The Nurses Organization of Veterans Affairs (NOVA) is a national nonprofit professional organization whose members are VA nurses working at VHA facilities throughout the country and caring for America’s heroes. For more than 35 years, NOVA has been the voice of VA nurses. Speaking strongly on behalf of its more than 3,000 members, NOVA leaders recently met in Washington, DC, for the annual Capitol Hill meetings and Legislative Roundtable.

With the elections over and new members taking their seats in the 115th Congress, NOVA leadership spoke candidly about ongoing VA transformation, choice, recruitment and retention, and access to care with respect to the new advanced practice registered nurse (APRN) regulation being implemented across VHA facilities. The APRN regulation allowing APRNs to practice to their full authority within the VA cleared in December. It grants 3 of the 4 APRN roles (nurse practitioners, certified nurse-midwives, and clinical nurse specialists) the ability to practice to the full extent of their education and training.

Armed with copies of the organization’s 2017 Legislative Priority Goals, NOVA leadership met with congressional members and staff of the House and Senate VA committees. Among NOVA’s priorities for the 115th Congress are the following:

• Effects of the federal hiring freeze
• VA transformation
• CHOICE/community-integrated health care
• Information technology
• Retention/recruitment and staffing

For a complete list of the 2017 Legislative Priority Goals, visit vanurse.org

Committee members were eager to hear the opinions of NOVA experts on the Choice Act and on the status of hiring initiatives at their facilities. A key staffing provision of the Veterans Access, Choice, and Accountability Act included an increase in hiring authority and a more generous loan repayment for those looking to work at the VA. In addition, Congress authorized $5 million in funding to hire more medical professionals. A VA internal audit found that the need for additional doctors, nurses, and specialty care was the highest barrier or challenge to providing access to care. NOVA testified on this issue before the 114th Congress.

Staff of House and Senate VA Committees shared other legislative priorities, including the reauthorization of the Choice Act and continued oversight of many areas within the VA, to include a sharp look at access and coordination of care and accountability.

The meeting concluded with the NOVA Legislative Roundtable discussion. Held at the Washington, DC, offices of the Disabled American Veterans service organization, the roundtable was attended by more than 25 organizations that have a stake in veterans’ health care. Leaders from various professional nursing organizations, veterans service organizations, VA Office of Nursing Services, the American Federation of Government Employees, and staff from both the House and Senate VA committees were in attendance.

A lively discussion was held regarding the future of VA health care, APRN implementation, workforce/ retention and recruitment issues, as well as telehealth and the opioid epidemic as it relates to VA patients. The release of the President’s proposed budget also was discussed. As is often the case with a new administration, a “skinny” or outline of a budget proposal is released in advance of an actual detailed budget, which included a substantial 10% increase in VA’s anticipated budget for overall discretionary items (over FY 2017) and an 8.3% increase for medical care (over FY 2017). The agency estimates it will treat about 7.1 million patients in FY 2018, and veterans who served in the ongoing operations in Iraq and Afghanistan are estimated to reach 995,196 in 2018.

For more information about NOVA or to become a member, visit vanurse.org.

The Nurses Organization of Veterans Affairs (NOVA) is a national nonprofit professional organization whose members are VA nurses working at VHA facilities throughout the country and caring for America’s heroes. For more than 35 years, NOVA has been the voice of VA nurses. Speaking strongly on behalf of its more than 3,000 members, NOVA leaders recently met in Washington, DC, for the annual Capitol Hill meetings and Legislative Roundtable.

With the elections over and new members taking their seats in the 115th Congress, NOVA leadership spoke candidly about ongoing VA transformation, choice, recruitment and retention, and access to care with respect to the new advanced practice registered nurse (APRN) regulation being implemented across VHA facilities. The APRN regulation allowing APRNs to practice to their full authority within the VA cleared in December. It grants 3 of the 4 APRN roles (nurse practitioners, certified nurse-midwives, and clinical nurse specialists) the ability to practice to the full extent of their education and training.

Armed with copies of the organization’s 2017 Legislative Priority Goals, NOVA leadership met with congressional members and staff of the House and Senate VA committees. Among NOVA’s priorities for the 115th Congress are the following:

• Effects of the federal hiring freeze
• VA transformation
• CHOICE/community-integrated health care
• Information technology
• Retention/recruitment and staffing

For a complete list of the 2017 Legislative Priority Goals, visit vanurse.org

Committee members were eager to hear the opinions of NOVA experts on the Choice Act and on the status of hiring initiatives at their facilities. A key staffing provision of the Veterans Access, Choice, and Accountability Act included an increase in hiring authority and a more generous loan repayment for those looking to work at the VA. In addition, Congress authorized $5 million in funding to hire more medical professionals. A VA internal audit found that the need for additional doctors, nurses, and specialty care was the highest barrier or challenge to providing access to care. NOVA testified on this issue before the 114th Congress.

Staff of House and Senate VA Committees shared other legislative priorities, including the reauthorization of the Choice Act and continued oversight of many areas within the VA, to include a sharp look at access and coordination of care and accountability.

The meeting concluded with the NOVA Legislative Roundtable discussion. Held at the Washington, DC, offices of the Disabled American Veterans service organization, the roundtable was attended by more than 25 organizations that have a stake in veterans’ health care. Leaders from various professional nursing organizations, veterans service organizations, VA Office of Nursing Services, the American Federation of Government Employees, and staff from both the House and Senate VA committees were in attendance.

A lively discussion was held regarding the future of VA health care, APRN implementation, workforce/ retention and recruitment issues, as well as telehealth and the opioid epidemic as it relates to VA patients. The release of the President’s proposed budget also was discussed. As is often the case with a new administration, a “skinny” or outline of a budget proposal is released in advance of an actual detailed budget, which included a substantial 10% increase in VA’s anticipated budget for overall discretionary items (over FY 2017) and an 8.3% increase for medical care (over FY 2017). The agency estimates it will treat about 7.1 million patients in FY 2018, and veterans who served in the ongoing operations in Iraq and Afghanistan are estimated to reach 995,196 in 2018.

For more information about NOVA or to become a member, visit vanurse.org.

The Nurses Organization of Veterans Affairs (NOVA) is a national nonprofit professional organization whose members are VA nurses working at VHA facilities throughout the country and caring for America’s heroes. For more than 35 years, NOVA has been the voice of VA nurses. Speaking strongly on behalf of its more than 3,000 members, NOVA leaders recently met in Washington, DC, for the annual Capitol Hill meetings and Legislative Roundtable.

With the elections over and new members taking their seats in the 115th Congress, NOVA leadership spoke candidly about ongoing VA transformation, choice, recruitment and retention, and access to care with respect to the new advanced practice registered nurse (APRN) regulation being implemented across VHA facilities. The APRN regulation allowing APRNs to practice to their full authority within the VA cleared in December. It grants 3 of the 4 APRN roles (nurse practitioners, certified nurse-midwives, and clinical nurse specialists) the ability to practice to the full extent of their education and training.

Armed with copies of the organization’s 2017 Legislative Priority Goals, NOVA leadership met with congressional members and staff of the House and Senate VA committees. Among NOVA’s priorities for the 115th Congress are the following:

• Effects of the federal hiring freeze
• VA transformation
• CHOICE/community-integrated health care
• Information technology
• Retention/recruitment and staffing

For a complete list of the 2017 Legislative Priority Goals, visit vanurse.org

Committee members were eager to hear the opinions of NOVA experts on the Choice Act and on the status of hiring initiatives at their facilities. A key staffing provision of the Veterans Access, Choice, and Accountability Act included an increase in hiring authority and a more generous loan repayment for those looking to work at the VA. In addition, Congress authorized $5 million in funding to hire more medical professionals. A VA internal audit found that the need for additional doctors, nurses, and specialty care was the highest barrier or challenge to providing access to care. NOVA testified on this issue before the 114th Congress.

Staff of House and Senate VA Committees shared other legislative priorities, including the reauthorization of the Choice Act and continued oversight of many areas within the VA, to include a sharp look at access and coordination of care and accountability.

The meeting concluded with the NOVA Legislative Roundtable discussion. Held at the Washington, DC, offices of the Disabled American Veterans service organization, the roundtable was attended by more than 25 organizations that have a stake in veterans’ health care. Leaders from various professional nursing organizations, veterans service organizations, VA Office of Nursing Services, the American Federation of Government Employees, and staff from both the House and Senate VA committees were in attendance.

A lively discussion was held regarding the future of VA health care, APRN implementation, workforce/ retention and recruitment issues, as well as telehealth and the opioid epidemic as it relates to VA patients. The release of the President’s proposed budget also was discussed. As is often the case with a new administration, a “skinny” or outline of a budget proposal is released in advance of an actual detailed budget, which included a substantial 10% increase in VA’s anticipated budget for overall discretionary items (over FY 2017) and an 8.3% increase for medical care (over FY 2017). The agency estimates it will treat about 7.1 million patients in FY 2018, and veterans who served in the ongoing operations in Iraq and Afghanistan are estimated to reach 995,196 in 2018.

For more information about NOVA or to become a member, visit vanurse.org.

Image by Graham Beards

Researchers have found evidence to suggest that thrombocytosis is a strong predictor of cancer, particularly lung and colorectal cancer.

The team therefore believes patients with thrombocytosis should be evaluated for an underlying malignancy, as such investigation could speed up cancer diagnosis and save lives.

“We know that early diagnosis is absolutely key in whether people survive cancer,” said Sarah Bailey, PhD, of the University of Exeter Medical School in the UK.

“Our research suggests that substantial numbers of people could have their cancer diagnosed up to 3 months earlier if thrombocytosis prompted investigation for cancer. This time could make a vital difference in achieving earlier diagnosis.”

Dr Bailey and her colleagues described their research in the British Journal of General Practice.

The team conducted a prospective cohort study using Clinical Practice Research Datalink data spanning the period from 2000 to 2013.

They compared the 1-year cancer incidence in 40,000 patients (age 40 and older) with thrombocytosis (platelet count >400 × 10⁹/L) and 10,000 matched controls with normal platelet counts.

Patients with thrombocytosis had a higher incidence of cancer than individuals with normal platelet counts.

The cancer incidence was 6.2% (1355/21,826) in women with thrombocytosis and 2.2% (119/5370) in women with normal platelet counts.

The cancer incidence was 11.6% (1098/9435) in men with thrombocytosis and 4.1% (106/2599) in men with normal platelet counts.

If patients in the thrombocytosis group had a second raised platelet count recorded within 6 months of their index date, the risk of cancer increased to 18.1% for men and 10.1% for women.

Lung and colorectal cancer were more common among patients with thrombocytosis than among individuals with normal platelet counts.

And about one-third of patients with thrombocytosis and lung/colorectal cancer had no other symptoms that would indicate they had cancer.

In addition, the researchers found that “substantial proportions” of lung/colorectal cancer diagnoses could be expedited if thrombocytosis were routinely investigated.

The team calculated that if 5% of patients with cancer have thrombocytosis before a cancer diagnosis, one-third of them have the potential to have their diagnosis expedited by at least 3 months if their doctor investigates the possibility of cancer based on the presence of thrombocytosis. This equates to 5500 earlier diagnoses annually.

“The UK lags well behind other developed countries on early cancer diagnosis,” said study author Willie Hamilton, MD, of the University of Exeter Medical School.

“In 2014, 163,000 people died of cancer in this country. Our findings on thrombocytosis show a strong association with cancer, particularly in men—far stronger than that of a breast lump for breast cancer in women. It is now crucial that we roll out cancer investigation of thrombocytosis. It could save hundreds of lives each year.” 

Image by Graham Beards

Researchers have found evidence to suggest that thrombocytosis is a strong predictor of cancer, particularly lung and colorectal cancer.

The team therefore believes patients with thrombocytosis should be evaluated for an underlying malignancy, as such investigation could speed up cancer diagnosis and save lives.

“We know that early diagnosis is absolutely key in whether people survive cancer,” said Sarah Bailey, PhD, of the University of Exeter Medical School in the UK.

“Our research suggests that substantial numbers of people could have their cancer diagnosed up to 3 months earlier if thrombocytosis prompted investigation for cancer. This time could make a vital difference in achieving earlier diagnosis.”

Dr Bailey and her colleagues described their research in the British Journal of General Practice.

The team conducted a prospective cohort study using Clinical Practice Research Datalink data spanning the period from 2000 to 2013.

They compared the 1-year cancer incidence in 40,000 patients (age 40 and older) with thrombocytosis (platelet count >400 × 10⁹/L) and 10,000 matched controls with normal platelet counts.

Patients with thrombocytosis had a higher incidence of cancer than individuals with normal platelet counts.

The cancer incidence was 6.2% (1355/21,826) in women with thrombocytosis and 2.2% (119/5370) in women with normal platelet counts.

The cancer incidence was 11.6% (1098/9435) in men with thrombocytosis and 4.1% (106/2599) in men with normal platelet counts.

If patients in the thrombocytosis group had a second raised platelet count recorded within 6 months of their index date, the risk of cancer increased to 18.1% for men and 10.1% for women.

Lung and colorectal cancer were more common among patients with thrombocytosis than among individuals with normal platelet counts.

And about one-third of patients with thrombocytosis and lung/colorectal cancer had no other symptoms that would indicate they had cancer.

In addition, the researchers found that “substantial proportions” of lung/colorectal cancer diagnoses could be expedited if thrombocytosis were routinely investigated.

The team calculated that if 5% of patients with cancer have thrombocytosis before a cancer diagnosis, one-third of them have the potential to have their diagnosis expedited by at least 3 months if their doctor investigates the possibility of cancer based on the presence of thrombocytosis. This equates to 5500 earlier diagnoses annually.

“The UK lags well behind other developed countries on early cancer diagnosis,” said study author Willie Hamilton, MD, of the University of Exeter Medical School.

“In 2014, 163,000 people died of cancer in this country. Our findings on thrombocytosis show a strong association with cancer, particularly in men—far stronger than that of a breast lump for breast cancer in women. It is now crucial that we roll out cancer investigation of thrombocytosis. It could save hundreds of lives each year.” 

Image by Graham Beards

Researchers have found evidence to suggest that thrombocytosis is a strong predictor of cancer, particularly lung and colorectal cancer.

The team therefore believes patients with thrombocytosis should be evaluated for an underlying malignancy, as such investigation could speed up cancer diagnosis and save lives.

“We know that early diagnosis is absolutely key in whether people survive cancer,” said Sarah Bailey, PhD, of the University of Exeter Medical School in the UK.

“Our research suggests that substantial numbers of people could have their cancer diagnosed up to 3 months earlier if thrombocytosis prompted investigation for cancer. This time could make a vital difference in achieving earlier diagnosis.”

Dr Bailey and her colleagues described their research in the British Journal of General Practice.

The team conducted a prospective cohort study using Clinical Practice Research Datalink data spanning the period from 2000 to 2013.

They compared the 1-year cancer incidence in 40,000 patients (age 40 and older) with thrombocytosis (platelet count >400 × 10⁹/L) and 10,000 matched controls with normal platelet counts.

Patients with thrombocytosis had a higher incidence of cancer than individuals with normal platelet counts.

The cancer incidence was 6.2% (1355/21,826) in women with thrombocytosis and 2.2% (119/5370) in women with normal platelet counts.

The cancer incidence was 11.6% (1098/9435) in men with thrombocytosis and 4.1% (106/2599) in men with normal platelet counts.

If patients in the thrombocytosis group had a second raised platelet count recorded within 6 months of their index date, the risk of cancer increased to 18.1% for men and 10.1% for women.

Lung and colorectal cancer were more common among patients with thrombocytosis than among individuals with normal platelet counts.

And about one-third of patients with thrombocytosis and lung/colorectal cancer had no other symptoms that would indicate they had cancer.

In addition, the researchers found that “substantial proportions” of lung/colorectal cancer diagnoses could be expedited if thrombocytosis were routinely investigated.

The team calculated that if 5% of patients with cancer have thrombocytosis before a cancer diagnosis, one-third of them have the potential to have their diagnosis expedited by at least 3 months if their doctor investigates the possibility of cancer based on the presence of thrombocytosis. This equates to 5500 earlier diagnoses annually.

“The UK lags well behind other developed countries on early cancer diagnosis,” said study author Willie Hamilton, MD, of the University of Exeter Medical School.

“In 2014, 163,000 people died of cancer in this country. Our findings on thrombocytosis show a strong association with cancer, particularly in men—far stronger than that of a breast lump for breast cancer in women. It is now crucial that we roll out cancer investigation of thrombocytosis. It could save hundreds of lives each year.” 

Antihemophilic factor

Personalized prophylaxis with a recombinant factor VIII product allowed for reduced dosing while still providing protection from bleeds in a small study of patients with severe hemophilia A.

Researchers tested pharmacokinetic (PK)-guided prophylaxis with simoctocog alfa in previously treated patients with severe hemophilia A.

The approach reduced the dose administered and increased the dosing interval compared to standard prophylaxis, without compromising protection from bleeds.

Researchers reported these results in the journal Haemophilia. The research was sponsored by Octapharma AG, the company marketing simoctocog alfa as Nuwiq.

Simoctocog alfa is a fourth-generation recombinant human factor VIII product produced in a human cell line.

In this phase 3b study, researchers tested PK-guided prophylaxis with simoctocog alfa in 66 previously treated adults with severe hemophilia A.

The patients’ mean age at baseline was 33.6. Most (62%) had received on-demand treatment in the 6 months prior to starting the study. Prophylaxis was largely irregular in the 38% of patients who received prophylaxis.

At baseline, the mean annualized bleeding rates (ABRs) were 38.9 in the entire cohort, 45.6 in the on-demand cohort, and 27.8 in the prophylaxis cohort.

Study design

The study had 3 phases. The first was the 72-hour PK phase. Patients received a single dose of simoctocog alfa (60 ± 5 IU kg^–1) and had blood samples taken at various time points. This helped the researchers determine the patients’ personalized prophylaxis regimen.

The second phase of the study was the standard prophylaxis phase, which lasted 1 to 3 months. In this phase, patients received simoctocog alfa at a dose of 30 to 40 IU kg^–1 every other day or 3 times a week until they began personalized prophylaxis.

The third phase was the 6-month personalized prophylaxis phase. A patient’s personalized prophylaxis regimen was based on individual PK modeling for each patient according to whether their PK profile most closely fit a 1- or 2-compartment model. In cases of uncertainty, the researchers used a non-compartment model.

A 2-compartment PK model was used for 36 patients, a 1-compartment model was used for 23 patients, and a non-compartment model was used for 7 patients.

Dosing

In total, the patients received 6612 infusions of simoctocog alfa.

During standard prophylaxis, the mean treatment duration was 2.7 months. Patients received a mean of 34.0 infusions and a total dose of 1157.6 IU kg^–1.

During the personalized prophylaxis phase, the mean treatment duration was 6.2 months. Patients received a mean of 58.8 infusions and a total dose of 2574.4 IU kg^–1.

The median dosing interval was 3.5 days during personalized prophylaxis, 3.5 days in the 1- and 2-compartment model groups, and 2.3 days in the non-compartment group. Fifty-seven percent of patients had twice-weekly dosing or less.

In the standard prophylaxis period, patients were dosed every other day or 3 times a week.

The median weekly dose was 100.0 IU kg^–1 during standard prophylaxis and 95.0 IU kg^–1 during personalized prophylaxis. It was 97.5 IU kg^–1 during months 1 to 4 of personalized prophylaxis and 92.8 IU kg^–1 during months 5 and 6 of personalized prophylaxis.

Bleeding and safety

Similar percentages of patients were bleed-free during the roughly 3-month standard prophylaxis period and the roughly 6-month personalized prophylaxis period—76.9% and 73.8%, respectively.

However, the mean ABR was 3.16 for the standard prophylaxis period and 1.45 for the personalized prophylaxis period. The median ABR was 0 for both periods.

In all, there were 95 breakthrough bleeds—46 during standard prophylaxis and 49 during personalized prophylaxis—in 23 of the patients. All of these bleeds were treated with at least 1 dose of simoctocog alfa.

There were no serious adverse events associated with treatment, and none of the patients developed factor VIII inhibitors.

One patient experienced malaise and dizziness after a single infusion during the standard prophylaxis period. These events were considered treatment-related, but both events resolved. 

Antihemophilic factor

Personalized prophylaxis with a recombinant factor VIII product allowed for reduced dosing while still providing protection from bleeds in a small study of patients with severe hemophilia A.

Researchers tested pharmacokinetic (PK)-guided prophylaxis with simoctocog alfa in previously treated patients with severe hemophilia A.

The approach reduced the dose administered and increased the dosing interval compared to standard prophylaxis, without compromising protection from bleeds.

Researchers reported these results in the journal Haemophilia. The research was sponsored by Octapharma AG, the company marketing simoctocog alfa as Nuwiq.

Simoctocog alfa is a fourth-generation recombinant human factor VIII product produced in a human cell line.

In this phase 3b study, researchers tested PK-guided prophylaxis with simoctocog alfa in 66 previously treated adults with severe hemophilia A.

The patients’ mean age at baseline was 33.6. Most (62%) had received on-demand treatment in the 6 months prior to starting the study. Prophylaxis was largely irregular in the 38% of patients who received prophylaxis.

At baseline, the mean annualized bleeding rates (ABRs) were 38.9 in the entire cohort, 45.6 in the on-demand cohort, and 27.8 in the prophylaxis cohort.

Study design

The study had 3 phases. The first was the 72-hour PK phase. Patients received a single dose of simoctocog alfa (60 ± 5 IU kg^–1) and had blood samples taken at various time points. This helped the researchers determine the patients’ personalized prophylaxis regimen.

The second phase of the study was the standard prophylaxis phase, which lasted 1 to 3 months. In this phase, patients received simoctocog alfa at a dose of 30 to 40 IU kg^–1 every other day or 3 times a week until they began personalized prophylaxis.

The third phase was the 6-month personalized prophylaxis phase. A patient’s personalized prophylaxis regimen was based on individual PK modeling for each patient according to whether their PK profile most closely fit a 1- or 2-compartment model. In cases of uncertainty, the researchers used a non-compartment model.

A 2-compartment PK model was used for 36 patients, a 1-compartment model was used for 23 patients, and a non-compartment model was used for 7 patients.

Dosing

In total, the patients received 6612 infusions of simoctocog alfa.

During standard prophylaxis, the mean treatment duration was 2.7 months. Patients received a mean of 34.0 infusions and a total dose of 1157.6 IU kg^–1.

During the personalized prophylaxis phase, the mean treatment duration was 6.2 months. Patients received a mean of 58.8 infusions and a total dose of 2574.4 IU kg^–1.

The median dosing interval was 3.5 days during personalized prophylaxis, 3.5 days in the 1- and 2-compartment model groups, and 2.3 days in the non-compartment group. Fifty-seven percent of patients had twice-weekly dosing or less.

In the standard prophylaxis period, patients were dosed every other day or 3 times a week.

The median weekly dose was 100.0 IU kg^–1 during standard prophylaxis and 95.0 IU kg^–1 during personalized prophylaxis. It was 97.5 IU kg^–1 during months 1 to 4 of personalized prophylaxis and 92.8 IU kg^–1 during months 5 and 6 of personalized prophylaxis.

Bleeding and safety

Similar percentages of patients were bleed-free during the roughly 3-month standard prophylaxis period and the roughly 6-month personalized prophylaxis period—76.9% and 73.8%, respectively.

However, the mean ABR was 3.16 for the standard prophylaxis period and 1.45 for the personalized prophylaxis period. The median ABR was 0 for both periods.

In all, there were 95 breakthrough bleeds—46 during standard prophylaxis and 49 during personalized prophylaxis—in 23 of the patients. All of these bleeds were treated with at least 1 dose of simoctocog alfa.

There were no serious adverse events associated with treatment, and none of the patients developed factor VIII inhibitors.

One patient experienced malaise and dizziness after a single infusion during the standard prophylaxis period. These events were considered treatment-related, but both events resolved. 

Antihemophilic factor

Personalized prophylaxis with a recombinant factor VIII product allowed for reduced dosing while still providing protection from bleeds in a small study of patients with severe hemophilia A.

Researchers tested pharmacokinetic (PK)-guided prophylaxis with simoctocog alfa in previously treated patients with severe hemophilia A.

The approach reduced the dose administered and increased the dosing interval compared to standard prophylaxis, without compromising protection from bleeds.

Researchers reported these results in the journal Haemophilia. The research was sponsored by Octapharma AG, the company marketing simoctocog alfa as Nuwiq.

Simoctocog alfa is a fourth-generation recombinant human factor VIII product produced in a human cell line.

In this phase 3b study, researchers tested PK-guided prophylaxis with simoctocog alfa in 66 previously treated adults with severe hemophilia A.

The patients’ mean age at baseline was 33.6. Most (62%) had received on-demand treatment in the 6 months prior to starting the study. Prophylaxis was largely irregular in the 38% of patients who received prophylaxis.

At baseline, the mean annualized bleeding rates (ABRs) were 38.9 in the entire cohort, 45.6 in the on-demand cohort, and 27.8 in the prophylaxis cohort.

Study design

The study had 3 phases. The first was the 72-hour PK phase. Patients received a single dose of simoctocog alfa (60 ± 5 IU kg^–1) and had blood samples taken at various time points. This helped the researchers determine the patients’ personalized prophylaxis regimen.

The second phase of the study was the standard prophylaxis phase, which lasted 1 to 3 months. In this phase, patients received simoctocog alfa at a dose of 30 to 40 IU kg^–1 every other day or 3 times a week until they began personalized prophylaxis.

The third phase was the 6-month personalized prophylaxis phase. A patient’s personalized prophylaxis regimen was based on individual PK modeling for each patient according to whether their PK profile most closely fit a 1- or 2-compartment model. In cases of uncertainty, the researchers used a non-compartment model.

A 2-compartment PK model was used for 36 patients, a 1-compartment model was used for 23 patients, and a non-compartment model was used for 7 patients.

Dosing

In total, the patients received 6612 infusions of simoctocog alfa.

During standard prophylaxis, the mean treatment duration was 2.7 months. Patients received a mean of 34.0 infusions and a total dose of 1157.6 IU kg^–1.

During the personalized prophylaxis phase, the mean treatment duration was 6.2 months. Patients received a mean of 58.8 infusions and a total dose of 2574.4 IU kg^–1.

The median dosing interval was 3.5 days during personalized prophylaxis, 3.5 days in the 1- and 2-compartment model groups, and 2.3 days in the non-compartment group. Fifty-seven percent of patients had twice-weekly dosing or less.

In the standard prophylaxis period, patients were dosed every other day or 3 times a week.

The median weekly dose was 100.0 IU kg^–1 during standard prophylaxis and 95.0 IU kg^–1 during personalized prophylaxis. It was 97.5 IU kg^–1 during months 1 to 4 of personalized prophylaxis and 92.8 IU kg^–1 during months 5 and 6 of personalized prophylaxis.

Bleeding and safety

Similar percentages of patients were bleed-free during the roughly 3-month standard prophylaxis period and the roughly 6-month personalized prophylaxis period—76.9% and 73.8%, respectively.

However, the mean ABR was 3.16 for the standard prophylaxis period and 1.45 for the personalized prophylaxis period. The median ABR was 0 for both periods.

In all, there were 95 breakthrough bleeds—46 during standard prophylaxis and 49 during personalized prophylaxis—in 23 of the patients. All of these bleeds were treated with at least 1 dose of simoctocog alfa.

There were no serious adverse events associated with treatment, and none of the patients developed factor VIII inhibitors.

One patient experienced malaise and dizziness after a single infusion during the standard prophylaxis period. These events were considered treatment-related, but both events resolved. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

[email protected]

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

[email protected]

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

[email protected]

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

[email protected]

On Twitter @karioakes

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

[email protected]

On Twitter @karioakes

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

[email protected]

On Twitter @karioakes

NEW YORK – A left atrial abnormality on a pretreatment electrocardiogram (ECG) is a moderately specific and sensitive finding that independently predicts risk for developing atrial fibrillation in chronic lymphocytic leukemia patients starting on ibrutinib, findings from a retrospective cohort study indicate.

ECGs are inexpensive and available in most physician’s offices. Routinely checking for a left atrial abnormality before starting ibrutinib would identify a patient subgroup that would benefit from increased monitoring and allow for proactive intervention strategies to reduce complications should atrial fibrillation develop, Anthony Mato, MD, said at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.

[email protected]

NEW YORK – A left atrial abnormality on a pretreatment electrocardiogram (ECG) is a moderately specific and sensitive finding that independently predicts risk for developing atrial fibrillation in chronic lymphocytic leukemia patients starting on ibrutinib, findings from a retrospective cohort study indicate.

ECGs are inexpensive and available in most physician’s offices. Routinely checking for a left atrial abnormality before starting ibrutinib would identify a patient subgroup that would benefit from increased monitoring and allow for proactive intervention strategies to reduce complications should atrial fibrillation develop, Anthony Mato, MD, said at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.

[email protected]

NEW YORK – A left atrial abnormality on a pretreatment electrocardiogram (ECG) is a moderately specific and sensitive finding that independently predicts risk for developing atrial fibrillation in chronic lymphocytic leukemia patients starting on ibrutinib, findings from a retrospective cohort study indicate.

ECGs are inexpensive and available in most physician’s offices. Routinely checking for a left atrial abnormality before starting ibrutinib would identify a patient subgroup that would benefit from increased monitoring and allow for proactive intervention strategies to reduce complications should atrial fibrillation develop, Anthony Mato, MD, said at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.

[email protected]

Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.

The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).

Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.

In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.

At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).

“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.

Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.

The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.

Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.

The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).

Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.

In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.

At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).

“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.

Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.

The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.

Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.

The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).

Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.

In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.

At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).

“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.

Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.

The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.

CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week^®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week^®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week^®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

SAN DIEGO – Is it okay for pregnant women to attend CrossFit classes? Are patients who run for fun at increased risk for osteoarthritis? Does stretching before exercise provide any benefits to athletes?

Experts discussed these topics during a session titled “Mythbusters in sports medicine” at the annual meeting of the American Medical Society for Sports Medicine.
 

Does exercise negatively impact pregnancy?

The idea that strenuous exercise during pregnancy can harm a baby’s health is a myth, according to Elizabeth A. Joy, MD.

“Women having healthy, uncomplicated pregnancies should be encouraged to be physically active throughout pregnancy, with a goal of achieving 150 minutes per week of moderate-intensity activity,” she said. “Fit pregnant women who were habitually performing high-intensity exercise before pregnancy can continue to do so during pregnancy, assuming an otherwise healthy, uncomplicated pregnancy.”

Results from more than 600 studies in the medical literature indicate that exercise during pregnancy is safe for moms and babies, noted Dr. Joy, medical director for community health and food and nutrition at Intermountain Healthcare in Salt Lake City, Utah.

In fact, the 2008 Physical Activity Guidelines for Americans state that pregnant women who habitually engage in vigorous-intensity aerobic activity or who are highly active “can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.”

Such advice wasn’t always supported by the medical profession. In fact, 1985 guidelines from the American College of Obstetricians and Gynecologists recommended that women limit exercise to no more than 15 minutes at a time during pregnancy and keep their maternal heart rate less than 140 beats per minute. ACOG also discouraged previously sedentary women from beginning an exercise program during pregnancy.

“Sadly, women are still getting this advice,” said Dr. Joy, who is also president of the American College of Sports Medicine. According to the 2005-2010 National Ambulatory Medical Care Survey, only 18% of pregnant women reported receiving counseling to be physically active during their pregnancies (Matern Child Health J. 2014 Sep;18[7]:1610-18). “That is just unacceptable,” she said.

In a prospective study of the association between vigorous physical activity during pregnancy and length of gestation and birth weight, researchers evaluated 1,647 births among primiparous women (Matern Child Health J. 2012 Jul;16[5]:1031-44).

Does running cause knee OA?

During another talk at the meeting, William O. Roberts, MD, characterized the notion that running causes knee osteoarthritis as largely a myth for recreational runners. However, elite runners and athletes who participate in other sports may face an increased risk of developing the condition.

Well-established risk factors for knee OA include post–joint injury proteases and cytokines and injury load stress on articular cartilage. “Other risk factors include overweight and obesity, a family history of OA, exercise, heavy work that involved squatting and kneeling, and being female,” said Dr. Roberts, professor of family medicine and community health at the University of Minnesota, Minneapolis.

He discussed three articles on the topic drawn from medical literature. One was a retrospective cross-sectional analysis of 2,637 Osteoarthritis Initiative participants, 45-79 years of age, who had knee-specific pain or knee x-ray data 4 years into the 10-year–long study (Arthritis Care Res. 2017 Feb;69[2]:183-91).

More than half of the participants (56%) were female, their mean body mass index was 28.5 kg/m², only 20% reported more than 2,000 bouts of running during their lifetime, and about 5% had run competitively.

Adjusted odds ratios of pain, radiographic OA, and symptomatic OA for those prior runners and current runners, compared with those who never ran, were 0.82 and 0.76 (P for trend = .02), 0.98 and 0.91 (P for trend = .05), and 0.88 and 0.71 (P for trend = .03), respectively.

Does it help to stretch before exercise?

Stretching before engaging in exercise is a common practice often recommended by coaches and clinicians – but it appears to have no role in preventing injuries during exercise itself.

Several decades ago, investigators subscribed to muscle spasm theory, which held that unaccustomed exercise caused muscle spasms.

“The thought was that muscle spasms impeded blood flow to the muscle, causing ischemic pain and further spasm,” Valerie E. Cothran, MD, said during a presentation at the meeting. “Stretching the muscle was thought to restore blood flow to the muscle and interrupt the pain-spasm-pain cycle. This theory has been discredited for 40 years, but the practice of stretching before exercise persists.”

According to Dr. Cothran, of the department of family and community medicine at the University of Maryland, Baltimore, a limited number of randomized, controlled trials exist on the topic – and many are fraught with limitations, such as the evaluation of multiple stretching methods and variable types of sports activities and the inclusion of multiple cointerventions.

One systematic review evaluated 361 randomized, controlled trials and cohort studies of interventions that included stretching and that appeared in the medical literature from 1966 to 2002 (Med Sci Sports Exerc. 2004 Mar;36[3]:371-8). Studies with no controls were excluded from the analysis, as were those in which stretching could not be assessed independently or those that did not include people engaged in sports or fitness activities.

The researchers determined that stretching was not significantly associated with a reduction in total injuries (OR, 0.93). “There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes,” they concluded.

[email protected]

SAN DIEGO – Is it okay for pregnant women to attend CrossFit classes? Are patients who run for fun at increased risk for osteoarthritis? Does stretching before exercise provide any benefits to athletes?

Experts discussed these topics during a session titled “Mythbusters in sports medicine” at the annual meeting of the American Medical Society for Sports Medicine.
 

Does exercise negatively impact pregnancy?

The idea that strenuous exercise during pregnancy can harm a baby’s health is a myth, according to Elizabeth A. Joy, MD.

“Women having healthy, uncomplicated pregnancies should be encouraged to be physically active throughout pregnancy, with a goal of achieving 150 minutes per week of moderate-intensity activity,” she said. “Fit pregnant women who were habitually performing high-intensity exercise before pregnancy can continue to do so during pregnancy, assuming an otherwise healthy, uncomplicated pregnancy.”

Results from more than 600 studies in the medical literature indicate that exercise during pregnancy is safe for moms and babies, noted Dr. Joy, medical director for community health and food and nutrition at Intermountain Healthcare in Salt Lake City, Utah.

In fact, the 2008 Physical Activity Guidelines for Americans state that pregnant women who habitually engage in vigorous-intensity aerobic activity or who are highly active “can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.”

Such advice wasn’t always supported by the medical profession. In fact, 1985 guidelines from the American College of Obstetricians and Gynecologists recommended that women limit exercise to no more than 15 minutes at a time during pregnancy and keep their maternal heart rate less than 140 beats per minute. ACOG also discouraged previously sedentary women from beginning an exercise program during pregnancy.

“Sadly, women are still getting this advice,” said Dr. Joy, who is also president of the American College of Sports Medicine. According to the 2005-2010 National Ambulatory Medical Care Survey, only 18% of pregnant women reported receiving counseling to be physically active during their pregnancies (Matern Child Health J. 2014 Sep;18[7]:1610-18). “That is just unacceptable,” she said.

In a prospective study of the association between vigorous physical activity during pregnancy and length of gestation and birth weight, researchers evaluated 1,647 births among primiparous women (Matern Child Health J. 2012 Jul;16[5]:1031-44).

Does running cause knee OA?

During another talk at the meeting, William O. Roberts, MD, characterized the notion that running causes knee osteoarthritis as largely a myth for recreational runners. However, elite runners and athletes who participate in other sports may face an increased risk of developing the condition.

Well-established risk factors for knee OA include post–joint injury proteases and cytokines and injury load stress on articular cartilage. “Other risk factors include overweight and obesity, a family history of OA, exercise, heavy work that involved squatting and kneeling, and being female,” said Dr. Roberts, professor of family medicine and community health at the University of Minnesota, Minneapolis.

He discussed three articles on the topic drawn from medical literature. One was a retrospective cross-sectional analysis of 2,637 Osteoarthritis Initiative participants, 45-79 years of age, who had knee-specific pain or knee x-ray data 4 years into the 10-year–long study (Arthritis Care Res. 2017 Feb;69[2]:183-91).

More than half of the participants (56%) were female, their mean body mass index was 28.5 kg/m², only 20% reported more than 2,000 bouts of running during their lifetime, and about 5% had run competitively.

Adjusted odds ratios of pain, radiographic OA, and symptomatic OA for those prior runners and current runners, compared with those who never ran, were 0.82 and 0.76 (P for trend = .02), 0.98 and 0.91 (P for trend = .05), and 0.88 and 0.71 (P for trend = .03), respectively.

Does it help to stretch before exercise?

Stretching before engaging in exercise is a common practice often recommended by coaches and clinicians – but it appears to have no role in preventing injuries during exercise itself.

Several decades ago, investigators subscribed to muscle spasm theory, which held that unaccustomed exercise caused muscle spasms.

“The thought was that muscle spasms impeded blood flow to the muscle, causing ischemic pain and further spasm,” Valerie E. Cothran, MD, said during a presentation at the meeting. “Stretching the muscle was thought to restore blood flow to the muscle and interrupt the pain-spasm-pain cycle. This theory has been discredited for 40 years, but the practice of stretching before exercise persists.”

According to Dr. Cothran, of the department of family and community medicine at the University of Maryland, Baltimore, a limited number of randomized, controlled trials exist on the topic – and many are fraught with limitations, such as the evaluation of multiple stretching methods and variable types of sports activities and the inclusion of multiple cointerventions.

One systematic review evaluated 361 randomized, controlled trials and cohort studies of interventions that included stretching and that appeared in the medical literature from 1966 to 2002 (Med Sci Sports Exerc. 2004 Mar;36[3]:371-8). Studies with no controls were excluded from the analysis, as were those in which stretching could not be assessed independently or those that did not include people engaged in sports or fitness activities.

The researchers determined that stretching was not significantly associated with a reduction in total injuries (OR, 0.93). “There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes,” they concluded.

[email protected]

SAN DIEGO – Is it okay for pregnant women to attend CrossFit classes? Are patients who run for fun at increased risk for osteoarthritis? Does stretching before exercise provide any benefits to athletes?

Experts discussed these topics during a session titled “Mythbusters in sports medicine” at the annual meeting of the American Medical Society for Sports Medicine.
 

Does exercise negatively impact pregnancy?

The idea that strenuous exercise during pregnancy can harm a baby’s health is a myth, according to Elizabeth A. Joy, MD.

“Women having healthy, uncomplicated pregnancies should be encouraged to be physically active throughout pregnancy, with a goal of achieving 150 minutes per week of moderate-intensity activity,” she said. “Fit pregnant women who were habitually performing high-intensity exercise before pregnancy can continue to do so during pregnancy, assuming an otherwise healthy, uncomplicated pregnancy.”

Results from more than 600 studies in the medical literature indicate that exercise during pregnancy is safe for moms and babies, noted Dr. Joy, medical director for community health and food and nutrition at Intermountain Healthcare in Salt Lake City, Utah.

In fact, the 2008 Physical Activity Guidelines for Americans state that pregnant women who habitually engage in vigorous-intensity aerobic activity or who are highly active “can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.”

Such advice wasn’t always supported by the medical profession. In fact, 1985 guidelines from the American College of Obstetricians and Gynecologists recommended that women limit exercise to no more than 15 minutes at a time during pregnancy and keep their maternal heart rate less than 140 beats per minute. ACOG also discouraged previously sedentary women from beginning an exercise program during pregnancy.

“Sadly, women are still getting this advice,” said Dr. Joy, who is also president of the American College of Sports Medicine. According to the 2005-2010 National Ambulatory Medical Care Survey, only 18% of pregnant women reported receiving counseling to be physically active during their pregnancies (Matern Child Health J. 2014 Sep;18[7]:1610-18). “That is just unacceptable,” she said.

In a prospective study of the association between vigorous physical activity during pregnancy and length of gestation and birth weight, researchers evaluated 1,647 births among primiparous women (Matern Child Health J. 2012 Jul;16[5]:1031-44).

Does running cause knee OA?

During another talk at the meeting, William O. Roberts, MD, characterized the notion that running causes knee osteoarthritis as largely a myth for recreational runners. However, elite runners and athletes who participate in other sports may face an increased risk of developing the condition.

Well-established risk factors for knee OA include post–joint injury proteases and cytokines and injury load stress on articular cartilage. “Other risk factors include overweight and obesity, a family history of OA, exercise, heavy work that involved squatting and kneeling, and being female,” said Dr. Roberts, professor of family medicine and community health at the University of Minnesota, Minneapolis.

He discussed three articles on the topic drawn from medical literature. One was a retrospective cross-sectional analysis of 2,637 Osteoarthritis Initiative participants, 45-79 years of age, who had knee-specific pain or knee x-ray data 4 years into the 10-year–long study (Arthritis Care Res. 2017 Feb;69[2]:183-91).

More than half of the participants (56%) were female, their mean body mass index was 28.5 kg/m², only 20% reported more than 2,000 bouts of running during their lifetime, and about 5% had run competitively.

Adjusted odds ratios of pain, radiographic OA, and symptomatic OA for those prior runners and current runners, compared with those who never ran, were 0.82 and 0.76 (P for trend = .02), 0.98 and 0.91 (P for trend = .05), and 0.88 and 0.71 (P for trend = .03), respectively.

Does it help to stretch before exercise?

Stretching before engaging in exercise is a common practice often recommended by coaches and clinicians – but it appears to have no role in preventing injuries during exercise itself.

Several decades ago, investigators subscribed to muscle spasm theory, which held that unaccustomed exercise caused muscle spasms.

“The thought was that muscle spasms impeded blood flow to the muscle, causing ischemic pain and further spasm,” Valerie E. Cothran, MD, said during a presentation at the meeting. “Stretching the muscle was thought to restore blood flow to the muscle and interrupt the pain-spasm-pain cycle. This theory has been discredited for 40 years, but the practice of stretching before exercise persists.”

According to Dr. Cothran, of the department of family and community medicine at the University of Maryland, Baltimore, a limited number of randomized, controlled trials exist on the topic – and many are fraught with limitations, such as the evaluation of multiple stretching methods and variable types of sports activities and the inclusion of multiple cointerventions.

One systematic review evaluated 361 randomized, controlled trials and cohort studies of interventions that included stretching and that appeared in the medical literature from 1966 to 2002 (Med Sci Sports Exerc. 2004 Mar;36[3]:371-8). Studies with no controls were excluded from the analysis, as were those in which stretching could not be assessed independently or those that did not include people engaged in sports or fitness activities.

The researchers determined that stretching was not significantly associated with a reduction in total injuries (OR, 0.93). “There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes,” they concluded.

[email protected]