Extended-release oxymorphone hydrochloride (Opana ER) tablets contain an inert ingredient that can trigger acute microangiopathic hemolytic anemia and thrombocytopenia in those who abuse the drug via intravenous injection, Ryan Hunt, of the Food and Drug Administration, and his colleagues reported.

High-molecular-weight polyethylene oxide appeared to be the cause of acute cases of thrombotic microangiopathy in three patients who were treated in the emergency department of a single hospital in Tennessee. All had chest pain, dyspnea, visual impairment, microangiopathic hemolytic anemia and thrombocytopenia, increased lactate dehydrogenase, and undetectable haptoglobin serum levels. Two patients also had acute renal failure. Plasma exchange therapy was initiated in all three; one required additional hemodialysis.

ADAMTS13 activity was normal in blood samples obtained in two patients before they started plasma exchange. Histologic evidence of thrombotic microangiopathy with endothelial swelling of arterioles and acute tubular injury without deposition of immune complexes was seen in kidney biopsies performed in two patients. In addition, gelatinous material occluded the dialysis catheter and apheresis tubings during the initial plasma exchange sessions, the researchers reported (Blood. 2017;129[7]:896-905).

To test the association of polyethylene oxide with thrombotic microangiopathy, the researchers heated a 40-mg Opana ER tablet cut in several pieces in a spoon with 2 mL water until boiling. They injected guinea pigs with 0.1 or 0.3 mg/kg of the extracted polyethylene oxide, either as a single dose or as five doses given at 1.5-hour intervals. A dose-dependent increase of polyethylene oxide in plasma peaked at 8 hours after the first dose was measured and paralleled with intravascular hemolysis with increased plasma concentration of free hemoglobin, schistocytes in the peripheral blood smear, and thrombocytopenia. Spiking control blood samples in vitro with polyethylene oxide did not result in hemolysis.

“Although injection abuse of prescription opioids is highly concentrated in certain regions of the United States, particularly in rural Appalachia, all physicians should be highly inquisitive of IV drug abuse when presented with cases of [thrombotic microangiopathy],” the researchers concluded.

The researchers had no relevant conflicts of interest. One of the researchers is employed by Quest Diagnostics.

[email protected]

On Twitter @maryjodales

Extended-release oxymorphone hydrochloride (Opana ER) tablets contain an inert ingredient that can trigger acute microangiopathic hemolytic anemia and thrombocytopenia in those who abuse the drug via intravenous injection, Ryan Hunt, of the Food and Drug Administration, and his colleagues reported.

High-molecular-weight polyethylene oxide appeared to be the cause of acute cases of thrombotic microangiopathy in three patients who were treated in the emergency department of a single hospital in Tennessee. All had chest pain, dyspnea, visual impairment, microangiopathic hemolytic anemia and thrombocytopenia, increased lactate dehydrogenase, and undetectable haptoglobin serum levels. Two patients also had acute renal failure. Plasma exchange therapy was initiated in all three; one required additional hemodialysis.

ADAMTS13 activity was normal in blood samples obtained in two patients before they started plasma exchange. Histologic evidence of thrombotic microangiopathy with endothelial swelling of arterioles and acute tubular injury without deposition of immune complexes was seen in kidney biopsies performed in two patients. In addition, gelatinous material occluded the dialysis catheter and apheresis tubings during the initial plasma exchange sessions, the researchers reported (Blood. 2017;129[7]:896-905).

To test the association of polyethylene oxide with thrombotic microangiopathy, the researchers heated a 40-mg Opana ER tablet cut in several pieces in a spoon with 2 mL water until boiling. They injected guinea pigs with 0.1 or 0.3 mg/kg of the extracted polyethylene oxide, either as a single dose or as five doses given at 1.5-hour intervals. A dose-dependent increase of polyethylene oxide in plasma peaked at 8 hours after the first dose was measured and paralleled with intravascular hemolysis with increased plasma concentration of free hemoglobin, schistocytes in the peripheral blood smear, and thrombocytopenia. Spiking control blood samples in vitro with polyethylene oxide did not result in hemolysis.

“Although injection abuse of prescription opioids is highly concentrated in certain regions of the United States, particularly in rural Appalachia, all physicians should be highly inquisitive of IV drug abuse when presented with cases of [thrombotic microangiopathy],” the researchers concluded.

The researchers had no relevant conflicts of interest. One of the researchers is employed by Quest Diagnostics.

[email protected]

On Twitter @maryjodales

Extended-release oxymorphone hydrochloride (Opana ER) tablets contain an inert ingredient that can trigger acute microangiopathic hemolytic anemia and thrombocytopenia in those who abuse the drug via intravenous injection, Ryan Hunt, of the Food and Drug Administration, and his colleagues reported.

High-molecular-weight polyethylene oxide appeared to be the cause of acute cases of thrombotic microangiopathy in three patients who were treated in the emergency department of a single hospital in Tennessee. All had chest pain, dyspnea, visual impairment, microangiopathic hemolytic anemia and thrombocytopenia, increased lactate dehydrogenase, and undetectable haptoglobin serum levels. Two patients also had acute renal failure. Plasma exchange therapy was initiated in all three; one required additional hemodialysis.

ADAMTS13 activity was normal in blood samples obtained in two patients before they started plasma exchange. Histologic evidence of thrombotic microangiopathy with endothelial swelling of arterioles and acute tubular injury without deposition of immune complexes was seen in kidney biopsies performed in two patients. In addition, gelatinous material occluded the dialysis catheter and apheresis tubings during the initial plasma exchange sessions, the researchers reported (Blood. 2017;129[7]:896-905).

To test the association of polyethylene oxide with thrombotic microangiopathy, the researchers heated a 40-mg Opana ER tablet cut in several pieces in a spoon with 2 mL water until boiling. They injected guinea pigs with 0.1 or 0.3 mg/kg of the extracted polyethylene oxide, either as a single dose or as five doses given at 1.5-hour intervals. A dose-dependent increase of polyethylene oxide in plasma peaked at 8 hours after the first dose was measured and paralleled with intravascular hemolysis with increased plasma concentration of free hemoglobin, schistocytes in the peripheral blood smear, and thrombocytopenia. Spiking control blood samples in vitro with polyethylene oxide did not result in hemolysis.

“Although injection abuse of prescription opioids is highly concentrated in certain regions of the United States, particularly in rural Appalachia, all physicians should be highly inquisitive of IV drug abuse when presented with cases of [thrombotic microangiopathy],” the researchers concluded.

The researchers had no relevant conflicts of interest. One of the researchers is employed by Quest Diagnostics.

[email protected]

On Twitter @maryjodales

Photo by Etan J. Tal

New research has revealed factors that may increase the risk of B-cell non-Hodgkin lymphoma (B-NHL) in Israelis and Palestinians.

This large-scale, epidemiological study indicated that each group had its own unique risk factors.

However, in both groups, recreational sun exposure, black hair-dye use, a history of hospitalization for infection, and having a first-degree relative with a hematopoietic malignancy were all associated with B-NHL.

A team of Palestinian and Israeli researchers reported these findings in PLOS ONE.

The researchers noted that Israelis and Palestinians share the same ecosystem but differ in terms of lifestyle, health behaviors, and medical systems. Yet both populations report high incidences of NHL.

To gain some insight into this phenomenon, the team conducted a study examining risk factors for B-NHL and its subtypes in these two populations.

The researchers looked at medical history, environmental factors, and lifestyle factors in 823 B-NHL patients and 808 healthy controls.

There were 516 Israeli Jews with B-NHL and 307 Palestinian Arabs with B-NHL. The mean age at diagnosis was 60 and 51, respectively.

The proportion of patients with diffuse large B-cell lymphoma was 71% of Palestinian Arabs and 41% of Israeli Jews. The proportion of patients with follicular lymphoma was 14% and 28%, respectively. And the proportion of patients with marginal zone lymphoma was 2% and 14%, respectively.

Using data from questionnaires, pathology review, serology, and genotyping, the researchers uncovered potential risk factors for B-NHL common to both populations and other factors unique to each population.

Results

The data showed that, in both Palestinian Arabs and Israeli Jews, B-NHL was associated with:

• Recreational sun exposure (odds ratio [OR]=1.4)
• Black hair-dye use (OR=1.70)
• A history of hospitalization for infection (OR=1.68)
• Having a first-degree relative with a hematopoietic malignancy (OR=1.69).

Smoking was associated with follicular lymphoma in both populations (OR=1.46). And greater-than-monthly indoor pesticide use was associated with diffuse large B-cell lymphoma in both populations (OR=2.01).

There was an inverse association between alcohol use and B-NHL for both populations (OR=0.46).

Among Palestinian Arabs only, risk factors for B-NHL included gardening (OR=1.93) and a history of herpes (OR=3.73), mononucleosis (OR=6.34), rubella (OR=2.86), and blood transfusion (OR=2.53).

Risk factors that applied to Israeli Jews only included growing fruits and vegetables (OR=1.87) and self-reported autoimmune diseases (OR=1.99).

The researchers said differences in risk factors by ethnicity could reflect differences in lifestyle, medical systems, and reporting patterns, while variations by B-NHL subtypes suggest specific causal factors for different types of disease. However, these findings require further investigation to reveal their mechanisms.

“Apart from the scientific contribution that this research provides in terms of understanding risk factors for NHL, the study entails an important research cooperation among many institutions,” said study author Ora Paltiel, of Hadassah-Hebrew University Medical Organization in Jerusalem, Israel.

“The study provided opportunities for training Palestinian and Israeli researchers and will provide for intellectual interaction for years to come. The data collected will also provide a research platform for the future study of lymphoma. Epidemiologic research has the potential to improve and preserve human health, and it can also serve as a bridge to dialogue among nations.” 

Photo by Etan J. Tal

New research has revealed factors that may increase the risk of B-cell non-Hodgkin lymphoma (B-NHL) in Israelis and Palestinians.

This large-scale, epidemiological study indicated that each group had its own unique risk factors.

However, in both groups, recreational sun exposure, black hair-dye use, a history of hospitalization for infection, and having a first-degree relative with a hematopoietic malignancy were all associated with B-NHL.

A team of Palestinian and Israeli researchers reported these findings in PLOS ONE.

The researchers noted that Israelis and Palestinians share the same ecosystem but differ in terms of lifestyle, health behaviors, and medical systems. Yet both populations report high incidences of NHL.

To gain some insight into this phenomenon, the team conducted a study examining risk factors for B-NHL and its subtypes in these two populations.

The researchers looked at medical history, environmental factors, and lifestyle factors in 823 B-NHL patients and 808 healthy controls.

There were 516 Israeli Jews with B-NHL and 307 Palestinian Arabs with B-NHL. The mean age at diagnosis was 60 and 51, respectively.

The proportion of patients with diffuse large B-cell lymphoma was 71% of Palestinian Arabs and 41% of Israeli Jews. The proportion of patients with follicular lymphoma was 14% and 28%, respectively. And the proportion of patients with marginal zone lymphoma was 2% and 14%, respectively.

Using data from questionnaires, pathology review, serology, and genotyping, the researchers uncovered potential risk factors for B-NHL common to both populations and other factors unique to each population.

Results

The data showed that, in both Palestinian Arabs and Israeli Jews, B-NHL was associated with:

• Recreational sun exposure (odds ratio [OR]=1.4)
• Black hair-dye use (OR=1.70)
• A history of hospitalization for infection (OR=1.68)
• Having a first-degree relative with a hematopoietic malignancy (OR=1.69).

Smoking was associated with follicular lymphoma in both populations (OR=1.46). And greater-than-monthly indoor pesticide use was associated with diffuse large B-cell lymphoma in both populations (OR=2.01).

There was an inverse association between alcohol use and B-NHL for both populations (OR=0.46).

Among Palestinian Arabs only, risk factors for B-NHL included gardening (OR=1.93) and a history of herpes (OR=3.73), mononucleosis (OR=6.34), rubella (OR=2.86), and blood transfusion (OR=2.53).

Risk factors that applied to Israeli Jews only included growing fruits and vegetables (OR=1.87) and self-reported autoimmune diseases (OR=1.99).

The researchers said differences in risk factors by ethnicity could reflect differences in lifestyle, medical systems, and reporting patterns, while variations by B-NHL subtypes suggest specific causal factors for different types of disease. However, these findings require further investigation to reveal their mechanisms.

“Apart from the scientific contribution that this research provides in terms of understanding risk factors for NHL, the study entails an important research cooperation among many institutions,” said study author Ora Paltiel, of Hadassah-Hebrew University Medical Organization in Jerusalem, Israel.

“The study provided opportunities for training Palestinian and Israeli researchers and will provide for intellectual interaction for years to come. The data collected will also provide a research platform for the future study of lymphoma. Epidemiologic research has the potential to improve and preserve human health, and it can also serve as a bridge to dialogue among nations.” 

Photo by Etan J. Tal

New research has revealed factors that may increase the risk of B-cell non-Hodgkin lymphoma (B-NHL) in Israelis and Palestinians.

This large-scale, epidemiological study indicated that each group had its own unique risk factors.

However, in both groups, recreational sun exposure, black hair-dye use, a history of hospitalization for infection, and having a first-degree relative with a hematopoietic malignancy were all associated with B-NHL.

A team of Palestinian and Israeli researchers reported these findings in PLOS ONE.

The researchers noted that Israelis and Palestinians share the same ecosystem but differ in terms of lifestyle, health behaviors, and medical systems. Yet both populations report high incidences of NHL.

To gain some insight into this phenomenon, the team conducted a study examining risk factors for B-NHL and its subtypes in these two populations.

The researchers looked at medical history, environmental factors, and lifestyle factors in 823 B-NHL patients and 808 healthy controls.

There were 516 Israeli Jews with B-NHL and 307 Palestinian Arabs with B-NHL. The mean age at diagnosis was 60 and 51, respectively.

The proportion of patients with diffuse large B-cell lymphoma was 71% of Palestinian Arabs and 41% of Israeli Jews. The proportion of patients with follicular lymphoma was 14% and 28%, respectively. And the proportion of patients with marginal zone lymphoma was 2% and 14%, respectively.

Using data from questionnaires, pathology review, serology, and genotyping, the researchers uncovered potential risk factors for B-NHL common to both populations and other factors unique to each population.

Results

The data showed that, in both Palestinian Arabs and Israeli Jews, B-NHL was associated with:

• Recreational sun exposure (odds ratio [OR]=1.4)
• Black hair-dye use (OR=1.70)
• A history of hospitalization for infection (OR=1.68)
• Having a first-degree relative with a hematopoietic malignancy (OR=1.69).

Smoking was associated with follicular lymphoma in both populations (OR=1.46). And greater-than-monthly indoor pesticide use was associated with diffuse large B-cell lymphoma in both populations (OR=2.01).

There was an inverse association between alcohol use and B-NHL for both populations (OR=0.46).

Among Palestinian Arabs only, risk factors for B-NHL included gardening (OR=1.93) and a history of herpes (OR=3.73), mononucleosis (OR=6.34), rubella (OR=2.86), and blood transfusion (OR=2.53).

Risk factors that applied to Israeli Jews only included growing fruits and vegetables (OR=1.87) and self-reported autoimmune diseases (OR=1.99).

The researchers said differences in risk factors by ethnicity could reflect differences in lifestyle, medical systems, and reporting patterns, while variations by B-NHL subtypes suggest specific causal factors for different types of disease. However, these findings require further investigation to reveal their mechanisms.

“Apart from the scientific contribution that this research provides in terms of understanding risk factors for NHL, the study entails an important research cooperation among many institutions,” said study author Ora Paltiel, of Hadassah-Hebrew University Medical Organization in Jerusalem, Israel.

“The study provided opportunities for training Palestinian and Israeli researchers and will provide for intellectual interaction for years to come. The data collected will also provide a research platform for the future study of lymphoma. Epidemiologic research has the potential to improve and preserve human health, and it can also serve as a bridge to dialogue among nations.” 

Helmholtz Zentrum München

Deep learning can be used to determine how murine hematopoietic stem and progenitor cells (HSPCs) will differentiate, according to research published in Nature Methods.

Deep learning algorithms simulate the learning processes in people using artificial neural networks.

Researchers have reported the development of software that uses deep learning to predict which type of cell murine HSPCs will differentiate into, based on microscopy images.

“A hematopoietic stem cell’s decision to become a certain cell type cannot be observed,” said study author Carsten Marr, PhD, of Helmholtz Zentrum München–German Research Center for Environmental Health in Neuherberg, Germany.

“At this time, it is only possible to verify the decision retrospectively with cell surface markers.”

Therefore, Dr Marr and his team set out to develop an algorithm that can predict the decision in advance, and deep learning was key.

“Deep neural networks play a major role in our method,” Dr Marr said. “Our algorithm classifies light microscopic images and videos of individual cells by comparing these data with past experience from the development of such cells. In this way, the algorithm ‘learns’ how certain cells behave.”

Specifically, the researchers examined murine HSPCs filmed under a microscope in the lab. Using information on the cells’ appearance and speed, the software was able to “memorize” the corresponding behavior patterns and then make its prediction.

“Compared to conventional methods, such as fluorescent antibodies against certain surface proteins, we know how the cells will decide 3 cell generations earlier,” said Felix Buggenthin, PhD, of Helmholtz Zentrum München–German Research Center for Environmental Health.

“Since we now know which cells will develop in which way, we can isolate them earlier than before and examine how they differ at a molecular level,” Dr Marr added. “We want to use this information to understand how the choices are made for particular developmental traits.”

Helmholtz Zentrum München

Deep learning can be used to determine how murine hematopoietic stem and progenitor cells (HSPCs) will differentiate, according to research published in Nature Methods.

Deep learning algorithms simulate the learning processes in people using artificial neural networks.

Researchers have reported the development of software that uses deep learning to predict which type of cell murine HSPCs will differentiate into, based on microscopy images.

“A hematopoietic stem cell’s decision to become a certain cell type cannot be observed,” said study author Carsten Marr, PhD, of Helmholtz Zentrum München–German Research Center for Environmental Health in Neuherberg, Germany.

“At this time, it is only possible to verify the decision retrospectively with cell surface markers.”

Therefore, Dr Marr and his team set out to develop an algorithm that can predict the decision in advance, and deep learning was key.

“Deep neural networks play a major role in our method,” Dr Marr said. “Our algorithm classifies light microscopic images and videos of individual cells by comparing these data with past experience from the development of such cells. In this way, the algorithm ‘learns’ how certain cells behave.”

Specifically, the researchers examined murine HSPCs filmed under a microscope in the lab. Using information on the cells’ appearance and speed, the software was able to “memorize” the corresponding behavior patterns and then make its prediction.

“Compared to conventional methods, such as fluorescent antibodies against certain surface proteins, we know how the cells will decide 3 cell generations earlier,” said Felix Buggenthin, PhD, of Helmholtz Zentrum München–German Research Center for Environmental Health.

“Since we now know which cells will develop in which way, we can isolate them earlier than before and examine how they differ at a molecular level,” Dr Marr added. “We want to use this information to understand how the choices are made for particular developmental traits.”

Helmholtz Zentrum München

Deep learning can be used to determine how murine hematopoietic stem and progenitor cells (HSPCs) will differentiate, according to research published in Nature Methods.

Deep learning algorithms simulate the learning processes in people using artificial neural networks.

Researchers have reported the development of software that uses deep learning to predict which type of cell murine HSPCs will differentiate into, based on microscopy images.

“A hematopoietic stem cell’s decision to become a certain cell type cannot be observed,” said study author Carsten Marr, PhD, of Helmholtz Zentrum München–German Research Center for Environmental Health in Neuherberg, Germany.

“At this time, it is only possible to verify the decision retrospectively with cell surface markers.”

Therefore, Dr Marr and his team set out to develop an algorithm that can predict the decision in advance, and deep learning was key.

“Deep neural networks play a major role in our method,” Dr Marr said. “Our algorithm classifies light microscopic images and videos of individual cells by comparing these data with past experience from the development of such cells. In this way, the algorithm ‘learns’ how certain cells behave.”

Specifically, the researchers examined murine HSPCs filmed under a microscope in the lab. Using information on the cells’ appearance and speed, the software was able to “memorize” the corresponding behavior patterns and then make its prediction.

“Compared to conventional methods, such as fluorescent antibodies against certain surface proteins, we know how the cells will decide 3 cell generations earlier,” said Felix Buggenthin, PhD, of Helmholtz Zentrum München–German Research Center for Environmental Health.

“Since we now know which cells will develop in which way, we can isolate them earlier than before and examine how they differ at a molecular level,” Dr Marr added. “We want to use this information to understand how the choices are made for particular developmental traits.”

Follicular lymphoma

The European Commission has approved a biosimilar rituximab product, Truxima™, for all the same indications as the reference product, MabThera.

This means Truxima (formerly called CT-P10) is approved for use in the European Union to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

Truxima, a product of Celltrion Healthcare Hungary Kft, is the first biosimilar monoclonal antibody approved in an oncology indication worldwide.

The approval is based on data submitted to the European Medicines Agency.

The agency’s Committee for Medicinal Products for Human Use (CHMP) said the evidence suggests Truxima and MabThera are similar in terms of efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics in patients with RA and advanced follicular lymphoma (FL).

Therefore, the European Commission approved Truxima for the following indications.

Non-Hodgkin lymphoma 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV FL.

Truxima maintenance therapy is indicated for the treatment of FL patients responding to induction therapy.

Truxima monotherapy is indicated for the treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

Chronic lymphocytic leukemia

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

The CHMP noted that limited efficacy and safety data are available for patients previously treated with monoclonal antibodies, including rituximab, or patients who are refractory to previous rituximab plus chemotherapy.

RA, GPA, and MPA 

Truxima in combination with methotrexate is indicated for the treatment of adults with severe, active RA who have had an inadequate response to or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active GPA or MPA.

Truxima studies

There are 3 ongoing, phase 3 trials of Truxima in patients with RA (NCT02149121), advanced FL (NCT02162771), and low-tumor-burden FL (NCT02260804).

Results from the phase 1/3 trial in patients with newly diagnosed, advanced FL suggest that Truxima and the reference rituximab are similar with regard to pharmacokinetics, immunogenicity, and safety (B Coiffier et al. ASH 2016, abstract 1807).

Results from the phase 3 study of RA patients indicate that Truxima is similar to reference products (EU and US-sourced rituximab) with regard to pharmacodynamics, safety, and efficacy for up to 24 weeks (DH Yoo et al. 2016 ACR/ARHP Annual Meeting, abstract 1635).  

Follicular lymphoma

The European Commission has approved a biosimilar rituximab product, Truxima™, for all the same indications as the reference product, MabThera.

This means Truxima (formerly called CT-P10) is approved for use in the European Union to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

Truxima, a product of Celltrion Healthcare Hungary Kft, is the first biosimilar monoclonal antibody approved in an oncology indication worldwide.

The approval is based on data submitted to the European Medicines Agency.

The agency’s Committee for Medicinal Products for Human Use (CHMP) said the evidence suggests Truxima and MabThera are similar in terms of efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics in patients with RA and advanced follicular lymphoma (FL).

Therefore, the European Commission approved Truxima for the following indications.

Non-Hodgkin lymphoma 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV FL.

Truxima maintenance therapy is indicated for the treatment of FL patients responding to induction therapy.

Truxima monotherapy is indicated for the treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

Chronic lymphocytic leukemia

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

The CHMP noted that limited efficacy and safety data are available for patients previously treated with monoclonal antibodies, including rituximab, or patients who are refractory to previous rituximab plus chemotherapy.

RA, GPA, and MPA 

Truxima in combination with methotrexate is indicated for the treatment of adults with severe, active RA who have had an inadequate response to or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active GPA or MPA.

Truxima studies

There are 3 ongoing, phase 3 trials of Truxima in patients with RA (NCT02149121), advanced FL (NCT02162771), and low-tumor-burden FL (NCT02260804).

Results from the phase 1/3 trial in patients with newly diagnosed, advanced FL suggest that Truxima and the reference rituximab are similar with regard to pharmacokinetics, immunogenicity, and safety (B Coiffier et al. ASH 2016, abstract 1807).

Results from the phase 3 study of RA patients indicate that Truxima is similar to reference products (EU and US-sourced rituximab) with regard to pharmacodynamics, safety, and efficacy for up to 24 weeks (DH Yoo et al. 2016 ACR/ARHP Annual Meeting, abstract 1635).  

Follicular lymphoma

The European Commission has approved a biosimilar rituximab product, Truxima™, for all the same indications as the reference product, MabThera.

This means Truxima (formerly called CT-P10) is approved for use in the European Union to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

Truxima, a product of Celltrion Healthcare Hungary Kft, is the first biosimilar monoclonal antibody approved in an oncology indication worldwide.

The approval is based on data submitted to the European Medicines Agency.

The agency’s Committee for Medicinal Products for Human Use (CHMP) said the evidence suggests Truxima and MabThera are similar in terms of efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics in patients with RA and advanced follicular lymphoma (FL).

Therefore, the European Commission approved Truxima for the following indications.

Non-Hodgkin lymphoma 

Truxima is indicated for use in combination with chemotherapy to treat previously untreated patients with stage III-IV FL.

Truxima maintenance therapy is indicated for the treatment of FL patients responding to induction therapy.

Truxima monotherapy is indicated for the treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

Truxima is indicated for use in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) for the treatment of patients with CD20-positive diffuse large B-cell lymphoma.

Chronic lymphocytic leukemia

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia.

The CHMP noted that limited efficacy and safety data are available for patients previously treated with monoclonal antibodies, including rituximab, or patients who are refractory to previous rituximab plus chemotherapy.

RA, GPA, and MPA 

Truxima in combination with methotrexate is indicated for the treatment of adults with severe, active RA who have had an inadequate response to or cannot tolerate other disease-modifying anti-rheumatic drugs, including one or more tumor necrosis factor inhibitor therapies.

Truxima in combination with glucocorticoids is indicated for the induction of remission in adults with severe, active GPA or MPA.

Truxima studies

There are 3 ongoing, phase 3 trials of Truxima in patients with RA (NCT02149121), advanced FL (NCT02162771), and low-tumor-burden FL (NCT02260804).

Results from the phase 1/3 trial in patients with newly diagnosed, advanced FL suggest that Truxima and the reference rituximab are similar with regard to pharmacokinetics, immunogenicity, and safety (B Coiffier et al. ASH 2016, abstract 1807).

Results from the phase 3 study of RA patients indicate that Truxima is similar to reference products (EU and US-sourced rituximab) with regard to pharmacodynamics, safety, and efficacy for up to 24 weeks (DH Yoo et al. 2016 ACR/ARHP Annual Meeting, abstract 1635).  

MIAMI – Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Systemic management of pruritus

There’s also promise for patients troubled by one of the top manifestations of AD – the itch. “We have new targeted therapies coming down the pike, some hopefully [gaining approval] in the next few months. We have biologics going after the cytokines of itch. It’s a very, very exciting time right now,” Dr. Friedman said.

Current clinical trials are not only focusing on AD but also specifically on pruritus, he added.

In the meantime, itch can be managed with prescription and over-the-counter topical agents, as well as systemic therapies such as gabapentin, some antidepressants, and the antiemetic aprepitant. Aprepitant is a substance P antagonist (through blocking neurokinin 1 receptor) and can be effective for some patients when taken three times a week, but it is not indicated for itch, Dr. Friedman said. Because of its off label indication “it’s a little tricky getting [insurance] coverage.”

Back to basics

“Even with all the excitement, even with the new therapeutics, you have to stick with the basics,” he said. “Put the lotion on, put the cream on. You have to put moisturizer on wet skin and be cautious with soaps.” He added, “don’t be afraid to ask for help. The National Eczema Association has a wonderful website with research, education, tools – you name it.”

Keeping it real

For regional eczemas like hand dermatitis, what are the options? “Tell patients they can glove up, there are various latex alternatives … but it probably won’t fly in the real world,” Dr. Friedman said. Zinc oxide “works like armor, and patients will probably do well,” but the aesthetics are unacceptable for most, he added. “Newer alternatives, such as those with aluminum magnesium hydroxide stearate, have similar protecting power, but are not opaque and rub on easier.”

A goal of topical therapy is to get rid of the inflammation, and steroids have a long history of evidence supporting their use, but “topical steroid phobia in parents” is a problem, he said. To counter the reluctance or refusal to use topical steroids, he suggested exploring reasons for noncompliance, dispelling any myths, and working with parent to make it easier to apply the steroids to their child.

Interestingly, there is some evidence that a simpler regimen may work well for some patients. “We always say ‘apply twice a day.’ Why? Because all the clinical trials had participants apply steroids twice a day. But there is no evidence to show twice a day is better than once a day, and in fact, a meta-analysis suggests once a day works just as well” (Br J Dermatol. 2005 Jan;152[1]:130-41).

Topical calcineurin inhibitors are another option. In general, Dr. Friedman prescribes these agents for delicate areas, for patients with thin skin, or for patients who use a topical steroid “on and on and on and can’t seem to get off it.” Calcineurin inhibitors can also be used on in-between days during steroid maintenance therapy, he added. When prescribing, warn patients about the initial burn (due to substance P release) that commonly occurs so that they have realistic expectations.

Education remains essential

“I encourage you to educate your patients and empathize with them,” he said. “Show them how to apply a moisturizer. Also, use your nurses and assistants to help with education – really empower them to be part of the process.”

“Explain, explain, explain, so they have realistic expectations,” and know that there is no cure, so that when they experience a flare, they understand that “it’s not that the steroid didn’t work – this is a chronic disease,” added Dr. Friedman, who recommends providing patients with handouts that answer many of their questions.

Maximize moisturizing

When it comes to moisturizing, more is usually better. Effective products contain all the key ingredients: emollients to soften the skin, an occlusive to keep the water there, and a humectant to bond the water. “Just one or two is not going to cut it,” he said.

“Something we now know is that starting early is key,” he pointed out, referring to recent studies that have shown that in babies at high risk for AD, starting moisturizers early can decrease their risk for developing AD later (J Allergy Clin Immunol. 2014 Oct; 134[4]: 818-23).

“Another study that received a ton of press was in JAMA Pediatrics recently,” Dr. Friedman said. The study concluded that the use of different moisturizers to prevent AD in high risk babies was likely to be cost-effective (JAMA Pediatr. 2017 Feb 6;171[2]:e163909. doi: 10.1001/jamapediatrics.2016.3909). Although some news reports claimed starting babies with Vaseline as a moisturizer will prevent AD, “that’s actually not what the study showed. All the over-the-counter moisturizers they used worked, but Vaseline was the least expensive,” Dr. Friedman noted

Help patients select the right soap

Educate patients to avoid “true soaps” such as Dial, Ivory, Irish Spring, or Lever 2000. “Soaps can be a real enemy here. You want lower pH types of soaps. Depending on skin type, our skin is somewhere between 5.5 and 6.5 pH,” Dr. Friedman explained. “The paradigm shift for your patients is to hydrate, not to clean. Showers are okay if they’re not blaring hot. Baths are okay ... but you should not be sitting in a sudsy bath.”

Also, instruct patients to avoid irritating fabrics, dryer sheets, or harsh laundry detergents that could exacerbate AD.

‘You’re not alone’

Sometimes it’s helpful to assure patients with AD that they’re not alone, and that many researchers and clinicians are working on effective treatment strategies. “We’re all familiar with atopic dermatitis because there’s so much of it. The numbers are surprisingly high,” Dr. Friedman said. Compared with the estimated 2.2 million Americans with psoriasis, AD eclipses their numbers substantially, affecting about 17 million people.

Dr. Friedman disclosed that he is a speaker for Amgen, Janssen, and Promius; receives research grants from Valeant; and is a consultant and/or advisory board member for Amgen, Aveeno, Biogen, Encore, Exeltis, Ferndale, Galderma, G&W Laboratories, Intraderm, La Roche-Posay, Loreal, Microcures, Nano Bio-Med, Novartis, Oakstone Institute, Occulus, Onset, Pfizer, Promius, Sanova Works, and Valeant. Dr. Friedman is also an editorial advisory board member for Dermatology News.

MIAMI – Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Systemic management of pruritus

There’s also promise for patients troubled by one of the top manifestations of AD – the itch. “We have new targeted therapies coming down the pike, some hopefully [gaining approval] in the next few months. We have biologics going after the cytokines of itch. It’s a very, very exciting time right now,” Dr. Friedman said.

Current clinical trials are not only focusing on AD but also specifically on pruritus, he added.

In the meantime, itch can be managed with prescription and over-the-counter topical agents, as well as systemic therapies such as gabapentin, some antidepressants, and the antiemetic aprepitant. Aprepitant is a substance P antagonist (through blocking neurokinin 1 receptor) and can be effective for some patients when taken three times a week, but it is not indicated for itch, Dr. Friedman said. Because of its off label indication “it’s a little tricky getting [insurance] coverage.”

Back to basics

“Even with all the excitement, even with the new therapeutics, you have to stick with the basics,” he said. “Put the lotion on, put the cream on. You have to put moisturizer on wet skin and be cautious with soaps.” He added, “don’t be afraid to ask for help. The National Eczema Association has a wonderful website with research, education, tools – you name it.”

Keeping it real

For regional eczemas like hand dermatitis, what are the options? “Tell patients they can glove up, there are various latex alternatives … but it probably won’t fly in the real world,” Dr. Friedman said. Zinc oxide “works like armor, and patients will probably do well,” but the aesthetics are unacceptable for most, he added. “Newer alternatives, such as those with aluminum magnesium hydroxide stearate, have similar protecting power, but are not opaque and rub on easier.”

A goal of topical therapy is to get rid of the inflammation, and steroids have a long history of evidence supporting their use, but “topical steroid phobia in parents” is a problem, he said. To counter the reluctance or refusal to use topical steroids, he suggested exploring reasons for noncompliance, dispelling any myths, and working with parent to make it easier to apply the steroids to their child.

Interestingly, there is some evidence that a simpler regimen may work well for some patients. “We always say ‘apply twice a day.’ Why? Because all the clinical trials had participants apply steroids twice a day. But there is no evidence to show twice a day is better than once a day, and in fact, a meta-analysis suggests once a day works just as well” (Br J Dermatol. 2005 Jan;152[1]:130-41).

Topical calcineurin inhibitors are another option. In general, Dr. Friedman prescribes these agents for delicate areas, for patients with thin skin, or for patients who use a topical steroid “on and on and on and can’t seem to get off it.” Calcineurin inhibitors can also be used on in-between days during steroid maintenance therapy, he added. When prescribing, warn patients about the initial burn (due to substance P release) that commonly occurs so that they have realistic expectations.

Education remains essential

“I encourage you to educate your patients and empathize with them,” he said. “Show them how to apply a moisturizer. Also, use your nurses and assistants to help with education – really empower them to be part of the process.”

“Explain, explain, explain, so they have realistic expectations,” and know that there is no cure, so that when they experience a flare, they understand that “it’s not that the steroid didn’t work – this is a chronic disease,” added Dr. Friedman, who recommends providing patients with handouts that answer many of their questions.

Maximize moisturizing

When it comes to moisturizing, more is usually better. Effective products contain all the key ingredients: emollients to soften the skin, an occlusive to keep the water there, and a humectant to bond the water. “Just one or two is not going to cut it,” he said.

“Something we now know is that starting early is key,” he pointed out, referring to recent studies that have shown that in babies at high risk for AD, starting moisturizers early can decrease their risk for developing AD later (J Allergy Clin Immunol. 2014 Oct; 134[4]: 818-23).

“Another study that received a ton of press was in JAMA Pediatrics recently,” Dr. Friedman said. The study concluded that the use of different moisturizers to prevent AD in high risk babies was likely to be cost-effective (JAMA Pediatr. 2017 Feb 6;171[2]:e163909. doi: 10.1001/jamapediatrics.2016.3909). Although some news reports claimed starting babies with Vaseline as a moisturizer will prevent AD, “that’s actually not what the study showed. All the over-the-counter moisturizers they used worked, but Vaseline was the least expensive,” Dr. Friedman noted

Help patients select the right soap

Educate patients to avoid “true soaps” such as Dial, Ivory, Irish Spring, or Lever 2000. “Soaps can be a real enemy here. You want lower pH types of soaps. Depending on skin type, our skin is somewhere between 5.5 and 6.5 pH,” Dr. Friedman explained. “The paradigm shift for your patients is to hydrate, not to clean. Showers are okay if they’re not blaring hot. Baths are okay ... but you should not be sitting in a sudsy bath.”

Also, instruct patients to avoid irritating fabrics, dryer sheets, or harsh laundry detergents that could exacerbate AD.

‘You’re not alone’

Sometimes it’s helpful to assure patients with AD that they’re not alone, and that many researchers and clinicians are working on effective treatment strategies. “We’re all familiar with atopic dermatitis because there’s so much of it. The numbers are surprisingly high,” Dr. Friedman said. Compared with the estimated 2.2 million Americans with psoriasis, AD eclipses their numbers substantially, affecting about 17 million people.

Dr. Friedman disclosed that he is a speaker for Amgen, Janssen, and Promius; receives research grants from Valeant; and is a consultant and/or advisory board member for Amgen, Aveeno, Biogen, Encore, Exeltis, Ferndale, Galderma, G&W Laboratories, Intraderm, La Roche-Posay, Loreal, Microcures, Nano Bio-Med, Novartis, Oakstone Institute, Occulus, Onset, Pfizer, Promius, Sanova Works, and Valeant. Dr. Friedman is also an editorial advisory board member for Dermatology News.

MIAMI – Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Systemic management of pruritus

There’s also promise for patients troubled by one of the top manifestations of AD – the itch. “We have new targeted therapies coming down the pike, some hopefully [gaining approval] in the next few months. We have biologics going after the cytokines of itch. It’s a very, very exciting time right now,” Dr. Friedman said.

Current clinical trials are not only focusing on AD but also specifically on pruritus, he added.

In the meantime, itch can be managed with prescription and over-the-counter topical agents, as well as systemic therapies such as gabapentin, some antidepressants, and the antiemetic aprepitant. Aprepitant is a substance P antagonist (through blocking neurokinin 1 receptor) and can be effective for some patients when taken three times a week, but it is not indicated for itch, Dr. Friedman said. Because of its off label indication “it’s a little tricky getting [insurance] coverage.”

Back to basics

“Even with all the excitement, even with the new therapeutics, you have to stick with the basics,” he said. “Put the lotion on, put the cream on. You have to put moisturizer on wet skin and be cautious with soaps.” He added, “don’t be afraid to ask for help. The National Eczema Association has a wonderful website with research, education, tools – you name it.”

Keeping it real

For regional eczemas like hand dermatitis, what are the options? “Tell patients they can glove up, there are various latex alternatives … but it probably won’t fly in the real world,” Dr. Friedman said. Zinc oxide “works like armor, and patients will probably do well,” but the aesthetics are unacceptable for most, he added. “Newer alternatives, such as those with aluminum magnesium hydroxide stearate, have similar protecting power, but are not opaque and rub on easier.”

A goal of topical therapy is to get rid of the inflammation, and steroids have a long history of evidence supporting their use, but “topical steroid phobia in parents” is a problem, he said. To counter the reluctance or refusal to use topical steroids, he suggested exploring reasons for noncompliance, dispelling any myths, and working with parent to make it easier to apply the steroids to their child.

Interestingly, there is some evidence that a simpler regimen may work well for some patients. “We always say ‘apply twice a day.’ Why? Because all the clinical trials had participants apply steroids twice a day. But there is no evidence to show twice a day is better than once a day, and in fact, a meta-analysis suggests once a day works just as well” (Br J Dermatol. 2005 Jan;152[1]:130-41).

Topical calcineurin inhibitors are another option. In general, Dr. Friedman prescribes these agents for delicate areas, for patients with thin skin, or for patients who use a topical steroid “on and on and on and can’t seem to get off it.” Calcineurin inhibitors can also be used on in-between days during steroid maintenance therapy, he added. When prescribing, warn patients about the initial burn (due to substance P release) that commonly occurs so that they have realistic expectations.

Education remains essential

“I encourage you to educate your patients and empathize with them,” he said. “Show them how to apply a moisturizer. Also, use your nurses and assistants to help with education – really empower them to be part of the process.”

“Explain, explain, explain, so they have realistic expectations,” and know that there is no cure, so that when they experience a flare, they understand that “it’s not that the steroid didn’t work – this is a chronic disease,” added Dr. Friedman, who recommends providing patients with handouts that answer many of their questions.

Maximize moisturizing

When it comes to moisturizing, more is usually better. Effective products contain all the key ingredients: emollients to soften the skin, an occlusive to keep the water there, and a humectant to bond the water. “Just one or two is not going to cut it,” he said.

“Something we now know is that starting early is key,” he pointed out, referring to recent studies that have shown that in babies at high risk for AD, starting moisturizers early can decrease their risk for developing AD later (J Allergy Clin Immunol. 2014 Oct; 134[4]: 818-23).

“Another study that received a ton of press was in JAMA Pediatrics recently,” Dr. Friedman said. The study concluded that the use of different moisturizers to prevent AD in high risk babies was likely to be cost-effective (JAMA Pediatr. 2017 Feb 6;171[2]:e163909. doi: 10.1001/jamapediatrics.2016.3909). Although some news reports claimed starting babies with Vaseline as a moisturizer will prevent AD, “that’s actually not what the study showed. All the over-the-counter moisturizers they used worked, but Vaseline was the least expensive,” Dr. Friedman noted

Help patients select the right soap

Educate patients to avoid “true soaps” such as Dial, Ivory, Irish Spring, or Lever 2000. “Soaps can be a real enemy here. You want lower pH types of soaps. Depending on skin type, our skin is somewhere between 5.5 and 6.5 pH,” Dr. Friedman explained. “The paradigm shift for your patients is to hydrate, not to clean. Showers are okay if they’re not blaring hot. Baths are okay ... but you should not be sitting in a sudsy bath.”

Also, instruct patients to avoid irritating fabrics, dryer sheets, or harsh laundry detergents that could exacerbate AD.

‘You’re not alone’

Sometimes it’s helpful to assure patients with AD that they’re not alone, and that many researchers and clinicians are working on effective treatment strategies. “We’re all familiar with atopic dermatitis because there’s so much of it. The numbers are surprisingly high,” Dr. Friedman said. Compared with the estimated 2.2 million Americans with psoriasis, AD eclipses their numbers substantially, affecting about 17 million people.

Dr. Friedman disclosed that he is a speaker for Amgen, Janssen, and Promius; receives research grants from Valeant; and is a consultant and/or advisory board member for Amgen, Aveeno, Biogen, Encore, Exeltis, Ferndale, Galderma, G&W Laboratories, Intraderm, La Roche-Posay, Loreal, Microcures, Nano Bio-Med, Novartis, Oakstone Institute, Occulus, Onset, Pfizer, Promius, Sanova Works, and Valeant. Dr. Friedman is also an editorial advisory board member for Dermatology News.

A 66-year-old woman 3 years status post hip replacement is seen for dental work. The dentist contacts the clinic for an antibiotic prescription. The patient has a penicillin allergy (rash). What do you recommend?

A. Clindamycin one dose before dental work.

B. Amoxicillin one dose before dental work.

C. Amoxicillin one dose before, one dose 4 hours after dental work.

D. Clindamycin one dose before dental work, one dose 4 hours after dental work.

E. No antibiotics.

Many patients with prosthetic joints will request antibiotics to take prior to dental procedures. Sometimes this request comes from the dental office.

When I ask patients why they feel they need antibiotics, they often reply that they were told by their orthopedic surgeons or their dentist that they would need to take antibiotics before dental procedures.

In an era when Clostridium difficile infection is a common and dangerous complication in the elderly, avoidance of unnecessary antibiotics is critical. In the United States, it is estimated that there are 240,000 patients infected with C. difficile annually, with 24,000 deaths at a cost of $6 billion.¹

Is there compelling evidence to justify giving antibiotic prophylaxis for dental procedures to patients with prosthetic joints?

References

1. Steckelberg J.M., Osmon D.R. Prosthetic joint infections. In: Bisno A.L., Waldvogel F.A., eds. Infections associated with indwelling medical devices. Third ed., Washington, D.C.: American Society of Microbiology Press, 2000:173-209.

2. J Dent Res. 2004 Feb;83(2):170-4.

3. J Clin Periodontol. 2006 Feb;33(6):401-7.

4. J Am Dent Assoc. 1997 Jul;128(7):1004-8.

5. J Am Dent Assoc. 2003 Jul;134(7):895-9.

6. Spec Care Dentist. 2009 Nov-Dec;29(6):229-31.

7. Clin Infect Dis. 2010 Jan 1;50(1):8-16.

8. J Dent (Shiraz). 2013 Mar;14(1):49-52.

9. Infect Control Hosp Epidemiol. 2017 Feb;38(2):154-61.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman 3 years status post hip replacement is seen for dental work. The dentist contacts the clinic for an antibiotic prescription. The patient has a penicillin allergy (rash). What do you recommend?

A. Clindamycin one dose before dental work.

B. Amoxicillin one dose before dental work.

C. Amoxicillin one dose before, one dose 4 hours after dental work.

D. Clindamycin one dose before dental work, one dose 4 hours after dental work.

E. No antibiotics.

Many patients with prosthetic joints will request antibiotics to take prior to dental procedures. Sometimes this request comes from the dental office.

When I ask patients why they feel they need antibiotics, they often reply that they were told by their orthopedic surgeons or their dentist that they would need to take antibiotics before dental procedures.

In an era when Clostridium difficile infection is a common and dangerous complication in the elderly, avoidance of unnecessary antibiotics is critical. In the United States, it is estimated that there are 240,000 patients infected with C. difficile annually, with 24,000 deaths at a cost of $6 billion.¹

Is there compelling evidence to justify giving antibiotic prophylaxis for dental procedures to patients with prosthetic joints?

References

1. Steckelberg J.M., Osmon D.R. Prosthetic joint infections. In: Bisno A.L., Waldvogel F.A., eds. Infections associated with indwelling medical devices. Third ed., Washington, D.C.: American Society of Microbiology Press, 2000:173-209.

2. J Dent Res. 2004 Feb;83(2):170-4.

3. J Clin Periodontol. 2006 Feb;33(6):401-7.

4. J Am Dent Assoc. 1997 Jul;128(7):1004-8.

5. J Am Dent Assoc. 2003 Jul;134(7):895-9.

6. Spec Care Dentist. 2009 Nov-Dec;29(6):229-31.

7. Clin Infect Dis. 2010 Jan 1;50(1):8-16.

8. J Dent (Shiraz). 2013 Mar;14(1):49-52.

9. Infect Control Hosp Epidemiol. 2017 Feb;38(2):154-61.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman 3 years status post hip replacement is seen for dental work. The dentist contacts the clinic for an antibiotic prescription. The patient has a penicillin allergy (rash). What do you recommend?

A. Clindamycin one dose before dental work.

B. Amoxicillin one dose before dental work.

C. Amoxicillin one dose before, one dose 4 hours after dental work.

D. Clindamycin one dose before dental work, one dose 4 hours after dental work.

E. No antibiotics.

Many patients with prosthetic joints will request antibiotics to take prior to dental procedures. Sometimes this request comes from the dental office.

When I ask patients why they feel they need antibiotics, they often reply that they were told by their orthopedic surgeons or their dentist that they would need to take antibiotics before dental procedures.

In an era when Clostridium difficile infection is a common and dangerous complication in the elderly, avoidance of unnecessary antibiotics is critical. In the United States, it is estimated that there are 240,000 patients infected with C. difficile annually, with 24,000 deaths at a cost of $6 billion.¹

Is there compelling evidence to justify giving antibiotic prophylaxis for dental procedures to patients with prosthetic joints?

References

1. Steckelberg J.M., Osmon D.R. Prosthetic joint infections. In: Bisno A.L., Waldvogel F.A., eds. Infections associated with indwelling medical devices. Third ed., Washington, D.C.: American Society of Microbiology Press, 2000:173-209.

2. J Dent Res. 2004 Feb;83(2):170-4.

3. J Clin Periodontol. 2006 Feb;33(6):401-7.

4. J Am Dent Assoc. 1997 Jul;128(7):1004-8.

5. J Am Dent Assoc. 2003 Jul;134(7):895-9.

6. Spec Care Dentist. 2009 Nov-Dec;29(6):229-31.

7. Clin Infect Dis. 2010 Jan 1;50(1):8-16.

8. J Dent (Shiraz). 2013 Mar;14(1):49-52.

9. Infect Control Hosp Epidemiol. 2017 Feb;38(2):154-61.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

WASHINGTON – The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.

The data from the pilot study suggest that arming the STEMI team with a protocol for managing PE “is an effective means to care for patients with massive and submassive pulmonary embolism,” said Michael R. Kendall, MD, of the University of Southern California, Los Angeles. He presented the findings at the 2017 Cardiovascular Research Technologies meeting.

There are obvious parallels between STEMI and PE. Like STEMI, PE requires rapid diagnosis, triage, and when appropriate, an endovascular procedure. This led the USC investigators to consider a formal pilot study to test the premise that the STEMI team is in a position to deliver urgent care and good outcomes to PE patients.

The objective of the pilot study was “to evaluate treatment times and clinical outcome for patients with massive and submassive PE using a dedicated PE protocol,” Dr. Kendall explained. Massive PE was defined as hemodynamic instability with systolic blood pressure below 90 mm Hg or requiring inotropic support. Submassive PE was defined as systolic BP greater than 90 mm Hg with right heart dysfunction, such as a dilated right ventricle and elevated troponin levels.

Over an 18-month period beginning in June 2014, 40 PE patients were treated. The average age was 55 years, 50% were obese, 32% had renal insufficiency, 30% had recent surgery or had recently been immobilized, 30% had a history of deep venous thrombosis, and 28% had an active malignancy. At 43%, the largest single source of cases was the emergency department (ED), while 38% were transferred in from other centers, and 19% were already hospitalized at the time of the PE.

All patients underwent computed tomographic pulmonary angiography (CTPA) as part of the diagnostic procedure prior to an invasive angiogram. Patients received one or more different treatments upon confirmation of the PE, including catheter-directed thrombolytics, rheolytic thrombectomy, mechanical fragmentation, mechanical aspiration, and surgical pulmonary embolectomy. Inferior vena cava filters were used as appropriate.

At presentation, 10% were in cardiac arrest, 22% required intubation, and 12% required extracorporeal membrane oxygenation. On the basis of the diagnostic studies, 57% had a massive PE, and the remainder had submassive disease.

The average time from door to CTPA among those presenting to the ED was roughly 5 hours. It took, on average, an additional 2 hours from CTPA to an invasive angiogram, and another 3 hours to treatment, producing a total average door to treatment time of 10 hours.

Most patients received rheolytic thrombectomy, often with another form of treatment, such as catheter-directed thrombolytics, but 15% were treated with anticoagulation alone. Although a few patients improved sufficiently to obviate the need for an invasive procedure, the remainder of the patients received anticoagulation alone because of contraindications for invasive strategies or treatment refusal.

The average length of a hospital stay was 15 days. Bleeding events occurred in 10% of patients and 18% required a blood transfusion. Survival to hospital discharge was 82%. Although there was no control group, this rate of survival was considered favorable in the context of the severity of the PE.

Overall, delivery of urgent care for PE by a STEMI team was found feasible. Even though treatment approaches were not standardized, the protocol for diagnosing and managing PE on an urgent basis produced encouraging times for delivery of care and outcomes, according to the data presented by Dr. Kendall. Because of the differences in the composition and function of the STEMI team, Dr. Kendall indicated that it is difficult to predict similar success at other centers, but the findings overall were considered positive.

The senior author of the study, David M. Shavelle, MD, also at USC, suggested that the program there might be a template. He believes that the STEMI team has the skills to deliver prompt PE care, and he believes that this approach would be appropriate at other centers. He also suggested that such formal programs may be useful in establishing better treatment protocols.

“For PE, there are no clear guidelines for treatment time intervals, such as time from door to endovascular treatment,” Dr. Shavelle observed. He said that the wide variation of devices currently being used for treatment complicates efforts to develop clear clinical protocols and measure outcomes and “would like to see more standardization of treatment and registries to address these areas.”

Dr. Kendall reported no financial relationships.

WASHINGTON – The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.

The data from the pilot study suggest that arming the STEMI team with a protocol for managing PE “is an effective means to care for patients with massive and submassive pulmonary embolism,” said Michael R. Kendall, MD, of the University of Southern California, Los Angeles. He presented the findings at the 2017 Cardiovascular Research Technologies meeting.

There are obvious parallels between STEMI and PE. Like STEMI, PE requires rapid diagnosis, triage, and when appropriate, an endovascular procedure. This led the USC investigators to consider a formal pilot study to test the premise that the STEMI team is in a position to deliver urgent care and good outcomes to PE patients.

The objective of the pilot study was “to evaluate treatment times and clinical outcome for patients with massive and submassive PE using a dedicated PE protocol,” Dr. Kendall explained. Massive PE was defined as hemodynamic instability with systolic blood pressure below 90 mm Hg or requiring inotropic support. Submassive PE was defined as systolic BP greater than 90 mm Hg with right heart dysfunction, such as a dilated right ventricle and elevated troponin levels.

Over an 18-month period beginning in June 2014, 40 PE patients were treated. The average age was 55 years, 50% were obese, 32% had renal insufficiency, 30% had recent surgery or had recently been immobilized, 30% had a history of deep venous thrombosis, and 28% had an active malignancy. At 43%, the largest single source of cases was the emergency department (ED), while 38% were transferred in from other centers, and 19% were already hospitalized at the time of the PE.

All patients underwent computed tomographic pulmonary angiography (CTPA) as part of the diagnostic procedure prior to an invasive angiogram. Patients received one or more different treatments upon confirmation of the PE, including catheter-directed thrombolytics, rheolytic thrombectomy, mechanical fragmentation, mechanical aspiration, and surgical pulmonary embolectomy. Inferior vena cava filters were used as appropriate.

At presentation, 10% were in cardiac arrest, 22% required intubation, and 12% required extracorporeal membrane oxygenation. On the basis of the diagnostic studies, 57% had a massive PE, and the remainder had submassive disease.

The average time from door to CTPA among those presenting to the ED was roughly 5 hours. It took, on average, an additional 2 hours from CTPA to an invasive angiogram, and another 3 hours to treatment, producing a total average door to treatment time of 10 hours.

Most patients received rheolytic thrombectomy, often with another form of treatment, such as catheter-directed thrombolytics, but 15% were treated with anticoagulation alone. Although a few patients improved sufficiently to obviate the need for an invasive procedure, the remainder of the patients received anticoagulation alone because of contraindications for invasive strategies or treatment refusal.

The average length of a hospital stay was 15 days. Bleeding events occurred in 10% of patients and 18% required a blood transfusion. Survival to hospital discharge was 82%. Although there was no control group, this rate of survival was considered favorable in the context of the severity of the PE.

Overall, delivery of urgent care for PE by a STEMI team was found feasible. Even though treatment approaches were not standardized, the protocol for diagnosing and managing PE on an urgent basis produced encouraging times for delivery of care and outcomes, according to the data presented by Dr. Kendall. Because of the differences in the composition and function of the STEMI team, Dr. Kendall indicated that it is difficult to predict similar success at other centers, but the findings overall were considered positive.

The senior author of the study, David M. Shavelle, MD, also at USC, suggested that the program there might be a template. He believes that the STEMI team has the skills to deliver prompt PE care, and he believes that this approach would be appropriate at other centers. He also suggested that such formal programs may be useful in establishing better treatment protocols.

“For PE, there are no clear guidelines for treatment time intervals, such as time from door to endovascular treatment,” Dr. Shavelle observed. He said that the wide variation of devices currently being used for treatment complicates efforts to develop clear clinical protocols and measure outcomes and “would like to see more standardization of treatment and registries to address these areas.”

Dr. Kendall reported no financial relationships.

WASHINGTON – The in-hospital team responsible for rapid management of ST-elevation myocardial infarction (STEMI) may also be the right team to manage pulmonary embolism (PE), according to a pilot study associating this approach with rapid treatment times and low overall mortality rates.

The data from the pilot study suggest that arming the STEMI team with a protocol for managing PE “is an effective means to care for patients with massive and submassive pulmonary embolism,” said Michael R. Kendall, MD, of the University of Southern California, Los Angeles. He presented the findings at the 2017 Cardiovascular Research Technologies meeting.

There are obvious parallels between STEMI and PE. Like STEMI, PE requires rapid diagnosis, triage, and when appropriate, an endovascular procedure. This led the USC investigators to consider a formal pilot study to test the premise that the STEMI team is in a position to deliver urgent care and good outcomes to PE patients.

The objective of the pilot study was “to evaluate treatment times and clinical outcome for patients with massive and submassive PE using a dedicated PE protocol,” Dr. Kendall explained. Massive PE was defined as hemodynamic instability with systolic blood pressure below 90 mm Hg or requiring inotropic support. Submassive PE was defined as systolic BP greater than 90 mm Hg with right heart dysfunction, such as a dilated right ventricle and elevated troponin levels.

Over an 18-month period beginning in June 2014, 40 PE patients were treated. The average age was 55 years, 50% were obese, 32% had renal insufficiency, 30% had recent surgery or had recently been immobilized, 30% had a history of deep venous thrombosis, and 28% had an active malignancy. At 43%, the largest single source of cases was the emergency department (ED), while 38% were transferred in from other centers, and 19% were already hospitalized at the time of the PE.

All patients underwent computed tomographic pulmonary angiography (CTPA) as part of the diagnostic procedure prior to an invasive angiogram. Patients received one or more different treatments upon confirmation of the PE, including catheter-directed thrombolytics, rheolytic thrombectomy, mechanical fragmentation, mechanical aspiration, and surgical pulmonary embolectomy. Inferior vena cava filters were used as appropriate.

At presentation, 10% were in cardiac arrest, 22% required intubation, and 12% required extracorporeal membrane oxygenation. On the basis of the diagnostic studies, 57% had a massive PE, and the remainder had submassive disease.

The average time from door to CTPA among those presenting to the ED was roughly 5 hours. It took, on average, an additional 2 hours from CTPA to an invasive angiogram, and another 3 hours to treatment, producing a total average door to treatment time of 10 hours.

Most patients received rheolytic thrombectomy, often with another form of treatment, such as catheter-directed thrombolytics, but 15% were treated with anticoagulation alone. Although a few patients improved sufficiently to obviate the need for an invasive procedure, the remainder of the patients received anticoagulation alone because of contraindications for invasive strategies or treatment refusal.

The average length of a hospital stay was 15 days. Bleeding events occurred in 10% of patients and 18% required a blood transfusion. Survival to hospital discharge was 82%. Although there was no control group, this rate of survival was considered favorable in the context of the severity of the PE.

Overall, delivery of urgent care for PE by a STEMI team was found feasible. Even though treatment approaches were not standardized, the protocol for diagnosing and managing PE on an urgent basis produced encouraging times for delivery of care and outcomes, according to the data presented by Dr. Kendall. Because of the differences in the composition and function of the STEMI team, Dr. Kendall indicated that it is difficult to predict similar success at other centers, but the findings overall were considered positive.

The senior author of the study, David M. Shavelle, MD, also at USC, suggested that the program there might be a template. He believes that the STEMI team has the skills to deliver prompt PE care, and he believes that this approach would be appropriate at other centers. He also suggested that such formal programs may be useful in establishing better treatment protocols.

“For PE, there are no clear guidelines for treatment time intervals, such as time from door to endovascular treatment,” Dr. Shavelle observed. He said that the wide variation of devices currently being used for treatment complicates efforts to develop clear clinical protocols and measure outcomes and “would like to see more standardization of treatment and registries to address these areas.”

Dr. Kendall reported no financial relationships.

Increased risks of schizophrenia and affective disorders were found to be associated with infections treated with anti-infective agents and with infections requiring hospitalization, a large-scale study shows.

Researchers examined health records of all 1,015,447 individuals born in Denmark from 1985 to 2002, their history of treatment of infection, and the risk of schizophrenia and affective disorders.

Infections previously have been shown to be associated with increased risks of mental disorders. The goal of the current study was to investigate whether the use of anti-infective agents in primary care settings had a similar association.

And the researchers did find such an association: an increased risk of schizophrenia (hazard ratio, 1.37; 95% confidence interval, 1.2-1.57) and an increased risk of affective disorders (HR, 1.64; 95% CI, 1.48-1.82) associated with the use of anti-infective agents.

“The excess risk was primarily driven by infections treated with antibiotics, whereas infections treated with antivirals, antimycotics, and antiparasitic agents were not significant after mutual adjustment,” wrote Ole Köhler, MD, of Aarhus University Hospital, Risskov, Denmark, and his associates (Acta Psychiatr Scand. 2017 Feb;135[2]:97-105).

An even higher risk of schizophrenia and affective disorders was found to be associated with individuals with infections requiring hospitalization (HR, 2.05; 95% CI, 1.77-2.38; and HR, 2.59; 95% CI, 2.31-2.89; respectively). Find more details about the study here.

[email protected]

Increased risks of schizophrenia and affective disorders were found to be associated with infections treated with anti-infective agents and with infections requiring hospitalization, a large-scale study shows.

Researchers examined health records of all 1,015,447 individuals born in Denmark from 1985 to 2002, their history of treatment of infection, and the risk of schizophrenia and affective disorders.

Infections previously have been shown to be associated with increased risks of mental disorders. The goal of the current study was to investigate whether the use of anti-infective agents in primary care settings had a similar association.

And the researchers did find such an association: an increased risk of schizophrenia (hazard ratio, 1.37; 95% confidence interval, 1.2-1.57) and an increased risk of affective disorders (HR, 1.64; 95% CI, 1.48-1.82) associated with the use of anti-infective agents.

“The excess risk was primarily driven by infections treated with antibiotics, whereas infections treated with antivirals, antimycotics, and antiparasitic agents were not significant after mutual adjustment,” wrote Ole Köhler, MD, of Aarhus University Hospital, Risskov, Denmark, and his associates (Acta Psychiatr Scand. 2017 Feb;135[2]:97-105).

An even higher risk of schizophrenia and affective disorders was found to be associated with individuals with infections requiring hospitalization (HR, 2.05; 95% CI, 1.77-2.38; and HR, 2.59; 95% CI, 2.31-2.89; respectively). Find more details about the study here.

[email protected]

Increased risks of schizophrenia and affective disorders were found to be associated with infections treated with anti-infective agents and with infections requiring hospitalization, a large-scale study shows.

Researchers examined health records of all 1,015,447 individuals born in Denmark from 1985 to 2002, their history of treatment of infection, and the risk of schizophrenia and affective disorders.

Infections previously have been shown to be associated with increased risks of mental disorders. The goal of the current study was to investigate whether the use of anti-infective agents in primary care settings had a similar association.

And the researchers did find such an association: an increased risk of schizophrenia (hazard ratio, 1.37; 95% confidence interval, 1.2-1.57) and an increased risk of affective disorders (HR, 1.64; 95% CI, 1.48-1.82) associated with the use of anti-infective agents.

“The excess risk was primarily driven by infections treated with antibiotics, whereas infections treated with antivirals, antimycotics, and antiparasitic agents were not significant after mutual adjustment,” wrote Ole Köhler, MD, of Aarhus University Hospital, Risskov, Denmark, and his associates (Acta Psychiatr Scand. 2017 Feb;135[2]:97-105).

An even higher risk of schizophrenia and affective disorders was found to be associated with individuals with infections requiring hospitalization (HR, 2.05; 95% CI, 1.77-2.38; and HR, 2.59; 95% CI, 2.31-2.89; respectively). Find more details about the study here.

[email protected]

WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.

WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.

WASHINGTON – The clinical and technical success rates are higher among patients undergoing robotic percutaneous coronary interventions through radial than femoral access, according to registry data presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

Although both the clinical and technical success rates were high with either type of access, the advantage for radial over femoral access was significant for each, reported Ali Pourdjabbar, MD, an interventional cardiologist completing his fellowship at the University of California, San Diego. However, as this was not a randomized trial, he placed emphasis on the message that robotic percutaneous coronary intervention (PCI) is safe and effective when performed through either access point.

Preterm infants are at greater risk for pertussis than full-term infants, according to a population-based study from the Norwegian Institute of Public Health.

Øystein Rolandsen Riise, MD, PhD, of the institute, and his colleagues identified all live births in Norway from 1998 to 2010 from the Medical Birth Registry of Norway and studied the gestational age of 713,166 infants as an indicator of increased risk of pertussis.

Infants born at 23-27 weeks of gestational age had an incidence rate ratio of pertussis more than fourfold higher than term infants (IRR = 4.49), while those born at 32-34 weeks and 35-36 weeks each had an IRR about 1.5 time higher than term infants (Pediatr Infect Dis J. doi: 10.1097/INF.0000000000001545).

The IRR of preterm infants hospitalized with pertussis was double that of full-term infants (IRR = 1.99).

The increased risk in preterm infants could be attributed to an incomplete transfer of maternal antibodies, specifically the “abundance of IgG [that] is acquired during the last month of full-term pregnancy,” Dr. Riise and colleagues wrote.

While previous studies have found links between preterm birth and pertussis infection, those studies used birth weight instead of gestational age, which leads to possibly inaccurate results, they added.

“Although other studies have used low birth weight to identify infants with increased risk of pertussis, we would have underestimated the number of infants with increased risk by using low birth weight instead of gestational age, since many of the late preterm infants have normal birth weight,” the researchers noted.

Early vaccination is key to protecting preterm infants from pertussis, Dr. Riise and colleagues said, adding that vaccine effectiveness was similar between preterm (93%) and full-term (88.8%) infants.

[email protected]

Preterm infants are at greater risk for pertussis than full-term infants, according to a population-based study from the Norwegian Institute of Public Health.

Øystein Rolandsen Riise, MD, PhD, of the institute, and his colleagues identified all live births in Norway from 1998 to 2010 from the Medical Birth Registry of Norway and studied the gestational age of 713,166 infants as an indicator of increased risk of pertussis.

Infants born at 23-27 weeks of gestational age had an incidence rate ratio of pertussis more than fourfold higher than term infants (IRR = 4.49), while those born at 32-34 weeks and 35-36 weeks each had an IRR about 1.5 time higher than term infants (Pediatr Infect Dis J. doi: 10.1097/INF.0000000000001545).

The IRR of preterm infants hospitalized with pertussis was double that of full-term infants (IRR = 1.99).

The increased risk in preterm infants could be attributed to an incomplete transfer of maternal antibodies, specifically the “abundance of IgG [that] is acquired during the last month of full-term pregnancy,” Dr. Riise and colleagues wrote.

While previous studies have found links between preterm birth and pertussis infection, those studies used birth weight instead of gestational age, which leads to possibly inaccurate results, they added.

“Although other studies have used low birth weight to identify infants with increased risk of pertussis, we would have underestimated the number of infants with increased risk by using low birth weight instead of gestational age, since many of the late preterm infants have normal birth weight,” the researchers noted.

Early vaccination is key to protecting preterm infants from pertussis, Dr. Riise and colleagues said, adding that vaccine effectiveness was similar between preterm (93%) and full-term (88.8%) infants.

[email protected]

Preterm infants are at greater risk for pertussis than full-term infants, according to a population-based study from the Norwegian Institute of Public Health.

Øystein Rolandsen Riise, MD, PhD, of the institute, and his colleagues identified all live births in Norway from 1998 to 2010 from the Medical Birth Registry of Norway and studied the gestational age of 713,166 infants as an indicator of increased risk of pertussis.

Infants born at 23-27 weeks of gestational age had an incidence rate ratio of pertussis more than fourfold higher than term infants (IRR = 4.49), while those born at 32-34 weeks and 35-36 weeks each had an IRR about 1.5 time higher than term infants (Pediatr Infect Dis J. doi: 10.1097/INF.0000000000001545).

The IRR of preterm infants hospitalized with pertussis was double that of full-term infants (IRR = 1.99).

The increased risk in preterm infants could be attributed to an incomplete transfer of maternal antibodies, specifically the “abundance of IgG [that] is acquired during the last month of full-term pregnancy,” Dr. Riise and colleagues wrote.

While previous studies have found links between preterm birth and pertussis infection, those studies used birth weight instead of gestational age, which leads to possibly inaccurate results, they added.

“Although other studies have used low birth weight to identify infants with increased risk of pertussis, we would have underestimated the number of infants with increased risk by using low birth weight instead of gestational age, since many of the late preterm infants have normal birth weight,” the researchers noted.

Early vaccination is key to protecting preterm infants from pertussis, Dr. Riise and colleagues said, adding that vaccine effectiveness was similar between preterm (93%) and full-term (88.8%) infants.

[email protected]