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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
Naltrexone/ketamine combo may reduce depressive symptoms in MDD/AUD patients
Combined naltrexone and ketamine reduced depressive symptoms in a small group of patients with major depressive disorder (MDD) and alcohol use disorder (AUD), according to Gihyun Yoon, MD, of the department of psychiatry at Yale University, New Haven, Conn., and associates.
A total of five patients with major depressive disorder and comorbid alcohol use disorder were included in the 8-week, open-label pilot study. The patients were followed for an additional 4 weeks. The primary outcome was the clinical response, defined as a 50% or higher improvement from baseline in the Montgomery-Åsberg Depression Rating Scale.
After the first ketamine dose, three of the five study participants met the primary outcome, and all five met the outcome after receiving all four doses. Depressive symptoms improved 57%-92% overall. In addition, four of the five patients reported improvement in alcohol craving and consumption; no adverse events were reported.
“Larger randomized clinical trials are needed to better understand whether opiate receptor stimulation contributes to the antidepressant effects of ketamine. If so, then preclinical research will be needed to help us to understand this role for opiates and its implications for future rapid-acting antidepressant treatments,” concluded Dr. Yoon and associates.
Two study authors reported conflicts of interest with numerous companies. All study authors are listed inventors on a patent application by Yale University.
SOURCE: Yoon G et al. JAMA Psychiatry. 2019 Jan 9. doi: 10.1001/jamapsychiatry.2018.3990.
Combined naltrexone and ketamine reduced depressive symptoms in a small group of patients with major depressive disorder (MDD) and alcohol use disorder (AUD), according to Gihyun Yoon, MD, of the department of psychiatry at Yale University, New Haven, Conn., and associates.
A total of five patients with major depressive disorder and comorbid alcohol use disorder were included in the 8-week, open-label pilot study. The patients were followed for an additional 4 weeks. The primary outcome was the clinical response, defined as a 50% or higher improvement from baseline in the Montgomery-Åsberg Depression Rating Scale.
After the first ketamine dose, three of the five study participants met the primary outcome, and all five met the outcome after receiving all four doses. Depressive symptoms improved 57%-92% overall. In addition, four of the five patients reported improvement in alcohol craving and consumption; no adverse events were reported.
“Larger randomized clinical trials are needed to better understand whether opiate receptor stimulation contributes to the antidepressant effects of ketamine. If so, then preclinical research will be needed to help us to understand this role for opiates and its implications for future rapid-acting antidepressant treatments,” concluded Dr. Yoon and associates.
Two study authors reported conflicts of interest with numerous companies. All study authors are listed inventors on a patent application by Yale University.
SOURCE: Yoon G et al. JAMA Psychiatry. 2019 Jan 9. doi: 10.1001/jamapsychiatry.2018.3990.
Combined naltrexone and ketamine reduced depressive symptoms in a small group of patients with major depressive disorder (MDD) and alcohol use disorder (AUD), according to Gihyun Yoon, MD, of the department of psychiatry at Yale University, New Haven, Conn., and associates.
A total of five patients with major depressive disorder and comorbid alcohol use disorder were included in the 8-week, open-label pilot study. The patients were followed for an additional 4 weeks. The primary outcome was the clinical response, defined as a 50% or higher improvement from baseline in the Montgomery-Åsberg Depression Rating Scale.
After the first ketamine dose, three of the five study participants met the primary outcome, and all five met the outcome after receiving all four doses. Depressive symptoms improved 57%-92% overall. In addition, four of the five patients reported improvement in alcohol craving and consumption; no adverse events were reported.
“Larger randomized clinical trials are needed to better understand whether opiate receptor stimulation contributes to the antidepressant effects of ketamine. If so, then preclinical research will be needed to help us to understand this role for opiates and its implications for future rapid-acting antidepressant treatments,” concluded Dr. Yoon and associates.
Two study authors reported conflicts of interest with numerous companies. All study authors are listed inventors on a patent application by Yale University.
SOURCE: Yoon G et al. JAMA Psychiatry. 2019 Jan 9. doi: 10.1001/jamapsychiatry.2018.3990.
FROM JAMA PSYCHIATRY
White matter volume reduced in first-episode depression
Decrements ‘seem to vanish’ after 2-year follow-up
White matter volume was significantly reduced initially in patients with first-episode depression, but not after a 2-year follow-up, according to Mar Carceller-Sindreu, MD, of the department of psychiatry at Hospital de la Santa Creu i Sant Pau in Barcelona, and her associates.
A total of 33 patients with first-episode depression and 33 healthy controls were included in the study. Among them, 27 first-episode depression patients and 17 controls completed the 2-year follow-up. They underwent structural MRIs at baseline and at follow-up, the Hamilton Depressive Rating Scale was administered throughout the study period, and whole-brain, voxel-based morphometry was used to measure white matter and gray matter, Dr. Carceller-Sindreu and her associates wrote. The report is in the Journal of Affective Disorders.
At baseline, the white matter volume in the prefrontal cortex of patients with first-episode depression was significantly lower than in healthy controls; no difference was seen in gray matter volume. At the 2-year follow-up, no difference was seen in either white matter or gray matter volume. In other words, the baseline differences “seem to vanish, as if they were normalized,” Dr. Carceller-Sindreu said. The normalization of white matter might have been caused by treatment normalization or attributable to lack of study power, she and her associates noted.
In addition, patients who had recurring depression over the study period had higher white matter volume in the left posterior corona radiata and right posterior thalamic radiation at follow-up, compared with patients whose depression did not recur. This finding “could represent compensatory effects to cope with the disease,” the investigators wrote.
“, so as to unveil many of the open questions,” they concluded.
The study was supported by the Spanish FIS grant, the European Regional Development Fund, and the CERCA Programme. Two study authors reported conflicts of interest with numerous pharmaceutical companies.
SOURCE: Carceller-Sindreu M et al. J Affect Disord. 2018 Nov 13. doi: 10.1016/j.jad.2018.11.085.
Decrements ‘seem to vanish’ after 2-year follow-up
Decrements ‘seem to vanish’ after 2-year follow-up
White matter volume was significantly reduced initially in patients with first-episode depression, but not after a 2-year follow-up, according to Mar Carceller-Sindreu, MD, of the department of psychiatry at Hospital de la Santa Creu i Sant Pau in Barcelona, and her associates.
A total of 33 patients with first-episode depression and 33 healthy controls were included in the study. Among them, 27 first-episode depression patients and 17 controls completed the 2-year follow-up. They underwent structural MRIs at baseline and at follow-up, the Hamilton Depressive Rating Scale was administered throughout the study period, and whole-brain, voxel-based morphometry was used to measure white matter and gray matter, Dr. Carceller-Sindreu and her associates wrote. The report is in the Journal of Affective Disorders.
At baseline, the white matter volume in the prefrontal cortex of patients with first-episode depression was significantly lower than in healthy controls; no difference was seen in gray matter volume. At the 2-year follow-up, no difference was seen in either white matter or gray matter volume. In other words, the baseline differences “seem to vanish, as if they were normalized,” Dr. Carceller-Sindreu said. The normalization of white matter might have been caused by treatment normalization or attributable to lack of study power, she and her associates noted.
In addition, patients who had recurring depression over the study period had higher white matter volume in the left posterior corona radiata and right posterior thalamic radiation at follow-up, compared with patients whose depression did not recur. This finding “could represent compensatory effects to cope with the disease,” the investigators wrote.
“, so as to unveil many of the open questions,” they concluded.
The study was supported by the Spanish FIS grant, the European Regional Development Fund, and the CERCA Programme. Two study authors reported conflicts of interest with numerous pharmaceutical companies.
SOURCE: Carceller-Sindreu M et al. J Affect Disord. 2018 Nov 13. doi: 10.1016/j.jad.2018.11.085.
White matter volume was significantly reduced initially in patients with first-episode depression, but not after a 2-year follow-up, according to Mar Carceller-Sindreu, MD, of the department of psychiatry at Hospital de la Santa Creu i Sant Pau in Barcelona, and her associates.
A total of 33 patients with first-episode depression and 33 healthy controls were included in the study. Among them, 27 first-episode depression patients and 17 controls completed the 2-year follow-up. They underwent structural MRIs at baseline and at follow-up, the Hamilton Depressive Rating Scale was administered throughout the study period, and whole-brain, voxel-based morphometry was used to measure white matter and gray matter, Dr. Carceller-Sindreu and her associates wrote. The report is in the Journal of Affective Disorders.
At baseline, the white matter volume in the prefrontal cortex of patients with first-episode depression was significantly lower than in healthy controls; no difference was seen in gray matter volume. At the 2-year follow-up, no difference was seen in either white matter or gray matter volume. In other words, the baseline differences “seem to vanish, as if they were normalized,” Dr. Carceller-Sindreu said. The normalization of white matter might have been caused by treatment normalization or attributable to lack of study power, she and her associates noted.
In addition, patients who had recurring depression over the study period had higher white matter volume in the left posterior corona radiata and right posterior thalamic radiation at follow-up, compared with patients whose depression did not recur. This finding “could represent compensatory effects to cope with the disease,” the investigators wrote.
“, so as to unveil many of the open questions,” they concluded.
The study was supported by the Spanish FIS grant, the European Regional Development Fund, and the CERCA Programme. Two study authors reported conflicts of interest with numerous pharmaceutical companies.
SOURCE: Carceller-Sindreu M et al. J Affect Disord. 2018 Nov 13. doi: 10.1016/j.jad.2018.11.085.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Bipolar patients’ ability to consent can be measured with MacCAT-CR
, according to Christina C. Klein and her associates.
A total of 50 patients who were enrolled in a clinical trial of approved, standard treatments for bipolar disease were included in the consent study. The MacCAT-CR was administered after patients had given consent to be included in the trial, but before the trial had started. Four patients lacked the ability to provide consent for the trial after receiving the MacCAT-CR. After these patients were reeducated and went through the consent process a second time, three were enrolled and one declined enrollment.
Patients with higher Schedule for Assessment of Positive Symptoms scores were more likely to have worse MacCAT-CR Understanding and Appreciation subscale scores; lower Hamilton Depression Rating Scale and higher Clinical Global Impression–Severity scores were associated with worse Reasoning and Understanding subscale scores.
Comorbid ADHD, sex, IQ scores, and age at onset of bipolar disorder were not correlated with any subscale scores. In addition, a history of substance use disorder was associated with higher Appreciation and Reasoning subscale scores.
“The current study provides important information for clinicians and researchers to consider when obtaining informed consent from an individual with bipolar disorder. The MacCAT-CR may serve to identify patients, specifically those with higher psychotic symptoms or global illness severity, as needing additional education regarding informed consent,” the investigators concluded.
Three study coauthors reported conflicts of interest with numerous pharmaceutical companies.
SOURCE: Klein CC et al. J Affect Disord. 2018 Aug 13. doi: 10.1016/j.jad.2018.08.049.
, according to Christina C. Klein and her associates.
A total of 50 patients who were enrolled in a clinical trial of approved, standard treatments for bipolar disease were included in the consent study. The MacCAT-CR was administered after patients had given consent to be included in the trial, but before the trial had started. Four patients lacked the ability to provide consent for the trial after receiving the MacCAT-CR. After these patients were reeducated and went through the consent process a second time, three were enrolled and one declined enrollment.
Patients with higher Schedule for Assessment of Positive Symptoms scores were more likely to have worse MacCAT-CR Understanding and Appreciation subscale scores; lower Hamilton Depression Rating Scale and higher Clinical Global Impression–Severity scores were associated with worse Reasoning and Understanding subscale scores.
Comorbid ADHD, sex, IQ scores, and age at onset of bipolar disorder were not correlated with any subscale scores. In addition, a history of substance use disorder was associated with higher Appreciation and Reasoning subscale scores.
“The current study provides important information for clinicians and researchers to consider when obtaining informed consent from an individual with bipolar disorder. The MacCAT-CR may serve to identify patients, specifically those with higher psychotic symptoms or global illness severity, as needing additional education regarding informed consent,” the investigators concluded.
Three study coauthors reported conflicts of interest with numerous pharmaceutical companies.
SOURCE: Klein CC et al. J Affect Disord. 2018 Aug 13. doi: 10.1016/j.jad.2018.08.049.
, according to Christina C. Klein and her associates.
A total of 50 patients who were enrolled in a clinical trial of approved, standard treatments for bipolar disease were included in the consent study. The MacCAT-CR was administered after patients had given consent to be included in the trial, but before the trial had started. Four patients lacked the ability to provide consent for the trial after receiving the MacCAT-CR. After these patients were reeducated and went through the consent process a second time, three were enrolled and one declined enrollment.
Patients with higher Schedule for Assessment of Positive Symptoms scores were more likely to have worse MacCAT-CR Understanding and Appreciation subscale scores; lower Hamilton Depression Rating Scale and higher Clinical Global Impression–Severity scores were associated with worse Reasoning and Understanding subscale scores.
Comorbid ADHD, sex, IQ scores, and age at onset of bipolar disorder were not correlated with any subscale scores. In addition, a history of substance use disorder was associated with higher Appreciation and Reasoning subscale scores.
“The current study provides important information for clinicians and researchers to consider when obtaining informed consent from an individual with bipolar disorder. The MacCAT-CR may serve to identify patients, specifically those with higher psychotic symptoms or global illness severity, as needing additional education regarding informed consent,” the investigators concluded.
Three study coauthors reported conflicts of interest with numerous pharmaceutical companies.
SOURCE: Klein CC et al. J Affect Disord. 2018 Aug 13. doi: 10.1016/j.jad.2018.08.049.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Early maladaptive schemas increase suicide risk, ideation in bipolar
The entitlement, social isolation, and defectiveness early maladaptive schemas (EMSs) were associated with increased suicide risk and ideation in patients with bipolar disorder, according to Vahid Khosravani of Shahid Beheshti University of Medical Sciences, Tehran, Iran, and his associates.
“These findings were in line with previous studies (J Nerv Ment Dis. 2016 Mar. 204[3]:236-9) showing higher scores of social isolation and entitlement in [bipolar disorder] patients with suicide attempts than those without such attempts,” Mr. Khosravani and his associates wrote in Psychiatry Research.
For the study, 100 inpatients with bipolar disorder completed the Young Schema Questionnaire–Short Form (YSQ-SF), the Bipolar Depression Rating Scale (BDRS), the Young Mania Rating Scale (YMRS), and the Beck Scale for Suicidal Ideation (BSSI). Of that group, 59% had attempted suicide and 59% had a BSSI score of 6 or higher, indicating high suicidal risk, reported Mr. Khosravani and his associates.
; they also had higher levels of depressive and hypomanic/manic symptoms. Current suicide ideation was associated with higher entitlement and defectiveness EMS scores, as well as with increased hypomanic/manic symptoms.
“The findings suggest that manic symptoms as well as specific EMSs including social isolation, entitlement, and defectiveness emerge as potentially implicated in suicidality in BD patients,” the investigators noted. “Therefore, providing social support in the economic, social, political, cultural, and educational spheres may be a factor in preventing suicide.”
Mr. Khosravani and his associates said their study received no funding from public, commercial, or nonprofit agencies. The investigators declared no conflicts of interest.
SOURCE: Khosravani V et al. Psychiatry Res. 2019 Jan. (271):351-9.
The entitlement, social isolation, and defectiveness early maladaptive schemas (EMSs) were associated with increased suicide risk and ideation in patients with bipolar disorder, according to Vahid Khosravani of Shahid Beheshti University of Medical Sciences, Tehran, Iran, and his associates.
“These findings were in line with previous studies (J Nerv Ment Dis. 2016 Mar. 204[3]:236-9) showing higher scores of social isolation and entitlement in [bipolar disorder] patients with suicide attempts than those without such attempts,” Mr. Khosravani and his associates wrote in Psychiatry Research.
For the study, 100 inpatients with bipolar disorder completed the Young Schema Questionnaire–Short Form (YSQ-SF), the Bipolar Depression Rating Scale (BDRS), the Young Mania Rating Scale (YMRS), and the Beck Scale for Suicidal Ideation (BSSI). Of that group, 59% had attempted suicide and 59% had a BSSI score of 6 or higher, indicating high suicidal risk, reported Mr. Khosravani and his associates.
; they also had higher levels of depressive and hypomanic/manic symptoms. Current suicide ideation was associated with higher entitlement and defectiveness EMS scores, as well as with increased hypomanic/manic symptoms.
“The findings suggest that manic symptoms as well as specific EMSs including social isolation, entitlement, and defectiveness emerge as potentially implicated in suicidality in BD patients,” the investigators noted. “Therefore, providing social support in the economic, social, political, cultural, and educational spheres may be a factor in preventing suicide.”
Mr. Khosravani and his associates said their study received no funding from public, commercial, or nonprofit agencies. The investigators declared no conflicts of interest.
SOURCE: Khosravani V et al. Psychiatry Res. 2019 Jan. (271):351-9.
The entitlement, social isolation, and defectiveness early maladaptive schemas (EMSs) were associated with increased suicide risk and ideation in patients with bipolar disorder, according to Vahid Khosravani of Shahid Beheshti University of Medical Sciences, Tehran, Iran, and his associates.
“These findings were in line with previous studies (J Nerv Ment Dis. 2016 Mar. 204[3]:236-9) showing higher scores of social isolation and entitlement in [bipolar disorder] patients with suicide attempts than those without such attempts,” Mr. Khosravani and his associates wrote in Psychiatry Research.
For the study, 100 inpatients with bipolar disorder completed the Young Schema Questionnaire–Short Form (YSQ-SF), the Bipolar Depression Rating Scale (BDRS), the Young Mania Rating Scale (YMRS), and the Beck Scale for Suicidal Ideation (BSSI). Of that group, 59% had attempted suicide and 59% had a BSSI score of 6 or higher, indicating high suicidal risk, reported Mr. Khosravani and his associates.
; they also had higher levels of depressive and hypomanic/manic symptoms. Current suicide ideation was associated with higher entitlement and defectiveness EMS scores, as well as with increased hypomanic/manic symptoms.
“The findings suggest that manic symptoms as well as specific EMSs including social isolation, entitlement, and defectiveness emerge as potentially implicated in suicidality in BD patients,” the investigators noted. “Therefore, providing social support in the economic, social, political, cultural, and educational spheres may be a factor in preventing suicide.”
Mr. Khosravani and his associates said their study received no funding from public, commercial, or nonprofit agencies. The investigators declared no conflicts of interest.
SOURCE: Khosravani V et al. Psychiatry Res. 2019 Jan. (271):351-9.
FROM PSYCHIATRY RESEARCH
ADHD more likely, causes worse outcomes in patients with BD
ADHD is significantly more common and is associated with worse outcomes in patients with bipolar disorder, according to Ross J. Baldessarini, MD, of McLean Hospital and Harvard Medical School, Boston, and his associates.
In a study of 703 patients diagnosed with bipolar disorder (BD) type I or II who were evaluated, treated, and followed at the Lucio Bini Mood Disorder Centers in Rome and Cagliari, Italy, 173 patients had co-occurring lifetime ADHD. Co-occurring conditions were more likely in men and in those with BD-I. The lifetime ADHD prevalence rate of 24.6% in patients with bipolar disorder is significantly higher than the incidence in the general population, the investigators wrote in the Journal of Affective Disorders.
Patients with co-occurring ADHD and BD were more likely to have performed worse in school, have higher Adult ADHD Self-Report Scale scores, be unemployed, have lower socioeconomic status, be married, have separated, have substance abuse, have attempted suicide, and have hypomania, compared with patients with only BD. However, they were less likely to have an anxiety disorder or a family history of mood disorders.
“The association of ADHD with a less successful and stable educational history, more unemployment, lack of or failed marriages, and greater risk of suicide attempts and substance abuse indicates unfavorable effects of having ADHD with BD. Such effects may arise by the impact of ADHD early during development,” the investigators concluded.
The study was partly supported by a research award from the Aretaeus Association of Rome and grants from the Bruce J. Anderson Foundation and the McLean Private Donors Research Fund. No conflicts of interest were reported.
SOURCE: Baldessarini RJ et al. J Affect Disord. 2018 Sep 17. doi: 10.1016/j.jad.2018.09.038.
ADHD is significantly more common and is associated with worse outcomes in patients with bipolar disorder, according to Ross J. Baldessarini, MD, of McLean Hospital and Harvard Medical School, Boston, and his associates.
In a study of 703 patients diagnosed with bipolar disorder (BD) type I or II who were evaluated, treated, and followed at the Lucio Bini Mood Disorder Centers in Rome and Cagliari, Italy, 173 patients had co-occurring lifetime ADHD. Co-occurring conditions were more likely in men and in those with BD-I. The lifetime ADHD prevalence rate of 24.6% in patients with bipolar disorder is significantly higher than the incidence in the general population, the investigators wrote in the Journal of Affective Disorders.
Patients with co-occurring ADHD and BD were more likely to have performed worse in school, have higher Adult ADHD Self-Report Scale scores, be unemployed, have lower socioeconomic status, be married, have separated, have substance abuse, have attempted suicide, and have hypomania, compared with patients with only BD. However, they were less likely to have an anxiety disorder or a family history of mood disorders.
“The association of ADHD with a less successful and stable educational history, more unemployment, lack of or failed marriages, and greater risk of suicide attempts and substance abuse indicates unfavorable effects of having ADHD with BD. Such effects may arise by the impact of ADHD early during development,” the investigators concluded.
The study was partly supported by a research award from the Aretaeus Association of Rome and grants from the Bruce J. Anderson Foundation and the McLean Private Donors Research Fund. No conflicts of interest were reported.
SOURCE: Baldessarini RJ et al. J Affect Disord. 2018 Sep 17. doi: 10.1016/j.jad.2018.09.038.
ADHD is significantly more common and is associated with worse outcomes in patients with bipolar disorder, according to Ross J. Baldessarini, MD, of McLean Hospital and Harvard Medical School, Boston, and his associates.
In a study of 703 patients diagnosed with bipolar disorder (BD) type I or II who were evaluated, treated, and followed at the Lucio Bini Mood Disorder Centers in Rome and Cagliari, Italy, 173 patients had co-occurring lifetime ADHD. Co-occurring conditions were more likely in men and in those with BD-I. The lifetime ADHD prevalence rate of 24.6% in patients with bipolar disorder is significantly higher than the incidence in the general population, the investigators wrote in the Journal of Affective Disorders.
Patients with co-occurring ADHD and BD were more likely to have performed worse in school, have higher Adult ADHD Self-Report Scale scores, be unemployed, have lower socioeconomic status, be married, have separated, have substance abuse, have attempted suicide, and have hypomania, compared with patients with only BD. However, they were less likely to have an anxiety disorder or a family history of mood disorders.
“The association of ADHD with a less successful and stable educational history, more unemployment, lack of or failed marriages, and greater risk of suicide attempts and substance abuse indicates unfavorable effects of having ADHD with BD. Such effects may arise by the impact of ADHD early during development,” the investigators concluded.
The study was partly supported by a research award from the Aretaeus Association of Rome and grants from the Bruce J. Anderson Foundation and the McLean Private Donors Research Fund. No conflicts of interest were reported.
SOURCE: Baldessarini RJ et al. J Affect Disord. 2018 Sep 17. doi: 10.1016/j.jad.2018.09.038.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
FDA approves ravulizumab for treatment of paroxysmal nocturnal hemoglobinuria
The Food and Drug Administration has approved ravulizumab (Ultomiris) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every 8 weeks, without compromising efficacy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release from the agency.
Patients with PNH, a rare disorder, lack a protein which protects red blood cells from being destroyed in the immune system. Episodes can be triggered by stresses on the body such as infection or physical exertion, and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, or recurrent pain.
FDA approval for ravulizumab is based on results from a pair of clinical trials. In the first, 246 treatment-naive PNH patients received either ravulizumab or eculizumab, the current standard of care; ravulizumab was noninferior, with no patients undergoing a transfusion and all patients having similar incidence of hemolysis. In the second trial, 195 patients who had clinically stable PNH after receiving eculizumab for 6 months were randomized to receive ravulizumab or continue eculizumab; again, ravulizumab was noninferior.
The most common adverse events associated with ravulizumab were headache and respiratory tract infection. Caution is recommended when prescribing ravulizumab to patients with any type of infection.
Find the full press release on the FDA website.
The Food and Drug Administration has approved ravulizumab (Ultomiris) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every 8 weeks, without compromising efficacy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release from the agency.
Patients with PNH, a rare disorder, lack a protein which protects red blood cells from being destroyed in the immune system. Episodes can be triggered by stresses on the body such as infection or physical exertion, and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, or recurrent pain.
FDA approval for ravulizumab is based on results from a pair of clinical trials. In the first, 246 treatment-naive PNH patients received either ravulizumab or eculizumab, the current standard of care; ravulizumab was noninferior, with no patients undergoing a transfusion and all patients having similar incidence of hemolysis. In the second trial, 195 patients who had clinically stable PNH after receiving eculizumab for 6 months were randomized to receive ravulizumab or continue eculizumab; again, ravulizumab was noninferior.
The most common adverse events associated with ravulizumab were headache and respiratory tract infection. Caution is recommended when prescribing ravulizumab to patients with any type of infection.
Find the full press release on the FDA website.
The Food and Drug Administration has approved ravulizumab (Ultomiris) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every 8 weeks, without compromising efficacy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release from the agency.
Patients with PNH, a rare disorder, lack a protein which protects red blood cells from being destroyed in the immune system. Episodes can be triggered by stresses on the body such as infection or physical exertion, and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, or recurrent pain.
FDA approval for ravulizumab is based on results from a pair of clinical trials. In the first, 246 treatment-naive PNH patients received either ravulizumab or eculizumab, the current standard of care; ravulizumab was noninferior, with no patients undergoing a transfusion and all patients having similar incidence of hemolysis. In the second trial, 195 patients who had clinically stable PNH after receiving eculizumab for 6 months were randomized to receive ravulizumab or continue eculizumab; again, ravulizumab was noninferior.
The most common adverse events associated with ravulizumab were headache and respiratory tract infection. Caution is recommended when prescribing ravulizumab to patients with any type of infection.
Find the full press release on the FDA website.
FDA reclassifies ECT devices for resistant depression, other conditions
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
Guideline-concordant treatment still unlikely in nonchildren’s hospitals for pediatric CAP
according to new research.
“This gap is concerning because approximately 70% of children hospitalized with pneumonia receive care in nonchildren’s hospitals,” wrote Alison C. Tribble, MD, of C. S. Mott Children’s Hospital, University of Michigan, Ann Arbor, and her associates. The report is in JAMA Pediatrics.
Data were collected from the Pediatric Health Information System (children’s hospitals) and Premier Perspectives (all hospitals) databases and included a total of 120,238 children aged 1-17 years diagnosed with CAP between Jan. 1, 2009, and Sept. 30, 2015. Before the publication of the new guideline in October 2011, the probability of receiving what would become guideline-concordant antibiotics was 0.25 in children’s hospitals and 0.06 in nonchildren’s hospitals.
By the end of the study period, the probability of receiving guideline-concordant antibiotics for pediatric CAP was 0.61 in children’s hospitals and 0.27 in nonchildren’s hospitals. Without the interventions, the probabilities would have been 0.31 and 0.08, respectively. The rate of growth over the 4-year postintervention period was similar in both children’s and nonchildren’s hospitals.
“Studies in children’s hospitals have suggested that local implementation efforts may be important in facilitating guideline uptake. Nonchildren’s hospitals likely have fewer resources to lead pediatric-specific efforts, and care may be influenced by adult CAP guidelines,” the authors noted.
No conflicts of interest were reported.
SOURCE: Tribble AC et al. JAMA Pediatr. 2018 Dec 10. doi: 10.1001/jamapediatrics.2018.4270.
according to new research.
“This gap is concerning because approximately 70% of children hospitalized with pneumonia receive care in nonchildren’s hospitals,” wrote Alison C. Tribble, MD, of C. S. Mott Children’s Hospital, University of Michigan, Ann Arbor, and her associates. The report is in JAMA Pediatrics.
Data were collected from the Pediatric Health Information System (children’s hospitals) and Premier Perspectives (all hospitals) databases and included a total of 120,238 children aged 1-17 years diagnosed with CAP between Jan. 1, 2009, and Sept. 30, 2015. Before the publication of the new guideline in October 2011, the probability of receiving what would become guideline-concordant antibiotics was 0.25 in children’s hospitals and 0.06 in nonchildren’s hospitals.
By the end of the study period, the probability of receiving guideline-concordant antibiotics for pediatric CAP was 0.61 in children’s hospitals and 0.27 in nonchildren’s hospitals. Without the interventions, the probabilities would have been 0.31 and 0.08, respectively. The rate of growth over the 4-year postintervention period was similar in both children’s and nonchildren’s hospitals.
“Studies in children’s hospitals have suggested that local implementation efforts may be important in facilitating guideline uptake. Nonchildren’s hospitals likely have fewer resources to lead pediatric-specific efforts, and care may be influenced by adult CAP guidelines,” the authors noted.
No conflicts of interest were reported.
SOURCE: Tribble AC et al. JAMA Pediatr. 2018 Dec 10. doi: 10.1001/jamapediatrics.2018.4270.
according to new research.
“This gap is concerning because approximately 70% of children hospitalized with pneumonia receive care in nonchildren’s hospitals,” wrote Alison C. Tribble, MD, of C. S. Mott Children’s Hospital, University of Michigan, Ann Arbor, and her associates. The report is in JAMA Pediatrics.
Data were collected from the Pediatric Health Information System (children’s hospitals) and Premier Perspectives (all hospitals) databases and included a total of 120,238 children aged 1-17 years diagnosed with CAP between Jan. 1, 2009, and Sept. 30, 2015. Before the publication of the new guideline in October 2011, the probability of receiving what would become guideline-concordant antibiotics was 0.25 in children’s hospitals and 0.06 in nonchildren’s hospitals.
By the end of the study period, the probability of receiving guideline-concordant antibiotics for pediatric CAP was 0.61 in children’s hospitals and 0.27 in nonchildren’s hospitals. Without the interventions, the probabilities would have been 0.31 and 0.08, respectively. The rate of growth over the 4-year postintervention period was similar in both children’s and nonchildren’s hospitals.
“Studies in children’s hospitals have suggested that local implementation efforts may be important in facilitating guideline uptake. Nonchildren’s hospitals likely have fewer resources to lead pediatric-specific efforts, and care may be influenced by adult CAP guidelines,” the authors noted.
No conflicts of interest were reported.
SOURCE: Tribble AC et al. JAMA Pediatr. 2018 Dec 10. doi: 10.1001/jamapediatrics.2018.4270.
FROM JAMA PEDIATRICS
Positive results reported for ixekizumab versus adalimumab in PsA
Eli Lilly and Co. has announced positive results from the phase 3b/4, multicenter, randomized, open-label, parallel-group SPIRIT-H2H trial, which compared ixekizumab (Taltz) with adalimumab (Humira) in patients with psoriatic arthritis who had previously not taken a biologic disease-modifying antirheumatic drug.
The 52-week study included 566 patients with psoriatic arthritis. Patients received either ixekizumab at 80 mg every 4 weeks after a 160-mg loading dose or adalimumab at 40 mg every 2 weeks. The primary endpoint was the proportion of patients achieving at least a 50% reduction in American College of Rheumatology (ACR50) criteria at 24 weeks.
After 24 weeks, patients in the ixekizumab group were more likely to achieve ACR50, compared with those in the adalimumab group. In addition, patients receiving ixekizumab were more likely to achieve 100% skin clearance according to the Psoriasis Area and Severity Index. Ixekizumab also met all secondary trial endpoints.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the press release.
More detailed results will be presented at meetings and published in peer-reviewed journals in 2019, the company said.
Eli Lilly and Co. has announced positive results from the phase 3b/4, multicenter, randomized, open-label, parallel-group SPIRIT-H2H trial, which compared ixekizumab (Taltz) with adalimumab (Humira) in patients with psoriatic arthritis who had previously not taken a biologic disease-modifying antirheumatic drug.
The 52-week study included 566 patients with psoriatic arthritis. Patients received either ixekizumab at 80 mg every 4 weeks after a 160-mg loading dose or adalimumab at 40 mg every 2 weeks. The primary endpoint was the proportion of patients achieving at least a 50% reduction in American College of Rheumatology (ACR50) criteria at 24 weeks.
After 24 weeks, patients in the ixekizumab group were more likely to achieve ACR50, compared with those in the adalimumab group. In addition, patients receiving ixekizumab were more likely to achieve 100% skin clearance according to the Psoriasis Area and Severity Index. Ixekizumab also met all secondary trial endpoints.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the press release.
More detailed results will be presented at meetings and published in peer-reviewed journals in 2019, the company said.
Eli Lilly and Co. has announced positive results from the phase 3b/4, multicenter, randomized, open-label, parallel-group SPIRIT-H2H trial, which compared ixekizumab (Taltz) with adalimumab (Humira) in patients with psoriatic arthritis who had previously not taken a biologic disease-modifying antirheumatic drug.
The 52-week study included 566 patients with psoriatic arthritis. Patients received either ixekizumab at 80 mg every 4 weeks after a 160-mg loading dose or adalimumab at 40 mg every 2 weeks. The primary endpoint was the proportion of patients achieving at least a 50% reduction in American College of Rheumatology (ACR50) criteria at 24 weeks.
After 24 weeks, patients in the ixekizumab group were more likely to achieve ACR50, compared with those in the adalimumab group. In addition, patients receiving ixekizumab were more likely to achieve 100% skin clearance according to the Psoriasis Area and Severity Index. Ixekizumab also met all secondary trial endpoints.
“The positive results from the SPIRIT-H2H trial reinforce that Taltz effectively treats the debilitating joint signs and symptoms of active psoriatic arthritis, while also providing skin clearance. These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the press release.
More detailed results will be presented at meetings and published in peer-reviewed journals in 2019, the company said.
Clinical trial: The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.