Photo from Shire

GLASGOW—Recombinant von Willebrand factor (rVWF) alone can be sufficient as perioperative management for some patients with severe von Willebrand disease (VWD), according to researchers.

In a phase 3 study, 10 of 15 patients were able to achieve hemostatic efficacy ratings of “good” or “excellent” when receiving only rVWF before, during, and/or after surgery.

The remaining 5 patients also achieved favorable hemostatic efficacy ratings, but they received recombinant factor VIII (FVIII) as well.

These results were presented at the World Federation of Hemophilia (WFH) 2018 World Congress (abstract W-MP-63 [749]). The research was sponsored by Shire, the company marketing rVWF as Vonvendi.

“There is an unmet clinical need for those living with von Willebrand disease, as they face a heightened risk of bleeding during surgery,” said study investigator Flora Peyvandi, MD, PhD, of the University of Milan in Italy.

“People with von Willebrand disease lack proper function or quantity of von Willebrand factor, and some also have a secondary factor VIII deficiency. In this study, recombinant von Willebrand factor was administered to replace the insufficient or dysfunctional von Willebrand factor, allowing the body to naturally replenish FVIII in most patients. These study results demonstrate clinical promise as physicians were able to tailor treatment based on each patient’s individual need for one or both factor therapies.”

The study included 15 adults with severe VWD who were undergoing elective surgical procedures. Ten patients were undergoing major surgery, 4 minor, and 1 oral surgery.

The patients’ median age was 40 (range, 20-70), and 8 were female. Most (n=8) had type 3 VWD, 3 had type 1, 2 had type 2A, 1 had 2B, and 1 had 2M.

At baseline, the mean endogenous FVIII level (FVIII:C) was 16.4 IU/dL, and the mean VWF ristocetin cofactor (VWF:Rco) was 10.6 IU/dL.

The patients received rVWF at 40 to 60 IU/kg VWF:RCo intravenously 12 to 24 hours before surgery to allow FVIII:C levels to increase to at least 30 IU/dL for minor or oral surgery or to at least 60 IU/dL for major surgery, within 3 hours before surgery.

If the desired levels were achieved, rVWF could be given alone. If the levels were not achieved, patients would receive rFVIII as well, within 1 to 2 hours before surgery. Patients were monitored for 14 days after surgery.

Results

All 15 patients had overall/intraoperative hemostatic efficacy ratings of “excellent” (as good as or better than expected) or “good” (probably as good as expected).

The patients received a median of 6 (range, 2 to 15) rVWF infusions at a median dose of 55 IU/kg (range, 36.1 to 59.9). Most patients (n=11) did not receive rVWF every day. For some, infusions were separated by 2 to 9 days.

Ten patients received rVWF alone, 12 did not receive any preoperative FVIII, and 2 did not receive rVWF postoperatively.

Most rVWF infusions (89.4%, 93/104) were given alone, and 70% (7/10) of the major surgeries were performed with rVWF alone.

The researchers said that, with rVWF alone, patients had hemostatically effective levels of FVIII:C as early as 6 hours after surgery, and this was sustained for 72 to 96 hours.

There were 5 patients who received rVWF with rFVIII. Of the 11 infusions these patients received, 9 were given when FVIII:C levels were above 60 IU/dL.

Three patients received rVWF with rFVIII 1 hour before major surgery—total hip replacement, molar extraction, and left ankle prosthesis. However, 2 of these patients had FVIII:C levels above 60 IU/dL.

The patient undergoing a molar extraction received rVWF with rFVIII 6 times after surgery. In 5 cases, the patient’s FVIII:C levels were 110 to 152 IU/dL. In the remaining case, the FVIII:C level was 23 IU/dL.

Two patients received rVWF with rFVIII for minor surgery. One patient undergoing a tooth extraction received rVWF with rFVIII intraoperatively when the FVIII:C level was 72 IU/dL.

The other patient received rVWF with rFVIII after radioisotope synovectomy when the FVIII:C level was 73 IU/dL. This patient received a postoperative dose of rVWF alone as well.

One patient tested positive for binding antibodies to VWF, and 1 patient developed deep vein thrombosis 3 days after total hip replacement while receiving rVWF.

Photo from Shire

GLASGOW—Recombinant von Willebrand factor (rVWF) alone can be sufficient as perioperative management for some patients with severe von Willebrand disease (VWD), according to researchers.

In a phase 3 study, 10 of 15 patients were able to achieve hemostatic efficacy ratings of “good” or “excellent” when receiving only rVWF before, during, and/or after surgery.

The remaining 5 patients also achieved favorable hemostatic efficacy ratings, but they received recombinant factor VIII (FVIII) as well.

These results were presented at the World Federation of Hemophilia (WFH) 2018 World Congress (abstract W-MP-63 [749]). The research was sponsored by Shire, the company marketing rVWF as Vonvendi.

“There is an unmet clinical need for those living with von Willebrand disease, as they face a heightened risk of bleeding during surgery,” said study investigator Flora Peyvandi, MD, PhD, of the University of Milan in Italy.

“People with von Willebrand disease lack proper function or quantity of von Willebrand factor, and some also have a secondary factor VIII deficiency. In this study, recombinant von Willebrand factor was administered to replace the insufficient or dysfunctional von Willebrand factor, allowing the body to naturally replenish FVIII in most patients. These study results demonstrate clinical promise as physicians were able to tailor treatment based on each patient’s individual need for one or both factor therapies.”

The study included 15 adults with severe VWD who were undergoing elective surgical procedures. Ten patients were undergoing major surgery, 4 minor, and 1 oral surgery.

The patients’ median age was 40 (range, 20-70), and 8 were female. Most (n=8) had type 3 VWD, 3 had type 1, 2 had type 2A, 1 had 2B, and 1 had 2M.

At baseline, the mean endogenous FVIII level (FVIII:C) was 16.4 IU/dL, and the mean VWF ristocetin cofactor (VWF:Rco) was 10.6 IU/dL.

The patients received rVWF at 40 to 60 IU/kg VWF:RCo intravenously 12 to 24 hours before surgery to allow FVIII:C levels to increase to at least 30 IU/dL for minor or oral surgery or to at least 60 IU/dL for major surgery, within 3 hours before surgery.

If the desired levels were achieved, rVWF could be given alone. If the levels were not achieved, patients would receive rFVIII as well, within 1 to 2 hours before surgery. Patients were monitored for 14 days after surgery.

Results

All 15 patients had overall/intraoperative hemostatic efficacy ratings of “excellent” (as good as or better than expected) or “good” (probably as good as expected).

The patients received a median of 6 (range, 2 to 15) rVWF infusions at a median dose of 55 IU/kg (range, 36.1 to 59.9). Most patients (n=11) did not receive rVWF every day. For some, infusions were separated by 2 to 9 days.

Ten patients received rVWF alone, 12 did not receive any preoperative FVIII, and 2 did not receive rVWF postoperatively.

Most rVWF infusions (89.4%, 93/104) were given alone, and 70% (7/10) of the major surgeries were performed with rVWF alone.

The researchers said that, with rVWF alone, patients had hemostatically effective levels of FVIII:C as early as 6 hours after surgery, and this was sustained for 72 to 96 hours.

There were 5 patients who received rVWF with rFVIII. Of the 11 infusions these patients received, 9 were given when FVIII:C levels were above 60 IU/dL.

Three patients received rVWF with rFVIII 1 hour before major surgery—total hip replacement, molar extraction, and left ankle prosthesis. However, 2 of these patients had FVIII:C levels above 60 IU/dL.

The patient undergoing a molar extraction received rVWF with rFVIII 6 times after surgery. In 5 cases, the patient’s FVIII:C levels were 110 to 152 IU/dL. In the remaining case, the FVIII:C level was 23 IU/dL.

Two patients received rVWF with rFVIII for minor surgery. One patient undergoing a tooth extraction received rVWF with rFVIII intraoperatively when the FVIII:C level was 72 IU/dL.

The other patient received rVWF with rFVIII after radioisotope synovectomy when the FVIII:C level was 73 IU/dL. This patient received a postoperative dose of rVWF alone as well.

One patient tested positive for binding antibodies to VWF, and 1 patient developed deep vein thrombosis 3 days after total hip replacement while receiving rVWF.

Photo from Shire

GLASGOW—Recombinant von Willebrand factor (rVWF) alone can be sufficient as perioperative management for some patients with severe von Willebrand disease (VWD), according to researchers.

In a phase 3 study, 10 of 15 patients were able to achieve hemostatic efficacy ratings of “good” or “excellent” when receiving only rVWF before, during, and/or after surgery.

The remaining 5 patients also achieved favorable hemostatic efficacy ratings, but they received recombinant factor VIII (FVIII) as well.

These results were presented at the World Federation of Hemophilia (WFH) 2018 World Congress (abstract W-MP-63 [749]). The research was sponsored by Shire, the company marketing rVWF as Vonvendi.

“There is an unmet clinical need for those living with von Willebrand disease, as they face a heightened risk of bleeding during surgery,” said study investigator Flora Peyvandi, MD, PhD, of the University of Milan in Italy.

“People with von Willebrand disease lack proper function or quantity of von Willebrand factor, and some also have a secondary factor VIII deficiency. In this study, recombinant von Willebrand factor was administered to replace the insufficient or dysfunctional von Willebrand factor, allowing the body to naturally replenish FVIII in most patients. These study results demonstrate clinical promise as physicians were able to tailor treatment based on each patient’s individual need for one or both factor therapies.”

The study included 15 adults with severe VWD who were undergoing elective surgical procedures. Ten patients were undergoing major surgery, 4 minor, and 1 oral surgery.

The patients’ median age was 40 (range, 20-70), and 8 were female. Most (n=8) had type 3 VWD, 3 had type 1, 2 had type 2A, 1 had 2B, and 1 had 2M.

At baseline, the mean endogenous FVIII level (FVIII:C) was 16.4 IU/dL, and the mean VWF ristocetin cofactor (VWF:Rco) was 10.6 IU/dL.

The patients received rVWF at 40 to 60 IU/kg VWF:RCo intravenously 12 to 24 hours before surgery to allow FVIII:C levels to increase to at least 30 IU/dL for minor or oral surgery or to at least 60 IU/dL for major surgery, within 3 hours before surgery.

If the desired levels were achieved, rVWF could be given alone. If the levels were not achieved, patients would receive rFVIII as well, within 1 to 2 hours before surgery. Patients were monitored for 14 days after surgery.

Results

All 15 patients had overall/intraoperative hemostatic efficacy ratings of “excellent” (as good as or better than expected) or “good” (probably as good as expected).

The patients received a median of 6 (range, 2 to 15) rVWF infusions at a median dose of 55 IU/kg (range, 36.1 to 59.9). Most patients (n=11) did not receive rVWF every day. For some, infusions were separated by 2 to 9 days.

Ten patients received rVWF alone, 12 did not receive any preoperative FVIII, and 2 did not receive rVWF postoperatively.

Most rVWF infusions (89.4%, 93/104) were given alone, and 70% (7/10) of the major surgeries were performed with rVWF alone.

The researchers said that, with rVWF alone, patients had hemostatically effective levels of FVIII:C as early as 6 hours after surgery, and this was sustained for 72 to 96 hours.

There were 5 patients who received rVWF with rFVIII. Of the 11 infusions these patients received, 9 were given when FVIII:C levels were above 60 IU/dL.

Three patients received rVWF with rFVIII 1 hour before major surgery—total hip replacement, molar extraction, and left ankle prosthesis. However, 2 of these patients had FVIII:C levels above 60 IU/dL.

The patient undergoing a molar extraction received rVWF with rFVIII 6 times after surgery. In 5 cases, the patient’s FVIII:C levels were 110 to 152 IU/dL. In the remaining case, the FVIII:C level was 23 IU/dL.

Two patients received rVWF with rFVIII for minor surgery. One patient undergoing a tooth extraction received rVWF with rFVIII intraoperatively when the FVIII:C level was 72 IU/dL.

The other patient received rVWF with rFVIII after radioisotope synovectomy when the FVIII:C level was 73 IU/dL. This patient received a postoperative dose of rVWF alone as well.

One patient tested positive for binding antibodies to VWF, and 1 patient developed deep vein thrombosis 3 days after total hip replacement while receiving rVWF.

College of Georgia

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the FlowTriever System for the treatment of pulmonary embolism (PE).

This makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.

The 510(k) clearance was based on results from the FlowTriever Pulmonary Embolectomy (FLARE) study.

In this prospective, single-arm study, researchers evaluated the FlowTriever System in 106 patients with acute PE. Patients with proximal PE and right heart strain (RV/LV ratio ≥ 0.9) were eligible to participate.

Treatment with the FlowTriever System was used to non-surgically remove blood clots in the pulmonary arteries without the need for thrombolytic drugs.

The mean RV/LV ratio decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (P<0.0001).

At 30 days, the rate of major adverse events was 3.8%. There were no device-related complications.

Patients had a median hospital stay of 3 days and a median stay in the intensive care unit of 1 day.

“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said FLARE investigator Wissam Jaber, MD, of Emory University Hospital in Atlanta, Georgia.

“Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications. The FlowTriever System represents a breakthrough in treatment options for this large patient population.”

The FlowTriever System is a product of Inari Medical, Inc.

College of Georgia

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the FlowTriever System for the treatment of pulmonary embolism (PE).

This makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.

The 510(k) clearance was based on results from the FlowTriever Pulmonary Embolectomy (FLARE) study.

In this prospective, single-arm study, researchers evaluated the FlowTriever System in 106 patients with acute PE. Patients with proximal PE and right heart strain (RV/LV ratio ≥ 0.9) were eligible to participate.

Treatment with the FlowTriever System was used to non-surgically remove blood clots in the pulmonary arteries without the need for thrombolytic drugs.

The mean RV/LV ratio decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (P<0.0001).

At 30 days, the rate of major adverse events was 3.8%. There were no device-related complications.

Patients had a median hospital stay of 3 days and a median stay in the intensive care unit of 1 day.

“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said FLARE investigator Wissam Jaber, MD, of Emory University Hospital in Atlanta, Georgia.

“Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications. The FlowTriever System represents a breakthrough in treatment options for this large patient population.”

The FlowTriever System is a product of Inari Medical, Inc.

College of Georgia

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the FlowTriever System for the treatment of pulmonary embolism (PE).

This makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.

The 510(k) clearance was based on results from the FlowTriever Pulmonary Embolectomy (FLARE) study.

In this prospective, single-arm study, researchers evaluated the FlowTriever System in 106 patients with acute PE. Patients with proximal PE and right heart strain (RV/LV ratio ≥ 0.9) were eligible to participate.

Treatment with the FlowTriever System was used to non-surgically remove blood clots in the pulmonary arteries without the need for thrombolytic drugs.

The mean RV/LV ratio decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, a difference of 0.39 (P<0.0001).

At 30 days, the rate of major adverse events was 3.8%. There were no device-related complications.

Patients had a median hospital stay of 3 days and a median stay in the intensive care unit of 1 day.

“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said FLARE investigator Wissam Jaber, MD, of Emory University Hospital in Atlanta, Georgia.

“Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications. The FlowTriever System represents a breakthrough in treatment options for this large patient population.”

The FlowTriever System is a product of Inari Medical, Inc.

Photo by Bill Branson

GLASGOW—Emicizumab prophylaxis provides “clinically meaningful” control of bleeding whether or not patients have factor VIII inhibitors, according to researchers.

In the phase 3 HAVEN 4 study, researchers evaluated emicizumab prophylaxis, given every 4 weeks, in hemophilia A patients with or without factor VIII inhibitors.

At a median follow-up of about 26 weeks, patients had a median annualized bleeding rate (ABR) of 0.0 for treated bleeds and 2.1 for all bleeds.

About 30% of patients had 0 bleeds, and about 56% had 0 treated bleeds.

There were no serious adverse events (AEs) related to emicizumab. The most common AE was injection-site reaction.

Steve Pipe, MD, of Mott Children’s Hospital in Ann Arbor, Michigan, presented these results at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The trial was sponsored by Hoffmann-La Roche.

HAVEN 4 included 48 patients, age 12 and older, who had hemophilia A with or without factor VIII inhibitors. Patients were previously treated with factor VIII or bypassing agents, on-demand or as prophylaxis.

The study was conducted in 2 parts: a pharmacokinetic (PK) run-in and an expansion cohort.

All patients in the PK run-in (n=7) were previously treated on-demand and received subcutaneous emicizumab at 6 mg/kg to fully characterize the PK profile after a single dose during 4 weeks. This was followed by 6 mg/kg every 4 weeks for at least 24 weeks.

Patients in the expansion cohort (n=41) received subcutaneous emicizumab prophylaxis at 3 mg/kg/wk for 4 weeks, followed by 6 mg/kg every 4 weeks for at least 24 weeks.

Episodic treatment of breakthrough bleeds with factor VIII therapy or bypassing agents, depending on a patient’s factor VIII inhibitor status, was allowed per study protocol.

Results

The efficacy analysis included the 41 patients in the expansion cohort, 5 of whom had inhibitors at baseline.

The median efficacy period was 25.6 weeks. The median ABR was 2.1 for all bleeds and 0.0 for treated bleeds.

The percentage of patients with 0 bleeds was 29.3% for all bleeds, 56.1% for treated bleeds, 82.9% for treated spontaneous bleeds, 70.7% for treated joint bleeds, and 85.4% for treated target joint bleeds.

Most treated bleeds (74.5%, 38/51) were traumatic.

There were 148 AEs, and 73.2% of patients had at least 1 AE.

Injection-site reaction was the most common AE related to emicizumab, occurring in 22.0% of patients (n=9).

There were 2 serious AEs (grade ≥3)—hypertension and rhabdomyolysis. Both were considered unrelated to emicizumab.

There were no AEs leading to emicizumab discontinuation or withdrawal. There were no thrombotic events, cases of thrombotic microangiopathy, hypersensitivity reactions, or fatalities.

None of the patients developed de novo factor VIII inhibitors, and there were no anti-drug antibodies detected.

Photo by Bill Branson

GLASGOW—Emicizumab prophylaxis provides “clinically meaningful” control of bleeding whether or not patients have factor VIII inhibitors, according to researchers.

In the phase 3 HAVEN 4 study, researchers evaluated emicizumab prophylaxis, given every 4 weeks, in hemophilia A patients with or without factor VIII inhibitors.

At a median follow-up of about 26 weeks, patients had a median annualized bleeding rate (ABR) of 0.0 for treated bleeds and 2.1 for all bleeds.

About 30% of patients had 0 bleeds, and about 56% had 0 treated bleeds.

There were no serious adverse events (AEs) related to emicizumab. The most common AE was injection-site reaction.

Steve Pipe, MD, of Mott Children’s Hospital in Ann Arbor, Michigan, presented these results at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The trial was sponsored by Hoffmann-La Roche.

HAVEN 4 included 48 patients, age 12 and older, who had hemophilia A with or without factor VIII inhibitors. Patients were previously treated with factor VIII or bypassing agents, on-demand or as prophylaxis.

The study was conducted in 2 parts: a pharmacokinetic (PK) run-in and an expansion cohort.

All patients in the PK run-in (n=7) were previously treated on-demand and received subcutaneous emicizumab at 6 mg/kg to fully characterize the PK profile after a single dose during 4 weeks. This was followed by 6 mg/kg every 4 weeks for at least 24 weeks.

Patients in the expansion cohort (n=41) received subcutaneous emicizumab prophylaxis at 3 mg/kg/wk for 4 weeks, followed by 6 mg/kg every 4 weeks for at least 24 weeks.

Episodic treatment of breakthrough bleeds with factor VIII therapy or bypassing agents, depending on a patient’s factor VIII inhibitor status, was allowed per study protocol.

Results

The efficacy analysis included the 41 patients in the expansion cohort, 5 of whom had inhibitors at baseline.

The median efficacy period was 25.6 weeks. The median ABR was 2.1 for all bleeds and 0.0 for treated bleeds.

The percentage of patients with 0 bleeds was 29.3% for all bleeds, 56.1% for treated bleeds, 82.9% for treated spontaneous bleeds, 70.7% for treated joint bleeds, and 85.4% for treated target joint bleeds.

Most treated bleeds (74.5%, 38/51) were traumatic.

There were 148 AEs, and 73.2% of patients had at least 1 AE.

Injection-site reaction was the most common AE related to emicizumab, occurring in 22.0% of patients (n=9).

There were 2 serious AEs (grade ≥3)—hypertension and rhabdomyolysis. Both were considered unrelated to emicizumab.

There were no AEs leading to emicizumab discontinuation or withdrawal. There were no thrombotic events, cases of thrombotic microangiopathy, hypersensitivity reactions, or fatalities.

None of the patients developed de novo factor VIII inhibitors, and there were no anti-drug antibodies detected.

Photo by Bill Branson

GLASGOW—Emicizumab prophylaxis provides “clinically meaningful” control of bleeding whether or not patients have factor VIII inhibitors, according to researchers.

In the phase 3 HAVEN 4 study, researchers evaluated emicizumab prophylaxis, given every 4 weeks, in hemophilia A patients with or without factor VIII inhibitors.

At a median follow-up of about 26 weeks, patients had a median annualized bleeding rate (ABR) of 0.0 for treated bleeds and 2.1 for all bleeds.

About 30% of patients had 0 bleeds, and about 56% had 0 treated bleeds.

There were no serious adverse events (AEs) related to emicizumab. The most common AE was injection-site reaction.

Steve Pipe, MD, of Mott Children’s Hospital in Ann Arbor, Michigan, presented these results at the World Federation of Hemophilia (WFH) 2018 World Congress during the late-breaking abstract session on Monday.

The trial was sponsored by Hoffmann-La Roche.

HAVEN 4 included 48 patients, age 12 and older, who had hemophilia A with or without factor VIII inhibitors. Patients were previously treated with factor VIII or bypassing agents, on-demand or as prophylaxis.

The study was conducted in 2 parts: a pharmacokinetic (PK) run-in and an expansion cohort.

All patients in the PK run-in (n=7) were previously treated on-demand and received subcutaneous emicizumab at 6 mg/kg to fully characterize the PK profile after a single dose during 4 weeks. This was followed by 6 mg/kg every 4 weeks for at least 24 weeks.

Patients in the expansion cohort (n=41) received subcutaneous emicizumab prophylaxis at 3 mg/kg/wk for 4 weeks, followed by 6 mg/kg every 4 weeks for at least 24 weeks.

Episodic treatment of breakthrough bleeds with factor VIII therapy or bypassing agents, depending on a patient’s factor VIII inhibitor status, was allowed per study protocol.

Results

The efficacy analysis included the 41 patients in the expansion cohort, 5 of whom had inhibitors at baseline.

The median efficacy period was 25.6 weeks. The median ABR was 2.1 for all bleeds and 0.0 for treated bleeds.

The percentage of patients with 0 bleeds was 29.3% for all bleeds, 56.1% for treated bleeds, 82.9% for treated spontaneous bleeds, 70.7% for treated joint bleeds, and 85.4% for treated target joint bleeds.

Most treated bleeds (74.5%, 38/51) were traumatic.

There were 148 AEs, and 73.2% of patients had at least 1 AE.

Injection-site reaction was the most common AE related to emicizumab, occurring in 22.0% of patients (n=9).

There were 2 serious AEs (grade ≥3)—hypertension and rhabdomyolysis. Both were considered unrelated to emicizumab.

There were no AEs leading to emicizumab discontinuation or withdrawal. There were no thrombotic events, cases of thrombotic microangiopathy, hypersensitivity reactions, or fatalities.

None of the patients developed de novo factor VIII inhibitors, and there were no anti-drug antibodies detected.

The FP recognized that this child had a large bathing trunk nevus with multiple small melanocytic satellite lesions on her arms.

He explained to the worried parents that their daughter had a bathing trunk nevus and that a local expert was needed. The FP consulted a local dermatologist, who subsequently explained to the parents that there was a significant risk of cutaneous melanoma if nothing was done about this large congenital nevus. The dermatologist indicated that while removal could decrease that risk, the process would require multiple large surgeries by a plastic surgeon. She also explained that a magnetic resonance imaging scan of the brain would be needed at about 6 months to look for neurocutaneous melanosis, which can cause seizures, hydrocephalus, and a central nervous system melanoma.

The parents were conflicted about whether to put their child through a series of massive surgeries or to accept the higher risk of melanoma and proceed with careful monitoring by the dermatologist. (No additional details on how this case resolved are available—Editor.)

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith, M. Congenital nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:953-957.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP recognized that this child had a large bathing trunk nevus with multiple small melanocytic satellite lesions on her arms.

He explained to the worried parents that their daughter had a bathing trunk nevus and that a local expert was needed. The FP consulted a local dermatologist, who subsequently explained to the parents that there was a significant risk of cutaneous melanoma if nothing was done about this large congenital nevus. The dermatologist indicated that while removal could decrease that risk, the process would require multiple large surgeries by a plastic surgeon. She also explained that a magnetic resonance imaging scan of the brain would be needed at about 6 months to look for neurocutaneous melanosis, which can cause seizures, hydrocephalus, and a central nervous system melanoma.

The parents were conflicted about whether to put their child through a series of massive surgeries or to accept the higher risk of melanoma and proceed with careful monitoring by the dermatologist. (No additional details on how this case resolved are available—Editor.)

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith, M. Congenital nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:953-957.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP recognized that this child had a large bathing trunk nevus with multiple small melanocytic satellite lesions on her arms.

He explained to the worried parents that their daughter had a bathing trunk nevus and that a local expert was needed. The FP consulted a local dermatologist, who subsequently explained to the parents that there was a significant risk of cutaneous melanoma if nothing was done about this large congenital nevus. The dermatologist indicated that while removal could decrease that risk, the process would require multiple large surgeries by a plastic surgeon. She also explained that a magnetic resonance imaging scan of the brain would be needed at about 6 months to look for neurocutaneous melanosis, which can cause seizures, hydrocephalus, and a central nervous system melanoma.

The parents were conflicted about whether to put their child through a series of massive surgeries or to accept the higher risk of melanoma and proceed with careful monitoring by the dermatologist. (No additional details on how this case resolved are available—Editor.)

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith, M. Congenital nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:953-957.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Severe atopic eczema could significantly increase the risk of cardiovascular disease, including stroke and heart failure, according to a case-control study published online May 23 in BMJ.

In a population-based cohort study, researchers compared the electronic health records of 387,439 adults with eczema and 1,528,477 patients without eczema in the United Kingddom, matched according to age, sex, general practice, and calendar time, during 1998-2015. Patients were followed up for a median of 5.1 years

With the exception of cardiovascular death, atopic eczema was associated with all cardiovascular outcomes (MI, unstable angina, heart failure, atrial fibrillation, and stroke). The associations were stronger for severe atopic eczema, with significantly higher risks of MI, unstable angina, atrial fibrillation, stroke, cardiovascular death, and coronary revascularization among individuals with severe atopic eczema, compared with controls.

After adjustment for potential mediators such as body mass index, smoking, hyperlipidemia, diabetes, and severe alcohol use, individuals with severe eczema had a significant 37% increased risk of MI, 67% greater risk of heart failure, 35% greater risk of atrial fibrillation, 30% greater risk of cardiovascular death, and 36% greater risk of coronary revascularization, compared with controls with no eczema.

Increased cardiovascular risks also were seen in individuals whose atopic eczema was active more than half the time at follow-up. This group had a 37% greater risk of heart failure, 36% greater risk of unstable angina, and 19% greater risk of stroke, as well as significantly elevated risks of MI, atrial fibrillation, cardiovascular death, and coronary revascularization, compared with those without eczema.

Overall, atopic eczema contributed around 2.4% of the population-attributable risk for unstable angina, and 1.9% for heart failure (the highest population attributable risks). Ethnicity or high-dose corticosteroid use did not significantly impact outcomes.

Richard J. Silverwood, PhD, from the London School of Hygiene and Tropical Medicine, and his coauthors wrote that previous work examining the relationship between atopic eczema and cardiovascular disease had shown inconsistent outcomes, with some studies even pointing to a possible protective effect of mild atopic eczema.

SOURCE: Silverwood R et al. BMJ 2018 May 23;361:k1786. doi: 10.1136/bmj.k1786.

Severe atopic eczema could significantly increase the risk of cardiovascular disease, including stroke and heart failure, according to a case-control study published online May 23 in BMJ.

In a population-based cohort study, researchers compared the electronic health records of 387,439 adults with eczema and 1,528,477 patients without eczema in the United Kingddom, matched according to age, sex, general practice, and calendar time, during 1998-2015. Patients were followed up for a median of 5.1 years

With the exception of cardiovascular death, atopic eczema was associated with all cardiovascular outcomes (MI, unstable angina, heart failure, atrial fibrillation, and stroke). The associations were stronger for severe atopic eczema, with significantly higher risks of MI, unstable angina, atrial fibrillation, stroke, cardiovascular death, and coronary revascularization among individuals with severe atopic eczema, compared with controls.

After adjustment for potential mediators such as body mass index, smoking, hyperlipidemia, diabetes, and severe alcohol use, individuals with severe eczema had a significant 37% increased risk of MI, 67% greater risk of heart failure, 35% greater risk of atrial fibrillation, 30% greater risk of cardiovascular death, and 36% greater risk of coronary revascularization, compared with controls with no eczema.

Increased cardiovascular risks also were seen in individuals whose atopic eczema was active more than half the time at follow-up. This group had a 37% greater risk of heart failure, 36% greater risk of unstable angina, and 19% greater risk of stroke, as well as significantly elevated risks of MI, atrial fibrillation, cardiovascular death, and coronary revascularization, compared with those without eczema.

Overall, atopic eczema contributed around 2.4% of the population-attributable risk for unstable angina, and 1.9% for heart failure (the highest population attributable risks). Ethnicity or high-dose corticosteroid use did not significantly impact outcomes.

Richard J. Silverwood, PhD, from the London School of Hygiene and Tropical Medicine, and his coauthors wrote that previous work examining the relationship between atopic eczema and cardiovascular disease had shown inconsistent outcomes, with some studies even pointing to a possible protective effect of mild atopic eczema.

SOURCE: Silverwood R et al. BMJ 2018 May 23;361:k1786. doi: 10.1136/bmj.k1786.

Severe atopic eczema could significantly increase the risk of cardiovascular disease, including stroke and heart failure, according to a case-control study published online May 23 in BMJ.

In a population-based cohort study, researchers compared the electronic health records of 387,439 adults with eczema and 1,528,477 patients without eczema in the United Kingddom, matched according to age, sex, general practice, and calendar time, during 1998-2015. Patients were followed up for a median of 5.1 years

With the exception of cardiovascular death, atopic eczema was associated with all cardiovascular outcomes (MI, unstable angina, heart failure, atrial fibrillation, and stroke). The associations were stronger for severe atopic eczema, with significantly higher risks of MI, unstable angina, atrial fibrillation, stroke, cardiovascular death, and coronary revascularization among individuals with severe atopic eczema, compared with controls.

After adjustment for potential mediators such as body mass index, smoking, hyperlipidemia, diabetes, and severe alcohol use, individuals with severe eczema had a significant 37% increased risk of MI, 67% greater risk of heart failure, 35% greater risk of atrial fibrillation, 30% greater risk of cardiovascular death, and 36% greater risk of coronary revascularization, compared with controls with no eczema.

Increased cardiovascular risks also were seen in individuals whose atopic eczema was active more than half the time at follow-up. This group had a 37% greater risk of heart failure, 36% greater risk of unstable angina, and 19% greater risk of stroke, as well as significantly elevated risks of MI, atrial fibrillation, cardiovascular death, and coronary revascularization, compared with those without eczema.

Overall, atopic eczema contributed around 2.4% of the population-attributable risk for unstable angina, and 1.9% for heart failure (the highest population attributable risks). Ethnicity or high-dose corticosteroid use did not significantly impact outcomes.

Richard J. Silverwood, PhD, from the London School of Hygiene and Tropical Medicine, and his coauthors wrote that previous work examining the relationship between atopic eczema and cardiovascular disease had shown inconsistent outcomes, with some studies even pointing to a possible protective effect of mild atopic eczema.

SOURCE: Silverwood R et al. BMJ 2018 May 23;361:k1786. doi: 10.1136/bmj.k1786.

Taking antidepressants appears associated with weight gain in a recent study, though the researchers caution that the link might not be causal. Antidepressant use already was lowest in those with an initially normal BMI, and it increased with each category of greater BMI.

“Participants of normal weight showed an increased risk of transitioning to overweight or obesity, and overweight participants were more likely to become obese if they were treated with an antidepressant,” Rafael Gafoor, PhD, of King’s College London, and his associates wrote in BMJ.

“The risk of weight gain was substantially increased during the second and third years of treatment,” they reported. “The risk of weight gain remained increased during at least 6 years of follow-up.”

The researchers retrospectively analyzed EHRs from the U.K. Clinical Practice Research Datalink, representing about 7% of general practices in the United Kingdom, to compare the risk of weight gain among those who were and were not prescribed antidepressants. Of more than 2 million registered participants, a random sample of those with at least three measurements for body mass index (BMI), representing different weight classes, were included.

Out of 136,762 men and 157,957 women, 13% of the men and 22.4% of the women received prescriptions for antidepressants. The 10-year follow-up period included more than 1.8 million person-years. The proportion of people gaining at least 5% in BMI was 11.1% in those with antidepressants prescriptions, compared with 8.1% in those not prescribed antidepressants.

“Antidepressant use was greater in patients with comorbidity and coprescriptions, particularly with diagnoses of stroke and diabetes or coprescribing of antiepileptics or antipsychotics, than in those without,” the researchers wrote. “Antidepressant use was also associated with current smoking and higher deprivation category.”

The researchers adjusted the analysis to account for age, sex, initial BMI classification, smoking, prescriptions for antiepileptics or antipsychotics, year, region of residence, socioeconomic status, or having received advice on weight management or diet. They also accounted for diabetes, coronary heart disease, stroke, cancer, and depression diagnoses, and they eliminated the 280 days before a newborn delivery to account for pregnancy-related weight increases.

SOURCE: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.

Taking antidepressants appears associated with weight gain in a recent study, though the researchers caution that the link might not be causal. Antidepressant use already was lowest in those with an initially normal BMI, and it increased with each category of greater BMI.

“Participants of normal weight showed an increased risk of transitioning to overweight or obesity, and overweight participants were more likely to become obese if they were treated with an antidepressant,” Rafael Gafoor, PhD, of King’s College London, and his associates wrote in BMJ.

“The risk of weight gain was substantially increased during the second and third years of treatment,” they reported. “The risk of weight gain remained increased during at least 6 years of follow-up.”

The researchers retrospectively analyzed EHRs from the U.K. Clinical Practice Research Datalink, representing about 7% of general practices in the United Kingdom, to compare the risk of weight gain among those who were and were not prescribed antidepressants. Of more than 2 million registered participants, a random sample of those with at least three measurements for body mass index (BMI), representing different weight classes, were included.

Out of 136,762 men and 157,957 women, 13% of the men and 22.4% of the women received prescriptions for antidepressants. The 10-year follow-up period included more than 1.8 million person-years. The proportion of people gaining at least 5% in BMI was 11.1% in those with antidepressants prescriptions, compared with 8.1% in those not prescribed antidepressants.

“Antidepressant use was greater in patients with comorbidity and coprescriptions, particularly with diagnoses of stroke and diabetes or coprescribing of antiepileptics or antipsychotics, than in those without,” the researchers wrote. “Antidepressant use was also associated with current smoking and higher deprivation category.”

The researchers adjusted the analysis to account for age, sex, initial BMI classification, smoking, prescriptions for antiepileptics or antipsychotics, year, region of residence, socioeconomic status, or having received advice on weight management or diet. They also accounted for diabetes, coronary heart disease, stroke, cancer, and depression diagnoses, and they eliminated the 280 days before a newborn delivery to account for pregnancy-related weight increases.

SOURCE: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.

Taking antidepressants appears associated with weight gain in a recent study, though the researchers caution that the link might not be causal. Antidepressant use already was lowest in those with an initially normal BMI, and it increased with each category of greater BMI.

“Participants of normal weight showed an increased risk of transitioning to overweight or obesity, and overweight participants were more likely to become obese if they were treated with an antidepressant,” Rafael Gafoor, PhD, of King’s College London, and his associates wrote in BMJ.

“The risk of weight gain was substantially increased during the second and third years of treatment,” they reported. “The risk of weight gain remained increased during at least 6 years of follow-up.”

The researchers retrospectively analyzed EHRs from the U.K. Clinical Practice Research Datalink, representing about 7% of general practices in the United Kingdom, to compare the risk of weight gain among those who were and were not prescribed antidepressants. Of more than 2 million registered participants, a random sample of those with at least three measurements for body mass index (BMI), representing different weight classes, were included.

Out of 136,762 men and 157,957 women, 13% of the men and 22.4% of the women received prescriptions for antidepressants. The 10-year follow-up period included more than 1.8 million person-years. The proportion of people gaining at least 5% in BMI was 11.1% in those with antidepressants prescriptions, compared with 8.1% in those not prescribed antidepressants.

“Antidepressant use was greater in patients with comorbidity and coprescriptions, particularly with diagnoses of stroke and diabetes or coprescribing of antiepileptics or antipsychotics, than in those without,” the researchers wrote. “Antidepressant use was also associated with current smoking and higher deprivation category.”

The researchers adjusted the analysis to account for age, sex, initial BMI classification, smoking, prescriptions for antiepileptics or antipsychotics, year, region of residence, socioeconomic status, or having received advice on weight management or diet. They also accounted for diabetes, coronary heart disease, stroke, cancer, and depression diagnoses, and they eliminated the 280 days before a newborn delivery to account for pregnancy-related weight increases.

SOURCE: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.

A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com

Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

“The observation of greater e-cigarette use in the free e-cigarette group than in the free cessation aids group, coupled with the absence of benefit of free e-cigarettes versus no intervention, supports the conclusion that offering free e-cigarettes does not promote smoking cessation,” they cautioned.

In the reward incentive and $600 redeemable-deposit groups, 2% and 2.9% of participants quit over a sustained period, respectively. Cessation rates in the $600 deposit group were superior to the free cessation aid group (P less than .001) and the free e-cigarette group (P = .008). Cessation rates in the incentive group were superior to those in the free cessation aid group (P = .006).

“Average costs per participant assigned to each intervention were lowest in the usual-care group ($0.82) and highest in the redeemable-deposit group ($100.96),” the researchers reported. “The overall cost of each program per participant who was abstinent for 6 months was lower in the rewards and redeemable-deposit groups than in the free e-cigarettes or free cessation aids groups.”

The study received grant support from the Vitality Institute. Most of the study authors reported no relevant disclosures. One author reported serving on the scientific advisory board of VAL Health, and another reported various grants and personal fees.

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com

Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

“The observation of greater e-cigarette use in the free e-cigarette group than in the free cessation aids group, coupled with the absence of benefit of free e-cigarettes versus no intervention, supports the conclusion that offering free e-cigarettes does not promote smoking cessation,” they cautioned.

In the reward incentive and $600 redeemable-deposit groups, 2% and 2.9% of participants quit over a sustained period, respectively. Cessation rates in the $600 deposit group were superior to the free cessation aid group (P less than .001) and the free e-cigarette group (P = .008). Cessation rates in the incentive group were superior to those in the free cessation aid group (P = .006).

“Average costs per participant assigned to each intervention were lowest in the usual-care group ($0.82) and highest in the redeemable-deposit group ($100.96),” the researchers reported. “The overall cost of each program per participant who was abstinent for 6 months was lower in the rewards and redeemable-deposit groups than in the free e-cigarettes or free cessation aids groups.”

The study received grant support from the Vitality Institute. Most of the study authors reported no relevant disclosures. One author reported serving on the scientific advisory board of VAL Health, and another reported various grants and personal fees.

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

A new study finds it pays to pay people to stop lighting up: Smokers were more likely to quit if they had an opportunity to gain rewards worth $600 than if they simply received free cessation aids or free e-cigarettes.

The wide majority of the more than 6,000 smokers in the randomized study didn’t quit despite offers of various incentives. All the same, “programs that offered financial incentives tripled the rates of smoking cessation, reduced employers’ costs per successful quit, as compared with programs that offered cessation aids alone, and yielded total costs that compared favorably with the costs of employing smokers,” the study authors wrote.

milosluz/istockphoto.com

Overall, 20% of the 6,006 participants logged onto the trial website, a sign that they were “engaged.” The number was highest in the free e-cigarette and reward groups (21%-23%) and lowest in the usual care group (16%).

The researchers focused on how many participants abstained from smoking – as confirmed by blood or urine test – for 6 months past the target quit date. The test data confirmed that just 1.3% of the total participants, 80 people, sustained cessation over 6 months.

Only 0.1% of the usual-care group sustained smoking cessation, and the number wasn’t much higher (0.5%) in the free cessation aids group.

One percent of those in the free e-cigarette group sustained cessation. However, the researchers noted there wasn’t a significant difference in the quit rates between the usual care, free cessation aid, and free e-cigarette groups.

“The observation of greater e-cigarette use in the free e-cigarette group than in the free cessation aids group, coupled with the absence of benefit of free e-cigarettes versus no intervention, supports the conclusion that offering free e-cigarettes does not promote smoking cessation,” they cautioned.

In the reward incentive and $600 redeemable-deposit groups, 2% and 2.9% of participants quit over a sustained period, respectively. Cessation rates in the $600 deposit group were superior to the free cessation aid group (P less than .001) and the free e-cigarette group (P = .008). Cessation rates in the incentive group were superior to those in the free cessation aid group (P = .006).

“Average costs per participant assigned to each intervention were lowest in the usual-care group ($0.82) and highest in the redeemable-deposit group ($100.96),” the researchers reported. “The overall cost of each program per participant who was abstinent for 6 months was lower in the rewards and redeemable-deposit groups than in the free e-cigarettes or free cessation aids groups.”

The study received grant support from the Vitality Institute. Most of the study authors reported no relevant disclosures. One author reported serving on the scientific advisory board of VAL Health, and another reported various grants and personal fees.

SOURCE: Halpern SD et al. N Engl J Med. 2018 May 23. doi: 10.1056/NEJMsa1715757.

“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.

Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.

Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.

Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.

An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).

iStock/Thinkstock.com

SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.

An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).

iStock/Thinkstock.com

SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.

An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).

iStock/Thinkstock.com

SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.

LIVERPOOL, ENGLAND – Individuals with axial spondyloarthritis (axSpA) who have comorbid fibromyalgia do respond to biologic therapy but at a seemingly lower rate if they have a high symptom score during early assessments.

Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) showed that participants with axSpA who were starting biologic therapy with a tumor necrosis factor inhibitor (TNFi) for the first time also had worse disease activity at baseline if they met fibromyalgia research criteria than if they did not.

Sara Freeman/MDedge News

The current aims of the study presented by Dr. Macfarlane were to first quantify the extent to which meeting fibromyalgia criteria was associated with higher measures of disease activity and impact, and then to see if meeting these criteria was associated with a poorer response to first use of a TNFi.

In order to find out, Dr. Macfarlane and his associates examined data from the prospective BSRBR-AS, which has been running since 2012. The BSRBR-AS recruits patients with ASAS-confirmed axSpA who are newly starting biologics from 83 U.K. centers.

At recruitment and at 3 months, patients starting biologic treatment undergo several assessments, which since 2015 has included research criteria for fibromyalgia (J Rheumatol. 2011;38:1113–22). The latter incorporate a Widespread Pain Index rated 0-19 and a Symptom Severity Scale rated 0-12 and cover items such as fatigue and waking up unrefreshed, and the presence of lower abdominal pain or headaches.

To date, around 1,750 participants in the BSRBR-AS have completed the fibromyalgia criteria, Dr. Macfarlane said.

Across the board, baseline measures of disease activity were lower in patients who met the fibromyalgia criteria versus those who did not. This included the BASDAI and the Bath Ankylosing Spondylitis Functional Index, where scores were approximately 6.5 and 4.5 for each measure.

“Quality of life was significantly lower in those who were fibromyalgia positive,” Dr. Macfarlane said. Indeed, whatever the measure used, from the disease-specific Ankylosing Spondylitis Quality of Life (ASQoL) Scale to the general EuroQoL Quality of Life Scale, there were significant differences between those who did and did not meet fibromyalgia criteria. There were also higher scores for depression, anxiety, poorer-quality sleep, and higher levels of fatigue.

Patients treated with TNFi therapy showed improvement in both BASDAI and ASQoL scores regardless of whether they met fibromyalgia criteria, but crucially, the responses were still lower and significantly different from those without fibromyalgia.

An ASAS20 response to TNFi therapy was met by “slightly fewer” patients who met the fibromyalgia criteria than by those who did not at all follow-up points: at 3 months (about 35% vs. 45%), 6 months (about 58% vs. 61%), and 12 months (about 60% vs. 62%).

A high score on the Symptom Severity Scale but not the Widespread Pain Index of the fibromyalgia criteria was associated with a lower response to TNFi therapy at 3 months. “Such patients may benefit from the use of TNFi and nonpharmacological therapy,” Dr. Macfarlane said.

The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

SOURCE: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.

LIVERPOOL, ENGLAND – Individuals with axial spondyloarthritis (axSpA) who have comorbid fibromyalgia do respond to biologic therapy but at a seemingly lower rate if they have a high symptom score during early assessments.

Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) showed that participants with axSpA who were starting biologic therapy with a tumor necrosis factor inhibitor (TNFi) for the first time also had worse disease activity at baseline if they met fibromyalgia research criteria than if they did not.

Sara Freeman/MDedge News

The current aims of the study presented by Dr. Macfarlane were to first quantify the extent to which meeting fibromyalgia criteria was associated with higher measures of disease activity and impact, and then to see if meeting these criteria was associated with a poorer response to first use of a TNFi.

In order to find out, Dr. Macfarlane and his associates examined data from the prospective BSRBR-AS, which has been running since 2012. The BSRBR-AS recruits patients with ASAS-confirmed axSpA who are newly starting biologics from 83 U.K. centers.

At recruitment and at 3 months, patients starting biologic treatment undergo several assessments, which since 2015 has included research criteria for fibromyalgia (J Rheumatol. 2011;38:1113–22). The latter incorporate a Widespread Pain Index rated 0-19 and a Symptom Severity Scale rated 0-12 and cover items such as fatigue and waking up unrefreshed, and the presence of lower abdominal pain or headaches.

To date, around 1,750 participants in the BSRBR-AS have completed the fibromyalgia criteria, Dr. Macfarlane said.

Across the board, baseline measures of disease activity were lower in patients who met the fibromyalgia criteria versus those who did not. This included the BASDAI and the Bath Ankylosing Spondylitis Functional Index, where scores were approximately 6.5 and 4.5 for each measure.

“Quality of life was significantly lower in those who were fibromyalgia positive,” Dr. Macfarlane said. Indeed, whatever the measure used, from the disease-specific Ankylosing Spondylitis Quality of Life (ASQoL) Scale to the general EuroQoL Quality of Life Scale, there were significant differences between those who did and did not meet fibromyalgia criteria. There were also higher scores for depression, anxiety, poorer-quality sleep, and higher levels of fatigue.

Patients treated with TNFi therapy showed improvement in both BASDAI and ASQoL scores regardless of whether they met fibromyalgia criteria, but crucially, the responses were still lower and significantly different from those without fibromyalgia.

An ASAS20 response to TNFi therapy was met by “slightly fewer” patients who met the fibromyalgia criteria than by those who did not at all follow-up points: at 3 months (about 35% vs. 45%), 6 months (about 58% vs. 61%), and 12 months (about 60% vs. 62%).

A high score on the Symptom Severity Scale but not the Widespread Pain Index of the fibromyalgia criteria was associated with a lower response to TNFi therapy at 3 months. “Such patients may benefit from the use of TNFi and nonpharmacological therapy,” Dr. Macfarlane said.

The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

SOURCE: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.

LIVERPOOL, ENGLAND – Individuals with axial spondyloarthritis (axSpA) who have comorbid fibromyalgia do respond to biologic therapy but at a seemingly lower rate if they have a high symptom score during early assessments.

Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) showed that participants with axSpA who were starting biologic therapy with a tumor necrosis factor inhibitor (TNFi) for the first time also had worse disease activity at baseline if they met fibromyalgia research criteria than if they did not.

Sara Freeman/MDedge News

The current aims of the study presented by Dr. Macfarlane were to first quantify the extent to which meeting fibromyalgia criteria was associated with higher measures of disease activity and impact, and then to see if meeting these criteria was associated with a poorer response to first use of a TNFi.

In order to find out, Dr. Macfarlane and his associates examined data from the prospective BSRBR-AS, which has been running since 2012. The BSRBR-AS recruits patients with ASAS-confirmed axSpA who are newly starting biologics from 83 U.K. centers.

At recruitment and at 3 months, patients starting biologic treatment undergo several assessments, which since 2015 has included research criteria for fibromyalgia (J Rheumatol. 2011;38:1113–22). The latter incorporate a Widespread Pain Index rated 0-19 and a Symptom Severity Scale rated 0-12 and cover items such as fatigue and waking up unrefreshed, and the presence of lower abdominal pain or headaches.

To date, around 1,750 participants in the BSRBR-AS have completed the fibromyalgia criteria, Dr. Macfarlane said.

Across the board, baseline measures of disease activity were lower in patients who met the fibromyalgia criteria versus those who did not. This included the BASDAI and the Bath Ankylosing Spondylitis Functional Index, where scores were approximately 6.5 and 4.5 for each measure.

“Quality of life was significantly lower in those who were fibromyalgia positive,” Dr. Macfarlane said. Indeed, whatever the measure used, from the disease-specific Ankylosing Spondylitis Quality of Life (ASQoL) Scale to the general EuroQoL Quality of Life Scale, there were significant differences between those who did and did not meet fibromyalgia criteria. There were also higher scores for depression, anxiety, poorer-quality sleep, and higher levels of fatigue.

Patients treated with TNFi therapy showed improvement in both BASDAI and ASQoL scores regardless of whether they met fibromyalgia criteria, but crucially, the responses were still lower and significantly different from those without fibromyalgia.

An ASAS20 response to TNFi therapy was met by “slightly fewer” patients who met the fibromyalgia criteria than by those who did not at all follow-up points: at 3 months (about 35% vs. 45%), 6 months (about 58% vs. 61%), and 12 months (about 60% vs. 62%).

A high score on the Symptom Severity Scale but not the Widespread Pain Index of the fibromyalgia criteria was associated with a lower response to TNFi therapy at 3 months. “Such patients may benefit from the use of TNFi and nonpharmacological therapy,” Dr. Macfarlane said.

The BSRBR-AS is funded by the British Society for Rheumatology, which in turn receives funding from AbbVie, Pfizer, and UCB. Dr. Macfarlane did not provide any disclosures but has previously acknowledged receiving an honorarium from Pfizer and research funding from AbbVie and Pfizer for the Scotland Registry for Ankylosing Spondylitis study.

SOURCE: Macfarlane GJ et al. Rheumatology. 2018;57(Suppl. 3):key075.183.