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Allergies linked to autism spectrum disorder in children
The prevalence of food, respiratory, and skin allergy is greater in U.S. children with autism spectrum disorder (ASD) than in U.S. children without the disorder, according to findings published June 8 in JAMA Network Open.
An analysis of data from the National Health Interview Survey found that the weighted prevalence of food, respiratory, and skin allergies was 11.25%, 18.73%, and 16.81%, respectively, in children with ASD, compared with 4.25%, 12.08%, and 9.84%, respectively, in children without ASD (P less than .001).
Survey data were collected between 1997 and 2016, and included patients aged 3-17 years. Allergic conditions were defined by the respondent, usually a parent, answering in the affirmative that the child had any kind of food, digestive, respiratory, or skin allergy in the past 12 months. ASD was defined based on an affirmative response to a question asking whether the child received an ASD diagnosis from a health professional. The question was asked as part of a 10-condition checklist from 1997 to 2013, and as a standalone item from 2014 onward, with revised wording to distinguish autism, Asperger’s disorder, pervasive developmental disorder, and ASD, wrote Guifeng Xu, MD, of the department of epidemiology at the University of Iowa, Iowa City, and her coauthors.
Of the 199,520 children included in the study, 8,734 had food allergy, 24,555 had respiratory allergy, and 19,399 had skin allergy. An ASD diagnosis was reported in 1,868 children. The weighted prevalence was 4.31% for food allergy (95% confidence interval, 4.20%-4.43%), 12.15% for respiratory allergy (95% CI, 11.92%-12.38%), and 9.91% for skin allergy (95% CI, 9.72%-10.10%), the authors said.
Children with ASD were more likely than were children without ASD to have food allergy, respiratory allergy, and skin allergy (P less than .001). After adjustment for factors including age, sex, ethnicity, and family education level, the odds ratio of ASD was more than double among children with food allergy, compared with those without food allergy (odds ratio, 2.72; 95% CI, 2.26-3.28; P less than .001).
Respiratory allergy and skin allergy also were significantly associated with ASD, but to a lesser degree, with an OR of 1.53 (95% CI, 1.32-1.78; P less than .001) for respiratory allergy and 1.80 (95% CI, 1.55-2.09; P less than .001) for skin allergy, Dr. Xu and her colleagues reported.
,” though the underlying mechanisms still need to be identified, the authors wrote.
Particularly striking were the connections found between ASD and food allergy. “Although the underlying mechanisms for the observed association between food allergy and ASD remain to be elucidated, the gut-brain-behavior axis could be one of the potential mechanisms,” Dr. Xu and her coauthors wrote. “Previous studies found higher prevalence of gastrointestinal symptoms among children with ASD.”
Limitations to the study include possible recall bias and misreporting, as well as an absence of information about onset of allergy and ASD diagnosis.
“Large prospective cohort studies starting from birth or early life are needed to confirm our findings,” the authors concluded.
No conflicts of interest were reported.
SOURCE: Guifeng X et al. JAMA Network Open. 2018 Jun 8. doi: 10.1001/jamanetworkopen.2018.0279.
The results of this study add to a “growing body of literature supporting an immune-mediated subtype of autism spectrum disorder (ASD),” Christopher J. McDougle, MD, wrote in an editorial published with the study.
Although prior studies have identified an association between ASD and respiratory and skin allergy, this study is “the first to document the association of food allergy with ASD with confidence, in part based on the large sample size they accessed,” he said (JAMA Network Open. 2018;1[2]:e180280. doi: 10.1001/jamanetworkopen.2018.0280).
Dr. McDougle is affiliated with the Lurie Center for Autism at Massachusetts General Hospital.
The results of this study add to a “growing body of literature supporting an immune-mediated subtype of autism spectrum disorder (ASD),” Christopher J. McDougle, MD, wrote in an editorial published with the study.
Although prior studies have identified an association between ASD and respiratory and skin allergy, this study is “the first to document the association of food allergy with ASD with confidence, in part based on the large sample size they accessed,” he said (JAMA Network Open. 2018;1[2]:e180280. doi: 10.1001/jamanetworkopen.2018.0280).
Dr. McDougle is affiliated with the Lurie Center for Autism at Massachusetts General Hospital.
The results of this study add to a “growing body of literature supporting an immune-mediated subtype of autism spectrum disorder (ASD),” Christopher J. McDougle, MD, wrote in an editorial published with the study.
Although prior studies have identified an association between ASD and respiratory and skin allergy, this study is “the first to document the association of food allergy with ASD with confidence, in part based on the large sample size they accessed,” he said (JAMA Network Open. 2018;1[2]:e180280. doi: 10.1001/jamanetworkopen.2018.0280).
Dr. McDougle is affiliated with the Lurie Center for Autism at Massachusetts General Hospital.
The prevalence of food, respiratory, and skin allergy is greater in U.S. children with autism spectrum disorder (ASD) than in U.S. children without the disorder, according to findings published June 8 in JAMA Network Open.
An analysis of data from the National Health Interview Survey found that the weighted prevalence of food, respiratory, and skin allergies was 11.25%, 18.73%, and 16.81%, respectively, in children with ASD, compared with 4.25%, 12.08%, and 9.84%, respectively, in children without ASD (P less than .001).
Survey data were collected between 1997 and 2016, and included patients aged 3-17 years. Allergic conditions were defined by the respondent, usually a parent, answering in the affirmative that the child had any kind of food, digestive, respiratory, or skin allergy in the past 12 months. ASD was defined based on an affirmative response to a question asking whether the child received an ASD diagnosis from a health professional. The question was asked as part of a 10-condition checklist from 1997 to 2013, and as a standalone item from 2014 onward, with revised wording to distinguish autism, Asperger’s disorder, pervasive developmental disorder, and ASD, wrote Guifeng Xu, MD, of the department of epidemiology at the University of Iowa, Iowa City, and her coauthors.
Of the 199,520 children included in the study, 8,734 had food allergy, 24,555 had respiratory allergy, and 19,399 had skin allergy. An ASD diagnosis was reported in 1,868 children. The weighted prevalence was 4.31% for food allergy (95% confidence interval, 4.20%-4.43%), 12.15% for respiratory allergy (95% CI, 11.92%-12.38%), and 9.91% for skin allergy (95% CI, 9.72%-10.10%), the authors said.
Children with ASD were more likely than were children without ASD to have food allergy, respiratory allergy, and skin allergy (P less than .001). After adjustment for factors including age, sex, ethnicity, and family education level, the odds ratio of ASD was more than double among children with food allergy, compared with those without food allergy (odds ratio, 2.72; 95% CI, 2.26-3.28; P less than .001).
Respiratory allergy and skin allergy also were significantly associated with ASD, but to a lesser degree, with an OR of 1.53 (95% CI, 1.32-1.78; P less than .001) for respiratory allergy and 1.80 (95% CI, 1.55-2.09; P less than .001) for skin allergy, Dr. Xu and her colleagues reported.
,” though the underlying mechanisms still need to be identified, the authors wrote.
Particularly striking were the connections found between ASD and food allergy. “Although the underlying mechanisms for the observed association between food allergy and ASD remain to be elucidated, the gut-brain-behavior axis could be one of the potential mechanisms,” Dr. Xu and her coauthors wrote. “Previous studies found higher prevalence of gastrointestinal symptoms among children with ASD.”
Limitations to the study include possible recall bias and misreporting, as well as an absence of information about onset of allergy and ASD diagnosis.
“Large prospective cohort studies starting from birth or early life are needed to confirm our findings,” the authors concluded.
No conflicts of interest were reported.
SOURCE: Guifeng X et al. JAMA Network Open. 2018 Jun 8. doi: 10.1001/jamanetworkopen.2018.0279.
The prevalence of food, respiratory, and skin allergy is greater in U.S. children with autism spectrum disorder (ASD) than in U.S. children without the disorder, according to findings published June 8 in JAMA Network Open.
An analysis of data from the National Health Interview Survey found that the weighted prevalence of food, respiratory, and skin allergies was 11.25%, 18.73%, and 16.81%, respectively, in children with ASD, compared with 4.25%, 12.08%, and 9.84%, respectively, in children without ASD (P less than .001).
Survey data were collected between 1997 and 2016, and included patients aged 3-17 years. Allergic conditions were defined by the respondent, usually a parent, answering in the affirmative that the child had any kind of food, digestive, respiratory, or skin allergy in the past 12 months. ASD was defined based on an affirmative response to a question asking whether the child received an ASD diagnosis from a health professional. The question was asked as part of a 10-condition checklist from 1997 to 2013, and as a standalone item from 2014 onward, with revised wording to distinguish autism, Asperger’s disorder, pervasive developmental disorder, and ASD, wrote Guifeng Xu, MD, of the department of epidemiology at the University of Iowa, Iowa City, and her coauthors.
Of the 199,520 children included in the study, 8,734 had food allergy, 24,555 had respiratory allergy, and 19,399 had skin allergy. An ASD diagnosis was reported in 1,868 children. The weighted prevalence was 4.31% for food allergy (95% confidence interval, 4.20%-4.43%), 12.15% for respiratory allergy (95% CI, 11.92%-12.38%), and 9.91% for skin allergy (95% CI, 9.72%-10.10%), the authors said.
Children with ASD were more likely than were children without ASD to have food allergy, respiratory allergy, and skin allergy (P less than .001). After adjustment for factors including age, sex, ethnicity, and family education level, the odds ratio of ASD was more than double among children with food allergy, compared with those without food allergy (odds ratio, 2.72; 95% CI, 2.26-3.28; P less than .001).
Respiratory allergy and skin allergy also were significantly associated with ASD, but to a lesser degree, with an OR of 1.53 (95% CI, 1.32-1.78; P less than .001) for respiratory allergy and 1.80 (95% CI, 1.55-2.09; P less than .001) for skin allergy, Dr. Xu and her colleagues reported.
,” though the underlying mechanisms still need to be identified, the authors wrote.
Particularly striking were the connections found between ASD and food allergy. “Although the underlying mechanisms for the observed association between food allergy and ASD remain to be elucidated, the gut-brain-behavior axis could be one of the potential mechanisms,” Dr. Xu and her coauthors wrote. “Previous studies found higher prevalence of gastrointestinal symptoms among children with ASD.”
Limitations to the study include possible recall bias and misreporting, as well as an absence of information about onset of allergy and ASD diagnosis.
“Large prospective cohort studies starting from birth or early life are needed to confirm our findings,” the authors concluded.
No conflicts of interest were reported.
SOURCE: Guifeng X et al. JAMA Network Open. 2018 Jun 8. doi: 10.1001/jamanetworkopen.2018.0279.
FROM JAMA NETWORK OPEN
Key clinical point: The prevalence of food, respiratory, and skin allergy was greater in children with autism spectrum disorder (ASD).
Major finding: The weighted prevalence of food, respiratory, and skin allergies was 11.25%, 18.73%, and 16.81%, respectively, in children with ASD, compared with 4.25%, 12.08%, and 9.84%, respectively, in children without ASD (P less than .001).
Study details: A population-based study of 199,520 children aged 3-17 years in the National Health Interview Survey.
Disclosures: No conflicts of interest were reported.
Source: Guifeng X et al. JAMA Network Open. 2018 Jun 8. doi: 10.1001/jamanetworkopen.2018.0279.
Older CLL and NHL patients are more vulnerable to toxicities
Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.
An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).
Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.
Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.
Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.
“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”
The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.
An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).
Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.
Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.
Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.
“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”
The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.
An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).
Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.
Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.
Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.
“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”
The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
FROM THE JOURNAL OF GERIATRIC ONCOLOGY
Key clinical point:
Major finding: Older CLL patients had significantly higher odds of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI 1.39-1.55).
Study details: An analysis of data from 1,199 CLL and NHL patients in the Alliance for Clinical Trials in Oncology.
Disclosures: The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
Source: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
8-Isoprostane levels predict OSA in children
The oxidative stress biomarker 8-isoprostane (8-IsoP) predicted obstructive sleep apnea (OSA) and disease severity in children better than the fractional concentration of exhaled nitric oxide (FENO), according to results published in Sleep Medicine.
In an analysis of 46 patients with sleep-disordered breathing and 20 controls, 8-IsoP values were also correlated with apnea hypopnea index (AHI) (r, 0.40; P = .003) and oxygen saturation, also known as SaO2, (r, –0.50; P = .001), reported Dr. Mario Berreto of the Pediatric Unit at Sant’Andrea Hospital in Rome and his coauthors.
The investigators studied 66 children aged 4.5-15.1 years, of whom 46 had sleep-disordered breathing (SDB) and were enrolled in the hospital’s Pediatric Sleep Center. The 20 healthy controls had no history of sleep problems, including snoring, apneas, and restless sleep. Exclusion criteria included acute respiratory infections in the 4 weeks preceding the study, chronic respiratory comorbidities, and therapy with corticosteroids or other anti-inflammatory drugs for at least 3 weeks.
Patients with SDB had a medical examination followed by overnight standard polysomnography (PSG), and EBC 8-IsoP and FENO measurements were collected the next morning upon waking. The SDB group also had spirometry and skin prick testing for common allergens. The children in the control group had the same tests and measurements done, except for PSG, Dr. Berreto and his colleagues wrote.
Central, obstructive, and mixed apnea events were counted according to American Academy of Sleep Medicine (AASM) criteria. AHI was defined as the average number of apnea and hypopnea events per hour of sleep. OSA was diagnosed with an AHI of one episode per hour and confirmed by the presence of SDB symptoms with AHI of one episode per hour.
Children with snoring and an AHI of less than one episode per hour were diagnosed with primary snoring (PS). Patients with an AHI greater than one episode per hour and less than five episodes per hour were diagnosed with mild OSA. Children with an AHI of greater than five episodes per hour were diagnosed with moderate to severe OSA, the authors said.
While 8-IsoP concentrations correlated with OSA severity for AHI and SaO2, FENO did not, Dr. Berreto and colleagues reported.
The difference in 8-IsoP concentrations for children with SDB and controls (mean, 39.6; P = .006) was increased when adjusted using multiple linear regression (mean, 43.2; P = .007), and the difference was even more pronounced when adjusted for all potential confounding variables (mean, 53.1; P = .008). The difference in FENO levels between SDB patients and controls was not statistically significant (mean, 1.67; P = .358) and did not change significantly when adjusted for confounding variables.
High area under the curve values were observed for 8-IsoP as a predictor of OSA (.839; 95% confidence interval, .744-.933, P = .000). The sensitivity and specificity of cutoff values of 8-IsoP concentrations above the 50th percentile were 76.5% and 78.1%, respectively.
“[It] seems that biomarkers of oxidative stress reflect OSA severity in children more closely than biomarkers of atopic-eosinophilic airway inflammation,” the authors concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Barreto M et al. Sleep Medicine. 2018. doi: 10.1016/j.sleep.2018.01.011.
The oxidative stress biomarker 8-isoprostane (8-IsoP) predicted obstructive sleep apnea (OSA) and disease severity in children better than the fractional concentration of exhaled nitric oxide (FENO), according to results published in Sleep Medicine.
In an analysis of 46 patients with sleep-disordered breathing and 20 controls, 8-IsoP values were also correlated with apnea hypopnea index (AHI) (r, 0.40; P = .003) and oxygen saturation, also known as SaO2, (r, –0.50; P = .001), reported Dr. Mario Berreto of the Pediatric Unit at Sant’Andrea Hospital in Rome and his coauthors.
The investigators studied 66 children aged 4.5-15.1 years, of whom 46 had sleep-disordered breathing (SDB) and were enrolled in the hospital’s Pediatric Sleep Center. The 20 healthy controls had no history of sleep problems, including snoring, apneas, and restless sleep. Exclusion criteria included acute respiratory infections in the 4 weeks preceding the study, chronic respiratory comorbidities, and therapy with corticosteroids or other anti-inflammatory drugs for at least 3 weeks.
Patients with SDB had a medical examination followed by overnight standard polysomnography (PSG), and EBC 8-IsoP and FENO measurements were collected the next morning upon waking. The SDB group also had spirometry and skin prick testing for common allergens. The children in the control group had the same tests and measurements done, except for PSG, Dr. Berreto and his colleagues wrote.
Central, obstructive, and mixed apnea events were counted according to American Academy of Sleep Medicine (AASM) criteria. AHI was defined as the average number of apnea and hypopnea events per hour of sleep. OSA was diagnosed with an AHI of one episode per hour and confirmed by the presence of SDB symptoms with AHI of one episode per hour.
Children with snoring and an AHI of less than one episode per hour were diagnosed with primary snoring (PS). Patients with an AHI greater than one episode per hour and less than five episodes per hour were diagnosed with mild OSA. Children with an AHI of greater than five episodes per hour were diagnosed with moderate to severe OSA, the authors said.
While 8-IsoP concentrations correlated with OSA severity for AHI and SaO2, FENO did not, Dr. Berreto and colleagues reported.
The difference in 8-IsoP concentrations for children with SDB and controls (mean, 39.6; P = .006) was increased when adjusted using multiple linear regression (mean, 43.2; P = .007), and the difference was even more pronounced when adjusted for all potential confounding variables (mean, 53.1; P = .008). The difference in FENO levels between SDB patients and controls was not statistically significant (mean, 1.67; P = .358) and did not change significantly when adjusted for confounding variables.
High area under the curve values were observed for 8-IsoP as a predictor of OSA (.839; 95% confidence interval, .744-.933, P = .000). The sensitivity and specificity of cutoff values of 8-IsoP concentrations above the 50th percentile were 76.5% and 78.1%, respectively.
“[It] seems that biomarkers of oxidative stress reflect OSA severity in children more closely than biomarkers of atopic-eosinophilic airway inflammation,” the authors concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Barreto M et al. Sleep Medicine. 2018. doi: 10.1016/j.sleep.2018.01.011.
The oxidative stress biomarker 8-isoprostane (8-IsoP) predicted obstructive sleep apnea (OSA) and disease severity in children better than the fractional concentration of exhaled nitric oxide (FENO), according to results published in Sleep Medicine.
In an analysis of 46 patients with sleep-disordered breathing and 20 controls, 8-IsoP values were also correlated with apnea hypopnea index (AHI) (r, 0.40; P = .003) and oxygen saturation, also known as SaO2, (r, –0.50; P = .001), reported Dr. Mario Berreto of the Pediatric Unit at Sant’Andrea Hospital in Rome and his coauthors.
The investigators studied 66 children aged 4.5-15.1 years, of whom 46 had sleep-disordered breathing (SDB) and were enrolled in the hospital’s Pediatric Sleep Center. The 20 healthy controls had no history of sleep problems, including snoring, apneas, and restless sleep. Exclusion criteria included acute respiratory infections in the 4 weeks preceding the study, chronic respiratory comorbidities, and therapy with corticosteroids or other anti-inflammatory drugs for at least 3 weeks.
Patients with SDB had a medical examination followed by overnight standard polysomnography (PSG), and EBC 8-IsoP and FENO measurements were collected the next morning upon waking. The SDB group also had spirometry and skin prick testing for common allergens. The children in the control group had the same tests and measurements done, except for PSG, Dr. Berreto and his colleagues wrote.
Central, obstructive, and mixed apnea events were counted according to American Academy of Sleep Medicine (AASM) criteria. AHI was defined as the average number of apnea and hypopnea events per hour of sleep. OSA was diagnosed with an AHI of one episode per hour and confirmed by the presence of SDB symptoms with AHI of one episode per hour.
Children with snoring and an AHI of less than one episode per hour were diagnosed with primary snoring (PS). Patients with an AHI greater than one episode per hour and less than five episodes per hour were diagnosed with mild OSA. Children with an AHI of greater than five episodes per hour were diagnosed with moderate to severe OSA, the authors said.
While 8-IsoP concentrations correlated with OSA severity for AHI and SaO2, FENO did not, Dr. Berreto and colleagues reported.
The difference in 8-IsoP concentrations for children with SDB and controls (mean, 39.6; P = .006) was increased when adjusted using multiple linear regression (mean, 43.2; P = .007), and the difference was even more pronounced when adjusted for all potential confounding variables (mean, 53.1; P = .008). The difference in FENO levels between SDB patients and controls was not statistically significant (mean, 1.67; P = .358) and did not change significantly when adjusted for confounding variables.
High area under the curve values were observed for 8-IsoP as a predictor of OSA (.839; 95% confidence interval, .744-.933, P = .000). The sensitivity and specificity of cutoff values of 8-IsoP concentrations above the 50th percentile were 76.5% and 78.1%, respectively.
“[It] seems that biomarkers of oxidative stress reflect OSA severity in children more closely than biomarkers of atopic-eosinophilic airway inflammation,” the authors concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Barreto M et al. Sleep Medicine. 2018. doi: 10.1016/j.sleep.2018.01.011.
FROM SLEEP MEDICINE
Key clinical point: The biomarker 8-isoprostane predicted OSA and correlated with disease severity in children.
Major finding: Children with OSA had higher levels of 8-IsoP than patients with primary snoring (PS) and controls; 8-IsoP values were also correlated with apnea hypopnea index (r, 0.40; P = .003).
Study details: A single-center, cross-sectional observational study of 46 children with sleep-disordered breathing and 20 healthy controls.
Disclosures: No disclosures or conflicts of interest were reported.
Source: Barreto M et al. Sleep Medicine. 2018. doi: https://doi.org/10.1016/j.sleep.2018.01.011.
Female cancer researchers receive less funding than male counterparts
Female cancer researchers receive significantly less funding than their male counterparts in terms of total investment, number of awards, and mean and median funding, according to an analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
In an analysis of 4,186 awards totaling 2.33 billion pounds, 2,890 grants (69%) with a total value of 1.82 billion pounds (78%) were awarded to male primary investigators (PIs), compared with just 1,296 grants (31%) with a total value of 512 million pounds(22%) for female PIs, investigators reported in BMJ Open.
Investigators studied openly accessible information on funding awards from public and philanthropic sources including the Medical Research Council, Department of Health, Biotechnology and Biological Sciences Research Council, Engineering and Physical Science Research Council, Wellcome Trust, European Commission, and nine members of the Association of Medical Research Charities. Awards were excluded if they were not relevant to oncology, led by a non-U.K. institution, and/or not considered a research and development activity, wrote Charlie D. Zhou, MD, of the Royal Free NHS Foundation Trust Department of Nuclear Medicine in London, and coauthors.
Median grant value was greater for men (252,647 pounds; interquartile range, 127,343-553,560 pounds) than for women (198,485 pounds; IQR, 99,317-382,650 pounds) (P less than .001). Mean grant value was also greater for men (630,324 pounds; standard deviation, 1,662,559 pounds) than for women (394,730 pounds; SD, 666,574 pounds), Dr. Zhou and colleagues reported.
Large funding discrepancies were seen for sex-specific cancer research. For instance, males received 13.8, 3.5, and 2.0 times the investment of their female counterparts in total, mean, and median prostate cancer funding, respectively. Likewise, men received 9.9, 6.6, and 2.9 times the funding of women PIs in total, mean, and median funding, respectively, for cervical cancer research. This pattern was true for ovarian cancer and breast cancer research, as well.
Men also received significantly greater median funding at all points of the research and development pipeline. For preclinical, phase 1, 2, or 3 clinical trials; and public health, men received 20%, 90%, and 50% more, respectively (P less than .001); for product development and cross-disciplinary research, the difference was 50% and 20%, respectively (P less than .01).
The results of the analysis demonstrate that “female PIs clearly and consistently receive less funding than their male counterparts,” the authors wrote. Although the study results are descriptive in nature and do not identify the underlying mechanisms for these discrepancies, they “demonstrate substantial gender imbalances in cancer research investment.
“We would strongly urge policy makers, funders and the academic and scientific community to investigate the factors leading to our observed differences and seek to ensure that women are appropriately supported in scientific endeavor,” they concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
Female cancer researchers receive significantly less funding than their male counterparts in terms of total investment, number of awards, and mean and median funding, according to an analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
In an analysis of 4,186 awards totaling 2.33 billion pounds, 2,890 grants (69%) with a total value of 1.82 billion pounds (78%) were awarded to male primary investigators (PIs), compared with just 1,296 grants (31%) with a total value of 512 million pounds(22%) for female PIs, investigators reported in BMJ Open.
Investigators studied openly accessible information on funding awards from public and philanthropic sources including the Medical Research Council, Department of Health, Biotechnology and Biological Sciences Research Council, Engineering and Physical Science Research Council, Wellcome Trust, European Commission, and nine members of the Association of Medical Research Charities. Awards were excluded if they were not relevant to oncology, led by a non-U.K. institution, and/or not considered a research and development activity, wrote Charlie D. Zhou, MD, of the Royal Free NHS Foundation Trust Department of Nuclear Medicine in London, and coauthors.
Median grant value was greater for men (252,647 pounds; interquartile range, 127,343-553,560 pounds) than for women (198,485 pounds; IQR, 99,317-382,650 pounds) (P less than .001). Mean grant value was also greater for men (630,324 pounds; standard deviation, 1,662,559 pounds) than for women (394,730 pounds; SD, 666,574 pounds), Dr. Zhou and colleagues reported.
Large funding discrepancies were seen for sex-specific cancer research. For instance, males received 13.8, 3.5, and 2.0 times the investment of their female counterparts in total, mean, and median prostate cancer funding, respectively. Likewise, men received 9.9, 6.6, and 2.9 times the funding of women PIs in total, mean, and median funding, respectively, for cervical cancer research. This pattern was true for ovarian cancer and breast cancer research, as well.
Men also received significantly greater median funding at all points of the research and development pipeline. For preclinical, phase 1, 2, or 3 clinical trials; and public health, men received 20%, 90%, and 50% more, respectively (P less than .001); for product development and cross-disciplinary research, the difference was 50% and 20%, respectively (P less than .01).
The results of the analysis demonstrate that “female PIs clearly and consistently receive less funding than their male counterparts,” the authors wrote. Although the study results are descriptive in nature and do not identify the underlying mechanisms for these discrepancies, they “demonstrate substantial gender imbalances in cancer research investment.
“We would strongly urge policy makers, funders and the academic and scientific community to investigate the factors leading to our observed differences and seek to ensure that women are appropriately supported in scientific endeavor,” they concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
Female cancer researchers receive significantly less funding than their male counterparts in terms of total investment, number of awards, and mean and median funding, according to an analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
In an analysis of 4,186 awards totaling 2.33 billion pounds, 2,890 grants (69%) with a total value of 1.82 billion pounds (78%) were awarded to male primary investigators (PIs), compared with just 1,296 grants (31%) with a total value of 512 million pounds(22%) for female PIs, investigators reported in BMJ Open.
Investigators studied openly accessible information on funding awards from public and philanthropic sources including the Medical Research Council, Department of Health, Biotechnology and Biological Sciences Research Council, Engineering and Physical Science Research Council, Wellcome Trust, European Commission, and nine members of the Association of Medical Research Charities. Awards were excluded if they were not relevant to oncology, led by a non-U.K. institution, and/or not considered a research and development activity, wrote Charlie D. Zhou, MD, of the Royal Free NHS Foundation Trust Department of Nuclear Medicine in London, and coauthors.
Median grant value was greater for men (252,647 pounds; interquartile range, 127,343-553,560 pounds) than for women (198,485 pounds; IQR, 99,317-382,650 pounds) (P less than .001). Mean grant value was also greater for men (630,324 pounds; standard deviation, 1,662,559 pounds) than for women (394,730 pounds; SD, 666,574 pounds), Dr. Zhou and colleagues reported.
Large funding discrepancies were seen for sex-specific cancer research. For instance, males received 13.8, 3.5, and 2.0 times the investment of their female counterparts in total, mean, and median prostate cancer funding, respectively. Likewise, men received 9.9, 6.6, and 2.9 times the funding of women PIs in total, mean, and median funding, respectively, for cervical cancer research. This pattern was true for ovarian cancer and breast cancer research, as well.
Men also received significantly greater median funding at all points of the research and development pipeline. For preclinical, phase 1, 2, or 3 clinical trials; and public health, men received 20%, 90%, and 50% more, respectively (P less than .001); for product development and cross-disciplinary research, the difference was 50% and 20%, respectively (P less than .01).
The results of the analysis demonstrate that “female PIs clearly and consistently receive less funding than their male counterparts,” the authors wrote. Although the study results are descriptive in nature and do not identify the underlying mechanisms for these discrepancies, they “demonstrate substantial gender imbalances in cancer research investment.
“We would strongly urge policy makers, funders and the academic and scientific community to investigate the factors leading to our observed differences and seek to ensure that women are appropriately supported in scientific endeavor,” they concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
FROM BMJ OPEN
Key clinical point: Female cancer researchers receive significantly less funding than their male counterparts.
Major finding: Of 4,186 awards, 2,890 grants (69%) were awarded to male primary investigators (PIs), compared with 1,296 grants (31%) for female PIs.
Study details: An analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
Disclosures: No disclosures or conflicts of interest were reported.
Source: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
Ivacaftor reduced hospitalizations in CF
with a variety of mutations, according to results published May 7 in Health Affairs.
The study involved 143 patients being treated with ivacaftor between February 2012 and February 2015. In 2014, the FDA expanded its approval for the use of ivacaftor by cystic fibrosis patients to include nine additional mutations, and patients with these mutations were included in this study.
Ms. Feng, who is senior director for policy and advocacy at the Cystic Fibrosis Foundation and her colleagues analyzed administrative claims data from the Truven Health Analytics Market Scan Commercial Research Database. All of the claims were for patients from the United States with employer-sponsored insurance plans. Eligibility criteria included an ICD-9 CM diagnosis of cystic fibrosis on one or more inpatient claims or two or more outpatient claims at least 30 days apart, a prescription claim for ivacaftor monotherapy, being at least 6 years of age at the time of the first filled prescription, and 12 months of continuous enrollment before and after the first filled prescription.
The “pre-ivacaftor” period was defined as the 12 months before the first filled prescription. The “post-ivacaftor” period was defined as the 12 months after the first filled prescription. For each period, the numbers and percentages of patients hospitalized were calculated, for any reason and for cystic fibrosis–related reasons. Hospitalization rates also were calculated as numbers of admissions per person-year, the authors said.
Data also were analyzed for two subcohorts: the 86 patients who started using ivacaftor between Feb. 6, 2012, and Feb. 21, 2014, under the initial Food and Drug Administration label; and the 57 patients who initiated use between Feb. 22, 2014, and Dec. 31, 2015, under the expanded FDA label, which included nine additional genetic mutations.
Of the 143 patients who had filled prescriptions for ivacaftor, 63% were aged 18 years or older. The rate of overall inpatient admissions decreased 55%, from 0.57 admissions per person-year in the pre-ivacaftor period to 0.26 admissions per person-year in the post-ivacaftor period, the investigators reported.
The declines in hospital admissions also were similar between the initial label and the expanded FDA label groups, with declines in overall admissions of 59% and 57%, respectively.
Hospital admissions related to cystic fibrosis also decreased significantly, by 78%. Admissions with principal diagnosis codes for cystic fibrosis decreased from 42 in the preprescription period, to 8 after filling the prescription. Rates per person per year decreased by 82% in patients aged 6-17 years and 80% among adults aged 18 years and older. Additionally, patients who filled at least 10 prescriptions during the study period experienced a 68% reduction in inpatient admissions, compared with 45% for those with three to nine prescriptions filled.
Ivacaftor also was associated with 60% lower per-person inpatient spending overall, with a greater proportional reduction in hospital costs for adults (68%) than for children (45%), and an absolute per-person reduction of $10,567, the authors reported.
“Treatments that target the protein defect that causes cystic fibrosis illustrate the promise of precision medicine,” the authors wrote. “To deliver the right care to the right patient, cystic fibrosis care must continue to account for other aspects unique to individuals such as environment, physiology, patients’ preferences, and lifestyle,” they concluded.
Ivacaftor (Kalydeco) is manufactured for Vertex Pharmaceuticals. No disclosures or conflicts of interest were reported.
SOURCE: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554
with a variety of mutations, according to results published May 7 in Health Affairs.
The study involved 143 patients being treated with ivacaftor between February 2012 and February 2015. In 2014, the FDA expanded its approval for the use of ivacaftor by cystic fibrosis patients to include nine additional mutations, and patients with these mutations were included in this study.
Ms. Feng, who is senior director for policy and advocacy at the Cystic Fibrosis Foundation and her colleagues analyzed administrative claims data from the Truven Health Analytics Market Scan Commercial Research Database. All of the claims were for patients from the United States with employer-sponsored insurance plans. Eligibility criteria included an ICD-9 CM diagnosis of cystic fibrosis on one or more inpatient claims or two or more outpatient claims at least 30 days apart, a prescription claim for ivacaftor monotherapy, being at least 6 years of age at the time of the first filled prescription, and 12 months of continuous enrollment before and after the first filled prescription.
The “pre-ivacaftor” period was defined as the 12 months before the first filled prescription. The “post-ivacaftor” period was defined as the 12 months after the first filled prescription. For each period, the numbers and percentages of patients hospitalized were calculated, for any reason and for cystic fibrosis–related reasons. Hospitalization rates also were calculated as numbers of admissions per person-year, the authors said.
Data also were analyzed for two subcohorts: the 86 patients who started using ivacaftor between Feb. 6, 2012, and Feb. 21, 2014, under the initial Food and Drug Administration label; and the 57 patients who initiated use between Feb. 22, 2014, and Dec. 31, 2015, under the expanded FDA label, which included nine additional genetic mutations.
Of the 143 patients who had filled prescriptions for ivacaftor, 63% were aged 18 years or older. The rate of overall inpatient admissions decreased 55%, from 0.57 admissions per person-year in the pre-ivacaftor period to 0.26 admissions per person-year in the post-ivacaftor period, the investigators reported.
The declines in hospital admissions also were similar between the initial label and the expanded FDA label groups, with declines in overall admissions of 59% and 57%, respectively.
Hospital admissions related to cystic fibrosis also decreased significantly, by 78%. Admissions with principal diagnosis codes for cystic fibrosis decreased from 42 in the preprescription period, to 8 after filling the prescription. Rates per person per year decreased by 82% in patients aged 6-17 years and 80% among adults aged 18 years and older. Additionally, patients who filled at least 10 prescriptions during the study period experienced a 68% reduction in inpatient admissions, compared with 45% for those with three to nine prescriptions filled.
Ivacaftor also was associated with 60% lower per-person inpatient spending overall, with a greater proportional reduction in hospital costs for adults (68%) than for children (45%), and an absolute per-person reduction of $10,567, the authors reported.
“Treatments that target the protein defect that causes cystic fibrosis illustrate the promise of precision medicine,” the authors wrote. “To deliver the right care to the right patient, cystic fibrosis care must continue to account for other aspects unique to individuals such as environment, physiology, patients’ preferences, and lifestyle,” they concluded.
Ivacaftor (Kalydeco) is manufactured for Vertex Pharmaceuticals. No disclosures or conflicts of interest were reported.
SOURCE: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554
with a variety of mutations, according to results published May 7 in Health Affairs.
The study involved 143 patients being treated with ivacaftor between February 2012 and February 2015. In 2014, the FDA expanded its approval for the use of ivacaftor by cystic fibrosis patients to include nine additional mutations, and patients with these mutations were included in this study.
Ms. Feng, who is senior director for policy and advocacy at the Cystic Fibrosis Foundation and her colleagues analyzed administrative claims data from the Truven Health Analytics Market Scan Commercial Research Database. All of the claims were for patients from the United States with employer-sponsored insurance plans. Eligibility criteria included an ICD-9 CM diagnosis of cystic fibrosis on one or more inpatient claims or two or more outpatient claims at least 30 days apart, a prescription claim for ivacaftor monotherapy, being at least 6 years of age at the time of the first filled prescription, and 12 months of continuous enrollment before and after the first filled prescription.
The “pre-ivacaftor” period was defined as the 12 months before the first filled prescription. The “post-ivacaftor” period was defined as the 12 months after the first filled prescription. For each period, the numbers and percentages of patients hospitalized were calculated, for any reason and for cystic fibrosis–related reasons. Hospitalization rates also were calculated as numbers of admissions per person-year, the authors said.
Data also were analyzed for two subcohorts: the 86 patients who started using ivacaftor between Feb. 6, 2012, and Feb. 21, 2014, under the initial Food and Drug Administration label; and the 57 patients who initiated use between Feb. 22, 2014, and Dec. 31, 2015, under the expanded FDA label, which included nine additional genetic mutations.
Of the 143 patients who had filled prescriptions for ivacaftor, 63% were aged 18 years or older. The rate of overall inpatient admissions decreased 55%, from 0.57 admissions per person-year in the pre-ivacaftor period to 0.26 admissions per person-year in the post-ivacaftor period, the investigators reported.
The declines in hospital admissions also were similar between the initial label and the expanded FDA label groups, with declines in overall admissions of 59% and 57%, respectively.
Hospital admissions related to cystic fibrosis also decreased significantly, by 78%. Admissions with principal diagnosis codes for cystic fibrosis decreased from 42 in the preprescription period, to 8 after filling the prescription. Rates per person per year decreased by 82% in patients aged 6-17 years and 80% among adults aged 18 years and older. Additionally, patients who filled at least 10 prescriptions during the study period experienced a 68% reduction in inpatient admissions, compared with 45% for those with three to nine prescriptions filled.
Ivacaftor also was associated with 60% lower per-person inpatient spending overall, with a greater proportional reduction in hospital costs for adults (68%) than for children (45%), and an absolute per-person reduction of $10,567, the authors reported.
“Treatments that target the protein defect that causes cystic fibrosis illustrate the promise of precision medicine,” the authors wrote. “To deliver the right care to the right patient, cystic fibrosis care must continue to account for other aspects unique to individuals such as environment, physiology, patients’ preferences, and lifestyle,” they concluded.
Ivacaftor (Kalydeco) is manufactured for Vertex Pharmaceuticals. No disclosures or conflicts of interest were reported.
SOURCE: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554
FROM HEALTH AFFAIRS
Key clinical point: Ivacaftor significantly reduced hospital admission rates in patients with cystic fibrosis.
Major finding: Overall rate of inpatient admissions dropped by 55% and cystic fibrosis related admissions rates by 78% (P less than .0001).
Study details: A study of 143 patients treated with ivacaftor between February 2012 and February 2015.
Disclosures: No disclosures or conflicts of interest were reported.
Source: Feng LB et al. Health Aff. 2018 May 8. doi: 10.1377/hlthaff.2017.1554.
Adolescents, young adults endorse marijuana for IBD
according to study findings.
In a cross-sectional study of 99 patients with IBD aged 13-22 years, 32% of participants reported ever having used marijuana or endorsing use in the past 6 months. Additionally, 42% of patients perceived little to no risk of harm with regular use, reported Edward J. Hoffenberg, MD, of the departments of pediatrics and psychiatry at the University of Colorado, Aurora, and his associates.
Overall, 62 patients had a diagnosis of Crohn’s disease, 27 had ulcerative colitis, and 10 had indeterminate/unknown colitis. Patients in the ever-use group were older (mean, 17 years) than those in the never-use group (mean, 15.9 years). Serum cannabinoids were detected in 50% of patients in the ever-use group. “The detection of serum cannabinoids only in the ever-users is consistent with truthful reporting,” the researchers said.
Additionally, 80% of ever-users and 25% of never users perceived low to no risk of harm with regular use. After adjustment for age, ever-users were 10.7 times more likely to perceive low to no risk of harm (odds ratio, 10.7; P less than .001), the authors reported.
Weekly and daily marijuana use was reported by 52% and 31% of ever-users, respectively; 9% reported daily or almost daily use. Medical reasons for use was endorsed by 57%, and 53% reported physical pain relief as a reason. Nonmedical recreational or psychological reasons for use were reported by 87%. Problems with use were reported by 37% of users, including cravings or strong desire to use (20%), needing to use more to achieve the same effect (17%), and using a larger amount for longer than intended (17%).
“There is a need for further understanding of the potential medical benefits of marijuana use in IBD,” Dr. Hoffenberg and his associates wrote. “Theoretically, a different study design, such as a randomized controlled trial of marijuana use or placebo, could better evaluate the safety and benefit of frequent marijuana use for induction or maintenance of remission.”
Limitations of the study include difficulty determining differences in disease activity between groups because of the large number of patients with inactive or mild disease, as well as the need to group patients with Crohn’s disease and ulcerative colitis together because of the small total number of participants who endorse marijuana use.
The study was funded by the Colorado Department of Public Health and Environment. No conflicts of interest were reported.
SOURCE: Hoffenberg EJ et al. 2018. doi: 10.1016/j.jpeds.2018.03.041.
according to study findings.
In a cross-sectional study of 99 patients with IBD aged 13-22 years, 32% of participants reported ever having used marijuana or endorsing use in the past 6 months. Additionally, 42% of patients perceived little to no risk of harm with regular use, reported Edward J. Hoffenberg, MD, of the departments of pediatrics and psychiatry at the University of Colorado, Aurora, and his associates.
Overall, 62 patients had a diagnosis of Crohn’s disease, 27 had ulcerative colitis, and 10 had indeterminate/unknown colitis. Patients in the ever-use group were older (mean, 17 years) than those in the never-use group (mean, 15.9 years). Serum cannabinoids were detected in 50% of patients in the ever-use group. “The detection of serum cannabinoids only in the ever-users is consistent with truthful reporting,” the researchers said.
Additionally, 80% of ever-users and 25% of never users perceived low to no risk of harm with regular use. After adjustment for age, ever-users were 10.7 times more likely to perceive low to no risk of harm (odds ratio, 10.7; P less than .001), the authors reported.
Weekly and daily marijuana use was reported by 52% and 31% of ever-users, respectively; 9% reported daily or almost daily use. Medical reasons for use was endorsed by 57%, and 53% reported physical pain relief as a reason. Nonmedical recreational or psychological reasons for use were reported by 87%. Problems with use were reported by 37% of users, including cravings or strong desire to use (20%), needing to use more to achieve the same effect (17%), and using a larger amount for longer than intended (17%).
“There is a need for further understanding of the potential medical benefits of marijuana use in IBD,” Dr. Hoffenberg and his associates wrote. “Theoretically, a different study design, such as a randomized controlled trial of marijuana use or placebo, could better evaluate the safety and benefit of frequent marijuana use for induction or maintenance of remission.”
Limitations of the study include difficulty determining differences in disease activity between groups because of the large number of patients with inactive or mild disease, as well as the need to group patients with Crohn’s disease and ulcerative colitis together because of the small total number of participants who endorse marijuana use.
The study was funded by the Colorado Department of Public Health and Environment. No conflicts of interest were reported.
SOURCE: Hoffenberg EJ et al. 2018. doi: 10.1016/j.jpeds.2018.03.041.
according to study findings.
In a cross-sectional study of 99 patients with IBD aged 13-22 years, 32% of participants reported ever having used marijuana or endorsing use in the past 6 months. Additionally, 42% of patients perceived little to no risk of harm with regular use, reported Edward J. Hoffenberg, MD, of the departments of pediatrics and psychiatry at the University of Colorado, Aurora, and his associates.
Overall, 62 patients had a diagnosis of Crohn’s disease, 27 had ulcerative colitis, and 10 had indeterminate/unknown colitis. Patients in the ever-use group were older (mean, 17 years) than those in the never-use group (mean, 15.9 years). Serum cannabinoids were detected in 50% of patients in the ever-use group. “The detection of serum cannabinoids only in the ever-users is consistent with truthful reporting,” the researchers said.
Additionally, 80% of ever-users and 25% of never users perceived low to no risk of harm with regular use. After adjustment for age, ever-users were 10.7 times more likely to perceive low to no risk of harm (odds ratio, 10.7; P less than .001), the authors reported.
Weekly and daily marijuana use was reported by 52% and 31% of ever-users, respectively; 9% reported daily or almost daily use. Medical reasons for use was endorsed by 57%, and 53% reported physical pain relief as a reason. Nonmedical recreational or psychological reasons for use were reported by 87%. Problems with use were reported by 37% of users, including cravings or strong desire to use (20%), needing to use more to achieve the same effect (17%), and using a larger amount for longer than intended (17%).
“There is a need for further understanding of the potential medical benefits of marijuana use in IBD,” Dr. Hoffenberg and his associates wrote. “Theoretically, a different study design, such as a randomized controlled trial of marijuana use or placebo, could better evaluate the safety and benefit of frequent marijuana use for induction or maintenance of remission.”
Limitations of the study include difficulty determining differences in disease activity between groups because of the large number of patients with inactive or mild disease, as well as the need to group patients with Crohn’s disease and ulcerative colitis together because of the small total number of participants who endorse marijuana use.
The study was funded by the Colorado Department of Public Health and Environment. No conflicts of interest were reported.
SOURCE: Hoffenberg EJ et al. 2018. doi: 10.1016/j.jpeds.2018.03.041.
FROM THE JOURNAL OF PEDIATRICS
Key clinical point: Many adolescents and young adults with IBD use marijuana and perceive little to no harm from regular use.
Major finding: Of the participants in the study, 32% reported ever having used marijuana or endorsing use in the past 6 months, and 42% perceived little to no risk of harm with regular use.
Study details: A cross-sectional study of 99 IBD patients aged 13-22 years at Children’s Hospital Colorado.
Disclosures: The study was funded by the Colorado Department of Public Health and Environment. No conflicts of interest were reported.
Source: Hoffenberg EJ et al. J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.03.041.
Esketamine nasal spray brings fast relief of depressive symptoms
Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation, according to results of a phase 2 study published April 16 in the American Journal of Psychiatry.
In a study of 68 patients randomly assigned to either esketamine or placebo with standard-of-care treatment, patients in the treatment group had a significantly greater improvement in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 hours’ and 24 hours’ follow-up after the first dose, reported Carla M. Canuso, MD, and her coauthors.
Esketamine, a more potent sibling of ketamine, is an N-methyl-D-aspartate receptor antagonist that modulates glutamatergic transmission. It is “being developed as an intranasal formulation for treatment-resistant depression and for rapid reduction of symptoms of major depressive disorder, including suicidal ideation, in patients at imminent risk for suicide,” Dr. Canuso and her coauthors reported.
In the study, participants were assigned randomly to twice-weekly treatment with either placebo or 84 mg of intranasal esketamine (or a reduced dose of 56 mg in the event of intolerance). The study included 4 weeks of double-blind treatment followed by 8 weeks of follow-up.
Depressive and suicidal symptoms were evaluated using MADRS criteria 4 hours and 24 hours after the initial dose, on day 25, and all visits during posttreatment follow-up. Severity of suicide risk was evaluated using the Suicide Ideation and Behavior Assessment Tool.
MADRS scores were significantly improved in the esketamine group, compared with the placebo group, both 4 hours and 24 hours after initial dosing, but not at 25 days, Dr. Canuso and her colleagues reported. The esketamine group also had significantly greater improvement on the MADRS suicidal thoughts item 4 hours after first dose (P = .002), but not 24 hours after the first dose (P = .129) or at day 25 (P = .143).
The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
Before ketamine is offered as a treatment option for depression or suicidal ideation, the potential risks for dependence and abuse need to be carefully evaluated, wrote Robert Freedman, MD, professor and former chair of the department of psychiatry at the University of Colorado at Denver, Aurora, and his coauthors.
“In order to obtain FDA [Food and Drug Administration] approval for marketing, phase 3 trials need to include rigorous monitoring of patients’ craving after ketamine administration and urine monitoring before each subsequent administration to detect evidence of drug seeking from other sources,” he and his coauthors wrote.
Physicians have a responsibility to try to prevent epidemics such as the opioid crisis, and preemptive research into ketamine’s addictive properties may be one way to avoid another such crisis, he added.
“It would be wise for physicians, regulatory agencies, and the pharmaceutical industry to work together preemptively to establish a suitable framework for its therapeutic use,” he wrote. “Education of the public and physicians needs to balance both potential benefits and the risk of abuse.”
Dr. Freedman did not report any relevant disclosures.
Robert Freedman, MD, and his coauthors are members of the American Journal of Psychiatry’s editorial board. Their comments came in an editorial accompanying the study (Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.18030290).
Before ketamine is offered as a treatment option for depression or suicidal ideation, the potential risks for dependence and abuse need to be carefully evaluated, wrote Robert Freedman, MD, professor and former chair of the department of psychiatry at the University of Colorado at Denver, Aurora, and his coauthors.
“In order to obtain FDA [Food and Drug Administration] approval for marketing, phase 3 trials need to include rigorous monitoring of patients’ craving after ketamine administration and urine monitoring before each subsequent administration to detect evidence of drug seeking from other sources,” he and his coauthors wrote.
Physicians have a responsibility to try to prevent epidemics such as the opioid crisis, and preemptive research into ketamine’s addictive properties may be one way to avoid another such crisis, he added.
“It would be wise for physicians, regulatory agencies, and the pharmaceutical industry to work together preemptively to establish a suitable framework for its therapeutic use,” he wrote. “Education of the public and physicians needs to balance both potential benefits and the risk of abuse.”
Dr. Freedman did not report any relevant disclosures.
Robert Freedman, MD, and his coauthors are members of the American Journal of Psychiatry’s editorial board. Their comments came in an editorial accompanying the study (Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.18030290).
Before ketamine is offered as a treatment option for depression or suicidal ideation, the potential risks for dependence and abuse need to be carefully evaluated, wrote Robert Freedman, MD, professor and former chair of the department of psychiatry at the University of Colorado at Denver, Aurora, and his coauthors.
“In order to obtain FDA [Food and Drug Administration] approval for marketing, phase 3 trials need to include rigorous monitoring of patients’ craving after ketamine administration and urine monitoring before each subsequent administration to detect evidence of drug seeking from other sources,” he and his coauthors wrote.
Physicians have a responsibility to try to prevent epidemics such as the opioid crisis, and preemptive research into ketamine’s addictive properties may be one way to avoid another such crisis, he added.
“It would be wise for physicians, regulatory agencies, and the pharmaceutical industry to work together preemptively to establish a suitable framework for its therapeutic use,” he wrote. “Education of the public and physicians needs to balance both potential benefits and the risk of abuse.”
Dr. Freedman did not report any relevant disclosures.
Robert Freedman, MD, and his coauthors are members of the American Journal of Psychiatry’s editorial board. Their comments came in an editorial accompanying the study (Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.18030290).
Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation, according to results of a phase 2 study published April 16 in the American Journal of Psychiatry.
In a study of 68 patients randomly assigned to either esketamine or placebo with standard-of-care treatment, patients in the treatment group had a significantly greater improvement in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 hours’ and 24 hours’ follow-up after the first dose, reported Carla M. Canuso, MD, and her coauthors.
Esketamine, a more potent sibling of ketamine, is an N-methyl-D-aspartate receptor antagonist that modulates glutamatergic transmission. It is “being developed as an intranasal formulation for treatment-resistant depression and for rapid reduction of symptoms of major depressive disorder, including suicidal ideation, in patients at imminent risk for suicide,” Dr. Canuso and her coauthors reported.
In the study, participants were assigned randomly to twice-weekly treatment with either placebo or 84 mg of intranasal esketamine (or a reduced dose of 56 mg in the event of intolerance). The study included 4 weeks of double-blind treatment followed by 8 weeks of follow-up.
Depressive and suicidal symptoms were evaluated using MADRS criteria 4 hours and 24 hours after the initial dose, on day 25, and all visits during posttreatment follow-up. Severity of suicide risk was evaluated using the Suicide Ideation and Behavior Assessment Tool.
MADRS scores were significantly improved in the esketamine group, compared with the placebo group, both 4 hours and 24 hours after initial dosing, but not at 25 days, Dr. Canuso and her colleagues reported. The esketamine group also had significantly greater improvement on the MADRS suicidal thoughts item 4 hours after first dose (P = .002), but not 24 hours after the first dose (P = .129) or at day 25 (P = .143).
The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation, according to results of a phase 2 study published April 16 in the American Journal of Psychiatry.
In a study of 68 patients randomly assigned to either esketamine or placebo with standard-of-care treatment, patients in the treatment group had a significantly greater improvement in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 hours’ and 24 hours’ follow-up after the first dose, reported Carla M. Canuso, MD, and her coauthors.
Esketamine, a more potent sibling of ketamine, is an N-methyl-D-aspartate receptor antagonist that modulates glutamatergic transmission. It is “being developed as an intranasal formulation for treatment-resistant depression and for rapid reduction of symptoms of major depressive disorder, including suicidal ideation, in patients at imminent risk for suicide,” Dr. Canuso and her coauthors reported.
In the study, participants were assigned randomly to twice-weekly treatment with either placebo or 84 mg of intranasal esketamine (or a reduced dose of 56 mg in the event of intolerance). The study included 4 weeks of double-blind treatment followed by 8 weeks of follow-up.
Depressive and suicidal symptoms were evaluated using MADRS criteria 4 hours and 24 hours after the initial dose, on day 25, and all visits during posttreatment follow-up. Severity of suicide risk was evaluated using the Suicide Ideation and Behavior Assessment Tool.
MADRS scores were significantly improved in the esketamine group, compared with the placebo group, both 4 hours and 24 hours after initial dosing, but not at 25 days, Dr. Canuso and her colleagues reported. The esketamine group also had significantly greater improvement on the MADRS suicidal thoughts item 4 hours after first dose (P = .002), but not 24 hours after the first dose (P = .129) or at day 25 (P = .143).
The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Key clinical point: Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation.
Major finding: Patients in the esketamine treatment group had a significantly greater improvement in scores on MADRS at 4 hours and 24 hours follow-up.
Study details: A double-blind, proof-of-concept, phase 2 study of 68 patients with major depressive disorder.
Disclosures: The study was funded by Janssen Research and Development.
Source: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
New study establishes IBD severity index
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.
Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.
Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.
This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.
Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.
“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.
The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.
Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.
Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.
This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.
Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.
“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.
The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648).
The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.
The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course.
A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.
A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity.
A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.
Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion.
Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.
This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.
Dr. Siegel and his colleagues noted that future studies should focus on prospective validation of the disease indexes in different patient populations, as well as conducting a conjoint analysis with patients.
“We expect this work to begin to address a change in how we think about patients with IBD and how to identify those at the higher end of the risk spectrum so that appropriate intensive treatment can be initiated and optimized in an efficient, precise, and cost-effective manner,” they concluded.
The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.
SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
AGA patient education materials can help your IBD patients better understand and manage their disease. Learn more at www.gastro.org/IBD
FROM GUT
Children with autism, younger siblings are undervaccinated
according to findings published March 26 in JAMA Pediatrics.
In a matched cohort study of 3,729 children with autism spectrum disorder (ASD) and 592,907 children without ASD, children with ASD were significantly less likely than children without ASD to be fully vaccinated for vaccines recommended at 4-6 years of age (adjusted rate ratio = 0.87; 95% confidence interval 0.85-0.88; P less than .05), wrote Ousseny Zerbo, PhD, of the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and his coauthors.
ASD was defined based on ICD-9-CM codes 299.0, 299.8, and 299.9 in EHRs at least twice from birth until either the patient’s 6th birthday or follow-up, whichever came first. Assessment included the Centers for Disease Control and Prevention’s ACIP (Advisory Committee Immunization Practices)–recommended vaccinations for ages 4-6 years and 11-12 years. Children who received all doses within the ACIP-recommended age limits were considered fully vaccinated, the investigators said.
Only 81.6% of children with ASD had received all recommended doses between ages 4 and 6 years, compared with 94.1% of children without ASD. For the MMR vaccine, 84.0% of children with ASD aged 4-6 years were vaccinated, compared with 95.9% of children without ASD. For vaccines recommended at 11-12 years of age, the proportion of children with and without ASD receiving all vaccines were 77.5% and 76.9%, respectively, and adjusted RR was not significant, Dr. Zerbo and colleagues reported.
In all age groups, the proportion of fully vaccinated children was lower among the younger siblings of children with ASD, compared with the younger siblings of children without ASD. The largest differences in vaccination rates were seen in children aged 1-11 months and 1-2 years, with 73.2% of ASD siblings and 85% of non-ASD siblings aged 1-11 months being fully vaccinated (aRR, 0.86; 95% confidence interval, 0.82-0.89), and 60.2% of ASD siblings and 70.7% of non-ASD siblings aged 1-2 years being fully vaccinated (aRR, 0.84; 95% CI, 0.79-0.89), the authors noted.
Although most parents vaccinate their children in accordance with the ACIP-recommended schedule, the results of this study suggest that for siblings of children with ASD, “the ASD diagnosis of the older sibling may have contributed to the undervaccination of the younger children,” Dr. Zerbo and his colleagues wrote.
“Children with ASD and their younger siblings were undervaccinated, compared with the general population, suggesting that they are at increased risk of vaccine-preventable diseases,” they wrote. “New strategies, including establishing or promoting a better dialogue among parents, health care professionals, and public health authorities, may be needed to increase vaccine uptake in populations with low uptake.”
The study was funded in part by a CDC grant. Dr. Zerbo had no relevant financial disclosures. Some authors disclosed relationships with MedImmune, GlaxoSmithKline, and other pharmaceutical companies.
SOURCE: Zerbo, O et al. JAMA Pediatr. 2018, Mar 26. doi: 10.1001/jamapediatrics.2018.0082.
according to findings published March 26 in JAMA Pediatrics.
In a matched cohort study of 3,729 children with autism spectrum disorder (ASD) and 592,907 children without ASD, children with ASD were significantly less likely than children without ASD to be fully vaccinated for vaccines recommended at 4-6 years of age (adjusted rate ratio = 0.87; 95% confidence interval 0.85-0.88; P less than .05), wrote Ousseny Zerbo, PhD, of the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and his coauthors.
ASD was defined based on ICD-9-CM codes 299.0, 299.8, and 299.9 in EHRs at least twice from birth until either the patient’s 6th birthday or follow-up, whichever came first. Assessment included the Centers for Disease Control and Prevention’s ACIP (Advisory Committee Immunization Practices)–recommended vaccinations for ages 4-6 years and 11-12 years. Children who received all doses within the ACIP-recommended age limits were considered fully vaccinated, the investigators said.
Only 81.6% of children with ASD had received all recommended doses between ages 4 and 6 years, compared with 94.1% of children without ASD. For the MMR vaccine, 84.0% of children with ASD aged 4-6 years were vaccinated, compared with 95.9% of children without ASD. For vaccines recommended at 11-12 years of age, the proportion of children with and without ASD receiving all vaccines were 77.5% and 76.9%, respectively, and adjusted RR was not significant, Dr. Zerbo and colleagues reported.
In all age groups, the proportion of fully vaccinated children was lower among the younger siblings of children with ASD, compared with the younger siblings of children without ASD. The largest differences in vaccination rates were seen in children aged 1-11 months and 1-2 years, with 73.2% of ASD siblings and 85% of non-ASD siblings aged 1-11 months being fully vaccinated (aRR, 0.86; 95% confidence interval, 0.82-0.89), and 60.2% of ASD siblings and 70.7% of non-ASD siblings aged 1-2 years being fully vaccinated (aRR, 0.84; 95% CI, 0.79-0.89), the authors noted.
Although most parents vaccinate their children in accordance with the ACIP-recommended schedule, the results of this study suggest that for siblings of children with ASD, “the ASD diagnosis of the older sibling may have contributed to the undervaccination of the younger children,” Dr. Zerbo and his colleagues wrote.
“Children with ASD and their younger siblings were undervaccinated, compared with the general population, suggesting that they are at increased risk of vaccine-preventable diseases,” they wrote. “New strategies, including establishing or promoting a better dialogue among parents, health care professionals, and public health authorities, may be needed to increase vaccine uptake in populations with low uptake.”
The study was funded in part by a CDC grant. Dr. Zerbo had no relevant financial disclosures. Some authors disclosed relationships with MedImmune, GlaxoSmithKline, and other pharmaceutical companies.
SOURCE: Zerbo, O et al. JAMA Pediatr. 2018, Mar 26. doi: 10.1001/jamapediatrics.2018.0082.
according to findings published March 26 in JAMA Pediatrics.
In a matched cohort study of 3,729 children with autism spectrum disorder (ASD) and 592,907 children without ASD, children with ASD were significantly less likely than children without ASD to be fully vaccinated for vaccines recommended at 4-6 years of age (adjusted rate ratio = 0.87; 95% confidence interval 0.85-0.88; P less than .05), wrote Ousseny Zerbo, PhD, of the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and his coauthors.
ASD was defined based on ICD-9-CM codes 299.0, 299.8, and 299.9 in EHRs at least twice from birth until either the patient’s 6th birthday or follow-up, whichever came first. Assessment included the Centers for Disease Control and Prevention’s ACIP (Advisory Committee Immunization Practices)–recommended vaccinations for ages 4-6 years and 11-12 years. Children who received all doses within the ACIP-recommended age limits were considered fully vaccinated, the investigators said.
Only 81.6% of children with ASD had received all recommended doses between ages 4 and 6 years, compared with 94.1% of children without ASD. For the MMR vaccine, 84.0% of children with ASD aged 4-6 years were vaccinated, compared with 95.9% of children without ASD. For vaccines recommended at 11-12 years of age, the proportion of children with and without ASD receiving all vaccines were 77.5% and 76.9%, respectively, and adjusted RR was not significant, Dr. Zerbo and colleagues reported.
In all age groups, the proportion of fully vaccinated children was lower among the younger siblings of children with ASD, compared with the younger siblings of children without ASD. The largest differences in vaccination rates were seen in children aged 1-11 months and 1-2 years, with 73.2% of ASD siblings and 85% of non-ASD siblings aged 1-11 months being fully vaccinated (aRR, 0.86; 95% confidence interval, 0.82-0.89), and 60.2% of ASD siblings and 70.7% of non-ASD siblings aged 1-2 years being fully vaccinated (aRR, 0.84; 95% CI, 0.79-0.89), the authors noted.
Although most parents vaccinate their children in accordance with the ACIP-recommended schedule, the results of this study suggest that for siblings of children with ASD, “the ASD diagnosis of the older sibling may have contributed to the undervaccination of the younger children,” Dr. Zerbo and his colleagues wrote.
“Children with ASD and their younger siblings were undervaccinated, compared with the general population, suggesting that they are at increased risk of vaccine-preventable diseases,” they wrote. “New strategies, including establishing or promoting a better dialogue among parents, health care professionals, and public health authorities, may be needed to increase vaccine uptake in populations with low uptake.”
The study was funded in part by a CDC grant. Dr. Zerbo had no relevant financial disclosures. Some authors disclosed relationships with MedImmune, GlaxoSmithKline, and other pharmaceutical companies.
SOURCE: Zerbo, O et al. JAMA Pediatr. 2018, Mar 26. doi: 10.1001/jamapediatrics.2018.0082.
FROM JAMA PEDIATRICS
Key clinical point: After receiving a diagnosis of ASD, children and their younger siblings were undervaccinated.
Major finding: Only 81.6% of children with ASD had received all recommended doses between ages 4 and 6 years, compared with 94.1% of children without ASD.
Study details: A matched cohort study of 3,729 children with ASD and 592,907 children without.
Disclosures: The study was funded in part by a CDC grant. Dr. Zerbo had no relevant financial disclosures. Some authors disclosed relationships with MedImmune, GlaxoSmithKline, and other pharmaceutical companies.
Source: Zerbo O et al. JAMA Pediatr. 2018 Mar 26. doi: 10.1001/jamapediatrics.2018.0082.
Study using U.K. data quantifies infection risk associated with psoriasis
Psoriasis was linked to increased risk of serious infection, with more severe disease associated with increased infection risk, in a study that used electronic medical records of patients in the United Kingdom.
The most common serious infections were lower respiratory tract, skin and soft tissue, and upper respiratory tract infections; and the most common opportunistic infection was tuberculosis, reported Junko Takeshita, MD, PhD, of the departments of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, and her coauthors.
They identified 199,700 psoriasis patients and 954,315 healthy patients from THIN (the Health Improvement Network), a medical records database in the United Kingdom. Of the psoriasis patients, 187,258 had mild disease and 12,442 had moderate to severe disease; almost 70% of patients with moderate to severe disease were treated with methotrexate.
Adjusted hazard ratios for serious infection were 1.21 (95% confidence interval, 1.18-1.23) for psoriasis patients overall, 1.18 (95% confidence interval, 1.16-1.21) for those with mild psoriasis, and 1.63 (95% CI, 1.52-1.75) for those with moderate to severe psoriasis, Dr. Takeshita and her coauthors wrote in the Journal of Investigative Dermatology.
Among all psoriasis patients, the attributable risk of serious infection was 16.2 per 10,000 person-years, compared with 14.4 per 10,000 person-years among those with mild psoriasis, and 49.5 per 10,000 person-years, among those with moderate to severe disease.
The investigators also analyzed data from a nested cohort – the iHOPE (Incident Health Outcomes and Psoriasis Events) study – of 8,569 psoriasis patients, with mild (less than 3% of body surface area involvement) or moderate to severe disease (3% or greater BSA), and 83,540 matched patients without psoriasis.
The adjusted HR for serious infection was 1.21 (95% CI, 1.09-1.35) for all psoriasis patients, 1.16 (95% CI, 0.99-1.35) for those with mild disease, and 1.27 (95% CI, 1.10-1.47) for those with moderate to severe disease. When patients who had received immunosuppressive treatment were excluded from the analysis, hazard ratios were similar among the different psoriasis groups, at 1.18 for all psoriasis patients (95% CI, 1.05-1.32), 1.15 among those with mild disease (95% CI, 0.99-1.34), and 1.21 for those with moderate to severe disease (95% CI, 1.03-1.42).
“Importantly, the risk of serious infection was observed to be similar in both the full THIN and iHOPE cohorts with the exception of the moderate to severe psoriasis subgroup among whom the risk of serious infection was attenuated but still significantly elevated in the iHOPE versus full THIN cohort,” they observed.
In the THIN cohort, the most common opportunistic infection “by far” was tuberculosis, with incidence rates of 1.05, 0.94, and 3.00 per 10,000 person-years among all psoriasis patients, patients with mild disease, and patients with moderate to severe disease, respectively, compared with 1.15 for those without psoriasis.
Patients with moderate to severe disease had an increased risk of opportunistic infection (HR, 1.57; 95% CI, 1.06-2.34), but rates were similar among those with mild disease and those without psoriasis, Dr. Takeshita and her colleagues reported. But the opportunistic infection risk was “substantially attenuated” when patients who had received immunosuppressive treatment were excluded (HR, 1.17; 95% CI, 0.44-3.12).
Patients with moderate to severe disease also had the greatest risk of herpes zoster (HR, 1.17; 95% CI, 1.06-1.30). While the increased risk of herpes zoster was smaller in patients with mild psoriasis, it was still significant (HR, 1.07; 95% CI, 1.05-1.10). Again, when exclusion of patients who had received immunosuppressive therapies, the risk for herpes zoster associated with moderate to severe psoriasis no longer was elevated (HR, 0.97; 95% CI, 0.76-1.23).
“Our findings suggest that psoriasis is associated with an increased risk of serious infection, and more severe psoriasis, whether defined by treatment pattern or by BSA involvement, is a predictor of greater serious infection risk,” the authors wrote. Clinicians should ensure that patients, especially those with severe disease and those who receive immunosuppressive treatment, are vaccinated against influenza and pneumonia, and “should also consider herpes zoster vaccination with the new nonlive vaccine.”
“Future studies will be important to further characterize the risk of various infections among patients with psoriasis, compare the risk of infection associated with psoriasis to that of other chronic diseases, and delineate the pathophysiologic mechanisms that contribute to the increased risk of infections associated with psoriasis and its therapies,” they concluded.
The study was funded by an unrestricted Pfizer grant. Dr. Takeshita has received a research grant (to the Trustees of the University of Pennsylvania) from Pfizer for unrelated work payment for continuing medical education work related to psoriasis supported indirectly by Eli Lilly and Novartis. Other authors’ disclosures included servings as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Coherus, and other pharmaceutical companies.
[email protected]
SOURCE: Takeshita J et al. J Invest Dermatol. 2018 Mar 2. doi: 10.1016/j.jid.2018.01.039.
Psoriasis was linked to increased risk of serious infection, with more severe disease associated with increased infection risk, in a study that used electronic medical records of patients in the United Kingdom.
The most common serious infections were lower respiratory tract, skin and soft tissue, and upper respiratory tract infections; and the most common opportunistic infection was tuberculosis, reported Junko Takeshita, MD, PhD, of the departments of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, and her coauthors.
They identified 199,700 psoriasis patients and 954,315 healthy patients from THIN (the Health Improvement Network), a medical records database in the United Kingdom. Of the psoriasis patients, 187,258 had mild disease and 12,442 had moderate to severe disease; almost 70% of patients with moderate to severe disease were treated with methotrexate.
Adjusted hazard ratios for serious infection were 1.21 (95% confidence interval, 1.18-1.23) for psoriasis patients overall, 1.18 (95% confidence interval, 1.16-1.21) for those with mild psoriasis, and 1.63 (95% CI, 1.52-1.75) for those with moderate to severe psoriasis, Dr. Takeshita and her coauthors wrote in the Journal of Investigative Dermatology.
Among all psoriasis patients, the attributable risk of serious infection was 16.2 per 10,000 person-years, compared with 14.4 per 10,000 person-years among those with mild psoriasis, and 49.5 per 10,000 person-years, among those with moderate to severe disease.
The investigators also analyzed data from a nested cohort – the iHOPE (Incident Health Outcomes and Psoriasis Events) study – of 8,569 psoriasis patients, with mild (less than 3% of body surface area involvement) or moderate to severe disease (3% or greater BSA), and 83,540 matched patients without psoriasis.
The adjusted HR for serious infection was 1.21 (95% CI, 1.09-1.35) for all psoriasis patients, 1.16 (95% CI, 0.99-1.35) for those with mild disease, and 1.27 (95% CI, 1.10-1.47) for those with moderate to severe disease. When patients who had received immunosuppressive treatment were excluded from the analysis, hazard ratios were similar among the different psoriasis groups, at 1.18 for all psoriasis patients (95% CI, 1.05-1.32), 1.15 among those with mild disease (95% CI, 0.99-1.34), and 1.21 for those with moderate to severe disease (95% CI, 1.03-1.42).
“Importantly, the risk of serious infection was observed to be similar in both the full THIN and iHOPE cohorts with the exception of the moderate to severe psoriasis subgroup among whom the risk of serious infection was attenuated but still significantly elevated in the iHOPE versus full THIN cohort,” they observed.
In the THIN cohort, the most common opportunistic infection “by far” was tuberculosis, with incidence rates of 1.05, 0.94, and 3.00 per 10,000 person-years among all psoriasis patients, patients with mild disease, and patients with moderate to severe disease, respectively, compared with 1.15 for those without psoriasis.
Patients with moderate to severe disease had an increased risk of opportunistic infection (HR, 1.57; 95% CI, 1.06-2.34), but rates were similar among those with mild disease and those without psoriasis, Dr. Takeshita and her colleagues reported. But the opportunistic infection risk was “substantially attenuated” when patients who had received immunosuppressive treatment were excluded (HR, 1.17; 95% CI, 0.44-3.12).
Patients with moderate to severe disease also had the greatest risk of herpes zoster (HR, 1.17; 95% CI, 1.06-1.30). While the increased risk of herpes zoster was smaller in patients with mild psoriasis, it was still significant (HR, 1.07; 95% CI, 1.05-1.10). Again, when exclusion of patients who had received immunosuppressive therapies, the risk for herpes zoster associated with moderate to severe psoriasis no longer was elevated (HR, 0.97; 95% CI, 0.76-1.23).
“Our findings suggest that psoriasis is associated with an increased risk of serious infection, and more severe psoriasis, whether defined by treatment pattern or by BSA involvement, is a predictor of greater serious infection risk,” the authors wrote. Clinicians should ensure that patients, especially those with severe disease and those who receive immunosuppressive treatment, are vaccinated against influenza and pneumonia, and “should also consider herpes zoster vaccination with the new nonlive vaccine.”
“Future studies will be important to further characterize the risk of various infections among patients with psoriasis, compare the risk of infection associated with psoriasis to that of other chronic diseases, and delineate the pathophysiologic mechanisms that contribute to the increased risk of infections associated with psoriasis and its therapies,” they concluded.
The study was funded by an unrestricted Pfizer grant. Dr. Takeshita has received a research grant (to the Trustees of the University of Pennsylvania) from Pfizer for unrelated work payment for continuing medical education work related to psoriasis supported indirectly by Eli Lilly and Novartis. Other authors’ disclosures included servings as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Coherus, and other pharmaceutical companies.
[email protected]
SOURCE: Takeshita J et al. J Invest Dermatol. 2018 Mar 2. doi: 10.1016/j.jid.2018.01.039.
Psoriasis was linked to increased risk of serious infection, with more severe disease associated with increased infection risk, in a study that used electronic medical records of patients in the United Kingdom.
The most common serious infections were lower respiratory tract, skin and soft tissue, and upper respiratory tract infections; and the most common opportunistic infection was tuberculosis, reported Junko Takeshita, MD, PhD, of the departments of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, and her coauthors.
They identified 199,700 psoriasis patients and 954,315 healthy patients from THIN (the Health Improvement Network), a medical records database in the United Kingdom. Of the psoriasis patients, 187,258 had mild disease and 12,442 had moderate to severe disease; almost 70% of patients with moderate to severe disease were treated with methotrexate.
Adjusted hazard ratios for serious infection were 1.21 (95% confidence interval, 1.18-1.23) for psoriasis patients overall, 1.18 (95% confidence interval, 1.16-1.21) for those with mild psoriasis, and 1.63 (95% CI, 1.52-1.75) for those with moderate to severe psoriasis, Dr. Takeshita and her coauthors wrote in the Journal of Investigative Dermatology.
Among all psoriasis patients, the attributable risk of serious infection was 16.2 per 10,000 person-years, compared with 14.4 per 10,000 person-years among those with mild psoriasis, and 49.5 per 10,000 person-years, among those with moderate to severe disease.
The investigators also analyzed data from a nested cohort – the iHOPE (Incident Health Outcomes and Psoriasis Events) study – of 8,569 psoriasis patients, with mild (less than 3% of body surface area involvement) or moderate to severe disease (3% or greater BSA), and 83,540 matched patients without psoriasis.
The adjusted HR for serious infection was 1.21 (95% CI, 1.09-1.35) for all psoriasis patients, 1.16 (95% CI, 0.99-1.35) for those with mild disease, and 1.27 (95% CI, 1.10-1.47) for those with moderate to severe disease. When patients who had received immunosuppressive treatment were excluded from the analysis, hazard ratios were similar among the different psoriasis groups, at 1.18 for all psoriasis patients (95% CI, 1.05-1.32), 1.15 among those with mild disease (95% CI, 0.99-1.34), and 1.21 for those with moderate to severe disease (95% CI, 1.03-1.42).
“Importantly, the risk of serious infection was observed to be similar in both the full THIN and iHOPE cohorts with the exception of the moderate to severe psoriasis subgroup among whom the risk of serious infection was attenuated but still significantly elevated in the iHOPE versus full THIN cohort,” they observed.
In the THIN cohort, the most common opportunistic infection “by far” was tuberculosis, with incidence rates of 1.05, 0.94, and 3.00 per 10,000 person-years among all psoriasis patients, patients with mild disease, and patients with moderate to severe disease, respectively, compared with 1.15 for those without psoriasis.
Patients with moderate to severe disease had an increased risk of opportunistic infection (HR, 1.57; 95% CI, 1.06-2.34), but rates were similar among those with mild disease and those without psoriasis, Dr. Takeshita and her colleagues reported. But the opportunistic infection risk was “substantially attenuated” when patients who had received immunosuppressive treatment were excluded (HR, 1.17; 95% CI, 0.44-3.12).
Patients with moderate to severe disease also had the greatest risk of herpes zoster (HR, 1.17; 95% CI, 1.06-1.30). While the increased risk of herpes zoster was smaller in patients with mild psoriasis, it was still significant (HR, 1.07; 95% CI, 1.05-1.10). Again, when exclusion of patients who had received immunosuppressive therapies, the risk for herpes zoster associated with moderate to severe psoriasis no longer was elevated (HR, 0.97; 95% CI, 0.76-1.23).
“Our findings suggest that psoriasis is associated with an increased risk of serious infection, and more severe psoriasis, whether defined by treatment pattern or by BSA involvement, is a predictor of greater serious infection risk,” the authors wrote. Clinicians should ensure that patients, especially those with severe disease and those who receive immunosuppressive treatment, are vaccinated against influenza and pneumonia, and “should also consider herpes zoster vaccination with the new nonlive vaccine.”
“Future studies will be important to further characterize the risk of various infections among patients with psoriasis, compare the risk of infection associated with psoriasis to that of other chronic diseases, and delineate the pathophysiologic mechanisms that contribute to the increased risk of infections associated with psoriasis and its therapies,” they concluded.
The study was funded by an unrestricted Pfizer grant. Dr. Takeshita has received a research grant (to the Trustees of the University of Pennsylvania) from Pfizer for unrelated work payment for continuing medical education work related to psoriasis supported indirectly by Eli Lilly and Novartis. Other authors’ disclosures included servings as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Coherus, and other pharmaceutical companies.
[email protected]
SOURCE: Takeshita J et al. J Invest Dermatol. 2018 Mar 2. doi: 10.1016/j.jid.2018.01.039.
Key clinical point: Psoriasis is linked to risk of serious infection, with increased risk in more severe disease.
Major finding: Hazard ratios for serious infection were 1.21 (95% CI, 1.18-1.23) for psoriasis overall, 1.18 (95% CI, 1.16-1.21) for mild psoriasis, and 1.63 (95% CI, 1.52-1.75) for moderate to severe psoriasis.
Study details: The evaluation included data on 199,700 patients with psoriasis and 954,315 patients without psoriasis in a U.K. electronic medical records database.
Disclosures: The study was funded by an unrestricted Pfizer grant. Dr. Takeshita has received a research grant (to the Trustees of the University of Pennsylvania) from Pfizer for unrelated work payment for continuing medical education work related to psoriasis supported indirectly by Eli Lilly and Novartis. Other authors’ disclosures included servings as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Coherus, and other pharmaceutical companies.
Source: Takeshita J et al. J Invest Dermatol. 2018 Mar 2. doi: 10.1016/j.jid.2018.01.039.
mainbar
Psoriasis was linked to increased risk of serious infection, with more severe disease associated with increased infection risk, in a study that used electronic medical records of patients in the United Kingdom.
The most common serious infections were lower respiratory tract, skin and soft tissue, and upper respiratory tract infections; and the most common opportunistic infection was tuberculosis, reported Junko Takeshita, MD, PhD, of the departments of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, and her coauthors.
Adjusted hazard ratios for serious infection were 1.21 (95% confidence interval, 1.18-1.23) for psoriasis patients overall, 1.18 (95% confidence interval, 1.16-1.21) for those with mild psoriasis, and 1.63 (95% CI, 1.52-1.75) for those with moderate to severe psoriasis, Dr. Takeshita and her coauthors wrote in the Journal of Investigative Dermatology.
Among all psoriasis patients, the attributable risk of serious infection was 16.2 per 10,000 person-years, compared with 14.4 per 10,000 person-years among those with mild psoriasis, and 49.5 per 10,000 person-years, among those with moderate to severe disease.
The investigators also analyzed data from a nested cohort – the iHOPE (Incident Health Outcomes and Psoriasis Events) study – of 8,569 psoriasis patients, with mild (less than 3% of body surface area involvement) or moderate to severe disease (3% or greater BSA), and 83,540 matched patients without psoriasis. The adjusted HR for serious infection was 1.21 (95% CI, 1.09-1.35) for all psoriasis patients, 1.16 (95% CI, 0.99-1.35) for those with mild disease, and 1.27 (95% CI, 1.10-1.47) for those with moderate to severe disease. When patients who had received immunosuppressive treatment were excluded from the analysis, hazard ratios were similar among the different psoriasis groups, at 1.18 for all psoriasis patients (95% CI, 1.05-1.32), 1.15 among those with mild disease (95% CI, 0.99-1.34), and 1.21 for those with moderate to severe disease (95% CI, 1.03-1.42).
“Importantly, the risk of serious infection was observed to be similar in both the full THIN and iHOPE cohorts with the exception of the moderate to severe psoriasis subgroup among whom the risk of serious infection was attenuated but still significantly elevated in the iHOPE versus full THIN cohort,” they observed.
In the THIN cohort, the most common opportunistic infection “by far” was tuberculosis, with incidence rates of 1.05, 0.94, and 3.00 per 10,000 person-years among all psoriasis patients, patients with mild disease, and patients with moderate to severe disease, respectively, compared with 1.15 for those without psoriasis.
Patients with moderate to severe disease had an increased risk of opportunistic infection (HR, 1.57; 95% CI, 1.06-2.34), but rates were similar among those with mild disease and those without psoriasis, Dr. Takeshita and her colleagues reported. But the opportunistic infection risk was “substantially attenuated” when patients who had received immunosuppressive treatment were excluded (HR, 1.17; 95% CI, 0.44-3.12).
Patients with moderate to severe disease also had the greatest risk of herpes zoster (HR, 1.17; 95% CI, 1.06-1.30). While the increased risk of herpes zoster was smaller in patients with mild psoriasis, it was still significant (HR, 1.07; 95% CI, 1.05-1.10). Again, when exclusion of patients who had received immunosuppressive therapies, the risk for herpes zoster associated with moderate to severe psoriasis no longer was elevated (HR, 0.97; 95% CI, 0.76-1.23).
“Our findings suggest that psoriasis is associated with an increased risk of serious infection, and more severe psoriasis, whether defined by treatment pattern or by BSA involvement, is a predictor of greater serious infection risk,” the authors wrote. Clinicians should ensure that patients, especially those with severe disease and those who receive immunosuppressive treatment, are vaccinated against influenza and pneumonia, and “should also consider herpes zoster vaccination with the new nonlive vaccine.”
“Future studies will be important to further characterize the risk of various infections among patients with psoriasis, compare the risk of infection associated with psoriasis to that of other chronic diseases, and delineate the pathophysiologic mechanisms that contribute to the increased risk of infections associated with psoriasis and its therapies,” they concluded.
The study was funded by an unrestricted Pfizer grant. Dr. Takeshita has received a research grant (to the Trustees of the University of Pennsylvania) from Pfizer for unrelated work payment for continuing medical education work related to psoriasis supported indirectly by Eli Lilly and Novartis. Other authors’ disclosures included servings as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Coherus, and other pharmaceutical companies.
SOURCE: Takeshita J et al. J Invest Dermatol. 2018 Mar 2. doi: 10.1016/j.jid.2018.01.039.