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Clinical Edge Journal Scan Commentary: Migraine June 2022
Many of our patients with refractory migraine do not respond to first-line acute or preventive treatments, and, almost by definition, first- and second-line treatments have failed in the majority of patients on calcitonin gene-related peptide (CGRP) antagonist medications. Three studies this month highlight the efficacy of CGRP monoclonal antibody (mAb) and small-molecule medications in this population specifically.
After an initial first dose of a CGRP mAb treatment, many patients ask whether a suboptimal response necessitates switching to another agent or whether a second (or third) dose should be given first. Eptinezumab is an intravenously administered mAb that is repeated every 12 weeks. Schim and colleagues present post hoc data for patients who initially had a minimally beneficial response to eptinezumab and received a second dose at week 13.
The authors define a suboptimal response as having less then a 50% decrease in monthly migraine days after 12 weeks. There were two pooled samples of patients — those who received 100 mg eptinezumab and those who received a 300 mg dose. Approximately 45% of patients in the pivotal trials of eptinezumab (PROMISE-1 and -2) were considered suboptimal responders, and 33%-37% of those suboptimal responders had a more than 50% decrease of their monthly migraine days after a second dose (week 24).
Further analysis determined predictive factors that favored a second dose response. The most prominent (and arguably most obvious) predictive factor was a favorable response after the first dose; the greater percent change in monthly migraine days after the first dose was proportional to the response after the second dose. Change in the Headache Impact Test (HIT-6) disability score after the first dose was also seen to be a strong predictive factor for improvement after the second dose.
When we discuss continuation of medications with our patients, especially when they have a suboptimal response, we should first keep in mind the degree of improvement that the patient initially had. There can be benefit from further treatment with the same medication; however, if the response truly was minimal, it may be better to consider another treatment option.
Practically every patient taking a preventive medication is taking at least one acute medication as well. Even the best preventive medication is not a guarantee that further exacerbations will not occur, and our patients will still need some acute treatment option even when their preventive medications are very effective. The study by Ambrosini and colleagues specifically shows how effective a preventive medication can be, specifically in allowing the patient to use fewer acute medications over time in a population of patients who have been resistant to two to four treatments.
Galcanezumab is a once-monthly mAb for the prevention of migraine. The authors of this study compared the acute use of medications for migraine in both the randomized and open-label stages of a study assessing treatment-refractory patients. A total of 462 patients were enrolled who were all resistant to two to four standard-of-care migraine-preventive medications that had been stopped either because of lack of efficacy or tolerance. The double-blind stage lasted 3 months; the open-label stage lasted another 3 months.
The treatment group was seen to use significantly fewer acute medications after just the first month and continued to improve through month 3. In the open-label phase, a similar improvement was noted in patients transitioning from placebo. In addition to acute medication use, emergency department use for migraine treatment was decreased significantly as well, by more than two thirds in month 3.
Migraine prevention will always remain the key ingredient for improvement for patients with higher frequencies of migraine, and adequate prevention will allow for the lower use of acute medications, and for less healthcare system use in general.
Most practitioners recommend migraine-specific medications for the acute treatment of migraine. Since the advent of sumatriptan, this has usually meant a triptan medication. However, a significant percentage of the population (up to 44% in one study) are either intolerant to, contraindicated for, or respond insufficiently to triptan medications. This can either be due to a strong triptan side effect (worsened nausea; tightness/soreness of the muscles of the chest, shoulders, and neck), having cardiovascular risk factors, or not responding adequately 2 hours after treatment. The study by Lipton and colleagues specifically assessed the efficacy of ubrogepant in this population.
Ubrogepant is a small-molecule CGRP antagonist for the acute treatment of migraine. Although somewhat controversial, most practitioners use ubrogepant in patients with some cardiovascular risk, a situation where they would be more likely to avoid the use of triptans. The study authors pooled post hoc data from the pivotal ubrogepant trials (ACHIEVE-1 and -2) to isolate patients with insufficient response to triptans, and their primary outcome was improvement in function 2 hours after medication dose.
Participants in the pivotal trials were separated into three groups: triptan responders, triptan insufficient responders, and triptan-naive patients. Triptan response was defined as achieving pain freedom 2 hours after medication dose. Both those who had an insufficient response and those who no longer use the triptan owing to intolerance or contraindications were included in the group with insufficient triptan response. Function improvement was defined as the primary outcome on the basis of a 4-point response scale (0 = no disability, 1 = mildly impaired, 2 = moderately impaired, 3 = severely impaired). In addition, patients were asked to report scores of satisfaction with the medication (yes or no) at 2 and 24 hours and their impression of overall change at 2 hours using a 7-point scale.
The population group of triptan insufficient responders (451 patients) had significant improvement in the primary outcome functional disability at 2, 4, and 7 hours after receipt of medications, but there was no statistical difference at 1 hour. This was similar when comparing those with intolerance to triptans, insufficient response to triptans, or contraindications for triptans. The secondary outcomes of satisfaction and global impression of change were also statistically improved in the insufficient-responders group. No additional tolerance issues or adverse events were noted in this group either.
It would certainly be worth considering the use of a gepant acute medication, such as ubrogepant, in patients who are intolerant to or inadequately treated by triptan medications. There still is much to learn about cardiovascular risk and the use of CGRP antagonists, and although no adverse events were noted, more data may be necessary to widely prescribe this class in higher-risk patients.
Many of our patients with refractory migraine do not respond to first-line acute or preventive treatments, and, almost by definition, first- and second-line treatments have failed in the majority of patients on calcitonin gene-related peptide (CGRP) antagonist medications. Three studies this month highlight the efficacy of CGRP monoclonal antibody (mAb) and small-molecule medications in this population specifically.
After an initial first dose of a CGRP mAb treatment, many patients ask whether a suboptimal response necessitates switching to another agent or whether a second (or third) dose should be given first. Eptinezumab is an intravenously administered mAb that is repeated every 12 weeks. Schim and colleagues present post hoc data for patients who initially had a minimally beneficial response to eptinezumab and received a second dose at week 13.
The authors define a suboptimal response as having less then a 50% decrease in monthly migraine days after 12 weeks. There were two pooled samples of patients — those who received 100 mg eptinezumab and those who received a 300 mg dose. Approximately 45% of patients in the pivotal trials of eptinezumab (PROMISE-1 and -2) were considered suboptimal responders, and 33%-37% of those suboptimal responders had a more than 50% decrease of their monthly migraine days after a second dose (week 24).
Further analysis determined predictive factors that favored a second dose response. The most prominent (and arguably most obvious) predictive factor was a favorable response after the first dose; the greater percent change in monthly migraine days after the first dose was proportional to the response after the second dose. Change in the Headache Impact Test (HIT-6) disability score after the first dose was also seen to be a strong predictive factor for improvement after the second dose.
When we discuss continuation of medications with our patients, especially when they have a suboptimal response, we should first keep in mind the degree of improvement that the patient initially had. There can be benefit from further treatment with the same medication; however, if the response truly was minimal, it may be better to consider another treatment option.
Practically every patient taking a preventive medication is taking at least one acute medication as well. Even the best preventive medication is not a guarantee that further exacerbations will not occur, and our patients will still need some acute treatment option even when their preventive medications are very effective. The study by Ambrosini and colleagues specifically shows how effective a preventive medication can be, specifically in allowing the patient to use fewer acute medications over time in a population of patients who have been resistant to two to four treatments.
Galcanezumab is a once-monthly mAb for the prevention of migraine. The authors of this study compared the acute use of medications for migraine in both the randomized and open-label stages of a study assessing treatment-refractory patients. A total of 462 patients were enrolled who were all resistant to two to four standard-of-care migraine-preventive medications that had been stopped either because of lack of efficacy or tolerance. The double-blind stage lasted 3 months; the open-label stage lasted another 3 months.
The treatment group was seen to use significantly fewer acute medications after just the first month and continued to improve through month 3. In the open-label phase, a similar improvement was noted in patients transitioning from placebo. In addition to acute medication use, emergency department use for migraine treatment was decreased significantly as well, by more than two thirds in month 3.
Migraine prevention will always remain the key ingredient for improvement for patients with higher frequencies of migraine, and adequate prevention will allow for the lower use of acute medications, and for less healthcare system use in general.
Most practitioners recommend migraine-specific medications for the acute treatment of migraine. Since the advent of sumatriptan, this has usually meant a triptan medication. However, a significant percentage of the population (up to 44% in one study) are either intolerant to, contraindicated for, or respond insufficiently to triptan medications. This can either be due to a strong triptan side effect (worsened nausea; tightness/soreness of the muscles of the chest, shoulders, and neck), having cardiovascular risk factors, or not responding adequately 2 hours after treatment. The study by Lipton and colleagues specifically assessed the efficacy of ubrogepant in this population.
Ubrogepant is a small-molecule CGRP antagonist for the acute treatment of migraine. Although somewhat controversial, most practitioners use ubrogepant in patients with some cardiovascular risk, a situation where they would be more likely to avoid the use of triptans. The study authors pooled post hoc data from the pivotal ubrogepant trials (ACHIEVE-1 and -2) to isolate patients with insufficient response to triptans, and their primary outcome was improvement in function 2 hours after medication dose.
Participants in the pivotal trials were separated into three groups: triptan responders, triptan insufficient responders, and triptan-naive patients. Triptan response was defined as achieving pain freedom 2 hours after medication dose. Both those who had an insufficient response and those who no longer use the triptan owing to intolerance or contraindications were included in the group with insufficient triptan response. Function improvement was defined as the primary outcome on the basis of a 4-point response scale (0 = no disability, 1 = mildly impaired, 2 = moderately impaired, 3 = severely impaired). In addition, patients were asked to report scores of satisfaction with the medication (yes or no) at 2 and 24 hours and their impression of overall change at 2 hours using a 7-point scale.
The population group of triptan insufficient responders (451 patients) had significant improvement in the primary outcome functional disability at 2, 4, and 7 hours after receipt of medications, but there was no statistical difference at 1 hour. This was similar when comparing those with intolerance to triptans, insufficient response to triptans, or contraindications for triptans. The secondary outcomes of satisfaction and global impression of change were also statistically improved in the insufficient-responders group. No additional tolerance issues or adverse events were noted in this group either.
It would certainly be worth considering the use of a gepant acute medication, such as ubrogepant, in patients who are intolerant to or inadequately treated by triptan medications. There still is much to learn about cardiovascular risk and the use of CGRP antagonists, and although no adverse events were noted, more data may be necessary to widely prescribe this class in higher-risk patients.
Many of our patients with refractory migraine do not respond to first-line acute or preventive treatments, and, almost by definition, first- and second-line treatments have failed in the majority of patients on calcitonin gene-related peptide (CGRP) antagonist medications. Three studies this month highlight the efficacy of CGRP monoclonal antibody (mAb) and small-molecule medications in this population specifically.
After an initial first dose of a CGRP mAb treatment, many patients ask whether a suboptimal response necessitates switching to another agent or whether a second (or third) dose should be given first. Eptinezumab is an intravenously administered mAb that is repeated every 12 weeks. Schim and colleagues present post hoc data for patients who initially had a minimally beneficial response to eptinezumab and received a second dose at week 13.
The authors define a suboptimal response as having less then a 50% decrease in monthly migraine days after 12 weeks. There were two pooled samples of patients — those who received 100 mg eptinezumab and those who received a 300 mg dose. Approximately 45% of patients in the pivotal trials of eptinezumab (PROMISE-1 and -2) were considered suboptimal responders, and 33%-37% of those suboptimal responders had a more than 50% decrease of their monthly migraine days after a second dose (week 24).
Further analysis determined predictive factors that favored a second dose response. The most prominent (and arguably most obvious) predictive factor was a favorable response after the first dose; the greater percent change in monthly migraine days after the first dose was proportional to the response after the second dose. Change in the Headache Impact Test (HIT-6) disability score after the first dose was also seen to be a strong predictive factor for improvement after the second dose.
When we discuss continuation of medications with our patients, especially when they have a suboptimal response, we should first keep in mind the degree of improvement that the patient initially had. There can be benefit from further treatment with the same medication; however, if the response truly was minimal, it may be better to consider another treatment option.
Practically every patient taking a preventive medication is taking at least one acute medication as well. Even the best preventive medication is not a guarantee that further exacerbations will not occur, and our patients will still need some acute treatment option even when their preventive medications are very effective. The study by Ambrosini and colleagues specifically shows how effective a preventive medication can be, specifically in allowing the patient to use fewer acute medications over time in a population of patients who have been resistant to two to four treatments.
Galcanezumab is a once-monthly mAb for the prevention of migraine. The authors of this study compared the acute use of medications for migraine in both the randomized and open-label stages of a study assessing treatment-refractory patients. A total of 462 patients were enrolled who were all resistant to two to four standard-of-care migraine-preventive medications that had been stopped either because of lack of efficacy or tolerance. The double-blind stage lasted 3 months; the open-label stage lasted another 3 months.
The treatment group was seen to use significantly fewer acute medications after just the first month and continued to improve through month 3. In the open-label phase, a similar improvement was noted in patients transitioning from placebo. In addition to acute medication use, emergency department use for migraine treatment was decreased significantly as well, by more than two thirds in month 3.
Migraine prevention will always remain the key ingredient for improvement for patients with higher frequencies of migraine, and adequate prevention will allow for the lower use of acute medications, and for less healthcare system use in general.
Most practitioners recommend migraine-specific medications for the acute treatment of migraine. Since the advent of sumatriptan, this has usually meant a triptan medication. However, a significant percentage of the population (up to 44% in one study) are either intolerant to, contraindicated for, or respond insufficiently to triptan medications. This can either be due to a strong triptan side effect (worsened nausea; tightness/soreness of the muscles of the chest, shoulders, and neck), having cardiovascular risk factors, or not responding adequately 2 hours after treatment. The study by Lipton and colleagues specifically assessed the efficacy of ubrogepant in this population.
Ubrogepant is a small-molecule CGRP antagonist for the acute treatment of migraine. Although somewhat controversial, most practitioners use ubrogepant in patients with some cardiovascular risk, a situation where they would be more likely to avoid the use of triptans. The study authors pooled post hoc data from the pivotal ubrogepant trials (ACHIEVE-1 and -2) to isolate patients with insufficient response to triptans, and their primary outcome was improvement in function 2 hours after medication dose.
Participants in the pivotal trials were separated into three groups: triptan responders, triptan insufficient responders, and triptan-naive patients. Triptan response was defined as achieving pain freedom 2 hours after medication dose. Both those who had an insufficient response and those who no longer use the triptan owing to intolerance or contraindications were included in the group with insufficient triptan response. Function improvement was defined as the primary outcome on the basis of a 4-point response scale (0 = no disability, 1 = mildly impaired, 2 = moderately impaired, 3 = severely impaired). In addition, patients were asked to report scores of satisfaction with the medication (yes or no) at 2 and 24 hours and their impression of overall change at 2 hours using a 7-point scale.
The population group of triptan insufficient responders (451 patients) had significant improvement in the primary outcome functional disability at 2, 4, and 7 hours after receipt of medications, but there was no statistical difference at 1 hour. This was similar when comparing those with intolerance to triptans, insufficient response to triptans, or contraindications for triptans. The secondary outcomes of satisfaction and global impression of change were also statistically improved in the insufficient-responders group. No additional tolerance issues or adverse events were noted in this group either.
It would certainly be worth considering the use of a gepant acute medication, such as ubrogepant, in patients who are intolerant to or inadequately treated by triptan medications. There still is much to learn about cardiovascular risk and the use of CGRP antagonists, and although no adverse events were noted, more data may be necessary to widely prescribe this class in higher-risk patients.
How do you treat noncompliance?
Mrs. Stevens has migraines. Fortunately, they’re well controlled on nortriptyline, and she’s never had side effects from it. She’s taken it for more than 20 years now.
In that time she and I have had a strange, slow-motion, waltz.
In spite of the medicine helping her, she stops it on her own roughly twice a year, never calling my office in advance. Sometimes it’s to see if the headaches come back (they always do). Other times it’s because of something she read online, or a friend told her, or she overheard in the grocery checkout line.
Whatever the reason, her migraines always come back within a week, and then she calls my office for an urgent appointment.
I’ve never really understood this, as I know her history and am happy to just tell her to restart the medication and call it in. But, for whatever reason, the return of her migraines is something that she wants to discuss with me in person. Since it’s usually a pretty brief visit, my secretary puts her on the schedule and I get paid to tell her what could have been handled by phone. I’m not complaining. I have to make a living, too.
But still, it makes me wonder. She can’t be the only patient out there who does this. Multiply that by the number of doctors, the cost of visits, the time she takes off from work to come in ... it adds up.
So why does this happen?
Believe me, for the past 20 years I’ve spent these occasional visits reminding Mrs. Stevens about the importance of sticking with her medication and calling my office if she has questions. She agrees to, but when she’s thinking about stopping nortriptyline ... she still does it and only tells me after the fact.
I can’t change human nature, or at least not hers. And when multiplied by many like her, it creates entirely unnecessary costs on our health care system. I wish there were a way to stop it.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Mrs. Stevens has migraines. Fortunately, they’re well controlled on nortriptyline, and she’s never had side effects from it. She’s taken it for more than 20 years now.
In that time she and I have had a strange, slow-motion, waltz.
In spite of the medicine helping her, she stops it on her own roughly twice a year, never calling my office in advance. Sometimes it’s to see if the headaches come back (they always do). Other times it’s because of something she read online, or a friend told her, or she overheard in the grocery checkout line.
Whatever the reason, her migraines always come back within a week, and then she calls my office for an urgent appointment.
I’ve never really understood this, as I know her history and am happy to just tell her to restart the medication and call it in. But, for whatever reason, the return of her migraines is something that she wants to discuss with me in person. Since it’s usually a pretty brief visit, my secretary puts her on the schedule and I get paid to tell her what could have been handled by phone. I’m not complaining. I have to make a living, too.
But still, it makes me wonder. She can’t be the only patient out there who does this. Multiply that by the number of doctors, the cost of visits, the time she takes off from work to come in ... it adds up.
So why does this happen?
Believe me, for the past 20 years I’ve spent these occasional visits reminding Mrs. Stevens about the importance of sticking with her medication and calling my office if she has questions. She agrees to, but when she’s thinking about stopping nortriptyline ... she still does it and only tells me after the fact.
I can’t change human nature, or at least not hers. And when multiplied by many like her, it creates entirely unnecessary costs on our health care system. I wish there were a way to stop it.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Mrs. Stevens has migraines. Fortunately, they’re well controlled on nortriptyline, and she’s never had side effects from it. She’s taken it for more than 20 years now.
In that time she and I have had a strange, slow-motion, waltz.
In spite of the medicine helping her, she stops it on her own roughly twice a year, never calling my office in advance. Sometimes it’s to see if the headaches come back (they always do). Other times it’s because of something she read online, or a friend told her, or she overheard in the grocery checkout line.
Whatever the reason, her migraines always come back within a week, and then she calls my office for an urgent appointment.
I’ve never really understood this, as I know her history and am happy to just tell her to restart the medication and call it in. But, for whatever reason, the return of her migraines is something that she wants to discuss with me in person. Since it’s usually a pretty brief visit, my secretary puts her on the schedule and I get paid to tell her what could have been handled by phone. I’m not complaining. I have to make a living, too.
But still, it makes me wonder. She can’t be the only patient out there who does this. Multiply that by the number of doctors, the cost of visits, the time she takes off from work to come in ... it adds up.
So why does this happen?
Believe me, for the past 20 years I’ve spent these occasional visits reminding Mrs. Stevens about the importance of sticking with her medication and calling my office if she has questions. She agrees to, but when she’s thinking about stopping nortriptyline ... she still does it and only tells me after the fact.
I can’t change human nature, or at least not hers. And when multiplied by many like her, it creates entirely unnecessary costs on our health care system. I wish there were a way to stop it.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Abortion debate may affect Rx decisions for pregnant women
Obstetrician Beverly Gray, MD, is already seeing the effects of the Roe v. Wade abortion debate in her North Carolina practice.
The state allows abortion but requires that women get counseling with a qualified health professional 72 hours before the procedure. “Aside from that, we still have patients asking for more efficacious contraceptive methods just in case,” said Dr. Gray, residency director and division director for women’s community and population health and associate professor for obstetrics and gynecology at Duke University, Durham, N.C.
Patients and staff in her clinic have also been approaching her about tubal ligation. “They’re asking about additional birth control methods because they’re concerned about what’s going to happen” with the challenge to the historic Roe v. Wade decision in the Supreme Court and subsequent actions in the states to restrict or ban abortion, she said.
This has implications not just for abortion but for medications known to affect pregnancy. “What I’m really worried about is physicians will be withholding medicine because they’re concerned about teratogenic effects,” said Dr. Gray.
With more states issuing restrictions on abortion, doctors are worried that patients needing certain drugs to maintain their lupus flares, cancer, or other diseases may decide not to take them in the event they accidentally become pregnant. If the drug is known to affect the fetus, the fear is a patient who lives in a state with abortion restrictions will no longer have the option to terminate a pregnancy.
Instead, a scenario may arise in which the patient – and their physician – may opt not to treat at all with an otherwise lifesaving medication, experts told this news organization.
The U.S. landscape on abortion restrictions
A leaked draft of a U.S. Supreme Court opinion on Mississippi’s 15-week abortion ban has sent the medical community into a tailspin. The case, Dobbs v. Jackson Women’s Health Organization, challenges the 1973 Roe v. Wade decision that affirms the constitutional right to abortion. It’s anticipated the high court will decide on the case in June.
Although the upcoming decision is subject to change, the draft indicated the high court would uphold the Mississippi ban. This would essentially overturn the 1973 ruling. An earlier Supreme Court decision allowing a Texas law banning abortion at 6 weeks suggests the court may already be heading in this direction. At the state level, legislatures have been moving on divergent paths – some taking steps to preserve abortion rights, others initiating restrictions.
More than 100 abortion restrictions in 19 states took effect in 2021, according to the Guttmacher Institute, which tracks such metrics. In 2022, “two key themes are anti-abortion policymakers’ continued pursuit of various types of abortion bans and restrictions on medication abortion,” the institute reported.
Forty-six states and the District of Columbia have introduced 2,025 restrictions or proactive measures on sexual and reproductive health and rights so far this year. The latest tally from Guttmacher, updated in late May, revealed that 11 states so far have enacted 42 abortion restrictions. A total of 6 states (Arizona, Florida, Idaho, Kentucky, Oklahoma, and Wyoming) have issued nine bans on abortion.
Comparatively, 11 states have enacted 19 protective abortion measures.
Twenty-two states have introduced 117 restrictions on medication abortions, which account for 54% of U.S. abortions. This includes seven measures that would ban medication abortion outright, according to Guttmacher. Kentucky and South Dakota collectively have enacted 14 restrictions on medication abortion, as well as provisions that ban mailing of abortion pills.
Chilling effect on prescribing
Some physicians anticipate that drugs such as the “morning-after” pill (levonorgestrel) will become less available as restrictions go into effect, since these are medications designed to prevent pregnancy.*
However, the ongoing effort to put a lid on abortion measures has prompted concerns about a trickle-down effect on other medications that are otherwise life-changing or lifesaving to patients but pose a risk to the fetus.
Several drugs are well documented to affect fetal growth and development of the fetus, ranging from mild, transitory effects to severe, permanent birth defects, said Ronald G. Grifka, MD, chief medical officer of University of Michigan Health-West and clinical professor of pediatrics at the University of Michigan Medical School, Ann Arbor. “As new medications are developed, we will need heightened attention to make sure they are safe for the fetus,” he added.
Certain teratogenic medications are associated with a high risk of abortion even though this isn’t their primary use, noted Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and associate director with the Altman Clinical & Translational Research Institute at the University of California, San Diego.
“I don’t think anyone would intentionally take these drugs to induce spontaneous abortion. But if the drugs pose a risk for it, I can see how the laws might be stretched” to include them, said Dr. Chambers.
Methotrexate, a medication for autoimmune disorders, has a high risk of spontaneous abortion. So do acne medications such as isotretinoin.
Patients are usually told they’re not supposed to get pregnant on these drugs because there’s a high risk of pregnancy loss and risk of malformations and potential learning problems in the fetus. But many pregnancies aren’t planned, said Dr. Chambers. “Patients may forget about the side effects or think their birth control will protect them. And the next time they refill the medication, they may not hear about the warnings again.”
With a restrictive abortion law or ban in effect, a woman might think: “I won’t take this drug because if there’s any potential that I might get pregnant, I won’t have the option to abort an at-risk pregnancy.” Women and their doctors, for that matter, don’t want to put themselves in this position, said Dr. Chambers.
Rheumatologist Megan Clowse, MD, who prescribes several medications that potentially cause major birth defects and pregnancy loss, worries about the ramifications of these accumulating bans.
“Methotrexate has been a leading drug for us for decades for rheumatoid arthritis. Mycophenolate is a vital drug for lupus,” said Dr. Clowse, associate professor of medicine at Duke University’s division of rheumatology and immunology.
Both methotrexate and mycophenolate pose about a 40% risk of pregnancy loss and significantly increase the risk for birth defects. “I’m definitely concerned that there might be doctors or women who elect not to use those medications in women of reproductive age because of the potential risk for pregnancy and absence of abortion rights,” said Dr. Clowse.
These situations might force women to use contraceptives they don’t want to use, such as hormonal implants or intrauterine devices, she added. Another side effect is that women and their partners may decide to abstain from sex.
The iPLEDGE factor
Some rheumatology drugs like lenalidomide (Revlimid) require a valid negative pregnancy test in a lab every month. Similarly, the iPLEDGE Risk Evaluation and Mitigation Strategy seeks to reduce the teratogenicity of isotretinoin by requiring two types of birth control and regular pregnancy tests by users.
For isotretinoin specifically, abortion restrictions “could lead to increased adherence to pregnancy prevention measures which are already stringent in iPLEDGE. But on the other hand, it could lead to reduced willingness of physicians to prescribe or patients to take the medication,” said Dr. Chambers.
With programs like iPLEDGE in effect, the rate of pregnancies and abortions that occur in dermatology are relatively low, said Jenny Murase, MD, associate clinical professor of dermatology at the University of California, San Francisco.
Nevertheless, as a physician who regularly prescribes medications like isotretinoin in women of childbearing age, “it’s terrifying to me that a woman wouldn’t have the option to terminate the pregnancy if a teratogenic effect from the medication caused a severe birth defect,” said Dr. Murase.
Dermatologists use other teratogenic medications such as thalidomide, mycophenolate mofetil, and methotrexate for chronic dermatologic disease like psoriasis and atopic dermatitis.
The situation is especially tricky for dermatologists since most patients – about 80% – never discuss their pregnancy with their specialist prior to pregnancy initiation. Dr. Murase recalls when a patient with chronic plaque psoriasis on methotrexate in her late 40s became pregnant and had an abortion even before Dr. Murase became aware of the pregnancy.
Because dermatologists routinely prescribe long-term medications for chronic diseases like acne, psoriasis, and atopic dermatitis, it is important to have a conversation regarding the risks and benefits of long-term medication should a pregnancy occur in any woman of childbearing age, she said.
Fewer women in clinical trials?
Abortion restrictions could possibly discourage women of reproductive age to participate in a clinical trial for a new medication, said Dr. Chambers.
A female patient with a chronic disease who’s randomized to receive a new medication may be required to use certain types of birth control because of unknown potential adverse effects the drug may have on the fetus. But in some cases, accidental pregnancies happen.
The participant in the trial may say, “I don’t know enough about the safety of this drug in pregnancy, and I’ve already taken it. I want to terminate the pregnancy,” said Dr. Chambers. Thinking ahead, a woman may decide not to do the trial to avoid the risk of getting pregnant and not having the option to terminate the pregnancy.
This could apply to new drugs such as antiviral treatments, or medications for severe chronic disease that typically have no clinical trial data in pregnancy prior to initial release into the market.
Women may start taking the drug without thinking about getting pregnant, then realize there are no safety data and become concerned about its effects on a future pregnancy.
The question is: Will abortion restrictions have a chilling effect on these new drugs as well? Patients and their doctors may decide not to try it until more data are available. “I can see where abortion restrictions would change the risk or benefit calculation in thinking about what you do or don’t prescribe or take during reproductive age,” said Dr. Chambers.
The upside of restrictions?
If there’s a positive side to these developments with abortion bans, it may encourage women taking new medications or joining clinical trials to think even more carefully about adherence to effective contraception, said Dr. Chambers.
Some methods are more effective than others, she emphasized. “When you have an unplanned pregnancy, it could mean that the method you used wasn’t optimal or you weren’t using it as recommended.” A goal moving forward is to encourage more thoughtful use of highly effective contraceptives, thus reducing the number of unplanned pregnancies, she added.
If patients are taking methotrexate, “the time to think about pregnancy is before getting pregnant so you can switch to a drug that’s compatible with pregnancy,” she said.
This whole thought process regarding pregnancy planning could work toward useful health goals, said Dr. Chambers. “Nobody thinks termination is the preferred method, but planning ahead should involve a discussion of what works best for the patient.”
Patients do have other choices, said Dr. Grifka. “Fortunately, there are many commonly prescribed medications which cross the placenta and have no ill effects on the fetus.”
Talking to patients about choices
Dr. Clowse, who spends a lot of time training rheumatologists, encourages them to have conversations with patients about pregnancy planning. It’s a lot to manage, getting the right drug to a female patient with chronic illness, especially in this current climate of abortion upheaval, she noted.
Her approach is to have an open and honest conversation with patients about their concerns and fears, what the realities are, and what the potential future options are for certain rheumatology drugs in the United States.
Some women who see what’s happening across the country may become so risk averse that they may choose to die rather than take a lifesaving drug that poses certain risks under new restrictions.
“I think that’s tragic,” said Dr. Clowse.
To help their patients, Dr. Gray believes physicians across specialties should better educate themselves about physiology in pregnancy and how to counsel patients on the impact of not taking medications in pregnancy.
In her view, it’s almost coercive to say to a patient, “You really need to have effective contraception if I’m going to give you this lifesaving or quality-of-life-improving medication.”
When confronting such scenarios, Dr. Gray doesn’t think physicians need to change how they counsel patients about contraception. “I don’t think we should be putting pressure on patients to consider other permanent methods just because there’s a lack of abortion options.”
Patients will eventually make those decisions for themselves, she said. “They’re going to want a more efficacious method because they’re worried about not having access to abortion if they get pregnant.”
Dr. Gray reports being a site principal investigator for a phase 3 trial for VeraCept IUD, funded by Sebela Pharmaceuticals. Dr. Clowse reports receiving research funding and doing consulting for GlaxoSmithKline.
*Correction, 6/2/2022: A previous version of this article misstated the intended use of drugs such as the “morning-after” pill (levonorgestrel). They are taken to prevent unintended pregnancy.
A version of this article first appeared on Medscape.com .
Obstetrician Beverly Gray, MD, is already seeing the effects of the Roe v. Wade abortion debate in her North Carolina practice.
The state allows abortion but requires that women get counseling with a qualified health professional 72 hours before the procedure. “Aside from that, we still have patients asking for more efficacious contraceptive methods just in case,” said Dr. Gray, residency director and division director for women’s community and population health and associate professor for obstetrics and gynecology at Duke University, Durham, N.C.
Patients and staff in her clinic have also been approaching her about tubal ligation. “They’re asking about additional birth control methods because they’re concerned about what’s going to happen” with the challenge to the historic Roe v. Wade decision in the Supreme Court and subsequent actions in the states to restrict or ban abortion, she said.
This has implications not just for abortion but for medications known to affect pregnancy. “What I’m really worried about is physicians will be withholding medicine because they’re concerned about teratogenic effects,” said Dr. Gray.
With more states issuing restrictions on abortion, doctors are worried that patients needing certain drugs to maintain their lupus flares, cancer, or other diseases may decide not to take them in the event they accidentally become pregnant. If the drug is known to affect the fetus, the fear is a patient who lives in a state with abortion restrictions will no longer have the option to terminate a pregnancy.
Instead, a scenario may arise in which the patient – and their physician – may opt not to treat at all with an otherwise lifesaving medication, experts told this news organization.
The U.S. landscape on abortion restrictions
A leaked draft of a U.S. Supreme Court opinion on Mississippi’s 15-week abortion ban has sent the medical community into a tailspin. The case, Dobbs v. Jackson Women’s Health Organization, challenges the 1973 Roe v. Wade decision that affirms the constitutional right to abortion. It’s anticipated the high court will decide on the case in June.
Although the upcoming decision is subject to change, the draft indicated the high court would uphold the Mississippi ban. This would essentially overturn the 1973 ruling. An earlier Supreme Court decision allowing a Texas law banning abortion at 6 weeks suggests the court may already be heading in this direction. At the state level, legislatures have been moving on divergent paths – some taking steps to preserve abortion rights, others initiating restrictions.
More than 100 abortion restrictions in 19 states took effect in 2021, according to the Guttmacher Institute, which tracks such metrics. In 2022, “two key themes are anti-abortion policymakers’ continued pursuit of various types of abortion bans and restrictions on medication abortion,” the institute reported.
Forty-six states and the District of Columbia have introduced 2,025 restrictions or proactive measures on sexual and reproductive health and rights so far this year. The latest tally from Guttmacher, updated in late May, revealed that 11 states so far have enacted 42 abortion restrictions. A total of 6 states (Arizona, Florida, Idaho, Kentucky, Oklahoma, and Wyoming) have issued nine bans on abortion.
Comparatively, 11 states have enacted 19 protective abortion measures.
Twenty-two states have introduced 117 restrictions on medication abortions, which account for 54% of U.S. abortions. This includes seven measures that would ban medication abortion outright, according to Guttmacher. Kentucky and South Dakota collectively have enacted 14 restrictions on medication abortion, as well as provisions that ban mailing of abortion pills.
Chilling effect on prescribing
Some physicians anticipate that drugs such as the “morning-after” pill (levonorgestrel) will become less available as restrictions go into effect, since these are medications designed to prevent pregnancy.*
However, the ongoing effort to put a lid on abortion measures has prompted concerns about a trickle-down effect on other medications that are otherwise life-changing or lifesaving to patients but pose a risk to the fetus.
Several drugs are well documented to affect fetal growth and development of the fetus, ranging from mild, transitory effects to severe, permanent birth defects, said Ronald G. Grifka, MD, chief medical officer of University of Michigan Health-West and clinical professor of pediatrics at the University of Michigan Medical School, Ann Arbor. “As new medications are developed, we will need heightened attention to make sure they are safe for the fetus,” he added.
Certain teratogenic medications are associated with a high risk of abortion even though this isn’t their primary use, noted Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and associate director with the Altman Clinical & Translational Research Institute at the University of California, San Diego.
“I don’t think anyone would intentionally take these drugs to induce spontaneous abortion. But if the drugs pose a risk for it, I can see how the laws might be stretched” to include them, said Dr. Chambers.
Methotrexate, a medication for autoimmune disorders, has a high risk of spontaneous abortion. So do acne medications such as isotretinoin.
Patients are usually told they’re not supposed to get pregnant on these drugs because there’s a high risk of pregnancy loss and risk of malformations and potential learning problems in the fetus. But many pregnancies aren’t planned, said Dr. Chambers. “Patients may forget about the side effects or think their birth control will protect them. And the next time they refill the medication, they may not hear about the warnings again.”
With a restrictive abortion law or ban in effect, a woman might think: “I won’t take this drug because if there’s any potential that I might get pregnant, I won’t have the option to abort an at-risk pregnancy.” Women and their doctors, for that matter, don’t want to put themselves in this position, said Dr. Chambers.
Rheumatologist Megan Clowse, MD, who prescribes several medications that potentially cause major birth defects and pregnancy loss, worries about the ramifications of these accumulating bans.
“Methotrexate has been a leading drug for us for decades for rheumatoid arthritis. Mycophenolate is a vital drug for lupus,” said Dr. Clowse, associate professor of medicine at Duke University’s division of rheumatology and immunology.
Both methotrexate and mycophenolate pose about a 40% risk of pregnancy loss and significantly increase the risk for birth defects. “I’m definitely concerned that there might be doctors or women who elect not to use those medications in women of reproductive age because of the potential risk for pregnancy and absence of abortion rights,” said Dr. Clowse.
These situations might force women to use contraceptives they don’t want to use, such as hormonal implants or intrauterine devices, she added. Another side effect is that women and their partners may decide to abstain from sex.
The iPLEDGE factor
Some rheumatology drugs like lenalidomide (Revlimid) require a valid negative pregnancy test in a lab every month. Similarly, the iPLEDGE Risk Evaluation and Mitigation Strategy seeks to reduce the teratogenicity of isotretinoin by requiring two types of birth control and regular pregnancy tests by users.
For isotretinoin specifically, abortion restrictions “could lead to increased adherence to pregnancy prevention measures which are already stringent in iPLEDGE. But on the other hand, it could lead to reduced willingness of physicians to prescribe or patients to take the medication,” said Dr. Chambers.
With programs like iPLEDGE in effect, the rate of pregnancies and abortions that occur in dermatology are relatively low, said Jenny Murase, MD, associate clinical professor of dermatology at the University of California, San Francisco.
Nevertheless, as a physician who regularly prescribes medications like isotretinoin in women of childbearing age, “it’s terrifying to me that a woman wouldn’t have the option to terminate the pregnancy if a teratogenic effect from the medication caused a severe birth defect,” said Dr. Murase.
Dermatologists use other teratogenic medications such as thalidomide, mycophenolate mofetil, and methotrexate for chronic dermatologic disease like psoriasis and atopic dermatitis.
The situation is especially tricky for dermatologists since most patients – about 80% – never discuss their pregnancy with their specialist prior to pregnancy initiation. Dr. Murase recalls when a patient with chronic plaque psoriasis on methotrexate in her late 40s became pregnant and had an abortion even before Dr. Murase became aware of the pregnancy.
Because dermatologists routinely prescribe long-term medications for chronic diseases like acne, psoriasis, and atopic dermatitis, it is important to have a conversation regarding the risks and benefits of long-term medication should a pregnancy occur in any woman of childbearing age, she said.
Fewer women in clinical trials?
Abortion restrictions could possibly discourage women of reproductive age to participate in a clinical trial for a new medication, said Dr. Chambers.
A female patient with a chronic disease who’s randomized to receive a new medication may be required to use certain types of birth control because of unknown potential adverse effects the drug may have on the fetus. But in some cases, accidental pregnancies happen.
The participant in the trial may say, “I don’t know enough about the safety of this drug in pregnancy, and I’ve already taken it. I want to terminate the pregnancy,” said Dr. Chambers. Thinking ahead, a woman may decide not to do the trial to avoid the risk of getting pregnant and not having the option to terminate the pregnancy.
This could apply to new drugs such as antiviral treatments, or medications for severe chronic disease that typically have no clinical trial data in pregnancy prior to initial release into the market.
Women may start taking the drug without thinking about getting pregnant, then realize there are no safety data and become concerned about its effects on a future pregnancy.
The question is: Will abortion restrictions have a chilling effect on these new drugs as well? Patients and their doctors may decide not to try it until more data are available. “I can see where abortion restrictions would change the risk or benefit calculation in thinking about what you do or don’t prescribe or take during reproductive age,” said Dr. Chambers.
The upside of restrictions?
If there’s a positive side to these developments with abortion bans, it may encourage women taking new medications or joining clinical trials to think even more carefully about adherence to effective contraception, said Dr. Chambers.
Some methods are more effective than others, she emphasized. “When you have an unplanned pregnancy, it could mean that the method you used wasn’t optimal or you weren’t using it as recommended.” A goal moving forward is to encourage more thoughtful use of highly effective contraceptives, thus reducing the number of unplanned pregnancies, she added.
If patients are taking methotrexate, “the time to think about pregnancy is before getting pregnant so you can switch to a drug that’s compatible with pregnancy,” she said.
This whole thought process regarding pregnancy planning could work toward useful health goals, said Dr. Chambers. “Nobody thinks termination is the preferred method, but planning ahead should involve a discussion of what works best for the patient.”
Patients do have other choices, said Dr. Grifka. “Fortunately, there are many commonly prescribed medications which cross the placenta and have no ill effects on the fetus.”
Talking to patients about choices
Dr. Clowse, who spends a lot of time training rheumatologists, encourages them to have conversations with patients about pregnancy planning. It’s a lot to manage, getting the right drug to a female patient with chronic illness, especially in this current climate of abortion upheaval, she noted.
Her approach is to have an open and honest conversation with patients about their concerns and fears, what the realities are, and what the potential future options are for certain rheumatology drugs in the United States.
Some women who see what’s happening across the country may become so risk averse that they may choose to die rather than take a lifesaving drug that poses certain risks under new restrictions.
“I think that’s tragic,” said Dr. Clowse.
To help their patients, Dr. Gray believes physicians across specialties should better educate themselves about physiology in pregnancy and how to counsel patients on the impact of not taking medications in pregnancy.
In her view, it’s almost coercive to say to a patient, “You really need to have effective contraception if I’m going to give you this lifesaving or quality-of-life-improving medication.”
When confronting such scenarios, Dr. Gray doesn’t think physicians need to change how they counsel patients about contraception. “I don’t think we should be putting pressure on patients to consider other permanent methods just because there’s a lack of abortion options.”
Patients will eventually make those decisions for themselves, she said. “They’re going to want a more efficacious method because they’re worried about not having access to abortion if they get pregnant.”
Dr. Gray reports being a site principal investigator for a phase 3 trial for VeraCept IUD, funded by Sebela Pharmaceuticals. Dr. Clowse reports receiving research funding and doing consulting for GlaxoSmithKline.
*Correction, 6/2/2022: A previous version of this article misstated the intended use of drugs such as the “morning-after” pill (levonorgestrel). They are taken to prevent unintended pregnancy.
A version of this article first appeared on Medscape.com .
Obstetrician Beverly Gray, MD, is already seeing the effects of the Roe v. Wade abortion debate in her North Carolina practice.
The state allows abortion but requires that women get counseling with a qualified health professional 72 hours before the procedure. “Aside from that, we still have patients asking for more efficacious contraceptive methods just in case,” said Dr. Gray, residency director and division director for women’s community and population health and associate professor for obstetrics and gynecology at Duke University, Durham, N.C.
Patients and staff in her clinic have also been approaching her about tubal ligation. “They’re asking about additional birth control methods because they’re concerned about what’s going to happen” with the challenge to the historic Roe v. Wade decision in the Supreme Court and subsequent actions in the states to restrict or ban abortion, she said.
This has implications not just for abortion but for medications known to affect pregnancy. “What I’m really worried about is physicians will be withholding medicine because they’re concerned about teratogenic effects,” said Dr. Gray.
With more states issuing restrictions on abortion, doctors are worried that patients needing certain drugs to maintain their lupus flares, cancer, or other diseases may decide not to take them in the event they accidentally become pregnant. If the drug is known to affect the fetus, the fear is a patient who lives in a state with abortion restrictions will no longer have the option to terminate a pregnancy.
Instead, a scenario may arise in which the patient – and their physician – may opt not to treat at all with an otherwise lifesaving medication, experts told this news organization.
The U.S. landscape on abortion restrictions
A leaked draft of a U.S. Supreme Court opinion on Mississippi’s 15-week abortion ban has sent the medical community into a tailspin. The case, Dobbs v. Jackson Women’s Health Organization, challenges the 1973 Roe v. Wade decision that affirms the constitutional right to abortion. It’s anticipated the high court will decide on the case in June.
Although the upcoming decision is subject to change, the draft indicated the high court would uphold the Mississippi ban. This would essentially overturn the 1973 ruling. An earlier Supreme Court decision allowing a Texas law banning abortion at 6 weeks suggests the court may already be heading in this direction. At the state level, legislatures have been moving on divergent paths – some taking steps to preserve abortion rights, others initiating restrictions.
More than 100 abortion restrictions in 19 states took effect in 2021, according to the Guttmacher Institute, which tracks such metrics. In 2022, “two key themes are anti-abortion policymakers’ continued pursuit of various types of abortion bans and restrictions on medication abortion,” the institute reported.
Forty-six states and the District of Columbia have introduced 2,025 restrictions or proactive measures on sexual and reproductive health and rights so far this year. The latest tally from Guttmacher, updated in late May, revealed that 11 states so far have enacted 42 abortion restrictions. A total of 6 states (Arizona, Florida, Idaho, Kentucky, Oklahoma, and Wyoming) have issued nine bans on abortion.
Comparatively, 11 states have enacted 19 protective abortion measures.
Twenty-two states have introduced 117 restrictions on medication abortions, which account for 54% of U.S. abortions. This includes seven measures that would ban medication abortion outright, according to Guttmacher. Kentucky and South Dakota collectively have enacted 14 restrictions on medication abortion, as well as provisions that ban mailing of abortion pills.
Chilling effect on prescribing
Some physicians anticipate that drugs such as the “morning-after” pill (levonorgestrel) will become less available as restrictions go into effect, since these are medications designed to prevent pregnancy.*
However, the ongoing effort to put a lid on abortion measures has prompted concerns about a trickle-down effect on other medications that are otherwise life-changing or lifesaving to patients but pose a risk to the fetus.
Several drugs are well documented to affect fetal growth and development of the fetus, ranging from mild, transitory effects to severe, permanent birth defects, said Ronald G. Grifka, MD, chief medical officer of University of Michigan Health-West and clinical professor of pediatrics at the University of Michigan Medical School, Ann Arbor. “As new medications are developed, we will need heightened attention to make sure they are safe for the fetus,” he added.
Certain teratogenic medications are associated with a high risk of abortion even though this isn’t their primary use, noted Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and associate director with the Altman Clinical & Translational Research Institute at the University of California, San Diego.
“I don’t think anyone would intentionally take these drugs to induce spontaneous abortion. But if the drugs pose a risk for it, I can see how the laws might be stretched” to include them, said Dr. Chambers.
Methotrexate, a medication for autoimmune disorders, has a high risk of spontaneous abortion. So do acne medications such as isotretinoin.
Patients are usually told they’re not supposed to get pregnant on these drugs because there’s a high risk of pregnancy loss and risk of malformations and potential learning problems in the fetus. But many pregnancies aren’t planned, said Dr. Chambers. “Patients may forget about the side effects or think their birth control will protect them. And the next time they refill the medication, they may not hear about the warnings again.”
With a restrictive abortion law or ban in effect, a woman might think: “I won’t take this drug because if there’s any potential that I might get pregnant, I won’t have the option to abort an at-risk pregnancy.” Women and their doctors, for that matter, don’t want to put themselves in this position, said Dr. Chambers.
Rheumatologist Megan Clowse, MD, who prescribes several medications that potentially cause major birth defects and pregnancy loss, worries about the ramifications of these accumulating bans.
“Methotrexate has been a leading drug for us for decades for rheumatoid arthritis. Mycophenolate is a vital drug for lupus,” said Dr. Clowse, associate professor of medicine at Duke University’s division of rheumatology and immunology.
Both methotrexate and mycophenolate pose about a 40% risk of pregnancy loss and significantly increase the risk for birth defects. “I’m definitely concerned that there might be doctors or women who elect not to use those medications in women of reproductive age because of the potential risk for pregnancy and absence of abortion rights,” said Dr. Clowse.
These situations might force women to use contraceptives they don’t want to use, such as hormonal implants or intrauterine devices, she added. Another side effect is that women and their partners may decide to abstain from sex.
The iPLEDGE factor
Some rheumatology drugs like lenalidomide (Revlimid) require a valid negative pregnancy test in a lab every month. Similarly, the iPLEDGE Risk Evaluation and Mitigation Strategy seeks to reduce the teratogenicity of isotretinoin by requiring two types of birth control and regular pregnancy tests by users.
For isotretinoin specifically, abortion restrictions “could lead to increased adherence to pregnancy prevention measures which are already stringent in iPLEDGE. But on the other hand, it could lead to reduced willingness of physicians to prescribe or patients to take the medication,” said Dr. Chambers.
With programs like iPLEDGE in effect, the rate of pregnancies and abortions that occur in dermatology are relatively low, said Jenny Murase, MD, associate clinical professor of dermatology at the University of California, San Francisco.
Nevertheless, as a physician who regularly prescribes medications like isotretinoin in women of childbearing age, “it’s terrifying to me that a woman wouldn’t have the option to terminate the pregnancy if a teratogenic effect from the medication caused a severe birth defect,” said Dr. Murase.
Dermatologists use other teratogenic medications such as thalidomide, mycophenolate mofetil, and methotrexate for chronic dermatologic disease like psoriasis and atopic dermatitis.
The situation is especially tricky for dermatologists since most patients – about 80% – never discuss their pregnancy with their specialist prior to pregnancy initiation. Dr. Murase recalls when a patient with chronic plaque psoriasis on methotrexate in her late 40s became pregnant and had an abortion even before Dr. Murase became aware of the pregnancy.
Because dermatologists routinely prescribe long-term medications for chronic diseases like acne, psoriasis, and atopic dermatitis, it is important to have a conversation regarding the risks and benefits of long-term medication should a pregnancy occur in any woman of childbearing age, she said.
Fewer women in clinical trials?
Abortion restrictions could possibly discourage women of reproductive age to participate in a clinical trial for a new medication, said Dr. Chambers.
A female patient with a chronic disease who’s randomized to receive a new medication may be required to use certain types of birth control because of unknown potential adverse effects the drug may have on the fetus. But in some cases, accidental pregnancies happen.
The participant in the trial may say, “I don’t know enough about the safety of this drug in pregnancy, and I’ve already taken it. I want to terminate the pregnancy,” said Dr. Chambers. Thinking ahead, a woman may decide not to do the trial to avoid the risk of getting pregnant and not having the option to terminate the pregnancy.
This could apply to new drugs such as antiviral treatments, or medications for severe chronic disease that typically have no clinical trial data in pregnancy prior to initial release into the market.
Women may start taking the drug without thinking about getting pregnant, then realize there are no safety data and become concerned about its effects on a future pregnancy.
The question is: Will abortion restrictions have a chilling effect on these new drugs as well? Patients and their doctors may decide not to try it until more data are available. “I can see where abortion restrictions would change the risk or benefit calculation in thinking about what you do or don’t prescribe or take during reproductive age,” said Dr. Chambers.
The upside of restrictions?
If there’s a positive side to these developments with abortion bans, it may encourage women taking new medications or joining clinical trials to think even more carefully about adherence to effective contraception, said Dr. Chambers.
Some methods are more effective than others, she emphasized. “When you have an unplanned pregnancy, it could mean that the method you used wasn’t optimal or you weren’t using it as recommended.” A goal moving forward is to encourage more thoughtful use of highly effective contraceptives, thus reducing the number of unplanned pregnancies, she added.
If patients are taking methotrexate, “the time to think about pregnancy is before getting pregnant so you can switch to a drug that’s compatible with pregnancy,” she said.
This whole thought process regarding pregnancy planning could work toward useful health goals, said Dr. Chambers. “Nobody thinks termination is the preferred method, but planning ahead should involve a discussion of what works best for the patient.”
Patients do have other choices, said Dr. Grifka. “Fortunately, there are many commonly prescribed medications which cross the placenta and have no ill effects on the fetus.”
Talking to patients about choices
Dr. Clowse, who spends a lot of time training rheumatologists, encourages them to have conversations with patients about pregnancy planning. It’s a lot to manage, getting the right drug to a female patient with chronic illness, especially in this current climate of abortion upheaval, she noted.
Her approach is to have an open and honest conversation with patients about their concerns and fears, what the realities are, and what the potential future options are for certain rheumatology drugs in the United States.
Some women who see what’s happening across the country may become so risk averse that they may choose to die rather than take a lifesaving drug that poses certain risks under new restrictions.
“I think that’s tragic,” said Dr. Clowse.
To help their patients, Dr. Gray believes physicians across specialties should better educate themselves about physiology in pregnancy and how to counsel patients on the impact of not taking medications in pregnancy.
In her view, it’s almost coercive to say to a patient, “You really need to have effective contraception if I’m going to give you this lifesaving or quality-of-life-improving medication.”
When confronting such scenarios, Dr. Gray doesn’t think physicians need to change how they counsel patients about contraception. “I don’t think we should be putting pressure on patients to consider other permanent methods just because there’s a lack of abortion options.”
Patients will eventually make those decisions for themselves, she said. “They’re going to want a more efficacious method because they’re worried about not having access to abortion if they get pregnant.”
Dr. Gray reports being a site principal investigator for a phase 3 trial for VeraCept IUD, funded by Sebela Pharmaceuticals. Dr. Clowse reports receiving research funding and doing consulting for GlaxoSmithKline.
*Correction, 6/2/2022: A previous version of this article misstated the intended use of drugs such as the “morning-after” pill (levonorgestrel). They are taken to prevent unintended pregnancy.
A version of this article first appeared on Medscape.com .
Attention deficit hyperactivity disorder increases the risk for migraine in children and adolescents
Key clinical point: The prevalence of migraine is higher in children and adolescents with attention deficit hyperactivity disorder (ADHD) vs those without.
Major finding: The risk of developing migraine was significantly higher in patients with ADHD than in matched controls (adjusted hazard ratio [aHR] 1.92; 95% CI 1.64-2.31) with the risk being prominent in children (aHR 2.01; 95% CI 1.63-2.49) and adolescents (aHR 1.94; 95% CI 1.35-2.79) but not in young adults with ADHD.
Study details: This was a nationwide longitudinal case-cohort study including 81,441 patients (including children, adolescents, and young adults aged 3-11, 12-17, and 18-29 years, respectively) with ADHD and 81,441 matched controls without ADHD.
Disclosures: The study was supported by grants from Taipei Veterans General Hospital; Kaohsiung Veterans General Hospital; Yen Tjing Ling Medical Foundation; and the Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.
Source: Hsu T-W et al. Attention deficit hyperactivity disorder and risk of migraine: A nationwide longitudinal study. Headache. 2022 (May 6). Doi: 10.1111/head.14306
Key clinical point: The prevalence of migraine is higher in children and adolescents with attention deficit hyperactivity disorder (ADHD) vs those without.
Major finding: The risk of developing migraine was significantly higher in patients with ADHD than in matched controls (adjusted hazard ratio [aHR] 1.92; 95% CI 1.64-2.31) with the risk being prominent in children (aHR 2.01; 95% CI 1.63-2.49) and adolescents (aHR 1.94; 95% CI 1.35-2.79) but not in young adults with ADHD.
Study details: This was a nationwide longitudinal case-cohort study including 81,441 patients (including children, adolescents, and young adults aged 3-11, 12-17, and 18-29 years, respectively) with ADHD and 81,441 matched controls without ADHD.
Disclosures: The study was supported by grants from Taipei Veterans General Hospital; Kaohsiung Veterans General Hospital; Yen Tjing Ling Medical Foundation; and the Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.
Source: Hsu T-W et al. Attention deficit hyperactivity disorder and risk of migraine: A nationwide longitudinal study. Headache. 2022 (May 6). Doi: 10.1111/head.14306
Key clinical point: The prevalence of migraine is higher in children and adolescents with attention deficit hyperactivity disorder (ADHD) vs those without.
Major finding: The risk of developing migraine was significantly higher in patients with ADHD than in matched controls (adjusted hazard ratio [aHR] 1.92; 95% CI 1.64-2.31) with the risk being prominent in children (aHR 2.01; 95% CI 1.63-2.49) and adolescents (aHR 1.94; 95% CI 1.35-2.79) but not in young adults with ADHD.
Study details: This was a nationwide longitudinal case-cohort study including 81,441 patients (including children, adolescents, and young adults aged 3-11, 12-17, and 18-29 years, respectively) with ADHD and 81,441 matched controls without ADHD.
Disclosures: The study was supported by grants from Taipei Veterans General Hospital; Kaohsiung Veterans General Hospital; Yen Tjing Ling Medical Foundation; and the Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.
Source: Hsu T-W et al. Attention deficit hyperactivity disorder and risk of migraine: A nationwide longitudinal study. Headache. 2022 (May 6). Doi: 10.1111/head.14306
Plasma glutamate level: A potential indicator for episodic and chronic migraines
Key clinical point: Interictal levels of plasma glutamate are elevated in patients with episodic migraine (EM) and chronic migraine (CM), thus qualifying it as a potential marker for both EM and CM.
Major finding: Plasma glutamate levels were significantly higher in patients with EM (49.73 μmol/L [95% CI 40.82-66.12] ) and CM (58.70 μmol/L [95% CI 44.64-72.46]) vs control participants (38.79 μmol/L [95% CI 29.50-53.60]; P < .001).
Study details: This single-center study included 240 women aged 19-65 years, of which 98 had EM, 92 had CM, and 50 were nonmigraine control participants.
Disclosures: The study was supported by a National Research Foundation of Korea (NRF) grant from the Korean government. MK Chu declared serving as a site investigator for a multicenter trial and an advisory member for and receiving lecture honoraria and grants from various organizations, including NRF.
Source: Park CG, Chu MK. Interictal plasma glutamate levels are elevated in individuals with episodic and chronic migraine. Sci Rep. 2022;12:6921 (Apr 28). Doi: 10.1038/s41598-022-10883-9
Key clinical point: Interictal levels of plasma glutamate are elevated in patients with episodic migraine (EM) and chronic migraine (CM), thus qualifying it as a potential marker for both EM and CM.
Major finding: Plasma glutamate levels were significantly higher in patients with EM (49.73 μmol/L [95% CI 40.82-66.12] ) and CM (58.70 μmol/L [95% CI 44.64-72.46]) vs control participants (38.79 μmol/L [95% CI 29.50-53.60]; P < .001).
Study details: This single-center study included 240 women aged 19-65 years, of which 98 had EM, 92 had CM, and 50 were nonmigraine control participants.
Disclosures: The study was supported by a National Research Foundation of Korea (NRF) grant from the Korean government. MK Chu declared serving as a site investigator for a multicenter trial and an advisory member for and receiving lecture honoraria and grants from various organizations, including NRF.
Source: Park CG, Chu MK. Interictal plasma glutamate levels are elevated in individuals with episodic and chronic migraine. Sci Rep. 2022;12:6921 (Apr 28). Doi: 10.1038/s41598-022-10883-9
Key clinical point: Interictal levels of plasma glutamate are elevated in patients with episodic migraine (EM) and chronic migraine (CM), thus qualifying it as a potential marker for both EM and CM.
Major finding: Plasma glutamate levels were significantly higher in patients with EM (49.73 μmol/L [95% CI 40.82-66.12] ) and CM (58.70 μmol/L [95% CI 44.64-72.46]) vs control participants (38.79 μmol/L [95% CI 29.50-53.60]; P < .001).
Study details: This single-center study included 240 women aged 19-65 years, of which 98 had EM, 92 had CM, and 50 were nonmigraine control participants.
Disclosures: The study was supported by a National Research Foundation of Korea (NRF) grant from the Korean government. MK Chu declared serving as a site investigator for a multicenter trial and an advisory member for and receiving lecture honoraria and grants from various organizations, including NRF.
Source: Park CG, Chu MK. Interictal plasma glutamate levels are elevated in individuals with episodic and chronic migraine. Sci Rep. 2022;12:6921 (Apr 28). Doi: 10.1038/s41598-022-10883-9
Patients with migraine show high adherence and persistence to fremanezumab in a real-world setting
Key clinical point: Adherence and persistence to fremanezumab was high among patients with migraine, especially for quarterly vs monthly dosing.
Major finding: After 6 months of fremanezumab initiation, the mean proportion of days covered (PDC) and medication possession ratio (MPR) were 86.1% and 88.7% respectively, with 74.8% and 79.0% of patients being classified as higher adherers by PDC (≥80%) and MPR (≥80%), respectively. Quarterly vs monthly fremanezumab was associated with significantly higher adherence (P ≤ .006) and mean persistence rates (P = .011).
Study details: This was a retrospective study including 987 adult patients with ≥1 migraine diagnosis during the study period who received fremanezumab on or after diagnosis.
Disclosures: The study was sponsored by Teva Pharmaceuticals. Some authors reported being current orformer employees of Teva.
Source: Krasenbaum LJ et al. A real-world study of acute and preventive medication use, adherence, and persistence in patients prescribed fremanezumab in the United States. J Headache Pain. 2022;23:54 (May 4). Doi: 10.1186/s10194-022-01413-z
Key clinical point: Adherence and persistence to fremanezumab was high among patients with migraine, especially for quarterly vs monthly dosing.
Major finding: After 6 months of fremanezumab initiation, the mean proportion of days covered (PDC) and medication possession ratio (MPR) were 86.1% and 88.7% respectively, with 74.8% and 79.0% of patients being classified as higher adherers by PDC (≥80%) and MPR (≥80%), respectively. Quarterly vs monthly fremanezumab was associated with significantly higher adherence (P ≤ .006) and mean persistence rates (P = .011).
Study details: This was a retrospective study including 987 adult patients with ≥1 migraine diagnosis during the study period who received fremanezumab on or after diagnosis.
Disclosures: The study was sponsored by Teva Pharmaceuticals. Some authors reported being current orformer employees of Teva.
Source: Krasenbaum LJ et al. A real-world study of acute and preventive medication use, adherence, and persistence in patients prescribed fremanezumab in the United States. J Headache Pain. 2022;23:54 (May 4). Doi: 10.1186/s10194-022-01413-z
Key clinical point: Adherence and persistence to fremanezumab was high among patients with migraine, especially for quarterly vs monthly dosing.
Major finding: After 6 months of fremanezumab initiation, the mean proportion of days covered (PDC) and medication possession ratio (MPR) were 86.1% and 88.7% respectively, with 74.8% and 79.0% of patients being classified as higher adherers by PDC (≥80%) and MPR (≥80%), respectively. Quarterly vs monthly fremanezumab was associated with significantly higher adherence (P ≤ .006) and mean persistence rates (P = .011).
Study details: This was a retrospective study including 987 adult patients with ≥1 migraine diagnosis during the study period who received fremanezumab on or after diagnosis.
Disclosures: The study was sponsored by Teva Pharmaceuticals. Some authors reported being current orformer employees of Teva.
Source: Krasenbaum LJ et al. A real-world study of acute and preventive medication use, adherence, and persistence in patients prescribed fremanezumab in the United States. J Headache Pain. 2022;23:54 (May 4). Doi: 10.1186/s10194-022-01413-z
Is migraine related to adverse pregnancy outcomes?
Key clinical point: With self-reported migraine being associated with 26% higher odds of adverse pregnancy outcomes (APO), it may be a significant risk factor for APO.
Major finding: After adjusting for confounding factors, women with migraine showed increased odds of any APO (adjusted odds ratio 1.26; 95% CI 1.12-1.41).
Study details: This was a multicenter prospective study, nuMoM2b, including 9450 nulliparous singleton pregnant women in early gestation, of which 1752 self-reported migraine at the first-trimester visit.
Disclosures: The nuMoM2b study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Case Western Reserve University, and Columbia University, among others. EC Miller and NA Bello declared receiving financial support from various sources.
Source: Miller EC et al. Migraine and adverse pregnancy outcomes: the nuMoM2b study. Am J Obstet Gynecol. 2022 (May 2). Doi: 10.1016/j.ajog.2022.04.049
Key clinical point: With self-reported migraine being associated with 26% higher odds of adverse pregnancy outcomes (APO), it may be a significant risk factor for APO.
Major finding: After adjusting for confounding factors, women with migraine showed increased odds of any APO (adjusted odds ratio 1.26; 95% CI 1.12-1.41).
Study details: This was a multicenter prospective study, nuMoM2b, including 9450 nulliparous singleton pregnant women in early gestation, of which 1752 self-reported migraine at the first-trimester visit.
Disclosures: The nuMoM2b study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Case Western Reserve University, and Columbia University, among others. EC Miller and NA Bello declared receiving financial support from various sources.
Source: Miller EC et al. Migraine and adverse pregnancy outcomes: the nuMoM2b study. Am J Obstet Gynecol. 2022 (May 2). Doi: 10.1016/j.ajog.2022.04.049
Key clinical point: With self-reported migraine being associated with 26% higher odds of adverse pregnancy outcomes (APO), it may be a significant risk factor for APO.
Major finding: After adjusting for confounding factors, women with migraine showed increased odds of any APO (adjusted odds ratio 1.26; 95% CI 1.12-1.41).
Study details: This was a multicenter prospective study, nuMoM2b, including 9450 nulliparous singleton pregnant women in early gestation, of which 1752 self-reported migraine at the first-trimester visit.
Disclosures: The nuMoM2b study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Case Western Reserve University, and Columbia University, among others. EC Miller and NA Bello declared receiving financial support from various sources.
Source: Miller EC et al. Migraine and adverse pregnancy outcomes: the nuMoM2b study. Am J Obstet Gynecol. 2022 (May 2). Doi: 10.1016/j.ajog.2022.04.049
Subcutaneous injection of diclofenac sodium is effective against acute migraine
Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.
Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.
Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.
Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.
Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712
Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.
Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.
Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.
Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.
Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712
Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.
Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.
Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.
Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.
Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712
Migraine: Ubrogepant therapy yields favorable 2-hour outcomes in triptan insufficient responders
Key clinical point: Compared with placebo, ubrogepant therapy provides favorable 2-hour outcomes, as measured by functional disability, medication satisfaction, and impression of overall change in migraine, in patients with migraine who are triptan insufficient responders (TIR).
Major finding: At 2 hours after initial dose of ubrogepant vs placebo, significantly greater proportion of patients reported no disability (38% vs 29%; odds ratio [OR] 1.5; P = .048), treatment satisfaction (33% vs 21%; OR 1.8; P = .006), and improvement in migraine (30% vs 18%; OR 2.0; P = .006).
Study details: This post hoc analysis included 1799 patients with migraine with or without aura from the phase 3 ACHIEVE I and ACHIEVE II trials who were self-reported TIR and received 50 mg ubrogepant (n = 887) or placebo (n = 912).
Disclosures: The study was funded by Allergan (before acquisition by AbbVie). Some authors declared serving as consultants or advisory board members and receiving research support, honoraria, or royalties from various sources, including AbbVie/Allergan. The other authors are current or former employees and stockholders of AbbVie.
Source: Lipton RB et al. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: A post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022;23:50 (Apr 25). Doi: 10.1186/s10194-022-01419-7
Key clinical point: Compared with placebo, ubrogepant therapy provides favorable 2-hour outcomes, as measured by functional disability, medication satisfaction, and impression of overall change in migraine, in patients with migraine who are triptan insufficient responders (TIR).
Major finding: At 2 hours after initial dose of ubrogepant vs placebo, significantly greater proportion of patients reported no disability (38% vs 29%; odds ratio [OR] 1.5; P = .048), treatment satisfaction (33% vs 21%; OR 1.8; P = .006), and improvement in migraine (30% vs 18%; OR 2.0; P = .006).
Study details: This post hoc analysis included 1799 patients with migraine with or without aura from the phase 3 ACHIEVE I and ACHIEVE II trials who were self-reported TIR and received 50 mg ubrogepant (n = 887) or placebo (n = 912).
Disclosures: The study was funded by Allergan (before acquisition by AbbVie). Some authors declared serving as consultants or advisory board members and receiving research support, honoraria, or royalties from various sources, including AbbVie/Allergan. The other authors are current or former employees and stockholders of AbbVie.
Source: Lipton RB et al. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: A post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022;23:50 (Apr 25). Doi: 10.1186/s10194-022-01419-7
Key clinical point: Compared with placebo, ubrogepant therapy provides favorable 2-hour outcomes, as measured by functional disability, medication satisfaction, and impression of overall change in migraine, in patients with migraine who are triptan insufficient responders (TIR).
Major finding: At 2 hours after initial dose of ubrogepant vs placebo, significantly greater proportion of patients reported no disability (38% vs 29%; odds ratio [OR] 1.5; P = .048), treatment satisfaction (33% vs 21%; OR 1.8; P = .006), and improvement in migraine (30% vs 18%; OR 2.0; P = .006).
Study details: This post hoc analysis included 1799 patients with migraine with or without aura from the phase 3 ACHIEVE I and ACHIEVE II trials who were self-reported TIR and received 50 mg ubrogepant (n = 887) or placebo (n = 912).
Disclosures: The study was funded by Allergan (before acquisition by AbbVie). Some authors declared serving as consultants or advisory board members and receiving research support, honoraria, or royalties from various sources, including AbbVie/Allergan. The other authors are current or former employees and stockholders of AbbVie.
Source: Lipton RB et al. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: A post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022;23:50 (Apr 25). Doi: 10.1186/s10194-022-01419-7
Galcanezumab reduces acute headache medication use in treatment-resistant migraine
Key clinical point: In treatment-resistant episodic or chronic migraine, galcanezumab therapy can help achieve a clinically meaningful reduction in monthly acute headache medication use.
Major finding: Galcanezumab vs. placebo led to a significantly greater least-squares mean reduction in monthly acute headache medication use from 1 to 3 months (4.2 vs 0.8 days; P < .0001). At 6 months, the monthly acute headache medication use was similar between the groups.
Study details: The data come from the phase 3 CONQUER study including 462 patients with treatment-resistant episodic or chronic migraine who were randomly assigned to receive galcanezumab (n = 232) or placebo (n = 230) in the double-blind phase (months 1-3), followed by galcanezumab in the open-label phase (months 4-6).
Disclosures: The study was sponsored by Eli Lilly and Company. Some authors declared being on the advisory board or speakers’ bureau for and receiving consulting fees, speaker fees, honoraria, or travel support from various sources, including Eli Lilly. The other authors are employees or stockholders of Eli Lilly or one of its subsidiaries.
Source: Ambrosini A et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022 (Apr 22). Doi: 10.18553/jmcp.2022.21375
Key clinical point: In treatment-resistant episodic or chronic migraine, galcanezumab therapy can help achieve a clinically meaningful reduction in monthly acute headache medication use.
Major finding: Galcanezumab vs. placebo led to a significantly greater least-squares mean reduction in monthly acute headache medication use from 1 to 3 months (4.2 vs 0.8 days; P < .0001). At 6 months, the monthly acute headache medication use was similar between the groups.
Study details: The data come from the phase 3 CONQUER study including 462 patients with treatment-resistant episodic or chronic migraine who were randomly assigned to receive galcanezumab (n = 232) or placebo (n = 230) in the double-blind phase (months 1-3), followed by galcanezumab in the open-label phase (months 4-6).
Disclosures: The study was sponsored by Eli Lilly and Company. Some authors declared being on the advisory board or speakers’ bureau for and receiving consulting fees, speaker fees, honoraria, or travel support from various sources, including Eli Lilly. The other authors are employees or stockholders of Eli Lilly or one of its subsidiaries.
Source: Ambrosini A et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022 (Apr 22). Doi: 10.18553/jmcp.2022.21375
Key clinical point: In treatment-resistant episodic or chronic migraine, galcanezumab therapy can help achieve a clinically meaningful reduction in monthly acute headache medication use.
Major finding: Galcanezumab vs. placebo led to a significantly greater least-squares mean reduction in monthly acute headache medication use from 1 to 3 months (4.2 vs 0.8 days; P < .0001). At 6 months, the monthly acute headache medication use was similar between the groups.
Study details: The data come from the phase 3 CONQUER study including 462 patients with treatment-resistant episodic or chronic migraine who were randomly assigned to receive galcanezumab (n = 232) or placebo (n = 230) in the double-blind phase (months 1-3), followed by galcanezumab in the open-label phase (months 4-6).
Disclosures: The study was sponsored by Eli Lilly and Company. Some authors declared being on the advisory board or speakers’ bureau for and receiving consulting fees, speaker fees, honoraria, or travel support from various sources, including Eli Lilly. The other authors are employees or stockholders of Eli Lilly or one of its subsidiaries.
Source: Ambrosini A et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022 (Apr 22). Doi: 10.18553/jmcp.2022.21375