SAN FRANCISCO – In patients on extracorporeal membrane oxygenation (ECMO) support, a 25% drop in regional oxygen saturation index (rSO₂) value on a bedside near-infrared spectroscopy (NIRS) system is a potential indicator of acute brain injury (ABI), according to a new pilot study. Patients on ECMO are in dire straits, with about a 50% survival rate, but the odds become much worse in the presence of brain injury – the fatality rate rises to about 90%. In addition, ABIs and other neurological complications are common in ECMO patients, occurring in about half.

Currently, clinicians must rely on clinical signs to pinpoint and address emerging injuries, but a bedside NIRS system could flag problems for earlier intervention. “Changes in brain oxygenation could prompt clinicians to do earlier investigations of what’s going on, and maybe they can intervene and reduce the extent of the injury,” Toan Huynh, MD, director of research at Carolinas Medical Center, Charlotte, N.C., said in an interview. Dr. Huynh comoderated the session at the annual clinical congress of the American College of Surgeons, where the research was presented. The study was “very novel,” Dr. Huynh added.

NIRS monitors oxygenation noninvasively. Its rSO₂ value balances cerebral oxygen delivery and oxygen consumption, reflecting aerobic metabolism, and therefore has the potential to reveal a patient’s status. A previous study (Artif Organs. 2012;36:659-67) showed that a drop in rSO₂ of more than 25%, or absolute values below 40, could predict ABI in ECMO patients, but the work was done retrospectively and is subject to the usual limitations.

The current work, which was presented by medical student Megan Hunt of Johns Hopkins School of Medicine, Baltimore, sought to determine the potential value of NIRS in a prospective study, as well as to determine the interpretation of NIRS that had the best predictive value.

The researchers enrolled 47 consecutive ECMO patients (39 venoarterial, 8 venovenous). Twenty-seven of 39 (69%) of venoarterial ECMO patients, and 6 of 8 (75%) of venovenous ECMO patients had a desaturation event; 53.2% of patients overall experienced an ABI – a number that was in line with previous studies. The researchers found that ABI risk factors such as atrial fibrillation, a lower pre-ECMO Glasgow Coma Score, and more blood transfusions were linked to greater odds of ABI. “Generally, more critically ill patients [had] acute brain injuries,” Ms. Hunt said during her talk.

A total of 65.6% of patients who had an ABI registered a 25% or more drop in rSO₂ from baseline, while 26.7% had no change (P = .03). No other measure showed a statistically significant association. A multivariate regression model of ABI variables found that a 25% decline in rSO₂ from baseline predicted ABI (adjusted odds ratio, 7.6; P = .03), which outperformed APACHE II (aOR, 1.2; P = .002). A receiver operating characteristic (ROC) curve showed that a 25% drop from baseline had a sensitivity of 85% and a specificity of 55% for ABI.

The study is limited by its small sample size, the fact that it was done at a single institution, and its lack of a control group for validation, but Ms. Hunt was confident in its value. “Ultimately, I think this data is significant in that it shows that NIRS can serve as a real-time bedside monitoring tool for detecting acute brain injury. A drop of greater than 25% should be worrisome for clinicians using this monitoring tool,” she said, and she called for further research to establish a consistent protocol.

The source of funding was not disclosed. Ms. Hunt and Dr. Huynh had no relevant disclosures.

SOURCE: Hunt MF et al. Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.666.

SAN FRANCISCO – In patients on extracorporeal membrane oxygenation (ECMO) support, a 25% drop in regional oxygen saturation index (rSO₂) value on a bedside near-infrared spectroscopy (NIRS) system is a potential indicator of acute brain injury (ABI), according to a new pilot study. Patients on ECMO are in dire straits, with about a 50% survival rate, but the odds become much worse in the presence of brain injury – the fatality rate rises to about 90%. In addition, ABIs and other neurological complications are common in ECMO patients, occurring in about half.

Currently, clinicians must rely on clinical signs to pinpoint and address emerging injuries, but a bedside NIRS system could flag problems for earlier intervention. “Changes in brain oxygenation could prompt clinicians to do earlier investigations of what’s going on, and maybe they can intervene and reduce the extent of the injury,” Toan Huynh, MD, director of research at Carolinas Medical Center, Charlotte, N.C., said in an interview. Dr. Huynh comoderated the session at the annual clinical congress of the American College of Surgeons, where the research was presented. The study was “very novel,” Dr. Huynh added.

NIRS monitors oxygenation noninvasively. Its rSO₂ value balances cerebral oxygen delivery and oxygen consumption, reflecting aerobic metabolism, and therefore has the potential to reveal a patient’s status. A previous study (Artif Organs. 2012;36:659-67) showed that a drop in rSO₂ of more than 25%, or absolute values below 40, could predict ABI in ECMO patients, but the work was done retrospectively and is subject to the usual limitations.

The current work, which was presented by medical student Megan Hunt of Johns Hopkins School of Medicine, Baltimore, sought to determine the potential value of NIRS in a prospective study, as well as to determine the interpretation of NIRS that had the best predictive value.

The researchers enrolled 47 consecutive ECMO patients (39 venoarterial, 8 venovenous). Twenty-seven of 39 (69%) of venoarterial ECMO patients, and 6 of 8 (75%) of venovenous ECMO patients had a desaturation event; 53.2% of patients overall experienced an ABI – a number that was in line with previous studies. The researchers found that ABI risk factors such as atrial fibrillation, a lower pre-ECMO Glasgow Coma Score, and more blood transfusions were linked to greater odds of ABI. “Generally, more critically ill patients [had] acute brain injuries,” Ms. Hunt said during her talk.

A total of 65.6% of patients who had an ABI registered a 25% or more drop in rSO₂ from baseline, while 26.7% had no change (P = .03). No other measure showed a statistically significant association. A multivariate regression model of ABI variables found that a 25% decline in rSO₂ from baseline predicted ABI (adjusted odds ratio, 7.6; P = .03), which outperformed APACHE II (aOR, 1.2; P = .002). A receiver operating characteristic (ROC) curve showed that a 25% drop from baseline had a sensitivity of 85% and a specificity of 55% for ABI.

The study is limited by its small sample size, the fact that it was done at a single institution, and its lack of a control group for validation, but Ms. Hunt was confident in its value. “Ultimately, I think this data is significant in that it shows that NIRS can serve as a real-time bedside monitoring tool for detecting acute brain injury. A drop of greater than 25% should be worrisome for clinicians using this monitoring tool,” she said, and she called for further research to establish a consistent protocol.

The source of funding was not disclosed. Ms. Hunt and Dr. Huynh had no relevant disclosures.

SOURCE: Hunt MF et al. Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.666.

SAN FRANCISCO – In patients on extracorporeal membrane oxygenation (ECMO) support, a 25% drop in regional oxygen saturation index (rSO₂) value on a bedside near-infrared spectroscopy (NIRS) system is a potential indicator of acute brain injury (ABI), according to a new pilot study. Patients on ECMO are in dire straits, with about a 50% survival rate, but the odds become much worse in the presence of brain injury – the fatality rate rises to about 90%. In addition, ABIs and other neurological complications are common in ECMO patients, occurring in about half.

Currently, clinicians must rely on clinical signs to pinpoint and address emerging injuries, but a bedside NIRS system could flag problems for earlier intervention. “Changes in brain oxygenation could prompt clinicians to do earlier investigations of what’s going on, and maybe they can intervene and reduce the extent of the injury,” Toan Huynh, MD, director of research at Carolinas Medical Center, Charlotte, N.C., said in an interview. Dr. Huynh comoderated the session at the annual clinical congress of the American College of Surgeons, where the research was presented. The study was “very novel,” Dr. Huynh added.

NIRS monitors oxygenation noninvasively. Its rSO₂ value balances cerebral oxygen delivery and oxygen consumption, reflecting aerobic metabolism, and therefore has the potential to reveal a patient’s status. A previous study (Artif Organs. 2012;36:659-67) showed that a drop in rSO₂ of more than 25%, or absolute values below 40, could predict ABI in ECMO patients, but the work was done retrospectively and is subject to the usual limitations.

The current work, which was presented by medical student Megan Hunt of Johns Hopkins School of Medicine, Baltimore, sought to determine the potential value of NIRS in a prospective study, as well as to determine the interpretation of NIRS that had the best predictive value.

The researchers enrolled 47 consecutive ECMO patients (39 venoarterial, 8 venovenous). Twenty-seven of 39 (69%) of venoarterial ECMO patients, and 6 of 8 (75%) of venovenous ECMO patients had a desaturation event; 53.2% of patients overall experienced an ABI – a number that was in line with previous studies. The researchers found that ABI risk factors such as atrial fibrillation, a lower pre-ECMO Glasgow Coma Score, and more blood transfusions were linked to greater odds of ABI. “Generally, more critically ill patients [had] acute brain injuries,” Ms. Hunt said during her talk.

A total of 65.6% of patients who had an ABI registered a 25% or more drop in rSO₂ from baseline, while 26.7% had no change (P = .03). No other measure showed a statistically significant association. A multivariate regression model of ABI variables found that a 25% decline in rSO₂ from baseline predicted ABI (adjusted odds ratio, 7.6; P = .03), which outperformed APACHE II (aOR, 1.2; P = .002). A receiver operating characteristic (ROC) curve showed that a 25% drop from baseline had a sensitivity of 85% and a specificity of 55% for ABI.

The study is limited by its small sample size, the fact that it was done at a single institution, and its lack of a control group for validation, but Ms. Hunt was confident in its value. “Ultimately, I think this data is significant in that it shows that NIRS can serve as a real-time bedside monitoring tool for detecting acute brain injury. A drop of greater than 25% should be worrisome for clinicians using this monitoring tool,” she said, and she called for further research to establish a consistent protocol.

The source of funding was not disclosed. Ms. Hunt and Dr. Huynh had no relevant disclosures.

SOURCE: Hunt MF et al. Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.666.

SAN FRANCISCO – When it comes to KRAS mutational status, liver metastases originating from left-sided colon tumors have different clinical and survival characteristics from those originating from primary rectal tumors. There was no significant difference in survival between bearers of mutated versus wild-type (WT) KRAS in rectal tumor cases, while there was a significant difference in survival from left-sided colon cases, according to a first-time analysis of the effect of KRAS status in this specific population.

The work was presented at the annual clinical congress of the American College of Surgeons by Neda Amini, MD. “The liver metastasis originating from a rectal tumor might have a different biology than from a primary colon tumor, and we should have stratification according to the primary tumor location in clinical trials testing chemotherapy and targeted agents,” said Dr. Amini, who is a surgical resident at Sinai Hospital of Baltimore, during her presentation of the research.

“I thought that was interesting because most of the studies that have been done look at KRAS mutations in colorectal cancers, and [colon and rectal cancers] are two completely different entities,” said session comoderator Valentine Nfonsam, MD, associate professor of surgery at the University of Arizona, Tucson, in an interview. The findings could also impact clinical practice. “If a patient has rectal cancer, if they have a KRAS mutation, whether you treat them with cetuximab or not, the overall survival doesn’t really change. Whereas for colon cancer patients you really want to make that distinction. You want to truly personalize their therapy, because of the difference in survival in a patient with the KRAS mutation in colon cancer” Dr. Nfonsam said.

“It gets to the heart that there might be different biology between colon cancers and rectal cancers. It’s important to understand the differences in the basic biology, which affects the treatment and the surgery,” said the other comoderator, Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at the University of Missouri–Columbia.

KRAS is common in colorectal cancer, occurring in 30% of cases, and multiple trials have shown it is associated with nonresponse to the epidermal growth factor receptor inhibitors cetuximab or panitumumab. All colorectal cancer patients with liver metastases should be screened for KRAS mutations, according to National Comprehensive Cancer Network guidelines.

The researchers conducted a retrospective analysis of 1,304 patients who underwent curative-intent surgery for colorectal liver metastases at nine institutions between 2000 and 2016. The KRAS mutation rate was similar in the primary colon and rectal tumors (34.2% vs. 30.9%; P = .24). The frequency was highest in right-sided colon tumors (39.4%). There was a statistically significant difference in the frequency of KRAS mutation between primary rectal tumors (30.9%), and left-sided colon tumors (21.1%; P = .001).

There were several differences in clinical characteristics between left-sided colon cancers and rectal cancers. Rectal cancer patients were more likely to be male (73.4% vs. 62.4%; P = .001); more likely to be stage T1-T2 (16.6% vs. 10.6%; P = .012); less likely to have serum carcinoembryonic antigen greater than 100 ng/mL (8.4% vs. 14.1%; P = .018); and less likely to have a liver metastasis under 3 cm (36.1% vs. 49.3%).

There were significant differences between KRAS mutant and KRAS wild-type patients with a colon primary tumor, including greater likelihood of lymph node metastasis in WT (65.2% vs. 55.37%; P = .004), greater likelihood of liver metastasis greater than 3 cm in WT (48.8% versus 39.3%; P = .01), greater likelihood of extrahepatic disease in mutant KRAS (16.3% vs. 10.4%; P = .01), greater likelihood of prehepatic resection chemotherapy in WT (65.5% vs. 56.0%; P = .005), greater likelihood of posthepatic resection chemotherapy in mutant KRAS (64.5% vs. 55.5%; P = .01), and greater likelihood of receiving anti–epidermal growth factor therapy in WT (5.7% vs. 0.3%; P less than .001). The only difference seen in patients with rectal primary tumors was the odds of receiving post-hepatic surgery chemotherapy, which was higher among patients with mutated KRAS (70.8% vs. 59.0%; P = .03).

After a median follow-up of 26.4 months, the 1-, 3-, and 5-year overall survival rates were 88.9%, 62.5%, and 44.5%. Among patients with primary colon cancer, there was a statistically significant lower survival curve in patients with a KRAS mutation overall and in those with left-sided colon tumors (log rank P less than .001 for both), but there was no significant survival difference between mutation bearers and wild-type patients with a primary rectal tumor (log rank P = .53). A multivariate analysis showed an 82% risk of death from KRAS mutation in primary colon cancer (hazard ratio, 1.82; P less than .001), but a univariate analysis showed no significant mortality association in rectal primary tumors (hazard ratio, 1.13; P = .46).

The funding source was not disclosed. The authors had no relevant financial disclosures.

SOURCE: Amini N et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S69-70.

SAN FRANCISCO – When it comes to KRAS mutational status, liver metastases originating from left-sided colon tumors have different clinical and survival characteristics from those originating from primary rectal tumors. There was no significant difference in survival between bearers of mutated versus wild-type (WT) KRAS in rectal tumor cases, while there was a significant difference in survival from left-sided colon cases, according to a first-time analysis of the effect of KRAS status in this specific population.

The work was presented at the annual clinical congress of the American College of Surgeons by Neda Amini, MD. “The liver metastasis originating from a rectal tumor might have a different biology than from a primary colon tumor, and we should have stratification according to the primary tumor location in clinical trials testing chemotherapy and targeted agents,” said Dr. Amini, who is a surgical resident at Sinai Hospital of Baltimore, during her presentation of the research.

“I thought that was interesting because most of the studies that have been done look at KRAS mutations in colorectal cancers, and [colon and rectal cancers] are two completely different entities,” said session comoderator Valentine Nfonsam, MD, associate professor of surgery at the University of Arizona, Tucson, in an interview. The findings could also impact clinical practice. “If a patient has rectal cancer, if they have a KRAS mutation, whether you treat them with cetuximab or not, the overall survival doesn’t really change. Whereas for colon cancer patients you really want to make that distinction. You want to truly personalize their therapy, because of the difference in survival in a patient with the KRAS mutation in colon cancer” Dr. Nfonsam said.

“It gets to the heart that there might be different biology between colon cancers and rectal cancers. It’s important to understand the differences in the basic biology, which affects the treatment and the surgery,” said the other comoderator, Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at the University of Missouri–Columbia.

KRAS is common in colorectal cancer, occurring in 30% of cases, and multiple trials have shown it is associated with nonresponse to the epidermal growth factor receptor inhibitors cetuximab or panitumumab. All colorectal cancer patients with liver metastases should be screened for KRAS mutations, according to National Comprehensive Cancer Network guidelines.

The researchers conducted a retrospective analysis of 1,304 patients who underwent curative-intent surgery for colorectal liver metastases at nine institutions between 2000 and 2016. The KRAS mutation rate was similar in the primary colon and rectal tumors (34.2% vs. 30.9%; P = .24). The frequency was highest in right-sided colon tumors (39.4%). There was a statistically significant difference in the frequency of KRAS mutation between primary rectal tumors (30.9%), and left-sided colon tumors (21.1%; P = .001).

There were several differences in clinical characteristics between left-sided colon cancers and rectal cancers. Rectal cancer patients were more likely to be male (73.4% vs. 62.4%; P = .001); more likely to be stage T1-T2 (16.6% vs. 10.6%; P = .012); less likely to have serum carcinoembryonic antigen greater than 100 ng/mL (8.4% vs. 14.1%; P = .018); and less likely to have a liver metastasis under 3 cm (36.1% vs. 49.3%).

There were significant differences between KRAS mutant and KRAS wild-type patients with a colon primary tumor, including greater likelihood of lymph node metastasis in WT (65.2% vs. 55.37%; P = .004), greater likelihood of liver metastasis greater than 3 cm in WT (48.8% versus 39.3%; P = .01), greater likelihood of extrahepatic disease in mutant KRAS (16.3% vs. 10.4%; P = .01), greater likelihood of prehepatic resection chemotherapy in WT (65.5% vs. 56.0%; P = .005), greater likelihood of posthepatic resection chemotherapy in mutant KRAS (64.5% vs. 55.5%; P = .01), and greater likelihood of receiving anti–epidermal growth factor therapy in WT (5.7% vs. 0.3%; P less than .001). The only difference seen in patients with rectal primary tumors was the odds of receiving post-hepatic surgery chemotherapy, which was higher among patients with mutated KRAS (70.8% vs. 59.0%; P = .03).

After a median follow-up of 26.4 months, the 1-, 3-, and 5-year overall survival rates were 88.9%, 62.5%, and 44.5%. Among patients with primary colon cancer, there was a statistically significant lower survival curve in patients with a KRAS mutation overall and in those with left-sided colon tumors (log rank P less than .001 for both), but there was no significant survival difference between mutation bearers and wild-type patients with a primary rectal tumor (log rank P = .53). A multivariate analysis showed an 82% risk of death from KRAS mutation in primary colon cancer (hazard ratio, 1.82; P less than .001), but a univariate analysis showed no significant mortality association in rectal primary tumors (hazard ratio, 1.13; P = .46).

The funding source was not disclosed. The authors had no relevant financial disclosures.

SOURCE: Amini N et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S69-70.

SAN FRANCISCO – When it comes to KRAS mutational status, liver metastases originating from left-sided colon tumors have different clinical and survival characteristics from those originating from primary rectal tumors. There was no significant difference in survival between bearers of mutated versus wild-type (WT) KRAS in rectal tumor cases, while there was a significant difference in survival from left-sided colon cases, according to a first-time analysis of the effect of KRAS status in this specific population.

The work was presented at the annual clinical congress of the American College of Surgeons by Neda Amini, MD. “The liver metastasis originating from a rectal tumor might have a different biology than from a primary colon tumor, and we should have stratification according to the primary tumor location in clinical trials testing chemotherapy and targeted agents,” said Dr. Amini, who is a surgical resident at Sinai Hospital of Baltimore, during her presentation of the research.

“I thought that was interesting because most of the studies that have been done look at KRAS mutations in colorectal cancers, and [colon and rectal cancers] are two completely different entities,” said session comoderator Valentine Nfonsam, MD, associate professor of surgery at the University of Arizona, Tucson, in an interview. The findings could also impact clinical practice. “If a patient has rectal cancer, if they have a KRAS mutation, whether you treat them with cetuximab or not, the overall survival doesn’t really change. Whereas for colon cancer patients you really want to make that distinction. You want to truly personalize their therapy, because of the difference in survival in a patient with the KRAS mutation in colon cancer” Dr. Nfonsam said.

“It gets to the heart that there might be different biology between colon cancers and rectal cancers. It’s important to understand the differences in the basic biology, which affects the treatment and the surgery,” said the other comoderator, Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at the University of Missouri–Columbia.

KRAS is common in colorectal cancer, occurring in 30% of cases, and multiple trials have shown it is associated with nonresponse to the epidermal growth factor receptor inhibitors cetuximab or panitumumab. All colorectal cancer patients with liver metastases should be screened for KRAS mutations, according to National Comprehensive Cancer Network guidelines.

The researchers conducted a retrospective analysis of 1,304 patients who underwent curative-intent surgery for colorectal liver metastases at nine institutions between 2000 and 2016. The KRAS mutation rate was similar in the primary colon and rectal tumors (34.2% vs. 30.9%; P = .24). The frequency was highest in right-sided colon tumors (39.4%). There was a statistically significant difference in the frequency of KRAS mutation between primary rectal tumors (30.9%), and left-sided colon tumors (21.1%; P = .001).

There were several differences in clinical characteristics between left-sided colon cancers and rectal cancers. Rectal cancer patients were more likely to be male (73.4% vs. 62.4%; P = .001); more likely to be stage T1-T2 (16.6% vs. 10.6%; P = .012); less likely to have serum carcinoembryonic antigen greater than 100 ng/mL (8.4% vs. 14.1%; P = .018); and less likely to have a liver metastasis under 3 cm (36.1% vs. 49.3%).

There were significant differences between KRAS mutant and KRAS wild-type patients with a colon primary tumor, including greater likelihood of lymph node metastasis in WT (65.2% vs. 55.37%; P = .004), greater likelihood of liver metastasis greater than 3 cm in WT (48.8% versus 39.3%; P = .01), greater likelihood of extrahepatic disease in mutant KRAS (16.3% vs. 10.4%; P = .01), greater likelihood of prehepatic resection chemotherapy in WT (65.5% vs. 56.0%; P = .005), greater likelihood of posthepatic resection chemotherapy in mutant KRAS (64.5% vs. 55.5%; P = .01), and greater likelihood of receiving anti–epidermal growth factor therapy in WT (5.7% vs. 0.3%; P less than .001). The only difference seen in patients with rectal primary tumors was the odds of receiving post-hepatic surgery chemotherapy, which was higher among patients with mutated KRAS (70.8% vs. 59.0%; P = .03).

After a median follow-up of 26.4 months, the 1-, 3-, and 5-year overall survival rates were 88.9%, 62.5%, and 44.5%. Among patients with primary colon cancer, there was a statistically significant lower survival curve in patients with a KRAS mutation overall and in those with left-sided colon tumors (log rank P less than .001 for both), but there was no significant survival difference between mutation bearers and wild-type patients with a primary rectal tumor (log rank P = .53). A multivariate analysis showed an 82% risk of death from KRAS mutation in primary colon cancer (hazard ratio, 1.82; P less than .001), but a univariate analysis showed no significant mortality association in rectal primary tumors (hazard ratio, 1.13; P = .46).

The funding source was not disclosed. The authors had no relevant financial disclosures.

SOURCE: Amini N et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S69-70.

NEW ORLEANS – Real-world data support the use of macitentan to treat pulmonary arterial hypertension (PAH) associated with connective tissue disease, according to a speaker at the annual meeting of the American College of Chest Physicians.

Jen Smith/MDedge News

Outcomes of macitentan (Opsumit) treatment were similar in patients who had PAH associated with systemic sclerosis (PAH-SSc) and patients who had idiopathic PAH (IPAH) or heritable PAH (HPAH), Vallerie McLaughlin, MD, of the University of Michigan, Ann Arbor, said at the meeting.

“Within the limits of a real-world registry, these data add to the growing body of evidence supporting the use of macitentan for treatment in patients with CTD [connective tissue disease],” Dr. McLaughlin said.

She and her colleagues evaluated data from the prospective OPUS registry (NCT02126943) and the retrospective OrPHeUS study (NCT03197688), both of which included patients who were newly started on macitentan.

Dr. McLaughlin presented data on 2,311 patients with IPAH/HPAH and 668 patients with PAH-SSc. She also presented data on patients with PAH-systemic lupus erythematosus and PAH-mixed CTD, but numbers in these groups were small, and outcomes were similar to those in the PAH-SSc group.

Demographic and disease characteristics at the start of macitentan were similar between the IPAH/HPAH and PAH-SSc groups. The median age was 64 years in both groups. The median time from PAH diagnosis was 7.6 months in the IPAH/HPAH group and 8.5 months in the PAH-SSc group.

The median duration of macitentan exposure was 13.4 months in the IPAH/HPAH group and 14.4 months in the PAH-SSc group. The proportion of patients receiving macitentan in combination with other therapies (double or triple combinations) increased from baseline to 6 months in both groups.

Hepatic adverse events occurred in 7.4% of IPAH/HPAH patients and 7.9% of PAH-SSc patients. The most common adverse events among the IPAH/HPAH and PAH-SSc groups in the OPUS registry alone were dyspnea (19% and 26.1%, respectively), peripheral edema (9.8% and 12.4%), fatigue (6.8% and 11.7%), anemia (6.7% and 11.7%), headache (10.2% and 11%), and dizziness (6.7% and 10.7%).

About 39% of patients in both groups discontinued macitentan. Similar proportions in each group discontinued because of adverse events (17% in the IPAH/HPAH group and 18.3% in the PAH-SSc group) and hepatic adverse events (0.2% and 0.7%, respectively).

The proportion of patients with at least one hospitalization was 36.2% in the IPAH/HPAH group and 40.1% in the PAH-SSc group.

The 12-month Kaplan-Meier survival estimate was 92.9% in the IPAH/HPAH group and 91.3% in the PAH-SSc group. The 24-month estimated survival rate was 85.6% and 82.1%, respectively.

The OPUS registry and OrPHeUS study are sponsored by Actelion. Dr. McLaughlin disclosed relationships with Actelion, Acceleron, Bayer, Caremark, CiVi Biopharma, Reata, Sonovie, and United Therapeutics.

jensmith@mdedge.com

SOURCE: McLaughlin V et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.827.

NEW ORLEANS – Real-world data support the use of macitentan to treat pulmonary arterial hypertension (PAH) associated with connective tissue disease, according to a speaker at the annual meeting of the American College of Chest Physicians.

Jen Smith/MDedge News

Outcomes of macitentan (Opsumit) treatment were similar in patients who had PAH associated with systemic sclerosis (PAH-SSc) and patients who had idiopathic PAH (IPAH) or heritable PAH (HPAH), Vallerie McLaughlin, MD, of the University of Michigan, Ann Arbor, said at the meeting.

“Within the limits of a real-world registry, these data add to the growing body of evidence supporting the use of macitentan for treatment in patients with CTD [connective tissue disease],” Dr. McLaughlin said.

She and her colleagues evaluated data from the prospective OPUS registry (NCT02126943) and the retrospective OrPHeUS study (NCT03197688), both of which included patients who were newly started on macitentan.

Dr. McLaughlin presented data on 2,311 patients with IPAH/HPAH and 668 patients with PAH-SSc. She also presented data on patients with PAH-systemic lupus erythematosus and PAH-mixed CTD, but numbers in these groups were small, and outcomes were similar to those in the PAH-SSc group.

Demographic and disease characteristics at the start of macitentan were similar between the IPAH/HPAH and PAH-SSc groups. The median age was 64 years in both groups. The median time from PAH diagnosis was 7.6 months in the IPAH/HPAH group and 8.5 months in the PAH-SSc group.

The median duration of macitentan exposure was 13.4 months in the IPAH/HPAH group and 14.4 months in the PAH-SSc group. The proportion of patients receiving macitentan in combination with other therapies (double or triple combinations) increased from baseline to 6 months in both groups.

Hepatic adverse events occurred in 7.4% of IPAH/HPAH patients and 7.9% of PAH-SSc patients. The most common adverse events among the IPAH/HPAH and PAH-SSc groups in the OPUS registry alone were dyspnea (19% and 26.1%, respectively), peripheral edema (9.8% and 12.4%), fatigue (6.8% and 11.7%), anemia (6.7% and 11.7%), headache (10.2% and 11%), and dizziness (6.7% and 10.7%).

About 39% of patients in both groups discontinued macitentan. Similar proportions in each group discontinued because of adverse events (17% in the IPAH/HPAH group and 18.3% in the PAH-SSc group) and hepatic adverse events (0.2% and 0.7%, respectively).

The proportion of patients with at least one hospitalization was 36.2% in the IPAH/HPAH group and 40.1% in the PAH-SSc group.

The 12-month Kaplan-Meier survival estimate was 92.9% in the IPAH/HPAH group and 91.3% in the PAH-SSc group. The 24-month estimated survival rate was 85.6% and 82.1%, respectively.

The OPUS registry and OrPHeUS study are sponsored by Actelion. Dr. McLaughlin disclosed relationships with Actelion, Acceleron, Bayer, Caremark, CiVi Biopharma, Reata, Sonovie, and United Therapeutics.

jensmith@mdedge.com

SOURCE: McLaughlin V et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.827.

NEW ORLEANS – Real-world data support the use of macitentan to treat pulmonary arterial hypertension (PAH) associated with connective tissue disease, according to a speaker at the annual meeting of the American College of Chest Physicians.

Jen Smith/MDedge News

Outcomes of macitentan (Opsumit) treatment were similar in patients who had PAH associated with systemic sclerosis (PAH-SSc) and patients who had idiopathic PAH (IPAH) or heritable PAH (HPAH), Vallerie McLaughlin, MD, of the University of Michigan, Ann Arbor, said at the meeting.

“Within the limits of a real-world registry, these data add to the growing body of evidence supporting the use of macitentan for treatment in patients with CTD [connective tissue disease],” Dr. McLaughlin said.

She and her colleagues evaluated data from the prospective OPUS registry (NCT02126943) and the retrospective OrPHeUS study (NCT03197688), both of which included patients who were newly started on macitentan.

Dr. McLaughlin presented data on 2,311 patients with IPAH/HPAH and 668 patients with PAH-SSc. She also presented data on patients with PAH-systemic lupus erythematosus and PAH-mixed CTD, but numbers in these groups were small, and outcomes were similar to those in the PAH-SSc group.

Demographic and disease characteristics at the start of macitentan were similar between the IPAH/HPAH and PAH-SSc groups. The median age was 64 years in both groups. The median time from PAH diagnosis was 7.6 months in the IPAH/HPAH group and 8.5 months in the PAH-SSc group.

The median duration of macitentan exposure was 13.4 months in the IPAH/HPAH group and 14.4 months in the PAH-SSc group. The proportion of patients receiving macitentan in combination with other therapies (double or triple combinations) increased from baseline to 6 months in both groups.

Hepatic adverse events occurred in 7.4% of IPAH/HPAH patients and 7.9% of PAH-SSc patients. The most common adverse events among the IPAH/HPAH and PAH-SSc groups in the OPUS registry alone were dyspnea (19% and 26.1%, respectively), peripheral edema (9.8% and 12.4%), fatigue (6.8% and 11.7%), anemia (6.7% and 11.7%), headache (10.2% and 11%), and dizziness (6.7% and 10.7%).

About 39% of patients in both groups discontinued macitentan. Similar proportions in each group discontinued because of adverse events (17% in the IPAH/HPAH group and 18.3% in the PAH-SSc group) and hepatic adverse events (0.2% and 0.7%, respectively).

The proportion of patients with at least one hospitalization was 36.2% in the IPAH/HPAH group and 40.1% in the PAH-SSc group.

The 12-month Kaplan-Meier survival estimate was 92.9% in the IPAH/HPAH group and 91.3% in the PAH-SSc group. The 24-month estimated survival rate was 85.6% and 82.1%, respectively.

The OPUS registry and OrPHeUS study are sponsored by Actelion. Dr. McLaughlin disclosed relationships with Actelion, Acceleron, Bayer, Caremark, CiVi Biopharma, Reata, Sonovie, and United Therapeutics.

jensmith@mdedge.com

SOURCE: McLaughlin V et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.827.

NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.

Kenishirotie/Thinkstock

List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.

The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.

List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.

Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.

gtwachtman@mdedge.com

SOURCE: Hernandez I et a. AMCP Nexus, poster U2.

NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.

Kenishirotie/Thinkstock

List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.

The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.

List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.

Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.

gtwachtman@mdedge.com

SOURCE: Hernandez I et a. AMCP Nexus, poster U2.

NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.

Kenishirotie/Thinkstock

List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.

The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.

List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.

Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.

gtwachtman@mdedge.com

SOURCE: Hernandez I et a. AMCP Nexus, poster U2.

Hundreds of scientists around the world enter a competition every 2 years called the Critical Assessment of Structure Prediction.

“Tackling a biological puzzle they call ‘the protein folding problem,’ they try to predict the three-dimensional shape of proteins in the human body. No one knows how to solve the problem. Even the winners only chip away at it. But a solution could streamline the way scientists create new medicines and fight disease,” according to a report in the New York Times.

In 2019, those scientists did not win the contest. “It was won by DeepMind, the artificial intelligence lab owned by Google’s parent company. DeepMind specializes in ‘deep learning,’ a type of artificial intelligence that is rapidly changing drug discovery science.”

Reference

1. Metz C. “Making New Drugs With a Dose of Artificial Intelligence,” New York Times. Feb. 5, 2019. https://www.nytimes.com/2019/02/05/technology/artificial-intelligence-drug-research-deepmind.html. Accessed Feb 7, 2019.

Hundreds of scientists around the world enter a competition every 2 years called the Critical Assessment of Structure Prediction.

“Tackling a biological puzzle they call ‘the protein folding problem,’ they try to predict the three-dimensional shape of proteins in the human body. No one knows how to solve the problem. Even the winners only chip away at it. But a solution could streamline the way scientists create new medicines and fight disease,” according to a report in the New York Times.

In 2019, those scientists did not win the contest. “It was won by DeepMind, the artificial intelligence lab owned by Google’s parent company. DeepMind specializes in ‘deep learning,’ a type of artificial intelligence that is rapidly changing drug discovery science.”

Reference

1. Metz C. “Making New Drugs With a Dose of Artificial Intelligence,” New York Times. Feb. 5, 2019. https://www.nytimes.com/2019/02/05/technology/artificial-intelligence-drug-research-deepmind.html. Accessed Feb 7, 2019.

Hundreds of scientists around the world enter a competition every 2 years called the Critical Assessment of Structure Prediction.

“Tackling a biological puzzle they call ‘the protein folding problem,’ they try to predict the three-dimensional shape of proteins in the human body. No one knows how to solve the problem. Even the winners only chip away at it. But a solution could streamline the way scientists create new medicines and fight disease,” according to a report in the New York Times.

In 2019, those scientists did not win the contest. “It was won by DeepMind, the artificial intelligence lab owned by Google’s parent company. DeepMind specializes in ‘deep learning,’ a type of artificial intelligence that is rapidly changing drug discovery science.”

Reference

1. Metz C. “Making New Drugs With a Dose of Artificial Intelligence,” New York Times. Feb. 5, 2019. https://www.nytimes.com/2019/02/05/technology/artificial-intelligence-drug-research-deepmind.html. Accessed Feb 7, 2019.

When veterans receive emergency care at non-VA facilities, they can file for reimbursement of non-VA emergency care costs. If the claims are denied or rejected, non-VA facilities and providers can bill the veterans for some or all of the costs.

A stunning VA Office of Inspector General (OIG) report issued in August revealed that the VA had wrongfully rejected thousands of those emergency-care claims between April 1, 2017 and September 30, 2017. The OIG report said VA supervisors had pressured staff to quickly decide claims and even deny claims to maximize productivity. That culture of “speed over accuracy” led to 31% of claims being “inappropriately processed.”

Under regulations, when a claim is denied it is because there is no basis for payment, but a claim may also be rejected, meaning it cannot be decided until the claimant provides additional or corrected information. When the Claims Adjudication and Reimbursement Directorate (CAR) in the VA Office of Community Care (OCC) denies a claim, the claimant may have to pay out of pocket for emergency care.

The billed amount of inappropriately processed claims in those 5 months that were denied or rejected was “large in the aggregate,” the report said: an estimated $716 million, presenting potential undue financial risk to an estimated 60,800 veterans. The OIG estimated that about 17,400 veterans, with bills of at least $53.3 million, were negatively affected during the audit period. If corrective actions are not taken, the OIG estimates that the errors could result in $533 million in improper underpayments over 5 years.

The OIG audit was initiated after then Representative Tim Walz (D-MN) raised the concern in September 2017 about claims processors denying non-VA claims not only to meet production goals, but also to receive incentives such as high-performance ratings, bonuses, and telework privileges. The OIG audit also found that examiners who did not consistently meet the production numbers were not considered for overtime and had their telework privileges removed.

Other processing errors were also significant, the report says. For example, claimants did not receive complete and accurate information regarding why their claims were denied or rejected. Those errors created a risk that claimants could not effectively respond with information to get their claims approved.

The pressure to approve or deny claims quickly stemmed from a backlog of claims > 30 days old, which OCC and CAR leaders tried to reduce, the report says.

The OIG notes that since FY 2017 the OCC “experienced several leadership changes,” including 3 CAR directors. While the audit’s findings cannot be tied directly to those changes, the instability “provided the context in which problems were allowed to continue without remediation.”

In May, VHA officials reported to the audit team that they had implemented process improvements and initiatives that affect claims processing nationwide, and “the environment in which claims are processed.” Richard Stone, executive in charge of the VHA, submitted plans to comply with the IG’s 11 recommendations, which included tying incentives to all performance standards rather than just production quantity.

The US Court of Appeals for Veterans Claims recently ruled that the VA must reimburse veterans for emergency medical care at non-VA facilities—potentially between $1.8 billion and $6.5 billion in reimbursements for veterans who have filed or will file claims between 2016 and 2025. The court also struck down an internal VA regulation that blocked such payments. In 2015, the court had struck down a previous version of the internal regulation that refused coverage for an emergency claim when another form of insurance covered even a small part of the bill. The court said that regulation violated a 2010 federal law. In last month’s ruling, the court found the department had violated the same federal law with its revision of the reimbursement regulation, issued in 2018. The new rule, the panel said, created a new obstacle for veterans.

When veterans receive emergency care at non-VA facilities, they can file for reimbursement of non-VA emergency care costs. If the claims are denied or rejected, non-VA facilities and providers can bill the veterans for some or all of the costs.

A stunning VA Office of Inspector General (OIG) report issued in August revealed that the VA had wrongfully rejected thousands of those emergency-care claims between April 1, 2017 and September 30, 2017. The OIG report said VA supervisors had pressured staff to quickly decide claims and even deny claims to maximize productivity. That culture of “speed over accuracy” led to 31% of claims being “inappropriately processed.”

Under regulations, when a claim is denied it is because there is no basis for payment, but a claim may also be rejected, meaning it cannot be decided until the claimant provides additional or corrected information. When the Claims Adjudication and Reimbursement Directorate (CAR) in the VA Office of Community Care (OCC) denies a claim, the claimant may have to pay out of pocket for emergency care.

The billed amount of inappropriately processed claims in those 5 months that were denied or rejected was “large in the aggregate,” the report said: an estimated $716 million, presenting potential undue financial risk to an estimated 60,800 veterans. The OIG estimated that about 17,400 veterans, with bills of at least $53.3 million, were negatively affected during the audit period. If corrective actions are not taken, the OIG estimates that the errors could result in $533 million in improper underpayments over 5 years.

The OIG audit was initiated after then Representative Tim Walz (D-MN) raised the concern in September 2017 about claims processors denying non-VA claims not only to meet production goals, but also to receive incentives such as high-performance ratings, bonuses, and telework privileges. The OIG audit also found that examiners who did not consistently meet the production numbers were not considered for overtime and had their telework privileges removed.

Other processing errors were also significant, the report says. For example, claimants did not receive complete and accurate information regarding why their claims were denied or rejected. Those errors created a risk that claimants could not effectively respond with information to get their claims approved.

The pressure to approve or deny claims quickly stemmed from a backlog of claims > 30 days old, which OCC and CAR leaders tried to reduce, the report says.

The OIG notes that since FY 2017 the OCC “experienced several leadership changes,” including 3 CAR directors. While the audit’s findings cannot be tied directly to those changes, the instability “provided the context in which problems were allowed to continue without remediation.”

In May, VHA officials reported to the audit team that they had implemented process improvements and initiatives that affect claims processing nationwide, and “the environment in which claims are processed.” Richard Stone, executive in charge of the VHA, submitted plans to comply with the IG’s 11 recommendations, which included tying incentives to all performance standards rather than just production quantity.

The US Court of Appeals for Veterans Claims recently ruled that the VA must reimburse veterans for emergency medical care at non-VA facilities—potentially between $1.8 billion and $6.5 billion in reimbursements for veterans who have filed or will file claims between 2016 and 2025. The court also struck down an internal VA regulation that blocked such payments. In 2015, the court had struck down a previous version of the internal regulation that refused coverage for an emergency claim when another form of insurance covered even a small part of the bill. The court said that regulation violated a 2010 federal law. In last month’s ruling, the court found the department had violated the same federal law with its revision of the reimbursement regulation, issued in 2018. The new rule, the panel said, created a new obstacle for veterans.

When veterans receive emergency care at non-VA facilities, they can file for reimbursement of non-VA emergency care costs. If the claims are denied or rejected, non-VA facilities and providers can bill the veterans for some or all of the costs.

A stunning VA Office of Inspector General (OIG) report issued in August revealed that the VA had wrongfully rejected thousands of those emergency-care claims between April 1, 2017 and September 30, 2017. The OIG report said VA supervisors had pressured staff to quickly decide claims and even deny claims to maximize productivity. That culture of “speed over accuracy” led to 31% of claims being “inappropriately processed.”

Under regulations, when a claim is denied it is because there is no basis for payment, but a claim may also be rejected, meaning it cannot be decided until the claimant provides additional or corrected information. When the Claims Adjudication and Reimbursement Directorate (CAR) in the VA Office of Community Care (OCC) denies a claim, the claimant may have to pay out of pocket for emergency care.

The billed amount of inappropriately processed claims in those 5 months that were denied or rejected was “large in the aggregate,” the report said: an estimated $716 million, presenting potential undue financial risk to an estimated 60,800 veterans. The OIG estimated that about 17,400 veterans, with bills of at least $53.3 million, were negatively affected during the audit period. If corrective actions are not taken, the OIG estimates that the errors could result in $533 million in improper underpayments over 5 years.

The OIG audit was initiated after then Representative Tim Walz (D-MN) raised the concern in September 2017 about claims processors denying non-VA claims not only to meet production goals, but also to receive incentives such as high-performance ratings, bonuses, and telework privileges. The OIG audit also found that examiners who did not consistently meet the production numbers were not considered for overtime and had their telework privileges removed.

Other processing errors were also significant, the report says. For example, claimants did not receive complete and accurate information regarding why their claims were denied or rejected. Those errors created a risk that claimants could not effectively respond with information to get their claims approved.

The pressure to approve or deny claims quickly stemmed from a backlog of claims > 30 days old, which OCC and CAR leaders tried to reduce, the report says.

The OIG notes that since FY 2017 the OCC “experienced several leadership changes,” including 3 CAR directors. While the audit’s findings cannot be tied directly to those changes, the instability “provided the context in which problems were allowed to continue without remediation.”

In May, VHA officials reported to the audit team that they had implemented process improvements and initiatives that affect claims processing nationwide, and “the environment in which claims are processed.” Richard Stone, executive in charge of the VHA, submitted plans to comply with the IG’s 11 recommendations, which included tying incentives to all performance standards rather than just production quantity.

The US Court of Appeals for Veterans Claims recently ruled that the VA must reimburse veterans for emergency medical care at non-VA facilities—potentially between $1.8 billion and $6.5 billion in reimbursements for veterans who have filed or will file claims between 2016 and 2025. The court also struck down an internal VA regulation that blocked such payments. In 2015, the court had struck down a previous version of the internal regulation that refused coverage for an emergency claim when another form of insurance covered even a small part of the bill. The court said that regulation violated a 2010 federal law. In last month’s ruling, the court found the department had violated the same federal law with its revision of the reimbursement regulation, issued in 2018. The new rule, the panel said, created a new obstacle for veterans.

AUSTIN, TEX. – When testing for acetylcholine receptor (AChR) autoantibodies in patients with suspected myasthenia gravis, testing for binding antibodies and for modulating antibodies is more accurate than testing for either subtype alone, researchers reported at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. Testing for both subtypes may be the most accurate approach, regardless of whether patients have coexisting neuromuscular disorders, the researchers said.

“The advent of improved methods of detecting AChR autoantibodies has greatly facilitated the diagnosis of myasthenia gravis,” said Pritikanta Paul, MBBS, a neuromuscular fellow at Mayo Clinic in Rochester, Minn., and his colleagues. AChR antibody assays frequently are part of evaluations for myasthenia gravis, but clinicians lack consensus as to which antibody subtypes – binding, blocking, or modulating – should be tested. Clinicians test for binding antibodies most commonly, while studies have found blocking antibodies to be “least useful as an initial diagnostic test,” Dr. Paul and his colleagues said.

To assess how combinatorial antibody testing and the presence of coexisting neuromuscular disorders affect testing’s sensitivity and specificity, the researchers reviewed clinical and electrophysiologic testing data from 360 patients with suspected myasthenia gravis who underwent serologic autoantibody testing between 2012 and 2015.

Titers of AChR binding antibodies greater than 0.02 nmol/L were considered positive, as were AChR modulating antibodies more than 20%. The researchers used a greater than 10% decrement of the compound muscle action potential to repetitive nerve stimulation at 2 Hz or positive response on single-fiber EMG as electrophysiologic confirmation of myasthenia gravis.

In all, 123 of the 360 patients had a final clinical and electrophysiologic diagnosis of myasthenia gravis, including 23 with ocular myasthenia gravis and 100 with generalized myasthenia gravis.

The sensitivity of testing for AChR binding autoantibodies was 92%, and the sensitivity of testing for modulating autoantibodies was 90%. In comparison, the sensitivity of testing for either antibody subtype or both was 94%.

Among 45 patients with myasthenia gravis and coexisting neuromuscular disorders, including peripheral neuropathy, mononeuropathies, radiculopathy, and motor neuron disease, the sensitivities of testing for binding antibodies, modulating antibodies, and either or both were 96%, 91%, and 96%, respectively.

Of the 237 patients who did not have myasthenia gravis, 89 had electrophysiologic confirmation of alternative diagnoses. Among these 89 patients, AChR autoantibody testing yielded 11 false positives. Three patients tested positive for both binding and modulating antibodies, six for binding antibodies only, and two for modulating antibodies only. Those with false-positive results had diagnoses that were “diverse and clinically distinguishable from myasthenia gravis,” including myalgia, neuropathy, blurred vision, epilepsy, encephalopathy, and hemifacial spasm, the researchers said.

The researchers had no relevant disclosures.

jremaly@mdedge.com

SOURCE: Paul P et al. AANEM 2019, Abstract 236.

AUSTIN, TEX. – When testing for acetylcholine receptor (AChR) autoantibodies in patients with suspected myasthenia gravis, testing for binding antibodies and for modulating antibodies is more accurate than testing for either subtype alone, researchers reported at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. Testing for both subtypes may be the most accurate approach, regardless of whether patients have coexisting neuromuscular disorders, the researchers said.

“The advent of improved methods of detecting AChR autoantibodies has greatly facilitated the diagnosis of myasthenia gravis,” said Pritikanta Paul, MBBS, a neuromuscular fellow at Mayo Clinic in Rochester, Minn., and his colleagues. AChR antibody assays frequently are part of evaluations for myasthenia gravis, but clinicians lack consensus as to which antibody subtypes – binding, blocking, or modulating – should be tested. Clinicians test for binding antibodies most commonly, while studies have found blocking antibodies to be “least useful as an initial diagnostic test,” Dr. Paul and his colleagues said.

To assess how combinatorial antibody testing and the presence of coexisting neuromuscular disorders affect testing’s sensitivity and specificity, the researchers reviewed clinical and electrophysiologic testing data from 360 patients with suspected myasthenia gravis who underwent serologic autoantibody testing between 2012 and 2015.

Titers of AChR binding antibodies greater than 0.02 nmol/L were considered positive, as were AChR modulating antibodies more than 20%. The researchers used a greater than 10% decrement of the compound muscle action potential to repetitive nerve stimulation at 2 Hz or positive response on single-fiber EMG as electrophysiologic confirmation of myasthenia gravis.

In all, 123 of the 360 patients had a final clinical and electrophysiologic diagnosis of myasthenia gravis, including 23 with ocular myasthenia gravis and 100 with generalized myasthenia gravis.

The sensitivity of testing for AChR binding autoantibodies was 92%, and the sensitivity of testing for modulating autoantibodies was 90%. In comparison, the sensitivity of testing for either antibody subtype or both was 94%.

Among 45 patients with myasthenia gravis and coexisting neuromuscular disorders, including peripheral neuropathy, mononeuropathies, radiculopathy, and motor neuron disease, the sensitivities of testing for binding antibodies, modulating antibodies, and either or both were 96%, 91%, and 96%, respectively.

Of the 237 patients who did not have myasthenia gravis, 89 had electrophysiologic confirmation of alternative diagnoses. Among these 89 patients, AChR autoantibody testing yielded 11 false positives. Three patients tested positive for both binding and modulating antibodies, six for binding antibodies only, and two for modulating antibodies only. Those with false-positive results had diagnoses that were “diverse and clinically distinguishable from myasthenia gravis,” including myalgia, neuropathy, blurred vision, epilepsy, encephalopathy, and hemifacial spasm, the researchers said.

The researchers had no relevant disclosures.

jremaly@mdedge.com

SOURCE: Paul P et al. AANEM 2019, Abstract 236.

AUSTIN, TEX. – When testing for acetylcholine receptor (AChR) autoantibodies in patients with suspected myasthenia gravis, testing for binding antibodies and for modulating antibodies is more accurate than testing for either subtype alone, researchers reported at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. Testing for both subtypes may be the most accurate approach, regardless of whether patients have coexisting neuromuscular disorders, the researchers said.

“The advent of improved methods of detecting AChR autoantibodies has greatly facilitated the diagnosis of myasthenia gravis,” said Pritikanta Paul, MBBS, a neuromuscular fellow at Mayo Clinic in Rochester, Minn., and his colleagues. AChR antibody assays frequently are part of evaluations for myasthenia gravis, but clinicians lack consensus as to which antibody subtypes – binding, blocking, or modulating – should be tested. Clinicians test for binding antibodies most commonly, while studies have found blocking antibodies to be “least useful as an initial diagnostic test,” Dr. Paul and his colleagues said.

To assess how combinatorial antibody testing and the presence of coexisting neuromuscular disorders affect testing’s sensitivity and specificity, the researchers reviewed clinical and electrophysiologic testing data from 360 patients with suspected myasthenia gravis who underwent serologic autoantibody testing between 2012 and 2015.

Titers of AChR binding antibodies greater than 0.02 nmol/L were considered positive, as were AChR modulating antibodies more than 20%. The researchers used a greater than 10% decrement of the compound muscle action potential to repetitive nerve stimulation at 2 Hz or positive response on single-fiber EMG as electrophysiologic confirmation of myasthenia gravis.

In all, 123 of the 360 patients had a final clinical and electrophysiologic diagnosis of myasthenia gravis, including 23 with ocular myasthenia gravis and 100 with generalized myasthenia gravis.

The sensitivity of testing for AChR binding autoantibodies was 92%, and the sensitivity of testing for modulating autoantibodies was 90%. In comparison, the sensitivity of testing for either antibody subtype or both was 94%.

Among 45 patients with myasthenia gravis and coexisting neuromuscular disorders, including peripheral neuropathy, mononeuropathies, radiculopathy, and motor neuron disease, the sensitivities of testing for binding antibodies, modulating antibodies, and either or both were 96%, 91%, and 96%, respectively.

Of the 237 patients who did not have myasthenia gravis, 89 had electrophysiologic confirmation of alternative diagnoses. Among these 89 patients, AChR autoantibody testing yielded 11 false positives. Three patients tested positive for both binding and modulating antibodies, six for binding antibodies only, and two for modulating antibodies only. Those with false-positive results had diagnoses that were “diverse and clinically distinguishable from myasthenia gravis,” including myalgia, neuropathy, blurred vision, epilepsy, encephalopathy, and hemifacial spasm, the researchers said.

The researchers had no relevant disclosures.

jremaly@mdedge.com

SOURCE: Paul P et al. AANEM 2019, Abstract 236.

WASHINGTON – Influenza vaccine continues to cut not just the incidence of flu but also mitigates infection severity in both children and adults, according to recent U.S. experience collected by the Centers for Disease Control and Prevention.

During recent U.S. flu seasons, children and adults who contracted influenza despite vaccination had significantly fewer severe infections and infection complications, compared with unimmunized people, according to two separate reports from CDC researchers presented at an annual scientific meeting on infectious diseases.

One of the reports tracked the impact of flu vaccine in children using data that the CDC collected at seven medical centers that participated in the agency’s New Vaccine Surveillance Network, which provided information on children aged 6 months to 17 years who were hospitalized for an acute respiratory illness, including more than 1,700 children during the 2016-2017 flu season and more than 1,900 during the 2017-2018 season. Roughly 10% of these children tested positive for influenza, and the subsequent analysis focused on these cases and compared incidence rates among children who had been vaccinated during the index season and those who had remained unvaccinated.

Combined data from both seasons showed that vaccinated children were 50% less likely to have been hospitalized for an acute influenza infection, compared with unvaccinated kids, a pattern consistently seen both in children aged 6 months to 8 years and in those aged 9-17 years. The pattern of vaccine effectiveness also held regardless of which flu strain caused the infections, reported Angela P. Campbell, MD, a CDC medical officer.

“We saw a nice benefit from vaccination, both in previously healthy children and in those with an underlying medical condition,” a finding that adds to existing evidence of vaccine effectiveness, Dr. Campbell said in a video interview. The results confirmed that flu vaccination does not just prevent infections but also cuts the rate of more severe infections that lead to hospitalization, she explained.

Another CDC study looked at data collected by the agency’s Influenza Hospitalization Surveillance Network from adults at least 18 years old who were hospitalized for a laboratory-confirmed influenza infection during five flu seasons, 2013-2014 through 2017-18. The data, which came from more than 250 acute-care hospitals in 13 states, included more than 43,000 people hospitalized for an identified influenza strain and with a known vaccination history who were not institutionalized and had not received any antiviral treatment.

After propensity-weighted adjustment to create better parity between the vaccinated and unvaccinated patients, the results showed that people 18-64 years old with vaccination had statistically significant decreases in mortality of a relative 36%, need for mechanical ventilation of 34%, pneumonia of 20%, and need for ICU admission of a relative 19%, as well as an 18% drop in average ICU length of stay, Shikha Garg, MD, said at the meeting. The propensity-weighted analysis of data from people at least 65 years old showed statistically significant relative reductions linked with vaccination: 46% reduction in the need for mechanical ventilation, 28% reduction in ICU admissions, and 9% reduction in hospitalized length of stay.

Further analysis of these outcomes by the strains that caused these influenza infections showed that the statistically significant benefits from vaccination were seen only in patients infected with an H1N1 strain. Statistically significant effects on these severe outcomes were not apparent among people infected with the H3N2 or B strains, said Dr. Garg, a medical epidemiologist at the CDC.

“All adults should receive an annual flu vaccination as it can improve outcomes among those who develop influenza despite vaccination,” she concluded.

Results from a third CDC study reported at the meeting examined the importance of two vaccine doses (administered at least 4 weeks apart) given to children aged 6 months to 8 years for the first season they receive flu vaccination, which is the immunization approach for flu recommended by the CDC. The findings from a total of more than 7,500 children immunized during the 2014-2018 seasons showed a clear increment in vaccine protection among kids who received two doses during their first season vaccinated, especially in children who were 2 years old or younger. In that age group, administration of two doses produced vaccine effectiveness of 53% versus a 23% vaccine effectiveness after a single vaccine dose, reported Jessie Chung, a CDC epidemiologist.

mzoler@mdedge.com

WASHINGTON – Influenza vaccine continues to cut not just the incidence of flu but also mitigates infection severity in both children and adults, according to recent U.S. experience collected by the Centers for Disease Control and Prevention.

During recent U.S. flu seasons, children and adults who contracted influenza despite vaccination had significantly fewer severe infections and infection complications, compared with unimmunized people, according to two separate reports from CDC researchers presented at an annual scientific meeting on infectious diseases.

One of the reports tracked the impact of flu vaccine in children using data that the CDC collected at seven medical centers that participated in the agency’s New Vaccine Surveillance Network, which provided information on children aged 6 months to 17 years who were hospitalized for an acute respiratory illness, including more than 1,700 children during the 2016-2017 flu season and more than 1,900 during the 2017-2018 season. Roughly 10% of these children tested positive for influenza, and the subsequent analysis focused on these cases and compared incidence rates among children who had been vaccinated during the index season and those who had remained unvaccinated.

Combined data from both seasons showed that vaccinated children were 50% less likely to have been hospitalized for an acute influenza infection, compared with unvaccinated kids, a pattern consistently seen both in children aged 6 months to 8 years and in those aged 9-17 years. The pattern of vaccine effectiveness also held regardless of which flu strain caused the infections, reported Angela P. Campbell, MD, a CDC medical officer.

“We saw a nice benefit from vaccination, both in previously healthy children and in those with an underlying medical condition,” a finding that adds to existing evidence of vaccine effectiveness, Dr. Campbell said in a video interview. The results confirmed that flu vaccination does not just prevent infections but also cuts the rate of more severe infections that lead to hospitalization, she explained.

Another CDC study looked at data collected by the agency’s Influenza Hospitalization Surveillance Network from adults at least 18 years old who were hospitalized for a laboratory-confirmed influenza infection during five flu seasons, 2013-2014 through 2017-18. The data, which came from more than 250 acute-care hospitals in 13 states, included more than 43,000 people hospitalized for an identified influenza strain and with a known vaccination history who were not institutionalized and had not received any antiviral treatment.

After propensity-weighted adjustment to create better parity between the vaccinated and unvaccinated patients, the results showed that people 18-64 years old with vaccination had statistically significant decreases in mortality of a relative 36%, need for mechanical ventilation of 34%, pneumonia of 20%, and need for ICU admission of a relative 19%, as well as an 18% drop in average ICU length of stay, Shikha Garg, MD, said at the meeting. The propensity-weighted analysis of data from people at least 65 years old showed statistically significant relative reductions linked with vaccination: 46% reduction in the need for mechanical ventilation, 28% reduction in ICU admissions, and 9% reduction in hospitalized length of stay.

Further analysis of these outcomes by the strains that caused these influenza infections showed that the statistically significant benefits from vaccination were seen only in patients infected with an H1N1 strain. Statistically significant effects on these severe outcomes were not apparent among people infected with the H3N2 or B strains, said Dr. Garg, a medical epidemiologist at the CDC.

“All adults should receive an annual flu vaccination as it can improve outcomes among those who develop influenza despite vaccination,” she concluded.

Results from a third CDC study reported at the meeting examined the importance of two vaccine doses (administered at least 4 weeks apart) given to children aged 6 months to 8 years for the first season they receive flu vaccination, which is the immunization approach for flu recommended by the CDC. The findings from a total of more than 7,500 children immunized during the 2014-2018 seasons showed a clear increment in vaccine protection among kids who received two doses during their first season vaccinated, especially in children who were 2 years old or younger. In that age group, administration of two doses produced vaccine effectiveness of 53% versus a 23% vaccine effectiveness after a single vaccine dose, reported Jessie Chung, a CDC epidemiologist.

mzoler@mdedge.com

WASHINGTON – Influenza vaccine continues to cut not just the incidence of flu but also mitigates infection severity in both children and adults, according to recent U.S. experience collected by the Centers for Disease Control and Prevention.

During recent U.S. flu seasons, children and adults who contracted influenza despite vaccination had significantly fewer severe infections and infection complications, compared with unimmunized people, according to two separate reports from CDC researchers presented at an annual scientific meeting on infectious diseases.

One of the reports tracked the impact of flu vaccine in children using data that the CDC collected at seven medical centers that participated in the agency’s New Vaccine Surveillance Network, which provided information on children aged 6 months to 17 years who were hospitalized for an acute respiratory illness, including more than 1,700 children during the 2016-2017 flu season and more than 1,900 during the 2017-2018 season. Roughly 10% of these children tested positive for influenza, and the subsequent analysis focused on these cases and compared incidence rates among children who had been vaccinated during the index season and those who had remained unvaccinated.

Combined data from both seasons showed that vaccinated children were 50% less likely to have been hospitalized for an acute influenza infection, compared with unvaccinated kids, a pattern consistently seen both in children aged 6 months to 8 years and in those aged 9-17 years. The pattern of vaccine effectiveness also held regardless of which flu strain caused the infections, reported Angela P. Campbell, MD, a CDC medical officer.

“We saw a nice benefit from vaccination, both in previously healthy children and in those with an underlying medical condition,” a finding that adds to existing evidence of vaccine effectiveness, Dr. Campbell said in a video interview. The results confirmed that flu vaccination does not just prevent infections but also cuts the rate of more severe infections that lead to hospitalization, she explained.

Another CDC study looked at data collected by the agency’s Influenza Hospitalization Surveillance Network from adults at least 18 years old who were hospitalized for a laboratory-confirmed influenza infection during five flu seasons, 2013-2014 through 2017-18. The data, which came from more than 250 acute-care hospitals in 13 states, included more than 43,000 people hospitalized for an identified influenza strain and with a known vaccination history who were not institutionalized and had not received any antiviral treatment.

After propensity-weighted adjustment to create better parity between the vaccinated and unvaccinated patients, the results showed that people 18-64 years old with vaccination had statistically significant decreases in mortality of a relative 36%, need for mechanical ventilation of 34%, pneumonia of 20%, and need for ICU admission of a relative 19%, as well as an 18% drop in average ICU length of stay, Shikha Garg, MD, said at the meeting. The propensity-weighted analysis of data from people at least 65 years old showed statistically significant relative reductions linked with vaccination: 46% reduction in the need for mechanical ventilation, 28% reduction in ICU admissions, and 9% reduction in hospitalized length of stay.

Further analysis of these outcomes by the strains that caused these influenza infections showed that the statistically significant benefits from vaccination were seen only in patients infected with an H1N1 strain. Statistically significant effects on these severe outcomes were not apparent among people infected with the H3N2 or B strains, said Dr. Garg, a medical epidemiologist at the CDC.

“All adults should receive an annual flu vaccination as it can improve outcomes among those who develop influenza despite vaccination,” she concluded.

Results from a third CDC study reported at the meeting examined the importance of two vaccine doses (administered at least 4 weeks apart) given to children aged 6 months to 8 years for the first season they receive flu vaccination, which is the immunization approach for flu recommended by the CDC. The findings from a total of more than 7,500 children immunized during the 2014-2018 seasons showed a clear increment in vaccine protection among kids who received two doses during their first season vaccinated, especially in children who were 2 years old or younger. In that age group, administration of two doses produced vaccine effectiveness of 53% versus a 23% vaccine effectiveness after a single vaccine dose, reported Jessie Chung, a CDC epidemiologist.

mzoler@mdedge.com

Click here to read the special report.

Click here to read the special report.

Click here to read the special report.

A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.

In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote the plaintiffs are likely to succeed in proving that Alabama’s law violates a woman’s constitutional right to obtain a per-viability abortion, and that enforcement of the law will cause irreparable harm to Alabama women. Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.

“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”

Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.

The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.

“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”

Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.

“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.

The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.

agallegos@mdedge.com

A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.

In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote the plaintiffs are likely to succeed in proving that Alabama’s law violates a woman’s constitutional right to obtain a per-viability abortion, and that enforcement of the law will cause irreparable harm to Alabama women. Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.

“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”

Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.

The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.

“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”

Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.

“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.

The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.

agallegos@mdedge.com

A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.

In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote the plaintiffs are likely to succeed in proving that Alabama’s law violates a woman’s constitutional right to obtain a per-viability abortion, and that enforcement of the law will cause irreparable harm to Alabama women. Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.

“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”

Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.

The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.

“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”

Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.

“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.

The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.

agallegos@mdedge.com