WASHINGTON – With proper counseling and oversight, many drugs used for psoriasis, pemphigus, and atopic dermatitis are safe to use during pregnancy, Jenny Murase, MD, said at the annual meeting of the American Academy of Dermatology.

But it’s important to have an early talk about potential pregnancies, because most dermatologists don’t think about it unless a patient is taking a known teratogen, like isotretinoin, said Dr. Murase of the University of California, San Francisco. “It’s only about 10% of the time that the dermatologist brings it up. In patients with these chronic skin diseases, we need to address family planning proactively. Most women don’t discover they’re pregnant until they’re 2-5 weeks along, and by that time the development of major organs has already started.”

As part of her expertise in this topic, Dr. Murase published two comprehensive reports on the safety of dermatologic drugs in pregnancy and lactation. They were grouped according to the newest federal guidance, the Food and Drug Administration Pregnancy and Lactation Label Ruling. Issued in 2014, it requires the inclusion of any contact information for drug registries and covers reproductive risks or both males and females. Slowly being phased in as new drugs are approved, the ruling is replacing the old category A, B, and C.

The articles were published in the Journal of the American Academy of Dermatology and in the international Journal of Women’s Dermatology, an open-access journal Dr. Murase founded.

Corticosteroids

These dermatology workhorses are largely safe in pregnancy, Dr. Murase said. Some very early reports suggested that systemic cortisone might be associated with oral clefts, but that has never been borne out in prospective data. Prednisone may be the safest as it has the most limited placental transport; betamethasone and dexamethasone cross the placenta easily.

In a Cochrane review, only one study showed an increased risk of orofacial clefts. A 2013 study of about 10,000 women suggested an increased risk of low birth weight associated with a total dose of more than 300 grams during the pregnancy.

Antihistamines

First-generation antihistamines, including hydroxyzine, have been used as antiemetics in pregnant women. Hydroxyzine is generally considered safe, but should be discussed carefully, as it carries a slightly increased risk of congenital malformations (5.8% vs. 2.3% background risk).

Newborns exposed to large doses of hydroxyzine (150 mg or more daily) have also exhibited withdrawal symptoms at birth, including irritability, poor feeding, and tonic-clinic seizures.

“Antihistamines can exert oxytocin-like effects, especially in overdose or when given intravenously, so please avoid using them in the last month of pregnancy. There have also been a few reports of retrolental fibroplasia in preterm infants who were exposed to antihistamines within 2 weeks of delivery,” Dr. Murase said.

Immunosuppressants

Mycophenolate is not compatible with pregnancy. In 2007, the FDA changed the labeling of mycophenolate from category C to D, because of reports of congenital malformations arising from the U.S. National Transplantation Pregnancy Registry and other sources.

“You need to treat these patients like you do someone who is going on isotretinoin,” Dr. Murase said. “Any woman prescribed it should be on mandatory contraception at least 4 weeks before beginning the medication and for 6 weeks after completing treatment.”

Thus far there are no reported pregnancy-related safety issues with dupilumab, although data are scarce.

Pregnancy itself exerts a positive effect on psoriasis in many women, but not all. “About half the time a women will improve,” Dr. Murase said. “A quarter of the time, there’s no change and a quarter of the time, she’ll get worse. But the ones who do improve, often improve dramatically with about 80% body surface area clearance.”

She considers light therapy to be the safest treatment during pregnancy, with one caveat: Ultraviolet light can degrade some vitamins, including folic acid. “Every one of my patients of childbearing age I have on folic acid or a prenatal vitamin just in case. You have to be proactive here.”

Cyclosporine appears to be “quite safe,” she said. The possibility of intrauterine growth restriction seen in some studies is tough to tease out, because it was reported mainly in transplant populations among women with other medical comorbidities. Children from these pregnancies have been followed through toddlerhood and showed no neurodevelopmental or kidney issues.

Apremilast is a category C drug. Some animal data suggested increased spontaneous abortions and fetal demise with doses given at two to four times the human dose.

Biologics

Antibodies are an interesting lot, Dr. Murase noted. Maternal antibodies are transported to the fetus across the villi by Fc receptor; most of this transfer happens during the third trimester. The large, hydrophilic monoclonal antibodies infliximab, adalimumab, and ustekinumab travel this way as well. Cord blood can contain 50% higher serum levels than in maternal blood. Etanercept, however, is a fusion protein that diffuses across the placenta. Cord blood levels generally exceed maternal levels by less than 7%.

There is one published report of a fetal death associated with maternal infliximab for Crohn’s disease. The infant was healthy until it received a Bacillus Calmette–Guerin vaccine. It then developed widespread eczematous dermatitis, head lag, and poor weight gain and died at 4.5 months.

“This is another important counseling point,” Dr. Murase said. “Babies who have been exposed to infliximab in utero can’t have that vaccination in the first 9 months of life.”

Perhaps the safest bet for a pregnant women who needs a biologic is PEGylated certolizumab. “Certolizumab is the only PEGylated anti-TNF [tumor necrosis factor] without an Fc region; study of patients greater than 30 weeks pregnant certolizumab levels were below 0.032 mcg/mL in 13 of 14 infant samples at birth.”

Pemphigus

Pemphigus (impetigo herpetiformous) is a serious dermatologic disorder that can manifest in the third trimester, and affect the fetus as well as the mother. “You have to take even mild cases very seriously, because there’s no distinct correlation between the extent of neonatal involvement and the extent of maternal disease,” Dr. Murase said

Oral pemphigus in the mother is especially worrisome, she added. “Fetal skin shares the same desmoglein-3 profile as adult oral mucosa, and neonatal pemphigus is more likely if mother has oral disease. There’s an increased risk of fetal demise as well.”

Treatment would generally start with topical steroids, progressing to systemic low-dose corticosteroids. If more than 20 mg of prednisone a day is required, consider intravenous immunoglobulin (IVIG), azathioprine, dapsone, or rituximab.

“IVIG is very safe for pregnant women, and in fact reproductive endocrinologists use this to increase the chance of pregnancy for infertility cases,” Dr. Murase said.

She reported relationships with Regeneron, UCB, Dermira, and Genzyme/Sanofi.

[email protected]

WASHINGTON – With proper counseling and oversight, many drugs used for psoriasis, pemphigus, and atopic dermatitis are safe to use during pregnancy, Jenny Murase, MD, said at the annual meeting of the American Academy of Dermatology.

But it’s important to have an early talk about potential pregnancies, because most dermatologists don’t think about it unless a patient is taking a known teratogen, like isotretinoin, said Dr. Murase of the University of California, San Francisco. “It’s only about 10% of the time that the dermatologist brings it up. In patients with these chronic skin diseases, we need to address family planning proactively. Most women don’t discover they’re pregnant until they’re 2-5 weeks along, and by that time the development of major organs has already started.”

As part of her expertise in this topic, Dr. Murase published two comprehensive reports on the safety of dermatologic drugs in pregnancy and lactation. They were grouped according to the newest federal guidance, the Food and Drug Administration Pregnancy and Lactation Label Ruling. Issued in 2014, it requires the inclusion of any contact information for drug registries and covers reproductive risks or both males and females. Slowly being phased in as new drugs are approved, the ruling is replacing the old category A, B, and C.

The articles were published in the Journal of the American Academy of Dermatology and in the international Journal of Women’s Dermatology, an open-access journal Dr. Murase founded.

Corticosteroids

These dermatology workhorses are largely safe in pregnancy, Dr. Murase said. Some very early reports suggested that systemic cortisone might be associated with oral clefts, but that has never been borne out in prospective data. Prednisone may be the safest as it has the most limited placental transport; betamethasone and dexamethasone cross the placenta easily.

In a Cochrane review, only one study showed an increased risk of orofacial clefts. A 2013 study of about 10,000 women suggested an increased risk of low birth weight associated with a total dose of more than 300 grams during the pregnancy.

Antihistamines

First-generation antihistamines, including hydroxyzine, have been used as antiemetics in pregnant women. Hydroxyzine is generally considered safe, but should be discussed carefully, as it carries a slightly increased risk of congenital malformations (5.8% vs. 2.3% background risk).

Newborns exposed to large doses of hydroxyzine (150 mg or more daily) have also exhibited withdrawal symptoms at birth, including irritability, poor feeding, and tonic-clinic seizures.

“Antihistamines can exert oxytocin-like effects, especially in overdose or when given intravenously, so please avoid using them in the last month of pregnancy. There have also been a few reports of retrolental fibroplasia in preterm infants who were exposed to antihistamines within 2 weeks of delivery,” Dr. Murase said.

Immunosuppressants

Mycophenolate is not compatible with pregnancy. In 2007, the FDA changed the labeling of mycophenolate from category C to D, because of reports of congenital malformations arising from the U.S. National Transplantation Pregnancy Registry and other sources.

“You need to treat these patients like you do someone who is going on isotretinoin,” Dr. Murase said. “Any woman prescribed it should be on mandatory contraception at least 4 weeks before beginning the medication and for 6 weeks after completing treatment.”

Thus far there are no reported pregnancy-related safety issues with dupilumab, although data are scarce.

Pregnancy itself exerts a positive effect on psoriasis in many women, but not all. “About half the time a women will improve,” Dr. Murase said. “A quarter of the time, there’s no change and a quarter of the time, she’ll get worse. But the ones who do improve, often improve dramatically with about 80% body surface area clearance.”

She considers light therapy to be the safest treatment during pregnancy, with one caveat: Ultraviolet light can degrade some vitamins, including folic acid. “Every one of my patients of childbearing age I have on folic acid or a prenatal vitamin just in case. You have to be proactive here.”

Cyclosporine appears to be “quite safe,” she said. The possibility of intrauterine growth restriction seen in some studies is tough to tease out, because it was reported mainly in transplant populations among women with other medical comorbidities. Children from these pregnancies have been followed through toddlerhood and showed no neurodevelopmental or kidney issues.

Apremilast is a category C drug. Some animal data suggested increased spontaneous abortions and fetal demise with doses given at two to four times the human dose.

Biologics

Antibodies are an interesting lot, Dr. Murase noted. Maternal antibodies are transported to the fetus across the villi by Fc receptor; most of this transfer happens during the third trimester. The large, hydrophilic monoclonal antibodies infliximab, adalimumab, and ustekinumab travel this way as well. Cord blood can contain 50% higher serum levels than in maternal blood. Etanercept, however, is a fusion protein that diffuses across the placenta. Cord blood levels generally exceed maternal levels by less than 7%.

There is one published report of a fetal death associated with maternal infliximab for Crohn’s disease. The infant was healthy until it received a Bacillus Calmette–Guerin vaccine. It then developed widespread eczematous dermatitis, head lag, and poor weight gain and died at 4.5 months.

“This is another important counseling point,” Dr. Murase said. “Babies who have been exposed to infliximab in utero can’t have that vaccination in the first 9 months of life.”

Perhaps the safest bet for a pregnant women who needs a biologic is PEGylated certolizumab. “Certolizumab is the only PEGylated anti-TNF [tumor necrosis factor] without an Fc region; study of patients greater than 30 weeks pregnant certolizumab levels were below 0.032 mcg/mL in 13 of 14 infant samples at birth.”

Pemphigus

Pemphigus (impetigo herpetiformous) is a serious dermatologic disorder that can manifest in the third trimester, and affect the fetus as well as the mother. “You have to take even mild cases very seriously, because there’s no distinct correlation between the extent of neonatal involvement and the extent of maternal disease,” Dr. Murase said

Oral pemphigus in the mother is especially worrisome, she added. “Fetal skin shares the same desmoglein-3 profile as adult oral mucosa, and neonatal pemphigus is more likely if mother has oral disease. There’s an increased risk of fetal demise as well.”

Treatment would generally start with topical steroids, progressing to systemic low-dose corticosteroids. If more than 20 mg of prednisone a day is required, consider intravenous immunoglobulin (IVIG), azathioprine, dapsone, or rituximab.

“IVIG is very safe for pregnant women, and in fact reproductive endocrinologists use this to increase the chance of pregnancy for infertility cases,” Dr. Murase said.

She reported relationships with Regeneron, UCB, Dermira, and Genzyme/Sanofi.

[email protected]

WASHINGTON – With proper counseling and oversight, many drugs used for psoriasis, pemphigus, and atopic dermatitis are safe to use during pregnancy, Jenny Murase, MD, said at the annual meeting of the American Academy of Dermatology.

But it’s important to have an early talk about potential pregnancies, because most dermatologists don’t think about it unless a patient is taking a known teratogen, like isotretinoin, said Dr. Murase of the University of California, San Francisco. “It’s only about 10% of the time that the dermatologist brings it up. In patients with these chronic skin diseases, we need to address family planning proactively. Most women don’t discover they’re pregnant until they’re 2-5 weeks along, and by that time the development of major organs has already started.”

As part of her expertise in this topic, Dr. Murase published two comprehensive reports on the safety of dermatologic drugs in pregnancy and lactation. They were grouped according to the newest federal guidance, the Food and Drug Administration Pregnancy and Lactation Label Ruling. Issued in 2014, it requires the inclusion of any contact information for drug registries and covers reproductive risks or both males and females. Slowly being phased in as new drugs are approved, the ruling is replacing the old category A, B, and C.

The articles were published in the Journal of the American Academy of Dermatology and in the international Journal of Women’s Dermatology, an open-access journal Dr. Murase founded.

Corticosteroids

These dermatology workhorses are largely safe in pregnancy, Dr. Murase said. Some very early reports suggested that systemic cortisone might be associated with oral clefts, but that has never been borne out in prospective data. Prednisone may be the safest as it has the most limited placental transport; betamethasone and dexamethasone cross the placenta easily.

In a Cochrane review, only one study showed an increased risk of orofacial clefts. A 2013 study of about 10,000 women suggested an increased risk of low birth weight associated with a total dose of more than 300 grams during the pregnancy.

Antihistamines

First-generation antihistamines, including hydroxyzine, have been used as antiemetics in pregnant women. Hydroxyzine is generally considered safe, but should be discussed carefully, as it carries a slightly increased risk of congenital malformations (5.8% vs. 2.3% background risk).

Newborns exposed to large doses of hydroxyzine (150 mg or more daily) have also exhibited withdrawal symptoms at birth, including irritability, poor feeding, and tonic-clinic seizures.

“Antihistamines can exert oxytocin-like effects, especially in overdose or when given intravenously, so please avoid using them in the last month of pregnancy. There have also been a few reports of retrolental fibroplasia in preterm infants who were exposed to antihistamines within 2 weeks of delivery,” Dr. Murase said.

Immunosuppressants

Mycophenolate is not compatible with pregnancy. In 2007, the FDA changed the labeling of mycophenolate from category C to D, because of reports of congenital malformations arising from the U.S. National Transplantation Pregnancy Registry and other sources.

“You need to treat these patients like you do someone who is going on isotretinoin,” Dr. Murase said. “Any woman prescribed it should be on mandatory contraception at least 4 weeks before beginning the medication and for 6 weeks after completing treatment.”

Thus far there are no reported pregnancy-related safety issues with dupilumab, although data are scarce.

Pregnancy itself exerts a positive effect on psoriasis in many women, but not all. “About half the time a women will improve,” Dr. Murase said. “A quarter of the time, there’s no change and a quarter of the time, she’ll get worse. But the ones who do improve, often improve dramatically with about 80% body surface area clearance.”

She considers light therapy to be the safest treatment during pregnancy, with one caveat: Ultraviolet light can degrade some vitamins, including folic acid. “Every one of my patients of childbearing age I have on folic acid or a prenatal vitamin just in case. You have to be proactive here.”

Cyclosporine appears to be “quite safe,” she said. The possibility of intrauterine growth restriction seen in some studies is tough to tease out, because it was reported mainly in transplant populations among women with other medical comorbidities. Children from these pregnancies have been followed through toddlerhood and showed no neurodevelopmental or kidney issues.

Apremilast is a category C drug. Some animal data suggested increased spontaneous abortions and fetal demise with doses given at two to four times the human dose.

Biologics

Antibodies are an interesting lot, Dr. Murase noted. Maternal antibodies are transported to the fetus across the villi by Fc receptor; most of this transfer happens during the third trimester. The large, hydrophilic monoclonal antibodies infliximab, adalimumab, and ustekinumab travel this way as well. Cord blood can contain 50% higher serum levels than in maternal blood. Etanercept, however, is a fusion protein that diffuses across the placenta. Cord blood levels generally exceed maternal levels by less than 7%.

There is one published report of a fetal death associated with maternal infliximab for Crohn’s disease. The infant was healthy until it received a Bacillus Calmette–Guerin vaccine. It then developed widespread eczematous dermatitis, head lag, and poor weight gain and died at 4.5 months.

“This is another important counseling point,” Dr. Murase said. “Babies who have been exposed to infliximab in utero can’t have that vaccination in the first 9 months of life.”

Perhaps the safest bet for a pregnant women who needs a biologic is PEGylated certolizumab. “Certolizumab is the only PEGylated anti-TNF [tumor necrosis factor] without an Fc region; study of patients greater than 30 weeks pregnant certolizumab levels were below 0.032 mcg/mL in 13 of 14 infant samples at birth.”

Pemphigus

Pemphigus (impetigo herpetiformous) is a serious dermatologic disorder that can manifest in the third trimester, and affect the fetus as well as the mother. “You have to take even mild cases very seriously, because there’s no distinct correlation between the extent of neonatal involvement and the extent of maternal disease,” Dr. Murase said

Oral pemphigus in the mother is especially worrisome, she added. “Fetal skin shares the same desmoglein-3 profile as adult oral mucosa, and neonatal pemphigus is more likely if mother has oral disease. There’s an increased risk of fetal demise as well.”

Treatment would generally start with topical steroids, progressing to systemic low-dose corticosteroids. If more than 20 mg of prednisone a day is required, consider intravenous immunoglobulin (IVIG), azathioprine, dapsone, or rituximab.

“IVIG is very safe for pregnant women, and in fact reproductive endocrinologists use this to increase the chance of pregnancy for infertility cases,” Dr. Murase said.

She reported relationships with Regeneron, UCB, Dermira, and Genzyme/Sanofi.

[email protected]

DALLAS – In a cohort of patients with multiple sclerosis, a history of migraine was associated with more severe disability and significantly slower walking speeds, researchers reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

“Traditional migraine risk factors such as obesity, anxiety, and depression were also overrepresented in our cohort” of patients with multiple sclerosis (MS) and migraine, said Anne M. Damian, MD, of Johns Hopkins University, Baltimore, and her research colleagues.

Migraine is common in patients with MS, but whether migraine plays a role in MS disease course or MS symptom severity is unknown. Dr. Damian and her colleagues conducted an observational study to examine the associations between migraine history, disability, and neurologic function in patients with MS and whether migraine tends to occur with other comorbid conditions in MS.

They analyzed data from 289 patients (79% female; mean age, 49.2 years) patients with MS who completed the Multiple Sclerosis Performance Test (MSPT), an iPad version of the MS Functional Composite. MS outcome measures included disability (such as the Patient Determined Disease Steps) and objective neurologic outcomes (such as walking speed, manual dexterity, and processing speed). Patients also completed a questionnaire about comorbidities, including history of physician-diagnosed migraine, diabetes, hypertension, hypercholesterolemia, heart disease, sleep apnea, depression, and anxiety.

The researchers used generalized linear models adjusted for age, sex, MS subtype, MS duration, years of education, and body mass index to evaluate the association between history of migraine and MS outcomes.

Compared with patients with MS without migraine, migraineurs (n = 65) tended to be younger (mean age, 44.3 years vs. 50.4 years) and were more likely to be overweight or obese (73.9% vs. 51.6%). In addition, patients with MS and migraine were more likely to have a history of depression (46.2% vs. 24.2%), anxiety (30.8% vs. 18.8%), and severe rather than mild disability (odds ratio, 3.08; 95% confidence, 1.04-9.20). Migraine also was associated with significantly slower walking speeds (9.08% slower; 95% CI, 0.82%-18.77%). Migraine was not associated with processing speed or manual dexterity, however.

If an association between migraine history and worse MS disability is confirmed, migraine history may be a factor that neurologists could consider when making MS treatment decisions, Dr. Damian said. The researchers noted that migraine was reported by patients and not detected using a validated questionnaire. Future studies should investigate whether MS lesions on MRI differ in migraineurs and whether migraine predicts future neurologic disability in patients with MS.

Collection of the MSPT outcomes was sponsored by Biogen.

[email protected]

SOURCE: Damian AM et al. ACTRIMS Forum 2019, Abstract 78.

DALLAS – In a cohort of patients with multiple sclerosis, a history of migraine was associated with more severe disability and significantly slower walking speeds, researchers reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

“Traditional migraine risk factors such as obesity, anxiety, and depression were also overrepresented in our cohort” of patients with multiple sclerosis (MS) and migraine, said Anne M. Damian, MD, of Johns Hopkins University, Baltimore, and her research colleagues.

Migraine is common in patients with MS, but whether migraine plays a role in MS disease course or MS symptom severity is unknown. Dr. Damian and her colleagues conducted an observational study to examine the associations between migraine history, disability, and neurologic function in patients with MS and whether migraine tends to occur with other comorbid conditions in MS.

They analyzed data from 289 patients (79% female; mean age, 49.2 years) patients with MS who completed the Multiple Sclerosis Performance Test (MSPT), an iPad version of the MS Functional Composite. MS outcome measures included disability (such as the Patient Determined Disease Steps) and objective neurologic outcomes (such as walking speed, manual dexterity, and processing speed). Patients also completed a questionnaire about comorbidities, including history of physician-diagnosed migraine, diabetes, hypertension, hypercholesterolemia, heart disease, sleep apnea, depression, and anxiety.

The researchers used generalized linear models adjusted for age, sex, MS subtype, MS duration, years of education, and body mass index to evaluate the association between history of migraine and MS outcomes.

Compared with patients with MS without migraine, migraineurs (n = 65) tended to be younger (mean age, 44.3 years vs. 50.4 years) and were more likely to be overweight or obese (73.9% vs. 51.6%). In addition, patients with MS and migraine were more likely to have a history of depression (46.2% vs. 24.2%), anxiety (30.8% vs. 18.8%), and severe rather than mild disability (odds ratio, 3.08; 95% confidence, 1.04-9.20). Migraine also was associated with significantly slower walking speeds (9.08% slower; 95% CI, 0.82%-18.77%). Migraine was not associated with processing speed or manual dexterity, however.

If an association between migraine history and worse MS disability is confirmed, migraine history may be a factor that neurologists could consider when making MS treatment decisions, Dr. Damian said. The researchers noted that migraine was reported by patients and not detected using a validated questionnaire. Future studies should investigate whether MS lesions on MRI differ in migraineurs and whether migraine predicts future neurologic disability in patients with MS.

Collection of the MSPT outcomes was sponsored by Biogen.

[email protected]

SOURCE: Damian AM et al. ACTRIMS Forum 2019, Abstract 78.

DALLAS – In a cohort of patients with multiple sclerosis, a history of migraine was associated with more severe disability and significantly slower walking speeds, researchers reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

“Traditional migraine risk factors such as obesity, anxiety, and depression were also overrepresented in our cohort” of patients with multiple sclerosis (MS) and migraine, said Anne M. Damian, MD, of Johns Hopkins University, Baltimore, and her research colleagues.

Migraine is common in patients with MS, but whether migraine plays a role in MS disease course or MS symptom severity is unknown. Dr. Damian and her colleagues conducted an observational study to examine the associations between migraine history, disability, and neurologic function in patients with MS and whether migraine tends to occur with other comorbid conditions in MS.

They analyzed data from 289 patients (79% female; mean age, 49.2 years) patients with MS who completed the Multiple Sclerosis Performance Test (MSPT), an iPad version of the MS Functional Composite. MS outcome measures included disability (such as the Patient Determined Disease Steps) and objective neurologic outcomes (such as walking speed, manual dexterity, and processing speed). Patients also completed a questionnaire about comorbidities, including history of physician-diagnosed migraine, diabetes, hypertension, hypercholesterolemia, heart disease, sleep apnea, depression, and anxiety.

The researchers used generalized linear models adjusted for age, sex, MS subtype, MS duration, years of education, and body mass index to evaluate the association between history of migraine and MS outcomes.

Compared with patients with MS without migraine, migraineurs (n = 65) tended to be younger (mean age, 44.3 years vs. 50.4 years) and were more likely to be overweight or obese (73.9% vs. 51.6%). In addition, patients with MS and migraine were more likely to have a history of depression (46.2% vs. 24.2%), anxiety (30.8% vs. 18.8%), and severe rather than mild disability (odds ratio, 3.08; 95% confidence, 1.04-9.20). Migraine also was associated with significantly slower walking speeds (9.08% slower; 95% CI, 0.82%-18.77%). Migraine was not associated with processing speed or manual dexterity, however.

If an association between migraine history and worse MS disability is confirmed, migraine history may be a factor that neurologists could consider when making MS treatment decisions, Dr. Damian said. The researchers noted that migraine was reported by patients and not detected using a validated questionnaire. Future studies should investigate whether MS lesions on MRI differ in migraineurs and whether migraine predicts future neurologic disability in patients with MS.

Collection of the MSPT outcomes was sponsored by Biogen.

[email protected]

SOURCE: Damian AM et al. ACTRIMS Forum 2019, Abstract 78.

HOUSTON — When given after transplant, azithromycin does not increase the risk of relapse in patients with moderate to severe chronic graft-versus-host disease (cGVHD) and bronchiolitis obliterans syndrome (BOS), according to a retrospective study.

A prior study, ALLOZITHRO (JAMA. 2017 Aug 8;318[6]:557-66), showed an increased risk of relapse and death in patients who received azithromycin as BOS prophylaxis prior to hematopoietic cell transplant (HCT).

That discovery prompted the Food and Drug Administration to release a safety communication warning prescribers about the risks associated with azithromycin as BOS prophylaxis. However, it wasn’t clear if the same risks exist when azithromycin is given for cGVHD management after HCT.

To gain some insight, Mark Shamoun, MD, of the University of Michigan, Ann Arbor, and his colleagues examined data on patients with moderate to severe cGVHD and BOS who received azithromycin after undergoing HCT to treat a hematologic malignancy.

Dr. Shamoun presented the group’s findings at the Transplantation & Cellular Therapy Meetings.

The researchers reviewed data on 239 patients enrolled in the University of Michigan’s HCT database from 2010 to 2017. The median age at baseline was 55 years (range, 4-72 years).

The patients received transplants to treat acute myeloid leukemia or myelodysplastic syndromes (n = 141), acute lymphoblastic leukemia (n = 40), lymphoma (n = 26), chronic leukemia (n = 24), multiple myeloma (n = 6), and myeloproliferative neoplasms (n = 2).

The patients had matched related donors (43%) or matched unrelated donors (57%). Most patients received peripheral blood transplants (84%), though some received bone marrow (14%) or cord blood (2%). All patients had moderate (38%) or severe (62%) cGVHD.

Patients were split into two cohorts. Patients in cohort A (n = 86) had BOS and received azithromycin for more than 14 days.

Patients in cohort B (n = 153) either did not receive azithromycin or received it for 14 days or less. Fewer than 5% of patients in cohort B had BOS.

Most other baseline characteristics were similar between the cohorts. However, severe cGVHD was more prevalent in cohort A than B — 78% and 51%, respectively.

In cohort A, the median time to the start of azithromycin was 15 months after HCT (range, 3-68 months). The median duration of azithromycin treatment was 26 months (range, 1-77 months).

Results

The 2-year relapse rate was significantly lower in patients who received azithromycin than in those who did not — 4% and 17%, respectively (P = .001).

There was a significant difference in relapse rate both from the time of HCT (P = .001) and from the start of azithromycin or cGVHD (P = .011).

There was no significant difference in overall survival between the cohorts, either from the time of HCT (P = .294) or from the start of azithromycin or cGVHD (P = .428).

Dr. Shamoun said these results suggest azithromycin does not increase the risk of relapse when it is used to manage cGVHD. However, this study is limited by its retrospective nature. In addition, most patients in cohort B did not have BOS, severe cGVHD was more common in cohort A, and the incidence of relapse was not calculated from the time of azithromycin initiation in both cohorts. Therefore, additional investigation is needed.

Dr. Shamoun presented these results at Transplantation & Cellular Therapy Meetings, which is held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At the meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society, the American Society for Transplantation and Cellular Therapy (ASTCT).

Dr. Shamoun reported no conflicts of interest.

[email protected]

SOURCE: Shamoun M et al. TCT 2019, Abstract 33.

HOUSTON — When given after transplant, azithromycin does not increase the risk of relapse in patients with moderate to severe chronic graft-versus-host disease (cGVHD) and bronchiolitis obliterans syndrome (BOS), according to a retrospective study.

A prior study, ALLOZITHRO (JAMA. 2017 Aug 8;318[6]:557-66), showed an increased risk of relapse and death in patients who received azithromycin as BOS prophylaxis prior to hematopoietic cell transplant (HCT).

That discovery prompted the Food and Drug Administration to release a safety communication warning prescribers about the risks associated with azithromycin as BOS prophylaxis. However, it wasn’t clear if the same risks exist when azithromycin is given for cGVHD management after HCT.

To gain some insight, Mark Shamoun, MD, of the University of Michigan, Ann Arbor, and his colleagues examined data on patients with moderate to severe cGVHD and BOS who received azithromycin after undergoing HCT to treat a hematologic malignancy.

Dr. Shamoun presented the group’s findings at the Transplantation & Cellular Therapy Meetings.

The researchers reviewed data on 239 patients enrolled in the University of Michigan’s HCT database from 2010 to 2017. The median age at baseline was 55 years (range, 4-72 years).

The patients received transplants to treat acute myeloid leukemia or myelodysplastic syndromes (n = 141), acute lymphoblastic leukemia (n = 40), lymphoma (n = 26), chronic leukemia (n = 24), multiple myeloma (n = 6), and myeloproliferative neoplasms (n = 2).

The patients had matched related donors (43%) or matched unrelated donors (57%). Most patients received peripheral blood transplants (84%), though some received bone marrow (14%) or cord blood (2%). All patients had moderate (38%) or severe (62%) cGVHD.

Patients were split into two cohorts. Patients in cohort A (n = 86) had BOS and received azithromycin for more than 14 days.

Patients in cohort B (n = 153) either did not receive azithromycin or received it for 14 days or less. Fewer than 5% of patients in cohort B had BOS.

Most other baseline characteristics were similar between the cohorts. However, severe cGVHD was more prevalent in cohort A than B — 78% and 51%, respectively.

In cohort A, the median time to the start of azithromycin was 15 months after HCT (range, 3-68 months). The median duration of azithromycin treatment was 26 months (range, 1-77 months).

Results

The 2-year relapse rate was significantly lower in patients who received azithromycin than in those who did not — 4% and 17%, respectively (P = .001).

There was a significant difference in relapse rate both from the time of HCT (P = .001) and from the start of azithromycin or cGVHD (P = .011).

There was no significant difference in overall survival between the cohorts, either from the time of HCT (P = .294) or from the start of azithromycin or cGVHD (P = .428).

Dr. Shamoun said these results suggest azithromycin does not increase the risk of relapse when it is used to manage cGVHD. However, this study is limited by its retrospective nature. In addition, most patients in cohort B did not have BOS, severe cGVHD was more common in cohort A, and the incidence of relapse was not calculated from the time of azithromycin initiation in both cohorts. Therefore, additional investigation is needed.

Dr. Shamoun presented these results at Transplantation & Cellular Therapy Meetings, which is held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At the meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society, the American Society for Transplantation and Cellular Therapy (ASTCT).

Dr. Shamoun reported no conflicts of interest.

[email protected]

SOURCE: Shamoun M et al. TCT 2019, Abstract 33.

HOUSTON — When given after transplant, azithromycin does not increase the risk of relapse in patients with moderate to severe chronic graft-versus-host disease (cGVHD) and bronchiolitis obliterans syndrome (BOS), according to a retrospective study.

A prior study, ALLOZITHRO (JAMA. 2017 Aug 8;318[6]:557-66), showed an increased risk of relapse and death in patients who received azithromycin as BOS prophylaxis prior to hematopoietic cell transplant (HCT).

That discovery prompted the Food and Drug Administration to release a safety communication warning prescribers about the risks associated with azithromycin as BOS prophylaxis. However, it wasn’t clear if the same risks exist when azithromycin is given for cGVHD management after HCT.

To gain some insight, Mark Shamoun, MD, of the University of Michigan, Ann Arbor, and his colleagues examined data on patients with moderate to severe cGVHD and BOS who received azithromycin after undergoing HCT to treat a hematologic malignancy.

Dr. Shamoun presented the group’s findings at the Transplantation & Cellular Therapy Meetings.

The researchers reviewed data on 239 patients enrolled in the University of Michigan’s HCT database from 2010 to 2017. The median age at baseline was 55 years (range, 4-72 years).

The patients received transplants to treat acute myeloid leukemia or myelodysplastic syndromes (n = 141), acute lymphoblastic leukemia (n = 40), lymphoma (n = 26), chronic leukemia (n = 24), multiple myeloma (n = 6), and myeloproliferative neoplasms (n = 2).

The patients had matched related donors (43%) or matched unrelated donors (57%). Most patients received peripheral blood transplants (84%), though some received bone marrow (14%) or cord blood (2%). All patients had moderate (38%) or severe (62%) cGVHD.

Patients were split into two cohorts. Patients in cohort A (n = 86) had BOS and received azithromycin for more than 14 days.

Patients in cohort B (n = 153) either did not receive azithromycin or received it for 14 days or less. Fewer than 5% of patients in cohort B had BOS.

Most other baseline characteristics were similar between the cohorts. However, severe cGVHD was more prevalent in cohort A than B — 78% and 51%, respectively.

In cohort A, the median time to the start of azithromycin was 15 months after HCT (range, 3-68 months). The median duration of azithromycin treatment was 26 months (range, 1-77 months).

Results

The 2-year relapse rate was significantly lower in patients who received azithromycin than in those who did not — 4% and 17%, respectively (P = .001).

There was a significant difference in relapse rate both from the time of HCT (P = .001) and from the start of azithromycin or cGVHD (P = .011).

There was no significant difference in overall survival between the cohorts, either from the time of HCT (P = .294) or from the start of azithromycin or cGVHD (P = .428).

Dr. Shamoun said these results suggest azithromycin does not increase the risk of relapse when it is used to manage cGVHD. However, this study is limited by its retrospective nature. In addition, most patients in cohort B did not have BOS, severe cGVHD was more common in cohort A, and the incidence of relapse was not calculated from the time of azithromycin initiation in both cohorts. Therefore, additional investigation is needed.

Dr. Shamoun presented these results at Transplantation & Cellular Therapy Meetings, which is held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At the meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society, the American Society for Transplantation and Cellular Therapy (ASTCT).

Dr. Shamoun reported no conflicts of interest.

[email protected]

SOURCE: Shamoun M et al. TCT 2019, Abstract 33.

DALLAS – “Stem cell therapy is something that has been a topic of interest for neurologists for a while,” said Wijdan Rai, MD, speaking at the meeting presented by the American Committee for Treatment and Research in Multiple Sclerosis.

However, “stem cell tourism is notoriously difficult to study, because it’s not regulated; there’s no database we can access to try to figure out what exactly is going on in these clinics,” said Dr. Rai.

Dr. Rai, a neurology resident at the Ohio State University, Columbus, said that she and her colleagues had noticed patients with multiple sclerosis (MS) were asking more frequently about stem cell therapies, and mesenchymal stem cell therapy in particular.

To translate these anecdotal observations into more concrete data, Dr. Rai and her colleagues surveyed academic neurologists in the outpatient setting to see if their patients were asking them about medical tourism for stem cell therapy. Additionally, they were asked about patients who actually had sought out the therapy and if there were adverse reactions from stem cell therapy.

The 25-item questionnaire was sent to academic neurologists via an online survey tool called Synapse through the American Academy of Neurology. Dr. Rai and her colleagues found that over 90% of respondents had been asked about stem cell therapies and that 25% of respondents said their patients had some kind of complication from the treatment.

“Most commonly, it was some variation of an infection, like meningitis, encephalitis, or hepatitis C,” said Dr. Rai. Other physicians reported that their patients had spinal cord tumors, deterioration of MS, or stroke.

Dr. Rai said the survey data show that stem cell tourism is common and that patients can experience adverse events; with this evidence in hand, she hopes that a fact sheet can be developed and hosted on a website so physicians can point their patients to evidence-based information about stem cell therapies in MS.

[email protected]

DALLAS – “Stem cell therapy is something that has been a topic of interest for neurologists for a while,” said Wijdan Rai, MD, speaking at the meeting presented by the American Committee for Treatment and Research in Multiple Sclerosis.

However, “stem cell tourism is notoriously difficult to study, because it’s not regulated; there’s no database we can access to try to figure out what exactly is going on in these clinics,” said Dr. Rai.

Dr. Rai, a neurology resident at the Ohio State University, Columbus, said that she and her colleagues had noticed patients with multiple sclerosis (MS) were asking more frequently about stem cell therapies, and mesenchymal stem cell therapy in particular.

To translate these anecdotal observations into more concrete data, Dr. Rai and her colleagues surveyed academic neurologists in the outpatient setting to see if their patients were asking them about medical tourism for stem cell therapy. Additionally, they were asked about patients who actually had sought out the therapy and if there were adverse reactions from stem cell therapy.

The 25-item questionnaire was sent to academic neurologists via an online survey tool called Synapse through the American Academy of Neurology. Dr. Rai and her colleagues found that over 90% of respondents had been asked about stem cell therapies and that 25% of respondents said their patients had some kind of complication from the treatment.

“Most commonly, it was some variation of an infection, like meningitis, encephalitis, or hepatitis C,” said Dr. Rai. Other physicians reported that their patients had spinal cord tumors, deterioration of MS, or stroke.

Dr. Rai said the survey data show that stem cell tourism is common and that patients can experience adverse events; with this evidence in hand, she hopes that a fact sheet can be developed and hosted on a website so physicians can point their patients to evidence-based information about stem cell therapies in MS.

[email protected]

DALLAS – “Stem cell therapy is something that has been a topic of interest for neurologists for a while,” said Wijdan Rai, MD, speaking at the meeting presented by the American Committee for Treatment and Research in Multiple Sclerosis.

However, “stem cell tourism is notoriously difficult to study, because it’s not regulated; there’s no database we can access to try to figure out what exactly is going on in these clinics,” said Dr. Rai.

Dr. Rai, a neurology resident at the Ohio State University, Columbus, said that she and her colleagues had noticed patients with multiple sclerosis (MS) were asking more frequently about stem cell therapies, and mesenchymal stem cell therapy in particular.

To translate these anecdotal observations into more concrete data, Dr. Rai and her colleagues surveyed academic neurologists in the outpatient setting to see if their patients were asking them about medical tourism for stem cell therapy. Additionally, they were asked about patients who actually had sought out the therapy and if there were adverse reactions from stem cell therapy.

The 25-item questionnaire was sent to academic neurologists via an online survey tool called Synapse through the American Academy of Neurology. Dr. Rai and her colleagues found that over 90% of respondents had been asked about stem cell therapies and that 25% of respondents said their patients had some kind of complication from the treatment.

“Most commonly, it was some variation of an infection, like meningitis, encephalitis, or hepatitis C,” said Dr. Rai. Other physicians reported that their patients had spinal cord tumors, deterioration of MS, or stroke.

Dr. Rai said the survey data show that stem cell tourism is common and that patients can experience adverse events; with this evidence in hand, she hopes that a fact sheet can be developed and hosted on a website so physicians can point their patients to evidence-based information about stem cell therapies in MS.

[email protected]

DALLAS – A smartphone can be a valuable extension of clinician assessment in multiple sclerosis and other neurologic disorders, affording the opportunity for patients to complete some assessments at home.

Alexandra Boukhvalova, a medical student at the University of Maryland School of Medicine, Baltimore, and her collaborators developed an interactive smartphone app to assess some aspects of cognitive and motor function for patients with multiple sclerosis (MS). Their findings were reported during a poster session at the meeting held by the American Society for Prevention and Treatment in Multiple Sclerosis.

“The clinician assessment is an hour-long assessment; it requires a trained neurologist,” Ms. Boukhvalova pointed out. In thinking about how app-based assessment could augment the clinical exam, she and her collaborators realized that “a lot of the neurologic exam is still quite subjective – so is there a way that we can make that exam more objective and quantifiable and also add a little bit of ease with accessibility and mobility?

“We created a suite of test apps ... to assess different neurological systems, ranging from motor function, cognitive and visual dysfunction, general fatigue, and strength,” she said. The apps included tapping tests and balloon-popping tasks, along with measures to give some indication of spasticity by assessing the smoothness of movements.

Participants completed the testing both in the clinic and from home. “We did not need an investigator present for patients to be able to complete the tests,” said Ms. Boukhvalova.

Ms. Boukhvalova and her colleagues compared performance on the gamified tasks between patients with MS and healthy controls. For all tasks, the participants with MS could clearly be differentiated from the healthy participants.

A further plus was that “The patients almost viewed these tests as games.” They reported that they enjoyed completing them, said Ms. Boukhvalova, adding that app-based assessments also offer an additional point of connection between MS patients and specialists, whom they may only see annually or semiannually.

Further app development may focus on utilizing sensor and accelerometer functions in smartphones to perform more natural and sophisticated motor analysis to look at gait and gross motor functioning, she said.

[email protected]

DALLAS – A smartphone can be a valuable extension of clinician assessment in multiple sclerosis and other neurologic disorders, affording the opportunity for patients to complete some assessments at home.

Alexandra Boukhvalova, a medical student at the University of Maryland School of Medicine, Baltimore, and her collaborators developed an interactive smartphone app to assess some aspects of cognitive and motor function for patients with multiple sclerosis (MS). Their findings were reported during a poster session at the meeting held by the American Society for Prevention and Treatment in Multiple Sclerosis.

“The clinician assessment is an hour-long assessment; it requires a trained neurologist,” Ms. Boukhvalova pointed out. In thinking about how app-based assessment could augment the clinical exam, she and her collaborators realized that “a lot of the neurologic exam is still quite subjective – so is there a way that we can make that exam more objective and quantifiable and also add a little bit of ease with accessibility and mobility?

“We created a suite of test apps ... to assess different neurological systems, ranging from motor function, cognitive and visual dysfunction, general fatigue, and strength,” she said. The apps included tapping tests and balloon-popping tasks, along with measures to give some indication of spasticity by assessing the smoothness of movements.

Participants completed the testing both in the clinic and from home. “We did not need an investigator present for patients to be able to complete the tests,” said Ms. Boukhvalova.

Ms. Boukhvalova and her colleagues compared performance on the gamified tasks between patients with MS and healthy controls. For all tasks, the participants with MS could clearly be differentiated from the healthy participants.

A further plus was that “The patients almost viewed these tests as games.” They reported that they enjoyed completing them, said Ms. Boukhvalova, adding that app-based assessments also offer an additional point of connection between MS patients and specialists, whom they may only see annually or semiannually.

Further app development may focus on utilizing sensor and accelerometer functions in smartphones to perform more natural and sophisticated motor analysis to look at gait and gross motor functioning, she said.

[email protected]

DALLAS – A smartphone can be a valuable extension of clinician assessment in multiple sclerosis and other neurologic disorders, affording the opportunity for patients to complete some assessments at home.

Alexandra Boukhvalova, a medical student at the University of Maryland School of Medicine, Baltimore, and her collaborators developed an interactive smartphone app to assess some aspects of cognitive and motor function for patients with multiple sclerosis (MS). Their findings were reported during a poster session at the meeting held by the American Society for Prevention and Treatment in Multiple Sclerosis.

“The clinician assessment is an hour-long assessment; it requires a trained neurologist,” Ms. Boukhvalova pointed out. In thinking about how app-based assessment could augment the clinical exam, she and her collaborators realized that “a lot of the neurologic exam is still quite subjective – so is there a way that we can make that exam more objective and quantifiable and also add a little bit of ease with accessibility and mobility?

“We created a suite of test apps ... to assess different neurological systems, ranging from motor function, cognitive and visual dysfunction, general fatigue, and strength,” she said. The apps included tapping tests and balloon-popping tasks, along with measures to give some indication of spasticity by assessing the smoothness of movements.

Participants completed the testing both in the clinic and from home. “We did not need an investigator present for patients to be able to complete the tests,” said Ms. Boukhvalova.

Ms. Boukhvalova and her colleagues compared performance on the gamified tasks between patients with MS and healthy controls. For all tasks, the participants with MS could clearly be differentiated from the healthy participants.

A further plus was that “The patients almost viewed these tests as games.” They reported that they enjoyed completing them, said Ms. Boukhvalova, adding that app-based assessments also offer an additional point of connection between MS patients and specialists, whom they may only see annually or semiannually.

Further app development may focus on utilizing sensor and accelerometer functions in smartphones to perform more natural and sophisticated motor analysis to look at gait and gross motor functioning, she said.

[email protected]

LAS VEGAS – A text messaging program connected black women at risk of postnatal hypertension with the care they needed to avoid blood pressure complications, Adi Hirshberg, MD, reported at the Pregnancy Meeting.

Violet Karyn

The text messaging system increased the compliance rate to 93%, compared with just 30% of those asked to return to the office after hospital discharge. Just as importantly, it completely erased racial disparity in compliance rates, compared with white women, with more than 90% of both groups complying, said Dr. Hirshberg of the University of Pennsylvania, Philadelphia.

“Our study shows that text-based monitoring eliminated the observed racial disparity in postpregnancy hypertension care,” she said at the meeting sponsored by the Society for Maternal-Fetal Medicine. “Using texts as a standard of care would have likely led to medication initiation or adjustment for an additional 20% or more women who missed an office visit. This is an innovative way to equally engage all women in the postpregnancy period.”

Dr. Hirshberg presented a preplanned subanalysis of the Remote Surveillance of Hypertension (TextBP) trial, published last year (BMJ Qual Saf. 2018;27:871-7). The publication gave overall data; this analysis broke results down by race.

TextBP equally randomized 206 postpartum women with pregnancy-induced hypertension to the usual practice of office-based BP monitoring, or to 2 weeks of text-based surveillance using a home BP cuff. It was open to all women with pregnancy-related hypertension who delivered in the Hospital of the University of Pennsylvania. Hypertension classes included gestational hypertension, preeclampsia, chronic hypertension with superimposed preeclampsia, and HELLP syndrome before or during the delivery admission. Women were randomized to usual care or to an office-based BP check within the first postpartum week.

The texting platform was developed through Way to Health, a web-based platform within the institution, with secure technological infrastructure. A starting introductory text message was sent by the Way to Health platform to the phone number provided on day of discharge.

Patients received reminders to text message their blood pressure twice daily for 2 weeks post partum, starting on the day after discharge. If the patient reported a systolic BP of more than 160 mm Hg or diastolic more than 110 mm Hg, the clinician received an alert.

The overall results showed that significantly more women in the texting group reported their blood pressure (92% vs. 44%), compared with the controls. Almost everyone in the texting group (84%) met the established criteria for BP measurement.

Dr. Hirshberg and her colleagues wanted to zero in on black women, to discover if the text reminders could help boost their compliance. This is important for a couple of reasons, she said. For one thing, black women face a higher baseline risk of hypertensive disorders and cardiovascular disease, both in general and during and after pregnancy. Second, “for every 100 black women who require postpartum hypertension surveillance, only about a third are likely to attended an office visit after discharge,” leaving them vulnerable to potentially preventable complications of hypertension.

Even in the original analysis, return rates for postpregnancy BP checks were low in both groups and, in fact, seemed to be declining over several years. In 2012, 56% of nonblack and 33% of black women returned for their checks. By 2014, that number had declined to 34% and 20%. The numbers parallel the increasing disparity in U.S. maternal death rate between black women and nonblack women. From 1989 to 2013, the death rate for black mothers doubled, jumping from 20 to 40 deaths per 100,000 live births. During the same period, the death rate for nonblack mothers increased from about 8 to about 11 per 10,000. Dr. Hirshberg said.

In the subanalysis, the primary outcomes were the percentage of patients in whom a blood pressure was obtained in the first 10 days following discharge. In the control office visit group, about 33% of black women had a measurement, compared with 70% of nonblack women – a significant difference. Text messaging, however, completely eliminated the disparity. In the texting group, 91% of nonblack women and 93% of black women had a BP measurement.

There were no hypertension readmissions in the texting arm; there were four in the office-visit arm, three of which occurred in black women.

“This suggests that the traditional office-based follow-up may have resulted in missed opportunities to start an antihypertensive in about 10 of the 55 women who missed their office visit,” Dr. Hirshberg said, adding that “these kinds of early interventions can reduce maternal morbidity and mortality and increase overall health in all.”

She reported no relevant financial disclosures.

[email protected]

SOURCE: Hirshberg A et al. Am J Obstet Gynecol. 2019 Jan;220(1):S6, Abstract 7.

LAS VEGAS – A text messaging program connected black women at risk of postnatal hypertension with the care they needed to avoid blood pressure complications, Adi Hirshberg, MD, reported at the Pregnancy Meeting.

Violet Karyn

The text messaging system increased the compliance rate to 93%, compared with just 30% of those asked to return to the office after hospital discharge. Just as importantly, it completely erased racial disparity in compliance rates, compared with white women, with more than 90% of both groups complying, said Dr. Hirshberg of the University of Pennsylvania, Philadelphia.

“Our study shows that text-based monitoring eliminated the observed racial disparity in postpregnancy hypertension care,” she said at the meeting sponsored by the Society for Maternal-Fetal Medicine. “Using texts as a standard of care would have likely led to medication initiation or adjustment for an additional 20% or more women who missed an office visit. This is an innovative way to equally engage all women in the postpregnancy period.”

Dr. Hirshberg presented a preplanned subanalysis of the Remote Surveillance of Hypertension (TextBP) trial, published last year (BMJ Qual Saf. 2018;27:871-7). The publication gave overall data; this analysis broke results down by race.

TextBP equally randomized 206 postpartum women with pregnancy-induced hypertension to the usual practice of office-based BP monitoring, or to 2 weeks of text-based surveillance using a home BP cuff. It was open to all women with pregnancy-related hypertension who delivered in the Hospital of the University of Pennsylvania. Hypertension classes included gestational hypertension, preeclampsia, chronic hypertension with superimposed preeclampsia, and HELLP syndrome before or during the delivery admission. Women were randomized to usual care or to an office-based BP check within the first postpartum week.

The texting platform was developed through Way to Health, a web-based platform within the institution, with secure technological infrastructure. A starting introductory text message was sent by the Way to Health platform to the phone number provided on day of discharge.

Patients received reminders to text message their blood pressure twice daily for 2 weeks post partum, starting on the day after discharge. If the patient reported a systolic BP of more than 160 mm Hg or diastolic more than 110 mm Hg, the clinician received an alert.

The overall results showed that significantly more women in the texting group reported their blood pressure (92% vs. 44%), compared with the controls. Almost everyone in the texting group (84%) met the established criteria for BP measurement.

Dr. Hirshberg and her colleagues wanted to zero in on black women, to discover if the text reminders could help boost their compliance. This is important for a couple of reasons, she said. For one thing, black women face a higher baseline risk of hypertensive disorders and cardiovascular disease, both in general and during and after pregnancy. Second, “for every 100 black women who require postpartum hypertension surveillance, only about a third are likely to attended an office visit after discharge,” leaving them vulnerable to potentially preventable complications of hypertension.

Even in the original analysis, return rates for postpregnancy BP checks were low in both groups and, in fact, seemed to be declining over several years. In 2012, 56% of nonblack and 33% of black women returned for their checks. By 2014, that number had declined to 34% and 20%. The numbers parallel the increasing disparity in U.S. maternal death rate between black women and nonblack women. From 1989 to 2013, the death rate for black mothers doubled, jumping from 20 to 40 deaths per 100,000 live births. During the same period, the death rate for nonblack mothers increased from about 8 to about 11 per 10,000. Dr. Hirshberg said.

In the subanalysis, the primary outcomes were the percentage of patients in whom a blood pressure was obtained in the first 10 days following discharge. In the control office visit group, about 33% of black women had a measurement, compared with 70% of nonblack women – a significant difference. Text messaging, however, completely eliminated the disparity. In the texting group, 91% of nonblack women and 93% of black women had a BP measurement.

There were no hypertension readmissions in the texting arm; there were four in the office-visit arm, three of which occurred in black women.

“This suggests that the traditional office-based follow-up may have resulted in missed opportunities to start an antihypertensive in about 10 of the 55 women who missed their office visit,” Dr. Hirshberg said, adding that “these kinds of early interventions can reduce maternal morbidity and mortality and increase overall health in all.”

She reported no relevant financial disclosures.

[email protected]

SOURCE: Hirshberg A et al. Am J Obstet Gynecol. 2019 Jan;220(1):S6, Abstract 7.

LAS VEGAS – A text messaging program connected black women at risk of postnatal hypertension with the care they needed to avoid blood pressure complications, Adi Hirshberg, MD, reported at the Pregnancy Meeting.

Violet Karyn

The text messaging system increased the compliance rate to 93%, compared with just 30% of those asked to return to the office after hospital discharge. Just as importantly, it completely erased racial disparity in compliance rates, compared with white women, with more than 90% of both groups complying, said Dr. Hirshberg of the University of Pennsylvania, Philadelphia.

“Our study shows that text-based monitoring eliminated the observed racial disparity in postpregnancy hypertension care,” she said at the meeting sponsored by the Society for Maternal-Fetal Medicine. “Using texts as a standard of care would have likely led to medication initiation or adjustment for an additional 20% or more women who missed an office visit. This is an innovative way to equally engage all women in the postpregnancy period.”

Dr. Hirshberg presented a preplanned subanalysis of the Remote Surveillance of Hypertension (TextBP) trial, published last year (BMJ Qual Saf. 2018;27:871-7). The publication gave overall data; this analysis broke results down by race.

TextBP equally randomized 206 postpartum women with pregnancy-induced hypertension to the usual practice of office-based BP monitoring, or to 2 weeks of text-based surveillance using a home BP cuff. It was open to all women with pregnancy-related hypertension who delivered in the Hospital of the University of Pennsylvania. Hypertension classes included gestational hypertension, preeclampsia, chronic hypertension with superimposed preeclampsia, and HELLP syndrome before or during the delivery admission. Women were randomized to usual care or to an office-based BP check within the first postpartum week.

The texting platform was developed through Way to Health, a web-based platform within the institution, with secure technological infrastructure. A starting introductory text message was sent by the Way to Health platform to the phone number provided on day of discharge.

Patients received reminders to text message their blood pressure twice daily for 2 weeks post partum, starting on the day after discharge. If the patient reported a systolic BP of more than 160 mm Hg or diastolic more than 110 mm Hg, the clinician received an alert.

The overall results showed that significantly more women in the texting group reported their blood pressure (92% vs. 44%), compared with the controls. Almost everyone in the texting group (84%) met the established criteria for BP measurement.

Dr. Hirshberg and her colleagues wanted to zero in on black women, to discover if the text reminders could help boost their compliance. This is important for a couple of reasons, she said. For one thing, black women face a higher baseline risk of hypertensive disorders and cardiovascular disease, both in general and during and after pregnancy. Second, “for every 100 black women who require postpartum hypertension surveillance, only about a third are likely to attended an office visit after discharge,” leaving them vulnerable to potentially preventable complications of hypertension.

Even in the original analysis, return rates for postpregnancy BP checks were low in both groups and, in fact, seemed to be declining over several years. In 2012, 56% of nonblack and 33% of black women returned for their checks. By 2014, that number had declined to 34% and 20%. The numbers parallel the increasing disparity in U.S. maternal death rate between black women and nonblack women. From 1989 to 2013, the death rate for black mothers doubled, jumping from 20 to 40 deaths per 100,000 live births. During the same period, the death rate for nonblack mothers increased from about 8 to about 11 per 10,000. Dr. Hirshberg said.

In the subanalysis, the primary outcomes were the percentage of patients in whom a blood pressure was obtained in the first 10 days following discharge. In the control office visit group, about 33% of black women had a measurement, compared with 70% of nonblack women – a significant difference. Text messaging, however, completely eliminated the disparity. In the texting group, 91% of nonblack women and 93% of black women had a BP measurement.

There were no hypertension readmissions in the texting arm; there were four in the office-visit arm, three of which occurred in black women.

“This suggests that the traditional office-based follow-up may have resulted in missed opportunities to start an antihypertensive in about 10 of the 55 women who missed their office visit,” Dr. Hirshberg said, adding that “these kinds of early interventions can reduce maternal morbidity and mortality and increase overall health in all.”

She reported no relevant financial disclosures.

[email protected]

SOURCE: Hirshberg A et al. Am J Obstet Gynecol. 2019 Jan;220(1):S6, Abstract 7.

DALLAS – Patients with multiple sclerosis (MS) have a nearly 100% higher incidence of new treated depression, compared with matched patients without MS, according to an analysis of data from patients in the United Kingdom.

After a diagnosis of MS, the incidence of new treated depression is 229 per 10,000 person-years. In comparison, the incidence of new treated depression among matched patients without MS is 121 per 10,000 person-years, Neil Minton, MD, drug safety head at Celgene, reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

MS causes changes in the CNS that are associated with depression, but “data on rates of incident depression after MS diagnosis ... are limited,” Dr. Minton and his research colleagues said. To examine rates of treated incident depression in patients with MS after an MS diagnosis, compared with rates in a matched population of patients without MS, the researchers analyzed data from the U.K. Clinical Practice Research Datalink.

Their analysis included patients with MS who received a diagnosis of MS between 2001 and 2016, had at least 1 year of history available before the MS diagnosis, and had no history of treated depression. The researchers matched these patients with as many as 10 patients without MS by age, sex, general practice, record history length, and no history of treated depression. Treated depression was defined as a diagnosis code for depression and a prescription for an antidepressant treatment within 90 days. They used Byar’s method to estimate incidence rates and incidence rate ratios, the Kaplan-Meier method to generate cumulative incidence curves, and a log-rank test to compare the curves.

In all, 5,456 patients with MS and 45,712 matched patients without MS were included in the study. Patients’ median age was 42 years; 65% were female. Compared with patients without MS, patients with MS were more likely to have a history of untreated depression (9.6% vs. 7.5%) and to have received an antidepressant treatment for any indication before cohort entry (28.0% vs. 15.5%). Diagnoses for other psychiatric conditions were similar between the groups.

Incidence rates of treated depression were higher among women with MS, compared with men with MS – 241 versus 202 per 10,000 person-years. Compared with patients without MS, however, men with MS had a higher relative risk of treated depression (2.40 vs. 1.73).

The incidence rate ratios were similar in sensitivity analyses that excluded patients with a history of any psychiatric disorder at cohort entry and that did not require treatment to confirm a depression diagnosis.

The study was funded by a grant from Celgene.

[email protected]

SOURCE: Minton N et al. ACTRIMS Forum 2019, Abstract 82.

DALLAS – Patients with multiple sclerosis (MS) have a nearly 100% higher incidence of new treated depression, compared with matched patients without MS, according to an analysis of data from patients in the United Kingdom.

After a diagnosis of MS, the incidence of new treated depression is 229 per 10,000 person-years. In comparison, the incidence of new treated depression among matched patients without MS is 121 per 10,000 person-years, Neil Minton, MD, drug safety head at Celgene, reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

MS causes changes in the CNS that are associated with depression, but “data on rates of incident depression after MS diagnosis ... are limited,” Dr. Minton and his research colleagues said. To examine rates of treated incident depression in patients with MS after an MS diagnosis, compared with rates in a matched population of patients without MS, the researchers analyzed data from the U.K. Clinical Practice Research Datalink.

Their analysis included patients with MS who received a diagnosis of MS between 2001 and 2016, had at least 1 year of history available before the MS diagnosis, and had no history of treated depression. The researchers matched these patients with as many as 10 patients without MS by age, sex, general practice, record history length, and no history of treated depression. Treated depression was defined as a diagnosis code for depression and a prescription for an antidepressant treatment within 90 days. They used Byar’s method to estimate incidence rates and incidence rate ratios, the Kaplan-Meier method to generate cumulative incidence curves, and a log-rank test to compare the curves.

In all, 5,456 patients with MS and 45,712 matched patients without MS were included in the study. Patients’ median age was 42 years; 65% were female. Compared with patients without MS, patients with MS were more likely to have a history of untreated depression (9.6% vs. 7.5%) and to have received an antidepressant treatment for any indication before cohort entry (28.0% vs. 15.5%). Diagnoses for other psychiatric conditions were similar between the groups.

Incidence rates of treated depression were higher among women with MS, compared with men with MS – 241 versus 202 per 10,000 person-years. Compared with patients without MS, however, men with MS had a higher relative risk of treated depression (2.40 vs. 1.73).

The incidence rate ratios were similar in sensitivity analyses that excluded patients with a history of any psychiatric disorder at cohort entry and that did not require treatment to confirm a depression diagnosis.

The study was funded by a grant from Celgene.

[email protected]

SOURCE: Minton N et al. ACTRIMS Forum 2019, Abstract 82.

DALLAS – Patients with multiple sclerosis (MS) have a nearly 100% higher incidence of new treated depression, compared with matched patients without MS, according to an analysis of data from patients in the United Kingdom.

After a diagnosis of MS, the incidence of new treated depression is 229 per 10,000 person-years. In comparison, the incidence of new treated depression among matched patients without MS is 121 per 10,000 person-years, Neil Minton, MD, drug safety head at Celgene, reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

MS causes changes in the CNS that are associated with depression, but “data on rates of incident depression after MS diagnosis ... are limited,” Dr. Minton and his research colleagues said. To examine rates of treated incident depression in patients with MS after an MS diagnosis, compared with rates in a matched population of patients without MS, the researchers analyzed data from the U.K. Clinical Practice Research Datalink.

Their analysis included patients with MS who received a diagnosis of MS between 2001 and 2016, had at least 1 year of history available before the MS diagnosis, and had no history of treated depression. The researchers matched these patients with as many as 10 patients without MS by age, sex, general practice, record history length, and no history of treated depression. Treated depression was defined as a diagnosis code for depression and a prescription for an antidepressant treatment within 90 days. They used Byar’s method to estimate incidence rates and incidence rate ratios, the Kaplan-Meier method to generate cumulative incidence curves, and a log-rank test to compare the curves.

In all, 5,456 patients with MS and 45,712 matched patients without MS were included in the study. Patients’ median age was 42 years; 65% were female. Compared with patients without MS, patients with MS were more likely to have a history of untreated depression (9.6% vs. 7.5%) and to have received an antidepressant treatment for any indication before cohort entry (28.0% vs. 15.5%). Diagnoses for other psychiatric conditions were similar between the groups.

Incidence rates of treated depression were higher among women with MS, compared with men with MS – 241 versus 202 per 10,000 person-years. Compared with patients without MS, however, men with MS had a higher relative risk of treated depression (2.40 vs. 1.73).

The incidence rate ratios were similar in sensitivity analyses that excluded patients with a history of any psychiatric disorder at cohort entry and that did not require treatment to confirm a depression diagnosis.

The study was funded by a grant from Celgene.

[email protected]

SOURCE: Minton N et al. ACTRIMS Forum 2019, Abstract 82.

WASHINGTON – When repigmentation therapy fails, dermatologists may offer depigmentation therapy to patients with vitiligo, Seemal Desai, MD, said at the annual meeting of the American Academy of Dermatology.

Depigmentation therapy is “an underutilized resource for those patients who have recalcitrant disease or whose disease is so bad that you have not been able to improve their clinical, visible outcome,” said Dr. Desai, clinical assistant professor of dermatology at the University of Texas, Dallas. “Some of these patients simply desire to be one uniform color.”

Therapy is administered through medications that destroy residual melanocytes with the goal of achieving a uniform appearance of the skin. Monobenzyl ether of hydroquinone (MBEH) is the most common drug used in depigmentation therapy, according to Dr. Desai. It is available in concentrations of 20% and 40% and can be compounded in other concentrations. At first, patients should apply MBEH to a nickel-sized area of the skin (such as the forearm, the back of the hand, or the thigh) for 3 or 4 days. Treatment is administered in the morning and evening, but not at bedtime. A common side effect is irritant contact dermatitis.

When the patient is able to tolerate the medication in the first area, he or she can apply it to larger areas of the skin. Parts of the body are treated one at a time, and successful treatment takes time, he noted. Hair may become depigmented, but patients can be assured that the eyes will not.

Repigmentation has been reported after sun exposure. For all patients undergoing depigmentation therapy, dermatologists should provide extensive counseling about the need for lifelong photoprotection, said Dr. Desai. Protective measures can include wide-brimmed hats and broad-spectrum sunscreen. Paradoxical repigmentation can be treated with a stronger concentration of MBEH, liquid nitrogen therapy, microdermabrasion, and peels.

For patients with vitiligo, which results from the immune-mediated destruction of melanocytes, dermatologists should assess the patient’s psychological status and discuss “the impact that the disease has on not only the patient, but also the family,” Dr. Desai said. “The psychological trauma from this disease, especially for our patients who have rapidly progressing vitiligo or who have failed multiple therapies, is something that we cannot discount.”

Patients with vitiligo often have comorbid depression, and evening of the skin tone that depigmentation provides can benefit the patient’s mental state, he observed. Patients with severe depression related to vitiligo should be referred to a psychologist or psychiatrist. Finally, counseling and appropriate patient selection for depigmentation is of paramount importance.

During the presentation, he noted that hair dyes, resin products and adhesives, detergents, and leather preservatives have been associated with vitiligo. Dermatologic drugs such as imiquimod, chemotherapeutic agents, and interferon also may cause the condition.

He referred to the thousands of reported cases of vitiligo related to rhododenol, a phenolic compound that has been used in cosmetics and topical products. Most cases resolved when those affected stopped using the product, but some developed vitiligo vulgaris. Cosmetics containing rhododenol have been recalled in Japan since 2013, but over-the-counter products in Asia and Africa have been found to contain similar compounds, so dermatologists should ask patients about their travel history and about what products they are using for their skin, Dr. Desai advised.

He reported receiving grants and research funding from AbbVie, Dermira, Dr. Reddy’s Laboratories, and Menlo Therapeutics and serving as a consultant for several pharmaceutical companies.

[email protected]

WASHINGTON – When repigmentation therapy fails, dermatologists may offer depigmentation therapy to patients with vitiligo, Seemal Desai, MD, said at the annual meeting of the American Academy of Dermatology.

Depigmentation therapy is “an underutilized resource for those patients who have recalcitrant disease or whose disease is so bad that you have not been able to improve their clinical, visible outcome,” said Dr. Desai, clinical assistant professor of dermatology at the University of Texas, Dallas. “Some of these patients simply desire to be one uniform color.”

Therapy is administered through medications that destroy residual melanocytes with the goal of achieving a uniform appearance of the skin. Monobenzyl ether of hydroquinone (MBEH) is the most common drug used in depigmentation therapy, according to Dr. Desai. It is available in concentrations of 20% and 40% and can be compounded in other concentrations. At first, patients should apply MBEH to a nickel-sized area of the skin (such as the forearm, the back of the hand, or the thigh) for 3 or 4 days. Treatment is administered in the morning and evening, but not at bedtime. A common side effect is irritant contact dermatitis.

When the patient is able to tolerate the medication in the first area, he or she can apply it to larger areas of the skin. Parts of the body are treated one at a time, and successful treatment takes time, he noted. Hair may become depigmented, but patients can be assured that the eyes will not.

Repigmentation has been reported after sun exposure. For all patients undergoing depigmentation therapy, dermatologists should provide extensive counseling about the need for lifelong photoprotection, said Dr. Desai. Protective measures can include wide-brimmed hats and broad-spectrum sunscreen. Paradoxical repigmentation can be treated with a stronger concentration of MBEH, liquid nitrogen therapy, microdermabrasion, and peels.

For patients with vitiligo, which results from the immune-mediated destruction of melanocytes, dermatologists should assess the patient’s psychological status and discuss “the impact that the disease has on not only the patient, but also the family,” Dr. Desai said. “The psychological trauma from this disease, especially for our patients who have rapidly progressing vitiligo or who have failed multiple therapies, is something that we cannot discount.”

Patients with vitiligo often have comorbid depression, and evening of the skin tone that depigmentation provides can benefit the patient’s mental state, he observed. Patients with severe depression related to vitiligo should be referred to a psychologist or psychiatrist. Finally, counseling and appropriate patient selection for depigmentation is of paramount importance.

During the presentation, he noted that hair dyes, resin products and adhesives, detergents, and leather preservatives have been associated with vitiligo. Dermatologic drugs such as imiquimod, chemotherapeutic agents, and interferon also may cause the condition.

He referred to the thousands of reported cases of vitiligo related to rhododenol, a phenolic compound that has been used in cosmetics and topical products. Most cases resolved when those affected stopped using the product, but some developed vitiligo vulgaris. Cosmetics containing rhododenol have been recalled in Japan since 2013, but over-the-counter products in Asia and Africa have been found to contain similar compounds, so dermatologists should ask patients about their travel history and about what products they are using for their skin, Dr. Desai advised.

He reported receiving grants and research funding from AbbVie, Dermira, Dr. Reddy’s Laboratories, and Menlo Therapeutics and serving as a consultant for several pharmaceutical companies.

[email protected]

WASHINGTON – When repigmentation therapy fails, dermatologists may offer depigmentation therapy to patients with vitiligo, Seemal Desai, MD, said at the annual meeting of the American Academy of Dermatology.

Depigmentation therapy is “an underutilized resource for those patients who have recalcitrant disease or whose disease is so bad that you have not been able to improve their clinical, visible outcome,” said Dr. Desai, clinical assistant professor of dermatology at the University of Texas, Dallas. “Some of these patients simply desire to be one uniform color.”

Therapy is administered through medications that destroy residual melanocytes with the goal of achieving a uniform appearance of the skin. Monobenzyl ether of hydroquinone (MBEH) is the most common drug used in depigmentation therapy, according to Dr. Desai. It is available in concentrations of 20% and 40% and can be compounded in other concentrations. At first, patients should apply MBEH to a nickel-sized area of the skin (such as the forearm, the back of the hand, or the thigh) for 3 or 4 days. Treatment is administered in the morning and evening, but not at bedtime. A common side effect is irritant contact dermatitis.

When the patient is able to tolerate the medication in the first area, he or she can apply it to larger areas of the skin. Parts of the body are treated one at a time, and successful treatment takes time, he noted. Hair may become depigmented, but patients can be assured that the eyes will not.

Repigmentation has been reported after sun exposure. For all patients undergoing depigmentation therapy, dermatologists should provide extensive counseling about the need for lifelong photoprotection, said Dr. Desai. Protective measures can include wide-brimmed hats and broad-spectrum sunscreen. Paradoxical repigmentation can be treated with a stronger concentration of MBEH, liquid nitrogen therapy, microdermabrasion, and peels.

For patients with vitiligo, which results from the immune-mediated destruction of melanocytes, dermatologists should assess the patient’s psychological status and discuss “the impact that the disease has on not only the patient, but also the family,” Dr. Desai said. “The psychological trauma from this disease, especially for our patients who have rapidly progressing vitiligo or who have failed multiple therapies, is something that we cannot discount.”

Patients with vitiligo often have comorbid depression, and evening of the skin tone that depigmentation provides can benefit the patient’s mental state, he observed. Patients with severe depression related to vitiligo should be referred to a psychologist or psychiatrist. Finally, counseling and appropriate patient selection for depigmentation is of paramount importance.

During the presentation, he noted that hair dyes, resin products and adhesives, detergents, and leather preservatives have been associated with vitiligo. Dermatologic drugs such as imiquimod, chemotherapeutic agents, and interferon also may cause the condition.

He referred to the thousands of reported cases of vitiligo related to rhododenol, a phenolic compound that has been used in cosmetics and topical products. Most cases resolved when those affected stopped using the product, but some developed vitiligo vulgaris. Cosmetics containing rhododenol have been recalled in Japan since 2013, but over-the-counter products in Asia and Africa have been found to contain similar compounds, so dermatologists should ask patients about their travel history and about what products they are using for their skin, Dr. Desai advised.

He reported receiving grants and research funding from AbbVie, Dermira, Dr. Reddy’s Laboratories, and Menlo Therapeutics and serving as a consultant for several pharmaceutical companies.

[email protected]

DALLAS – Patients with relapsing emitting multiple sclerosis who discontinued treatment after a period of disease inactivity had a similar time to next event, compared with those who remained on treatment, results from a single-center study showed.

In addition, being over the age of 45 years was associated with a better disease course after treatment discontinuation.

“Being clinically and radiologically stable for more than 2 years can be a potential milestone to regard the discontinuation of DMT [disease-modifying therapy] as a reasonable option in a subset of patients, especially patients who are nondisabled,” lead study author Hajime Yano, MD, said in an interview at the Americas Committee for Treatment and Research in Multiple Sclerosis.

According to Dr. Yano, a research fellow at the Ann Romney Center for Neurologic Diseases and Partners Multiple Sclerosis Center in Boston, relapsing remitting multiple sclerosis (RRMS) patients without relapse for long periods on treatment may consider discontinuing DMT, but there is limited information regarding the impact of discontinuation, especially in terms of MRI activity.

In an effort to investigate the impact of DMT discontinuation on clinical and radiologic outcomes in RRMS patients, he and his colleagues identified 70 patients from the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB) study, which was initiated in 2000 and has enrolled more than 2,400 patients cared for at the Partners Multiple Sclerosis Center. Relapse date, symptoms, and Expanded Disability Status Scale (EDSS) were evaluated at 6-month intervals for each patient during the time of clinic visits by the treating neurologist. Additionally, brain MRIs were performed annually.

Next, the researchers matched the patients with 70 patients who remained on DMT identified by age, sex, treatment, treatment duration, disease duration, and EDSS. They used univariate and multivariable Cox proportional hazard models to test the differences between DMT discontinuation status with time to clinical relapse, MRI event, disability progression, and any inflammatory event (either clinical relapse or MRI event).

The mean age of patients was 45 years, 87% were female, their mean disease duration was about 13 years, and they had been receiving treatment for a mean of about 6 years. In adjusted analyses, the 70 pairs of patients who discontinued DMT and patients who continued DMT had similar outcomes in time to clinical relapse (hazard ratio, 0.93; P = .84), MRI event (HR, 1.01; P = .98), disability progression (HR, 1.33; P = .43), and any inflammatory event (HR, 0.93; P = .85). In a subgroup analysis, which compared the impact of DMT discontinuation between patients over the age of 45 years and those aged 45 years and younger, the researchers observed a statistically significant difference in effect of discontinuation on time to clinical relapse (P = .032), time to MRI event (P = .013), and time to any inflammatory event (P = .0005), all favoring patients over the age of 45 years.

“This finding makes sense since age has been reported as one of the factors that negatively impacts on the inflammatory activity in patients with RRMS,” Dr. Yano said. “However, our study is the first study [to find] that the impact of discontinuing DMT on RRMS patient prognosis may differ based on the age at the discontinuation. In short, stopping DMT at a younger age has a statistically significant higher risk on inflammatory activities, compared to [stopping DMT at an] older age.”

He acknowledged certain limitations of the study, including its small sample size and single-center design. However, Dr. Yano said that a key strength of the analysis was the inclusion of MRI activity prior to DMT as the definition of stable state, “which is an integral piece of information when physicians and patients consider DMT discontinuation in a ‘real world’ clinical setting. We also used MRI activity as an outcome measure, which is lacking in prior discontinuation studies.”

Dr. Yano reported that he has received a research grant from Yoshida Scholarship Foundation in Japan. His coauthors reported having numerous financial ties to industry.

[email protected]

SOURCE: Yano H et al. ACTRIMS Forum 2019, Poster 061.

DALLAS – Patients with relapsing emitting multiple sclerosis who discontinued treatment after a period of disease inactivity had a similar time to next event, compared with those who remained on treatment, results from a single-center study showed.

In addition, being over the age of 45 years was associated with a better disease course after treatment discontinuation.

“Being clinically and radiologically stable for more than 2 years can be a potential milestone to regard the discontinuation of DMT [disease-modifying therapy] as a reasonable option in a subset of patients, especially patients who are nondisabled,” lead study author Hajime Yano, MD, said in an interview at the Americas Committee for Treatment and Research in Multiple Sclerosis.

According to Dr. Yano, a research fellow at the Ann Romney Center for Neurologic Diseases and Partners Multiple Sclerosis Center in Boston, relapsing remitting multiple sclerosis (RRMS) patients without relapse for long periods on treatment may consider discontinuing DMT, but there is limited information regarding the impact of discontinuation, especially in terms of MRI activity.

In an effort to investigate the impact of DMT discontinuation on clinical and radiologic outcomes in RRMS patients, he and his colleagues identified 70 patients from the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB) study, which was initiated in 2000 and has enrolled more than 2,400 patients cared for at the Partners Multiple Sclerosis Center. Relapse date, symptoms, and Expanded Disability Status Scale (EDSS) were evaluated at 6-month intervals for each patient during the time of clinic visits by the treating neurologist. Additionally, brain MRIs were performed annually.

Next, the researchers matched the patients with 70 patients who remained on DMT identified by age, sex, treatment, treatment duration, disease duration, and EDSS. They used univariate and multivariable Cox proportional hazard models to test the differences between DMT discontinuation status with time to clinical relapse, MRI event, disability progression, and any inflammatory event (either clinical relapse or MRI event).

The mean age of patients was 45 years, 87% were female, their mean disease duration was about 13 years, and they had been receiving treatment for a mean of about 6 years. In adjusted analyses, the 70 pairs of patients who discontinued DMT and patients who continued DMT had similar outcomes in time to clinical relapse (hazard ratio, 0.93; P = .84), MRI event (HR, 1.01; P = .98), disability progression (HR, 1.33; P = .43), and any inflammatory event (HR, 0.93; P = .85). In a subgroup analysis, which compared the impact of DMT discontinuation between patients over the age of 45 years and those aged 45 years and younger, the researchers observed a statistically significant difference in effect of discontinuation on time to clinical relapse (P = .032), time to MRI event (P = .013), and time to any inflammatory event (P = .0005), all favoring patients over the age of 45 years.

“This finding makes sense since age has been reported as one of the factors that negatively impacts on the inflammatory activity in patients with RRMS,” Dr. Yano said. “However, our study is the first study [to find] that the impact of discontinuing DMT on RRMS patient prognosis may differ based on the age at the discontinuation. In short, stopping DMT at a younger age has a statistically significant higher risk on inflammatory activities, compared to [stopping DMT at an] older age.”

He acknowledged certain limitations of the study, including its small sample size and single-center design. However, Dr. Yano said that a key strength of the analysis was the inclusion of MRI activity prior to DMT as the definition of stable state, “which is an integral piece of information when physicians and patients consider DMT discontinuation in a ‘real world’ clinical setting. We also used MRI activity as an outcome measure, which is lacking in prior discontinuation studies.”

Dr. Yano reported that he has received a research grant from Yoshida Scholarship Foundation in Japan. His coauthors reported having numerous financial ties to industry.

[email protected]

SOURCE: Yano H et al. ACTRIMS Forum 2019, Poster 061.

DALLAS – Patients with relapsing emitting multiple sclerosis who discontinued treatment after a period of disease inactivity had a similar time to next event, compared with those who remained on treatment, results from a single-center study showed.

In addition, being over the age of 45 years was associated with a better disease course after treatment discontinuation.

“Being clinically and radiologically stable for more than 2 years can be a potential milestone to regard the discontinuation of DMT [disease-modifying therapy] as a reasonable option in a subset of patients, especially patients who are nondisabled,” lead study author Hajime Yano, MD, said in an interview at the Americas Committee for Treatment and Research in Multiple Sclerosis.

According to Dr. Yano, a research fellow at the Ann Romney Center for Neurologic Diseases and Partners Multiple Sclerosis Center in Boston, relapsing remitting multiple sclerosis (RRMS) patients without relapse for long periods on treatment may consider discontinuing DMT, but there is limited information regarding the impact of discontinuation, especially in terms of MRI activity.

In an effort to investigate the impact of DMT discontinuation on clinical and radiologic outcomes in RRMS patients, he and his colleagues identified 70 patients from the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB) study, which was initiated in 2000 and has enrolled more than 2,400 patients cared for at the Partners Multiple Sclerosis Center. Relapse date, symptoms, and Expanded Disability Status Scale (EDSS) were evaluated at 6-month intervals for each patient during the time of clinic visits by the treating neurologist. Additionally, brain MRIs were performed annually.

Next, the researchers matched the patients with 70 patients who remained on DMT identified by age, sex, treatment, treatment duration, disease duration, and EDSS. They used univariate and multivariable Cox proportional hazard models to test the differences between DMT discontinuation status with time to clinical relapse, MRI event, disability progression, and any inflammatory event (either clinical relapse or MRI event).

The mean age of patients was 45 years, 87% were female, their mean disease duration was about 13 years, and they had been receiving treatment for a mean of about 6 years. In adjusted analyses, the 70 pairs of patients who discontinued DMT and patients who continued DMT had similar outcomes in time to clinical relapse (hazard ratio, 0.93; P = .84), MRI event (HR, 1.01; P = .98), disability progression (HR, 1.33; P = .43), and any inflammatory event (HR, 0.93; P = .85). In a subgroup analysis, which compared the impact of DMT discontinuation between patients over the age of 45 years and those aged 45 years and younger, the researchers observed a statistically significant difference in effect of discontinuation on time to clinical relapse (P = .032), time to MRI event (P = .013), and time to any inflammatory event (P = .0005), all favoring patients over the age of 45 years.

“This finding makes sense since age has been reported as one of the factors that negatively impacts on the inflammatory activity in patients with RRMS,” Dr. Yano said. “However, our study is the first study [to find] that the impact of discontinuing DMT on RRMS patient prognosis may differ based on the age at the discontinuation. In short, stopping DMT at a younger age has a statistically significant higher risk on inflammatory activities, compared to [stopping DMT at an] older age.”

He acknowledged certain limitations of the study, including its small sample size and single-center design. However, Dr. Yano said that a key strength of the analysis was the inclusion of MRI activity prior to DMT as the definition of stable state, “which is an integral piece of information when physicians and patients consider DMT discontinuation in a ‘real world’ clinical setting. We also used MRI activity as an outcome measure, which is lacking in prior discontinuation studies.”

Dr. Yano reported that he has received a research grant from Yoshida Scholarship Foundation in Japan. His coauthors reported having numerous financial ties to industry.

[email protected]

SOURCE: Yano H et al. ACTRIMS Forum 2019, Poster 061.

New research suggests a gene expression signature can distinguish high-grade diffuse large B-cell lymphomas (DLBCLs) from other germinal center B-cell–like (GCB) DLBCLs.

Gio_tto/Thinkstock

Researchers identified GCB DLBCL patients with this 104-gene signature who had a “distinct mutational landscape” and inferior treatment outcomes. David W. Scott, MBChB, PhD, of the British Columbia Cancer Research Centre in Vancouver, and his colleagues described these patients in the Journal of Clinical Oncology.

The findings were published alongside a related editorial and a similar study from another group.

Dr. Scott and his colleagues began their study by analyzing data from 157 patients with de novo GCB DLBCL. Twenty-five of these patients had double- or triple-hit high-grade B-cell lymphoma with BCL2 translocations (HGBL-DH/TH-BCL2).

The researchers identified 104 genes that were the “most significantly differentially expressed between HGBL-DH/TH-BCL2 and other GCB DLBCLs” to create their double-hit gene signature (DHITsig).

The signature divided the patients into two groups — 42 patients (27%) whose tumors were positive for the DHITsig and 115 (73%) whose tumors were negative. Notably, 22 of the 25 HGBL-DH/TH-BCL2 tumors were DHITsig-positive and 3 were negative.

The DHITsig was not associated with clinical variables such as tumor volume, but it was associated with prognosis. Treatment outcomes were inferior in patients who were DHITsig-positive.

The 5-year time to progression rate was 81% in patients who were DHITsig-negative and 57% in those who were positive (P less than .001). The 5-year overall survival rate was 81% and 60%, respectively (P = .001).

The researchers observed similar results in a validation cohort of 262 patients with GCB-DLBCL who received rituximab-based therapy. The 5-year overall survival rate was 76% in patients who were DHITsig-negative and 49% in those who were positive (P less than .001).

Dr. Scott and his colleagues also evaluated the DHITsig in a second validation cohort of 162 patients with GCB DLBCL.

In analyzing data from all three cohorts, the researchers found that mutations in MYC, BCL2, CREBBP, EZH2^Y646, DDX3X, TP53, and KMT2D were more frequent in DHITsig-positive patients and mutations in TNFAIP3, KLHL6, NFKBIE, TET2, CD58, and STAT3 were more common in DHITsig-negative patients.

Additional analyses suggested the cell of origin for DHITsig-positive tumors comes from the intermediate zone or dark zone of the germinal center.

Finally, the researchers found they could use a “clinically relevant assay” to detect the DHITsig. They added a 30-gene module to the Lymph3Cx assay to create a NanoString-based assay called DLBCL90.

The team tested DLBCL90 in 171 GCB DLBCL patients. In this group, 26% of patients were DHITsig-positive, 64% were negative, and 10% were indeterminate. The prognostic significance of the signature was maintained with the assay results, according to the researchers.

Dr. Scott and his colleagues also wanted to validate the association between the DHITsig and HGBL-DH/TH-BCL2, so they tested the DLBCL90 assay in two additional groups of patients.

First, the assay was used in 88 patients who had transformed follicular lymphoma with DLBCL morphology. Eleven of the 25 DHITsig-positive tumors and 4 of the 13 DHITsig-indeterminate tumors were HGBL-DH/TH-BCL2. However, none of the 50 DHITsig-negative tumors were HGBL-DH/TH-BCL2.

The researchers then used the DLBCL90 assay on 26 HGBL tumors. Twenty-three of these were DHITsig-positive and 3 were indeterminate.

This research was supported by the Canadian Cancer Society Research Institute and other organizations. The researchers reported relationships with Seattle Genetics, Roche, Janssen, Celgene, and various other companies.

[email protected]

SOURCE: Scott DW et al. J Clin Oncol. 2019 Jan 20;37(3):190-201.
 

New research suggests a gene expression signature can distinguish high-grade diffuse large B-cell lymphomas (DLBCLs) from other germinal center B-cell–like (GCB) DLBCLs.

Gio_tto/Thinkstock

Researchers identified GCB DLBCL patients with this 104-gene signature who had a “distinct mutational landscape” and inferior treatment outcomes. David W. Scott, MBChB, PhD, of the British Columbia Cancer Research Centre in Vancouver, and his colleagues described these patients in the Journal of Clinical Oncology.

The findings were published alongside a related editorial and a similar study from another group.

Dr. Scott and his colleagues began their study by analyzing data from 157 patients with de novo GCB DLBCL. Twenty-five of these patients had double- or triple-hit high-grade B-cell lymphoma with BCL2 translocations (HGBL-DH/TH-BCL2).

The researchers identified 104 genes that were the “most significantly differentially expressed between HGBL-DH/TH-BCL2 and other GCB DLBCLs” to create their double-hit gene signature (DHITsig).

The signature divided the patients into two groups — 42 patients (27%) whose tumors were positive for the DHITsig and 115 (73%) whose tumors were negative. Notably, 22 of the 25 HGBL-DH/TH-BCL2 tumors were DHITsig-positive and 3 were negative.

The DHITsig was not associated with clinical variables such as tumor volume, but it was associated with prognosis. Treatment outcomes were inferior in patients who were DHITsig-positive.

The 5-year time to progression rate was 81% in patients who were DHITsig-negative and 57% in those who were positive (P less than .001). The 5-year overall survival rate was 81% and 60%, respectively (P = .001).

The researchers observed similar results in a validation cohort of 262 patients with GCB-DLBCL who received rituximab-based therapy. The 5-year overall survival rate was 76% in patients who were DHITsig-negative and 49% in those who were positive (P less than .001).

Dr. Scott and his colleagues also evaluated the DHITsig in a second validation cohort of 162 patients with GCB DLBCL.

In analyzing data from all three cohorts, the researchers found that mutations in MYC, BCL2, CREBBP, EZH2^Y646, DDX3X, TP53, and KMT2D were more frequent in DHITsig-positive patients and mutations in TNFAIP3, KLHL6, NFKBIE, TET2, CD58, and STAT3 were more common in DHITsig-negative patients.

Additional analyses suggested the cell of origin for DHITsig-positive tumors comes from the intermediate zone or dark zone of the germinal center.

Finally, the researchers found they could use a “clinically relevant assay” to detect the DHITsig. They added a 30-gene module to the Lymph3Cx assay to create a NanoString-based assay called DLBCL90.

The team tested DLBCL90 in 171 GCB DLBCL patients. In this group, 26% of patients were DHITsig-positive, 64% were negative, and 10% were indeterminate. The prognostic significance of the signature was maintained with the assay results, according to the researchers.

Dr. Scott and his colleagues also wanted to validate the association between the DHITsig and HGBL-DH/TH-BCL2, so they tested the DLBCL90 assay in two additional groups of patients.

First, the assay was used in 88 patients who had transformed follicular lymphoma with DLBCL morphology. Eleven of the 25 DHITsig-positive tumors and 4 of the 13 DHITsig-indeterminate tumors were HGBL-DH/TH-BCL2. However, none of the 50 DHITsig-negative tumors were HGBL-DH/TH-BCL2.

The researchers then used the DLBCL90 assay on 26 HGBL tumors. Twenty-three of these were DHITsig-positive and 3 were indeterminate.

This research was supported by the Canadian Cancer Society Research Institute and other organizations. The researchers reported relationships with Seattle Genetics, Roche, Janssen, Celgene, and various other companies.

[email protected]

SOURCE: Scott DW et al. J Clin Oncol. 2019 Jan 20;37(3):190-201.
 

New research suggests a gene expression signature can distinguish high-grade diffuse large B-cell lymphomas (DLBCLs) from other germinal center B-cell–like (GCB) DLBCLs.

Gio_tto/Thinkstock

Researchers identified GCB DLBCL patients with this 104-gene signature who had a “distinct mutational landscape” and inferior treatment outcomes. David W. Scott, MBChB, PhD, of the British Columbia Cancer Research Centre in Vancouver, and his colleagues described these patients in the Journal of Clinical Oncology.

The findings were published alongside a related editorial and a similar study from another group.

Dr. Scott and his colleagues began their study by analyzing data from 157 patients with de novo GCB DLBCL. Twenty-five of these patients had double- or triple-hit high-grade B-cell lymphoma with BCL2 translocations (HGBL-DH/TH-BCL2).

The researchers identified 104 genes that were the “most significantly differentially expressed between HGBL-DH/TH-BCL2 and other GCB DLBCLs” to create their double-hit gene signature (DHITsig).

The signature divided the patients into two groups — 42 patients (27%) whose tumors were positive for the DHITsig and 115 (73%) whose tumors were negative. Notably, 22 of the 25 HGBL-DH/TH-BCL2 tumors were DHITsig-positive and 3 were negative.

The DHITsig was not associated with clinical variables such as tumor volume, but it was associated with prognosis. Treatment outcomes were inferior in patients who were DHITsig-positive.

The 5-year time to progression rate was 81% in patients who were DHITsig-negative and 57% in those who were positive (P less than .001). The 5-year overall survival rate was 81% and 60%, respectively (P = .001).

The researchers observed similar results in a validation cohort of 262 patients with GCB-DLBCL who received rituximab-based therapy. The 5-year overall survival rate was 76% in patients who were DHITsig-negative and 49% in those who were positive (P less than .001).

Dr. Scott and his colleagues also evaluated the DHITsig in a second validation cohort of 162 patients with GCB DLBCL.

In analyzing data from all three cohorts, the researchers found that mutations in MYC, BCL2, CREBBP, EZH2^Y646, DDX3X, TP53, and KMT2D were more frequent in DHITsig-positive patients and mutations in TNFAIP3, KLHL6, NFKBIE, TET2, CD58, and STAT3 were more common in DHITsig-negative patients.

Additional analyses suggested the cell of origin for DHITsig-positive tumors comes from the intermediate zone or dark zone of the germinal center.

Finally, the researchers found they could use a “clinically relevant assay” to detect the DHITsig. They added a 30-gene module to the Lymph3Cx assay to create a NanoString-based assay called DLBCL90.

The team tested DLBCL90 in 171 GCB DLBCL patients. In this group, 26% of patients were DHITsig-positive, 64% were negative, and 10% were indeterminate. The prognostic significance of the signature was maintained with the assay results, according to the researchers.

Dr. Scott and his colleagues also wanted to validate the association between the DHITsig and HGBL-DH/TH-BCL2, so they tested the DLBCL90 assay in two additional groups of patients.

First, the assay was used in 88 patients who had transformed follicular lymphoma with DLBCL morphology. Eleven of the 25 DHITsig-positive tumors and 4 of the 13 DHITsig-indeterminate tumors were HGBL-DH/TH-BCL2. However, none of the 50 DHITsig-negative tumors were HGBL-DH/TH-BCL2.

The researchers then used the DLBCL90 assay on 26 HGBL tumors. Twenty-three of these were DHITsig-positive and 3 were indeterminate.

This research was supported by the Canadian Cancer Society Research Institute and other organizations. The researchers reported relationships with Seattle Genetics, Roche, Janssen, Celgene, and various other companies.

[email protected]

SOURCE: Scott DW et al. J Clin Oncol. 2019 Jan 20;37(3):190-201.