Clinical Edge Journal Scan

The US Food and Drug Administration (FDA) has issued a warning to the public about counterfeit semaglutide (Ozempic) products that have entered the US drug supply. 

Clinicians and patients are advised to check the product packages they have received and not to use those labeled with lot number NAR0074 and serial number 430834149057. Some of these counterfeit products may still be available for purchase, the FDA said in a statement. 

Together with Ozempic manufacturer Novo Nordisk, the FDA is investigating “thousands of units” of the 1-mg injection product. Information is not yet available regarding the drugs’ identity, quality, or safety. However, the pen needles have been confirmed as fake — thereby raising the potential risk for infection — as have the pen labels, accompanying health care professional and patient label information, and carton. 

“FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US,” the statement says. 

Patients are advised to only obtain Ozempic with a valid prescription through state-licensed pharmacies and to check the product before using for any signs of counterfeiting. There are several differences between the genuine and counterfeit products in the way the pen needle is packaged. The most obvious is that the paper tab covering the fake needle says “Novofine®” whereas the genuine one says “Novofine® Plus.” 

There have been at least five adverse events reported from this lot; none were serious and all were consistent with gastrointestinal issues known to occur with the genuine product. 

Counterfeit products should be reported to the FDA ‘s consumer complaint coordinator or to the criminal activity division.

A version of this article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has issued a warning to the public about counterfeit semaglutide (Ozempic) products that have entered the US drug supply. 

Clinicians and patients are advised to check the product packages they have received and not to use those labeled with lot number NAR0074 and serial number 430834149057. Some of these counterfeit products may still be available for purchase, the FDA said in a statement. 

Together with Ozempic manufacturer Novo Nordisk, the FDA is investigating “thousands of units” of the 1-mg injection product. Information is not yet available regarding the drugs’ identity, quality, or safety. However, the pen needles have been confirmed as fake — thereby raising the potential risk for infection — as have the pen labels, accompanying health care professional and patient label information, and carton. 

“FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US,” the statement says. 

Patients are advised to only obtain Ozempic with a valid prescription through state-licensed pharmacies and to check the product before using for any signs of counterfeiting. There are several differences between the genuine and counterfeit products in the way the pen needle is packaged. The most obvious is that the paper tab covering the fake needle says “Novofine®” whereas the genuine one says “Novofine® Plus.” 

There have been at least five adverse events reported from this lot; none were serious and all were consistent with gastrointestinal issues known to occur with the genuine product. 

Counterfeit products should be reported to the FDA ‘s consumer complaint coordinator or to the criminal activity division.

A version of this article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has issued a warning to the public about counterfeit semaglutide (Ozempic) products that have entered the US drug supply. 

Clinicians and patients are advised to check the product packages they have received and not to use those labeled with lot number NAR0074 and serial number 430834149057. Some of these counterfeit products may still be available for purchase, the FDA said in a statement. 

Together with Ozempic manufacturer Novo Nordisk, the FDA is investigating “thousands of units” of the 1-mg injection product. Information is not yet available regarding the drugs’ identity, quality, or safety. However, the pen needles have been confirmed as fake — thereby raising the potential risk for infection — as have the pen labels, accompanying health care professional and patient label information, and carton. 

“FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US,” the statement says. 

Patients are advised to only obtain Ozempic with a valid prescription through state-licensed pharmacies and to check the product before using for any signs of counterfeiting. There are several differences between the genuine and counterfeit products in the way the pen needle is packaged. The most obvious is that the paper tab covering the fake needle says “Novofine®” whereas the genuine one says “Novofine® Plus.” 

There have been at least five adverse events reported from this lot; none were serious and all were consistent with gastrointestinal issues known to occur with the genuine product. 

Counterfeit products should be reported to the FDA ‘s consumer complaint coordinator or to the criminal activity division.

A version of this article first appeared on Medscape.com.

The recent 3-month double-blind study by Schwedt and colleagues included 580 participants and compared the effects of galcanezumab (Emgality) with those of rimegepant (Nurtec ODT). These medications are administered by different methods when used for migraine prevention; galcanezumab is given subcutaneously (SC) every month, whereas rimegepant is taken by mouth every other day. To blind the study, participants were randomly assigned to receive either 120 mg galcanezumab SC per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet every other day or every-other-day 75 mg rimegepant as oral disintegrating tablets and a monthly SC placebo. According to the study authors, 62% of the patients receiving galcanezumab vs 61% of those receiving rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, with no statistically significant difference between the groups. Comparisons between CGRP receptor antagonists are scarce. The studies tend to be of a short duration and to include small sample sizes — and most are retrospective. To date, physicians who treat patients with these drugs do not have information about the distinguishing characteristics between these treatments that could be used to guide drug selection for subtypes of migraine or different patient populations. As further research emerges, we may see distinctions between these therapies, or we might continue to see that their effects are similar in terms of benefits, duration of action, and patient characteristics.

Many patients who are prescribed these new medications have already been treated with a variety of other previously available migraine therapies, with varying degrees of improvement. Physicians who prescribe treatments for migraine patients often move on to new therapeutic options when patients only experience partial relief, but recent research suggests that even these incomplete responses could be beneficial for patients.

Researchers at the Headache Centre — Neurology Clinic at the Spedali Civili di Brescia in Brescia, Italy, conducted a retrospective study to examine whether previous treatment with onabotulinumtoxinA affected patent response to anti-CGRP mAb (Ceccardi et al). These treatments have differing mechanisms. OnabotulinumtoxinA is an exotoxin produced by Clostridium botulinum that blocks the acetylcholine release from nerve endings temporarily disabling postsynaptic action. Anti-CGRP mAb work by inhibiting the inflammatory receptor, thereby inhibiting the pain sensation.²

Several studies have examined the effects of combining onabotulinumtoxinA (Botox) with anti-CGRP mAb, with varying results. For example, researchers of a study designed to compare the two treatments concluded, "In patients with chronic migraine who have only had a partial response to Botox, adjunctive preventative therapy with a CGRP-mAb drug is safe and effective."² A review examining several small studies that evaluated the response of dual therapy included a few studies that found no significant differences between an anti-CGRP mAb monotherapy and dual therapy with onabotulinumtoxinA, as well as some studies that noted improvement with dual therapy over either therapy alone. The review authors concluded that a real-life application is not yet determined and that "Further sufficiently powered, placebo-controlled studies are warranted to shed light on potential additive or synergistic effects of combining onabotulinumtoxin A with a CGRP antagonist."³

The Brescia study was designed to examine the effect of previous onabotulinumtoxinA treatment on subsequent anti-CGRP mAb response. The researchers enrolled 128 patients, of whom 51 (39.9%) had previously been treated with onabotulinumtoxinA, with the last dose 3 months before preventive treatment with an anti-CGRP mAb was started. The study was conducted between November 2018 and May 2023. The outcomes noted included monthly headache days, monthly migraine days, mean analgesic consumption, and clinical disability according to the Migraine Disability Assessment test (MIDAS). Participants received 3 months of treatment with an anti-CGRP mAb.

In addition to comparing patients who had previously received onabotulinumtoxinA with those who did not, the researchers also "aimed to evaluate whether the clinical response to anti-CGRP mAb was affected by the number of previous Onabotulinumtoxin-A administrations.

The documented baseline prior to treatment with an anti-CGRP mAb was as follows: mean monthly headache days 23.7 (SD 5.7), monthly migraine days 13.9 (SD 8.0); mean MIDAS score 108.9 (SD 76.1); and mean analgesic consumption 24.8 (SD 18.8). After 3 months of treatment with an anti-CGRP mAb, both groups experienced significant improvement in all these parameters. Furthermore, after 3 months of treatment with an anti-CGRP mAb, the patients who received at least three onabotulinumtoxinA administrations prior to the study experienced lower MMD compared with those who had received fewer cycles.

For physicians and patients, this outcome provides validation that patients can potentially gain long-term benefits from migraine treatment, even if such interventions do not provide sufficient migraine relief. The conclusion cannot be generalized to other migraine treatment sequences, and the authors did not suggest deliberately postponing any treatment or using any treatment as "priming" for another treatment. Yet physicians may be able to give patients some reassurance that an incomplete response in migraine therapy is not futile.

Migraine treatment can be very effective, but sometimes it is not clear whether patients should take their medication before or during a migraine episode, or whether the signal to take medication should be based on specific symptoms. Many patients wait to take their migraine treatment until they are sure that they will have a migraine, especially if they frequently have prodromal symptoms that do not consistently lead to a migraine. Additionally, some of the new CGRP receptor antagonists are expensive, and many payers only approve a limited amount per month. Patients might not want to waste their CGRP receptor antagonist supply in case they run out before their next refill authorization.

AbbVie, the makers of ubrogepant (Ubrelvy), a CGRP receptor antagonist approved for acute treatment of migraine, conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial of ubrogepant at 75 research centers and headache clinics in the US (Dodick et al). According to the manufacturer, the aim of the trial was to evaluate the efficacy, safety, and tolerability of 100 mg ubrogepant for the acute treatment of migraine when administered during the prodrome of a migraine attack. The study included 518 participants age 18-75 years who had at least a 1-year history of migraine and had had two to eight migraine attacks per month that included symptoms of a moderate to severe headache in each of the 3 months before the study. Because this was a crossover trial, the participants were randomly assigned to either receive placebo for treatment of the first qualifying prodrome event and 100 mg ubrogepant for treatment of the second qualifying prodrome event or to receive 100 mg ubrogepant to treat the first qualifying prodrome event and placebo to treat the second qualifying prodrome event.

According to AbbVie's news release following publication of the study, "Absence of moderate or severe intensity headache within 24 hours was achieved following 46% of qualifying prodrome events when treated with UBRELVY vs 29% of placebo-treated events" and "absence of moderate or severe intensity headache within 48 hours was achieved following 41% of qualifying prodrome events when treated with UBRELVY vs 25% of placebo-treated events" (both P < .0001).⁴ Safety and tolerability of treatment during the prodromal period were also established.

In clinical practice, these results hold promise because patients can gain some assurance in knowing that taking their migraine treatment during their early prodromal symptoms is safe and could potentially improve the outcome of the event, preventing migraine symptoms for 48 hours. Even for patients who do not have an ample supply of ubrogepant or another CGRP antagonist, taking a treatment that is approved by their doctor at the onset of prodromal symptoms can provide relief compared with waiting until symptoms worsen.

Additional References

1. Waliszewska-Prosół M, Vuralli D, Martelletti P. What to do with non-responders to CGRP(r) monoclonal antibodies: Switch to another or move to gepants? J Headache Pain. 2023;24:163. doi: 10.1186/s10194-023-01698-8

2. Pallapothu MR, Quintana Mariñez MG, Chakkera M, et al. Long-term management of migraine with OnabotulinumtoxinA (Botox) vs calcitonin gene-related peptide antibodies (Anti-CGRP). Cureus. 2023;15:e46696. doi: 10.7759/cureus.46696

3. Pellesi L. Combining onabotulinumtoxin A with a CGRP antagonist for chronic migraine prophylaxis: Where do we stand? Front Pain Res (Lausanne). 2023;4:1292994. doi: 10.3389/fpain.2023.1292994

4. AbbVie. Results published in The Lancet show UBRELVY® (ubrogepant) reduces the headache phase of a migraine attack when dosed during the prodrome of migraine. November 16, 2023. Source

The recent 3-month double-blind study by Schwedt and colleagues included 580 participants and compared the effects of galcanezumab (Emgality) with those of rimegepant (Nurtec ODT). These medications are administered by different methods when used for migraine prevention; galcanezumab is given subcutaneously (SC) every month, whereas rimegepant is taken by mouth every other day. To blind the study, participants were randomly assigned to receive either 120 mg galcanezumab SC per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet every other day or every-other-day 75 mg rimegepant as oral disintegrating tablets and a monthly SC placebo. According to the study authors, 62% of the patients receiving galcanezumab vs 61% of those receiving rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, with no statistically significant difference between the groups. Comparisons between CGRP receptor antagonists are scarce. The studies tend to be of a short duration and to include small sample sizes — and most are retrospective. To date, physicians who treat patients with these drugs do not have information about the distinguishing characteristics between these treatments that could be used to guide drug selection for subtypes of migraine or different patient populations. As further research emerges, we may see distinctions between these therapies, or we might continue to see that their effects are similar in terms of benefits, duration of action, and patient characteristics.

Many patients who are prescribed these new medications have already been treated with a variety of other previously available migraine therapies, with varying degrees of improvement. Physicians who prescribe treatments for migraine patients often move on to new therapeutic options when patients only experience partial relief, but recent research suggests that even these incomplete responses could be beneficial for patients.

Researchers at the Headache Centre — Neurology Clinic at the Spedali Civili di Brescia in Brescia, Italy, conducted a retrospective study to examine whether previous treatment with onabotulinumtoxinA affected patent response to anti-CGRP mAb (Ceccardi et al). These treatments have differing mechanisms. OnabotulinumtoxinA is an exotoxin produced by Clostridium botulinum that blocks the acetylcholine release from nerve endings temporarily disabling postsynaptic action. Anti-CGRP mAb work by inhibiting the inflammatory receptor, thereby inhibiting the pain sensation.²

Several studies have examined the effects of combining onabotulinumtoxinA (Botox) with anti-CGRP mAb, with varying results. For example, researchers of a study designed to compare the two treatments concluded, "In patients with chronic migraine who have only had a partial response to Botox, adjunctive preventative therapy with a CGRP-mAb drug is safe and effective."² A review examining several small studies that evaluated the response of dual therapy included a few studies that found no significant differences between an anti-CGRP mAb monotherapy and dual therapy with onabotulinumtoxinA, as well as some studies that noted improvement with dual therapy over either therapy alone. The review authors concluded that a real-life application is not yet determined and that "Further sufficiently powered, placebo-controlled studies are warranted to shed light on potential additive or synergistic effects of combining onabotulinumtoxin A with a CGRP antagonist."³

The Brescia study was designed to examine the effect of previous onabotulinumtoxinA treatment on subsequent anti-CGRP mAb response. The researchers enrolled 128 patients, of whom 51 (39.9%) had previously been treated with onabotulinumtoxinA, with the last dose 3 months before preventive treatment with an anti-CGRP mAb was started. The study was conducted between November 2018 and May 2023. The outcomes noted included monthly headache days, monthly migraine days, mean analgesic consumption, and clinical disability according to the Migraine Disability Assessment test (MIDAS). Participants received 3 months of treatment with an anti-CGRP mAb.

In addition to comparing patients who had previously received onabotulinumtoxinA with those who did not, the researchers also "aimed to evaluate whether the clinical response to anti-CGRP mAb was affected by the number of previous Onabotulinumtoxin-A administrations.

The documented baseline prior to treatment with an anti-CGRP mAb was as follows: mean monthly headache days 23.7 (SD 5.7), monthly migraine days 13.9 (SD 8.0); mean MIDAS score 108.9 (SD 76.1); and mean analgesic consumption 24.8 (SD 18.8). After 3 months of treatment with an anti-CGRP mAb, both groups experienced significant improvement in all these parameters. Furthermore, after 3 months of treatment with an anti-CGRP mAb, the patients who received at least three onabotulinumtoxinA administrations prior to the study experienced lower MMD compared with those who had received fewer cycles.

For physicians and patients, this outcome provides validation that patients can potentially gain long-term benefits from migraine treatment, even if such interventions do not provide sufficient migraine relief. The conclusion cannot be generalized to other migraine treatment sequences, and the authors did not suggest deliberately postponing any treatment or using any treatment as "priming" for another treatment. Yet physicians may be able to give patients some reassurance that an incomplete response in migraine therapy is not futile.

Migraine treatment can be very effective, but sometimes it is not clear whether patients should take their medication before or during a migraine episode, or whether the signal to take medication should be based on specific symptoms. Many patients wait to take their migraine treatment until they are sure that they will have a migraine, especially if they frequently have prodromal symptoms that do not consistently lead to a migraine. Additionally, some of the new CGRP receptor antagonists are expensive, and many payers only approve a limited amount per month. Patients might not want to waste their CGRP receptor antagonist supply in case they run out before their next refill authorization.

AbbVie, the makers of ubrogepant (Ubrelvy), a CGRP receptor antagonist approved for acute treatment of migraine, conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial of ubrogepant at 75 research centers and headache clinics in the US (Dodick et al). According to the manufacturer, the aim of the trial was to evaluate the efficacy, safety, and tolerability of 100 mg ubrogepant for the acute treatment of migraine when administered during the prodrome of a migraine attack. The study included 518 participants age 18-75 years who had at least a 1-year history of migraine and had had two to eight migraine attacks per month that included symptoms of a moderate to severe headache in each of the 3 months before the study. Because this was a crossover trial, the participants were randomly assigned to either receive placebo for treatment of the first qualifying prodrome event and 100 mg ubrogepant for treatment of the second qualifying prodrome event or to receive 100 mg ubrogepant to treat the first qualifying prodrome event and placebo to treat the second qualifying prodrome event.

According to AbbVie's news release following publication of the study, "Absence of moderate or severe intensity headache within 24 hours was achieved following 46% of qualifying prodrome events when treated with UBRELVY vs 29% of placebo-treated events" and "absence of moderate or severe intensity headache within 48 hours was achieved following 41% of qualifying prodrome events when treated with UBRELVY vs 25% of placebo-treated events" (both P < .0001).⁴ Safety and tolerability of treatment during the prodromal period were also established.

In clinical practice, these results hold promise because patients can gain some assurance in knowing that taking their migraine treatment during their early prodromal symptoms is safe and could potentially improve the outcome of the event, preventing migraine symptoms for 48 hours. Even for patients who do not have an ample supply of ubrogepant or another CGRP antagonist, taking a treatment that is approved by their doctor at the onset of prodromal symptoms can provide relief compared with waiting until symptoms worsen.

Additional References

1. Waliszewska-Prosół M, Vuralli D, Martelletti P. What to do with non-responders to CGRP(r) monoclonal antibodies: Switch to another or move to gepants? J Headache Pain. 2023;24:163. doi: 10.1186/s10194-023-01698-8

2. Pallapothu MR, Quintana Mariñez MG, Chakkera M, et al. Long-term management of migraine with OnabotulinumtoxinA (Botox) vs calcitonin gene-related peptide antibodies (Anti-CGRP). Cureus. 2023;15:e46696. doi: 10.7759/cureus.46696

3. Pellesi L. Combining onabotulinumtoxin A with a CGRP antagonist for chronic migraine prophylaxis: Where do we stand? Front Pain Res (Lausanne). 2023;4:1292994. doi: 10.3389/fpain.2023.1292994

4. AbbVie. Results published in The Lancet show UBRELVY® (ubrogepant) reduces the headache phase of a migraine attack when dosed during the prodrome of migraine. November 16, 2023. Source

The recent 3-month double-blind study by Schwedt and colleagues included 580 participants and compared the effects of galcanezumab (Emgality) with those of rimegepant (Nurtec ODT). These medications are administered by different methods when used for migraine prevention; galcanezumab is given subcutaneously (SC) every month, whereas rimegepant is taken by mouth every other day. To blind the study, participants were randomly assigned to receive either 120 mg galcanezumab SC per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet every other day or every-other-day 75 mg rimegepant as oral disintegrating tablets and a monthly SC placebo. According to the study authors, 62% of the patients receiving galcanezumab vs 61% of those receiving rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, with no statistically significant difference between the groups. Comparisons between CGRP receptor antagonists are scarce. The studies tend to be of a short duration and to include small sample sizes — and most are retrospective. To date, physicians who treat patients with these drugs do not have information about the distinguishing characteristics between these treatments that could be used to guide drug selection for subtypes of migraine or different patient populations. As further research emerges, we may see distinctions between these therapies, or we might continue to see that their effects are similar in terms of benefits, duration of action, and patient characteristics.

Many patients who are prescribed these new medications have already been treated with a variety of other previously available migraine therapies, with varying degrees of improvement. Physicians who prescribe treatments for migraine patients often move on to new therapeutic options when patients only experience partial relief, but recent research suggests that even these incomplete responses could be beneficial for patients.

Researchers at the Headache Centre — Neurology Clinic at the Spedali Civili di Brescia in Brescia, Italy, conducted a retrospective study to examine whether previous treatment with onabotulinumtoxinA affected patent response to anti-CGRP mAb (Ceccardi et al). These treatments have differing mechanisms. OnabotulinumtoxinA is an exotoxin produced by Clostridium botulinum that blocks the acetylcholine release from nerve endings temporarily disabling postsynaptic action. Anti-CGRP mAb work by inhibiting the inflammatory receptor, thereby inhibiting the pain sensation.²

Several studies have examined the effects of combining onabotulinumtoxinA (Botox) with anti-CGRP mAb, with varying results. For example, researchers of a study designed to compare the two treatments concluded, "In patients with chronic migraine who have only had a partial response to Botox, adjunctive preventative therapy with a CGRP-mAb drug is safe and effective."² A review examining several small studies that evaluated the response of dual therapy included a few studies that found no significant differences between an anti-CGRP mAb monotherapy and dual therapy with onabotulinumtoxinA, as well as some studies that noted improvement with dual therapy over either therapy alone. The review authors concluded that a real-life application is not yet determined and that "Further sufficiently powered, placebo-controlled studies are warranted to shed light on potential additive or synergistic effects of combining onabotulinumtoxin A with a CGRP antagonist."³

The Brescia study was designed to examine the effect of previous onabotulinumtoxinA treatment on subsequent anti-CGRP mAb response. The researchers enrolled 128 patients, of whom 51 (39.9%) had previously been treated with onabotulinumtoxinA, with the last dose 3 months before preventive treatment with an anti-CGRP mAb was started. The study was conducted between November 2018 and May 2023. The outcomes noted included monthly headache days, monthly migraine days, mean analgesic consumption, and clinical disability according to the Migraine Disability Assessment test (MIDAS). Participants received 3 months of treatment with an anti-CGRP mAb.

In addition to comparing patients who had previously received onabotulinumtoxinA with those who did not, the researchers also "aimed to evaluate whether the clinical response to anti-CGRP mAb was affected by the number of previous Onabotulinumtoxin-A administrations.

The documented baseline prior to treatment with an anti-CGRP mAb was as follows: mean monthly headache days 23.7 (SD 5.7), monthly migraine days 13.9 (SD 8.0); mean MIDAS score 108.9 (SD 76.1); and mean analgesic consumption 24.8 (SD 18.8). After 3 months of treatment with an anti-CGRP mAb, both groups experienced significant improvement in all these parameters. Furthermore, after 3 months of treatment with an anti-CGRP mAb, the patients who received at least three onabotulinumtoxinA administrations prior to the study experienced lower MMD compared with those who had received fewer cycles.

For physicians and patients, this outcome provides validation that patients can potentially gain long-term benefits from migraine treatment, even if such interventions do not provide sufficient migraine relief. The conclusion cannot be generalized to other migraine treatment sequences, and the authors did not suggest deliberately postponing any treatment or using any treatment as "priming" for another treatment. Yet physicians may be able to give patients some reassurance that an incomplete response in migraine therapy is not futile.

Migraine treatment can be very effective, but sometimes it is not clear whether patients should take their medication before or during a migraine episode, or whether the signal to take medication should be based on specific symptoms. Many patients wait to take their migraine treatment until they are sure that they will have a migraine, especially if they frequently have prodromal symptoms that do not consistently lead to a migraine. Additionally, some of the new CGRP receptor antagonists are expensive, and many payers only approve a limited amount per month. Patients might not want to waste their CGRP receptor antagonist supply in case they run out before their next refill authorization.

AbbVie, the makers of ubrogepant (Ubrelvy), a CGRP receptor antagonist approved for acute treatment of migraine, conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial of ubrogepant at 75 research centers and headache clinics in the US (Dodick et al). According to the manufacturer, the aim of the trial was to evaluate the efficacy, safety, and tolerability of 100 mg ubrogepant for the acute treatment of migraine when administered during the prodrome of a migraine attack. The study included 518 participants age 18-75 years who had at least a 1-year history of migraine and had had two to eight migraine attacks per month that included symptoms of a moderate to severe headache in each of the 3 months before the study. Because this was a crossover trial, the participants were randomly assigned to either receive placebo for treatment of the first qualifying prodrome event and 100 mg ubrogepant for treatment of the second qualifying prodrome event or to receive 100 mg ubrogepant to treat the first qualifying prodrome event and placebo to treat the second qualifying prodrome event.

According to AbbVie's news release following publication of the study, "Absence of moderate or severe intensity headache within 24 hours was achieved following 46% of qualifying prodrome events when treated with UBRELVY vs 29% of placebo-treated events" and "absence of moderate or severe intensity headache within 48 hours was achieved following 41% of qualifying prodrome events when treated with UBRELVY vs 25% of placebo-treated events" (both P < .0001).⁴ Safety and tolerability of treatment during the prodromal period were also established.

In clinical practice, these results hold promise because patients can gain some assurance in knowing that taking their migraine treatment during their early prodromal symptoms is safe and could potentially improve the outcome of the event, preventing migraine symptoms for 48 hours. Even for patients who do not have an ample supply of ubrogepant or another CGRP antagonist, taking a treatment that is approved by their doctor at the onset of prodromal symptoms can provide relief compared with waiting until symptoms worsen.

Additional References

1. Waliszewska-Prosół M, Vuralli D, Martelletti P. What to do with non-responders to CGRP(r) monoclonal antibodies: Switch to another or move to gepants? J Headache Pain. 2023;24:163. doi: 10.1186/s10194-023-01698-8

2. Pallapothu MR, Quintana Mariñez MG, Chakkera M, et al. Long-term management of migraine with OnabotulinumtoxinA (Botox) vs calcitonin gene-related peptide antibodies (Anti-CGRP). Cureus. 2023;15:e46696. doi: 10.7759/cureus.46696

3. Pellesi L. Combining onabotulinumtoxin A with a CGRP antagonist for chronic migraine prophylaxis: Where do we stand? Front Pain Res (Lausanne). 2023;4:1292994. doi: 10.3389/fpain.2023.1292994

4. AbbVie. Results published in The Lancet show UBRELVY® (ubrogepant) reduces the headache phase of a migraine attack when dosed during the prodrome of migraine. November 16, 2023. Source

Key clinical point: Fremanezumab demonstrated improved efficacy, tolerability, and safety outcomes in patients with chronic or episodic migraine who reported prior inadequate response to 2-4 classes of preventive migraine medications.

Major finding: At 12 weeks, the number needed to treat to achieve ≥50% reduction in monthly average number of migraine days was 3.9 with both quarterly and monthly fremanezumab dosing. The numbers needed to harm for one patient to discontinue treatment due to adverse events were 1000 and 144 for quarterly and monthly fremanezumab dosing, respectively.

Study details: This post hoc analysis of the FOCUS trial included 838 patients with chronic (n = 509) or episodic (n = 329) migraine who had prior inadequate response to 2-4 migraine preventive medication classes and were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Three authors declared being employees of Teva Pharmaceuticals, and  other authors declared having ties with various sources including Teva Pharmaceuticals.

Source: Ashina M et al. Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis. Headache. 2023;63(10):1351-1358 (Nov 13). doi: 10.1111/head.14651

Key clinical point: Fremanezumab demonstrated improved efficacy, tolerability, and safety outcomes in patients with chronic or episodic migraine who reported prior inadequate response to 2-4 classes of preventive migraine medications.

Major finding: At 12 weeks, the number needed to treat to achieve ≥50% reduction in monthly average number of migraine days was 3.9 with both quarterly and monthly fremanezumab dosing. The numbers needed to harm for one patient to discontinue treatment due to adverse events were 1000 and 144 for quarterly and monthly fremanezumab dosing, respectively.

Study details: This post hoc analysis of the FOCUS trial included 838 patients with chronic (n = 509) or episodic (n = 329) migraine who had prior inadequate response to 2-4 migraine preventive medication classes and were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Three authors declared being employees of Teva Pharmaceuticals, and  other authors declared having ties with various sources including Teva Pharmaceuticals.

Source: Ashina M et al. Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis. Headache. 2023;63(10):1351-1358 (Nov 13). doi: 10.1111/head.14651

Key clinical point: Fremanezumab demonstrated improved efficacy, tolerability, and safety outcomes in patients with chronic or episodic migraine who reported prior inadequate response to 2-4 classes of preventive migraine medications.

Major finding: At 12 weeks, the number needed to treat to achieve ≥50% reduction in monthly average number of migraine days was 3.9 with both quarterly and monthly fremanezumab dosing. The numbers needed to harm for one patient to discontinue treatment due to adverse events were 1000 and 144 for quarterly and monthly fremanezumab dosing, respectively.

Study details: This post hoc analysis of the FOCUS trial included 838 patients with chronic (n = 509) or episodic (n = 329) migraine who had prior inadequate response to 2-4 migraine preventive medication classes and were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Three authors declared being employees of Teva Pharmaceuticals, and  other authors declared having ties with various sources including Teva Pharmaceuticals.

Source: Ashina M et al. Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis. Headache. 2023;63(10):1351-1358 (Nov 13). doi: 10.1111/head.14651

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: Both galcanezumab and rimegepant were effective as a preventive treatment for episodic migraine, with galcanezumab not being superior to rimegepant.

Major finding: Overall, 62% vs 61% of the patients receiving galcanezumab vs rimegepant achieved ≥ 50% reduction in monthly migraine headache days after 3 months, respectively, with no statistically significant difference between the groups (P = .70). Treatment-emergent adverse events were similar between study interventions and were mostly mild or moderate in severity.

Study details: Findings are from the CHALLENGE-MIG study including 580 patients with episodic migraine with or without aura who were randomly assigned to receive galcanezumab (n = 287) or rimegepant (n = 293) for 3 months.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Eight authors declared being employees of Eli Lilly and Company. Some other authors declared ties with various sources, including Eli Lilly and Company.

Source: Schwedt TJ et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: Results from a randomized, controlled clinical trial. Neurol Ther. 2023 (Nov 10). doi: 10.1007/s40120-023-00562-w

Key clinical point: The anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) fremanezumab, erenumab, and galcanezumab demonstrated similar efficacy during the first year of therapy in patients with chronic and high-frequency episodic migraine, and galcanezumab demonstrated a higher response rate than the other two mAb during the 1-month suspension period in patients with chronic migraine.

Major finding: The three anti-CGRP mAb significantly reduced overall migraine frequency and intensity and symptomatic medication intake per month with similar efficacy across all follow-ups up to 12 months. Patients with chronic migraine receiving galcanezumab vs fremanezumab or erenumab showed higher response rates during the 1-month suspension period (57% vs 39% or 17%, respectively; P = .009).

Study details: This retrospective longitudinal single-center study included 160 patients with chronic and high-frequency episodic migraine who were treated with an anti-CGRP mAb (fremanezumab, erenumab, or galcanezumab) for 12 months.

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

Source: Tereshko Y et al. Comparative study of the efficacy of anti-CGRP mAbs on migraineurs: Analysis of the first year of therapy, 1-month suspension period, and reprisal. J Clin Med. 2023;12(23):7329 (Nov 26). doi: 10.3390/jcm12237329

Key clinical point: The anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) fremanezumab, erenumab, and galcanezumab demonstrated similar efficacy during the first year of therapy in patients with chronic and high-frequency episodic migraine, and galcanezumab demonstrated a higher response rate than the other two mAb during the 1-month suspension period in patients with chronic migraine.

Major finding: The three anti-CGRP mAb significantly reduced overall migraine frequency and intensity and symptomatic medication intake per month with similar efficacy across all follow-ups up to 12 months. Patients with chronic migraine receiving galcanezumab vs fremanezumab or erenumab showed higher response rates during the 1-month suspension period (57% vs 39% or 17%, respectively; P = .009).

Study details: This retrospective longitudinal single-center study included 160 patients with chronic and high-frequency episodic migraine who were treated with an anti-CGRP mAb (fremanezumab, erenumab, or galcanezumab) for 12 months.

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

Source: Tereshko Y et al. Comparative study of the efficacy of anti-CGRP mAbs on migraineurs: Analysis of the first year of therapy, 1-month suspension period, and reprisal. J Clin Med. 2023;12(23):7329 (Nov 26). doi: 10.3390/jcm12237329

Key clinical point: The anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) fremanezumab, erenumab, and galcanezumab demonstrated similar efficacy during the first year of therapy in patients with chronic and high-frequency episodic migraine, and galcanezumab demonstrated a higher response rate than the other two mAb during the 1-month suspension period in patients with chronic migraine.

Major finding: The three anti-CGRP mAb significantly reduced overall migraine frequency and intensity and symptomatic medication intake per month with similar efficacy across all follow-ups up to 12 months. Patients with chronic migraine receiving galcanezumab vs fremanezumab or erenumab showed higher response rates during the 1-month suspension period (57% vs 39% or 17%, respectively; P = .009).

Study details: This retrospective longitudinal single-center study included 160 patients with chronic and high-frequency episodic migraine who were treated with an anti-CGRP mAb (fremanezumab, erenumab, or galcanezumab) for 12 months.

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

Source: Tereshko Y et al. Comparative study of the efficacy of anti-CGRP mAbs on migraineurs: Analysis of the first year of therapy, 1-month suspension period, and reprisal. J Clin Med. 2023;12(23):7329 (Nov 26). doi: 10.3390/jcm12237329

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987