NATIONAL HARBOR, MARYLAND — Implementation of a standardized induction of labor protocol had no significant effect on the rates of cesarean delivery in patients with obesity, based on data from more than 5000 individuals.

Previous research has shown that the risk for cesarean delivery increases by 5% with each 1-kg/m² increase in body mass index (BMI) among nulliparous patients, said Melissa Riegel, MD, of the University of Pennsylvania, Philadelphia, in a presentation at the meeting sponsored by the Society for Maternal-Fetal Medicine. (abstract 82).

Research on the relationship between obesity and higher cesarean delivery rates “has been clouded by the inability to reduce variation in care,” Dr. Riegel said at the meeting sponsored by the Society for Maternal Fetal Medicine. Failed induction of labor (IOL) is a leading indicator for cesarean delivery, and cesarean delivery is 80% more likely in patients with obesity undergoing IOL than in normal-weight patients, Dr. Riegel said.

Possible explanations for these differences include provider factors such as variability in care management, conscious and unconscious biases, or physiologic differences in patients with obesity such as elevated hormones, differences in the labor curve, and higher doses of oxytocin and prostaglandins, Dr. Riegel said.

Dr. Riegel and colleagues hypothesized that differences in cesarean delivery rates would persist despite a standardized labor induction protocol, thereby supporting the effects of factors other than variations in care on increased cesarean delivery risk after IOL in patients with obesity.

The researchers reviewed data from two sites comparing 2-year periods before and after implementation of an IOL protocol from 2018 to 2022. The study population included nulliparous women with singleton pregnancies at term who underwent IOL with intact membranes and unfavorable cervices, and had a BMI of at least 30 kg/m² at delivery. The preimplementation group (PRE) included 2480 individuals and the postimplementation group (POST) included 2651 individuals. Patients were divided into weight classes based on BMI: 30-34.9; 35-39.9; ≥40.

The standardized protocol consisted of active labor management with cervical exams, with an amniotomy by the time of the first exam with 4 cm or greater cervical dilation, and further intervention with medication such as oxytocin or an intrauterine pressure catheter if no cervical change was noted after 2 hours.

In a multivariate analysis, the overall cesarean delivery rate was 24.9% before the protocol implementation and 26.0% in the postimplementation group. There were no differences in the risk of cesarean delivery in any obesity class from the PRE to POST period.

In addition, no significant differences appeared in the secondary outcomes of duration of labor, maternal morbidity, or neonatal morbidity, Dr. Riegel said. Nonreassuring fetal heart rate tracing was the most common reason for cesarean delivery across all obesity classes and the PRE and POST groups.

Study limitations included the use of data from only two sites, but the results were strengthened by the large sample size, said Dr. Reigel. The results indicate that reducing variation in IOL management had no significant effect on the relationship between obesity and cesarean delivery and support underlying physiologic explanations, she said.
 

Making the Case for Physiology

“By standardizing induction practices, we were able to minimize differences in care and better answer why the increased cesarean delivery rate exists in this patient population,” Dr. Riegel said in an interview. The findings were in line with the primary hypothesis that standardized induction would not affect cesarean delivery rates in patients with obesity, she said. Instead, the findings support potential physiologic differences as “the driving force behind this relationship,” she added.

Looking ahead, “There is a role for translational work to investigate the specific biological changes in patients with obesity that might contribute to an increased risk of cesarean delivery and there is also a role for investigating the effectiveness of different labor induction interventions specifically in patients with obesity,” Dr. Riegel said.
 

Different Induction Protocols Needed for Obese Patients?

“Given that severe maternal morbidity and mortality are continuing to increase in the United States, this study is critical, as we know that both cesarean delivery and obesity are driving factors in increasing maternal morbidity,” said Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, Georgia, in an interview.

However, the novel takeaway message from the current study is that patients with obesity were more likely to require cesarean delivery even with a protocol in which variation in labor induction techniques are minimized, said Dr. Platner, who was not involved in the study. “This leads to the question of [whether] we should have different standards or protocols for our patients with obesity, as well as a need for clear counseling for these patients early on in pregnancy,” she said.

As for further research, “It would be interesting to see if the risk of cesarean delivery changed based on class of obesity, and the primary drivers of cesarean delivery in this study,” Dr. Platner said. “Additionally, it would be helpful to know how much pitocin was needed for patients, based on their BMI category, to achieve successful vaginal delivery,” she noted.

The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Development. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Implementation of a standardized induction of labor protocol had no significant effect on the rates of cesarean delivery in patients with obesity, based on data from more than 5000 individuals.

Previous research has shown that the risk for cesarean delivery increases by 5% with each 1-kg/m² increase in body mass index (BMI) among nulliparous patients, said Melissa Riegel, MD, of the University of Pennsylvania, Philadelphia, in a presentation at the meeting sponsored by the Society for Maternal-Fetal Medicine. (abstract 82).

Research on the relationship between obesity and higher cesarean delivery rates “has been clouded by the inability to reduce variation in care,” Dr. Riegel said at the meeting sponsored by the Society for Maternal Fetal Medicine. Failed induction of labor (IOL) is a leading indicator for cesarean delivery, and cesarean delivery is 80% more likely in patients with obesity undergoing IOL than in normal-weight patients, Dr. Riegel said.

Possible explanations for these differences include provider factors such as variability in care management, conscious and unconscious biases, or physiologic differences in patients with obesity such as elevated hormones, differences in the labor curve, and higher doses of oxytocin and prostaglandins, Dr. Riegel said.

Dr. Riegel and colleagues hypothesized that differences in cesarean delivery rates would persist despite a standardized labor induction protocol, thereby supporting the effects of factors other than variations in care on increased cesarean delivery risk after IOL in patients with obesity.

The researchers reviewed data from two sites comparing 2-year periods before and after implementation of an IOL protocol from 2018 to 2022. The study population included nulliparous women with singleton pregnancies at term who underwent IOL with intact membranes and unfavorable cervices, and had a BMI of at least 30 kg/m² at delivery. The preimplementation group (PRE) included 2480 individuals and the postimplementation group (POST) included 2651 individuals. Patients were divided into weight classes based on BMI: 30-34.9; 35-39.9; ≥40.

The standardized protocol consisted of active labor management with cervical exams, with an amniotomy by the time of the first exam with 4 cm or greater cervical dilation, and further intervention with medication such as oxytocin or an intrauterine pressure catheter if no cervical change was noted after 2 hours.

In a multivariate analysis, the overall cesarean delivery rate was 24.9% before the protocol implementation and 26.0% in the postimplementation group. There were no differences in the risk of cesarean delivery in any obesity class from the PRE to POST period.

In addition, no significant differences appeared in the secondary outcomes of duration of labor, maternal morbidity, or neonatal morbidity, Dr. Riegel said. Nonreassuring fetal heart rate tracing was the most common reason for cesarean delivery across all obesity classes and the PRE and POST groups.

Study limitations included the use of data from only two sites, but the results were strengthened by the large sample size, said Dr. Reigel. The results indicate that reducing variation in IOL management had no significant effect on the relationship between obesity and cesarean delivery and support underlying physiologic explanations, she said.
 

Making the Case for Physiology

“By standardizing induction practices, we were able to minimize differences in care and better answer why the increased cesarean delivery rate exists in this patient population,” Dr. Riegel said in an interview. The findings were in line with the primary hypothesis that standardized induction would not affect cesarean delivery rates in patients with obesity, she said. Instead, the findings support potential physiologic differences as “the driving force behind this relationship,” she added.

Looking ahead, “There is a role for translational work to investigate the specific biological changes in patients with obesity that might contribute to an increased risk of cesarean delivery and there is also a role for investigating the effectiveness of different labor induction interventions specifically in patients with obesity,” Dr. Riegel said.
 

Different Induction Protocols Needed for Obese Patients?

“Given that severe maternal morbidity and mortality are continuing to increase in the United States, this study is critical, as we know that both cesarean delivery and obesity are driving factors in increasing maternal morbidity,” said Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, Georgia, in an interview.

However, the novel takeaway message from the current study is that patients with obesity were more likely to require cesarean delivery even with a protocol in which variation in labor induction techniques are minimized, said Dr. Platner, who was not involved in the study. “This leads to the question of [whether] we should have different standards or protocols for our patients with obesity, as well as a need for clear counseling for these patients early on in pregnancy,” she said.

As for further research, “It would be interesting to see if the risk of cesarean delivery changed based on class of obesity, and the primary drivers of cesarean delivery in this study,” Dr. Platner said. “Additionally, it would be helpful to know how much pitocin was needed for patients, based on their BMI category, to achieve successful vaginal delivery,” she noted.

The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Development. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Implementation of a standardized induction of labor protocol had no significant effect on the rates of cesarean delivery in patients with obesity, based on data from more than 5000 individuals.

Previous research has shown that the risk for cesarean delivery increases by 5% with each 1-kg/m² increase in body mass index (BMI) among nulliparous patients, said Melissa Riegel, MD, of the University of Pennsylvania, Philadelphia, in a presentation at the meeting sponsored by the Society for Maternal-Fetal Medicine. (abstract 82).

Research on the relationship between obesity and higher cesarean delivery rates “has been clouded by the inability to reduce variation in care,” Dr. Riegel said at the meeting sponsored by the Society for Maternal Fetal Medicine. Failed induction of labor (IOL) is a leading indicator for cesarean delivery, and cesarean delivery is 80% more likely in patients with obesity undergoing IOL than in normal-weight patients, Dr. Riegel said.

Possible explanations for these differences include provider factors such as variability in care management, conscious and unconscious biases, or physiologic differences in patients with obesity such as elevated hormones, differences in the labor curve, and higher doses of oxytocin and prostaglandins, Dr. Riegel said.

Dr. Riegel and colleagues hypothesized that differences in cesarean delivery rates would persist despite a standardized labor induction protocol, thereby supporting the effects of factors other than variations in care on increased cesarean delivery risk after IOL in patients with obesity.

The researchers reviewed data from two sites comparing 2-year periods before and after implementation of an IOL protocol from 2018 to 2022. The study population included nulliparous women with singleton pregnancies at term who underwent IOL with intact membranes and unfavorable cervices, and had a BMI of at least 30 kg/m² at delivery. The preimplementation group (PRE) included 2480 individuals and the postimplementation group (POST) included 2651 individuals. Patients were divided into weight classes based on BMI: 30-34.9; 35-39.9; ≥40.

The standardized protocol consisted of active labor management with cervical exams, with an amniotomy by the time of the first exam with 4 cm or greater cervical dilation, and further intervention with medication such as oxytocin or an intrauterine pressure catheter if no cervical change was noted after 2 hours.

In a multivariate analysis, the overall cesarean delivery rate was 24.9% before the protocol implementation and 26.0% in the postimplementation group. There were no differences in the risk of cesarean delivery in any obesity class from the PRE to POST period.

In addition, no significant differences appeared in the secondary outcomes of duration of labor, maternal morbidity, or neonatal morbidity, Dr. Riegel said. Nonreassuring fetal heart rate tracing was the most common reason for cesarean delivery across all obesity classes and the PRE and POST groups.

Study limitations included the use of data from only two sites, but the results were strengthened by the large sample size, said Dr. Reigel. The results indicate that reducing variation in IOL management had no significant effect on the relationship between obesity and cesarean delivery and support underlying physiologic explanations, she said.
 

Making the Case for Physiology

“By standardizing induction practices, we were able to minimize differences in care and better answer why the increased cesarean delivery rate exists in this patient population,” Dr. Riegel said in an interview. The findings were in line with the primary hypothesis that standardized induction would not affect cesarean delivery rates in patients with obesity, she said. Instead, the findings support potential physiologic differences as “the driving force behind this relationship,” she added.

Looking ahead, “There is a role for translational work to investigate the specific biological changes in patients with obesity that might contribute to an increased risk of cesarean delivery and there is also a role for investigating the effectiveness of different labor induction interventions specifically in patients with obesity,” Dr. Riegel said.
 

Different Induction Protocols Needed for Obese Patients?

“Given that severe maternal morbidity and mortality are continuing to increase in the United States, this study is critical, as we know that both cesarean delivery and obesity are driving factors in increasing maternal morbidity,” said Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, Georgia, in an interview.

However, the novel takeaway message from the current study is that patients with obesity were more likely to require cesarean delivery even with a protocol in which variation in labor induction techniques are minimized, said Dr. Platner, who was not involved in the study. “This leads to the question of [whether] we should have different standards or protocols for our patients with obesity, as well as a need for clear counseling for these patients early on in pregnancy,” she said.

As for further research, “It would be interesting to see if the risk of cesarean delivery changed based on class of obesity, and the primary drivers of cesarean delivery in this study,” Dr. Platner said. “Additionally, it would be helpful to know how much pitocin was needed for patients, based on their BMI category, to achieve successful vaginal delivery,” she noted.

The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Development. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

WEST PALM BEACH, FLORIDA — In an interim analysis of an extension study, intrathecal injection of autologous bone marrow-derived mesenchymal stem cells (MSC) has been associated with favorable effects on both symptoms and biomarkers in patients with progressive multiple sclerosis (MS), according to data presented as a late-breaker at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

After at least 1 year of follow-up in 23 patients participating in the extension analysis, “there has been favorable effects on cognitive function, neurological functional tests, quality of life, and both of two major biomarkers linked to neurodegeneration,” reported Dimitrios Karussis, MD, PhD, Chairman of the Multiple Sclerosis Center, Hadassah Hospital, Jerusalem.

Based on promising preclinical studies, the initial clinical study with MSCs was published in Brain in 2020. In that study, 48 participants were randomized to receive an intrathecal injection of MSCs, an intravenous injection of MSCs, or a sham injection. The MSCs were collected from the bone marrow of each participant and cultured.

A second injection in the active treatment groups was administered at 6 months. At this time, those initially randomized to a sham injection received either an intrathecal or an IV injection of MSCs harvested from their bone marrow.
 

No Disease Activity Seen in 60% at 1 Year

When evaluated at the end of 1 year, there was no evidence of disease activity in 58.6% of those receiving the two intrathecal injections of MSCs, 40.6% of those receiving two IV injections of MSCs, and 9.7% of those initially randomized to the sham group. The intrathecal injection of MSCs, which was well tolerated, appeared to offer greater efficacy and was associated with relative benefits on multiple additional measures, including reduced T2 lesion load, lower relapse rates, and sustained cognitive function.

Ted Bosworth/MDedge News

Forty of the patients in the initial study were enrolled in the extension. In the late-breaker presentation, Dr. Karussis provided interim results on 23, of which all had been followed for at least another additional year. These patients had been treated with one to three intrathecal injects of MSCs at intervals of 3 to 6 months.

Of further gains during the extension, Dr. Karussis described gains in cognitive function, represented by a 3-degree improvement in the Symbol Digit Modalities Test (SDMT), a median 17% improvement in the 25-foot walk test, and an improvement in quality of life, captured in domains of both physical and mental function. All of these gains were statistically significant.

The clinical responses were supported by reductions in both serum neurofilament light chain (sNfL) levels and in the glial fibrillary acid protein (GFAP), which Dr. Karussis described as important biomarkers of disease progression. For sNfL, the reduction was 33.2% (P = .001), and there was further decline observed after repeated MSC injections.

The 22% (P < .0004) reduction in GFAP, which Dr. Karussis said has not been shown before, was observed in all 23 patients. Again, there was an additional reduction with repeated MSC treatments.

The safety and tolerability remained encouraging with longer follow-up. As in the original series, there were no serious adverse events. Headache and backache, which were more common among those receiving intrathecal injections of MSC in the original study, continued to be reported in the extension, but these were time-limited.

Although Dr. Karussis emphasized that these interim results await confirmation with longer follow-up and larger studies, he suggested that the consistency of benefit with early report provides “an additional hint of possible neuroprotective and neurotrophic effects.”
 

Mechanism of MSC Benefit Incompletely Documented

In patients with progressive MS, there is an urgent need for more and better therapies. MSCs, which reside primarily in bone marrow but can be found in other tissues, have been associated with immunomodulatory as well as neuroprotective effects in experimental studies, but whether one or the other or both of these activities are responsible for the clinical benefits observed so far is unresolved.

Others evaluating MSCs in the experimental setting have shown that these “produce a variety of soluble factors with immunomodulatory, neuroprotective, and repair-promoting properties,” said Jeffrey A. Cohen, MD, who was asked to comment on the findings. Dr. Cohen is director of the experimental therapeutics program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic. He said that previous experimental work has encouraged clinical studies, including the work presented by Dr. Karussis.

While the late-breaker presentation provided data suggesting “persistent potent efficacy with good safety and tolerability,” Dr. Cohen pointed out that “the results from this group are substantially better than those reported by several other groups.” He called the difference in results “uncertain,” suggesting that more work is needed to prove that clinical benefit is reliably achieved.

“I think it is too early to tell if MSC transplantation is going to be useful. Other than [the data] reported by the Karussis group, the results have been rather disappointing,” Dr. Cohen said.

Dr. Karussis reports no potential conflicts of interest.

WEST PALM BEACH, FLORIDA — In an interim analysis of an extension study, intrathecal injection of autologous bone marrow-derived mesenchymal stem cells (MSC) has been associated with favorable effects on both symptoms and biomarkers in patients with progressive multiple sclerosis (MS), according to data presented as a late-breaker at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

After at least 1 year of follow-up in 23 patients participating in the extension analysis, “there has been favorable effects on cognitive function, neurological functional tests, quality of life, and both of two major biomarkers linked to neurodegeneration,” reported Dimitrios Karussis, MD, PhD, Chairman of the Multiple Sclerosis Center, Hadassah Hospital, Jerusalem.

Based on promising preclinical studies, the initial clinical study with MSCs was published in Brain in 2020. In that study, 48 participants were randomized to receive an intrathecal injection of MSCs, an intravenous injection of MSCs, or a sham injection. The MSCs were collected from the bone marrow of each participant and cultured.

A second injection in the active treatment groups was administered at 6 months. At this time, those initially randomized to a sham injection received either an intrathecal or an IV injection of MSCs harvested from their bone marrow.
 

No Disease Activity Seen in 60% at 1 Year

When evaluated at the end of 1 year, there was no evidence of disease activity in 58.6% of those receiving the two intrathecal injections of MSCs, 40.6% of those receiving two IV injections of MSCs, and 9.7% of those initially randomized to the sham group. The intrathecal injection of MSCs, which was well tolerated, appeared to offer greater efficacy and was associated with relative benefits on multiple additional measures, including reduced T2 lesion load, lower relapse rates, and sustained cognitive function.

Ted Bosworth/MDedge News

Forty of the patients in the initial study were enrolled in the extension. In the late-breaker presentation, Dr. Karussis provided interim results on 23, of which all had been followed for at least another additional year. These patients had been treated with one to three intrathecal injects of MSCs at intervals of 3 to 6 months.

Of further gains during the extension, Dr. Karussis described gains in cognitive function, represented by a 3-degree improvement in the Symbol Digit Modalities Test (SDMT), a median 17% improvement in the 25-foot walk test, and an improvement in quality of life, captured in domains of both physical and mental function. All of these gains were statistically significant.

The clinical responses were supported by reductions in both serum neurofilament light chain (sNfL) levels and in the glial fibrillary acid protein (GFAP), which Dr. Karussis described as important biomarkers of disease progression. For sNfL, the reduction was 33.2% (P = .001), and there was further decline observed after repeated MSC injections.

The 22% (P < .0004) reduction in GFAP, which Dr. Karussis said has not been shown before, was observed in all 23 patients. Again, there was an additional reduction with repeated MSC treatments.

The safety and tolerability remained encouraging with longer follow-up. As in the original series, there were no serious adverse events. Headache and backache, which were more common among those receiving intrathecal injections of MSC in the original study, continued to be reported in the extension, but these were time-limited.

Although Dr. Karussis emphasized that these interim results await confirmation with longer follow-up and larger studies, he suggested that the consistency of benefit with early report provides “an additional hint of possible neuroprotective and neurotrophic effects.”
 

Mechanism of MSC Benefit Incompletely Documented

In patients with progressive MS, there is an urgent need for more and better therapies. MSCs, which reside primarily in bone marrow but can be found in other tissues, have been associated with immunomodulatory as well as neuroprotective effects in experimental studies, but whether one or the other or both of these activities are responsible for the clinical benefits observed so far is unresolved.

Others evaluating MSCs in the experimental setting have shown that these “produce a variety of soluble factors with immunomodulatory, neuroprotective, and repair-promoting properties,” said Jeffrey A. Cohen, MD, who was asked to comment on the findings. Dr. Cohen is director of the experimental therapeutics program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic. He said that previous experimental work has encouraged clinical studies, including the work presented by Dr. Karussis.

While the late-breaker presentation provided data suggesting “persistent potent efficacy with good safety and tolerability,” Dr. Cohen pointed out that “the results from this group are substantially better than those reported by several other groups.” He called the difference in results “uncertain,” suggesting that more work is needed to prove that clinical benefit is reliably achieved.

“I think it is too early to tell if MSC transplantation is going to be useful. Other than [the data] reported by the Karussis group, the results have been rather disappointing,” Dr. Cohen said.

Dr. Karussis reports no potential conflicts of interest.

WEST PALM BEACH, FLORIDA — In an interim analysis of an extension study, intrathecal injection of autologous bone marrow-derived mesenchymal stem cells (MSC) has been associated with favorable effects on both symptoms and biomarkers in patients with progressive multiple sclerosis (MS), according to data presented as a late-breaker at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

After at least 1 year of follow-up in 23 patients participating in the extension analysis, “there has been favorable effects on cognitive function, neurological functional tests, quality of life, and both of two major biomarkers linked to neurodegeneration,” reported Dimitrios Karussis, MD, PhD, Chairman of the Multiple Sclerosis Center, Hadassah Hospital, Jerusalem.

Based on promising preclinical studies, the initial clinical study with MSCs was published in Brain in 2020. In that study, 48 participants were randomized to receive an intrathecal injection of MSCs, an intravenous injection of MSCs, or a sham injection. The MSCs were collected from the bone marrow of each participant and cultured.

A second injection in the active treatment groups was administered at 6 months. At this time, those initially randomized to a sham injection received either an intrathecal or an IV injection of MSCs harvested from their bone marrow.
 

No Disease Activity Seen in 60% at 1 Year

When evaluated at the end of 1 year, there was no evidence of disease activity in 58.6% of those receiving the two intrathecal injections of MSCs, 40.6% of those receiving two IV injections of MSCs, and 9.7% of those initially randomized to the sham group. The intrathecal injection of MSCs, which was well tolerated, appeared to offer greater efficacy and was associated with relative benefits on multiple additional measures, including reduced T2 lesion load, lower relapse rates, and sustained cognitive function.

Ted Bosworth/MDedge News

Forty of the patients in the initial study were enrolled in the extension. In the late-breaker presentation, Dr. Karussis provided interim results on 23, of which all had been followed for at least another additional year. These patients had been treated with one to three intrathecal injects of MSCs at intervals of 3 to 6 months.

Of further gains during the extension, Dr. Karussis described gains in cognitive function, represented by a 3-degree improvement in the Symbol Digit Modalities Test (SDMT), a median 17% improvement in the 25-foot walk test, and an improvement in quality of life, captured in domains of both physical and mental function. All of these gains were statistically significant.

The clinical responses were supported by reductions in both serum neurofilament light chain (sNfL) levels and in the glial fibrillary acid protein (GFAP), which Dr. Karussis described as important biomarkers of disease progression. For sNfL, the reduction was 33.2% (P = .001), and there was further decline observed after repeated MSC injections.

The 22% (P < .0004) reduction in GFAP, which Dr. Karussis said has not been shown before, was observed in all 23 patients. Again, there was an additional reduction with repeated MSC treatments.

The safety and tolerability remained encouraging with longer follow-up. As in the original series, there were no serious adverse events. Headache and backache, which were more common among those receiving intrathecal injections of MSC in the original study, continued to be reported in the extension, but these were time-limited.

Although Dr. Karussis emphasized that these interim results await confirmation with longer follow-up and larger studies, he suggested that the consistency of benefit with early report provides “an additional hint of possible neuroprotective and neurotrophic effects.”
 

Mechanism of MSC Benefit Incompletely Documented

In patients with progressive MS, there is an urgent need for more and better therapies. MSCs, which reside primarily in bone marrow but can be found in other tissues, have been associated with immunomodulatory as well as neuroprotective effects in experimental studies, but whether one or the other or both of these activities are responsible for the clinical benefits observed so far is unresolved.

Others evaluating MSCs in the experimental setting have shown that these “produce a variety of soluble factors with immunomodulatory, neuroprotective, and repair-promoting properties,” said Jeffrey A. Cohen, MD, who was asked to comment on the findings. Dr. Cohen is director of the experimental therapeutics program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic. He said that previous experimental work has encouraged clinical studies, including the work presented by Dr. Karussis.

While the late-breaker presentation provided data suggesting “persistent potent efficacy with good safety and tolerability,” Dr. Cohen pointed out that “the results from this group are substantially better than those reported by several other groups.” He called the difference in results “uncertain,” suggesting that more work is needed to prove that clinical benefit is reliably achieved.

“I think it is too early to tell if MSC transplantation is going to be useful. Other than [the data] reported by the Karussis group, the results have been rather disappointing,” Dr. Cohen said.

Dr. Karussis reports no potential conflicts of interest.

Key clinical point: Long-term fremanezumab treatment appears to be highly effective, safe, and well tolerated in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have experienced multiple (more than three) treatment failures and have various comorbidities.

Major finding: At 48 weeks, fremanezumab led to significant reductions in the monthly migraine days in patients with HFEM (mean change −6.4 days) and monthly headache days in patients with CM (mean change −14.5 days; both P < .001). Overall, 7.8% of patients reported mild and transient treatment-emergent adverse events, and none of the patients discontinued the treatment for any reason.

Study details: This prospective, multicenter, cohort study included 130 patients with migraine (49 with HEFM; 81 with CM) and multiple treatment failures who received fremanezumab for at least 48 weeks (≥ 12 doses).

Disclosures: This study was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente) San Raffaele and Fondazione Italiana Cefalee. Several authors declared receiving travel grants, research support, or honoraria from or having other ties with various sources. Twenty authors declared no conflicts of interest.

Source: Barbanti P, Egeo G, Proietti S, et al for the Italian Migraine Registry study group. Assessing the long-term (48-week) effectiveness, safety, and tolerability of fremanezumab in migraine in real life: Insights from the multicenter, prospective, FRIEND3 study. Neurol Ther. 2024 (Mar 7). doi: 10.1007/s40120-024-00591-z Source

Key clinical point: Long-term fremanezumab treatment appears to be highly effective, safe, and well tolerated in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have experienced multiple (more than three) treatment failures and have various comorbidities.

Major finding: At 48 weeks, fremanezumab led to significant reductions in the monthly migraine days in patients with HFEM (mean change −6.4 days) and monthly headache days in patients with CM (mean change −14.5 days; both P < .001). Overall, 7.8% of patients reported mild and transient treatment-emergent adverse events, and none of the patients discontinued the treatment for any reason.

Study details: This prospective, multicenter, cohort study included 130 patients with migraine (49 with HEFM; 81 with CM) and multiple treatment failures who received fremanezumab for at least 48 weeks (≥ 12 doses).

Disclosures: This study was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente) San Raffaele and Fondazione Italiana Cefalee. Several authors declared receiving travel grants, research support, or honoraria from or having other ties with various sources. Twenty authors declared no conflicts of interest.

Source: Barbanti P, Egeo G, Proietti S, et al for the Italian Migraine Registry study group. Assessing the long-term (48-week) effectiveness, safety, and tolerability of fremanezumab in migraine in real life: Insights from the multicenter, prospective, FRIEND3 study. Neurol Ther. 2024 (Mar 7). doi: 10.1007/s40120-024-00591-z Source

Key clinical point: Long-term fremanezumab treatment appears to be highly effective, safe, and well tolerated in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have experienced multiple (more than three) treatment failures and have various comorbidities.

Major finding: At 48 weeks, fremanezumab led to significant reductions in the monthly migraine days in patients with HFEM (mean change −6.4 days) and monthly headache days in patients with CM (mean change −14.5 days; both P < .001). Overall, 7.8% of patients reported mild and transient treatment-emergent adverse events, and none of the patients discontinued the treatment for any reason.

Study details: This prospective, multicenter, cohort study included 130 patients with migraine (49 with HEFM; 81 with CM) and multiple treatment failures who received fremanezumab for at least 48 weeks (≥ 12 doses).

Disclosures: This study was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente) San Raffaele and Fondazione Italiana Cefalee. Several authors declared receiving travel grants, research support, or honoraria from or having other ties with various sources. Twenty authors declared no conflicts of interest.

Source: Barbanti P, Egeo G, Proietti S, et al for the Italian Migraine Registry study group. Assessing the long-term (48-week) effectiveness, safety, and tolerability of fremanezumab in migraine in real life: Insights from the multicenter, prospective, FRIEND3 study. Neurol Ther. 2024 (Mar 7). doi: 10.1007/s40120-024-00591-z Source

Key clinical point: Untreated women with endometriosis and concomitant migraine (EM-MO) experienced more severe symptoms and frequent painful days than those with endometriosis alone (EM-O) or migraine alone (MG-O).

Major finding: The prevalence of severe adenomyosis (14% vs 4%; P = .027) and posterior (48% vs 30%; P = .031) and anterior (10% vs 2%; P = .029) deep infiltrating endometriosis was higher in women with EM-MO vs EM-O. Women with EM-MO vs MG-O had significantly higher pain intensity (visual analogue scale scores 8.44 vs 7.74; P = .004), monthly migraine days (6.68 vs 5.44 days; P = .042), and Headache Impact Test-6 scores (62.33 vs 57.38; P = .010).

Study details: This prospective case-control study included 50 women with EM-MO and matched control patients with EM-O (n = 100) and MG-O (n = 100) who underwent pelvic and neurologic examination.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Selntigia A, Exacoustos C, Ortoleva C, et al. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 (Mar 4). doi: 10.1177/03331024241235 Source

Key clinical point: Untreated women with endometriosis and concomitant migraine (EM-MO) experienced more severe symptoms and frequent painful days than those with endometriosis alone (EM-O) or migraine alone (MG-O).

Major finding: The prevalence of severe adenomyosis (14% vs 4%; P = .027) and posterior (48% vs 30%; P = .031) and anterior (10% vs 2%; P = .029) deep infiltrating endometriosis was higher in women with EM-MO vs EM-O. Women with EM-MO vs MG-O had significantly higher pain intensity (visual analogue scale scores 8.44 vs 7.74; P = .004), monthly migraine days (6.68 vs 5.44 days; P = .042), and Headache Impact Test-6 scores (62.33 vs 57.38; P = .010).

Study details: This prospective case-control study included 50 women with EM-MO and matched control patients with EM-O (n = 100) and MG-O (n = 100) who underwent pelvic and neurologic examination.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Selntigia A, Exacoustos C, Ortoleva C, et al. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 (Mar 4). doi: 10.1177/03331024241235 Source

Key clinical point: Untreated women with endometriosis and concomitant migraine (EM-MO) experienced more severe symptoms and frequent painful days than those with endometriosis alone (EM-O) or migraine alone (MG-O).

Major finding: The prevalence of severe adenomyosis (14% vs 4%; P = .027) and posterior (48% vs 30%; P = .031) and anterior (10% vs 2%; P = .029) deep infiltrating endometriosis was higher in women with EM-MO vs EM-O. Women with EM-MO vs MG-O had significantly higher pain intensity (visual analogue scale scores 8.44 vs 7.74; P = .004), monthly migraine days (6.68 vs 5.44 days; P = .042), and Headache Impact Test-6 scores (62.33 vs 57.38; P = .010).

Study details: This prospective case-control study included 50 women with EM-MO and matched control patients with EM-O (n = 100) and MG-O (n = 100) who underwent pelvic and neurologic examination.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Selntigia A, Exacoustos C, Ortoleva C, et al. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 (Mar 4). doi: 10.1177/03331024241235 Source

Key clinical point: Migraine is more prevalent among patients with inflammatory bowel disease (IBD), especially women, suggesting an influence of sex-related factors.

Major finding: The prevalence of migraine was significantly higher in patients with IBD (20.8%; P < .0001) than in the general population (12.6%; P < .0001), and this association was statistically significant in women (29.8%; P < .0001) but not in men (9.6%; P = .30). However, there were no significant differences in migraine prevalence between patients with ulcerative colitis and those with Crohn’s disease (P = .88).

Study details: This cross-sectional study included 283 patients age 18-65 years with IBD, of whom 20.85% had definite (11.66%) or probable (9.18%) migraine based on their response to the ID-Migraine questionnaire.

Disclosures: This study was funded by the Instituto de Salud Carlos III, Spain, and  Fondos Europeos de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Pascual-Mato M, Gárate G, de Prado-Tejerina C, et al. Increased prevalence of migraine in women with inflammatory bowel disease: A cross-sectional study. Cephalalgia. 2024 (Mar 1). doi: 10.1177/03331024241233979 Source

Key clinical point: Migraine is more prevalent among patients with inflammatory bowel disease (IBD), especially women, suggesting an influence of sex-related factors.

Major finding: The prevalence of migraine was significantly higher in patients with IBD (20.8%; P < .0001) than in the general population (12.6%; P < .0001), and this association was statistically significant in women (29.8%; P < .0001) but not in men (9.6%; P = .30). However, there were no significant differences in migraine prevalence between patients with ulcerative colitis and those with Crohn’s disease (P = .88).

Study details: This cross-sectional study included 283 patients age 18-65 years with IBD, of whom 20.85% had definite (11.66%) or probable (9.18%) migraine based on their response to the ID-Migraine questionnaire.

Disclosures: This study was funded by the Instituto de Salud Carlos III, Spain, and  Fondos Europeos de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Pascual-Mato M, Gárate G, de Prado-Tejerina C, et al. Increased prevalence of migraine in women with inflammatory bowel disease: A cross-sectional study. Cephalalgia. 2024 (Mar 1). doi: 10.1177/03331024241233979 Source

Key clinical point: Migraine is more prevalent among patients with inflammatory bowel disease (IBD), especially women, suggesting an influence of sex-related factors.

Major finding: The prevalence of migraine was significantly higher in patients with IBD (20.8%; P < .0001) than in the general population (12.6%; P < .0001), and this association was statistically significant in women (29.8%; P < .0001) but not in men (9.6%; P = .30). However, there were no significant differences in migraine prevalence between patients with ulcerative colitis and those with Crohn’s disease (P = .88).

Study details: This cross-sectional study included 283 patients age 18-65 years with IBD, of whom 20.85% had definite (11.66%) or probable (9.18%) migraine based on their response to the ID-Migraine questionnaire.

Disclosures: This study was funded by the Instituto de Salud Carlos III, Spain, and  Fondos Europeos de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Pascual-Mato M, Gárate G, de Prado-Tejerina C, et al. Increased prevalence of migraine in women with inflammatory bowel disease: A cross-sectional study. Cephalalgia. 2024 (Mar 1). doi: 10.1177/03331024241233979 Source

Key clinical point: Patients with migraine experiencing typically left-sided headache during attacks had a higher burden of headache frequency and severity than those experiencing typically right-sided headache.

Major finding: Patients with left-sided vs right-sided migraine had 3.5 (95% CI 0.6-6.4) fewer headache-free days and 3.3 (95% CI 1.3-5.4) more severe headache days per 4 weeks. There were no other significant differences in migraine characteristics or psychiatric comorbidities between patients with left- and right-sided migraine.

Study details: This cross-sectional study included 340 patients with migraine, of whom 166 (48.8%) and 174 (51.2%) had left- and right-sided migraines, respectively.

Disclosures: The study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Sprouse Blum AS, DaSilva LA, Greenberg MD, et al. Comparison of migraine with left- versus right-sided headache: A cross-sectional study. Headache. 2024 (Mar 3). doi: 10.1111/head.14689 Source

Key clinical point: Patients with migraine experiencing typically left-sided headache during attacks had a higher burden of headache frequency and severity than those experiencing typically right-sided headache.

Major finding: Patients with left-sided vs right-sided migraine had 3.5 (95% CI 0.6-6.4) fewer headache-free days and 3.3 (95% CI 1.3-5.4) more severe headache days per 4 weeks. There were no other significant differences in migraine characteristics or psychiatric comorbidities between patients with left- and right-sided migraine.

Study details: This cross-sectional study included 340 patients with migraine, of whom 166 (48.8%) and 174 (51.2%) had left- and right-sided migraines, respectively.

Disclosures: The study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Sprouse Blum AS, DaSilva LA, Greenberg MD, et al. Comparison of migraine with left- versus right-sided headache: A cross-sectional study. Headache. 2024 (Mar 3). doi: 10.1111/head.14689 Source

Key clinical point: Patients with migraine experiencing typically left-sided headache during attacks had a higher burden of headache frequency and severity than those experiencing typically right-sided headache.

Major finding: Patients with left-sided vs right-sided migraine had 3.5 (95% CI 0.6-6.4) fewer headache-free days and 3.3 (95% CI 1.3-5.4) more severe headache days per 4 weeks. There were no other significant differences in migraine characteristics or psychiatric comorbidities between patients with left- and right-sided migraine.

Study details: This cross-sectional study included 340 patients with migraine, of whom 166 (48.8%) and 174 (51.2%) had left- and right-sided migraines, respectively.

Disclosures: The study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Sprouse Blum AS, DaSilva LA, Greenberg MD, et al. Comparison of migraine with left- versus right-sided headache: A cross-sectional study. Headache. 2024 (Mar 3). doi: 10.1111/head.14689 Source

Key clinical point: Nearly a quarter of patients with migraine who initiated erenumab experienced worsening blood pressure (BP), especially those with atrial fibrillation, highlighting the need for routine BP monitoring among these patients.

Major finding: Among patients with migraine receiving erenumab, 23.3% had worsening BP and 3.9% had an improvement in BP, with the risk of worsening BP being significantly higher among those with atrial fibrillation (adjusted odds ratio 4.72; P = .040). However, worsening BP was not associated with preexisting hypertension, sex, body mass index, and age.

Study details: This single-center observational retrospective cohort study included patients with migraine with (n = 70) and without (n = 265) preexisting hypertension who were treated with erenumab.

Disclosures: This study did not disclose the funding source. Dr David Dodick declared receiving research support, honoraria, and payment or honoraria for lectures from; serving on advisory boards or as a consultant for; and holding stock or stock options in various sources.

Source: Chhabra N, Mead-Harvey C, Dodoo CA, et al. Blood pressure elevation in erenumab-treated patients with migraine: A retrospective real-world experience. Headache. 2024 (Feb 27). doi: 10.1111/head.14679 Source

Key clinical point: Nearly a quarter of patients with migraine who initiated erenumab experienced worsening blood pressure (BP), especially those with atrial fibrillation, highlighting the need for routine BP monitoring among these patients.

Major finding: Among patients with migraine receiving erenumab, 23.3% had worsening BP and 3.9% had an improvement in BP, with the risk of worsening BP being significantly higher among those with atrial fibrillation (adjusted odds ratio 4.72; P = .040). However, worsening BP was not associated with preexisting hypertension, sex, body mass index, and age.

Study details: This single-center observational retrospective cohort study included patients with migraine with (n = 70) and without (n = 265) preexisting hypertension who were treated with erenumab.

Disclosures: This study did not disclose the funding source. Dr David Dodick declared receiving research support, honoraria, and payment or honoraria for lectures from; serving on advisory boards or as a consultant for; and holding stock or stock options in various sources.

Source: Chhabra N, Mead-Harvey C, Dodoo CA, et al. Blood pressure elevation in erenumab-treated patients with migraine: A retrospective real-world experience. Headache. 2024 (Feb 27). doi: 10.1111/head.14679 Source

Key clinical point: Nearly a quarter of patients with migraine who initiated erenumab experienced worsening blood pressure (BP), especially those with atrial fibrillation, highlighting the need for routine BP monitoring among these patients.

Major finding: Among patients with migraine receiving erenumab, 23.3% had worsening BP and 3.9% had an improvement in BP, with the risk of worsening BP being significantly higher among those with atrial fibrillation (adjusted odds ratio 4.72; P = .040). However, worsening BP was not associated with preexisting hypertension, sex, body mass index, and age.

Study details: This single-center observational retrospective cohort study included patients with migraine with (n = 70) and without (n = 265) preexisting hypertension who were treated with erenumab.

Disclosures: This study did not disclose the funding source. Dr David Dodick declared receiving research support, honoraria, and payment or honoraria for lectures from; serving on advisory boards or as a consultant for; and holding stock or stock options in various sources.

Source: Chhabra N, Mead-Harvey C, Dodoo CA, et al. Blood pressure elevation in erenumab-treated patients with migraine: A retrospective real-world experience. Headache. 2024 (Feb 27). doi: 10.1111/head.14679 Source

Key clinical point: Atogepant led to greater improvements in efficacy and quality of life than rimegepant in patients with episodic migraine (EM), although both treatments had comparable safety profiles.

Major finding: Atogepant vs rimegepant led to significantly greater reductions in mean monthly migraine days (mean difference [MD] −1.65; P < .001) and acute medication use days (MD −2.08; P < .0001) across 1-12 weeks and significantly greater improvements in Migraine-Specific Quality of Life questionnaire version 2.1 Role Function-Restrictive domain scores at 12 weeks (MD 7.36; P < .01). Both treatments had comparable safety or tolerability profiles.

Study details: This anchored matching-adjusted indirect comparison analysis compared the efficacy and safety or tolerability of once-daily atogepant (60 mg) and once-every-other-day rimegepant (75 mg) for EM prevention using data from two phase 3 trials for atogepant (ADVANCE and PROGRESS) and one phase 2/3 trial for rimegepant.

Disclosures: This study was funded by AbbVie. Four authors declared being employees of or holding stocks in AbbVie at the time of the study. Two authors are employees of Luminity, which was paid by AbbVie for the statistical analyses in this study. The other authors declared ties with various sources, including AbbVie. One author is an associate editor of Cephalalgia.

Source: Tassorelli C, Onishchenko K, Halker Singh RB, et al. Comparative efficacy, quality of life, safety, and tolerability of atogepant and rimegepant in migraine prevention: A matching-adjusted indirect comparison analysis. Cephalalgia. 2024 (Feb 27). doi: 10.1177/03331024241235156 Source

Key clinical point: Atogepant led to greater improvements in efficacy and quality of life than rimegepant in patients with episodic migraine (EM), although both treatments had comparable safety profiles.

Major finding: Atogepant vs rimegepant led to significantly greater reductions in mean monthly migraine days (mean difference [MD] −1.65; P < .001) and acute medication use days (MD −2.08; P < .0001) across 1-12 weeks and significantly greater improvements in Migraine-Specific Quality of Life questionnaire version 2.1 Role Function-Restrictive domain scores at 12 weeks (MD 7.36; P < .01). Both treatments had comparable safety or tolerability profiles.

Study details: This anchored matching-adjusted indirect comparison analysis compared the efficacy and safety or tolerability of once-daily atogepant (60 mg) and once-every-other-day rimegepant (75 mg) for EM prevention using data from two phase 3 trials for atogepant (ADVANCE and PROGRESS) and one phase 2/3 trial for rimegepant.

Disclosures: This study was funded by AbbVie. Four authors declared being employees of or holding stocks in AbbVie at the time of the study. Two authors are employees of Luminity, which was paid by AbbVie for the statistical analyses in this study. The other authors declared ties with various sources, including AbbVie. One author is an associate editor of Cephalalgia.

Source: Tassorelli C, Onishchenko K, Halker Singh RB, et al. Comparative efficacy, quality of life, safety, and tolerability of atogepant and rimegepant in migraine prevention: A matching-adjusted indirect comparison analysis. Cephalalgia. 2024 (Feb 27). doi: 10.1177/03331024241235156 Source

Key clinical point: Atogepant led to greater improvements in efficacy and quality of life than rimegepant in patients with episodic migraine (EM), although both treatments had comparable safety profiles.

Major finding: Atogepant vs rimegepant led to significantly greater reductions in mean monthly migraine days (mean difference [MD] −1.65; P < .001) and acute medication use days (MD −2.08; P < .0001) across 1-12 weeks and significantly greater improvements in Migraine-Specific Quality of Life questionnaire version 2.1 Role Function-Restrictive domain scores at 12 weeks (MD 7.36; P < .01). Both treatments had comparable safety or tolerability profiles.

Study details: This anchored matching-adjusted indirect comparison analysis compared the efficacy and safety or tolerability of once-daily atogepant (60 mg) and once-every-other-day rimegepant (75 mg) for EM prevention using data from two phase 3 trials for atogepant (ADVANCE and PROGRESS) and one phase 2/3 trial for rimegepant.

Disclosures: This study was funded by AbbVie. Four authors declared being employees of or holding stocks in AbbVie at the time of the study. Two authors are employees of Luminity, which was paid by AbbVie for the statistical analyses in this study. The other authors declared ties with various sources, including AbbVie. One author is an associate editor of Cephalalgia.

Source: Tassorelli C, Onishchenko K, Halker Singh RB, et al. Comparative efficacy, quality of life, safety, and tolerability of atogepant and rimegepant in migraine prevention: A matching-adjusted indirect comparison analysis. Cephalalgia. 2024 (Feb 27). doi: 10.1177/03331024241235156 Source

Key clinical point: OnabotulinumtoxinA (BoNTA) had beneficial effects in reducing frequency or severity of interictal burden and cutaneous allodynia in patients with chronic migraine (CM).

Major finding: After three courses of BoNTA treatment, median Migraine Interictal Burden Scale-4 scores significantly reduced from 9 at baseline to 2 (z −7.222), median Allodynia Symptom Checklist-12 scores significantly reduced from 6 at baseline to 1 (z −5.393), and median pain intensity numerical rating scale scores for hair brushing significantly reduced from 5 at baseline to 1 (z −5.398; all P < .001).

Study details: This prospective open-label study included 70 BoNTA-naive patients with CM who received three consecutive cycles of BoNTA.

Disclosures: This study did not receive any funding. Several authors declared receiving investigator fees or travel grants from or serving as advisory board members or consultants for various sources.

Source: Argyriou AA, Dermitzakis EV, Rikos D, et al. Effects of onabotulinumtoxinA on allodynia and interictal burden of patients with chronic migraine. Toxins (Basel). 2024;16(2):106 (Feb 15). doi: 10.3390/toxins16020106 Source

Key clinical point: OnabotulinumtoxinA (BoNTA) had beneficial effects in reducing frequency or severity of interictal burden and cutaneous allodynia in patients with chronic migraine (CM).

Major finding: After three courses of BoNTA treatment, median Migraine Interictal Burden Scale-4 scores significantly reduced from 9 at baseline to 2 (z −7.222), median Allodynia Symptom Checklist-12 scores significantly reduced from 6 at baseline to 1 (z −5.393), and median pain intensity numerical rating scale scores for hair brushing significantly reduced from 5 at baseline to 1 (z −5.398; all P < .001).

Study details: This prospective open-label study included 70 BoNTA-naive patients with CM who received three consecutive cycles of BoNTA.

Disclosures: This study did not receive any funding. Several authors declared receiving investigator fees or travel grants from or serving as advisory board members or consultants for various sources.

Source: Argyriou AA, Dermitzakis EV, Rikos D, et al. Effects of onabotulinumtoxinA on allodynia and interictal burden of patients with chronic migraine. Toxins (Basel). 2024;16(2):106 (Feb 15). doi: 10.3390/toxins16020106 Source

Key clinical point: OnabotulinumtoxinA (BoNTA) had beneficial effects in reducing frequency or severity of interictal burden and cutaneous allodynia in patients with chronic migraine (CM).

Major finding: After three courses of BoNTA treatment, median Migraine Interictal Burden Scale-4 scores significantly reduced from 9 at baseline to 2 (z −7.222), median Allodynia Symptom Checklist-12 scores significantly reduced from 6 at baseline to 1 (z −5.393), and median pain intensity numerical rating scale scores for hair brushing significantly reduced from 5 at baseline to 1 (z −5.398; all P < .001).

Study details: This prospective open-label study included 70 BoNTA-naive patients with CM who received three consecutive cycles of BoNTA.

Disclosures: This study did not receive any funding. Several authors declared receiving investigator fees or travel grants from or serving as advisory board members or consultants for various sources.

Source: Argyriou AA, Dermitzakis EV, Rikos D, et al. Effects of onabotulinumtoxinA on allodynia and interictal burden of patients with chronic migraine. Toxins (Basel). 2024;16(2):106 (Feb 15). doi: 10.3390/toxins16020106 Source

Key clinical point: Atogepant (dosage 60 mg/day) may be an effective and safe treatment option in patients with difficult to treat episodic migraine who have previously failed 2-4 conventional oral preventive treatments.

Major finding: Patients receiving atogepant vs placebo had a significantly greater reduction in monthly migraine days across 12 weeks (adjusted least squares mean difference −2.4 days; P < .0001). Constipation was the most common treatment-emergent adverse event (TEAE) in the atogepant group (10%), with TEAE leading to treatment discontinuation in only 2% vs 1% of patients receiving atogepant vs placebo.

Study details: Findings are from the phase 3b ELEVATE trial including 315 patients with episodic migraine who had previously failed 2-4 classes of conventional oral migraine prevention treatments and were randomly assigned to receive 60 mg/day atogepant or placebo.

Disclosures: This study was funded by AbbVie. Five authors declared being employees of or holding stocks in AbbVie. The other authors declared ties with various sources, including AbbVie.

Source: Tassorelli C, Nagy K, Pozo-Rosich P, et al. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): A randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 (Feb 13). doi: 10.1016/S1474-4422(24)00025-5 Source

Key clinical point: Atogepant (dosage 60 mg/day) may be an effective and safe treatment option in patients with difficult to treat episodic migraine who have previously failed 2-4 conventional oral preventive treatments.

Major finding: Patients receiving atogepant vs placebo had a significantly greater reduction in monthly migraine days across 12 weeks (adjusted least squares mean difference −2.4 days; P < .0001). Constipation was the most common treatment-emergent adverse event (TEAE) in the atogepant group (10%), with TEAE leading to treatment discontinuation in only 2% vs 1% of patients receiving atogepant vs placebo.

Study details: Findings are from the phase 3b ELEVATE trial including 315 patients with episodic migraine who had previously failed 2-4 classes of conventional oral migraine prevention treatments and were randomly assigned to receive 60 mg/day atogepant or placebo.

Disclosures: This study was funded by AbbVie. Five authors declared being employees of or holding stocks in AbbVie. The other authors declared ties with various sources, including AbbVie.

Source: Tassorelli C, Nagy K, Pozo-Rosich P, et al. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): A randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 (Feb 13). doi: 10.1016/S1474-4422(24)00025-5 Source

Key clinical point: Atogepant (dosage 60 mg/day) may be an effective and safe treatment option in patients with difficult to treat episodic migraine who have previously failed 2-4 conventional oral preventive treatments.

Major finding: Patients receiving atogepant vs placebo had a significantly greater reduction in monthly migraine days across 12 weeks (adjusted least squares mean difference −2.4 days; P < .0001). Constipation was the most common treatment-emergent adverse event (TEAE) in the atogepant group (10%), with TEAE leading to treatment discontinuation in only 2% vs 1% of patients receiving atogepant vs placebo.

Study details: Findings are from the phase 3b ELEVATE trial including 315 patients with episodic migraine who had previously failed 2-4 classes of conventional oral migraine prevention treatments and were randomly assigned to receive 60 mg/day atogepant or placebo.

Disclosures: This study was funded by AbbVie. Five authors declared being employees of or holding stocks in AbbVie. The other authors declared ties with various sources, including AbbVie.

Source: Tassorelli C, Nagy K, Pozo-Rosich P, et al. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): A randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 (Feb 13). doi: 10.1016/S1474-4422(24)00025-5 Source