean difference, 0.87; P = .006) and palpability (mean difference, 1.59; P less than .001).
Similar differences favoring hyaluronidase persisted at 4 months.
The researchers also found that 9.0-U treatments of hyaluronidase led to significantly less palpability than 1.5-U treatments at 4 weeks and 4 months. The researchers noticed a larger dose-related difference for hyaluronidase for Restylane-L sites, and they noted that all the filler nodules diminished over time regardless of the study treatment.
“The clinical relevance of these findings is clear,” they concluded. “Minor filler-associated asymmetries, nodules, and textural abnormalities may be corrected safely and effectively with low-volume, low-dose hyaluronidase. Rather than dissolving all the offending filler, waiting, and then reinjecting fresh filler weeks or months later, dermatologists may precisely sculpt already injected excess filler by titration with low-volume, low-dose hyaluronidase to the desired skin contour.”
Other types of hyaluronidase may work in different ways, the study authors noted, and larger doses may be needed to treat longer-lasting types of fillers.
In an accompanying commentary, Derek H. Jones, MD, of Skin Care and Laser Physicians of Beverly Hills, Calif., praised the study, which he wrote, “proves that smaller, less-concentrated doses of hyaluronidase are capable of removing small amounts of HA [hyaluronic acid] without removing the entire implant.”
Dr. Jones added that he uses 10 U of Vitrase (hyaluronidase) for each 0.1 cc of Juvéderm that he estimates should be removed. He also uses 5 U of Vitrase for each 0.1 cc of Restylane, and 30 U for each 0.1 cc of Juvéderm Voluma.
“When attempting to remove smaller or partial amounts of HA implant,” he added, “I often dilute Vitrase with normal saline to go from 20 U/0.1 cc to 10 U/0.1 cc or less.”
Northwestern University funded the study. Dr. Alam, the lead author, reported various disclosures, and the university disclosed that its clinical trials branch receives various government and corporate grants. The other authors reported no disclosures. Dr. Jones disclosed serving as an investigator, consultant, and/or speaker for Allergan, Merz, and Galderma.
SOURCE: Alam M et al. JAMA Dermatol. 2018 Apr 25. doi: 10.1001/jamadermatol.2018.0515.
FROM JAMA DERMATOLOGY
Key clinical point: Low doses of hyaluronidase can effectively remove unwanted hyaluronic acid filler.
Major finding: At 4 weeks, palpability favored hyaluronidase vs. saline (mean difference, 1.22; P less than .001).
Study details: A split-arm, parallel-group randomized clinical trial of nine women. Arms were given one of two types of filler injections and saline or various doses of hyaluronidase.
Disclosures: Northwestern University funded the study. One author reported various financial disclosures.
Source: Alam M et al. JAMA Dermatol. 2018 Apr 25. doi: 10.1001/jamadermatol.2018.0515.
Take precautions as cancer picture in MS remains hazy
NASHVILLE, TENN. – With much unknown about the risks of cancer and vaccination associated with immunosuppressants used in multiple sclerosis treatment, a neurologist advised colleagues to be aware of the potential dangers and take appropriate precautions.
For example, Eric Williamson, MD, of the University of Pennsylvania and Philadelphia Veterans Administration Hospital, said he goes a step further than recommending that adult female patients with MS who take ocrelizumab (Ocrevus) get regular mammograms. Per policy, he also double-checks to make sure that patients actually get screened.
“I know two women who were diagnosed with breast cancer before they began on their treatment because we asked about mammograms,” said Dr. Williamson, who spoke in a presentation about the risks of immunosuppressants in MS at the annual meeting of the Consortium of Multiple Sclerosis Centers.
In regard to cancer as a whole, he said, “it’s unclear if there is any true increased risk in MS patients.” But this doesn’t mean there is no danger, he said, since research into immunosuppressants in other contexts show that they can boost the risk of cancer by three times to as much as several hundred times.
In transplant patients, he said, immunosuppressants are linked to higher rates of lymphoproliferative tumors (such as those linked to Epstein-Barr virus), Kaposi sarcoma, and cutaneous, renal, hepatobiliary, and anogenital tumors.
Research is also hazy in regard to specific immunosuppressants used to treat MS. Two reports published about a decade ago raised the possibility that natalizumab (Tysabri) may have sparked a slightly higher risk cancer in patients taking the drug for Crohn’s disease and MS, respectively; the latter report hinted at a higher risk of melanoma specifically. However, Dr. Williamson said postmarketing surveillance has not detected any further sign of trouble (N Engl J Med. 2006;354:899‐910; N Engl J Med. 2008;358;647‐8).
Another drug, ocrelizumab (Ocrevus), has sparked questions about a possible breast cancer risk. As Genentech, its manufacturer, notes: “breast cancer occurred in 6 of 781 females treated with Ocrevus and none of 668 females treated with Rebif [interferon beta-1a] or placebo.”
However, a researcher reported ocrelizumab open-label extension study data at the 2017 CMSC annual meeting and said, “incidence rates of malignancies and breast cancer observed with ocrelizumab treatment in MS remain within the range of epidemiologic background data.”
For now, Dr. Williamson, said, it may take decades to understand if there’s actually an increased breast cancer risk with ocrelizumab.
Skin cancer is a concern for fingolimod (Gilenya), Dr. Williamson said, specifically basal cell carcinoma and melanoma. It’s debatable whether patients should be required to see a dermatologist or make annual visits, he said. Per policy, his VA employer requires these patients to visit a dermatologist.
Whatever the case, it’s important to keep in mind that skin cancer screenings are advisable in general, he said.
Guidance on vaccinations
On the vaccination front, Dr. Williamson said vaccines are a good idea for MS patients – as long as they’re “relatively safe” – because some infectious diseases appear to be more severe in this population.
Flu is a special danger, Dr. Williamson said. He recommends the flu vaccine to patients “because people with MS are at higher risk of influenza-related complications or hospitalizations.”
With guidance from a report led by Dr. Williamson, the National Multiple Sclerosis Society offers recommendations about whether patients with MS should use various vaccines (Curr Neurol Neurosci Rep. 2016;16:36).
Dr. Williamson cautioned that patients with MS who take dimethyl fumarate (Tecfidera), ocrelizumab (Ocrevus), and fingolimod (Gilenya) should not use live vaccines. The drugs can pose issues in regard to other vaccines, too, he said (Plos ONE 2013; 8:e78532; Neurol Res 2012;34:730-3; Neurology. 2013;81:552-8).
Autoimmune risk with alemtuzumab
Alemtuzumab (Lemtrada) has been linked to autoimmune thyroid disorders, especially Graves’ disease, Dr. Williamson said. It’s estimated to affect 17%-41% of patients (Front Endocrinol [Lausanne]. 2017;8:254).
Potentially life-threatening idiopathic thrombocytopenic purpura occurs in 2% of patients on Lemtrada, he said, and anti-GMB nephropathy/Goodpasture’s syndrome has been reported in 0.1%.
Dr. Williamson also noted case reports of autoimmune hemolytic anemia and hepatitis. Earlier this year, three reports in Neurology noted acute coronary syndrome in one patient, hemophagocytic lymphohistiocytosis (HLH) in two patients, and acute acalculous cholecystitis in eight patients (Neurology. 2018 Mar 30. doi: 10.1212/WNL.0000000000005422, doi: 10.1212/WNL.0000000000005420, doi: 10.1212/WNL.0000000000005417).
Dr. Williamson disclosed past consulting for Bayer, Biogen, Celgene, Genentech, EMD Serono, Teva, and Novartis, and current research support from Actelion and Alexion.
NASHVILLE, TENN. – With much unknown about the risks of cancer and vaccination associated with immunosuppressants used in multiple sclerosis treatment, a neurologist advised colleagues to be aware of the potential dangers and take appropriate precautions.
For example, Eric Williamson, MD, of the University of Pennsylvania and Philadelphia Veterans Administration Hospital, said he goes a step further than recommending that adult female patients with MS who take ocrelizumab (Ocrevus) get regular mammograms. Per policy, he also double-checks to make sure that patients actually get screened.
“I know two women who were diagnosed with breast cancer before they began on their treatment because we asked about mammograms,” said Dr. Williamson, who spoke in a presentation about the risks of immunosuppressants in MS at the annual meeting of the Consortium of Multiple Sclerosis Centers.
In regard to cancer as a whole, he said, “it’s unclear if there is any true increased risk in MS patients.” But this doesn’t mean there is no danger, he said, since research into immunosuppressants in other contexts show that they can boost the risk of cancer by three times to as much as several hundred times.
In transplant patients, he said, immunosuppressants are linked to higher rates of lymphoproliferative tumors (such as those linked to Epstein-Barr virus), Kaposi sarcoma, and cutaneous, renal, hepatobiliary, and anogenital tumors.
Research is also hazy in regard to specific immunosuppressants used to treat MS. Two reports published about a decade ago raised the possibility that natalizumab (Tysabri) may have sparked a slightly higher risk cancer in patients taking the drug for Crohn’s disease and MS, respectively; the latter report hinted at a higher risk of melanoma specifically. However, Dr. Williamson said postmarketing surveillance has not detected any further sign of trouble (N Engl J Med. 2006;354:899‐910; N Engl J Med. 2008;358;647‐8).
Another drug, ocrelizumab (Ocrevus), has sparked questions about a possible breast cancer risk. As Genentech, its manufacturer, notes: “breast cancer occurred in 6 of 781 females treated with Ocrevus and none of 668 females treated with Rebif [interferon beta-1a] or placebo.”
However, a researcher reported ocrelizumab open-label extension study data at the 2017 CMSC annual meeting and said, “incidence rates of malignancies and breast cancer observed with ocrelizumab treatment in MS remain within the range of epidemiologic background data.”
For now, Dr. Williamson, said, it may take decades to understand if there’s actually an increased breast cancer risk with ocrelizumab.
Skin cancer is a concern for fingolimod (Gilenya), Dr. Williamson said, specifically basal cell carcinoma and melanoma. It’s debatable whether patients should be required to see a dermatologist or make annual visits, he said. Per policy, his VA employer requires these patients to visit a dermatologist.
Whatever the case, it’s important to keep in mind that skin cancer screenings are advisable in general, he said.
Guidance on vaccinations
On the vaccination front, Dr. Williamson said vaccines are a good idea for MS patients – as long as they’re “relatively safe” – because some infectious diseases appear to be more severe in this population.
Flu is a special danger, Dr. Williamson said. He recommends the flu vaccine to patients “because people with MS are at higher risk of influenza-related complications or hospitalizations.”
With guidance from a report led by Dr. Williamson, the National Multiple Sclerosis Society offers recommendations about whether patients with MS should use various vaccines (Curr Neurol Neurosci Rep. 2016;16:36).
Dr. Williamson cautioned that patients with MS who take dimethyl fumarate (Tecfidera), ocrelizumab (Ocrevus), and fingolimod (Gilenya) should not use live vaccines. The drugs can pose issues in regard to other vaccines, too, he said (Plos ONE 2013; 8:e78532; Neurol Res 2012;34:730-3; Neurology. 2013;81:552-8).
Autoimmune risk with alemtuzumab
Alemtuzumab (Lemtrada) has been linked to autoimmune thyroid disorders, especially Graves’ disease, Dr. Williamson said. It’s estimated to affect 17%-41% of patients (Front Endocrinol [Lausanne]. 2017;8:254).
Potentially life-threatening idiopathic thrombocytopenic purpura occurs in 2% of patients on Lemtrada, he said, and anti-GMB nephropathy/Goodpasture’s syndrome has been reported in 0.1%.
Dr. Williamson also noted case reports of autoimmune hemolytic anemia and hepatitis. Earlier this year, three reports in Neurology noted acute coronary syndrome in one patient, hemophagocytic lymphohistiocytosis (HLH) in two patients, and acute acalculous cholecystitis in eight patients (Neurology. 2018 Mar 30. doi: 10.1212/WNL.0000000000005422, doi: 10.1212/WNL.0000000000005420, doi: 10.1212/WNL.0000000000005417).
Dr. Williamson disclosed past consulting for Bayer, Biogen, Celgene, Genentech, EMD Serono, Teva, and Novartis, and current research support from Actelion and Alexion.
NASHVILLE, TENN. – With much unknown about the risks of cancer and vaccination associated with immunosuppressants used in multiple sclerosis treatment, a neurologist advised colleagues to be aware of the potential dangers and take appropriate precautions.
For example, Eric Williamson, MD, of the University of Pennsylvania and Philadelphia Veterans Administration Hospital, said he goes a step further than recommending that adult female patients with MS who take ocrelizumab (Ocrevus) get regular mammograms. Per policy, he also double-checks to make sure that patients actually get screened.
“I know two women who were diagnosed with breast cancer before they began on their treatment because we asked about mammograms,” said Dr. Williamson, who spoke in a presentation about the risks of immunosuppressants in MS at the annual meeting of the Consortium of Multiple Sclerosis Centers.
In regard to cancer as a whole, he said, “it’s unclear if there is any true increased risk in MS patients.” But this doesn’t mean there is no danger, he said, since research into immunosuppressants in other contexts show that they can boost the risk of cancer by three times to as much as several hundred times.
In transplant patients, he said, immunosuppressants are linked to higher rates of lymphoproliferative tumors (such as those linked to Epstein-Barr virus), Kaposi sarcoma, and cutaneous, renal, hepatobiliary, and anogenital tumors.
Research is also hazy in regard to specific immunosuppressants used to treat MS. Two reports published about a decade ago raised the possibility that natalizumab (Tysabri) may have sparked a slightly higher risk cancer in patients taking the drug for Crohn’s disease and MS, respectively; the latter report hinted at a higher risk of melanoma specifically. However, Dr. Williamson said postmarketing surveillance has not detected any further sign of trouble (N Engl J Med. 2006;354:899‐910; N Engl J Med. 2008;358;647‐8).
Another drug, ocrelizumab (Ocrevus), has sparked questions about a possible breast cancer risk. As Genentech, its manufacturer, notes: “breast cancer occurred in 6 of 781 females treated with Ocrevus and none of 668 females treated with Rebif [interferon beta-1a] or placebo.”
However, a researcher reported ocrelizumab open-label extension study data at the 2017 CMSC annual meeting and said, “incidence rates of malignancies and breast cancer observed with ocrelizumab treatment in MS remain within the range of epidemiologic background data.”
For now, Dr. Williamson, said, it may take decades to understand if there’s actually an increased breast cancer risk with ocrelizumab.
Skin cancer is a concern for fingolimod (Gilenya), Dr. Williamson said, specifically basal cell carcinoma and melanoma. It’s debatable whether patients should be required to see a dermatologist or make annual visits, he said. Per policy, his VA employer requires these patients to visit a dermatologist.
Whatever the case, it’s important to keep in mind that skin cancer screenings are advisable in general, he said.
Guidance on vaccinations
On the vaccination front, Dr. Williamson said vaccines are a good idea for MS patients – as long as they’re “relatively safe” – because some infectious diseases appear to be more severe in this population.
Flu is a special danger, Dr. Williamson said. He recommends the flu vaccine to patients “because people with MS are at higher risk of influenza-related complications or hospitalizations.”
With guidance from a report led by Dr. Williamson, the National Multiple Sclerosis Society offers recommendations about whether patients with MS should use various vaccines (Curr Neurol Neurosci Rep. 2016;16:36).
Dr. Williamson cautioned that patients with MS who take dimethyl fumarate (Tecfidera), ocrelizumab (Ocrevus), and fingolimod (Gilenya) should not use live vaccines. The drugs can pose issues in regard to other vaccines, too, he said (Plos ONE 2013; 8:e78532; Neurol Res 2012;34:730-3; Neurology. 2013;81:552-8).
Autoimmune risk with alemtuzumab
Alemtuzumab (Lemtrada) has been linked to autoimmune thyroid disorders, especially Graves’ disease, Dr. Williamson said. It’s estimated to affect 17%-41% of patients (Front Endocrinol [Lausanne]. 2017;8:254).
Potentially life-threatening idiopathic thrombocytopenic purpura occurs in 2% of patients on Lemtrada, he said, and anti-GMB nephropathy/Goodpasture’s syndrome has been reported in 0.1%.
Dr. Williamson also noted case reports of autoimmune hemolytic anemia and hepatitis. Earlier this year, three reports in Neurology noted acute coronary syndrome in one patient, hemophagocytic lymphohistiocytosis (HLH) in two patients, and acute acalculous cholecystitis in eight patients (Neurology. 2018 Mar 30. doi: 10.1212/WNL.0000000000005422, doi: 10.1212/WNL.0000000000005420, doi: 10.1212/WNL.0000000000005417).
Dr. Williamson disclosed past consulting for Bayer, Biogen, Celgene, Genentech, EMD Serono, Teva, and Novartis, and current research support from Actelion and Alexion.
REPORTING FROM THE CMSC ANNUAL MEETING
Focus on preventing comorbidities in MS, physician urges
NASHVILLE, TENN. – Some patients use multiple sclerosis as an excuse to make poor health choices, but Allen C. Bowling, MD, PhD, of the Colorado Neurological Institute has seen another kind of story unfold. Fifteen to 20 years ago, Dr. Bowling said, he treated patients who took the development of MS in their 20s as a sign they needed to take better care of themselves. “They said MS was the best thing that happened to them ‘because it motivated me to make these healthy lifestyle changes I wouldn’t have made otherwise.’ ”
These patients have maintained their lifestyle changes, he said, lowering their risk of comorbidities and – perhaps – changing the course of their MS for the better.
“It’s all one machine, and sometimes we lose sight of that in our sub-sub-specialized world of treating MS ... You’re caring for a whole person. If you start thinking about that, it does make you think differently about how you treat the person, how you try to prevent disease in terms of certain pathways,” Dr. Bowling said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where he spoke to colleagues about the importance of helping patients to adopt lifestyle changes.
According to Dr. Bowling, there’s evidence linking lifestyle-related comorbidities, poorer food quality, and tobacco use to higher levels of overall MS risk, relapses, disability, and symptoms.
Researchers have also linked other life factors to higher MS risks: obesity (linked to overall MS risk, disability, symptoms); lack of physical activity (linked to relapses, disability, symptoms); emotional factors (relapses, symptoms); and alcohol overuse (linked to overall risk, disability, symptoms).
“Data is mild to moderate to strong in all those areas for lifestyle approaches like diet, physical activity, emotional health, alcohol in moderation or less, and no tobacco smoking,” Dr. Bowling said.
He said he believes physical activity leads to “much higher and earlier success than diet” in MS patients, although there’s no confirmed “best exercise.”
As for nutrition, he said vitamins D and B12 are possibly beneficial. But he cautioned against the potential for harm from supplements and added that there’s no proven best diet for MS.
As for finding time to address these issues in clinic, Dr. Bowling recommended mentioning various lifestyle issues over multiple office visits.
“Some of the effort should be switched to the primary care doctor,” he said, “but you can use a strong collection of words to convey to the person with MS that this is serious: ‘It’s not MS, but it’s a serious issue, and you must see your primary care doctor.’ ”
He believes that this approach can have a significant impact, “especially for those aged 20-40, because the doctor they pay the most attention to may be their MS clinician.”
Dr. Bowling said that he receives royalties from a book he authored, “Optimal Health With Multiple Sclerosis.”
NASHVILLE, TENN. – Some patients use multiple sclerosis as an excuse to make poor health choices, but Allen C. Bowling, MD, PhD, of the Colorado Neurological Institute has seen another kind of story unfold. Fifteen to 20 years ago, Dr. Bowling said, he treated patients who took the development of MS in their 20s as a sign they needed to take better care of themselves. “They said MS was the best thing that happened to them ‘because it motivated me to make these healthy lifestyle changes I wouldn’t have made otherwise.’ ”
These patients have maintained their lifestyle changes, he said, lowering their risk of comorbidities and – perhaps – changing the course of their MS for the better.
“It’s all one machine, and sometimes we lose sight of that in our sub-sub-specialized world of treating MS ... You’re caring for a whole person. If you start thinking about that, it does make you think differently about how you treat the person, how you try to prevent disease in terms of certain pathways,” Dr. Bowling said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where he spoke to colleagues about the importance of helping patients to adopt lifestyle changes.
According to Dr. Bowling, there’s evidence linking lifestyle-related comorbidities, poorer food quality, and tobacco use to higher levels of overall MS risk, relapses, disability, and symptoms.
Researchers have also linked other life factors to higher MS risks: obesity (linked to overall MS risk, disability, symptoms); lack of physical activity (linked to relapses, disability, symptoms); emotional factors (relapses, symptoms); and alcohol overuse (linked to overall risk, disability, symptoms).
“Data is mild to moderate to strong in all those areas for lifestyle approaches like diet, physical activity, emotional health, alcohol in moderation or less, and no tobacco smoking,” Dr. Bowling said.
He said he believes physical activity leads to “much higher and earlier success than diet” in MS patients, although there’s no confirmed “best exercise.”
As for nutrition, he said vitamins D and B12 are possibly beneficial. But he cautioned against the potential for harm from supplements and added that there’s no proven best diet for MS.
As for finding time to address these issues in clinic, Dr. Bowling recommended mentioning various lifestyle issues over multiple office visits.
“Some of the effort should be switched to the primary care doctor,” he said, “but you can use a strong collection of words to convey to the person with MS that this is serious: ‘It’s not MS, but it’s a serious issue, and you must see your primary care doctor.’ ”
He believes that this approach can have a significant impact, “especially for those aged 20-40, because the doctor they pay the most attention to may be their MS clinician.”
Dr. Bowling said that he receives royalties from a book he authored, “Optimal Health With Multiple Sclerosis.”
NASHVILLE, TENN. – Some patients use multiple sclerosis as an excuse to make poor health choices, but Allen C. Bowling, MD, PhD, of the Colorado Neurological Institute has seen another kind of story unfold. Fifteen to 20 years ago, Dr. Bowling said, he treated patients who took the development of MS in their 20s as a sign they needed to take better care of themselves. “They said MS was the best thing that happened to them ‘because it motivated me to make these healthy lifestyle changes I wouldn’t have made otherwise.’ ”
These patients have maintained their lifestyle changes, he said, lowering their risk of comorbidities and – perhaps – changing the course of their MS for the better.
“It’s all one machine, and sometimes we lose sight of that in our sub-sub-specialized world of treating MS ... You’re caring for a whole person. If you start thinking about that, it does make you think differently about how you treat the person, how you try to prevent disease in terms of certain pathways,” Dr. Bowling said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where he spoke to colleagues about the importance of helping patients to adopt lifestyle changes.
According to Dr. Bowling, there’s evidence linking lifestyle-related comorbidities, poorer food quality, and tobacco use to higher levels of overall MS risk, relapses, disability, and symptoms.
Researchers have also linked other life factors to higher MS risks: obesity (linked to overall MS risk, disability, symptoms); lack of physical activity (linked to relapses, disability, symptoms); emotional factors (relapses, symptoms); and alcohol overuse (linked to overall risk, disability, symptoms).
“Data is mild to moderate to strong in all those areas for lifestyle approaches like diet, physical activity, emotional health, alcohol in moderation or less, and no tobacco smoking,” Dr. Bowling said.
He said he believes physical activity leads to “much higher and earlier success than diet” in MS patients, although there’s no confirmed “best exercise.”
As for nutrition, he said vitamins D and B12 are possibly beneficial. But he cautioned against the potential for harm from supplements and added that there’s no proven best diet for MS.
As for finding time to address these issues in clinic, Dr. Bowling recommended mentioning various lifestyle issues over multiple office visits.
“Some of the effort should be switched to the primary care doctor,” he said, “but you can use a strong collection of words to convey to the person with MS that this is serious: ‘It’s not MS, but it’s a serious issue, and you must see your primary care doctor.’ ”
He believes that this approach can have a significant impact, “especially for those aged 20-40, because the doctor they pay the most attention to may be their MS clinician.”
Dr. Bowling said that he receives royalties from a book he authored, “Optimal Health With Multiple Sclerosis.”
REPORTING FROM THE CMSC ANNUAL MEETING
Pregnancy may be ideal time to consider switching MS drugs
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NASHVILLE, TENN – Women with multiple sclerosis who fare poorly on specific medications before pregnancy don’t tend to do any better afterward, a new study finds. This suggests that pregnancy – a period when many women with MS stop taking their medication – should trigger discussions about switching from drugs that aren’t doing the job, the study’s lead author said.
“It’s a good time to consider the therapy that the individual is on, whether it’s one that’s effective for them, and whether it’s one they should return to when they start up therapy post-partum. It’s likely it will affect them the same way” after pregnancy as before, Caila Vaughn, MPH, PhD, of the University of Buffalo, said in an interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.
From 2012-2017, the study authors sent surveys to 1,651 women in the New York State Multiple Sclerosis Consortium as part of an effort to understand how pregnancy affects women with MS, especially when relapses return in the post-partum period.
Of the 1,651 women, 635 (38% of the total) agreed to answer questions about their reproductive history.
Pregnancy data was available for 627 patients of whom 490 (78%) had been pregnant. Of those, 109 said they became pregnant after their MS diagnosis.
Fifty-three (49%) reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Just 12% reported relapses during pregnancy, and 16% said they took disease-modifying drugs during pregnancy (60% had taken them before pregnancy).
Why does MS become less severe during pregnancy? “We believe the dormancy of the disease is related to an immune system that is naturally decreased and depressed during pregnancy,” Dr. Vaughn said. Afterward, she said, “the relapses are related to the recovery of the immune system post-partum.”
The researchers didn’t find any links between the use of disease-modifying drugs and relapses before, during, or after pregnancy.
Those who had relapses prior to pregnancy were more likely (P = 0.011) to have them afterward too. But researchers didn’t find a statistically significant link between relapses that occurred during and after pregnancy.
More than three-quarters of those who took disease-modifying drugs before pregnancy returned to using them afterward, in most cases within 3 months.
The study findings suggest that pregnancy is a helpful decision point when patients should take a closer look at the effects of their medications, Dr. Vaughn said. “In conjunction with a physician, they should decide if it’s a good one they should return to.”
Reflecting the findings of other research that suggests pregnancy is safe in women with MS, the study shows no sign that pregnancy – either before or after diagnosis of MS – boosts the risk that MS will get worse.
As for the possible effects of disease-modifying drugs on new mothers who breast-feed, the researchers found no evidence of adverse outcomes in 5 patients who took the medications while breast-feeding.
The study was funded by Teva. Dr. Vaughn reported no relevant disclosures. Several other study authors report various disclosures, including relationships with Teva.
SOURCE: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NASHVILLE, TENN – Women with multiple sclerosis who fare poorly on specific medications before pregnancy don’t tend to do any better afterward, a new study finds. This suggests that pregnancy – a period when many women with MS stop taking their medication – should trigger discussions about switching from drugs that aren’t doing the job, the study’s lead author said.
“It’s a good time to consider the therapy that the individual is on, whether it’s one that’s effective for them, and whether it’s one they should return to when they start up therapy post-partum. It’s likely it will affect them the same way” after pregnancy as before, Caila Vaughn, MPH, PhD, of the University of Buffalo, said in an interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.
From 2012-2017, the study authors sent surveys to 1,651 women in the New York State Multiple Sclerosis Consortium as part of an effort to understand how pregnancy affects women with MS, especially when relapses return in the post-partum period.
Of the 1,651 women, 635 (38% of the total) agreed to answer questions about their reproductive history.
Pregnancy data was available for 627 patients of whom 490 (78%) had been pregnant. Of those, 109 said they became pregnant after their MS diagnosis.
Fifty-three (49%) reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Just 12% reported relapses during pregnancy, and 16% said they took disease-modifying drugs during pregnancy (60% had taken them before pregnancy).
Why does MS become less severe during pregnancy? “We believe the dormancy of the disease is related to an immune system that is naturally decreased and depressed during pregnancy,” Dr. Vaughn said. Afterward, she said, “the relapses are related to the recovery of the immune system post-partum.”
The researchers didn’t find any links between the use of disease-modifying drugs and relapses before, during, or after pregnancy.
Those who had relapses prior to pregnancy were more likely (P = 0.011) to have them afterward too. But researchers didn’t find a statistically significant link between relapses that occurred during and after pregnancy.
More than three-quarters of those who took disease-modifying drugs before pregnancy returned to using them afterward, in most cases within 3 months.
The study findings suggest that pregnancy is a helpful decision point when patients should take a closer look at the effects of their medications, Dr. Vaughn said. “In conjunction with a physician, they should decide if it’s a good one they should return to.”
Reflecting the findings of other research that suggests pregnancy is safe in women with MS, the study shows no sign that pregnancy – either before or after diagnosis of MS – boosts the risk that MS will get worse.
As for the possible effects of disease-modifying drugs on new mothers who breast-feed, the researchers found no evidence of adverse outcomes in 5 patients who took the medications while breast-feeding.
The study was funded by Teva. Dr. Vaughn reported no relevant disclosures. Several other study authors report various disclosures, including relationships with Teva.
SOURCE: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NASHVILLE, TENN – Women with multiple sclerosis who fare poorly on specific medications before pregnancy don’t tend to do any better afterward, a new study finds. This suggests that pregnancy – a period when many women with MS stop taking their medication – should trigger discussions about switching from drugs that aren’t doing the job, the study’s lead author said.
“It’s a good time to consider the therapy that the individual is on, whether it’s one that’s effective for them, and whether it’s one they should return to when they start up therapy post-partum. It’s likely it will affect them the same way” after pregnancy as before, Caila Vaughn, MPH, PhD, of the University of Buffalo, said in an interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.
From 2012-2017, the study authors sent surveys to 1,651 women in the New York State Multiple Sclerosis Consortium as part of an effort to understand how pregnancy affects women with MS, especially when relapses return in the post-partum period.
Of the 1,651 women, 635 (38% of the total) agreed to answer questions about their reproductive history.
Pregnancy data was available for 627 patients of whom 490 (78%) had been pregnant. Of those, 109 said they became pregnant after their MS diagnosis.
Fifty-three (49%) reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Just 12% reported relapses during pregnancy, and 16% said they took disease-modifying drugs during pregnancy (60% had taken them before pregnancy).
Why does MS become less severe during pregnancy? “We believe the dormancy of the disease is related to an immune system that is naturally decreased and depressed during pregnancy,” Dr. Vaughn said. Afterward, she said, “the relapses are related to the recovery of the immune system post-partum.”
The researchers didn’t find any links between the use of disease-modifying drugs and relapses before, during, or after pregnancy.
Those who had relapses prior to pregnancy were more likely (P = 0.011) to have them afterward too. But researchers didn’t find a statistically significant link between relapses that occurred during and after pregnancy.
More than three-quarters of those who took disease-modifying drugs before pregnancy returned to using them afterward, in most cases within 3 months.
The study findings suggest that pregnancy is a helpful decision point when patients should take a closer look at the effects of their medications, Dr. Vaughn said. “In conjunction with a physician, they should decide if it’s a good one they should return to.”
Reflecting the findings of other research that suggests pregnancy is safe in women with MS, the study shows no sign that pregnancy – either before or after diagnosis of MS – boosts the risk that MS will get worse.
As for the possible effects of disease-modifying drugs on new mothers who breast-feed, the researchers found no evidence of adverse outcomes in 5 patients who took the medications while breast-feeding.
The study was funded by Teva. Dr. Vaughn reported no relevant disclosures. Several other study authors report various disclosures, including relationships with Teva.
SOURCE: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.
REPORTING FROM THE CMSC ANNUAL MEETING
Key clinical point: Multiple sclerosis relapse rates are similar before and after pregnancy, suggesting it may be a good time to consider switching medications if feasible.
Major finding: 49% of women who were pregnant after MS diagnosis reported relapses in the 2 years prior to pregnancy and 46% reported them in the 2 subsequent years. Those who had relapses prior to pregnancy were more likely to have them afterward, too.
Study details: Survey of 109 women who became pregnant after MS diagnosis.
Disclosures: Teva funded the study. Several study authors report various disclosures, including relationships with Teva.
Source: Vaughn C. et al. Abstract FC04, 2018 annual meeting, Consortium of Multiple Sclerosis Centers.
MS clinic thrives by making regular care a ‘loss leader’
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NASHVILLE, TENN. – Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.
“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.
Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”
The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”
To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”
Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.
Mr. Smith discloses a consulting fee from Novartis.
Watch the interview to learn more about the center’s efforts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NASHVILLE, TENN. – Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.
“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.
Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”
The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”
To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”
Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.
Mr. Smith discloses a consulting fee from Novartis.
Watch the interview to learn more about the center’s efforts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NASHVILLE, TENN. – Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.
“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics.
Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”
The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”
To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”
Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.
Mr. Smith discloses a consulting fee from Novartis.
Watch the interview to learn more about the center’s efforts.
REPORTING FROM THE CMSC ANNUAL MEETING
