Updated April 2, 2020.

The commander of a US Navy aircraft carrier in the midst of a COVID-19 outbreak was swiftly fired by Acting Secretary of the Navy Thomas Modly following media coverage of the plight of more than 200 COVID-19 positive sailors on the USS Theodore Roosevelt.

In a statement released April 2, Modly announced the removal of Capt. Brett Crozier for writing a memo that was later leaked to the San Francisco Chronicle newspaper. According to Acting Secretary Modly, the memo was sent “outside the chain of command” and his action “made his Sailors, their families, and many in the public believe that his letter was the only reason help from our larger Navy family was forthcoming, which was hardly the case.”

On Monday, March 30, Capt. Crozier, commanding officer of the nuclear aircraft carrier USS Theodore Roosevelt, sent an urgent request for assistance to senior Navy officials: “[I]n combat we are willing to take certain risks that are not acceptable in peacetime. However, we are not at war, and therefore cannot allow a single Sailor to perish as a result of this pandemic unnecessarily. Decisive action is required now in order to comply with CDC and NAVADMIN 083/20 guidance and prevent tragic outcomes.”

Even as a number of cruise ships with ill and dying passengers were—are—waiting to be allowed to dock in Florida and elsewhere, the USS Theodore Roosevelt was also dealing with a COVID-19 outbreak onboard—and awaiting permission to let the crew of more than 4,000 on shore so they could quarantine safely.

Crozier pointed to “lessons learned” from the Diamond Princess—the only comparable situation at the time. He quoted from the abstract to an epidemiological research study: An index case on board the cruise ship was reported in late January; a month later, 619 of 3,700 passengers and crew had tested positive. Without any interventions, the abstract noted, between January 21st and February 19th an estimated 2,920 of the passengers would have been infected. Isolation and quarantine, it concluded, prevented 2,307 cases. Further, an early evacuation would have been associated with 76 infected persons.

The Diamond Princess, Crozier wrote, was able to more effectively isolate people due to a higher percentage of individual and compartmentalized accommodations. However, due to a warship’s “inherent limitations of space,” his crew could not comply with orders to practice social distancing. “With the exceptions of a handful of senior officer staterooms,” he wrote, “none of the berthing onboard a warship is appropriate for quarantine or isolation.” He also pointed to other obstacles: shared bathrooms, shared sleeping quarters, group mealtimes, and ladders and other surfaces touched and possibly contaminated as crew move around the ship.

Moreover, Crozier wrote, “The spread of the disease is ongoing and accelerating.” By Tuesday March 31st, nearly 1,300 sailors had been tested, and hundreds were testing negative, but 243 sailors had tested positive and 87 more were showing symptoms, according to the latest reports. So far, none are showing serious symptoms.

“If we do not act now, we are failing to take care of our most trusted asset—our sailors,” Capt Crozier wrote. At first, no one seemed to be listening, but after the Chronicle broke the story and it began circulating in the media—things changed. “I heard about the letter from Capt. Crozier [Tuesday] morning,” said Acting Secretary Modly in an interview with the Chronicle. “I know that our command organization has been aware of this for about 24 hours and we have been working actually the last 7 days to move those sailors off the ship and get them into accommodations in Guam. The problem is that Guam doesn’t have enough beds right now and we’re having to talk to the government there to see if we can get some hotel space, create tent-type facilities.”

He noted that the situation for the USS Theodore Roosevelt is “a little bit different and unique” in that it has aircraft and armaments on it, fire hazards, and “we have to run a nuclear power plant.” Crozier had proposed that approximately 10% of the crew remain on board to take care of the duties such as tending to the nuclear reactor.

As of April 1, the Navy plans to remove some 2,700 sailors to the hotel rooms government officials on Guam have secured for them. Secretary Modly made no mention of the care or treatment of infected sailors in his April 2nd statement, but offered this reassurance: "You can offer comfort to your fellow citizens who are struggling and fearful here at home by standing the watch, and working your way through this pandemic with courage and optimism and set the example for the nation. We have an obligation to ensure you have everything you need as fast as we can get it there, and you have my commitment that we will not let you down."

Updated April 2, 2020.

The commander of a US Navy aircraft carrier in the midst of a COVID-19 outbreak was swiftly fired by Acting Secretary of the Navy Thomas Modly following media coverage of the plight of more than 200 COVID-19 positive sailors on the USS Theodore Roosevelt.

In a statement released April 2, Modly announced the removal of Capt. Brett Crozier for writing a memo that was later leaked to the San Francisco Chronicle newspaper. According to Acting Secretary Modly, the memo was sent “outside the chain of command” and his action “made his Sailors, their families, and many in the public believe that his letter was the only reason help from our larger Navy family was forthcoming, which was hardly the case.”

On Monday, March 30, Capt. Crozier, commanding officer of the nuclear aircraft carrier USS Theodore Roosevelt, sent an urgent request for assistance to senior Navy officials: “[I]n combat we are willing to take certain risks that are not acceptable in peacetime. However, we are not at war, and therefore cannot allow a single Sailor to perish as a result of this pandemic unnecessarily. Decisive action is required now in order to comply with CDC and NAVADMIN 083/20 guidance and prevent tragic outcomes.”

Even as a number of cruise ships with ill and dying passengers were—are—waiting to be allowed to dock in Florida and elsewhere, the USS Theodore Roosevelt was also dealing with a COVID-19 outbreak onboard—and awaiting permission to let the crew of more than 4,000 on shore so they could quarantine safely.

Crozier pointed to “lessons learned” from the Diamond Princess—the only comparable situation at the time. He quoted from the abstract to an epidemiological research study: An index case on board the cruise ship was reported in late January; a month later, 619 of 3,700 passengers and crew had tested positive. Without any interventions, the abstract noted, between January 21st and February 19th an estimated 2,920 of the passengers would have been infected. Isolation and quarantine, it concluded, prevented 2,307 cases. Further, an early evacuation would have been associated with 76 infected persons.

The Diamond Princess, Crozier wrote, was able to more effectively isolate people due to a higher percentage of individual and compartmentalized accommodations. However, due to a warship’s “inherent limitations of space,” his crew could not comply with orders to practice social distancing. “With the exceptions of a handful of senior officer staterooms,” he wrote, “none of the berthing onboard a warship is appropriate for quarantine or isolation.” He also pointed to other obstacles: shared bathrooms, shared sleeping quarters, group mealtimes, and ladders and other surfaces touched and possibly contaminated as crew move around the ship.

Moreover, Crozier wrote, “The spread of the disease is ongoing and accelerating.” By Tuesday March 31st, nearly 1,300 sailors had been tested, and hundreds were testing negative, but 243 sailors had tested positive and 87 more were showing symptoms, according to the latest reports. So far, none are showing serious symptoms.

“If we do not act now, we are failing to take care of our most trusted asset—our sailors,” Capt Crozier wrote. At first, no one seemed to be listening, but after the Chronicle broke the story and it began circulating in the media—things changed. “I heard about the letter from Capt. Crozier [Tuesday] morning,” said Acting Secretary Modly in an interview with the Chronicle. “I know that our command organization has been aware of this for about 24 hours and we have been working actually the last 7 days to move those sailors off the ship and get them into accommodations in Guam. The problem is that Guam doesn’t have enough beds right now and we’re having to talk to the government there to see if we can get some hotel space, create tent-type facilities.”

He noted that the situation for the USS Theodore Roosevelt is “a little bit different and unique” in that it has aircraft and armaments on it, fire hazards, and “we have to run a nuclear power plant.” Crozier had proposed that approximately 10% of the crew remain on board to take care of the duties such as tending to the nuclear reactor.

As of April 1, the Navy plans to remove some 2,700 sailors to the hotel rooms government officials on Guam have secured for them. Secretary Modly made no mention of the care or treatment of infected sailors in his April 2nd statement, but offered this reassurance: "You can offer comfort to your fellow citizens who are struggling and fearful here at home by standing the watch, and working your way through this pandemic with courage and optimism and set the example for the nation. We have an obligation to ensure you have everything you need as fast as we can get it there, and you have my commitment that we will not let you down."

Updated April 2, 2020.

The commander of a US Navy aircraft carrier in the midst of a COVID-19 outbreak was swiftly fired by Acting Secretary of the Navy Thomas Modly following media coverage of the plight of more than 200 COVID-19 positive sailors on the USS Theodore Roosevelt.

In a statement released April 2, Modly announced the removal of Capt. Brett Crozier for writing a memo that was later leaked to the San Francisco Chronicle newspaper. According to Acting Secretary Modly, the memo was sent “outside the chain of command” and his action “made his Sailors, their families, and many in the public believe that his letter was the only reason help from our larger Navy family was forthcoming, which was hardly the case.”

On Monday, March 30, Capt. Crozier, commanding officer of the nuclear aircraft carrier USS Theodore Roosevelt, sent an urgent request for assistance to senior Navy officials: “[I]n combat we are willing to take certain risks that are not acceptable in peacetime. However, we are not at war, and therefore cannot allow a single Sailor to perish as a result of this pandemic unnecessarily. Decisive action is required now in order to comply with CDC and NAVADMIN 083/20 guidance and prevent tragic outcomes.”

Even as a number of cruise ships with ill and dying passengers were—are—waiting to be allowed to dock in Florida and elsewhere, the USS Theodore Roosevelt was also dealing with a COVID-19 outbreak onboard—and awaiting permission to let the crew of more than 4,000 on shore so they could quarantine safely.

Crozier pointed to “lessons learned” from the Diamond Princess—the only comparable situation at the time. He quoted from the abstract to an epidemiological research study: An index case on board the cruise ship was reported in late January; a month later, 619 of 3,700 passengers and crew had tested positive. Without any interventions, the abstract noted, between January 21st and February 19th an estimated 2,920 of the passengers would have been infected. Isolation and quarantine, it concluded, prevented 2,307 cases. Further, an early evacuation would have been associated with 76 infected persons.

The Diamond Princess, Crozier wrote, was able to more effectively isolate people due to a higher percentage of individual and compartmentalized accommodations. However, due to a warship’s “inherent limitations of space,” his crew could not comply with orders to practice social distancing. “With the exceptions of a handful of senior officer staterooms,” he wrote, “none of the berthing onboard a warship is appropriate for quarantine or isolation.” He also pointed to other obstacles: shared bathrooms, shared sleeping quarters, group mealtimes, and ladders and other surfaces touched and possibly contaminated as crew move around the ship.

Moreover, Crozier wrote, “The spread of the disease is ongoing and accelerating.” By Tuesday March 31st, nearly 1,300 sailors had been tested, and hundreds were testing negative, but 243 sailors had tested positive and 87 more were showing symptoms, according to the latest reports. So far, none are showing serious symptoms.

“If we do not act now, we are failing to take care of our most trusted asset—our sailors,” Capt Crozier wrote. At first, no one seemed to be listening, but after the Chronicle broke the story and it began circulating in the media—things changed. “I heard about the letter from Capt. Crozier [Tuesday] morning,” said Acting Secretary Modly in an interview with the Chronicle. “I know that our command organization has been aware of this for about 24 hours and we have been working actually the last 7 days to move those sailors off the ship and get them into accommodations in Guam. The problem is that Guam doesn’t have enough beds right now and we’re having to talk to the government there to see if we can get some hotel space, create tent-type facilities.”

He noted that the situation for the USS Theodore Roosevelt is “a little bit different and unique” in that it has aircraft and armaments on it, fire hazards, and “we have to run a nuclear power plant.” Crozier had proposed that approximately 10% of the crew remain on board to take care of the duties such as tending to the nuclear reactor.

As of April 1, the Navy plans to remove some 2,700 sailors to the hotel rooms government officials on Guam have secured for them. Secretary Modly made no mention of the care or treatment of infected sailors in his April 2nd statement, but offered this reassurance: "You can offer comfort to your fellow citizens who are struggling and fearful here at home by standing the watch, and working your way through this pandemic with courage and optimism and set the example for the nation. We have an obligation to ensure you have everything you need as fast as we can get it there, and you have my commitment that we will not let you down."

Key clinical point: Cervical noninvasive vagus nerve stimulation (nVNS) is a safe and effective technique for relieving acute pain in migraine and cluster headaches.

Major finding: The nVNS vs. sham-device treatment was effective in attaining a pain-free status within 30 minutes (P = .02), pain-relief status within 30 minutes (P = .007), pain-relief status at 60 minutes (P = .006), pain-free status in ≥50% of treated attacks (P = .005) and reduced use of abortive medication (P = .02). No significant differences were observed in decreased headache days (P = .117), adverse events (P = .81), and satisfaction (P = .07) between the nVNS and sham-device groups.

Study details: A systematic review and meta-analysis of 6 randomized controlled trials of nVNS for treating headaches (n = 983).

Disclosures: The authors declared no conflicts of interest.

Citation: Lai YH et al. Neuromodulation. 2020 Mar 12. doi: 10.1111/ner.13122. 

Key clinical point: Cervical noninvasive vagus nerve stimulation (nVNS) is a safe and effective technique for relieving acute pain in migraine and cluster headaches.

Major finding: The nVNS vs. sham-device treatment was effective in attaining a pain-free status within 30 minutes (P = .02), pain-relief status within 30 minutes (P = .007), pain-relief status at 60 minutes (P = .006), pain-free status in ≥50% of treated attacks (P = .005) and reduced use of abortive medication (P = .02). No significant differences were observed in decreased headache days (P = .117), adverse events (P = .81), and satisfaction (P = .07) between the nVNS and sham-device groups.

Study details: A systematic review and meta-analysis of 6 randomized controlled trials of nVNS for treating headaches (n = 983).

Disclosures: The authors declared no conflicts of interest.

Citation: Lai YH et al. Neuromodulation. 2020 Mar 12. doi: 10.1111/ner.13122. 

Key clinical point: Cervical noninvasive vagus nerve stimulation (nVNS) is a safe and effective technique for relieving acute pain in migraine and cluster headaches.

Major finding: The nVNS vs. sham-device treatment was effective in attaining a pain-free status within 30 minutes (P = .02), pain-relief status within 30 minutes (P = .007), pain-relief status at 60 minutes (P = .006), pain-free status in ≥50% of treated attacks (P = .005) and reduced use of abortive medication (P = .02). No significant differences were observed in decreased headache days (P = .117), adverse events (P = .81), and satisfaction (P = .07) between the nVNS and sham-device groups.

Study details: A systematic review and meta-analysis of 6 randomized controlled trials of nVNS for treating headaches (n = 983).

Disclosures: The authors declared no conflicts of interest.

Citation: Lai YH et al. Neuromodulation. 2020 Mar 12. doi: 10.1111/ner.13122. 

Key clinical point: Topiramate can reduce the number of headache days in a month and disability levels in children with migraine.

Major finding: Topiramate vs. placebo significantly reduced the number of migraine days in a month (P = .0008) and migraine-related disability in pediatric patients (P = .04), but showed no significant difference in the proportion of patients experiencing a ≥50% reduction in monthly headache days (P = .11). Topiramate was associated with higher rates of side effects, including weight loss and paresthesia (P less than .01 for both).

Study details: A meta-analysis of 5 randomized controlled trials, including 531 children with migraine aged 6-17 years.

Disclosures: The authors declared no conflicts of interest.

Citation: Wu X et al. Front Pediatr. 2020 Feb 27. doi: 10.3389/fped.2020.00028. 

Key clinical point: Topiramate can reduce the number of headache days in a month and disability levels in children with migraine.

Major finding: Topiramate vs. placebo significantly reduced the number of migraine days in a month (P = .0008) and migraine-related disability in pediatric patients (P = .04), but showed no significant difference in the proportion of patients experiencing a ≥50% reduction in monthly headache days (P = .11). Topiramate was associated with higher rates of side effects, including weight loss and paresthesia (P less than .01 for both).

Study details: A meta-analysis of 5 randomized controlled trials, including 531 children with migraine aged 6-17 years.

Disclosures: The authors declared no conflicts of interest.

Citation: Wu X et al. Front Pediatr. 2020 Feb 27. doi: 10.3389/fped.2020.00028. 

Key clinical point: Topiramate can reduce the number of headache days in a month and disability levels in children with migraine.

Major finding: Topiramate vs. placebo significantly reduced the number of migraine days in a month (P = .0008) and migraine-related disability in pediatric patients (P = .04), but showed no significant difference in the proportion of patients experiencing a ≥50% reduction in monthly headache days (P = .11). Topiramate was associated with higher rates of side effects, including weight loss and paresthesia (P less than .01 for both).

Study details: A meta-analysis of 5 randomized controlled trials, including 531 children with migraine aged 6-17 years.

Disclosures: The authors declared no conflicts of interest.

Citation: Wu X et al. Front Pediatr. 2020 Feb 27. doi: 10.3389/fped.2020.00028. 

Key clinical point: Vitamin D supplementation may improve headache characteristics and disability levels in patients with episodic migraine, especially among those with aura, possibly through attenuation of calcitonin gene-related peptide level.

Major finding: After 12 weeks, the vitamin D vs placebo group had a significant improvement in mean headache days (4.71 vs 6.43 days/month; P = .031) and mean Migraine Disability Assessment Questionnaire score (21.49 vs 31.16; P = .016).  

Study details: A post hoc analysis of a double-blind study which included patients with episodic migraine randomly assigned to receive either vitamin D 2,000 IU/day (n = 40) or placebo (n = 40). 

Disclosures: This study was supported by the Tehran University of Medical Sciences & Health Services. The authors reported no competing interests.

Citation: Ghorbani Z et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01090-w. 

Key clinical point: Vitamin D supplementation may improve headache characteristics and disability levels in patients with episodic migraine, especially among those with aura, possibly through attenuation of calcitonin gene-related peptide level.

Major finding: After 12 weeks, the vitamin D vs placebo group had a significant improvement in mean headache days (4.71 vs 6.43 days/month; P = .031) and mean Migraine Disability Assessment Questionnaire score (21.49 vs 31.16; P = .016).  

Study details: A post hoc analysis of a double-blind study which included patients with episodic migraine randomly assigned to receive either vitamin D 2,000 IU/day (n = 40) or placebo (n = 40). 

Disclosures: This study was supported by the Tehran University of Medical Sciences & Health Services. The authors reported no competing interests.

Citation: Ghorbani Z et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01090-w. 

Key clinical point: Vitamin D supplementation may improve headache characteristics and disability levels in patients with episodic migraine, especially among those with aura, possibly through attenuation of calcitonin gene-related peptide level.

Major finding: After 12 weeks, the vitamin D vs placebo group had a significant improvement in mean headache days (4.71 vs 6.43 days/month; P = .031) and mean Migraine Disability Assessment Questionnaire score (21.49 vs 31.16; P = .016).  

Study details: A post hoc analysis of a double-blind study which included patients with episodic migraine randomly assigned to receive either vitamin D 2,000 IU/day (n = 40) or placebo (n = 40). 

Disclosures: This study was supported by the Tehran University of Medical Sciences & Health Services. The authors reported no competing interests.

Citation: Ghorbani Z et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01090-w. 

Key clinical point: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are clinically safe and effective, and non-inferior to other active drugs for the prophylaxis of migraine and vestibular migraine (VM).

Major finding: Fewer migraine days were reported with SNRIs vs placebo (standardized mean difference [SMD] -0.38; P = .04). In patients with VM, venlafaxine had a significant advantage in decreasing the vertigo severity score (weighted mean difference (MD) -1.45; P less than .0001) and emotional domain score of dizziness handicap inventory (MD -2.64; P = .03) vs other active drugs. No significant difference was noted in withdrawal rates between the groups.

Study details: Meta-analysis of six randomized controlled trials including 418 participants.

Disclosures: This study was funded by the Natural Science Foundation of Liaoning Province. The authors declared no conflicts of interests.

Citation: Wang F et al. Reg Anesth Pain Med. 2020 March. doi: 10.1136/rapm-2019-101207

Key clinical point: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are clinically safe and effective, and non-inferior to other active drugs for the prophylaxis of migraine and vestibular migraine (VM).

Major finding: Fewer migraine days were reported with SNRIs vs placebo (standardized mean difference [SMD] -0.38; P = .04). In patients with VM, venlafaxine had a significant advantage in decreasing the vertigo severity score (weighted mean difference (MD) -1.45; P less than .0001) and emotional domain score of dizziness handicap inventory (MD -2.64; P = .03) vs other active drugs. No significant difference was noted in withdrawal rates between the groups.

Study details: Meta-analysis of six randomized controlled trials including 418 participants.

Disclosures: This study was funded by the Natural Science Foundation of Liaoning Province. The authors declared no conflicts of interests.

Citation: Wang F et al. Reg Anesth Pain Med. 2020 March. doi: 10.1136/rapm-2019-101207

Key clinical point: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are clinically safe and effective, and non-inferior to other active drugs for the prophylaxis of migraine and vestibular migraine (VM).

Major finding: Fewer migraine days were reported with SNRIs vs placebo (standardized mean difference [SMD] -0.38; P = .04). In patients with VM, venlafaxine had a significant advantage in decreasing the vertigo severity score (weighted mean difference (MD) -1.45; P less than .0001) and emotional domain score of dizziness handicap inventory (MD -2.64; P = .03) vs other active drugs. No significant difference was noted in withdrawal rates between the groups.

Study details: Meta-analysis of six randomized controlled trials including 418 participants.

Disclosures: This study was funded by the Natural Science Foundation of Liaoning Province. The authors declared no conflicts of interests.

Citation: Wang F et al. Reg Anesth Pain Med. 2020 March. doi: 10.1136/rapm-2019-101207

Key clinical points: In episodic migraine, enhanced mindfulness-based stress reduction (MBSR+) is more effective than stress management for headache (SMH) in reducing headache and migraine days and headache related disability.

Major finding: At week 20, MBSR+ group vs. SHM group reported fewer headache days (4.6 vs. 6.0 headache days; P = .04) and had greater reduction in headache-related disability (59.6 to 54.6 vs 59.6 to 57.5; P =.02). Treatment response rate was higher in the MBSR+ group vs SMH group (52% vs. 23% reduction in headache days; P = .004). 

Study details: Patients with episodic migraine (aged, 18-65 years) were randomly assigned to receive either MBSR+ (n = 50) or SMH (n = 48).

Disclosures: This study was funded by the National Center for Complementary and Integrative Health and National Institutes of Health. The authors declared no conflicts of interest.

Citation: Seminowicz DA et al. Pain. 2020 Mar 13. doi: 10.1097/j.pain.0000000000001860.

Key clinical points: In episodic migraine, enhanced mindfulness-based stress reduction (MBSR+) is more effective than stress management for headache (SMH) in reducing headache and migraine days and headache related disability.

Major finding: At week 20, MBSR+ group vs. SHM group reported fewer headache days (4.6 vs. 6.0 headache days; P = .04) and had greater reduction in headache-related disability (59.6 to 54.6 vs 59.6 to 57.5; P =.02). Treatment response rate was higher in the MBSR+ group vs SMH group (52% vs. 23% reduction in headache days; P = .004). 

Study details: Patients with episodic migraine (aged, 18-65 years) were randomly assigned to receive either MBSR+ (n = 50) or SMH (n = 48).

Disclosures: This study was funded by the National Center for Complementary and Integrative Health and National Institutes of Health. The authors declared no conflicts of interest.

Citation: Seminowicz DA et al. Pain. 2020 Mar 13. doi: 10.1097/j.pain.0000000000001860.

Key clinical points: In episodic migraine, enhanced mindfulness-based stress reduction (MBSR+) is more effective than stress management for headache (SMH) in reducing headache and migraine days and headache related disability.

Major finding: At week 20, MBSR+ group vs. SHM group reported fewer headache days (4.6 vs. 6.0 headache days; P = .04) and had greater reduction in headache-related disability (59.6 to 54.6 vs 59.6 to 57.5; P =.02). Treatment response rate was higher in the MBSR+ group vs SMH group (52% vs. 23% reduction in headache days; P = .004). 

Study details: Patients with episodic migraine (aged, 18-65 years) were randomly assigned to receive either MBSR+ (n = 50) or SMH (n = 48).

Disclosures: This study was funded by the National Center for Complementary and Integrative Health and National Institutes of Health. The authors declared no conflicts of interest.

Citation: Seminowicz DA et al. Pain. 2020 Mar 13. doi: 10.1097/j.pain.0000000000001860.

Key clinical points: Galcanezumab significantly reduces monthly headache frequency in patients with migraine and episodic cluster headache; 120 mg is superior to 240 mg for treatment of migraine and 300 mg is effective for episodic cluster headache with no increased risk for adverse events.

Major finding: Subcutaneous injections of galcanezumab 120 mg and 240 mg were associated with a significantly increased 50% response rate vs placebo for the treatment of migraine (120 mg: relative risk [RR], 1.51; 240 mg: RR, 1.58; P less than .001 for both). Galcanezumab 120 mg vs 240 mg had similar efficacy (50% response: RR, 1.06; 75% response: RR, 1.07; 100% response: RR, 1.06; migraine headache days: RR, -0.08) and lower risk for adverse effects (120 mg: RR, 1.06; 240 mg: RR, 1.17). Galcanezumab 300 mg dose was effective in reducing episodic cluster headache (RR, 1.36; P = .048).

Study details: Meta-analysis of 6 randomized controlled trials (n=3,889) evaluating the efficacy and safety of galcanezumab across different doses.

Disclosure: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. J Headache Pain. 2020 Feb 11. doi: 10.1186/s10194-020-1085-x.

Key clinical points: Galcanezumab significantly reduces monthly headache frequency in patients with migraine and episodic cluster headache; 120 mg is superior to 240 mg for treatment of migraine and 300 mg is effective for episodic cluster headache with no increased risk for adverse events.

Major finding: Subcutaneous injections of galcanezumab 120 mg and 240 mg were associated with a significantly increased 50% response rate vs placebo for the treatment of migraine (120 mg: relative risk [RR], 1.51; 240 mg: RR, 1.58; P less than .001 for both). Galcanezumab 120 mg vs 240 mg had similar efficacy (50% response: RR, 1.06; 75% response: RR, 1.07; 100% response: RR, 1.06; migraine headache days: RR, -0.08) and lower risk for adverse effects (120 mg: RR, 1.06; 240 mg: RR, 1.17). Galcanezumab 300 mg dose was effective in reducing episodic cluster headache (RR, 1.36; P = .048).

Study details: Meta-analysis of 6 randomized controlled trials (n=3,889) evaluating the efficacy and safety of galcanezumab across different doses.

Disclosure: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. J Headache Pain. 2020 Feb 11. doi: 10.1186/s10194-020-1085-x.

Key clinical points: Galcanezumab significantly reduces monthly headache frequency in patients with migraine and episodic cluster headache; 120 mg is superior to 240 mg for treatment of migraine and 300 mg is effective for episodic cluster headache with no increased risk for adverse events.

Major finding: Subcutaneous injections of galcanezumab 120 mg and 240 mg were associated with a significantly increased 50% response rate vs placebo for the treatment of migraine (120 mg: relative risk [RR], 1.51; 240 mg: RR, 1.58; P less than .001 for both). Galcanezumab 120 mg vs 240 mg had similar efficacy (50% response: RR, 1.06; 75% response: RR, 1.07; 100% response: RR, 1.06; migraine headache days: RR, -0.08) and lower risk for adverse effects (120 mg: RR, 1.06; 240 mg: RR, 1.17). Galcanezumab 300 mg dose was effective in reducing episodic cluster headache (RR, 1.36; P = .048).

Study details: Meta-analysis of 6 randomized controlled trials (n=3,889) evaluating the efficacy and safety of galcanezumab across different doses.

Disclosure: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. J Headache Pain. 2020 Feb 11. doi: 10.1186/s10194-020-1085-x.

Key clinical point: Ubrogepant as an acute treatment for episodic migraine in adults is associated with an increased rate of achieving freedom from pain and absence of the most bothersome symptoms at 2 hours post-dose.

Major finding: At 2 hours post-dose, ubrogepant vs placebo use was associated with a significantly higher percentage of patients with pain freedom (20.80% vs 12.60%; relative risk [RR], 1.65) and absence of the most bothersome migraine-associated symptoms (37.34% vs 27.58%; RR, 1.35) (P less than .001 for both). No significant difference was observed in treatment-related adverse events within 48 hours or 30 days between the two groups.

Study details: Meta-analysis of 3 randomized clinical trials including 3,326 participants.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. CNS Drugs. 2020 Mar 19. doi: 10.1007/s40263-020-00715-7.

Key clinical point: Ubrogepant as an acute treatment for episodic migraine in adults is associated with an increased rate of achieving freedom from pain and absence of the most bothersome symptoms at 2 hours post-dose.

Major finding: At 2 hours post-dose, ubrogepant vs placebo use was associated with a significantly higher percentage of patients with pain freedom (20.80% vs 12.60%; relative risk [RR], 1.65) and absence of the most bothersome migraine-associated symptoms (37.34% vs 27.58%; RR, 1.35) (P less than .001 for both). No significant difference was observed in treatment-related adverse events within 48 hours or 30 days between the two groups.

Study details: Meta-analysis of 3 randomized clinical trials including 3,326 participants.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. CNS Drugs. 2020 Mar 19. doi: 10.1007/s40263-020-00715-7.

Key clinical point: Ubrogepant as an acute treatment for episodic migraine in adults is associated with an increased rate of achieving freedom from pain and absence of the most bothersome symptoms at 2 hours post-dose.

Major finding: At 2 hours post-dose, ubrogepant vs placebo use was associated with a significantly higher percentage of patients with pain freedom (20.80% vs 12.60%; relative risk [RR], 1.65) and absence of the most bothersome migraine-associated symptoms (37.34% vs 27.58%; RR, 1.35) (P less than .001 for both). No significant difference was observed in treatment-related adverse events within 48 hours or 30 days between the two groups.

Study details: Meta-analysis of 3 randomized clinical trials including 3,326 participants.

Disclosures: This study was supported by the Suzhou Health Talents Training Project. The authors declared no conflicts of interest.

Citation: Yang Y et al. CNS Drugs. 2020 Mar 19. doi: 10.1007/s40263-020-00715-7.

Key clinical points: Migraine and non-migraine headache show no association with all-cause mortality; however, the risk of cardiovascular mortality is higher in women experiencing from migraine with aura.

Major finding: All-cause mortality did not differ among individuals experiencing any migraine (hazard ratio [HR], 0.96; 95% confidence interval, 0.89-1.04) or non-migraine headache (HR, 1.01; 95% confidence interval, 0.93-1.10). Women experiencing migraine with aura had a higher risk of cardiovascular mortality vs. those with no history of migraine or headache (HR, 1.64; 95% confidence interval, 1.06-2.54).

Study details: The data come from an analysis of 27,844 Women’s Health Study participants, (aged ≥ 45 years) who were followed up for a median of 22.7 years.

Disclosures: Tobias Kurth reported receiving honoraria from Novartis and Daiichi-Sankyo for lectures on neuroepidemiology and research methods, from Lilly, Newsenselab, and Total for providing methodological advice, and from The BMJ for editorial services. The Women’s Health Study was funded by grants from the National Institutes of Health.

Citation: Rohmann JL et al. J Headache Pain. 2020 Mar 17. doi: 10.1186/s10194-020-01091-9. 

Key clinical points: Migraine and non-migraine headache show no association with all-cause mortality; however, the risk of cardiovascular mortality is higher in women experiencing from migraine with aura.

Major finding: All-cause mortality did not differ among individuals experiencing any migraine (hazard ratio [HR], 0.96; 95% confidence interval, 0.89-1.04) or non-migraine headache (HR, 1.01; 95% confidence interval, 0.93-1.10). Women experiencing migraine with aura had a higher risk of cardiovascular mortality vs. those with no history of migraine or headache (HR, 1.64; 95% confidence interval, 1.06-2.54).

Study details: The data come from an analysis of 27,844 Women’s Health Study participants, (aged ≥ 45 years) who were followed up for a median of 22.7 years.

Disclosures: Tobias Kurth reported receiving honoraria from Novartis and Daiichi-Sankyo for lectures on neuroepidemiology and research methods, from Lilly, Newsenselab, and Total for providing methodological advice, and from The BMJ for editorial services. The Women’s Health Study was funded by grants from the National Institutes of Health.

Citation: Rohmann JL et al. J Headache Pain. 2020 Mar 17. doi: 10.1186/s10194-020-01091-9. 

Key clinical points: Migraine and non-migraine headache show no association with all-cause mortality; however, the risk of cardiovascular mortality is higher in women experiencing from migraine with aura.

Major finding: All-cause mortality did not differ among individuals experiencing any migraine (hazard ratio [HR], 0.96; 95% confidence interval, 0.89-1.04) or non-migraine headache (HR, 1.01; 95% confidence interval, 0.93-1.10). Women experiencing migraine with aura had a higher risk of cardiovascular mortality vs. those with no history of migraine or headache (HR, 1.64; 95% confidence interval, 1.06-2.54).

Study details: The data come from an analysis of 27,844 Women’s Health Study participants, (aged ≥ 45 years) who were followed up for a median of 22.7 years.

Disclosures: Tobias Kurth reported receiving honoraria from Novartis and Daiichi-Sankyo for lectures on neuroepidemiology and research methods, from Lilly, Newsenselab, and Total for providing methodological advice, and from The BMJ for editorial services. The Women’s Health Study was funded by grants from the National Institutes of Health.

Citation: Rohmann JL et al. J Headache Pain. 2020 Mar 17. doi: 10.1186/s10194-020-01091-9. 

Almost all patients who develop gastrointestinal side effects from oral immunotherapy for severe food allergies develop some degree of esophageal eosinophilia, but that eventually resolves in most of them after a year of treatment, according to results of a pilot study that was to be presented at the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

The findings may help identify biomarkers of persistent eosinophilia despite oral immunotherapy.

In January of this year the Food and Drug Administration approved oral immunotherapy (OIT), known as peanut allergen powder-dnfp, or peanut OIT (POIT), for severe food allergies. In an interview, lead study author Benjamin Wright, MD, of the Mayo Clinic, Phoenix, said OIT is a “promising proactive” treatment for food allergies. “But questions regarding the safety of immunotherapy remain,” he said. “About 30% of patients can develop GI side effects, including abdominal pain and vomiting; most concerning is that some patients develop eosinophilic esophagitis (EoE).”

The pilot study was a mechanistic substudy of 20 adult patients with immunoglobulin E–mediated peanut allergies enrolled in the phase 2 Peanut Oral Immunotherapy Safety, Efficacy and Discovery trial (POISED), with 15 randomized to treatment and the remainder to placebo. They had serial gastrointestinal biopsies at baseline (n = 20), 1 year (n = 7 treatment, 3 placebo) and 2 years (n = 7 treatment, 4 placebo) to evaluate eosinophils per high-power field (eos/hpf).

Baseline characteristics between the treatment and placebo groups were similar, with some having signs of preexisting disease. About 14% of them had clinically significant EoE, represented as a measure of more than 15 eos/hpf, Dr. Wright said. “One of the findings that was really fascinating to us was that all of the subjects had evidence of dilated intercellular spaces at baseline,” he said. “This indicates that all the subjects have some degree of epithelial barrier dysfunction before they start OIT.” Dilated intercellular spaces are a marker of inflammation.

Four patients in the treatment group had mild endoscopic findings at weeks 52 and 104, as did one patient on placebo, Dr. Wright said. A plot of eosinophil counts showed a peak at 52 weeks but near resolution at 104 weeks for all but one patient on OIT. “One of the most interesting trends that we noted was that, for most of patients, OIT-induced eosinophilia was transient and not fixed,” he said. “We noted a triangle pattern where tissue eosinophilia peaks and then resolves with the continuation of therapy.” EoE Histologic scoring system results followed a similar pattern in these patients, he added.

Also, results of the comprehensive GI Symptom Questionnaire, which assessed symptoms such as abdominal pain, difficulty swallowing, refusal to eat, and vomiting, showed that patient-reported GI symptoms did not correlate with tissue eosinophilia, Dr. Wright said. “To us, that suggests that perhaps eosinophils are not central to disease pathology or symptom development in these patients,” he said.

However, the findings validate that, in a small number of patients, OIT induces EoE, Dr. Wright said. He used a treadmill analogy to explain how OIT influences epithelial remodeling in some patients. “We’re constantly renewing our esophageal epithelium every 2 weeks, and when you challenge it with an antigen (i.e., OIT), the treadmill speeds up,” he said. “There may be some patients who will fall if the treadmill gets too fast, and they develop disease.”

He added, “Distinguishing someone’s fitness before they get on the treadmill is really going be a key moving forward in determining which subjects are good participants for OIT or how to dose OIT.”

Dr. Wright reported receiving grants from the Arizona Biomedical Research Consortium and Phoenix Children’s Hospital Foundation. Coauthors reported receiving grants from the National Institutes of Health and the Consortium for Food Allergy Research, as well as relationships with Aimmune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Consortium for Food Allergy Research, DBV Technologies, Astellas, AnaptysBio, and Novartis.

SOURCE: Wright B et al. AAAAI, Session 2605, Abstract No. 259.

Almost all patients who develop gastrointestinal side effects from oral immunotherapy for severe food allergies develop some degree of esophageal eosinophilia, but that eventually resolves in most of them after a year of treatment, according to results of a pilot study that was to be presented at the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

The findings may help identify biomarkers of persistent eosinophilia despite oral immunotherapy.

In January of this year the Food and Drug Administration approved oral immunotherapy (OIT), known as peanut allergen powder-dnfp, or peanut OIT (POIT), for severe food allergies. In an interview, lead study author Benjamin Wright, MD, of the Mayo Clinic, Phoenix, said OIT is a “promising proactive” treatment for food allergies. “But questions regarding the safety of immunotherapy remain,” he said. “About 30% of patients can develop GI side effects, including abdominal pain and vomiting; most concerning is that some patients develop eosinophilic esophagitis (EoE).”

The pilot study was a mechanistic substudy of 20 adult patients with immunoglobulin E–mediated peanut allergies enrolled in the phase 2 Peanut Oral Immunotherapy Safety, Efficacy and Discovery trial (POISED), with 15 randomized to treatment and the remainder to placebo. They had serial gastrointestinal biopsies at baseline (n = 20), 1 year (n = 7 treatment, 3 placebo) and 2 years (n = 7 treatment, 4 placebo) to evaluate eosinophils per high-power field (eos/hpf).

Baseline characteristics between the treatment and placebo groups were similar, with some having signs of preexisting disease. About 14% of them had clinically significant EoE, represented as a measure of more than 15 eos/hpf, Dr. Wright said. “One of the findings that was really fascinating to us was that all of the subjects had evidence of dilated intercellular spaces at baseline,” he said. “This indicates that all the subjects have some degree of epithelial barrier dysfunction before they start OIT.” Dilated intercellular spaces are a marker of inflammation.

Four patients in the treatment group had mild endoscopic findings at weeks 52 and 104, as did one patient on placebo, Dr. Wright said. A plot of eosinophil counts showed a peak at 52 weeks but near resolution at 104 weeks for all but one patient on OIT. “One of the most interesting trends that we noted was that, for most of patients, OIT-induced eosinophilia was transient and not fixed,” he said. “We noted a triangle pattern where tissue eosinophilia peaks and then resolves with the continuation of therapy.” EoE Histologic scoring system results followed a similar pattern in these patients, he added.

Also, results of the comprehensive GI Symptom Questionnaire, which assessed symptoms such as abdominal pain, difficulty swallowing, refusal to eat, and vomiting, showed that patient-reported GI symptoms did not correlate with tissue eosinophilia, Dr. Wright said. “To us, that suggests that perhaps eosinophils are not central to disease pathology or symptom development in these patients,” he said.

However, the findings validate that, in a small number of patients, OIT induces EoE, Dr. Wright said. He used a treadmill analogy to explain how OIT influences epithelial remodeling in some patients. “We’re constantly renewing our esophageal epithelium every 2 weeks, and when you challenge it with an antigen (i.e., OIT), the treadmill speeds up,” he said. “There may be some patients who will fall if the treadmill gets too fast, and they develop disease.”

He added, “Distinguishing someone’s fitness before they get on the treadmill is really going be a key moving forward in determining which subjects are good participants for OIT or how to dose OIT.”

Dr. Wright reported receiving grants from the Arizona Biomedical Research Consortium and Phoenix Children’s Hospital Foundation. Coauthors reported receiving grants from the National Institutes of Health and the Consortium for Food Allergy Research, as well as relationships with Aimmune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Consortium for Food Allergy Research, DBV Technologies, Astellas, AnaptysBio, and Novartis.

SOURCE: Wright B et al. AAAAI, Session 2605, Abstract No. 259.

Almost all patients who develop gastrointestinal side effects from oral immunotherapy for severe food allergies develop some degree of esophageal eosinophilia, but that eventually resolves in most of them after a year of treatment, according to results of a pilot study that was to be presented at the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

The findings may help identify biomarkers of persistent eosinophilia despite oral immunotherapy.

In January of this year the Food and Drug Administration approved oral immunotherapy (OIT), known as peanut allergen powder-dnfp, or peanut OIT (POIT), for severe food allergies. In an interview, lead study author Benjamin Wright, MD, of the Mayo Clinic, Phoenix, said OIT is a “promising proactive” treatment for food allergies. “But questions regarding the safety of immunotherapy remain,” he said. “About 30% of patients can develop GI side effects, including abdominal pain and vomiting; most concerning is that some patients develop eosinophilic esophagitis (EoE).”

The pilot study was a mechanistic substudy of 20 adult patients with immunoglobulin E–mediated peanut allergies enrolled in the phase 2 Peanut Oral Immunotherapy Safety, Efficacy and Discovery trial (POISED), with 15 randomized to treatment and the remainder to placebo. They had serial gastrointestinal biopsies at baseline (n = 20), 1 year (n = 7 treatment, 3 placebo) and 2 years (n = 7 treatment, 4 placebo) to evaluate eosinophils per high-power field (eos/hpf).

Baseline characteristics between the treatment and placebo groups were similar, with some having signs of preexisting disease. About 14% of them had clinically significant EoE, represented as a measure of more than 15 eos/hpf, Dr. Wright said. “One of the findings that was really fascinating to us was that all of the subjects had evidence of dilated intercellular spaces at baseline,” he said. “This indicates that all the subjects have some degree of epithelial barrier dysfunction before they start OIT.” Dilated intercellular spaces are a marker of inflammation.

Four patients in the treatment group had mild endoscopic findings at weeks 52 and 104, as did one patient on placebo, Dr. Wright said. A plot of eosinophil counts showed a peak at 52 weeks but near resolution at 104 weeks for all but one patient on OIT. “One of the most interesting trends that we noted was that, for most of patients, OIT-induced eosinophilia was transient and not fixed,” he said. “We noted a triangle pattern where tissue eosinophilia peaks and then resolves with the continuation of therapy.” EoE Histologic scoring system results followed a similar pattern in these patients, he added.

Also, results of the comprehensive GI Symptom Questionnaire, which assessed symptoms such as abdominal pain, difficulty swallowing, refusal to eat, and vomiting, showed that patient-reported GI symptoms did not correlate with tissue eosinophilia, Dr. Wright said. “To us, that suggests that perhaps eosinophils are not central to disease pathology or symptom development in these patients,” he said.

However, the findings validate that, in a small number of patients, OIT induces EoE, Dr. Wright said. He used a treadmill analogy to explain how OIT influences epithelial remodeling in some patients. “We’re constantly renewing our esophageal epithelium every 2 weeks, and when you challenge it with an antigen (i.e., OIT), the treadmill speeds up,” he said. “There may be some patients who will fall if the treadmill gets too fast, and they develop disease.”

He added, “Distinguishing someone’s fitness before they get on the treadmill is really going be a key moving forward in determining which subjects are good participants for OIT or how to dose OIT.”

Dr. Wright reported receiving grants from the Arizona Biomedical Research Consortium and Phoenix Children’s Hospital Foundation. Coauthors reported receiving grants from the National Institutes of Health and the Consortium for Food Allergy Research, as well as relationships with Aimmune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Consortium for Food Allergy Research, DBV Technologies, Astellas, AnaptysBio, and Novartis.

SOURCE: Wright B et al. AAAAI, Session 2605, Abstract No. 259.