Caleb Rans

The presence of hematuria on screening urinalysis was found to be highly prevalent in children with hemophilia, according to results from a retrospective chart review.

The findings emphasize the need to measure the population‐wide prevalence of hematuria in pediatric patients with hemophilia, in addition to better understanding its influence on renal function.

“Little is known about the prevalence of haematuria in [patients with hemophilia] or its long‐term impact on the renal system,” wrote Kyle A. Davis, MD, of the Nationwide Children’s Hospital in Columbus, and his coauthors. The results were published in Haemophilia.

The researchers retrospectively reviewed data from 93 patients with hemophilia A and B who were treated at a pediatric hemophilia treatment center from August 2011 to September 2015. The children in the study were all male and aged 2 years and older.

The team detected the frequency of hematuria, defined as greater than or equal to three red blood cells (RBCs) for each high power field, on screening urinalysis.

Other clinical data, including demographic, treatment, and laboratory information were also collected and analyzed.

After analysis, the researchers found that hematuria was detected in 45% of patients with hemophilia (mean RBCs, 332; median RBCs, 7), 76% of whom were identified using urinalysis, rather than clinical symptoms.

In total, recurrent hematuria was seen in 52% of patients. Hemophilia A and older age were associated with a higher likelihood of hematuria. However, there was no correlation between the severity of hemophilia or the treatment regimen and hematuria.

“We suspect patients with haemophilia may be having unrecognized, recurrent microscopic haematuria,” the researchers wrote.

The authors noted a key limitation of the study was the retrospective design.

“We suggest paediatric haematologists should consider routine evaluation for hypertension and renal disease in their patients,” the researchers wrote.

No funding sources were reported. The authors reported financial affiliations with Bioverativ, CSL Behring, Medscape, Shire, the American Society of Hematology, and others.

SOURCE: Davis KA et al. Haemophilia. 2019 Jul 10. doi: 10.1111/hae.13815.
 

The presence of hematuria on screening urinalysis was found to be highly prevalent in children with hemophilia, according to results from a retrospective chart review.

The findings emphasize the need to measure the population‐wide prevalence of hematuria in pediatric patients with hemophilia, in addition to better understanding its influence on renal function.

“Little is known about the prevalence of haematuria in [patients with hemophilia] or its long‐term impact on the renal system,” wrote Kyle A. Davis, MD, of the Nationwide Children’s Hospital in Columbus, and his coauthors. The results were published in Haemophilia.

The researchers retrospectively reviewed data from 93 patients with hemophilia A and B who were treated at a pediatric hemophilia treatment center from August 2011 to September 2015. The children in the study were all male and aged 2 years and older.

The team detected the frequency of hematuria, defined as greater than or equal to three red blood cells (RBCs) for each high power field, on screening urinalysis.

Other clinical data, including demographic, treatment, and laboratory information were also collected and analyzed.

After analysis, the researchers found that hematuria was detected in 45% of patients with hemophilia (mean RBCs, 332; median RBCs, 7), 76% of whom were identified using urinalysis, rather than clinical symptoms.

In total, recurrent hematuria was seen in 52% of patients. Hemophilia A and older age were associated with a higher likelihood of hematuria. However, there was no correlation between the severity of hemophilia or the treatment regimen and hematuria.

“We suspect patients with haemophilia may be having unrecognized, recurrent microscopic haematuria,” the researchers wrote.

The authors noted a key limitation of the study was the retrospective design.

“We suggest paediatric haematologists should consider routine evaluation for hypertension and renal disease in their patients,” the researchers wrote.

No funding sources were reported. The authors reported financial affiliations with Bioverativ, CSL Behring, Medscape, Shire, the American Society of Hematology, and others.

SOURCE: Davis KA et al. Haemophilia. 2019 Jul 10. doi: 10.1111/hae.13815.
 

The presence of hematuria on screening urinalysis was found to be highly prevalent in children with hemophilia, according to results from a retrospective chart review.

The findings emphasize the need to measure the population‐wide prevalence of hematuria in pediatric patients with hemophilia, in addition to better understanding its influence on renal function.

“Little is known about the prevalence of haematuria in [patients with hemophilia] or its long‐term impact on the renal system,” wrote Kyle A. Davis, MD, of the Nationwide Children’s Hospital in Columbus, and his coauthors. The results were published in Haemophilia.

The researchers retrospectively reviewed data from 93 patients with hemophilia A and B who were treated at a pediatric hemophilia treatment center from August 2011 to September 2015. The children in the study were all male and aged 2 years and older.

The team detected the frequency of hematuria, defined as greater than or equal to three red blood cells (RBCs) for each high power field, on screening urinalysis.

Other clinical data, including demographic, treatment, and laboratory information were also collected and analyzed.

After analysis, the researchers found that hematuria was detected in 45% of patients with hemophilia (mean RBCs, 332; median RBCs, 7), 76% of whom were identified using urinalysis, rather than clinical symptoms.

In total, recurrent hematuria was seen in 52% of patients. Hemophilia A and older age were associated with a higher likelihood of hematuria. However, there was no correlation between the severity of hemophilia or the treatment regimen and hematuria.

“We suspect patients with haemophilia may be having unrecognized, recurrent microscopic haematuria,” the researchers wrote.

The authors noted a key limitation of the study was the retrospective design.

“We suggest paediatric haematologists should consider routine evaluation for hypertension and renal disease in their patients,” the researchers wrote.

No funding sources were reported. The authors reported financial affiliations with Bioverativ, CSL Behring, Medscape, Shire, the American Society of Hematology, and others.

SOURCE: Davis KA et al. Haemophilia. 2019 Jul 10. doi: 10.1111/hae.13815.
 

Concomitant emicizumab prophylaxis and immune tolerance induction (ITI) may be suitable for bleeding prevention in pediatric patients with severe hemophilia A and inhibitors, according to a retrospective analysis.

“The primary objective of this study [was] to review a case series of pediatric patients with hemophilia A and inhibitors at our institution who have received emicizumab concurrently with ITI,” wrote Glaivy Batsuli, MD, of Emory University in Atlanta, and her colleagues. The results of the study were reported in Haemophilia.

The case series included seven pediatric patients with severe hemophilia A who received concurrent emicizumab for bleeding prevention and ITI for inhibitor eradication. Data were collected from electronic medical records at a single hemophilia treatment center from Aug. 1 to Dec. 1, 2018.

The researchers included male patients from 0 to 21 years old who had titres greater than 0.6 chromogenic Bethesda units (CBU) per mL on two instances more than 2 weeks apart.

The treatment protocol, termed the “Atlanta Protocol,” used a novel dosing regimen, established using provider consensus, for the concomitant use of ITI and emicizumab.

After analysis, the researchers found that three patients attained a negative inhibitor titer of less than 0.6 CBU/mL, and two patients had a normal factor VIII recovery of greater than or equal to 66%.

In total, nine bleeding events were observed in four patients; however, no thrombotic events were reported. All patients continued on concomitant therapy at the point of data analysis.

The researchers reported that six patients used three different recombinant factor VIII products at 100 IU/kg, three times each week. The remaining patient used a plasma‐derived factor VIII product at an initial dose of 50 IU/kg, three times each week.

The small sample size, retrospective design, and short follow‐up period were key limitations of the study.

“Prospective studies will be necessary to compare treatment outcomes of ITI and emicizumab to other ITI regimens and to investigate whether emicizumab modifies the immunologic response to FVIII,” the researchers wrote.

No funding sources were reported. The authors reported financial affiliations with Bayer, Bioverativ, CSL Behring, Catalyst Biosciences, Genentech, HEMA Biologics, Novo Nordisk, Octapharma, and several others.

SOURCE: Batsuli G et al. Haemophilia. 2019 Aug 2. doi: 10.1111/hae.13819.

Concomitant emicizumab prophylaxis and immune tolerance induction (ITI) may be suitable for bleeding prevention in pediatric patients with severe hemophilia A and inhibitors, according to a retrospective analysis.

“The primary objective of this study [was] to review a case series of pediatric patients with hemophilia A and inhibitors at our institution who have received emicizumab concurrently with ITI,” wrote Glaivy Batsuli, MD, of Emory University in Atlanta, and her colleagues. The results of the study were reported in Haemophilia.

The case series included seven pediatric patients with severe hemophilia A who received concurrent emicizumab for bleeding prevention and ITI for inhibitor eradication. Data were collected from electronic medical records at a single hemophilia treatment center from Aug. 1 to Dec. 1, 2018.

The researchers included male patients from 0 to 21 years old who had titres greater than 0.6 chromogenic Bethesda units (CBU) per mL on two instances more than 2 weeks apart.

The treatment protocol, termed the “Atlanta Protocol,” used a novel dosing regimen, established using provider consensus, for the concomitant use of ITI and emicizumab.

After analysis, the researchers found that three patients attained a negative inhibitor titer of less than 0.6 CBU/mL, and two patients had a normal factor VIII recovery of greater than or equal to 66%.

In total, nine bleeding events were observed in four patients; however, no thrombotic events were reported. All patients continued on concomitant therapy at the point of data analysis.

The researchers reported that six patients used three different recombinant factor VIII products at 100 IU/kg, three times each week. The remaining patient used a plasma‐derived factor VIII product at an initial dose of 50 IU/kg, three times each week.

The small sample size, retrospective design, and short follow‐up period were key limitations of the study.

“Prospective studies will be necessary to compare treatment outcomes of ITI and emicizumab to other ITI regimens and to investigate whether emicizumab modifies the immunologic response to FVIII,” the researchers wrote.

No funding sources were reported. The authors reported financial affiliations with Bayer, Bioverativ, CSL Behring, Catalyst Biosciences, Genentech, HEMA Biologics, Novo Nordisk, Octapharma, and several others.

SOURCE: Batsuli G et al. Haemophilia. 2019 Aug 2. doi: 10.1111/hae.13819.

Concomitant emicizumab prophylaxis and immune tolerance induction (ITI) may be suitable for bleeding prevention in pediatric patients with severe hemophilia A and inhibitors, according to a retrospective analysis.

“The primary objective of this study [was] to review a case series of pediatric patients with hemophilia A and inhibitors at our institution who have received emicizumab concurrently with ITI,” wrote Glaivy Batsuli, MD, of Emory University in Atlanta, and her colleagues. The results of the study were reported in Haemophilia.

The case series included seven pediatric patients with severe hemophilia A who received concurrent emicizumab for bleeding prevention and ITI for inhibitor eradication. Data were collected from electronic medical records at a single hemophilia treatment center from Aug. 1 to Dec. 1, 2018.

The researchers included male patients from 0 to 21 years old who had titres greater than 0.6 chromogenic Bethesda units (CBU) per mL on two instances more than 2 weeks apart.

The treatment protocol, termed the “Atlanta Protocol,” used a novel dosing regimen, established using provider consensus, for the concomitant use of ITI and emicizumab.

After analysis, the researchers found that three patients attained a negative inhibitor titer of less than 0.6 CBU/mL, and two patients had a normal factor VIII recovery of greater than or equal to 66%.

In total, nine bleeding events were observed in four patients; however, no thrombotic events were reported. All patients continued on concomitant therapy at the point of data analysis.

The researchers reported that six patients used three different recombinant factor VIII products at 100 IU/kg, three times each week. The remaining patient used a plasma‐derived factor VIII product at an initial dose of 50 IU/kg, three times each week.

The small sample size, retrospective design, and short follow‐up period were key limitations of the study.

“Prospective studies will be necessary to compare treatment outcomes of ITI and emicizumab to other ITI regimens and to investigate whether emicizumab modifies the immunologic response to FVIII,” the researchers wrote.

No funding sources were reported. The authors reported financial affiliations with Bayer, Bioverativ, CSL Behring, Catalyst Biosciences, Genentech, HEMA Biologics, Novo Nordisk, Octapharma, and several others.

SOURCE: Batsuli G et al. Haemophilia. 2019 Aug 2. doi: 10.1111/hae.13819.

Considerable differences may exist between objective and subjective measures of adherence to prophylaxis in patients with hemophilia, according to a cross-sectional study.

The results highlight the effect of social desirability bias in self-reported measures of adherence and differences in conceptual understanding of adherence between hemophilia experts and patients.

Vanessa Giroto Guedes, MPH, of the Federal University of Rio de Janeiro and colleagues studied 29 male patients with hemophilia who received prophylactic treatment between August 2015 and January 2016. The study was conducted at two hemophilia treatment centers in São Paulo.

Self-perceived adherence, measured using the estimated number of clotting factor concentrate doses missed over the previous dispensing interval, was compared with an objective estimate of adherence, measured using the number of vials returned by study participants. The findings were published in Haemophilia.

Patient interviews were conducted during regularly scheduled visits to the treatment facility. The team collected self-perceived adherence data using a 5-point Likert scale, scored from very poor to very good adherence.

After analysis, the researchers found no significant correlation between the objective categorization of adherence and self-perceived extent of adherence (correlation coefficient, 0.10; 95% confidence interval, –0.28 to 0.46; P = .61).

Additionally, there was no significant correlation between the categorization of adherence measured using the proportion of missed doses evaluated objectively and using participants’ self‐reports (correlation coefficient, 0.32; 95% CI, –0.01 to 0.59; P = .11).

“Participants’ self-reported perception of adherence was almost three times more likely to be rated as very good or good than it was for the objective assessment of adherence to be classified as adherent or suboptimally adherent,” the researchers wrote.

No funding sources were reported. One coauthor reported providing consultancy services for manufacturers of therapies for hemophilia. The others reported no conflicts of interest.

SOURCE: Guedes VG et al. Haemophilia. 2019 Jul 19. doi: 10.1111/hae.13811.

Considerable differences may exist between objective and subjective measures of adherence to prophylaxis in patients with hemophilia, according to a cross-sectional study.

The results highlight the effect of social desirability bias in self-reported measures of adherence and differences in conceptual understanding of adherence between hemophilia experts and patients.

Vanessa Giroto Guedes, MPH, of the Federal University of Rio de Janeiro and colleagues studied 29 male patients with hemophilia who received prophylactic treatment between August 2015 and January 2016. The study was conducted at two hemophilia treatment centers in São Paulo.

Self-perceived adherence, measured using the estimated number of clotting factor concentrate doses missed over the previous dispensing interval, was compared with an objective estimate of adherence, measured using the number of vials returned by study participants. The findings were published in Haemophilia.

Patient interviews were conducted during regularly scheduled visits to the treatment facility. The team collected self-perceived adherence data using a 5-point Likert scale, scored from very poor to very good adherence.

After analysis, the researchers found no significant correlation between the objective categorization of adherence and self-perceived extent of adherence (correlation coefficient, 0.10; 95% confidence interval, –0.28 to 0.46; P = .61).

Additionally, there was no significant correlation between the categorization of adherence measured using the proportion of missed doses evaluated objectively and using participants’ self‐reports (correlation coefficient, 0.32; 95% CI, –0.01 to 0.59; P = .11).

“Participants’ self-reported perception of adherence was almost three times more likely to be rated as very good or good than it was for the objective assessment of adherence to be classified as adherent or suboptimally adherent,” the researchers wrote.

No funding sources were reported. One coauthor reported providing consultancy services for manufacturers of therapies for hemophilia. The others reported no conflicts of interest.

SOURCE: Guedes VG et al. Haemophilia. 2019 Jul 19. doi: 10.1111/hae.13811.

Considerable differences may exist between objective and subjective measures of adherence to prophylaxis in patients with hemophilia, according to a cross-sectional study.

The results highlight the effect of social desirability bias in self-reported measures of adherence and differences in conceptual understanding of adherence between hemophilia experts and patients.

Vanessa Giroto Guedes, MPH, of the Federal University of Rio de Janeiro and colleagues studied 29 male patients with hemophilia who received prophylactic treatment between August 2015 and January 2016. The study was conducted at two hemophilia treatment centers in São Paulo.

Self-perceived adherence, measured using the estimated number of clotting factor concentrate doses missed over the previous dispensing interval, was compared with an objective estimate of adherence, measured using the number of vials returned by study participants. The findings were published in Haemophilia.

Patient interviews were conducted during regularly scheduled visits to the treatment facility. The team collected self-perceived adherence data using a 5-point Likert scale, scored from very poor to very good adherence.

After analysis, the researchers found no significant correlation between the objective categorization of adherence and self-perceived extent of adherence (correlation coefficient, 0.10; 95% confidence interval, –0.28 to 0.46; P = .61).

Additionally, there was no significant correlation between the categorization of adherence measured using the proportion of missed doses evaluated objectively and using participants’ self‐reports (correlation coefficient, 0.32; 95% CI, –0.01 to 0.59; P = .11).

“Participants’ self-reported perception of adherence was almost three times more likely to be rated as very good or good than it was for the objective assessment of adherence to be classified as adherent or suboptimally adherent,” the researchers wrote.

No funding sources were reported. One coauthor reported providing consultancy services for manufacturers of therapies for hemophilia. The others reported no conflicts of interest.

SOURCE: Guedes VG et al. Haemophilia. 2019 Jul 19. doi: 10.1111/hae.13811.

A nationwide survey of radiation oncologists showed a decline in the use of prophylactic cranial irradiation (PCI) for extensive-stage small cell lung cancer (ES-SCLC) after the release of phase 3 study results by Takahashi et al.

The recent study by Toshiaki Takahashi, MD, and colleagues (Lancet Oncol. 2017;18[5]:663-71) demonstrated no overall survival benefit when comparing active magnetic resonance imaging surveillance with PCI in patients with ES-SCLC. The results challenged the formerly accepted belief of the benefit of PCI for patients with ES-SCLC.

“We conducted a nationwide survey study of radiation oncologists to assess changes in the use of PCI for patients with ES-SCLC following publication of the trial by Takahashi et al.,” wrote Olsi Gjyshi, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings were reported in a research letter published in JAMA Network Open.

Dr. Gjyshi and colleagues distributed the anonymous survey to 3,851 United States–based radiation oncologists registered with the American Society for Radiation Oncology (ASTRO). In total, 487 members (12.6%) completed the survey.

After analysis, the researchers found that 72% of respondents regularly offered PCI to patients before the publication of the study by Takahashi et al., while only 44% do so currently (difference, 28%; 95% confidence interval, 25%-31%; P less than .001).

With respect to radiation oncologists in private versus academic settings, no significant difference in practice patterns was observed (P = .71).

“Regression analysis showed no difference in likelihood of offering PCI based on practice setting, location, or size; volume of patients treated for lung cancer; or years in practice,” the researchers wrote.

In respondents unaware of the Takahashi et al. study, 85% continued to propose PCI, which was greater than those aware of the trial (odds ratio, 0.11; 95% CI, 0.04-0.32; P less than .001).

The researchers acknowledged a key limitation of the study was that radiation oncologists familiar with the study by Dr. Takahashi and colleagues may have been more apt to respond to the survey. As a result, participation bias could have influenced the results.

“These results highlight the continued lack of consensus for PCI in SCLC and support ongoing investigations,” they concluded.

No funding sources were reported. One co-author reported financial affiliations with Novocure, Inc. The other authors reported no conflicts of interest.

SOURCE: Gjyshi O et al. JAMA Netw Open. 2019 Aug 14. doi: 10.1001/jamanetworkopen.2019.9135.

A nationwide survey of radiation oncologists showed a decline in the use of prophylactic cranial irradiation (PCI) for extensive-stage small cell lung cancer (ES-SCLC) after the release of phase 3 study results by Takahashi et al.

The recent study by Toshiaki Takahashi, MD, and colleagues (Lancet Oncol. 2017;18[5]:663-71) demonstrated no overall survival benefit when comparing active magnetic resonance imaging surveillance with PCI in patients with ES-SCLC. The results challenged the formerly accepted belief of the benefit of PCI for patients with ES-SCLC.

“We conducted a nationwide survey study of radiation oncologists to assess changes in the use of PCI for patients with ES-SCLC following publication of the trial by Takahashi et al.,” wrote Olsi Gjyshi, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings were reported in a research letter published in JAMA Network Open.

Dr. Gjyshi and colleagues distributed the anonymous survey to 3,851 United States–based radiation oncologists registered with the American Society for Radiation Oncology (ASTRO). In total, 487 members (12.6%) completed the survey.

After analysis, the researchers found that 72% of respondents regularly offered PCI to patients before the publication of the study by Takahashi et al., while only 44% do so currently (difference, 28%; 95% confidence interval, 25%-31%; P less than .001).

With respect to radiation oncologists in private versus academic settings, no significant difference in practice patterns was observed (P = .71).

“Regression analysis showed no difference in likelihood of offering PCI based on practice setting, location, or size; volume of patients treated for lung cancer; or years in practice,” the researchers wrote.

In respondents unaware of the Takahashi et al. study, 85% continued to propose PCI, which was greater than those aware of the trial (odds ratio, 0.11; 95% CI, 0.04-0.32; P less than .001).

The researchers acknowledged a key limitation of the study was that radiation oncologists familiar with the study by Dr. Takahashi and colleagues may have been more apt to respond to the survey. As a result, participation bias could have influenced the results.

“These results highlight the continued lack of consensus for PCI in SCLC and support ongoing investigations,” they concluded.

No funding sources were reported. One co-author reported financial affiliations with Novocure, Inc. The other authors reported no conflicts of interest.

SOURCE: Gjyshi O et al. JAMA Netw Open. 2019 Aug 14. doi: 10.1001/jamanetworkopen.2019.9135.

A nationwide survey of radiation oncologists showed a decline in the use of prophylactic cranial irradiation (PCI) for extensive-stage small cell lung cancer (ES-SCLC) after the release of phase 3 study results by Takahashi et al.

The recent study by Toshiaki Takahashi, MD, and colleagues (Lancet Oncol. 2017;18[5]:663-71) demonstrated no overall survival benefit when comparing active magnetic resonance imaging surveillance with PCI in patients with ES-SCLC. The results challenged the formerly accepted belief of the benefit of PCI for patients with ES-SCLC.

“We conducted a nationwide survey study of radiation oncologists to assess changes in the use of PCI for patients with ES-SCLC following publication of the trial by Takahashi et al.,” wrote Olsi Gjyshi, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues. The findings were reported in a research letter published in JAMA Network Open.

Dr. Gjyshi and colleagues distributed the anonymous survey to 3,851 United States–based radiation oncologists registered with the American Society for Radiation Oncology (ASTRO). In total, 487 members (12.6%) completed the survey.

After analysis, the researchers found that 72% of respondents regularly offered PCI to patients before the publication of the study by Takahashi et al., while only 44% do so currently (difference, 28%; 95% confidence interval, 25%-31%; P less than .001).

With respect to radiation oncologists in private versus academic settings, no significant difference in practice patterns was observed (P = .71).

“Regression analysis showed no difference in likelihood of offering PCI based on practice setting, location, or size; volume of patients treated for lung cancer; or years in practice,” the researchers wrote.

In respondents unaware of the Takahashi et al. study, 85% continued to propose PCI, which was greater than those aware of the trial (odds ratio, 0.11; 95% CI, 0.04-0.32; P less than .001).

The researchers acknowledged a key limitation of the study was that radiation oncologists familiar with the study by Dr. Takahashi and colleagues may have been more apt to respond to the survey. As a result, participation bias could have influenced the results.

“These results highlight the continued lack of consensus for PCI in SCLC and support ongoing investigations,” they concluded.

No funding sources were reported. One co-author reported financial affiliations with Novocure, Inc. The other authors reported no conflicts of interest.

SOURCE: Gjyshi O et al. JAMA Netw Open. 2019 Aug 14. doi: 10.1001/jamanetworkopen.2019.9135.

A considerable proportion of patients treated with immune checkpoint inhibitors were hospitalized for immune-related toxicities, according to a retrospective cohort study.

In addition, the majority of the immune-related toxicities were high-grade events of grade 3 or higher (65%), necessitated multidisciplinary care (91%), and eventually improved or resolved (65%). The results highlight potential risk factors for hospitalizations due to immune-related toxicities in oncology patients.

“[We aimed to] characterize the spectrum of toxicities, management, and outcomes of hospitalizations for immune-related adverse events,” wrote Aanika Balaji, BS, of Johns Hopkins University, Baltimore, and colleagues. The findings were reported in the Journal of Oncology Practice.

The researchers studied 443 patients admitted to solid tumor oncology service at an oncology center over a period of 6-months. Of these, 100 patients had at any point received checkpoint inhibitor therapy.

The proportion of hospital admissions for patients with confirmed immune-related toxicities and associations between hospitalizations due to immune-related toxicity and patient characteristics were assessed by the team. Nearly half of the patients admitted with immune-related toxicities had thoracic or head and neck cancers.

In the analysis, patients treated with combination checkpoint inhibitor therapy (odds ratio, 6.8; 95% confidence interval, 2.0-23.2), in addition to those aged 65 years and over (OR, 5.4; 95% CI, 1.6-17.8), were more likely to be hospitalized for immune-related toxicities.

Overall, 5% of all hospitalizations were the result of immune-related toxicities. Furthermore, 87% of patients discontinued checkpoint inhibitor therapy post discharge.

“We found that the most common immune-related adverse events warranting hospital admission were pneumonitis (26%) and colitis (17%),” they wrote.

The researchers acknowledged two key limitations of the study were the small sample size and lack of generalizability in community settings. Future studies that include patients from community oncology settings could improve the generalizability of the results.

“These data indicate potential risk factors for immune-related adverse event hospitalization and are likely to indicate future service needs” they concluded.

Financial support was provided by Jarushka Naidoo. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Compugen, Genentech, GlaxoSmithKline, Exelixis, MedImmune, and several others.

SOURCE: Balaji A et al. J Oncol Pract. 2019 Aug 6. doi: 10.1200/JOP.18.00703.

A considerable proportion of patients treated with immune checkpoint inhibitors were hospitalized for immune-related toxicities, according to a retrospective cohort study.

In addition, the majority of the immune-related toxicities were high-grade events of grade 3 or higher (65%), necessitated multidisciplinary care (91%), and eventually improved or resolved (65%). The results highlight potential risk factors for hospitalizations due to immune-related toxicities in oncology patients.

“[We aimed to] characterize the spectrum of toxicities, management, and outcomes of hospitalizations for immune-related adverse events,” wrote Aanika Balaji, BS, of Johns Hopkins University, Baltimore, and colleagues. The findings were reported in the Journal of Oncology Practice.

The researchers studied 443 patients admitted to solid tumor oncology service at an oncology center over a period of 6-months. Of these, 100 patients had at any point received checkpoint inhibitor therapy.

The proportion of hospital admissions for patients with confirmed immune-related toxicities and associations between hospitalizations due to immune-related toxicity and patient characteristics were assessed by the team. Nearly half of the patients admitted with immune-related toxicities had thoracic or head and neck cancers.

In the analysis, patients treated with combination checkpoint inhibitor therapy (odds ratio, 6.8; 95% confidence interval, 2.0-23.2), in addition to those aged 65 years and over (OR, 5.4; 95% CI, 1.6-17.8), were more likely to be hospitalized for immune-related toxicities.

Overall, 5% of all hospitalizations were the result of immune-related toxicities. Furthermore, 87% of patients discontinued checkpoint inhibitor therapy post discharge.

“We found that the most common immune-related adverse events warranting hospital admission were pneumonitis (26%) and colitis (17%),” they wrote.

The researchers acknowledged two key limitations of the study were the small sample size and lack of generalizability in community settings. Future studies that include patients from community oncology settings could improve the generalizability of the results.

“These data indicate potential risk factors for immune-related adverse event hospitalization and are likely to indicate future service needs” they concluded.

Financial support was provided by Jarushka Naidoo. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Compugen, Genentech, GlaxoSmithKline, Exelixis, MedImmune, and several others.

SOURCE: Balaji A et al. J Oncol Pract. 2019 Aug 6. doi: 10.1200/JOP.18.00703.

A considerable proportion of patients treated with immune checkpoint inhibitors were hospitalized for immune-related toxicities, according to a retrospective cohort study.

In addition, the majority of the immune-related toxicities were high-grade events of grade 3 or higher (65%), necessitated multidisciplinary care (91%), and eventually improved or resolved (65%). The results highlight potential risk factors for hospitalizations due to immune-related toxicities in oncology patients.

“[We aimed to] characterize the spectrum of toxicities, management, and outcomes of hospitalizations for immune-related adverse events,” wrote Aanika Balaji, BS, of Johns Hopkins University, Baltimore, and colleagues. The findings were reported in the Journal of Oncology Practice.

The researchers studied 443 patients admitted to solid tumor oncology service at an oncology center over a period of 6-months. Of these, 100 patients had at any point received checkpoint inhibitor therapy.

The proportion of hospital admissions for patients with confirmed immune-related toxicities and associations between hospitalizations due to immune-related toxicity and patient characteristics were assessed by the team. Nearly half of the patients admitted with immune-related toxicities had thoracic or head and neck cancers.

In the analysis, patients treated with combination checkpoint inhibitor therapy (odds ratio, 6.8; 95% confidence interval, 2.0-23.2), in addition to those aged 65 years and over (OR, 5.4; 95% CI, 1.6-17.8), were more likely to be hospitalized for immune-related toxicities.

Overall, 5% of all hospitalizations were the result of immune-related toxicities. Furthermore, 87% of patients discontinued checkpoint inhibitor therapy post discharge.

“We found that the most common immune-related adverse events warranting hospital admission were pneumonitis (26%) and colitis (17%),” they wrote.

The researchers acknowledged two key limitations of the study were the small sample size and lack of generalizability in community settings. Future studies that include patients from community oncology settings could improve the generalizability of the results.

“These data indicate potential risk factors for immune-related adverse event hospitalization and are likely to indicate future service needs” they concluded.

Financial support was provided by Jarushka Naidoo. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Compugen, Genentech, GlaxoSmithKline, Exelixis, MedImmune, and several others.

SOURCE: Balaji A et al. J Oncol Pract. 2019 Aug 6. doi: 10.1200/JOP.18.00703.

Cardiovascular (CV) adverse events were common in patients receiving proteasome inhibitor therapy for relapsed multiple myeloma, especially with carfilzomib-based therapy, according to results from the PROTECT study.

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While prior studies have shown an increased risk for CV toxicities with proteasome inhibitor therapy, detailed descriptions of the events and risk factors have been lacking. “Furthermore, there is no validated protocol to help determine which patients are at highest risk of CV toxicity during therapy, nor is there management guidance for patients who experience a [CV adverse event],” wrote Robert F. Cornell, MD, of Vanderbilt University, Nashville, Tenn., and colleagues in the Journal of Clinical Oncology.

The PROTECT (Prospective Observation of Cardiac Safety with Proteasome Inhibitor) study was conducted at Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center, Philadelphia, between September 2015 and March 2018.

Researchers followed 95 patients with relapsed multiple myeloma who were treated with either bortezomib or carfilzomib for a total duration of 18 months. A total of 65 patients received a carfilzomib-based therapy and 30 patients received a bortezomib-based therapy.

Study patients received a CV assessment at baseline and at the beginning of each treatment cycle for the initial six cycles of proteasome inhibitor therapy. Subsequently, patients were monitored for the development of CV adverse events. CV assessments included ECG, echocardiography, and measurement of other cardiac biomarkers, such as NTproBNP and troponin I or T.

CV toxicities were reported among 5 patients (16.7%) of patients treated with bortezomib and 33 patients (50.7%) treated with carfilzomib (P = .005).

In total, there were 64 CV adverse events reported, most of which were grade 2 or 3, and 56 of which occurred while on carfilzomib-based therapy. For carfilzomib, the most common complications were heart failure (23 cases), followed by grade 3 or 4 hypertension (13 cases). Cardiac chest pain, atrial fibrillation, and acute coronary syndrome were reported in fewer cases.

The researchers also found that elevated natriuretic peptides that occurred before starting carfilzomib therapy or within the first 3 weeks of carfilzomib therapy were associated with a substantially higher risk of CV adverse events.

Patients who have multiple CV risk factors, and especially patients with a history of CV complications and elevated baseline natriuretic peptides, should be referred for a comprehensive cardiac evaluation, the researchers advised. “Such patients are at highest risk of CV [adverse events] with carfilzomib-based therapy, and optimization of CV therapy seems to improve overall care, allow continuation of potentially lifesaving cancer treatment, and affect severity or development of CV [adverse events],” they wrote.

A key limitation of the study was the lack of standardized treatment regimens. As a result, there was a broad dosing range for carfilzomib, in comparison to bortezomib.

Some authors reported financial relationships with carfilzomib maker Amgen and bortezomib maker Takeda, as well as with other companies.

SOURCE: Cornell RF et al. J Clin Oncol. 2019 Jun 12. doi: 10.1200/JCO.19.00231.

Cardiovascular (CV) adverse events were common in patients receiving proteasome inhibitor therapy for relapsed multiple myeloma, especially with carfilzomib-based therapy, according to results from the PROTECT study.

sudok1/Getty Images

While prior studies have shown an increased risk for CV toxicities with proteasome inhibitor therapy, detailed descriptions of the events and risk factors have been lacking. “Furthermore, there is no validated protocol to help determine which patients are at highest risk of CV toxicity during therapy, nor is there management guidance for patients who experience a [CV adverse event],” wrote Robert F. Cornell, MD, of Vanderbilt University, Nashville, Tenn., and colleagues in the Journal of Clinical Oncology.

The PROTECT (Prospective Observation of Cardiac Safety with Proteasome Inhibitor) study was conducted at Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center, Philadelphia, between September 2015 and March 2018.

Researchers followed 95 patients with relapsed multiple myeloma who were treated with either bortezomib or carfilzomib for a total duration of 18 months. A total of 65 patients received a carfilzomib-based therapy and 30 patients received a bortezomib-based therapy.

Study patients received a CV assessment at baseline and at the beginning of each treatment cycle for the initial six cycles of proteasome inhibitor therapy. Subsequently, patients were monitored for the development of CV adverse events. CV assessments included ECG, echocardiography, and measurement of other cardiac biomarkers, such as NTproBNP and troponin I or T.

CV toxicities were reported among 5 patients (16.7%) of patients treated with bortezomib and 33 patients (50.7%) treated with carfilzomib (P = .005).

In total, there were 64 CV adverse events reported, most of which were grade 2 or 3, and 56 of which occurred while on carfilzomib-based therapy. For carfilzomib, the most common complications were heart failure (23 cases), followed by grade 3 or 4 hypertension (13 cases). Cardiac chest pain, atrial fibrillation, and acute coronary syndrome were reported in fewer cases.

The researchers also found that elevated natriuretic peptides that occurred before starting carfilzomib therapy or within the first 3 weeks of carfilzomib therapy were associated with a substantially higher risk of CV adverse events.

Patients who have multiple CV risk factors, and especially patients with a history of CV complications and elevated baseline natriuretic peptides, should be referred for a comprehensive cardiac evaluation, the researchers advised. “Such patients are at highest risk of CV [adverse events] with carfilzomib-based therapy, and optimization of CV therapy seems to improve overall care, allow continuation of potentially lifesaving cancer treatment, and affect severity or development of CV [adverse events],” they wrote.

A key limitation of the study was the lack of standardized treatment regimens. As a result, there was a broad dosing range for carfilzomib, in comparison to bortezomib.

Some authors reported financial relationships with carfilzomib maker Amgen and bortezomib maker Takeda, as well as with other companies.

SOURCE: Cornell RF et al. J Clin Oncol. 2019 Jun 12. doi: 10.1200/JCO.19.00231.

Cardiovascular (CV) adverse events were common in patients receiving proteasome inhibitor therapy for relapsed multiple myeloma, especially with carfilzomib-based therapy, according to results from the PROTECT study.

sudok1/Getty Images

While prior studies have shown an increased risk for CV toxicities with proteasome inhibitor therapy, detailed descriptions of the events and risk factors have been lacking. “Furthermore, there is no validated protocol to help determine which patients are at highest risk of CV toxicity during therapy, nor is there management guidance for patients who experience a [CV adverse event],” wrote Robert F. Cornell, MD, of Vanderbilt University, Nashville, Tenn., and colleagues in the Journal of Clinical Oncology.

The PROTECT (Prospective Observation of Cardiac Safety with Proteasome Inhibitor) study was conducted at Vanderbilt University Medical Center and the University of Pennsylvania Abramson Cancer Center, Philadelphia, between September 2015 and March 2018.

Researchers followed 95 patients with relapsed multiple myeloma who were treated with either bortezomib or carfilzomib for a total duration of 18 months. A total of 65 patients received a carfilzomib-based therapy and 30 patients received a bortezomib-based therapy.

Study patients received a CV assessment at baseline and at the beginning of each treatment cycle for the initial six cycles of proteasome inhibitor therapy. Subsequently, patients were monitored for the development of CV adverse events. CV assessments included ECG, echocardiography, and measurement of other cardiac biomarkers, such as NTproBNP and troponin I or T.

CV toxicities were reported among 5 patients (16.7%) of patients treated with bortezomib and 33 patients (50.7%) treated with carfilzomib (P = .005).

In total, there were 64 CV adverse events reported, most of which were grade 2 or 3, and 56 of which occurred while on carfilzomib-based therapy. For carfilzomib, the most common complications were heart failure (23 cases), followed by grade 3 or 4 hypertension (13 cases). Cardiac chest pain, atrial fibrillation, and acute coronary syndrome were reported in fewer cases.

The researchers also found that elevated natriuretic peptides that occurred before starting carfilzomib therapy or within the first 3 weeks of carfilzomib therapy were associated with a substantially higher risk of CV adverse events.

Patients who have multiple CV risk factors, and especially patients with a history of CV complications and elevated baseline natriuretic peptides, should be referred for a comprehensive cardiac evaluation, the researchers advised. “Such patients are at highest risk of CV [adverse events] with carfilzomib-based therapy, and optimization of CV therapy seems to improve overall care, allow continuation of potentially lifesaving cancer treatment, and affect severity or development of CV [adverse events],” they wrote.

A key limitation of the study was the lack of standardized treatment regimens. As a result, there was a broad dosing range for carfilzomib, in comparison to bortezomib.

Some authors reported financial relationships with carfilzomib maker Amgen and bortezomib maker Takeda, as well as with other companies.

SOURCE: Cornell RF et al. J Clin Oncol. 2019 Jun 12. doi: 10.1200/JCO.19.00231.

The need for universal screening for Lynch syndrome in elderly patients with newly diagnosed colorectal cancer (CRC) has been questioned, according to results from a retrospective cohort study.

In addition, discontinuing reflex CRC screening for Lynch syndrome in patients over age 80 years could be feasible because of very low efficiency.

“The universal strategy advocates screening all patients with newly diagnosed CRC for Lynch syndrome and has been shown to be the most sensitive method,” wrote Dan Li, MD, of Kaiser Permanente Northern California, Santa Clara, and colleagues. The findings were published in Annals of Internal Medicine.

The researchers studied 3,891 patients with newly diagnosed CRC who were screened for Lynch syndrome from 2011 to 2016. Data were collected from a population-based screening program at Kaiser Permanente Northern California.

“The system provides comprehensive medical care for more than 4 million members across 21 medical centers covering urban, suburban, and semirural areas,” Dr. Li and his colleagues wrote.

To compare universal and age-restricted screening, the team obtained surgical samples of all newly diagnosed CRC tumors and tested them for reflex mismatch repair protein expression using immunohistochemistry.

Subsequently, the age-restricted screening groups were divided into several age categories, ranging from age 50 to 85 years.

The diagnostic yield, defined as the “percentage of patients with pathogenic reflex mismatch repair gene variants among all patients with CRC screened with immunohistochemistry,” was measured and compared with the universal screening technique.

“We calculated the number of patients with CRC who needed to be screened in each age group to identify one case of Lynch syndrome by dividing the number of patients screened in each age group by the number of Lynch syndrome cases diagnosed in that group,” they explained.

After analysis, the researchers detected a total of 63 cases of Lynch syndrome (diagnostic yield, 1.62%) with universal screening, among which 5 (7.9%) were over age 70 years and 1 (1.6%) was over age 80 years.

When patients with CRC who were universally screened were used as the denominator, 58 cases (diagnostic yield, 1.49%) were detected in those with CRC diagnosed at or prior to age 70 years.

In addition, in patients diagnosed at or before age 75 and 80 years, 60 and 62 cases of Lynch syndrome (diagnostic yield, 1.54% and 1.59%) were detected, respectively.

“The incremental diagnostic yield decreased substantially after age 70 to 75 years,” they wrote.

With these findings, Dr. Li and his colleagues suggested that cessation of screening for Lynch syndrome post age 80 years may be acceptable, especially in resource-limited environments.

“Using age as the primary criterion is a simple method of selecting patients for Lynch syndrome screening in clinical practice,” they added.

In accordance with previous studies, a major reduction in Lynch syndrome incidence has been noted among elderly populations.

There remains a need for additional studies exploring the effects of diagnosing Lynch syndrome in elderly patients on family members.

The researchers acknowledged a key limitation of the study was that patients who did not finish germline analysis but were eligible for it were excluded from certain measurements. To reduce potential bias, the team conducted a sensitivity analysis, and the findings were negligible with respect to main results.

“Given the geographic variation in the reported prevalence of Lynch syndrome, the diagnostic efficiency of Lynch syndrome screening among elderly populations should be further investigated in other populations,” they concluded.

The study was funded by Kaiser Permanente Northern California. The authors reported financial affiliations with Bayer, Clinical Genomics, Covidien, Exact Sciences, Motus GI, Quorum, Universal DX, and the National Cancer Institute.

SOURCE: Li D et al. Ann Intern Med. 2019 Jun 11. doi: 10.7326/M18-3316.

The need for universal screening for Lynch syndrome in elderly patients with newly diagnosed colorectal cancer (CRC) has been questioned, according to results from a retrospective cohort study.

In addition, discontinuing reflex CRC screening for Lynch syndrome in patients over age 80 years could be feasible because of very low efficiency.

“The universal strategy advocates screening all patients with newly diagnosed CRC for Lynch syndrome and has been shown to be the most sensitive method,” wrote Dan Li, MD, of Kaiser Permanente Northern California, Santa Clara, and colleagues. The findings were published in Annals of Internal Medicine.

The researchers studied 3,891 patients with newly diagnosed CRC who were screened for Lynch syndrome from 2011 to 2016. Data were collected from a population-based screening program at Kaiser Permanente Northern California.

“The system provides comprehensive medical care for more than 4 million members across 21 medical centers covering urban, suburban, and semirural areas,” Dr. Li and his colleagues wrote.

To compare universal and age-restricted screening, the team obtained surgical samples of all newly diagnosed CRC tumors and tested them for reflex mismatch repair protein expression using immunohistochemistry.

Subsequently, the age-restricted screening groups were divided into several age categories, ranging from age 50 to 85 years.

The diagnostic yield, defined as the “percentage of patients with pathogenic reflex mismatch repair gene variants among all patients with CRC screened with immunohistochemistry,” was measured and compared with the universal screening technique.

“We calculated the number of patients with CRC who needed to be screened in each age group to identify one case of Lynch syndrome by dividing the number of patients screened in each age group by the number of Lynch syndrome cases diagnosed in that group,” they explained.

After analysis, the researchers detected a total of 63 cases of Lynch syndrome (diagnostic yield, 1.62%) with universal screening, among which 5 (7.9%) were over age 70 years and 1 (1.6%) was over age 80 years.

When patients with CRC who were universally screened were used as the denominator, 58 cases (diagnostic yield, 1.49%) were detected in those with CRC diagnosed at or prior to age 70 years.

In addition, in patients diagnosed at or before age 75 and 80 years, 60 and 62 cases of Lynch syndrome (diagnostic yield, 1.54% and 1.59%) were detected, respectively.

“The incremental diagnostic yield decreased substantially after age 70 to 75 years,” they wrote.

With these findings, Dr. Li and his colleagues suggested that cessation of screening for Lynch syndrome post age 80 years may be acceptable, especially in resource-limited environments.

“Using age as the primary criterion is a simple method of selecting patients for Lynch syndrome screening in clinical practice,” they added.

In accordance with previous studies, a major reduction in Lynch syndrome incidence has been noted among elderly populations.

There remains a need for additional studies exploring the effects of diagnosing Lynch syndrome in elderly patients on family members.

The researchers acknowledged a key limitation of the study was that patients who did not finish germline analysis but were eligible for it were excluded from certain measurements. To reduce potential bias, the team conducted a sensitivity analysis, and the findings were negligible with respect to main results.

“Given the geographic variation in the reported prevalence of Lynch syndrome, the diagnostic efficiency of Lynch syndrome screening among elderly populations should be further investigated in other populations,” they concluded.

The study was funded by Kaiser Permanente Northern California. The authors reported financial affiliations with Bayer, Clinical Genomics, Covidien, Exact Sciences, Motus GI, Quorum, Universal DX, and the National Cancer Institute.

SOURCE: Li D et al. Ann Intern Med. 2019 Jun 11. doi: 10.7326/M18-3316.

The need for universal screening for Lynch syndrome in elderly patients with newly diagnosed colorectal cancer (CRC) has been questioned, according to results from a retrospective cohort study.

In addition, discontinuing reflex CRC screening for Lynch syndrome in patients over age 80 years could be feasible because of very low efficiency.

“The universal strategy advocates screening all patients with newly diagnosed CRC for Lynch syndrome and has been shown to be the most sensitive method,” wrote Dan Li, MD, of Kaiser Permanente Northern California, Santa Clara, and colleagues. The findings were published in Annals of Internal Medicine.

The researchers studied 3,891 patients with newly diagnosed CRC who were screened for Lynch syndrome from 2011 to 2016. Data were collected from a population-based screening program at Kaiser Permanente Northern California.

“The system provides comprehensive medical care for more than 4 million members across 21 medical centers covering urban, suburban, and semirural areas,” Dr. Li and his colleagues wrote.

To compare universal and age-restricted screening, the team obtained surgical samples of all newly diagnosed CRC tumors and tested them for reflex mismatch repair protein expression using immunohistochemistry.

Subsequently, the age-restricted screening groups were divided into several age categories, ranging from age 50 to 85 years.

The diagnostic yield, defined as the “percentage of patients with pathogenic reflex mismatch repair gene variants among all patients with CRC screened with immunohistochemistry,” was measured and compared with the universal screening technique.

“We calculated the number of patients with CRC who needed to be screened in each age group to identify one case of Lynch syndrome by dividing the number of patients screened in each age group by the number of Lynch syndrome cases diagnosed in that group,” they explained.

After analysis, the researchers detected a total of 63 cases of Lynch syndrome (diagnostic yield, 1.62%) with universal screening, among which 5 (7.9%) were over age 70 years and 1 (1.6%) was over age 80 years.

When patients with CRC who were universally screened were used as the denominator, 58 cases (diagnostic yield, 1.49%) were detected in those with CRC diagnosed at or prior to age 70 years.

In addition, in patients diagnosed at or before age 75 and 80 years, 60 and 62 cases of Lynch syndrome (diagnostic yield, 1.54% and 1.59%) were detected, respectively.

“The incremental diagnostic yield decreased substantially after age 70 to 75 years,” they wrote.

With these findings, Dr. Li and his colleagues suggested that cessation of screening for Lynch syndrome post age 80 years may be acceptable, especially in resource-limited environments.

“Using age as the primary criterion is a simple method of selecting patients for Lynch syndrome screening in clinical practice,” they added.

In accordance with previous studies, a major reduction in Lynch syndrome incidence has been noted among elderly populations.

There remains a need for additional studies exploring the effects of diagnosing Lynch syndrome in elderly patients on family members.

The researchers acknowledged a key limitation of the study was that patients who did not finish germline analysis but were eligible for it were excluded from certain measurements. To reduce potential bias, the team conducted a sensitivity analysis, and the findings were negligible with respect to main results.

“Given the geographic variation in the reported prevalence of Lynch syndrome, the diagnostic efficiency of Lynch syndrome screening among elderly populations should be further investigated in other populations,” they concluded.

The study was funded by Kaiser Permanente Northern California. The authors reported financial affiliations with Bayer, Clinical Genomics, Covidien, Exact Sciences, Motus GI, Quorum, Universal DX, and the National Cancer Institute.

SOURCE: Li D et al. Ann Intern Med. 2019 Jun 11. doi: 10.7326/M18-3316.

Women with preeclampsia were found to be at the highest risk for transfusion reactions when receiving a blood transfusion post partum, according to results from a retrospective study.

SOURCE: Thurn L et al. Blood Adv. 2019 Jul 31. doi: 10.1182/bloodadvances.2019000074.

Women with preeclampsia were found to be at the highest risk for transfusion reactions when receiving a blood transfusion post partum, according to results from a retrospective study.

SOURCE: Thurn L et al. Blood Adv. 2019 Jul 31. doi: 10.1182/bloodadvances.2019000074.

Women with preeclampsia were found to be at the highest risk for transfusion reactions when receiving a blood transfusion post partum, according to results from a retrospective study.

SOURCE: Thurn L et al. Blood Adv. 2019 Jul 31. doi: 10.1182/bloodadvances.2019000074.

A new clinical practice guideline for the treatment of luminal Crohn’s disease (CD) in children has been released by the Canadian Association of Gastroenterology (CAG).

The new guideline provides evidence-based recommendations regarding optimal medical treatment strategies for achieving clinical remission based on a multi-item assessment of disease activity in pediatric patients with luminal CD. The guideline does not address surgical management, diagnosis, psychosocial therapies, preventative health considerations, or growth monitoring.

“The implications of inadequately treated CD are of particular importance in children because of the potentially serious and irreversible consequences,” wrote David R. Mack, MD, of the University of Ottawa and associates. Dr. Mack is the lead author of the pediatric practice guideline copublished in Gastroenterology and the Journal of the Canadian Association of Gastroenterology.

The consensus group reached its recommendations based on a systematic review of the literature for studies related to the medical treatment of pediatric CD. The majority of studies were randomized trials conducted in adults with CD.

“Evidence of efficacy of specific treatments in achieving mucosal healing is limited; therefore, “complete” or “deep” remission (clinical remission plus mucosal healing) was not the chosen primary outcome,” the guideline authors wrote.

The panel recommended that corticosteroids can be used as induction therapy in children with moderate to severe disease. Moreover, budesonide may be an appropriate alternative for induction therapy in patients with mild to moderate CD.

In contrast, the group recommended against the use of corticosteroids as maintenance therapy, largely because of adverse events reported with long-term use.

At diagnosis or initial stages of severe disease, as well as in patients who have failed with immunosuppressant and corticosteroid induction strategies, enteral nutrition should be used exclusively for induction therapy. In addition, anti–tumor necrosis factor biologics are an appropriate option for induction and maintenance therapy in these patients, according to the guideline.

“The group recommended against the use of oral 5-aminosalicylate for induction or maintenance therapy in patients with moderate disease, and recommended against thiopurines for induction therapy,” they wrote.

With respect to cannabis-based products, the panel made a strong recommendation against the use of these agents in all pediatric patients.

In terms of assessment, the team recommended that patients in clinical remission receiving methotrexate or a thiopurine agent as maintenance therapy should be evaluated for mucosal healing within 1 year of therapy initiation.

No consensus was reached on the adjuvant use of immunosuppressants during initiation therapy with a biologic drug, but the consensus panel recommended against the use of thiopurine combinations in male patients. Furthermore, no consensus was reached on the role of vedolizumab or antibiotics for induction or maintenance therapy, methotrexate for induction therapy, and the function of aminosalicylates in patients with mild CD.

The panel highlighted the importance of incorporating patient perspectives into treatment decision making.

“It is hoped that the available information will enhance the discussion between the clinician and the patient and enable the patient to make an evidence-based informed decision.”

The expert consensus was made up of 15 voting members that consisted of pediatric gastroenterologists throughout the United States and Canada, with expertise in several domains, including clinical epidemiology, nutrition, health services research, and patient engagement.

Quality of evidence and risk of bias was assessed using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) criteria. The quality of evidence for each consensus statement was denoted as either high, moderate, low, or very low, based on the criteria.

The consensus statements were finalized at an in-person meeting conducted in Toronto in October 2017.

The guideline was supported through grant funding provided by AbbVie and Takeda. The authors reported financial affiliations with AbbVie and Takeda, as well as Janssen, Nestle Health Sciences, Shire, and several others.

SOURCE: Mack DR et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.022.

A new clinical practice guideline for the treatment of luminal Crohn’s disease (CD) in children has been released by the Canadian Association of Gastroenterology (CAG).

The new guideline provides evidence-based recommendations regarding optimal medical treatment strategies for achieving clinical remission based on a multi-item assessment of disease activity in pediatric patients with luminal CD. The guideline does not address surgical management, diagnosis, psychosocial therapies, preventative health considerations, or growth monitoring.

“The implications of inadequately treated CD are of particular importance in children because of the potentially serious and irreversible consequences,” wrote David R. Mack, MD, of the University of Ottawa and associates. Dr. Mack is the lead author of the pediatric practice guideline copublished in Gastroenterology and the Journal of the Canadian Association of Gastroenterology.

The consensus group reached its recommendations based on a systematic review of the literature for studies related to the medical treatment of pediatric CD. The majority of studies were randomized trials conducted in adults with CD.

“Evidence of efficacy of specific treatments in achieving mucosal healing is limited; therefore, “complete” or “deep” remission (clinical remission plus mucosal healing) was not the chosen primary outcome,” the guideline authors wrote.

The panel recommended that corticosteroids can be used as induction therapy in children with moderate to severe disease. Moreover, budesonide may be an appropriate alternative for induction therapy in patients with mild to moderate CD.

In contrast, the group recommended against the use of corticosteroids as maintenance therapy, largely because of adverse events reported with long-term use.

At diagnosis or initial stages of severe disease, as well as in patients who have failed with immunosuppressant and corticosteroid induction strategies, enteral nutrition should be used exclusively for induction therapy. In addition, anti–tumor necrosis factor biologics are an appropriate option for induction and maintenance therapy in these patients, according to the guideline.

“The group recommended against the use of oral 5-aminosalicylate for induction or maintenance therapy in patients with moderate disease, and recommended against thiopurines for induction therapy,” they wrote.

With respect to cannabis-based products, the panel made a strong recommendation against the use of these agents in all pediatric patients.

In terms of assessment, the team recommended that patients in clinical remission receiving methotrexate or a thiopurine agent as maintenance therapy should be evaluated for mucosal healing within 1 year of therapy initiation.

No consensus was reached on the adjuvant use of immunosuppressants during initiation therapy with a biologic drug, but the consensus panel recommended against the use of thiopurine combinations in male patients. Furthermore, no consensus was reached on the role of vedolizumab or antibiotics for induction or maintenance therapy, methotrexate for induction therapy, and the function of aminosalicylates in patients with mild CD.

The panel highlighted the importance of incorporating patient perspectives into treatment decision making.

“It is hoped that the available information will enhance the discussion between the clinician and the patient and enable the patient to make an evidence-based informed decision.”

The expert consensus was made up of 15 voting members that consisted of pediatric gastroenterologists throughout the United States and Canada, with expertise in several domains, including clinical epidemiology, nutrition, health services research, and patient engagement.

Quality of evidence and risk of bias was assessed using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) criteria. The quality of evidence for each consensus statement was denoted as either high, moderate, low, or very low, based on the criteria.

The consensus statements were finalized at an in-person meeting conducted in Toronto in October 2017.

The guideline was supported through grant funding provided by AbbVie and Takeda. The authors reported financial affiliations with AbbVie and Takeda, as well as Janssen, Nestle Health Sciences, Shire, and several others.

SOURCE: Mack DR et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.022.

A new clinical practice guideline for the treatment of luminal Crohn’s disease (CD) in children has been released by the Canadian Association of Gastroenterology (CAG).

The new guideline provides evidence-based recommendations regarding optimal medical treatment strategies for achieving clinical remission based on a multi-item assessment of disease activity in pediatric patients with luminal CD. The guideline does not address surgical management, diagnosis, psychosocial therapies, preventative health considerations, or growth monitoring.

“The implications of inadequately treated CD are of particular importance in children because of the potentially serious and irreversible consequences,” wrote David R. Mack, MD, of the University of Ottawa and associates. Dr. Mack is the lead author of the pediatric practice guideline copublished in Gastroenterology and the Journal of the Canadian Association of Gastroenterology.

The consensus group reached its recommendations based on a systematic review of the literature for studies related to the medical treatment of pediatric CD. The majority of studies were randomized trials conducted in adults with CD.

“Evidence of efficacy of specific treatments in achieving mucosal healing is limited; therefore, “complete” or “deep” remission (clinical remission plus mucosal healing) was not the chosen primary outcome,” the guideline authors wrote.

The panel recommended that corticosteroids can be used as induction therapy in children with moderate to severe disease. Moreover, budesonide may be an appropriate alternative for induction therapy in patients with mild to moderate CD.

In contrast, the group recommended against the use of corticosteroids as maintenance therapy, largely because of adverse events reported with long-term use.

At diagnosis or initial stages of severe disease, as well as in patients who have failed with immunosuppressant and corticosteroid induction strategies, enteral nutrition should be used exclusively for induction therapy. In addition, anti–tumor necrosis factor biologics are an appropriate option for induction and maintenance therapy in these patients, according to the guideline.

“The group recommended against the use of oral 5-aminosalicylate for induction or maintenance therapy in patients with moderate disease, and recommended against thiopurines for induction therapy,” they wrote.

With respect to cannabis-based products, the panel made a strong recommendation against the use of these agents in all pediatric patients.

In terms of assessment, the team recommended that patients in clinical remission receiving methotrexate or a thiopurine agent as maintenance therapy should be evaluated for mucosal healing within 1 year of therapy initiation.

No consensus was reached on the adjuvant use of immunosuppressants during initiation therapy with a biologic drug, but the consensus panel recommended against the use of thiopurine combinations in male patients. Furthermore, no consensus was reached on the role of vedolizumab or antibiotics for induction or maintenance therapy, methotrexate for induction therapy, and the function of aminosalicylates in patients with mild CD.

The panel highlighted the importance of incorporating patient perspectives into treatment decision making.

“It is hoped that the available information will enhance the discussion between the clinician and the patient and enable the patient to make an evidence-based informed decision.”

The expert consensus was made up of 15 voting members that consisted of pediatric gastroenterologists throughout the United States and Canada, with expertise in several domains, including clinical epidemiology, nutrition, health services research, and patient engagement.

Quality of evidence and risk of bias was assessed using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) criteria. The quality of evidence for each consensus statement was denoted as either high, moderate, low, or very low, based on the criteria.

The consensus statements were finalized at an in-person meeting conducted in Toronto in October 2017.

The guideline was supported through grant funding provided by AbbVie and Takeda. The authors reported financial affiliations with AbbVie and Takeda, as well as Janssen, Nestle Health Sciences, Shire, and several others.

SOURCE: Mack DR et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.022.

The Canadian Association of Gastroenterology has released a new clinical practice guideline for the treatment of luminal Crohn’s disease (CD) in adults.

“In the last decade, treatment paradigms have changed, recognizing that certain clinical parameters carry an increased risk of progressive and disabling disease,” wrote Remo Panaccione, MD, of the University of Calgary (Canada) and collaborators. Dr. Panaccione is the lead author of this practice guideline copublished in Clinical Gastroenterology and Hepatology and the Journal of the Canadian Association of Gastroenterology.

The expert consensus panel consisted of 20 voting members, including both academic and community gastroenterologists, in addition to a specialist nurse practitioner. Other nonvoting members included two GRADE experts, lay observers, and a patient representative.

The panel systematically reviewed the body of literature for studies related to the management of CD in adults. After applying the search criteria, the team found that the majority of evidence was extracted from systematic reviews and meta-analyses of randomized trials.

Quality of evidence and risk of bias was assessed using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) methodology. The quality of evidence for each consensus statement was classified as either high, moderate, low, or very low, based on the methodology’s criteria.

The consensus statements were finalized at a face-to-face meeting in Toronto held in September 2016. Prior to completion, a web-based system was used to allow for anonymous voting on level of agreement for each consensus statement.

The new guideline provides evidence-based recommendations about optimal treatment approaches for patients with mild to severe active luminal CD in an ambulatory setting, with particular focus on six major drug classes, including corticosteroids, biologic therapies, immunosuppressants, 5-aminosalicylate, antibiotics, and other therapies.

The consensus group recommended against the use of 5-aminosalicylate or antibiotics as induction or maintenance treatment strategies. Alternatively, they suggested that corticosteroids, including budesonide, could be used as induction therapy, but not as maintenance therapy.

“Parenteral methotrexate was proposed for induction and maintenance therapy in patients with corticosteroid-dependent CD,” they wrote.

With respect to immunosuppressive therapy, thiopurine agents could be an appropriate option for maintenance therapy in certain low-risk patients, but were not recommended as induction therapy, according to the guideline.

In patients who fail with conventional induction therapies, Dr. Panaccione and colleagues recommended that biological treatments, including ustekinumab, vedolizumab, and anti–tumor necrosis factor agents, could be used. No consensus was reached on the concomitant use of immunosuppressants and biologics.

In recent years, an increasing amount of evidence has emphasized the importance of mucosal healing as a key goal of therapy. In particular, the use of some therapies can result in mucosal healing and symptomatic improvement in certain patients with luminal CD.

In addition, the authors explained that mucosal healing has been linked to better clinical outcomes over the short and long term. As a result, the recommendations in the guideline target complete remission, defined as both endoscopic and symptomatic remission.

“The outcome assessed in most randomized controlled trials (RCTs) has been either symptomatic remission or symptomatic response, with only more contemporary clinical trials including endoscopic outcomes,” the guideline authors wrote.

For this reason, the GRADE criteria–based quality of evidence for some of the consensus statements had to be lowered, they noted.

The panel acknowledged the importance of incorporating patient perspectives into treatment decision making; however, they reported that many gaps in clinical practice still remain.

“In many instances, factors that influence patient decisions relating to therapy choice and goals of therapy are not the same as those of the treating clinician,” they wrote. “[Current] surveys indicate a discrepancy between patient and physician treatment goals.”

In response, the guideline authors highlighted the importance of improved patient-physician collaboration and patient education.

The guideline was supported through grant funding provided by AbbVie, Janssen, Pfizer, and Takeda. The authors reported financial affiliations with AbbVie, Amgen, Baxter, Janssen, Shire, Takeda, and several others.
 

SOURCE: Panaccione R et al. Clin Gastroenterol Hepatol. 2019 Mar 7. doi: 10.1016/j.cgh.2019.02.043.

The Canadian Association of Gastroenterology has released a new clinical practice guideline for the treatment of luminal Crohn’s disease (CD) in adults.

“In the last decade, treatment paradigms have changed, recognizing that certain clinical parameters carry an increased risk of progressive and disabling disease,” wrote Remo Panaccione, MD, of the University of Calgary (Canada) and collaborators. Dr. Panaccione is the lead author of this practice guideline copublished in Clinical Gastroenterology and Hepatology and the Journal of the Canadian Association of Gastroenterology.

The expert consensus panel consisted of 20 voting members, including both academic and community gastroenterologists, in addition to a specialist nurse practitioner. Other nonvoting members included two GRADE experts, lay observers, and a patient representative.

The panel systematically reviewed the body of literature for studies related to the management of CD in adults. After applying the search criteria, the team found that the majority of evidence was extracted from systematic reviews and meta-analyses of randomized trials.

Quality of evidence and risk of bias was assessed using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) methodology. The quality of evidence for each consensus statement was classified as either high, moderate, low, or very low, based on the methodology’s criteria.

The consensus statements were finalized at a face-to-face meeting in Toronto held in September 2016. Prior to completion, a web-based system was used to allow for anonymous voting on level of agreement for each consensus statement.

The new guideline provides evidence-based recommendations about optimal treatment approaches for patients with mild to severe active luminal CD in an ambulatory setting, with particular focus on six major drug classes, including corticosteroids, biologic therapies, immunosuppressants, 5-aminosalicylate, antibiotics, and other therapies.

The consensus group recommended against the use of 5-aminosalicylate or antibiotics as induction or maintenance treatment strategies. Alternatively, they suggested that corticosteroids, including budesonide, could be used as induction therapy, but not as maintenance therapy.

“Parenteral methotrexate was proposed for induction and maintenance therapy in patients with corticosteroid-dependent CD,” they wrote.

With respect to immunosuppressive therapy, thiopurine agents could be an appropriate option for maintenance therapy in certain low-risk patients, but were not recommended as induction therapy, according to the guideline.

In patients who fail with conventional induction therapies, Dr. Panaccione and colleagues recommended that biological treatments, including ustekinumab, vedolizumab, and anti–tumor necrosis factor agents, could be used. No consensus was reached on the concomitant use of immunosuppressants and biologics.

In recent years, an increasing amount of evidence has emphasized the importance of mucosal healing as a key goal of therapy. In particular, the use of some therapies can result in mucosal healing and symptomatic improvement in certain patients with luminal CD.

In addition, the authors explained that mucosal healing has been linked to better clinical outcomes over the short and long term. As a result, the recommendations in the guideline target complete remission, defined as both endoscopic and symptomatic remission.

“The outcome assessed in most randomized controlled trials (RCTs) has been either symptomatic remission or symptomatic response, with only more contemporary clinical trials including endoscopic outcomes,” the guideline authors wrote.

For this reason, the GRADE criteria–based quality of evidence for some of the consensus statements had to be lowered, they noted.

The panel acknowledged the importance of incorporating patient perspectives into treatment decision making; however, they reported that many gaps in clinical practice still remain.

“In many instances, factors that influence patient decisions relating to therapy choice and goals of therapy are not the same as those of the treating clinician,” they wrote. “[Current] surveys indicate a discrepancy between patient and physician treatment goals.”

In response, the guideline authors highlighted the importance of improved patient-physician collaboration and patient education.

The guideline was supported through grant funding provided by AbbVie, Janssen, Pfizer, and Takeda. The authors reported financial affiliations with AbbVie, Amgen, Baxter, Janssen, Shire, Takeda, and several others.
 

SOURCE: Panaccione R et al. Clin Gastroenterol Hepatol. 2019 Mar 7. doi: 10.1016/j.cgh.2019.02.043.

The Canadian Association of Gastroenterology has released a new clinical practice guideline for the treatment of luminal Crohn’s disease (CD) in adults.

“In the last decade, treatment paradigms have changed, recognizing that certain clinical parameters carry an increased risk of progressive and disabling disease,” wrote Remo Panaccione, MD, of the University of Calgary (Canada) and collaborators. Dr. Panaccione is the lead author of this practice guideline copublished in Clinical Gastroenterology and Hepatology and the Journal of the Canadian Association of Gastroenterology.

The expert consensus panel consisted of 20 voting members, including both academic and community gastroenterologists, in addition to a specialist nurse practitioner. Other nonvoting members included two GRADE experts, lay observers, and a patient representative.

The panel systematically reviewed the body of literature for studies related to the management of CD in adults. After applying the search criteria, the team found that the majority of evidence was extracted from systematic reviews and meta-analyses of randomized trials.

Quality of evidence and risk of bias was assessed using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) methodology. The quality of evidence for each consensus statement was classified as either high, moderate, low, or very low, based on the methodology’s criteria.

The consensus statements were finalized at a face-to-face meeting in Toronto held in September 2016. Prior to completion, a web-based system was used to allow for anonymous voting on level of agreement for each consensus statement.

The new guideline provides evidence-based recommendations about optimal treatment approaches for patients with mild to severe active luminal CD in an ambulatory setting, with particular focus on six major drug classes, including corticosteroids, biologic therapies, immunosuppressants, 5-aminosalicylate, antibiotics, and other therapies.

The consensus group recommended against the use of 5-aminosalicylate or antibiotics as induction or maintenance treatment strategies. Alternatively, they suggested that corticosteroids, including budesonide, could be used as induction therapy, but not as maintenance therapy.

“Parenteral methotrexate was proposed for induction and maintenance therapy in patients with corticosteroid-dependent CD,” they wrote.

With respect to immunosuppressive therapy, thiopurine agents could be an appropriate option for maintenance therapy in certain low-risk patients, but were not recommended as induction therapy, according to the guideline.

In patients who fail with conventional induction therapies, Dr. Panaccione and colleagues recommended that biological treatments, including ustekinumab, vedolizumab, and anti–tumor necrosis factor agents, could be used. No consensus was reached on the concomitant use of immunosuppressants and biologics.

In recent years, an increasing amount of evidence has emphasized the importance of mucosal healing as a key goal of therapy. In particular, the use of some therapies can result in mucosal healing and symptomatic improvement in certain patients with luminal CD.

In addition, the authors explained that mucosal healing has been linked to better clinical outcomes over the short and long term. As a result, the recommendations in the guideline target complete remission, defined as both endoscopic and symptomatic remission.

“The outcome assessed in most randomized controlled trials (RCTs) has been either symptomatic remission or symptomatic response, with only more contemporary clinical trials including endoscopic outcomes,” the guideline authors wrote.

For this reason, the GRADE criteria–based quality of evidence for some of the consensus statements had to be lowered, they noted.

The panel acknowledged the importance of incorporating patient perspectives into treatment decision making; however, they reported that many gaps in clinical practice still remain.

“In many instances, factors that influence patient decisions relating to therapy choice and goals of therapy are not the same as those of the treating clinician,” they wrote. “[Current] surveys indicate a discrepancy between patient and physician treatment goals.”

In response, the guideline authors highlighted the importance of improved patient-physician collaboration and patient education.

The guideline was supported through grant funding provided by AbbVie, Janssen, Pfizer, and Takeda. The authors reported financial affiliations with AbbVie, Amgen, Baxter, Janssen, Shire, Takeda, and several others.
 

SOURCE: Panaccione R et al. Clin Gastroenterol Hepatol. 2019 Mar 7. doi: 10.1016/j.cgh.2019.02.043.