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DDSEP® 8 Quick quiz - July 2017 Question 1
Q1: Answer: D
Objective: Understand the role of the restrictive transfusion strategy during patient stabilization and resuscitation as the initial step in the management of a variceal bleed.
Discussion: The initial therapy for acute variceal hemorrhage is resuscitation in an intensive care unit. Blood volume restitution should be undertaken promptly but with caution, with the goals of maintaining hemodynamic stability and hemoglobin around 7–8 g/dL.
Over-transfusion or volume overexpansion can precipitate variceal re-bleeding. A randomized clinical trial found that a restrictive transfusion strategy (transfusion when the hemoglobin fell below 7 g/dL) in patients with cirrhosis significantly improved survival. Endoscopic evaluation with potential variceal band ligation is appropriate only after initial resuscitation and stabilization of the patient.
Placement of a Blakemore tube and TIPS are not first-line therapy for this patient with Childs class A cirrhosis, and could be considered for recurrent bleeding that fails endoscopic therapy.
Endoscopic variceal ligation is more effective than sclerotherapy and is associated with fewer side effects. However, in patients for whom endoscopic variceal ligation is not feasible, sclerotherapy is a reasonable alternative.
References
1. Garcia-Tsao G., Sanyal A.J., Grace N.D., Carey W. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007;46(3):922-38.
2. Garcia-Tsao G., Bosch J.. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010;362(9):823-32.
3. Villanueva C., Colomo A., Bosch A., et al. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013;368(1):11-21.
4. Villanueva C., Piqueras M., Aracil C., et al. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol. 2006;45(4):560-7.
Q1: Answer: D
Objective: Understand the role of the restrictive transfusion strategy during patient stabilization and resuscitation as the initial step in the management of a variceal bleed.
Discussion: The initial therapy for acute variceal hemorrhage is resuscitation in an intensive care unit. Blood volume restitution should be undertaken promptly but with caution, with the goals of maintaining hemodynamic stability and hemoglobin around 7–8 g/dL.
Over-transfusion or volume overexpansion can precipitate variceal re-bleeding. A randomized clinical trial found that a restrictive transfusion strategy (transfusion when the hemoglobin fell below 7 g/dL) in patients with cirrhosis significantly improved survival. Endoscopic evaluation with potential variceal band ligation is appropriate only after initial resuscitation and stabilization of the patient.
Placement of a Blakemore tube and TIPS are not first-line therapy for this patient with Childs class A cirrhosis, and could be considered for recurrent bleeding that fails endoscopic therapy.
Endoscopic variceal ligation is more effective than sclerotherapy and is associated with fewer side effects. However, in patients for whom endoscopic variceal ligation is not feasible, sclerotherapy is a reasonable alternative.
References
1. Garcia-Tsao G., Sanyal A.J., Grace N.D., Carey W. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007;46(3):922-38.
2. Garcia-Tsao G., Bosch J.. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010;362(9):823-32.
3. Villanueva C., Colomo A., Bosch A., et al. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013;368(1):11-21.
4. Villanueva C., Piqueras M., Aracil C., et al. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol. 2006;45(4):560-7.
Q1: Answer: D
Objective: Understand the role of the restrictive transfusion strategy during patient stabilization and resuscitation as the initial step in the management of a variceal bleed.
Discussion: The initial therapy for acute variceal hemorrhage is resuscitation in an intensive care unit. Blood volume restitution should be undertaken promptly but with caution, with the goals of maintaining hemodynamic stability and hemoglobin around 7–8 g/dL.
Over-transfusion or volume overexpansion can precipitate variceal re-bleeding. A randomized clinical trial found that a restrictive transfusion strategy (transfusion when the hemoglobin fell below 7 g/dL) in patients with cirrhosis significantly improved survival. Endoscopic evaluation with potential variceal band ligation is appropriate only after initial resuscitation and stabilization of the patient.
Placement of a Blakemore tube and TIPS are not first-line therapy for this patient with Childs class A cirrhosis, and could be considered for recurrent bleeding that fails endoscopic therapy.
Endoscopic variceal ligation is more effective than sclerotherapy and is associated with fewer side effects. However, in patients for whom endoscopic variceal ligation is not feasible, sclerotherapy is a reasonable alternative.
References
1. Garcia-Tsao G., Sanyal A.J., Grace N.D., Carey W. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007;46(3):922-38.
2. Garcia-Tsao G., Bosch J.. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010;362(9):823-32.
3. Villanueva C., Colomo A., Bosch A., et al. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013;368(1):11-21.
4. Villanueva C., Piqueras M., Aracil C., et al. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol. 2006;45(4):560-7.
A 46-year-old man with a history of alcoholic cirrhosis presents to the ED with new-onset melena and hematemesis. On examination, he appears weak, but his mental status is stable with no signs of encephalopathy. His abdomen is soft, with no clinical ascites. Vitals include temperature 97.9º, BP of 83/42 mm Hg, HR 112. Labs reveal hemoglobin 6.3 g/dL, hematocrit 18%, creatinine 1.3 mg/dL, total bilirubin 1.2 mg/dL, INR 1.0, platelet count of 63 x 103/microL. You suspect that this is an esophageal variceal bleed.
Idarucizumab reverses effects of dabigatran in emergencies
BERLIN—Final results from the RE-VERSE AD trial suggest idarucizumab can reverse the anticoagulant effect of dabigatran etexilate mesylate in emergency situations.
Patients who required dabigatran reversal because they needed urgent surgery were able to have their procedure a median of 1.6 hours from idarucizumab administration.
In patients who required dabigatran reversal due to uncontrollable bleeding, the median time to bleeding cessation was 2.5 hours. However, the time to bleeding cessation could not be assessed in all patients.
“RE-VERSE AD has shown that idarucizumab reverses the anticoagulant effect of dabigatran within minutes so that treating physicians can fully focus on dealing with the emergency at hand,” said study investigator Charles Pollack, MD, of Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, Pennsylvania.
“Prior to idarucizumab, there was no rapid, reliable, and effective method for reversing dabigatran and other orally administered blood thinners, which otherwise may take at least 12 to 24 hours to clear from the body.”
The rate of thrombotic events in RE-VERSE AD was low (6% to 7%), and researchers said there were no serious adverse safety signals related to idarucizumab.
These results were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress and published in NEJM. The research was funded by Boehringer Ingelheim Pharmaceuticals.
The phase 3 trial enrolled 503 patients who required dabigatran reversal. They were divided into 2 groups.
Group A included 301 patients with uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage or severe trauma after a car accident).
Group B included 202 patients requiring an invasive procedure or an emergency surgery or intervention (eg, surgery for an open fracture after a fall).
Results
The study’s primary endpoint was the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab within 4 hours. This was measured by diluted thrombin time or ecarin clotting time.
The median maximum percentage of dabigatran reversal was 100%. Dabigatran reversal occurred independently of patients’ age, sex, renal function, and dabigatran concentration at baseline.
Group A
Roughly 68% of evaluable patients in Group A (134/203) had confirmed bleeding cessation within 24 hours of idarucizumab administration.
Bleeding cessation was not confirmed in 67 patients, bleeding stopped before treatment in 2 patients, and the time to bleeding cessation could not be assessed in the 98 patients with intracranial bleeding.
Among the 134 patients in who had confirmed bleeding cessation, the median time to hemostasis after idarucizumab administration was 2.5 hours.
Sixty-seven percent (n=201) of patients in Group A received hemostatic treatment, 62% (n=185) received whole blood/blood components, 7% (n=20) received plasma derivatives, and 23% (n=69) received volume expanders, pro-hemostatic agents, albumin, and other treatments.
At 90 days, thrombotic events had occurred in 6.3% of the patients in Group A, and the mortality rate was 18.8%.
Group B
For patients in Group B, their required procedures began a median of 1.6 hours from idarucizumab administration.
Hemostasis during the procedure was described as normal for 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%.
Thirty-nine percent (n=79) of patients in Group B received hemostatic treatment, 26% (n=53) received whole blood/blood components, 4% (n=8) received plasma derivatives, and 21% (n=42) received volume expanders, pro-hemostatic agents, albumin, and other treatments.
At 90 days, thrombotic events had occurred in 7.4% of patients in Group B, and the mortality rate was 18.9%. 
BERLIN—Final results from the RE-VERSE AD trial suggest idarucizumab can reverse the anticoagulant effect of dabigatran etexilate mesylate in emergency situations.
Patients who required dabigatran reversal because they needed urgent surgery were able to have their procedure a median of 1.6 hours from idarucizumab administration.
In patients who required dabigatran reversal due to uncontrollable bleeding, the median time to bleeding cessation was 2.5 hours. However, the time to bleeding cessation could not be assessed in all patients.
“RE-VERSE AD has shown that idarucizumab reverses the anticoagulant effect of dabigatran within minutes so that treating physicians can fully focus on dealing with the emergency at hand,” said study investigator Charles Pollack, MD, of Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, Pennsylvania.
“Prior to idarucizumab, there was no rapid, reliable, and effective method for reversing dabigatran and other orally administered blood thinners, which otherwise may take at least 12 to 24 hours to clear from the body.”
The rate of thrombotic events in RE-VERSE AD was low (6% to 7%), and researchers said there were no serious adverse safety signals related to idarucizumab.
These results were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress and published in NEJM. The research was funded by Boehringer Ingelheim Pharmaceuticals.
The phase 3 trial enrolled 503 patients who required dabigatran reversal. They were divided into 2 groups.
Group A included 301 patients with uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage or severe trauma after a car accident).
Group B included 202 patients requiring an invasive procedure or an emergency surgery or intervention (eg, surgery for an open fracture after a fall).
Results
The study’s primary endpoint was the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab within 4 hours. This was measured by diluted thrombin time or ecarin clotting time.
The median maximum percentage of dabigatran reversal was 100%. Dabigatran reversal occurred independently of patients’ age, sex, renal function, and dabigatran concentration at baseline.
Group A
Roughly 68% of evaluable patients in Group A (134/203) had confirmed bleeding cessation within 24 hours of idarucizumab administration.
Bleeding cessation was not confirmed in 67 patients, bleeding stopped before treatment in 2 patients, and the time to bleeding cessation could not be assessed in the 98 patients with intracranial bleeding.
Among the 134 patients in who had confirmed bleeding cessation, the median time to hemostasis after idarucizumab administration was 2.5 hours.
Sixty-seven percent (n=201) of patients in Group A received hemostatic treatment, 62% (n=185) received whole blood/blood components, 7% (n=20) received plasma derivatives, and 23% (n=69) received volume expanders, pro-hemostatic agents, albumin, and other treatments.
At 90 days, thrombotic events had occurred in 6.3% of the patients in Group A, and the mortality rate was 18.8%.
Group B
For patients in Group B, their required procedures began a median of 1.6 hours from idarucizumab administration.
Hemostasis during the procedure was described as normal for 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%.
Thirty-nine percent (n=79) of patients in Group B received hemostatic treatment, 26% (n=53) received whole blood/blood components, 4% (n=8) received plasma derivatives, and 21% (n=42) received volume expanders, pro-hemostatic agents, albumin, and other treatments.
At 90 days, thrombotic events had occurred in 7.4% of patients in Group B, and the mortality rate was 18.9%.
BERLIN—Final results from the RE-VERSE AD trial suggest idarucizumab can reverse the anticoagulant effect of dabigatran etexilate mesylate in emergency situations.
Patients who required dabigatran reversal because they needed urgent surgery were able to have their procedure a median of 1.6 hours from idarucizumab administration.
In patients who required dabigatran reversal due to uncontrollable bleeding, the median time to bleeding cessation was 2.5 hours. However, the time to bleeding cessation could not be assessed in all patients.
“RE-VERSE AD has shown that idarucizumab reverses the anticoagulant effect of dabigatran within minutes so that treating physicians can fully focus on dealing with the emergency at hand,” said study investigator Charles Pollack, MD, of Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, Pennsylvania.
“Prior to idarucizumab, there was no rapid, reliable, and effective method for reversing dabigatran and other orally administered blood thinners, which otherwise may take at least 12 to 24 hours to clear from the body.”
The rate of thrombotic events in RE-VERSE AD was low (6% to 7%), and researchers said there were no serious adverse safety signals related to idarucizumab.
These results were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress and published in NEJM. The research was funded by Boehringer Ingelheim Pharmaceuticals.
The phase 3 trial enrolled 503 patients who required dabigatran reversal. They were divided into 2 groups.
Group A included 301 patients with uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage or severe trauma after a car accident).
Group B included 202 patients requiring an invasive procedure or an emergency surgery or intervention (eg, surgery for an open fracture after a fall).
Results
The study’s primary endpoint was the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab within 4 hours. This was measured by diluted thrombin time or ecarin clotting time.
The median maximum percentage of dabigatran reversal was 100%. Dabigatran reversal occurred independently of patients’ age, sex, renal function, and dabigatran concentration at baseline.
Group A
Roughly 68% of evaluable patients in Group A (134/203) had confirmed bleeding cessation within 24 hours of idarucizumab administration.
Bleeding cessation was not confirmed in 67 patients, bleeding stopped before treatment in 2 patients, and the time to bleeding cessation could not be assessed in the 98 patients with intracranial bleeding.
Among the 134 patients in who had confirmed bleeding cessation, the median time to hemostasis after idarucizumab administration was 2.5 hours.
Sixty-seven percent (n=201) of patients in Group A received hemostatic treatment, 62% (n=185) received whole blood/blood components, 7% (n=20) received plasma derivatives, and 23% (n=69) received volume expanders, pro-hemostatic agents, albumin, and other treatments.
At 90 days, thrombotic events had occurred in 6.3% of the patients in Group A, and the mortality rate was 18.8%.
Group B
For patients in Group B, their required procedures began a median of 1.6 hours from idarucizumab administration.
Hemostasis during the procedure was described as normal for 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%.
Thirty-nine percent (n=79) of patients in Group B received hemostatic treatment, 26% (n=53) received whole blood/blood components, 4% (n=8) received plasma derivatives, and 21% (n=42) received volume expanders, pro-hemostatic agents, albumin, and other treatments.
At 90 days, thrombotic events had occurred in 7.4% of patients in Group B, and the mortality rate was 18.9%.
FDA grants priority review to sNDA for dasatinib
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for dasatinib (Sprycel).
Bristol Myers Squibb is seeking approval for dasatinib as a treatment for children with Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML), as well as approval for a powder formulation of dasatinib for oral suspension.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA plans to make a decision on the dasatinib sNDA by November 9, 2017.
The sNDA includes data from CA180-226 (NCT00777036), an ongoing, phase 2 trial of dasatinib in pediatric patients with CP-CML who are resistant to or cannot tolerate imatinib and pediatric patients newly diagnosed with CP-CML.
The trial enrolled patients aged 18 and younger with newly diagnosed CML or Ph+ leukemias resistant to or intolerant of imatinib.
Cohort 1 included 29 CP-CML patients resistant to or intolerant of imatinib. Cohort 2 included patients with accelerated/blast phase CML or Ph+ acute lymphoblastic leukemia. Cohort 3 included 84 patients with newly diagnosed CP-CML.
Data from Cohorts 1 and 3 were recently presented at the 2017 ASCO Annual Meeting.
Three months into treatment with dasatinib, patients with CP-CML who were resistant to or intolerant of imatinib (Cohort 1) had a cumulative major cytogenetic response rate of 55.2%. This response rate increased over time to exceed 90% at 24 months.
Newly diagnosed patients with CP-CML (Cohort 3) received dasatinib orally or as powder for oral suspension once daily. They achieved a cumulative complete cytogenetic response rate of 64% as early as 6 months into treatment. This response rate increased to 94% at 24 months.
The median duration of response was not estimable or not yet reached in each cohort at the time of follow-up.
The estimated progression-free survival at 48 months was greater than 75% for patients in Cohort 1 and greater than 90% for patients in Cohort 3.
The safety profile of dasatinib in this study was deemed comparable to that reported in adults with CP-CML. In this study, there were no reported events of pleural/pericardial effusion, pulmonary edema/hypertension, or pulmonary arterial hypertension related to dasatinib.
Dasatinib first received FDA approval in 2006. The drug is currently approved to treat adults with:
- Newly diagnosed Ph+ CP-CML
- Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
- Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for dasatinib (Sprycel).
Bristol Myers Squibb is seeking approval for dasatinib as a treatment for children with Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML), as well as approval for a powder formulation of dasatinib for oral suspension.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA plans to make a decision on the dasatinib sNDA by November 9, 2017.
The sNDA includes data from CA180-226 (NCT00777036), an ongoing, phase 2 trial of dasatinib in pediatric patients with CP-CML who are resistant to or cannot tolerate imatinib and pediatric patients newly diagnosed with CP-CML.
The trial enrolled patients aged 18 and younger with newly diagnosed CML or Ph+ leukemias resistant to or intolerant of imatinib.
Cohort 1 included 29 CP-CML patients resistant to or intolerant of imatinib. Cohort 2 included patients with accelerated/blast phase CML or Ph+ acute lymphoblastic leukemia. Cohort 3 included 84 patients with newly diagnosed CP-CML.
Data from Cohorts 1 and 3 were recently presented at the 2017 ASCO Annual Meeting.
Three months into treatment with dasatinib, patients with CP-CML who were resistant to or intolerant of imatinib (Cohort 1) had a cumulative major cytogenetic response rate of 55.2%. This response rate increased over time to exceed 90% at 24 months.
Newly diagnosed patients with CP-CML (Cohort 3) received dasatinib orally or as powder for oral suspension once daily. They achieved a cumulative complete cytogenetic response rate of 64% as early as 6 months into treatment. This response rate increased to 94% at 24 months.
The median duration of response was not estimable or not yet reached in each cohort at the time of follow-up.
The estimated progression-free survival at 48 months was greater than 75% for patients in Cohort 1 and greater than 90% for patients in Cohort 3.
The safety profile of dasatinib in this study was deemed comparable to that reported in adults with CP-CML. In this study, there were no reported events of pleural/pericardial effusion, pulmonary edema/hypertension, or pulmonary arterial hypertension related to dasatinib.
Dasatinib first received FDA approval in 2006. The drug is currently approved to treat adults with:
- Newly diagnosed Ph+ CP-CML
- Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
- Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for dasatinib (Sprycel).
Bristol Myers Squibb is seeking approval for dasatinib as a treatment for children with Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML), as well as approval for a powder formulation of dasatinib for oral suspension.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA plans to make a decision on the dasatinib sNDA by November 9, 2017.
The sNDA includes data from CA180-226 (NCT00777036), an ongoing, phase 2 trial of dasatinib in pediatric patients with CP-CML who are resistant to or cannot tolerate imatinib and pediatric patients newly diagnosed with CP-CML.
The trial enrolled patients aged 18 and younger with newly diagnosed CML or Ph+ leukemias resistant to or intolerant of imatinib.
Cohort 1 included 29 CP-CML patients resistant to or intolerant of imatinib. Cohort 2 included patients with accelerated/blast phase CML or Ph+ acute lymphoblastic leukemia. Cohort 3 included 84 patients with newly diagnosed CP-CML.
Data from Cohorts 1 and 3 were recently presented at the 2017 ASCO Annual Meeting.
Three months into treatment with dasatinib, patients with CP-CML who were resistant to or intolerant of imatinib (Cohort 1) had a cumulative major cytogenetic response rate of 55.2%. This response rate increased over time to exceed 90% at 24 months.
Newly diagnosed patients with CP-CML (Cohort 3) received dasatinib orally or as powder for oral suspension once daily. They achieved a cumulative complete cytogenetic response rate of 64% as early as 6 months into treatment. This response rate increased to 94% at 24 months.
The median duration of response was not estimable or not yet reached in each cohort at the time of follow-up.
The estimated progression-free survival at 48 months was greater than 75% for patients in Cohort 1 and greater than 90% for patients in Cohort 3.
The safety profile of dasatinib in this study was deemed comparable to that reported in adults with CP-CML. In this study, there were no reported events of pleural/pericardial effusion, pulmonary edema/hypertension, or pulmonary arterial hypertension related to dasatinib.
Dasatinib first received FDA approval in 2006. The drug is currently approved to treat adults with:
- Newly diagnosed Ph+ CP-CML
- Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
- Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Company launches automated hematology analyzers in US
Sysmex America, Inc. has launched its XN-L™ automated hematology analyzers in the US.
The company says this new, smaller XN-L line delivers the same clinical and operational value as its XN-Series™ to lower-volume hematology laboratories.
“The XN-Series has been our flagship hematology analyzer line, and, today, we expand our offering by introducing the XN-L Series to meet the demands of lower-volume facilities,” said Andy Hay, chief operating officer of Sysmex America.
“With an XN-L analyzer, clinicians can rely upon the same expanded complete blood count (CBC) featured in our XN-Series analyzers to assess and monitor patients. This expanded CBC goes well beyond the 3-part differential that is currently available to most of the low-volume segment today and can aid in the assessment of sepsis and other hematological disorders.”
The XN-L automated hematology analyzers offer a 6-part differential, including immature granulocyte analysis on each sample.
In addition, the XN-L Series offers optional software licenses for (1) a reticulocyte channel to aid in anemia management and (2) body fluid cell counts.
The XN-L analyzers will also be the first to feature BeyondCare Quality Monitor, a new approach to quality assurance.
“BeyondCare Quality Monitor, a Sysmex proprietary innovation, is a leading-edge, evidence-based QC and calibration verification management program that partners Sysmex with the laboratory to proactively monitor quality assurance metrics,” Hay said. “It will be standard on all XN-L hematology analyzers.
Additional information on XN-L analyzers is available on the Sysmex website at www.sysmex.com/XNL.
The XN-L analyzers will be available both directly through the company and through its distribution partners. Interested parties should contact their Sysmex representative or Sysmex distributor for complete details.
Sysmex America, Inc. has launched its XN-L™ automated hematology analyzers in the US.
The company says this new, smaller XN-L line delivers the same clinical and operational value as its XN-Series™ to lower-volume hematology laboratories.
“The XN-Series has been our flagship hematology analyzer line, and, today, we expand our offering by introducing the XN-L Series to meet the demands of lower-volume facilities,” said Andy Hay, chief operating officer of Sysmex America.
“With an XN-L analyzer, clinicians can rely upon the same expanded complete blood count (CBC) featured in our XN-Series analyzers to assess and monitor patients. This expanded CBC goes well beyond the 3-part differential that is currently available to most of the low-volume segment today and can aid in the assessment of sepsis and other hematological disorders.”
The XN-L automated hematology analyzers offer a 6-part differential, including immature granulocyte analysis on each sample.
In addition, the XN-L Series offers optional software licenses for (1) a reticulocyte channel to aid in anemia management and (2) body fluid cell counts.
The XN-L analyzers will also be the first to feature BeyondCare Quality Monitor, a new approach to quality assurance.
“BeyondCare Quality Monitor, a Sysmex proprietary innovation, is a leading-edge, evidence-based QC and calibration verification management program that partners Sysmex with the laboratory to proactively monitor quality assurance metrics,” Hay said. “It will be standard on all XN-L hematology analyzers.
Additional information on XN-L analyzers is available on the Sysmex website at www.sysmex.com/XNL.
The XN-L analyzers will be available both directly through the company and through its distribution partners. Interested parties should contact their Sysmex representative or Sysmex distributor for complete details.
Sysmex America, Inc. has launched its XN-L™ automated hematology analyzers in the US.
The company says this new, smaller XN-L line delivers the same clinical and operational value as its XN-Series™ to lower-volume hematology laboratories.
“The XN-Series has been our flagship hematology analyzer line, and, today, we expand our offering by introducing the XN-L Series to meet the demands of lower-volume facilities,” said Andy Hay, chief operating officer of Sysmex America.
“With an XN-L analyzer, clinicians can rely upon the same expanded complete blood count (CBC) featured in our XN-Series analyzers to assess and monitor patients. This expanded CBC goes well beyond the 3-part differential that is currently available to most of the low-volume segment today and can aid in the assessment of sepsis and other hematological disorders.”
The XN-L automated hematology analyzers offer a 6-part differential, including immature granulocyte analysis on each sample.
In addition, the XN-L Series offers optional software licenses for (1) a reticulocyte channel to aid in anemia management and (2) body fluid cell counts.
The XN-L analyzers will also be the first to feature BeyondCare Quality Monitor, a new approach to quality assurance.
“BeyondCare Quality Monitor, a Sysmex proprietary innovation, is a leading-edge, evidence-based QC and calibration verification management program that partners Sysmex with the laboratory to proactively monitor quality assurance metrics,” Hay said. “It will be standard on all XN-L hematology analyzers.
Additional information on XN-L analyzers is available on the Sysmex website at www.sysmex.com/XNL.
The XN-L analyzers will be available both directly through the company and through its distribution partners. Interested parties should contact their Sysmex representative or Sysmex distributor for complete details.
Knee Pain, Heart Strain?
ANSWER
The correct interpretation includes normal sinus rhythm with left ventricular hypertrophy (LVH) and possible left atrial enlargement. Criteria for LVH include high voltages in the limb leads (R wave in lead I and S wave in lead III ≥ 25 mm) or the precordial leads (S wave in V1 and R wave in V6 ≥ 35 mm). Left atrial enlargement and ST-T wave abnormalities are often seen with LVH. The notched P wave in lead II and biphasic P wave in V1 raise suspicion for left atrial involvement. Finally, repolarization of a hypertrophic left ventricle following systole is responsible for the tall T waves seen in leads
ANSWER
The correct interpretation includes normal sinus rhythm with left ventricular hypertrophy (LVH) and possible left atrial enlargement. Criteria for LVH include high voltages in the limb leads (R wave in lead I and S wave in lead III ≥ 25 mm) or the precordial leads (S wave in V1 and R wave in V6 ≥ 35 mm). Left atrial enlargement and ST-T wave abnormalities are often seen with LVH. The notched P wave in lead II and biphasic P wave in V1 raise suspicion for left atrial involvement. Finally, repolarization of a hypertrophic left ventricle following systole is responsible for the tall T waves seen in leads
ANSWER
The correct interpretation includes normal sinus rhythm with left ventricular hypertrophy (LVH) and possible left atrial enlargement. Criteria for LVH include high voltages in the limb leads (R wave in lead I and S wave in lead III ≥ 25 mm) or the precordial leads (S wave in V1 and R wave in V6 ≥ 35 mm). Left atrial enlargement and ST-T wave abnormalities are often seen with LVH. The notched P wave in lead II and biphasic P wave in V1 raise suspicion for left atrial involvement. Finally, repolarization of a hypertrophic left ventricle following systole is responsible for the tall T waves seen in leads
A 47-year-old man presents for preoperative exam prior to right knee arthroplasty. He twisted his knee while training for a triathlon; MRI showed a bucket handle tear of the medial meniscus.
The patient has been very active throughout his life. Medical history is remarkable for essential hypertension. He has no history of chest pain, palpitations, shortness of breath, syncope, or near-syncope.
Current medications include metoprolol XL (25 mg/d)—which he hasn’t taken in five days, since he hasn’t been able to pick up his refill—and ibuprofen (600 mg tid, prn for knee pain). He denies illicit drug use.
The patient works as an accountant and is married with two children. His parents and grandparents are all alive and well. He has never smoked tobacco but does use marijuana socially on weekends. He also has one to two glasses of wine each night.
Review of systems is noncontributory: no recent colds or flu, bowel or bladder dysfunction, or weight changes. Vital signs include a blood pressure of 138/80 mm Hg; pulse, 80 beats/min; respiratory rate, 14 breaths/min-1; and temperature, 98°F. His weight is 194 lb and his height, 75 in. Pertinent physical findings include pain on palpation of the medial aspect of the right knee and a positive McMurray sign.
Bloodwork, a chest x-ray, and an ECG are obtained. The ECG shows a ventricular rate of 79 beats/min; PR interval, 184 ms; QRS duration, 76 ms; QT/QTc intervals, 382/438 ms; P axis, 48°; R axis, –29°; and T axis, 33°. What is your interpretation of this ECG?
New federal health IT leadership, same goals
WASHINGTON – Although the leadership at the Office of the National Coordinator for Health Information Technology is new, the focus of the federal office – reducing physician burden and improving interoperability of electronic heath records – remains the same.
“One priority is on the whole question of burden of [EHR] usability,” said Don Rucker, MD, the new national coordinator, at a July 11 press briefing. “The other is interoperability. We’ve obviously spent a lot of money collectively in the country on these systems, and there’s a widespread dissatisfaction with the level of interoperability.”
“We are looking at documentation and the whole quality framework around value-based purchasing,” he said. “For a lot of practices now, this has become a challenge that we just have to think about what’s the win. At some point, the expense of complying with the quality measures is a much greater expense than the innate value of the quality measures. ”
EHRs “have become symbolic of physician administrative burden, but by no means are they the whole cause,” John Flemming, MD, ONC deputy assistant secretary for health technology reform, said at the briefing. “The physician, particularly in an independent practice, must manage the practice. So he or she is the CEO. They are also on the assembly line, seeing patients. Now with EHRs, they have to be the data input person as well. It’s time consuming.”
Dr. Fleming is a family physician from Louisiana and a former Republican member of congress.
Dr. Rucker acknowledged that reducing the burden of EHRs has been discussed for quite a long time now. He recalled beginning working with them in his private practice back in 1988 and figured, based on the quick rate of technological innovation demonstrated in Silicon Valley, the issues would be solved by 1992 or 1993 at the latest.
“Right now, [EHRs] are really about documentation, about billing, but that is a funny kind of beast,” he said. “Every other industry uses their enterprise computer software to do automation, to become more efficient. We are the only business that I am aware of to have used computers to become less efficient. ... I think part of what we are trying to do ... is let some of these newer technologies that will actually reduce costs, reduce variance, have those technologies have an entrée into some of these data collections that are out there.”
WASHINGTON – Although the leadership at the Office of the National Coordinator for Health Information Technology is new, the focus of the federal office – reducing physician burden and improving interoperability of electronic heath records – remains the same.
“One priority is on the whole question of burden of [EHR] usability,” said Don Rucker, MD, the new national coordinator, at a July 11 press briefing. “The other is interoperability. We’ve obviously spent a lot of money collectively in the country on these systems, and there’s a widespread dissatisfaction with the level of interoperability.”
“We are looking at documentation and the whole quality framework around value-based purchasing,” he said. “For a lot of practices now, this has become a challenge that we just have to think about what’s the win. At some point, the expense of complying with the quality measures is a much greater expense than the innate value of the quality measures. ”
EHRs “have become symbolic of physician administrative burden, but by no means are they the whole cause,” John Flemming, MD, ONC deputy assistant secretary for health technology reform, said at the briefing. “The physician, particularly in an independent practice, must manage the practice. So he or she is the CEO. They are also on the assembly line, seeing patients. Now with EHRs, they have to be the data input person as well. It’s time consuming.”
Dr. Fleming is a family physician from Louisiana and a former Republican member of congress.
Dr. Rucker acknowledged that reducing the burden of EHRs has been discussed for quite a long time now. He recalled beginning working with them in his private practice back in 1988 and figured, based on the quick rate of technological innovation demonstrated in Silicon Valley, the issues would be solved by 1992 or 1993 at the latest.
“Right now, [EHRs] are really about documentation, about billing, but that is a funny kind of beast,” he said. “Every other industry uses their enterprise computer software to do automation, to become more efficient. We are the only business that I am aware of to have used computers to become less efficient. ... I think part of what we are trying to do ... is let some of these newer technologies that will actually reduce costs, reduce variance, have those technologies have an entrée into some of these data collections that are out there.”
WASHINGTON – Although the leadership at the Office of the National Coordinator for Health Information Technology is new, the focus of the federal office – reducing physician burden and improving interoperability of electronic heath records – remains the same.
“One priority is on the whole question of burden of [EHR] usability,” said Don Rucker, MD, the new national coordinator, at a July 11 press briefing. “The other is interoperability. We’ve obviously spent a lot of money collectively in the country on these systems, and there’s a widespread dissatisfaction with the level of interoperability.”
“We are looking at documentation and the whole quality framework around value-based purchasing,” he said. “For a lot of practices now, this has become a challenge that we just have to think about what’s the win. At some point, the expense of complying with the quality measures is a much greater expense than the innate value of the quality measures. ”
EHRs “have become symbolic of physician administrative burden, but by no means are they the whole cause,” John Flemming, MD, ONC deputy assistant secretary for health technology reform, said at the briefing. “The physician, particularly in an independent practice, must manage the practice. So he or she is the CEO. They are also on the assembly line, seeing patients. Now with EHRs, they have to be the data input person as well. It’s time consuming.”
Dr. Fleming is a family physician from Louisiana and a former Republican member of congress.
Dr. Rucker acknowledged that reducing the burden of EHRs has been discussed for quite a long time now. He recalled beginning working with them in his private practice back in 1988 and figured, based on the quick rate of technological innovation demonstrated in Silicon Valley, the issues would be solved by 1992 or 1993 at the latest.
“Right now, [EHRs] are really about documentation, about billing, but that is a funny kind of beast,” he said. “Every other industry uses their enterprise computer software to do automation, to become more efficient. We are the only business that I am aware of to have used computers to become less efficient. ... I think part of what we are trying to do ... is let some of these newer technologies that will actually reduce costs, reduce variance, have those technologies have an entrée into some of these data collections that are out there.”
Hexavalent hepatitis B vaccination mostly immunogenic 10 years later
results of an Italian study show.
The phase 3 open-label, controlled study included 732 healthy Italian children aged 11-13 years who as infants had received a two-dose primary and booster course with either Hexavac (5 mcg hepatitis B surface antigen [HBsAg]) or Infanrix hexa (10 mcg HBsAg) at 3, 5, and 11 months of age; the last dose was received at least 10 years prior to the challenge dose of a monovalent HB vaccine (HBVaxPro, 5 mcg HBsAg).
Although some of the children had HB surface antigen antibody concentrations below the seroprotection threshold, most of them had an anamnestic response when challenged with the dose of HB vaccine, “indicating the presence of specific immune memory,” the investigators said. There was no evidence of active HB disease in any of the children.
Just what the meaning of the lack of immune memory is, defined as the failure to develop an anamnestic response following an HB vaccine challenge, remains to be determined.
results of an Italian study show.
The phase 3 open-label, controlled study included 732 healthy Italian children aged 11-13 years who as infants had received a two-dose primary and booster course with either Hexavac (5 mcg hepatitis B surface antigen [HBsAg]) or Infanrix hexa (10 mcg HBsAg) at 3, 5, and 11 months of age; the last dose was received at least 10 years prior to the challenge dose of a monovalent HB vaccine (HBVaxPro, 5 mcg HBsAg).
Although some of the children had HB surface antigen antibody concentrations below the seroprotection threshold, most of them had an anamnestic response when challenged with the dose of HB vaccine, “indicating the presence of specific immune memory,” the investigators said. There was no evidence of active HB disease in any of the children.
Just what the meaning of the lack of immune memory is, defined as the failure to develop an anamnestic response following an HB vaccine challenge, remains to be determined.
results of an Italian study show.
The phase 3 open-label, controlled study included 732 healthy Italian children aged 11-13 years who as infants had received a two-dose primary and booster course with either Hexavac (5 mcg hepatitis B surface antigen [HBsAg]) or Infanrix hexa (10 mcg HBsAg) at 3, 5, and 11 months of age; the last dose was received at least 10 years prior to the challenge dose of a monovalent HB vaccine (HBVaxPro, 5 mcg HBsAg).
Although some of the children had HB surface antigen antibody concentrations below the seroprotection threshold, most of them had an anamnestic response when challenged with the dose of HB vaccine, “indicating the presence of specific immune memory,” the investigators said. There was no evidence of active HB disease in any of the children.
Just what the meaning of the lack of immune memory is, defined as the failure to develop an anamnestic response following an HB vaccine challenge, remains to be determined.
FROM VACCINE
Three-drug combo keeps early RA at bay long term
MADRID – A triple combination of methotrexate, hydroxychloroquine, and triamcinolone used to induce remission in patients with early rheumatoid arthritis (RA) was associated with higher long-term remission rates than methotrexate used alone in a study presented at the European Congress of Rheumatology.
The percentages of patients in remission were a respective 88.2% versus 72.1% at 1 year, 86.6% versus 81.9% at 2 years, and 88.0% versus 85.8% at 3 years.
“Combination treatment results in a higher remission rate in the first 2 years of treatment and a similar remission rate in the third year,” said Tammo Brunekreef, a medical student at Ziekenhuisgroep Twente in Almelo, the Netherlands, who presented the findings.
“There is no consensus on what the initial treatment should look like, however,” he said. For instance, should remission be induced with methotrexate alone? Or should methotrexate be used in combination with other synthetic disease-modifying antirheumatic drugs (DMARDs)? Or is methotrexate best combined with steroids?
“The early treatment [of RA] is very important because a shorter time to remission is related to sustainability of remission,” Mr. Brunekreef said. “Combination therapy has also been compared in previous studies with methotrexate monotherapy and had been shown to be more effective at 3 and 6 months, although not at 12 months.”
Data on the longer-term follow-up in routine care is lacking, so Mr. Brunekreef and Dutch rheumatologist Hein J. Bernelot Moens, MD, created two historical cohorts of patients with early RA. One cohort of 296 patients had a disease onset between 2006 and 2011 and had received methotrexate monotherapy initiated at 15-20 mg/week. The other cohort of 157 patients had a disease onset between 2012 and 2014 and had been given a combination of oral methotrexate, started at 20 mg/week; oral hydroxychloroquine, started at 200 mg twice daily; and a single 80-120 mg intramuscular injection of triamcinolone that could be repeated after 4 weeks, if necessary.
The mean age of the recruited patients in the monotherapy and combination cohorts was a respective 59.5 and 58.9 years, and 60.5% and 65% were female. More patients in the combination than monotherapy group were rheumatoid factor positive (72.3% vs. 62.2%), with 72.1% and 64.5% being positive for anticitrullinated protein antibodies.
“A number of patients were lost to follow-up due to death (3.7% vs. 1.9%) [or] drug-free remission (1.7% vs. 0.6%) or did not start methotrexate or for other reasons (2.4% vs. 0.6%), but this was not significantly different,” Mr. Brunekreef reported. This left 273 and 124 in each cohort, respectively, who completed 3 years’ of follow-up.
The same percentage of patients in the methotrexate and combination cohorts started a biologic DMARD in the first year (10.8%). A biologic DMARD was recommended if remission was not achieved within 6 months or if there was sustained disease activity after 6 months.
In the second year, however, 6.6% more patients in the methotrexate cohort started a biologic (9.8% vs. 3.2%). Conversely, 1.3% more patients started a biologic in the third year in the combination arm (4% vs. 2.7%). Overall, the receipt of biologics by 21% of monotherapy patients and 14% of combination therapy patients did not differ significantly.
The mean time to the start of the biologic DMARD was similar, however, at around 11-12 months.
Mr. Brunekreef answered that the DAS28-ESR had been used up to 2015 and then the DAS-CRP from 2016 onward, although the latter was only for patients in year 3, a small number of patients. “We’re looking into a way to translate those data to make them comparable,” Brunekreef said.
“That’s a real problem,” Dr. Fleischmann said, as the DAS28-ESR and DAS28-CRP are not interchangeable. He proposed that these data needed to be looked at using another measure, perhaps the Clinical Disease Activity Index.
Further, Dr. Fleischmann observed that the methotrexate monotherapy data were “absolutely incredible, compared to what we’ve seen in randomized, controlled trials, with 40%-50% of patients in remission.” In clinical trials, about 15% on methotrexate alone achieve an American College of Rheumatology 20 Response Criteria.
“These are very, very strong data, but now I wonder whether or not it’s because of that switch” in DAS28 scoring, Dr. Fleischmann said.
Mr. Brunekreef had no disclosures to report. Dr. Fleischmann has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi Genzyme, and UCB.
MADRID – A triple combination of methotrexate, hydroxychloroquine, and triamcinolone used to induce remission in patients with early rheumatoid arthritis (RA) was associated with higher long-term remission rates than methotrexate used alone in a study presented at the European Congress of Rheumatology.
The percentages of patients in remission were a respective 88.2% versus 72.1% at 1 year, 86.6% versus 81.9% at 2 years, and 88.0% versus 85.8% at 3 years.
“Combination treatment results in a higher remission rate in the first 2 years of treatment and a similar remission rate in the third year,” said Tammo Brunekreef, a medical student at Ziekenhuisgroep Twente in Almelo, the Netherlands, who presented the findings.
“There is no consensus on what the initial treatment should look like, however,” he said. For instance, should remission be induced with methotrexate alone? Or should methotrexate be used in combination with other synthetic disease-modifying antirheumatic drugs (DMARDs)? Or is methotrexate best combined with steroids?
“The early treatment [of RA] is very important because a shorter time to remission is related to sustainability of remission,” Mr. Brunekreef said. “Combination therapy has also been compared in previous studies with methotrexate monotherapy and had been shown to be more effective at 3 and 6 months, although not at 12 months.”
Data on the longer-term follow-up in routine care is lacking, so Mr. Brunekreef and Dutch rheumatologist Hein J. Bernelot Moens, MD, created two historical cohorts of patients with early RA. One cohort of 296 patients had a disease onset between 2006 and 2011 and had received methotrexate monotherapy initiated at 15-20 mg/week. The other cohort of 157 patients had a disease onset between 2012 and 2014 and had been given a combination of oral methotrexate, started at 20 mg/week; oral hydroxychloroquine, started at 200 mg twice daily; and a single 80-120 mg intramuscular injection of triamcinolone that could be repeated after 4 weeks, if necessary.
The mean age of the recruited patients in the monotherapy and combination cohorts was a respective 59.5 and 58.9 years, and 60.5% and 65% were female. More patients in the combination than monotherapy group were rheumatoid factor positive (72.3% vs. 62.2%), with 72.1% and 64.5% being positive for anticitrullinated protein antibodies.
“A number of patients were lost to follow-up due to death (3.7% vs. 1.9%) [or] drug-free remission (1.7% vs. 0.6%) or did not start methotrexate or for other reasons (2.4% vs. 0.6%), but this was not significantly different,” Mr. Brunekreef reported. This left 273 and 124 in each cohort, respectively, who completed 3 years’ of follow-up.
The same percentage of patients in the methotrexate and combination cohorts started a biologic DMARD in the first year (10.8%). A biologic DMARD was recommended if remission was not achieved within 6 months or if there was sustained disease activity after 6 months.
In the second year, however, 6.6% more patients in the methotrexate cohort started a biologic (9.8% vs. 3.2%). Conversely, 1.3% more patients started a biologic in the third year in the combination arm (4% vs. 2.7%). Overall, the receipt of biologics by 21% of monotherapy patients and 14% of combination therapy patients did not differ significantly.
The mean time to the start of the biologic DMARD was similar, however, at around 11-12 months.
Mr. Brunekreef answered that the DAS28-ESR had been used up to 2015 and then the DAS-CRP from 2016 onward, although the latter was only for patients in year 3, a small number of patients. “We’re looking into a way to translate those data to make them comparable,” Brunekreef said.
“That’s a real problem,” Dr. Fleischmann said, as the DAS28-ESR and DAS28-CRP are not interchangeable. He proposed that these data needed to be looked at using another measure, perhaps the Clinical Disease Activity Index.
Further, Dr. Fleischmann observed that the methotrexate monotherapy data were “absolutely incredible, compared to what we’ve seen in randomized, controlled trials, with 40%-50% of patients in remission.” In clinical trials, about 15% on methotrexate alone achieve an American College of Rheumatology 20 Response Criteria.
“These are very, very strong data, but now I wonder whether or not it’s because of that switch” in DAS28 scoring, Dr. Fleischmann said.
Mr. Brunekreef had no disclosures to report. Dr. Fleischmann has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi Genzyme, and UCB.
MADRID – A triple combination of methotrexate, hydroxychloroquine, and triamcinolone used to induce remission in patients with early rheumatoid arthritis (RA) was associated with higher long-term remission rates than methotrexate used alone in a study presented at the European Congress of Rheumatology.
The percentages of patients in remission were a respective 88.2% versus 72.1% at 1 year, 86.6% versus 81.9% at 2 years, and 88.0% versus 85.8% at 3 years.
“Combination treatment results in a higher remission rate in the first 2 years of treatment and a similar remission rate in the third year,” said Tammo Brunekreef, a medical student at Ziekenhuisgroep Twente in Almelo, the Netherlands, who presented the findings.
“There is no consensus on what the initial treatment should look like, however,” he said. For instance, should remission be induced with methotrexate alone? Or should methotrexate be used in combination with other synthetic disease-modifying antirheumatic drugs (DMARDs)? Or is methotrexate best combined with steroids?
“The early treatment [of RA] is very important because a shorter time to remission is related to sustainability of remission,” Mr. Brunekreef said. “Combination therapy has also been compared in previous studies with methotrexate monotherapy and had been shown to be more effective at 3 and 6 months, although not at 12 months.”
Data on the longer-term follow-up in routine care is lacking, so Mr. Brunekreef and Dutch rheumatologist Hein J. Bernelot Moens, MD, created two historical cohorts of patients with early RA. One cohort of 296 patients had a disease onset between 2006 and 2011 and had received methotrexate monotherapy initiated at 15-20 mg/week. The other cohort of 157 patients had a disease onset between 2012 and 2014 and had been given a combination of oral methotrexate, started at 20 mg/week; oral hydroxychloroquine, started at 200 mg twice daily; and a single 80-120 mg intramuscular injection of triamcinolone that could be repeated after 4 weeks, if necessary.
The mean age of the recruited patients in the monotherapy and combination cohorts was a respective 59.5 and 58.9 years, and 60.5% and 65% were female. More patients in the combination than monotherapy group were rheumatoid factor positive (72.3% vs. 62.2%), with 72.1% and 64.5% being positive for anticitrullinated protein antibodies.
“A number of patients were lost to follow-up due to death (3.7% vs. 1.9%) [or] drug-free remission (1.7% vs. 0.6%) or did not start methotrexate or for other reasons (2.4% vs. 0.6%), but this was not significantly different,” Mr. Brunekreef reported. This left 273 and 124 in each cohort, respectively, who completed 3 years’ of follow-up.
The same percentage of patients in the methotrexate and combination cohorts started a biologic DMARD in the first year (10.8%). A biologic DMARD was recommended if remission was not achieved within 6 months or if there was sustained disease activity after 6 months.
In the second year, however, 6.6% more patients in the methotrexate cohort started a biologic (9.8% vs. 3.2%). Conversely, 1.3% more patients started a biologic in the third year in the combination arm (4% vs. 2.7%). Overall, the receipt of biologics by 21% of monotherapy patients and 14% of combination therapy patients did not differ significantly.
The mean time to the start of the biologic DMARD was similar, however, at around 11-12 months.
Mr. Brunekreef answered that the DAS28-ESR had been used up to 2015 and then the DAS-CRP from 2016 onward, although the latter was only for patients in year 3, a small number of patients. “We’re looking into a way to translate those data to make them comparable,” Brunekreef said.
“That’s a real problem,” Dr. Fleischmann said, as the DAS28-ESR and DAS28-CRP are not interchangeable. He proposed that these data needed to be looked at using another measure, perhaps the Clinical Disease Activity Index.
Further, Dr. Fleischmann observed that the methotrexate monotherapy data were “absolutely incredible, compared to what we’ve seen in randomized, controlled trials, with 40%-50% of patients in remission.” In clinical trials, about 15% on methotrexate alone achieve an American College of Rheumatology 20 Response Criteria.
“These are very, very strong data, but now I wonder whether or not it’s because of that switch” in DAS28 scoring, Dr. Fleischmann said.
Mr. Brunekreef had no disclosures to report. Dr. Fleischmann has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi Genzyme, and UCB.
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: A DAS28 less than 2.6 was achieved in 88.2% who received a methotrexate-based triple combination versus 72.1% with methotrexate monotherapy at 1 year, 86.6% versus 81.9% at 2 years, and 88.0% versus 85.8% at 3 years.
Data source: Two historical cohorts of early arthritis patients treated with methotrexate alone (n = 296) or a combination of methotrexate, hydroxychloroquine, and triamcinolone (n = 157) in routine care.
Disclosures: The study presenter had no disclosures to report. An independent commentator has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi Genzyme, and UCB.
FDA okays ClearLLab test for hematologic cancer detection
Beckman Coulter has been authorized to market its ClearLLab Reagents (T1, T2, B1, B2, M) tests for use with flow cytometry to detect leukemias, lymphomas, and myeloproliferative disorders in blood, bone marrow, and lymph nodes, according to the U.S. Food and Drug Administration.
A study evaluating the efficacy of the test compared the test results (n = 279) with clinical evaluations at four independent clinical sites. The results matched the diagnoses 93.4% of the time and correctly detected cancer 84.2% of the time.
“This represents a major step forward for the hematology-oncology community,” Alberto Gutierrez, PhD, of the FDA’s Center for Devices and Radiological Health said in the FDA’s release. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.”
The approval coincides with criteria for ongoing evaluation of the ClearLLab tests and approval of future tests. The release notes that the ClearLLab test results must be reviewed by a trained professional.
Beckman Coulter has been authorized to market its ClearLLab Reagents (T1, T2, B1, B2, M) tests for use with flow cytometry to detect leukemias, lymphomas, and myeloproliferative disorders in blood, bone marrow, and lymph nodes, according to the U.S. Food and Drug Administration.
A study evaluating the efficacy of the test compared the test results (n = 279) with clinical evaluations at four independent clinical sites. The results matched the diagnoses 93.4% of the time and correctly detected cancer 84.2% of the time.
“This represents a major step forward for the hematology-oncology community,” Alberto Gutierrez, PhD, of the FDA’s Center for Devices and Radiological Health said in the FDA’s release. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.”
The approval coincides with criteria for ongoing evaluation of the ClearLLab tests and approval of future tests. The release notes that the ClearLLab test results must be reviewed by a trained professional.
Beckman Coulter has been authorized to market its ClearLLab Reagents (T1, T2, B1, B2, M) tests for use with flow cytometry to detect leukemias, lymphomas, and myeloproliferative disorders in blood, bone marrow, and lymph nodes, according to the U.S. Food and Drug Administration.
A study evaluating the efficacy of the test compared the test results (n = 279) with clinical evaluations at four independent clinical sites. The results matched the diagnoses 93.4% of the time and correctly detected cancer 84.2% of the time.
“This represents a major step forward for the hematology-oncology community,” Alberto Gutierrez, PhD, of the FDA’s Center for Devices and Radiological Health said in the FDA’s release. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.”
The approval coincides with criteria for ongoing evaluation of the ClearLLab tests and approval of future tests. The release notes that the ClearLLab test results must be reviewed by a trained professional.
Sustained remission on biologics bodes well for children with JIA
MADRID – Many children with juvenile idiopathic arthritis (JIA) who do well on biologics for a prolonged period will stay in remission after the medication is withdrawn, some new real-world data suggest.
A database review found that 70% of those in remission for at least 1.5 years remained in remission after stopping their biologic agent. Patients taking tocilizumab had the best outcomes, with 8 months of sustained, drug-free remission and only a 12% rate of disease flare, Ekaterina Alexeeva, MD, reported at the European Congress of Rheumatology.
“Prolonged therapy with biologic agents may cause adverse events which lead to the necessity of discontinuation of therapy in patients once complete disease quiescence has been achieved,” she said. While long-term drug studies do offer some glimpse into the stability of remission after drug discontinuation, these data don’t often reflect real-world experience.
“Clinical trials are made up of highly selected participants in contorted conditions with limited duration. Real-word data, collected under real-life practical circumstances, provide additional characteristics of patient populations, information on the effectiveness and safety of treatment over time, and the outcomes we can achieve under real-world conditions,” Dr. Alexeeva said.
She plumbed a national JIA database to find 83 patients who had achieved longstanding clinical remission on a biologic therapy, then either rapidly discontinued treatment (61) or went through a tapering protocol (22), according to their doctors’ decision. These children were a mean of 11 years old, with mean disease duration of 2 years before the initiation of a biologic treatment. Systemic JIA was present in 40%; 22% had oligoarthritis, and 38% had polyarthritis.
All of the patients with systemic JIA were taking tocilizumab, although only 25% took it as monotherapy. Other medications being used were methotrexate (42%), cyclosporine (15%), glucocorticoids (15%), and leflunomide (3%).
For those with oligo- and polyarthritis, etanercept was the most commonly employed biologic (70%), followed by adalimumab (30%). Most (68%) were on monotherapy with their agent; however, 18% of those taking etanercept and 14% of those taking adalimumab were also taking methotrexate.
Before discontinuing their medication, the systemic JIA patients taking tocilizumab had a mean 43 months of inactive disease and a mean 37 months of remission. Among those taking adalimumab, the mean period of inactive disease was 48 months and the mean remission was 40 months. Among those taking etanercept, the mean period of inactive disease was 40 months and the mean remission was 34 months.
After discontinuing the biologic, the mean overall remission length was 6 months for all patients. However, this varied considerably with diagnosis and medication, Dr. Alexeeva noted. For systemic JIA patients taking tocilizumab, remission ranged from a minimum of 1 month to a maximum of 48 months. For those taking adalimumab, remission ranged from 4 to 38 months. Remission ranged from 1 to 20 months among those taking etanercept.
Disease flare occurred in 12% of those taking tocilizumab, at a mean of 8 months after discontinuation; 31% of those taking etanercept at a mean of 5.5 months; and 60% of those taking adalimumab at a mean of 4 months. Time to flare was longest among those taking tocilizumab (6-18 months), followed by etanercept (1.5-12 months) and adalimumab (1-13 months).
Dr. Alexeeva disclosed research funding and support from numerous pharmaceutical companies.
[email protected]
On Twitter @alz_gal
MADRID – Many children with juvenile idiopathic arthritis (JIA) who do well on biologics for a prolonged period will stay in remission after the medication is withdrawn, some new real-world data suggest.
A database review found that 70% of those in remission for at least 1.5 years remained in remission after stopping their biologic agent. Patients taking tocilizumab had the best outcomes, with 8 months of sustained, drug-free remission and only a 12% rate of disease flare, Ekaterina Alexeeva, MD, reported at the European Congress of Rheumatology.
“Prolonged therapy with biologic agents may cause adverse events which lead to the necessity of discontinuation of therapy in patients once complete disease quiescence has been achieved,” she said. While long-term drug studies do offer some glimpse into the stability of remission after drug discontinuation, these data don’t often reflect real-world experience.
“Clinical trials are made up of highly selected participants in contorted conditions with limited duration. Real-word data, collected under real-life practical circumstances, provide additional characteristics of patient populations, information on the effectiveness and safety of treatment over time, and the outcomes we can achieve under real-world conditions,” Dr. Alexeeva said.
She plumbed a national JIA database to find 83 patients who had achieved longstanding clinical remission on a biologic therapy, then either rapidly discontinued treatment (61) or went through a tapering protocol (22), according to their doctors’ decision. These children were a mean of 11 years old, with mean disease duration of 2 years before the initiation of a biologic treatment. Systemic JIA was present in 40%; 22% had oligoarthritis, and 38% had polyarthritis.
All of the patients with systemic JIA were taking tocilizumab, although only 25% took it as monotherapy. Other medications being used were methotrexate (42%), cyclosporine (15%), glucocorticoids (15%), and leflunomide (3%).
For those with oligo- and polyarthritis, etanercept was the most commonly employed biologic (70%), followed by adalimumab (30%). Most (68%) were on monotherapy with their agent; however, 18% of those taking etanercept and 14% of those taking adalimumab were also taking methotrexate.
Before discontinuing their medication, the systemic JIA patients taking tocilizumab had a mean 43 months of inactive disease and a mean 37 months of remission. Among those taking adalimumab, the mean period of inactive disease was 48 months and the mean remission was 40 months. Among those taking etanercept, the mean period of inactive disease was 40 months and the mean remission was 34 months.
After discontinuing the biologic, the mean overall remission length was 6 months for all patients. However, this varied considerably with diagnosis and medication, Dr. Alexeeva noted. For systemic JIA patients taking tocilizumab, remission ranged from a minimum of 1 month to a maximum of 48 months. For those taking adalimumab, remission ranged from 4 to 38 months. Remission ranged from 1 to 20 months among those taking etanercept.
Disease flare occurred in 12% of those taking tocilizumab, at a mean of 8 months after discontinuation; 31% of those taking etanercept at a mean of 5.5 months; and 60% of those taking adalimumab at a mean of 4 months. Time to flare was longest among those taking tocilizumab (6-18 months), followed by etanercept (1.5-12 months) and adalimumab (1-13 months).
Dr. Alexeeva disclosed research funding and support from numerous pharmaceutical companies.
[email protected]
On Twitter @alz_gal
MADRID – Many children with juvenile idiopathic arthritis (JIA) who do well on biologics for a prolonged period will stay in remission after the medication is withdrawn, some new real-world data suggest.
A database review found that 70% of those in remission for at least 1.5 years remained in remission after stopping their biologic agent. Patients taking tocilizumab had the best outcomes, with 8 months of sustained, drug-free remission and only a 12% rate of disease flare, Ekaterina Alexeeva, MD, reported at the European Congress of Rheumatology.
“Prolonged therapy with biologic agents may cause adverse events which lead to the necessity of discontinuation of therapy in patients once complete disease quiescence has been achieved,” she said. While long-term drug studies do offer some glimpse into the stability of remission after drug discontinuation, these data don’t often reflect real-world experience.
“Clinical trials are made up of highly selected participants in contorted conditions with limited duration. Real-word data, collected under real-life practical circumstances, provide additional characteristics of patient populations, information on the effectiveness and safety of treatment over time, and the outcomes we can achieve under real-world conditions,” Dr. Alexeeva said.
She plumbed a national JIA database to find 83 patients who had achieved longstanding clinical remission on a biologic therapy, then either rapidly discontinued treatment (61) or went through a tapering protocol (22), according to their doctors’ decision. These children were a mean of 11 years old, with mean disease duration of 2 years before the initiation of a biologic treatment. Systemic JIA was present in 40%; 22% had oligoarthritis, and 38% had polyarthritis.
All of the patients with systemic JIA were taking tocilizumab, although only 25% took it as monotherapy. Other medications being used were methotrexate (42%), cyclosporine (15%), glucocorticoids (15%), and leflunomide (3%).
For those with oligo- and polyarthritis, etanercept was the most commonly employed biologic (70%), followed by adalimumab (30%). Most (68%) were on monotherapy with their agent; however, 18% of those taking etanercept and 14% of those taking adalimumab were also taking methotrexate.
Before discontinuing their medication, the systemic JIA patients taking tocilizumab had a mean 43 months of inactive disease and a mean 37 months of remission. Among those taking adalimumab, the mean period of inactive disease was 48 months and the mean remission was 40 months. Among those taking etanercept, the mean period of inactive disease was 40 months and the mean remission was 34 months.
After discontinuing the biologic, the mean overall remission length was 6 months for all patients. However, this varied considerably with diagnosis and medication, Dr. Alexeeva noted. For systemic JIA patients taking tocilizumab, remission ranged from a minimum of 1 month to a maximum of 48 months. For those taking adalimumab, remission ranged from 4 to 38 months. Remission ranged from 1 to 20 months among those taking etanercept.
Disease flare occurred in 12% of those taking tocilizumab, at a mean of 8 months after discontinuation; 31% of those taking etanercept at a mean of 5.5 months; and 60% of those taking adalimumab at a mean of 4 months. Time to flare was longest among those taking tocilizumab (6-18 months), followed by etanercept (1.5-12 months) and adalimumab (1-13 months).
Dr. Alexeeva disclosed research funding and support from numerous pharmaceutical companies.
[email protected]
On Twitter @alz_gal
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Overall, 70% of those who were in remission for at least 1.5 years remained in remission after stopping their biologic.
Data source: A database review comprising 83 children.
Disclosures: Dr. Alexeeva disclosed research and grant support from numerous pharmaceutical companies.