Swollen right hand and forearm • minor trauma to hand • previous diagnosis of cellulitis • Dx?

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Swollen right hand and forearm • minor trauma to hand • previous diagnosis of cellulitis • Dx?

THE CASE

A 63-year-old woman with a history of hyperlipidemia presented to our hospital with a swollen right hand. The patient noted that she had closed her hand in a car door one week earlier, causing minor trauma to the right third metacarpophalangeal joint. Shortly after injuring her hand, she’d sought care at an outpatient facility, where she was given a diagnosis of cellulitis and a prescription for an oral antibiotic. The swelling, however, worsened, prompting her visit to our hospital. She was admitted for further work-up and started on intravenous (IV) antibiotics.

Her family history included a sister with deep vein thrombosis (DVT) and a maternal aunt with breast cancer. The patient denied oral contraceptive use or a personal history of malignancy. On physical examination, her right hand and forearm were swollen, tender, and erythematous.

THE DIAGNOSIS

Laboratory data showed a normal complete blood count and complete metabolic panel. The patient’s sedimentation rate and C-reactive protein level were elevated at 65 mm/hr and 110 mg/L, respectively. The patient was not improving on IV antibiotics, so we performed a right upper extremity venous duplex ultrasound. The ultrasound showed an occlusive thrombus in the right ulnar and radial veins (FIGURES 1 AND 2), and we diagnosed the patient with upper extremity deep vein thrombosis (UEDVT). (The timing of the diagnosis, relative to the injury to the patient’s hand, appeared to have been coincidental.)

Further work-up revealed normal complement C3 and C4 tests, as well as negative antinuclear, anti-double stranded DNA, anti-Smith, and anticardiolipin antibody tests. Similarly, a factor II DNA analysis was negative. However, the patient was positive for the factor V Leiden heterozygous mutation.

DISCUSSION

More than 350,000 people are diagnosed with DVT or pulmonary embolism (PE) in the United States each year.1 Up to 4% of all DVTs involve the upper extremities.2 Secondary UEDVT, which occurs in patients with central venous catheters, malignancies, and thrombophilia, accounts for the majority of UEDVT cases; primary UEDVT is less common.3

Large epidemiologic studies have demonstrated that hypercoagulability is a risk factor for lower extremity DVT, but few data exist on the role of coagulation abnormalities in patients with primary UEDVT. The prevalence of clotting abnormalities in patients with primary UEDVT ranges from 8% to 43%.4,5 Factor V Leiden is the most common cause of inherited thrombophilia. Patients with heterozygous factor V Leiden mutation have a 7-fold increased risk of venous thrombosis.6

Héron and colleagues7 reported that 16 of 51 patients with at least one clotting abnormality had primary UEDVT. Factor V Leiden was found in 5 of those patients (20%). Interestingly, 3 of the 5 carriers of the factor V Leiden mutation were older than 45 years. Our patient was 63, which was consistent with these findings.

Malignancy is also an important risk factor for UEDVT.8,9 In patients with a DVT in an unusual location, age- and sex-appropriate cancer screenings are strongly recommended. (Our patient had undergone a colonoscopy 8 years earlier, which was normal. She’d also had a recent mammogram and Pap smear, which were normal, as well.)

It’s often difficult to distinguish between cellulitis and UEDVT

The differential diagnosis for UEDVT includes effort thrombosis (also known as Paget-Schroetter syndrome) and cellulitis.

Effort thrombosis usually occurs in young, otherwise healthy individuals and almost exclusively in the axillary and subclavian veins. Our patient’s age and a venous duplex ultrasound ruled out any thrombosis in these locations.

Distinguishing cellulitis from UEDVT based on clinical features can be difficult. In both conditions, the limb is swollen and painful and the skin is warm and erythematous. As a result, each condition is often misdiagnosed as the other.

But there are features that distinguish the 2. In patients with UEDVT, you’re likely to see limb pain and a palpable cord (a hard, thickened palpable vein along the line of the deep veins). On the other hand, patients with cellulitis tend to have more systemic symptoms, such as fever, chills, and swollen lymph nodes, as well as skin breakdown, ulcers, and pus.

The American College of Chest Physicians (ACCP) recommends that the initial evaluation for patients with suspected UEDVT be a combined modality ultrasound (compression with either Doppler or color Doppler) rather than D-dimer or venography.10 Quickly arriving at a proper diagnosis is critical, given that up to one-third of patients with UEDVT will develop a PE.7 Other complications include superior vena cava syndrome, septic thrombophlebitis, thoracic duct obstruction, and brachial plexopathy.11

Treat with anticoagulants for no longer than 3 months

The ACCP also recommends that patients who have UEDVT that isn’t associated with a central venous catheter or with cancer be treated with anticoagulation for no longer than 3 months.10

 

 

Our patient was started on enoxaparin and warfarin. After 5 days at our hospital, she was taken off the enoxaparin and discharged home on warfarin 5 mg/d. The swelling completely resolved one week later.

THE TAKEAWAY

Ulnar and radial DVT in a patient with factor V Leiden mutation is a rare condition. UEDVT should be included in the differential diagnosis for cellulitis whenever the diagnosis is uncertain or the patient doesn’t respond to antibiotics. Factor V Leiden mutation appears to be a risk factor in UEDVT and testing for it should be considered.

References

1. Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Available at: http://www.ncbi.nlm.nih.gov/books/NBK44178/. Rockville, MD: Office of the Surgeon General (US); 2008.

2. Sawyer GA, Hayda R. Upper-extremity deep venous thrombosis following humeral shaft fracture. Orthopedics. 2011;34:141.

3. Leebeek FW, Stadhouders NA, van Stein D, et al. Hypercoagulability states in upper-extremity deep venous thrombosis. Am J Hematol. 2001;67:15-19.

4. Prandoni P, Polistena P, Bernardi E, et al. Upper-extremity deep vein thrombosis. Risk factors, diagnosis, and complications. Arch Intern Med. 1997;157:57-62.

5. Ruggeri M, Castaman G, Tosetto A, et al. Low prevalence of thrombophilic coagulation defects in patients with deep vein thrombosis of the upper limbs. Blood Coagul Fibrinolysis. 1997;8:191-194.

6. Ornstein DL, Cushman M. Cardiology patient page. Factor V Leiden. Circulation. 2003;107:e94-e97.

7. Héron E, Lozinguez O, Alhenc-Gelas M, et al. Hypercoagulable states in primary upper-extremity deep vein thrombosis. Arch Intern Med. 2000;160:382-386.

8. Linnemann B, Meister F, Schwonberg J, et al; MAISTHRO registry. Hereditary and acquired thrombophilia in patients with upper extremity deep-vein thrombosis. Results from the MAISTHRO registry. Thromb Haemost. 2008;100:440-446.

9. Monreal M, Lafoz E, Ruiz J, et al. Upper-extremity deep venous thrombosis and pulmonary embolism. A prospective study. Chest. 1991;99:280-283.

10. Holbrook A, Schulman S, Witt DM, et al; American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e152S-e184S.

11. Becker DM, Philbrick JT, Walker FB 4th. Axillary and subclavian venous thrombosis. Prognosis and treatment. Arch Intern Med. 1991;151:1934-1943.

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Mahmoud Farhoud, MD
Melissa Gaines, MD

University of Kansas School of Medicine—Wichita (Drs. Rahal and Gaines); University of Central Florida, College of Medicine, Orlando (Dr. Farhoud)
[email protected]

The authors acknowledge K. James Kallail, PhD (University of Kansas School of Medicine—Wichita) for his assistance in the writing of this manuscript.

The authors reported no potential conflict of interest relevant to this article.

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Mahmoud Farhoud, MD
Melissa Gaines, MD

University of Kansas School of Medicine—Wichita (Drs. Rahal and Gaines); University of Central Florida, College of Medicine, Orlando (Dr. Farhoud)
[email protected]

The authors acknowledge K. James Kallail, PhD (University of Kansas School of Medicine—Wichita) for his assistance in the writing of this manuscript.

The authors reported no potential conflict of interest relevant to this article.

Author and Disclosure Information

Ahmad Rahal, MD
Mahmoud Farhoud, MD
Melissa Gaines, MD

University of Kansas School of Medicine—Wichita (Drs. Rahal and Gaines); University of Central Florida, College of Medicine, Orlando (Dr. Farhoud)
[email protected]

The authors acknowledge K. James Kallail, PhD (University of Kansas School of Medicine—Wichita) for his assistance in the writing of this manuscript.

The authors reported no potential conflict of interest relevant to this article.

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THE CASE

A 63-year-old woman with a history of hyperlipidemia presented to our hospital with a swollen right hand. The patient noted that she had closed her hand in a car door one week earlier, causing minor trauma to the right third metacarpophalangeal joint. Shortly after injuring her hand, she’d sought care at an outpatient facility, where she was given a diagnosis of cellulitis and a prescription for an oral antibiotic. The swelling, however, worsened, prompting her visit to our hospital. She was admitted for further work-up and started on intravenous (IV) antibiotics.

Her family history included a sister with deep vein thrombosis (DVT) and a maternal aunt with breast cancer. The patient denied oral contraceptive use or a personal history of malignancy. On physical examination, her right hand and forearm were swollen, tender, and erythematous.

THE DIAGNOSIS

Laboratory data showed a normal complete blood count and complete metabolic panel. The patient’s sedimentation rate and C-reactive protein level were elevated at 65 mm/hr and 110 mg/L, respectively. The patient was not improving on IV antibiotics, so we performed a right upper extremity venous duplex ultrasound. The ultrasound showed an occlusive thrombus in the right ulnar and radial veins (FIGURES 1 AND 2), and we diagnosed the patient with upper extremity deep vein thrombosis (UEDVT). (The timing of the diagnosis, relative to the injury to the patient’s hand, appeared to have been coincidental.)

Further work-up revealed normal complement C3 and C4 tests, as well as negative antinuclear, anti-double stranded DNA, anti-Smith, and anticardiolipin antibody tests. Similarly, a factor II DNA analysis was negative. However, the patient was positive for the factor V Leiden heterozygous mutation.

DISCUSSION

More than 350,000 people are diagnosed with DVT or pulmonary embolism (PE) in the United States each year.1 Up to 4% of all DVTs involve the upper extremities.2 Secondary UEDVT, which occurs in patients with central venous catheters, malignancies, and thrombophilia, accounts for the majority of UEDVT cases; primary UEDVT is less common.3

Large epidemiologic studies have demonstrated that hypercoagulability is a risk factor for lower extremity DVT, but few data exist on the role of coagulation abnormalities in patients with primary UEDVT. The prevalence of clotting abnormalities in patients with primary UEDVT ranges from 8% to 43%.4,5 Factor V Leiden is the most common cause of inherited thrombophilia. Patients with heterozygous factor V Leiden mutation have a 7-fold increased risk of venous thrombosis.6

Héron and colleagues7 reported that 16 of 51 patients with at least one clotting abnormality had primary UEDVT. Factor V Leiden was found in 5 of those patients (20%). Interestingly, 3 of the 5 carriers of the factor V Leiden mutation were older than 45 years. Our patient was 63, which was consistent with these findings.

Malignancy is also an important risk factor for UEDVT.8,9 In patients with a DVT in an unusual location, age- and sex-appropriate cancer screenings are strongly recommended. (Our patient had undergone a colonoscopy 8 years earlier, which was normal. She’d also had a recent mammogram and Pap smear, which were normal, as well.)

It’s often difficult to distinguish between cellulitis and UEDVT

The differential diagnosis for UEDVT includes effort thrombosis (also known as Paget-Schroetter syndrome) and cellulitis.

Effort thrombosis usually occurs in young, otherwise healthy individuals and almost exclusively in the axillary and subclavian veins. Our patient’s age and a venous duplex ultrasound ruled out any thrombosis in these locations.

Distinguishing cellulitis from UEDVT based on clinical features can be difficult. In both conditions, the limb is swollen and painful and the skin is warm and erythematous. As a result, each condition is often misdiagnosed as the other.

But there are features that distinguish the 2. In patients with UEDVT, you’re likely to see limb pain and a palpable cord (a hard, thickened palpable vein along the line of the deep veins). On the other hand, patients with cellulitis tend to have more systemic symptoms, such as fever, chills, and swollen lymph nodes, as well as skin breakdown, ulcers, and pus.

The American College of Chest Physicians (ACCP) recommends that the initial evaluation for patients with suspected UEDVT be a combined modality ultrasound (compression with either Doppler or color Doppler) rather than D-dimer or venography.10 Quickly arriving at a proper diagnosis is critical, given that up to one-third of patients with UEDVT will develop a PE.7 Other complications include superior vena cava syndrome, septic thrombophlebitis, thoracic duct obstruction, and brachial plexopathy.11

Treat with anticoagulants for no longer than 3 months

The ACCP also recommends that patients who have UEDVT that isn’t associated with a central venous catheter or with cancer be treated with anticoagulation for no longer than 3 months.10

 

 

Our patient was started on enoxaparin and warfarin. After 5 days at our hospital, she was taken off the enoxaparin and discharged home on warfarin 5 mg/d. The swelling completely resolved one week later.

THE TAKEAWAY

Ulnar and radial DVT in a patient with factor V Leiden mutation is a rare condition. UEDVT should be included in the differential diagnosis for cellulitis whenever the diagnosis is uncertain or the patient doesn’t respond to antibiotics. Factor V Leiden mutation appears to be a risk factor in UEDVT and testing for it should be considered.

THE CASE

A 63-year-old woman with a history of hyperlipidemia presented to our hospital with a swollen right hand. The patient noted that she had closed her hand in a car door one week earlier, causing minor trauma to the right third metacarpophalangeal joint. Shortly after injuring her hand, she’d sought care at an outpatient facility, where she was given a diagnosis of cellulitis and a prescription for an oral antibiotic. The swelling, however, worsened, prompting her visit to our hospital. She was admitted for further work-up and started on intravenous (IV) antibiotics.

Her family history included a sister with deep vein thrombosis (DVT) and a maternal aunt with breast cancer. The patient denied oral contraceptive use or a personal history of malignancy. On physical examination, her right hand and forearm were swollen, tender, and erythematous.

THE DIAGNOSIS

Laboratory data showed a normal complete blood count and complete metabolic panel. The patient’s sedimentation rate and C-reactive protein level were elevated at 65 mm/hr and 110 mg/L, respectively. The patient was not improving on IV antibiotics, so we performed a right upper extremity venous duplex ultrasound. The ultrasound showed an occlusive thrombus in the right ulnar and radial veins (FIGURES 1 AND 2), and we diagnosed the patient with upper extremity deep vein thrombosis (UEDVT). (The timing of the diagnosis, relative to the injury to the patient’s hand, appeared to have been coincidental.)

Further work-up revealed normal complement C3 and C4 tests, as well as negative antinuclear, anti-double stranded DNA, anti-Smith, and anticardiolipin antibody tests. Similarly, a factor II DNA analysis was negative. However, the patient was positive for the factor V Leiden heterozygous mutation.

DISCUSSION

More than 350,000 people are diagnosed with DVT or pulmonary embolism (PE) in the United States each year.1 Up to 4% of all DVTs involve the upper extremities.2 Secondary UEDVT, which occurs in patients with central venous catheters, malignancies, and thrombophilia, accounts for the majority of UEDVT cases; primary UEDVT is less common.3

Large epidemiologic studies have demonstrated that hypercoagulability is a risk factor for lower extremity DVT, but few data exist on the role of coagulation abnormalities in patients with primary UEDVT. The prevalence of clotting abnormalities in patients with primary UEDVT ranges from 8% to 43%.4,5 Factor V Leiden is the most common cause of inherited thrombophilia. Patients with heterozygous factor V Leiden mutation have a 7-fold increased risk of venous thrombosis.6

Héron and colleagues7 reported that 16 of 51 patients with at least one clotting abnormality had primary UEDVT. Factor V Leiden was found in 5 of those patients (20%). Interestingly, 3 of the 5 carriers of the factor V Leiden mutation were older than 45 years. Our patient was 63, which was consistent with these findings.

Malignancy is also an important risk factor for UEDVT.8,9 In patients with a DVT in an unusual location, age- and sex-appropriate cancer screenings are strongly recommended. (Our patient had undergone a colonoscopy 8 years earlier, which was normal. She’d also had a recent mammogram and Pap smear, which were normal, as well.)

It’s often difficult to distinguish between cellulitis and UEDVT

The differential diagnosis for UEDVT includes effort thrombosis (also known as Paget-Schroetter syndrome) and cellulitis.

Effort thrombosis usually occurs in young, otherwise healthy individuals and almost exclusively in the axillary and subclavian veins. Our patient’s age and a venous duplex ultrasound ruled out any thrombosis in these locations.

Distinguishing cellulitis from UEDVT based on clinical features can be difficult. In both conditions, the limb is swollen and painful and the skin is warm and erythematous. As a result, each condition is often misdiagnosed as the other.

But there are features that distinguish the 2. In patients with UEDVT, you’re likely to see limb pain and a palpable cord (a hard, thickened palpable vein along the line of the deep veins). On the other hand, patients with cellulitis tend to have more systemic symptoms, such as fever, chills, and swollen lymph nodes, as well as skin breakdown, ulcers, and pus.

The American College of Chest Physicians (ACCP) recommends that the initial evaluation for patients with suspected UEDVT be a combined modality ultrasound (compression with either Doppler or color Doppler) rather than D-dimer or venography.10 Quickly arriving at a proper diagnosis is critical, given that up to one-third of patients with UEDVT will develop a PE.7 Other complications include superior vena cava syndrome, septic thrombophlebitis, thoracic duct obstruction, and brachial plexopathy.11

Treat with anticoagulants for no longer than 3 months

The ACCP also recommends that patients who have UEDVT that isn’t associated with a central venous catheter or with cancer be treated with anticoagulation for no longer than 3 months.10

 

 

Our patient was started on enoxaparin and warfarin. After 5 days at our hospital, she was taken off the enoxaparin and discharged home on warfarin 5 mg/d. The swelling completely resolved one week later.

THE TAKEAWAY

Ulnar and radial DVT in a patient with factor V Leiden mutation is a rare condition. UEDVT should be included in the differential diagnosis for cellulitis whenever the diagnosis is uncertain or the patient doesn’t respond to antibiotics. Factor V Leiden mutation appears to be a risk factor in UEDVT and testing for it should be considered.

References

1. Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Available at: http://www.ncbi.nlm.nih.gov/books/NBK44178/. Rockville, MD: Office of the Surgeon General (US); 2008.

2. Sawyer GA, Hayda R. Upper-extremity deep venous thrombosis following humeral shaft fracture. Orthopedics. 2011;34:141.

3. Leebeek FW, Stadhouders NA, van Stein D, et al. Hypercoagulability states in upper-extremity deep venous thrombosis. Am J Hematol. 2001;67:15-19.

4. Prandoni P, Polistena P, Bernardi E, et al. Upper-extremity deep vein thrombosis. Risk factors, diagnosis, and complications. Arch Intern Med. 1997;157:57-62.

5. Ruggeri M, Castaman G, Tosetto A, et al. Low prevalence of thrombophilic coagulation defects in patients with deep vein thrombosis of the upper limbs. Blood Coagul Fibrinolysis. 1997;8:191-194.

6. Ornstein DL, Cushman M. Cardiology patient page. Factor V Leiden. Circulation. 2003;107:e94-e97.

7. Héron E, Lozinguez O, Alhenc-Gelas M, et al. Hypercoagulable states in primary upper-extremity deep vein thrombosis. Arch Intern Med. 2000;160:382-386.

8. Linnemann B, Meister F, Schwonberg J, et al; MAISTHRO registry. Hereditary and acquired thrombophilia in patients with upper extremity deep-vein thrombosis. Results from the MAISTHRO registry. Thromb Haemost. 2008;100:440-446.

9. Monreal M, Lafoz E, Ruiz J, et al. Upper-extremity deep venous thrombosis and pulmonary embolism. A prospective study. Chest. 1991;99:280-283.

10. Holbrook A, Schulman S, Witt DM, et al; American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e152S-e184S.

11. Becker DM, Philbrick JT, Walker FB 4th. Axillary and subclavian venous thrombosis. Prognosis and treatment. Arch Intern Med. 1991;151:1934-1943.

References

1. Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Available at: http://www.ncbi.nlm.nih.gov/books/NBK44178/. Rockville, MD: Office of the Surgeon General (US); 2008.

2. Sawyer GA, Hayda R. Upper-extremity deep venous thrombosis following humeral shaft fracture. Orthopedics. 2011;34:141.

3. Leebeek FW, Stadhouders NA, van Stein D, et al. Hypercoagulability states in upper-extremity deep venous thrombosis. Am J Hematol. 2001;67:15-19.

4. Prandoni P, Polistena P, Bernardi E, et al. Upper-extremity deep vein thrombosis. Risk factors, diagnosis, and complications. Arch Intern Med. 1997;157:57-62.

5. Ruggeri M, Castaman G, Tosetto A, et al. Low prevalence of thrombophilic coagulation defects in patients with deep vein thrombosis of the upper limbs. Blood Coagul Fibrinolysis. 1997;8:191-194.

6. Ornstein DL, Cushman M. Cardiology patient page. Factor V Leiden. Circulation. 2003;107:e94-e97.

7. Héron E, Lozinguez O, Alhenc-Gelas M, et al. Hypercoagulable states in primary upper-extremity deep vein thrombosis. Arch Intern Med. 2000;160:382-386.

8. Linnemann B, Meister F, Schwonberg J, et al; MAISTHRO registry. Hereditary and acquired thrombophilia in patients with upper extremity deep-vein thrombosis. Results from the MAISTHRO registry. Thromb Haemost. 2008;100:440-446.

9. Monreal M, Lafoz E, Ruiz J, et al. Upper-extremity deep venous thrombosis and pulmonary embolism. A prospective study. Chest. 1991;99:280-283.

10. Holbrook A, Schulman S, Witt DM, et al; American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e152S-e184S.

11. Becker DM, Philbrick JT, Walker FB 4th. Axillary and subclavian venous thrombosis. Prognosis and treatment. Arch Intern Med. 1991;151:1934-1943.

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Multivisceral resection for growing teratoma syndrome: overcoming pessimism

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Multivisceral resection for growing teratoma syndrome: overcoming pessimism

Growing teratoma syndrome (GTS) is a rare condition seen in patients with germ-cell tumors (GCT) who present with enlarging masses during or after appropriate chemotherapy with normalized serum markers.1 Three defining criteria for GTS are: a persistently growing tumor mass or evolving new mass during or after chemotherapy, normalization of tumor markers, and presence of only mature teratoma in the resected specimen on the final histopathological examination.1 Growing teratomas lack the metastatic potential; however, their relentless local growth causes compression and infiltration of adjacent organs, which produces symptoms.

 

Click on the PDF icon at the top of this introduction to read the full article. 

 

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Growing teratoma syndrome (GTS) is a rare condition seen in patients with germ-cell tumors (GCT) who present with enlarging masses during or after appropriate chemotherapy with normalized serum markers.1 Three defining criteria for GTS are: a persistently growing tumor mass or evolving new mass during or after chemotherapy, normalization of tumor markers, and presence of only mature teratoma in the resected specimen on the final histopathological examination.1 Growing teratomas lack the metastatic potential; however, their relentless local growth causes compression and infiltration of adjacent organs, which produces symptoms.

 

Click on the PDF icon at the top of this introduction to read the full article. 

 

Growing teratoma syndrome (GTS) is a rare condition seen in patients with germ-cell tumors (GCT) who present with enlarging masses during or after appropriate chemotherapy with normalized serum markers.1 Three defining criteria for GTS are: a persistently growing tumor mass or evolving new mass during or after chemotherapy, normalization of tumor markers, and presence of only mature teratoma in the resected specimen on the final histopathological examination.1 Growing teratomas lack the metastatic potential; however, their relentless local growth causes compression and infiltration of adjacent organs, which produces symptoms.

 

Click on the PDF icon at the top of this introduction to read the full article. 

 

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Pathways, processes, team work: paving the way for value-based care with the quadruple aim

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Pathways, processes, team work: paving the way for value-based care with the quadruple aim

While we can imagine what a high-quality, state-of- the-art cancer care system might deliver in terms of value-based care and how it might yield exceptional patient outcomes and job satisfaction for our staff, most of us are struggling with the processes and tools needed to achieve defined outcomes that can be benchmarked and further refined – all within the limits of our already hectic 12-, 14,- 16+-hour days. As more community practices, academic centers, and hospitals align to share and leverage expertise in their efforts to form more streamlined, patient-centered delivery systems for cancer care, we need to set up, refine, and integrate pathways into pathway programs that will pave the way to the delivery of value-based care.

 

Click on the PDF icon at the top of this introduction to read the full article.

 
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While we can imagine what a high-quality, state-of- the-art cancer care system might deliver in terms of value-based care and how it might yield exceptional patient outcomes and job satisfaction for our staff, most of us are struggling with the processes and tools needed to achieve defined outcomes that can be benchmarked and further refined – all within the limits of our already hectic 12-, 14,- 16+-hour days. As more community practices, academic centers, and hospitals align to share and leverage expertise in their efforts to form more streamlined, patient-centered delivery systems for cancer care, we need to set up, refine, and integrate pathways into pathway programs that will pave the way to the delivery of value-based care.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

While we can imagine what a high-quality, state-of- the-art cancer care system might deliver in terms of value-based care and how it might yield exceptional patient outcomes and job satisfaction for our staff, most of us are struggling with the processes and tools needed to achieve defined outcomes that can be benchmarked and further refined – all within the limits of our already hectic 12-, 14,- 16+-hour days. As more community practices, academic centers, and hospitals align to share and leverage expertise in their efforts to form more streamlined, patient-centered delivery systems for cancer care, we need to set up, refine, and integrate pathways into pathway programs that will pave the way to the delivery of value-based care.

 

Click on the PDF icon at the top of this introduction to read the full article.

 
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Pathways, processes, team work: paving the way for value-based care with the quadruple aim
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Psoriatic flare assessment tool in validation stage

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MIAMI – Reaching a consensus on measurement and assessment of flare in psoriatic arthritis remains challenging, especially with no widely accepted definition and differing opinions among patients and physicians. But getting standard evaluation of flare under control is critical for both clinical and research outcomes.

Through a series of patient interviews, physician surveys, and lessons learned in rheumatoid arthritis, the GRAPPA Flare Project is close to a validated flare instrument. A 10-question flare assessment tool is now in the final validation stage, according to a presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“Flare is a clearly personal experience and varies from patient to patient. It’s clear that physicians and patients have clearly different ideas of what flare is. Bringing those two worlds together was a challenge,” Philip Helliwell, MD, of Leeds (England) University and GRAPPA president, said at the meeting.

James Heilman, MD/Wikimedia Commons/CC BY-SA 3.0

“Some societies – I’m not going to mention any names – have gone down the route of a definition of flare linked to disease activity measures. We have not done this,” Dr. Helliwell said.

Instead, the Flare Project is taking a patient-driven and physician-reviewed approach. Investigators cast a wide net, identifying 79 factors important to patients in six major domains: skin, joint, emotional, participation, fatigue, and unclassified. The results were published in 2015 (Rheumatology [Oxford]. 2015 Aug;54[8]:1448-53). Through a Delphi survey, physicians reviewed these considerations. Then GRAPPA identified items important to both patients and physicians and developed a preliminary flare instrument.

Unlike most assessment tools for psoriatic disease, the new instrument includes patient-reported emotional well-being. Niti Goel, MD, of Duke University, Durham, N.C., said that physicians do not always ask patients about the psychological impact of their disease, so the tool “could provide additional information.”

Another goal of the project is to provide standard answers to some of the common questions related to psoriatic arthritis, including: What exactly is a flare? Does the definition truly capture the worsening of disease? Are there different types of flares? Is flare different if you start from a point of high disease activity? What self-management and other interventions are effective for flare?

GRAPPA adopted a definition of flare developed from rheumatoid arthritis, stating that flare is any worsening of disease activity that would, if persistent, in most cases lead to initiation or change of therapy (J Rheumatol. 2009 Oct;36[10]:2335-41).

“It took [them] some time to get to that definition,” Dr. Helliwell said. “We know from rheumatoid arthritis that there is a lot more to a flare than joint swelling and pain.”

The GRAPPA flare tool is now in the validation stage, Dr. Helliwell said, and will be tested in several studies, including a prospective multicenter study where the 10-item questionnaire will be administered to patients.

A meeting attendee commented that the patient and physician global scales are sufficient and asked: “Is there really a need for a flare instrument?”

“I accept what you are saying, but I would also retort that knowledge is power, and the more information we get, the more we know about what we are doing,” Dr. Helliwell said. “We are going to collect all our information – physician global, patient global, composite disease measures – everything within that study.”

Dr. Helliwell and Dr. Goel reported having no relevant financial disclosures.

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MIAMI – Reaching a consensus on measurement and assessment of flare in psoriatic arthritis remains challenging, especially with no widely accepted definition and differing opinions among patients and physicians. But getting standard evaluation of flare under control is critical for both clinical and research outcomes.

Through a series of patient interviews, physician surveys, and lessons learned in rheumatoid arthritis, the GRAPPA Flare Project is close to a validated flare instrument. A 10-question flare assessment tool is now in the final validation stage, according to a presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“Flare is a clearly personal experience and varies from patient to patient. It’s clear that physicians and patients have clearly different ideas of what flare is. Bringing those two worlds together was a challenge,” Philip Helliwell, MD, of Leeds (England) University and GRAPPA president, said at the meeting.

James Heilman, MD/Wikimedia Commons/CC BY-SA 3.0

“Some societies – I’m not going to mention any names – have gone down the route of a definition of flare linked to disease activity measures. We have not done this,” Dr. Helliwell said.

Instead, the Flare Project is taking a patient-driven and physician-reviewed approach. Investigators cast a wide net, identifying 79 factors important to patients in six major domains: skin, joint, emotional, participation, fatigue, and unclassified. The results were published in 2015 (Rheumatology [Oxford]. 2015 Aug;54[8]:1448-53). Through a Delphi survey, physicians reviewed these considerations. Then GRAPPA identified items important to both patients and physicians and developed a preliminary flare instrument.

Unlike most assessment tools for psoriatic disease, the new instrument includes patient-reported emotional well-being. Niti Goel, MD, of Duke University, Durham, N.C., said that physicians do not always ask patients about the psychological impact of their disease, so the tool “could provide additional information.”

Another goal of the project is to provide standard answers to some of the common questions related to psoriatic arthritis, including: What exactly is a flare? Does the definition truly capture the worsening of disease? Are there different types of flares? Is flare different if you start from a point of high disease activity? What self-management and other interventions are effective for flare?

GRAPPA adopted a definition of flare developed from rheumatoid arthritis, stating that flare is any worsening of disease activity that would, if persistent, in most cases lead to initiation or change of therapy (J Rheumatol. 2009 Oct;36[10]:2335-41).

“It took [them] some time to get to that definition,” Dr. Helliwell said. “We know from rheumatoid arthritis that there is a lot more to a flare than joint swelling and pain.”

The GRAPPA flare tool is now in the validation stage, Dr. Helliwell said, and will be tested in several studies, including a prospective multicenter study where the 10-item questionnaire will be administered to patients.

A meeting attendee commented that the patient and physician global scales are sufficient and asked: “Is there really a need for a flare instrument?”

“I accept what you are saying, but I would also retort that knowledge is power, and the more information we get, the more we know about what we are doing,” Dr. Helliwell said. “We are going to collect all our information – physician global, patient global, composite disease measures – everything within that study.”

Dr. Helliwell and Dr. Goel reported having no relevant financial disclosures.

MIAMI – Reaching a consensus on measurement and assessment of flare in psoriatic arthritis remains challenging, especially with no widely accepted definition and differing opinions among patients and physicians. But getting standard evaluation of flare under control is critical for both clinical and research outcomes.

Through a series of patient interviews, physician surveys, and lessons learned in rheumatoid arthritis, the GRAPPA Flare Project is close to a validated flare instrument. A 10-question flare assessment tool is now in the final validation stage, according to a presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“Flare is a clearly personal experience and varies from patient to patient. It’s clear that physicians and patients have clearly different ideas of what flare is. Bringing those two worlds together was a challenge,” Philip Helliwell, MD, of Leeds (England) University and GRAPPA president, said at the meeting.

James Heilman, MD/Wikimedia Commons/CC BY-SA 3.0

“Some societies – I’m not going to mention any names – have gone down the route of a definition of flare linked to disease activity measures. We have not done this,” Dr. Helliwell said.

Instead, the Flare Project is taking a patient-driven and physician-reviewed approach. Investigators cast a wide net, identifying 79 factors important to patients in six major domains: skin, joint, emotional, participation, fatigue, and unclassified. The results were published in 2015 (Rheumatology [Oxford]. 2015 Aug;54[8]:1448-53). Through a Delphi survey, physicians reviewed these considerations. Then GRAPPA identified items important to both patients and physicians and developed a preliminary flare instrument.

Unlike most assessment tools for psoriatic disease, the new instrument includes patient-reported emotional well-being. Niti Goel, MD, of Duke University, Durham, N.C., said that physicians do not always ask patients about the psychological impact of their disease, so the tool “could provide additional information.”

Another goal of the project is to provide standard answers to some of the common questions related to psoriatic arthritis, including: What exactly is a flare? Does the definition truly capture the worsening of disease? Are there different types of flares? Is flare different if you start from a point of high disease activity? What self-management and other interventions are effective for flare?

GRAPPA adopted a definition of flare developed from rheumatoid arthritis, stating that flare is any worsening of disease activity that would, if persistent, in most cases lead to initiation or change of therapy (J Rheumatol. 2009 Oct;36[10]:2335-41).

“It took [them] some time to get to that definition,” Dr. Helliwell said. “We know from rheumatoid arthritis that there is a lot more to a flare than joint swelling and pain.”

The GRAPPA flare tool is now in the validation stage, Dr. Helliwell said, and will be tested in several studies, including a prospective multicenter study where the 10-item questionnaire will be administered to patients.

A meeting attendee commented that the patient and physician global scales are sufficient and asked: “Is there really a need for a flare instrument?”

“I accept what you are saying, but I would also retort that knowledge is power, and the more information we get, the more we know about what we are doing,” Dr. Helliwell said. “We are going to collect all our information – physician global, patient global, composite disease measures – everything within that study.”

Dr. Helliwell and Dr. Goel reported having no relevant financial disclosures.

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EXPERT ANALYSIS FROM 2016 GRAPPA ANNUAL MEETING

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Meningococcal B vaccine less protective than expected during outbreak

MenB vaccine presents challenges in making public health recommendations
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One-third of the individuals who received a multicomponent meningococcal B vaccine during an outbreak did not show a protective response against the outbreak strain, though they also did not contract the disease, a study showed.

“This level of seropositivity was lower than expected, given the antigenic similarity between the outbreak strain and the components of the vaccine and given that the Meningococcal Antigen Typing System predicted that 4CMenB would induce responses against the outbreak strain,” Nicole E. Basta, PhD, of the University of Minnesota, Minneapolis, and her associates wrote in the New England Journal of Medicine (2016;375:220-8. doi:10.1056/NEJMoa1514866).

©Steve Mann/thinkstockphotos.com

“Our results indicate that knowledge of [human complement serum bactericidal antibodies] immunity against the vaccine reference strains is not sufficient to predict individual-level immunity against an outbreak strain, even when the strain expresses one or more antigens that are closely related to the vaccine antigens,” the investigators added.

Amidst an outbreak of meningococcal B at Princeton (N.J.) University in the winter of 2013, the Food and Drug Administration allowed use of the meningococcal serogroup B (4CMenB) vaccine before its licensure, in an attempt to control the outbreak. Two strains of meningitis were used in developing this vaccine: 5/99 strain, which was not at all similar to the outbreak strain, and 44/76-SL, which was 96% genetically similar to the outbreak strain.

Among 535 people who completed the study, 499 individuals received two doses of 4CMenB 10 weeks apart, 17 received one dose of the vaccine, and 19 were unvaccinated. When the fully vaccinated individuals were tested for titers 8 weeks after their second dose, two-thirds (66.1%) had low-level seropositivity for the outbreak strain, with a geometric mean titer (GMT) of 7.6. One in five of the unvaccinated people (21.1%) had low seropositivity for the outbreak strain (GMT, 2.8), and 58.8% of the partly vaccinated individuals had seropositivity with a GMT of 5.4.

The researchers then assessed titers for the two strains used in developing 4CMenB in 61 fully vaccinated individuals, all randomly selected from the one-third of fully vaccinated people who did not have a detectable response to the outbreak strain. Most of them (86.9%) were seropositive for the 44/76-SL strain with a GMT of 17.4, and all of them were seropositive for the 5/99 strain, with a considerably larger GMT of 256.3.

Among those fully vaccinated who responded to the outbreak strain with titers above 8, all had seropositivity for 44/76-SL (GMT, 178.8), and 96.7% had seropositivity for the 5/99 strain (GMT, 214.2). Among the 18 unvaccinated individuals, just 1 had very low seropositivity to the 5/99 strain (GMT, 1.2), and 6 of them (33.3%) responded to the 44/76-SL strain (GMT, 3.2).

“These findings have implications for vaccination policies aimed at preventing and controlling meningococcal B disease,” the authors wrote.

The research was funded by Princeton University, the National Institutes of Health, and the Department of Homeland Security. Dr. Bai, Dr. Borrow, and Dr. Findlow reported having previously received research funding, unrelated to this study, from GlaxoSmithKline, Novartis, Pfizer, and Sanofi Pasteur. Dr. Johnsen has been reimbursed for travel expenses from Pfizer for a presentation. No other authors had financial disclosures.

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Proving the clinical efficacy of Neisseria meningitidis serogroup B (MenB) vaccines has been difficult. There is substantial genetic (and corresponding antigenic) diversity, and serogroup B meningococcal disease is both uncommon and in decline in countries where the burden is well understood. The Advisory Committee on Immunization Practices reviewed available data and concluded that a public health recommendation for vaccination of all adolescents could not be supported but that sufficient evidence existed to support individual decision making by clinicians with regard to patients between 16 and 23 years of age. Vaccination of all adolescents would prevent 15-29 cases and five to nine deaths annually in the United States. The effect of vaccinating college students is correspondingly smaller – preventing perhaps nine cases and one death, at an estimated cost per quality-adjusted life-year of $9.4 million.

The Centers for Disease Control and Prevention notes that the MenB vaccines approved in the United States should provide “protection against most, but not all, serogroup B strains” and represent an important contribution to the prevention of serogroup B meningococcal disease. More than 60,000 persons have received at least one vaccination with 4CMenB in studies conducted worldwide, including studies at universities in the United States and Canada, and the safety profile for 4CMenB has been good. For a relatively uncommon but devastating infectious disease, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is deployed in the context of a systematic public health response and if there is a commitment to the generation of additional information necessary for determining recommendations for use. The regulatory approval and clinical use of vaccines for pathogens that cause outbreaks will remain challenging.

Jerome H. Kim, MD, is with the International Vaccine Institute in Seoul, South Korea. He reported having no relevant financial disclosures. These comments were excerpted from the editorial accompanying the study (doi:10.1056/NEJMe1606015).

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Proving the clinical efficacy of Neisseria meningitidis serogroup B (MenB) vaccines has been difficult. There is substantial genetic (and corresponding antigenic) diversity, and serogroup B meningococcal disease is both uncommon and in decline in countries where the burden is well understood. The Advisory Committee on Immunization Practices reviewed available data and concluded that a public health recommendation for vaccination of all adolescents could not be supported but that sufficient evidence existed to support individual decision making by clinicians with regard to patients between 16 and 23 years of age. Vaccination of all adolescents would prevent 15-29 cases and five to nine deaths annually in the United States. The effect of vaccinating college students is correspondingly smaller – preventing perhaps nine cases and one death, at an estimated cost per quality-adjusted life-year of $9.4 million.

The Centers for Disease Control and Prevention notes that the MenB vaccines approved in the United States should provide “protection against most, but not all, serogroup B strains” and represent an important contribution to the prevention of serogroup B meningococcal disease. More than 60,000 persons have received at least one vaccination with 4CMenB in studies conducted worldwide, including studies at universities in the United States and Canada, and the safety profile for 4CMenB has been good. For a relatively uncommon but devastating infectious disease, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is deployed in the context of a systematic public health response and if there is a commitment to the generation of additional information necessary for determining recommendations for use. The regulatory approval and clinical use of vaccines for pathogens that cause outbreaks will remain challenging.

Jerome H. Kim, MD, is with the International Vaccine Institute in Seoul, South Korea. He reported having no relevant financial disclosures. These comments were excerpted from the editorial accompanying the study (doi:10.1056/NEJMe1606015).

Body

Proving the clinical efficacy of Neisseria meningitidis serogroup B (MenB) vaccines has been difficult. There is substantial genetic (and corresponding antigenic) diversity, and serogroup B meningococcal disease is both uncommon and in decline in countries where the burden is well understood. The Advisory Committee on Immunization Practices reviewed available data and concluded that a public health recommendation for vaccination of all adolescents could not be supported but that sufficient evidence existed to support individual decision making by clinicians with regard to patients between 16 and 23 years of age. Vaccination of all adolescents would prevent 15-29 cases and five to nine deaths annually in the United States. The effect of vaccinating college students is correspondingly smaller – preventing perhaps nine cases and one death, at an estimated cost per quality-adjusted life-year of $9.4 million.

The Centers for Disease Control and Prevention notes that the MenB vaccines approved in the United States should provide “protection against most, but not all, serogroup B strains” and represent an important contribution to the prevention of serogroup B meningococcal disease. More than 60,000 persons have received at least one vaccination with 4CMenB in studies conducted worldwide, including studies at universities in the United States and Canada, and the safety profile for 4CMenB has been good. For a relatively uncommon but devastating infectious disease, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is deployed in the context of a systematic public health response and if there is a commitment to the generation of additional information necessary for determining recommendations for use. The regulatory approval and clinical use of vaccines for pathogens that cause outbreaks will remain challenging.

Jerome H. Kim, MD, is with the International Vaccine Institute in Seoul, South Korea. He reported having no relevant financial disclosures. These comments were excerpted from the editorial accompanying the study (doi:10.1056/NEJMe1606015).

Title
MenB vaccine presents challenges in making public health recommendations
MenB vaccine presents challenges in making public health recommendations

One-third of the individuals who received a multicomponent meningococcal B vaccine during an outbreak did not show a protective response against the outbreak strain, though they also did not contract the disease, a study showed.

“This level of seropositivity was lower than expected, given the antigenic similarity between the outbreak strain and the components of the vaccine and given that the Meningococcal Antigen Typing System predicted that 4CMenB would induce responses against the outbreak strain,” Nicole E. Basta, PhD, of the University of Minnesota, Minneapolis, and her associates wrote in the New England Journal of Medicine (2016;375:220-8. doi:10.1056/NEJMoa1514866).

©Steve Mann/thinkstockphotos.com

“Our results indicate that knowledge of [human complement serum bactericidal antibodies] immunity against the vaccine reference strains is not sufficient to predict individual-level immunity against an outbreak strain, even when the strain expresses one or more antigens that are closely related to the vaccine antigens,” the investigators added.

Amidst an outbreak of meningococcal B at Princeton (N.J.) University in the winter of 2013, the Food and Drug Administration allowed use of the meningococcal serogroup B (4CMenB) vaccine before its licensure, in an attempt to control the outbreak. Two strains of meningitis were used in developing this vaccine: 5/99 strain, which was not at all similar to the outbreak strain, and 44/76-SL, which was 96% genetically similar to the outbreak strain.

Among 535 people who completed the study, 499 individuals received two doses of 4CMenB 10 weeks apart, 17 received one dose of the vaccine, and 19 were unvaccinated. When the fully vaccinated individuals were tested for titers 8 weeks after their second dose, two-thirds (66.1%) had low-level seropositivity for the outbreak strain, with a geometric mean titer (GMT) of 7.6. One in five of the unvaccinated people (21.1%) had low seropositivity for the outbreak strain (GMT, 2.8), and 58.8% of the partly vaccinated individuals had seropositivity with a GMT of 5.4.

The researchers then assessed titers for the two strains used in developing 4CMenB in 61 fully vaccinated individuals, all randomly selected from the one-third of fully vaccinated people who did not have a detectable response to the outbreak strain. Most of them (86.9%) were seropositive for the 44/76-SL strain with a GMT of 17.4, and all of them were seropositive for the 5/99 strain, with a considerably larger GMT of 256.3.

Among those fully vaccinated who responded to the outbreak strain with titers above 8, all had seropositivity for 44/76-SL (GMT, 178.8), and 96.7% had seropositivity for the 5/99 strain (GMT, 214.2). Among the 18 unvaccinated individuals, just 1 had very low seropositivity to the 5/99 strain (GMT, 1.2), and 6 of them (33.3%) responded to the 44/76-SL strain (GMT, 3.2).

“These findings have implications for vaccination policies aimed at preventing and controlling meningococcal B disease,” the authors wrote.

The research was funded by Princeton University, the National Institutes of Health, and the Department of Homeland Security. Dr. Bai, Dr. Borrow, and Dr. Findlow reported having previously received research funding, unrelated to this study, from GlaxoSmithKline, Novartis, Pfizer, and Sanofi Pasteur. Dr. Johnsen has been reimbursed for travel expenses from Pfizer for a presentation. No other authors had financial disclosures.

One-third of the individuals who received a multicomponent meningococcal B vaccine during an outbreak did not show a protective response against the outbreak strain, though they also did not contract the disease, a study showed.

“This level of seropositivity was lower than expected, given the antigenic similarity between the outbreak strain and the components of the vaccine and given that the Meningococcal Antigen Typing System predicted that 4CMenB would induce responses against the outbreak strain,” Nicole E. Basta, PhD, of the University of Minnesota, Minneapolis, and her associates wrote in the New England Journal of Medicine (2016;375:220-8. doi:10.1056/NEJMoa1514866).

©Steve Mann/thinkstockphotos.com

“Our results indicate that knowledge of [human complement serum bactericidal antibodies] immunity against the vaccine reference strains is not sufficient to predict individual-level immunity against an outbreak strain, even when the strain expresses one or more antigens that are closely related to the vaccine antigens,” the investigators added.

Amidst an outbreak of meningococcal B at Princeton (N.J.) University in the winter of 2013, the Food and Drug Administration allowed use of the meningococcal serogroup B (4CMenB) vaccine before its licensure, in an attempt to control the outbreak. Two strains of meningitis were used in developing this vaccine: 5/99 strain, which was not at all similar to the outbreak strain, and 44/76-SL, which was 96% genetically similar to the outbreak strain.

Among 535 people who completed the study, 499 individuals received two doses of 4CMenB 10 weeks apart, 17 received one dose of the vaccine, and 19 were unvaccinated. When the fully vaccinated individuals were tested for titers 8 weeks after their second dose, two-thirds (66.1%) had low-level seropositivity for the outbreak strain, with a geometric mean titer (GMT) of 7.6. One in five of the unvaccinated people (21.1%) had low seropositivity for the outbreak strain (GMT, 2.8), and 58.8% of the partly vaccinated individuals had seropositivity with a GMT of 5.4.

The researchers then assessed titers for the two strains used in developing 4CMenB in 61 fully vaccinated individuals, all randomly selected from the one-third of fully vaccinated people who did not have a detectable response to the outbreak strain. Most of them (86.9%) were seropositive for the 44/76-SL strain with a GMT of 17.4, and all of them were seropositive for the 5/99 strain, with a considerably larger GMT of 256.3.

Among those fully vaccinated who responded to the outbreak strain with titers above 8, all had seropositivity for 44/76-SL (GMT, 178.8), and 96.7% had seropositivity for the 5/99 strain (GMT, 214.2). Among the 18 unvaccinated individuals, just 1 had very low seropositivity to the 5/99 strain (GMT, 1.2), and 6 of them (33.3%) responded to the 44/76-SL strain (GMT, 3.2).

“These findings have implications for vaccination policies aimed at preventing and controlling meningococcal B disease,” the authors wrote.

The research was funded by Princeton University, the National Institutes of Health, and the Department of Homeland Security. Dr. Bai, Dr. Borrow, and Dr. Findlow reported having previously received research funding, unrelated to this study, from GlaxoSmithKline, Novartis, Pfizer, and Sanofi Pasteur. Dr. Johnsen has been reimbursed for travel expenses from Pfizer for a presentation. No other authors had financial disclosures.

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Key clinical point: The 4CMenB vaccine provided less protection than anticipated during an outbreak.

Major finding: A total of 66.1% of vaccinated individuals had seropositivity against the meningococcal B outbreak strain.

Data source: The findings are based on the immunogenicity of 4CMenB against a meningococcal B outbreak strain in 535 individuals during an outbreak at a New Jersey university in the winter of 2013.

Disclosures: The research was funded by Princeton University, the National Institutes of Health, and the Department of Homeland Security. Dr. Bai, Dr. Borrow, and Dr. Findlow reported having previously received research funding, unrelated to this study, from GlaxoSmithKline, Novartis, Pfizer, and Sanofi Pasteur. Dr. Johnsen has been reimbursed for travel expenses from Pfizer for a presentation. No other authors had disclosures.

Candida colonization raises risk of Acinetobacter-based VAP

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Candida colonization raises risk of Acinetobacter-based VAP

Acinetobacter baumanii was the most common cause of ventilator-associated pneumonia in ICU patients, and the risk of A. baumannii infection was significantly higher when airways were colonized with Candida species, based on data from 618 adults.

A. baumannii is a frequent cause of ventilator-associated pneumonia (VAP) in ICU patients, but its potential interactions with Candida species have not been well studied, wrote Dr. Xiaojiang Tan of Southern Medical University, Guangzhou, China, and colleagues (Med Mycol. 2016 Aug 1;54[6]:557-66. doi: 10.1093/mmy/myw009). The researchers reviewed data from 264 ICU patients on mechanical ventilation who had Candida species airway colonization and 354 who did not.

Overall, Candida was an independent risk factor for A. baumannii VAP; patients with Candida were significantly more likely than those without Candida to develop A. baumannii (23% vs. 15%). Other independent risk factors for A. baumannii VAP included the use of a central venous catheter and the use of mechanical ventilation for at least 7 days. Among patients on mechanical ventilation for at least 48 hours, Candida airway colonization occurred in 43%, and A. baumannii VAP occurred in 18%.

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Candida albicans showed an especially strong association with A. baumannii VAP; it was identified in 38% of cases, compared with 21% caused by non-albicans species.

No significant differences in hospital stay or in-hospital mortality were noted between Candida-colonized and noncolonized patients, and antifungal treatment had no apparent impact on the development of A. baumannii VAP, but antifungals were associated with higher in-hospital mortality (53% vs. 39%, P = .037).

The results were limited by the retrospective nature of the study and the use of data from a single center; thus, the relationship between Candida and A. baumannii VAP may not be generalizable, the researchers noted. However, “the strong independent association between the two suggests that Candida spp. growth from the lower respiratory tract in intubated patients could be an important indicator of the risk for VAP, and even that C. albicans airway colonization may play a role in subsequent development of A. baumannii VAP,” they wrote.

The researchers reported having no relevant financial conflicts.

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Acinetobacter baumanii was the most common cause of ventilator-associated pneumonia in ICU patients, and the risk of A. baumannii infection was significantly higher when airways were colonized with Candida species, based on data from 618 adults.

A. baumannii is a frequent cause of ventilator-associated pneumonia (VAP) in ICU patients, but its potential interactions with Candida species have not been well studied, wrote Dr. Xiaojiang Tan of Southern Medical University, Guangzhou, China, and colleagues (Med Mycol. 2016 Aug 1;54[6]:557-66. doi: 10.1093/mmy/myw009). The researchers reviewed data from 264 ICU patients on mechanical ventilation who had Candida species airway colonization and 354 who did not.

Overall, Candida was an independent risk factor for A. baumannii VAP; patients with Candida were significantly more likely than those without Candida to develop A. baumannii (23% vs. 15%). Other independent risk factors for A. baumannii VAP included the use of a central venous catheter and the use of mechanical ventilation for at least 7 days. Among patients on mechanical ventilation for at least 48 hours, Candida airway colonization occurred in 43%, and A. baumannii VAP occurred in 18%.

GrahamColm/Wikimedia Commons

Candida albicans showed an especially strong association with A. baumannii VAP; it was identified in 38% of cases, compared with 21% caused by non-albicans species.

No significant differences in hospital stay or in-hospital mortality were noted between Candida-colonized and noncolonized patients, and antifungal treatment had no apparent impact on the development of A. baumannii VAP, but antifungals were associated with higher in-hospital mortality (53% vs. 39%, P = .037).

The results were limited by the retrospective nature of the study and the use of data from a single center; thus, the relationship between Candida and A. baumannii VAP may not be generalizable, the researchers noted. However, “the strong independent association between the two suggests that Candida spp. growth from the lower respiratory tract in intubated patients could be an important indicator of the risk for VAP, and even that C. albicans airway colonization may play a role in subsequent development of A. baumannii VAP,” they wrote.

The researchers reported having no relevant financial conflicts.

Acinetobacter baumanii was the most common cause of ventilator-associated pneumonia in ICU patients, and the risk of A. baumannii infection was significantly higher when airways were colonized with Candida species, based on data from 618 adults.

A. baumannii is a frequent cause of ventilator-associated pneumonia (VAP) in ICU patients, but its potential interactions with Candida species have not been well studied, wrote Dr. Xiaojiang Tan of Southern Medical University, Guangzhou, China, and colleagues (Med Mycol. 2016 Aug 1;54[6]:557-66. doi: 10.1093/mmy/myw009). The researchers reviewed data from 264 ICU patients on mechanical ventilation who had Candida species airway colonization and 354 who did not.

Overall, Candida was an independent risk factor for A. baumannii VAP; patients with Candida were significantly more likely than those without Candida to develop A. baumannii (23% vs. 15%). Other independent risk factors for A. baumannii VAP included the use of a central venous catheter and the use of mechanical ventilation for at least 7 days. Among patients on mechanical ventilation for at least 48 hours, Candida airway colonization occurred in 43%, and A. baumannii VAP occurred in 18%.

GrahamColm/Wikimedia Commons

Candida albicans showed an especially strong association with A. baumannii VAP; it was identified in 38% of cases, compared with 21% caused by non-albicans species.

No significant differences in hospital stay or in-hospital mortality were noted between Candida-colonized and noncolonized patients, and antifungal treatment had no apparent impact on the development of A. baumannii VAP, but antifungals were associated with higher in-hospital mortality (53% vs. 39%, P = .037).

The results were limited by the retrospective nature of the study and the use of data from a single center; thus, the relationship between Candida and A. baumannii VAP may not be generalizable, the researchers noted. However, “the strong independent association between the two suggests that Candida spp. growth from the lower respiratory tract in intubated patients could be an important indicator of the risk for VAP, and even that C. albicans airway colonization may play a role in subsequent development of A. baumannii VAP,” they wrote.

The researchers reported having no relevant financial conflicts.

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Key clinical point: Candida species colonization was an independent risk factor for ventilator-associated pneumonia caused by Acinetobacter baumannii among ICU patients.

Major finding: Hospitalized patients with Candida species airway colonization were significantly more likely to develop A. baumannii infection than were those without Candida (23% vs. 15%).

Data source: A retrospective case-control study of 618 ICU patients.

Disclosures: The researchers reported having no relevant financial conflicts.

CHMP recommends enoxaparin biosimilars

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Thrombus

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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

  • Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
  • VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
  • Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
  • Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
  • Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
  • VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

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Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

  • Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
  • VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
  • Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
  • Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
  • Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
  • VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

  • Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
  • VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
  • Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
  • Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
  • Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
  • VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

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Psoriatic Arthritis Patients Face More Endocrine Comorbidities

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MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

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MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

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MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

 

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

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MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

 

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

 

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

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AT 2016 GRAPPA ANNUAL MEETING

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Key clinical point:Patients with psoriatic disease had a significantly higher prevalence of diabetes mellitus and some other endocrine comorbidities.

Major finding: In a univariate analysis, the risk for Cushing’s disease was notably higher among psoriatic arthritis patients, compared with controls (odds ratio, 5.31).

Data source: Retrospective, cross-sectional comparison of 3,161 patients with psoriatic arthritis and 31,610 matched controls.

Disclosures: Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

Hemophilia drugs top Medicaid spending per prescription

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Hemophilia drugs top Medicaid spending per prescription

Medicaid’s three most expensive drugs by spending per prescription were for treatment of hemophilia, with the cost leader coming in at almost $59,000, according to an analysis by the Kaiser Family Foundation covering 2014 and the first half of 2015.

The trio of hemophilia drugs was topped by NovoSeven RT (coagulation factor VIIa [recombinant]), with Koate-DVI (antihemophilic factor [human]) second at $57,000 per prescription and Feiba (anti-inhibitor coagulant complex) third at $48,000 for each prescription.

None of the Medicaid costs include rebates since those data are unavailable to the public, Kaiser noted.

The fourth and fifth most expensive drugs were Adagen (pegademase bovine), which is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase and cost Medicaid $45,000 per prescription, and the multiple sclerosis drug HP Acthar (repository corticotropin), which went for almost $44,000 a prescription, Kaiser said in its analysis, which used State Drug Utilization Data that are part of the Medicaid Drug Rebate Program.

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Medicaid’s three most expensive drugs by spending per prescription were for treatment of hemophilia, with the cost leader coming in at almost $59,000, according to an analysis by the Kaiser Family Foundation covering 2014 and the first half of 2015.

The trio of hemophilia drugs was topped by NovoSeven RT (coagulation factor VIIa [recombinant]), with Koate-DVI (antihemophilic factor [human]) second at $57,000 per prescription and Feiba (anti-inhibitor coagulant complex) third at $48,000 for each prescription.

None of the Medicaid costs include rebates since those data are unavailable to the public, Kaiser noted.

The fourth and fifth most expensive drugs were Adagen (pegademase bovine), which is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase and cost Medicaid $45,000 per prescription, and the multiple sclerosis drug HP Acthar (repository corticotropin), which went for almost $44,000 a prescription, Kaiser said in its analysis, which used State Drug Utilization Data that are part of the Medicaid Drug Rebate Program.

[email protected]

Medicaid’s three most expensive drugs by spending per prescription were for treatment of hemophilia, with the cost leader coming in at almost $59,000, according to an analysis by the Kaiser Family Foundation covering 2014 and the first half of 2015.

The trio of hemophilia drugs was topped by NovoSeven RT (coagulation factor VIIa [recombinant]), with Koate-DVI (antihemophilic factor [human]) second at $57,000 per prescription and Feiba (anti-inhibitor coagulant complex) third at $48,000 for each prescription.

None of the Medicaid costs include rebates since those data are unavailable to the public, Kaiser noted.

The fourth and fifth most expensive drugs were Adagen (pegademase bovine), which is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase and cost Medicaid $45,000 per prescription, and the multiple sclerosis drug HP Acthar (repository corticotropin), which went for almost $44,000 a prescription, Kaiser said in its analysis, which used State Drug Utilization Data that are part of the Medicaid Drug Rebate Program.

[email protected]

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Hemophilia drugs top Medicaid spending per prescription
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Hemophilia drugs top Medicaid spending per prescription
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hemophilia drugs, Medicaid spending, prescription drugs
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