VIDEO: Beware of over-relying on MRI findings in axSpA

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Tue, 04/30/2019 - 11:44

– Healthy individuals can show signs of spinal and pelvic inflammation on MRI, but these scans can be misleading if relied on to make a diagnosis of axial spondyloarthritis, according to findings from three separate studies at the annual meeting of the American College of Rheumatology.

“Don’t rely on MRI alone is our message,” said Robert Landewé, MD, PhD, of the University of Amsterdam, who was a coauthor of one of the three studies. “A positive MRI may occur in individuals that are completely healthy. We need to make sure that not too many patients with chronic lower back pain are diagnosed with a disease they don’t have.”

The axial form of spondyloarthritis (axSpA) affects the spinal and pelvic joints of an estimated 1.4% of the U.S. population, and the term encompasses the diagnosis of ankylosing spondylitis (0.5% of U.S. population) in which advanced sacroiliitis is seen on conventional radiography, according to the ACR. Axial SpA is particularly common in young people, especially males, in their teens and 20s.

Researchers believe that MRI scans can misleadingly suggest that patients have the condition. “We know that MRI is a sensitive method, but there’s a lack of data regarding its specificity,” Thomas Renson, MD, of Ghent (Belgium) University, said at a press conference during the meeting.

Dr. Landewé led a study that compared MRIs of sacroiliac joints in 47 healthy people, 47 axSpA patients matched for gender and age, 47 chronic back pain patients, 7 women with postpartum back pain, and 24 frequent runners. Positive MRIs were common in the axSpA patients (43 of 47), but they were also found in healthy people (11 of 47), chronic back pain patients (3 of 47), frequent runners (3 of 24), and women with postpartum back pain (4 of 7).

In another study, Dr. Renson and his colleagues sought to understand whether a sustained period of intense physical activity affected spinal findings in 22 healthy military recruits who did not have SpA.

Dr. Ulrich Weber
The recruits underwent scans before and after 6 weeks of intensive training. “All the recruits followed the same daily training program, lived in the same housing, and were in same environmental conditions,” Dr. Renson said. Bone marrow edema (BME) and structural lesions were common in the recruits both before and after training, but the differences weren’t statistically significant. The same was true for positive MRIs. This may be because the bones of the recruits had already been under physical strain due to their existing abilities, Dr. Renson said, and didn’t respond to additional activity.

However, there was a statistically significant increase of combined structural and inflammatory lesions (P = .038) from baseline to post training.

The findings underscore “the importance of interpretation of imaging in the right clinical context,” Dr. Renson said, since they point to the possibility of an incorrect diagnosis “even in a young, active population.”

Another study, led by Ulrich Weber, MD, of King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark, sought to understand levels of normal low-grade BME in 20 amateur runners (8 men) and 22 professional Danish hockey players (all men). On average, the researchers found signs of BME in 3.1 sacroiliac joint quadrants in the runners before and after they ran a race. Hockey players were scanned at the end of the competitive season and showed signs of BME in an average of 3.6 sacroiliac joint quadrants.

In an interview, Dr. Landewé said the studies point to how common positive MRIs are in healthy people. “It was far higher than we would have thought 10 years ago,” he said.

Are MRIs still useful then? Dr. Weber said MRI scans are still helpful in axSpA diagnoses even though they have major limitations. “The imaging method is the only one that’s halfway reliable,” he said. “These joints are deep in the body, so we have virtually no clinical ways to diagnose this.”

However, Dr. Landewé said, “you should do it only when you have sufficient suspicion of spondyloarthritis” – due to accompanying conditions such as positive family history, acute anterior uveitis, psoriasis, or peripheral arthritis – and not just when a patient has chronic back pain.

Dr. Renson reported having no relevant disclosures; two of his coauthors reported extensive disclosures. Dr. Weber and his coauthors reported having no relevant disclosures. Dr. Landewé reported having no relevant disclosures; several of his coauthors reported various disclosures. Funding for the studies was not reported.

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– Healthy individuals can show signs of spinal and pelvic inflammation on MRI, but these scans can be misleading if relied on to make a diagnosis of axial spondyloarthritis, according to findings from three separate studies at the annual meeting of the American College of Rheumatology.

“Don’t rely on MRI alone is our message,” said Robert Landewé, MD, PhD, of the University of Amsterdam, who was a coauthor of one of the three studies. “A positive MRI may occur in individuals that are completely healthy. We need to make sure that not too many patients with chronic lower back pain are diagnosed with a disease they don’t have.”

The axial form of spondyloarthritis (axSpA) affects the spinal and pelvic joints of an estimated 1.4% of the U.S. population, and the term encompasses the diagnosis of ankylosing spondylitis (0.5% of U.S. population) in which advanced sacroiliitis is seen on conventional radiography, according to the ACR. Axial SpA is particularly common in young people, especially males, in their teens and 20s.

Researchers believe that MRI scans can misleadingly suggest that patients have the condition. “We know that MRI is a sensitive method, but there’s a lack of data regarding its specificity,” Thomas Renson, MD, of Ghent (Belgium) University, said at a press conference during the meeting.

Dr. Landewé led a study that compared MRIs of sacroiliac joints in 47 healthy people, 47 axSpA patients matched for gender and age, 47 chronic back pain patients, 7 women with postpartum back pain, and 24 frequent runners. Positive MRIs were common in the axSpA patients (43 of 47), but they were also found in healthy people (11 of 47), chronic back pain patients (3 of 47), frequent runners (3 of 24), and women with postpartum back pain (4 of 7).

In another study, Dr. Renson and his colleagues sought to understand whether a sustained period of intense physical activity affected spinal findings in 22 healthy military recruits who did not have SpA.

Dr. Ulrich Weber
The recruits underwent scans before and after 6 weeks of intensive training. “All the recruits followed the same daily training program, lived in the same housing, and were in same environmental conditions,” Dr. Renson said. Bone marrow edema (BME) and structural lesions were common in the recruits both before and after training, but the differences weren’t statistically significant. The same was true for positive MRIs. This may be because the bones of the recruits had already been under physical strain due to their existing abilities, Dr. Renson said, and didn’t respond to additional activity.

However, there was a statistically significant increase of combined structural and inflammatory lesions (P = .038) from baseline to post training.

The findings underscore “the importance of interpretation of imaging in the right clinical context,” Dr. Renson said, since they point to the possibility of an incorrect diagnosis “even in a young, active population.”

Another study, led by Ulrich Weber, MD, of King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark, sought to understand levels of normal low-grade BME in 20 amateur runners (8 men) and 22 professional Danish hockey players (all men). On average, the researchers found signs of BME in 3.1 sacroiliac joint quadrants in the runners before and after they ran a race. Hockey players were scanned at the end of the competitive season and showed signs of BME in an average of 3.6 sacroiliac joint quadrants.

In an interview, Dr. Landewé said the studies point to how common positive MRIs are in healthy people. “It was far higher than we would have thought 10 years ago,” he said.

Are MRIs still useful then? Dr. Weber said MRI scans are still helpful in axSpA diagnoses even though they have major limitations. “The imaging method is the only one that’s halfway reliable,” he said. “These joints are deep in the body, so we have virtually no clinical ways to diagnose this.”

However, Dr. Landewé said, “you should do it only when you have sufficient suspicion of spondyloarthritis” – due to accompanying conditions such as positive family history, acute anterior uveitis, psoriasis, or peripheral arthritis – and not just when a patient has chronic back pain.

Dr. Renson reported having no relevant disclosures; two of his coauthors reported extensive disclosures. Dr. Weber and his coauthors reported having no relevant disclosures. Dr. Landewé reported having no relevant disclosures; several of his coauthors reported various disclosures. Funding for the studies was not reported.

– Healthy individuals can show signs of spinal and pelvic inflammation on MRI, but these scans can be misleading if relied on to make a diagnosis of axial spondyloarthritis, according to findings from three separate studies at the annual meeting of the American College of Rheumatology.

“Don’t rely on MRI alone is our message,” said Robert Landewé, MD, PhD, of the University of Amsterdam, who was a coauthor of one of the three studies. “A positive MRI may occur in individuals that are completely healthy. We need to make sure that not too many patients with chronic lower back pain are diagnosed with a disease they don’t have.”

The axial form of spondyloarthritis (axSpA) affects the spinal and pelvic joints of an estimated 1.4% of the U.S. population, and the term encompasses the diagnosis of ankylosing spondylitis (0.5% of U.S. population) in which advanced sacroiliitis is seen on conventional radiography, according to the ACR. Axial SpA is particularly common in young people, especially males, in their teens and 20s.

Researchers believe that MRI scans can misleadingly suggest that patients have the condition. “We know that MRI is a sensitive method, but there’s a lack of data regarding its specificity,” Thomas Renson, MD, of Ghent (Belgium) University, said at a press conference during the meeting.

Dr. Landewé led a study that compared MRIs of sacroiliac joints in 47 healthy people, 47 axSpA patients matched for gender and age, 47 chronic back pain patients, 7 women with postpartum back pain, and 24 frequent runners. Positive MRIs were common in the axSpA patients (43 of 47), but they were also found in healthy people (11 of 47), chronic back pain patients (3 of 47), frequent runners (3 of 24), and women with postpartum back pain (4 of 7).

In another study, Dr. Renson and his colleagues sought to understand whether a sustained period of intense physical activity affected spinal findings in 22 healthy military recruits who did not have SpA.

Dr. Ulrich Weber
The recruits underwent scans before and after 6 weeks of intensive training. “All the recruits followed the same daily training program, lived in the same housing, and were in same environmental conditions,” Dr. Renson said. Bone marrow edema (BME) and structural lesions were common in the recruits both before and after training, but the differences weren’t statistically significant. The same was true for positive MRIs. This may be because the bones of the recruits had already been under physical strain due to their existing abilities, Dr. Renson said, and didn’t respond to additional activity.

However, there was a statistically significant increase of combined structural and inflammatory lesions (P = .038) from baseline to post training.

The findings underscore “the importance of interpretation of imaging in the right clinical context,” Dr. Renson said, since they point to the possibility of an incorrect diagnosis “even in a young, active population.”

Another study, led by Ulrich Weber, MD, of King Christian 10th Hospital for Rheumatic Diseases, Gråsten, Denmark, sought to understand levels of normal low-grade BME in 20 amateur runners (8 men) and 22 professional Danish hockey players (all men). On average, the researchers found signs of BME in 3.1 sacroiliac joint quadrants in the runners before and after they ran a race. Hockey players were scanned at the end of the competitive season and showed signs of BME in an average of 3.6 sacroiliac joint quadrants.

In an interview, Dr. Landewé said the studies point to how common positive MRIs are in healthy people. “It was far higher than we would have thought 10 years ago,” he said.

Are MRIs still useful then? Dr. Weber said MRI scans are still helpful in axSpA diagnoses even though they have major limitations. “The imaging method is the only one that’s halfway reliable,” he said. “These joints are deep in the body, so we have virtually no clinical ways to diagnose this.”

However, Dr. Landewé said, “you should do it only when you have sufficient suspicion of spondyloarthritis” – due to accompanying conditions such as positive family history, acute anterior uveitis, psoriasis, or peripheral arthritis – and not just when a patient has chronic back pain.

Dr. Renson reported having no relevant disclosures; two of his coauthors reported extensive disclosures. Dr. Weber and his coauthors reported having no relevant disclosures. Dr. Landewé reported having no relevant disclosures; several of his coauthors reported various disclosures. Funding for the studies was not reported.

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DAPT produces better CABG outcomes than aspirin alone

DAPT must also show clinical benefits
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Tue, 07/21/2020 - 14:18

 

– Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.

After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.

Mitchel L. Zoler/Frontline Medical News
Dr. Qiang Zhao
But with a study of 500 patients that was only powered to address vein-graft patency the trial was underpowered to prove that the reductions in cardiovascular death, MI, and stroke outweighed the increase in major bleeds.

“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.

The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy J. Gardner
Although arterial grafts are much preferred for CABG, “saphenous vein grafts are still plenty used,” commented Timothy J. Gardner, MD, a cardiac surgeon and medical director of the Center for Heart & Vascular Health of Christiana Care in Newark, Del. That’s especially true when patients require multivessel bypass, in which case placement of saphenous veins grafts are a virtual given in current U.S. practice, Dr. Gardner said in an interview.

“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.

DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.

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Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.

But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.

The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .

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Body

 

Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.

But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.

The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .

Body

 

Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.

But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.

The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .

Title
DAPT must also show clinical benefits
DAPT must also show clinical benefits

 

– Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.

After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.

Mitchel L. Zoler/Frontline Medical News
Dr. Qiang Zhao
But with a study of 500 patients that was only powered to address vein-graft patency the trial was underpowered to prove that the reductions in cardiovascular death, MI, and stroke outweighed the increase in major bleeds.

“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.

The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy J. Gardner
Although arterial grafts are much preferred for CABG, “saphenous vein grafts are still plenty used,” commented Timothy J. Gardner, MD, a cardiac surgeon and medical director of the Center for Heart & Vascular Health of Christiana Care in Newark, Del. That’s especially true when patients require multivessel bypass, in which case placement of saphenous veins grafts are a virtual given in current U.S. practice, Dr. Gardner said in an interview.

“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.

DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.

 

– Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.

After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.

Mitchel L. Zoler/Frontline Medical News
Dr. Qiang Zhao
But with a study of 500 patients that was only powered to address vein-graft patency the trial was underpowered to prove that the reductions in cardiovascular death, MI, and stroke outweighed the increase in major bleeds.

“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.

The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy J. Gardner
Although arterial grafts are much preferred for CABG, “saphenous vein grafts are still plenty used,” commented Timothy J. Gardner, MD, a cardiac surgeon and medical director of the Center for Heart & Vascular Health of Christiana Care in Newark, Del. That’s especially true when patients require multivessel bypass, in which case placement of saphenous veins grafts are a virtual given in current U.S. practice, Dr. Gardner said in an interview.

“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.

DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.

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Key clinical point: Using dual-antiplatelet therapy to treat patients receiving a saphenous vein coronary bypass graft led to better graft patency after 1 year, compared with bypass patients treated with aspirin alone.

Major finding: The 1-year saphenous-vein graft patency rate was 89% with DAPT treatment and 77% with aspirin alone. Data source: DACAB, a multicenter, randomized trial with 500 Chinese patients.

Disclosures: DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi.

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MACRA Monday: Documenting current medications

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Changed
Wed, 04/03/2019 - 10:24

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #130: Documentation of Current Medications in the Medical Record

This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.

What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #130: Documentation of Current Medications in the Medical Record

This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.

What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #130: Documentation of Current Medications in the Medical Record

This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.

What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Evidence mounts for pulmonary embolism benefit from catheter thrombolysis

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– Catheter-directed thrombolysis of pulmonary embolism using an ultrasound-assisted device led to significantly better outcomes in patients hospitalized for pulmonary embolism, compared with conventional systemic thrombolytic treatment, in a propensity score–adjusted analysis of nearly 3,400 patients.

Catheter-directed thrombolysis (CDT) “represents an opportunity to locally treat pulmonary embolism with significant thrombus burden with lower bleeding complications,” Abhishek Mishra, MD, said at the CHEST annual meeting. “I think we are underusing CDT,” said Dr. Mishra, a cardiovascular disease physician at Guthrie Robert Packer Hospital in Sayre, Pa.

Although one CDT device, the EKOS endovascular system that uses ultrasound to facilitate pulmonary embolism (PE) thrombolysis, received Food & Drug Administration approval for U.S. marketing in 2014, the trials that have compared it with systemic thrombolysis have been small, noted Dr. Mishra, and none have looked at whether CDT improves patient survival, compared with standard treatments. The largest report on CDT treatment of PE came from a single-arm, uncontrolled study with 150 patients who received ultrasound-facilitated CDT (JACC Cardiovasc Interv. 2015 Aug;8[10]:1382-92).

To better document the incremental benefit from CDT, Dr. Mishra and his associates used data collected by the Nationwide Readmissions Database during 2013 and 2014, both before and after a CDT device became available for U.S. use. From among 4,426 patients hospitalized with a primary diagnosis of PE and treated with thrombolytic therapy, they used propensity score matching to compare 2,256 patients treated with systemic thrombolysis with 1,128 matched patients treated with CDT using tissue plasminogen activator.

The analysis showed that in-hospital death was 15% in the systemic patients and 6% in the CDT group, a relative risk reduction of 63%, and 30-day readmissions occurred in 11% of the systemic patients and in 8% of those treated with CDT, a 30% relative risk reduction. Both were statistically significant differences for the study’s two primary endpoints, Dr. Mishra reported at the meeting. Rates of intracerebral hemorrhage and gastrointestinal bleeds were both numerically lower with CDT, and significantly lower for gastrointestinal bleeds.

The researchers also ran a multivariate analysis on their data that showed CDT was linked with significant relative reductions of about 60% for both in-hospital death and 30-day readmissions, compared with patients on systemic therapy. The results Dr. Mishra reported also appeared in a published report (Am J Cardiol. 2017 Nov 1;120[9]:1653-61).

These findings help buttress the case for using CDT for at least some PE patients. “The key is which patients need it. What is the best way to stratify patients?” commented Victor F. Tapson, MD, a pulmonologist at Cedars-Sinai Medical Center in Los Angeles.

“Patients with PE and a normal right ventricle generally don’t need anything more aggressive than anticoagulation, and really sick patients with massive PE need systemic thrombolytics. Intermediate-risk patients” are best suited to CDT, but “the problem is that intermediate-risk patients are heterogeneous,” Dr. Tapson said in a video interview. Future studies should establish a more specific subgroup of intermediate-risk patients who benefit from routinely employed CDT, he suggested.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

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Daniel Ouellette, MD, FCCP, comments: Recently, practitioners at my hospital have become interested in the use of catheter-directed thrombolysis to treat patients with hemodynamically significant pulmonary embolus. We developed an on-call, multidisciplinary team to make treatment decisions for patients with a significant pulmonary embolus based on institutional protocols. While we await definitive data concerning outcomes for these exciting new technologies, the team approach to this process has led to judicious and well-thought-out plans for our patients. 
BY MITCHEL L. ZOLER 
Frontline Medical News

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Daniel Ouellette, MD, FCCP, comments: Recently, practitioners at my hospital have become interested in the use of catheter-directed thrombolysis to treat patients with hemodynamically significant pulmonary embolus. We developed an on-call, multidisciplinary team to make treatment decisions for patients with a significant pulmonary embolus based on institutional protocols. While we await definitive data concerning outcomes for these exciting new technologies, the team approach to this process has led to judicious and well-thought-out plans for our patients. 
BY MITCHEL L. ZOLER 
Frontline Medical News

Body

Daniel Ouellette, MD, FCCP, comments: Recently, practitioners at my hospital have become interested in the use of catheter-directed thrombolysis to treat patients with hemodynamically significant pulmonary embolus. We developed an on-call, multidisciplinary team to make treatment decisions for patients with a significant pulmonary embolus based on institutional protocols. While we await definitive data concerning outcomes for these exciting new technologies, the team approach to this process has led to judicious and well-thought-out plans for our patients. 
BY MITCHEL L. ZOLER 
Frontline Medical News

 

– Catheter-directed thrombolysis of pulmonary embolism using an ultrasound-assisted device led to significantly better outcomes in patients hospitalized for pulmonary embolism, compared with conventional systemic thrombolytic treatment, in a propensity score–adjusted analysis of nearly 3,400 patients.

Catheter-directed thrombolysis (CDT) “represents an opportunity to locally treat pulmonary embolism with significant thrombus burden with lower bleeding complications,” Abhishek Mishra, MD, said at the CHEST annual meeting. “I think we are underusing CDT,” said Dr. Mishra, a cardiovascular disease physician at Guthrie Robert Packer Hospital in Sayre, Pa.

Although one CDT device, the EKOS endovascular system that uses ultrasound to facilitate pulmonary embolism (PE) thrombolysis, received Food & Drug Administration approval for U.S. marketing in 2014, the trials that have compared it with systemic thrombolysis have been small, noted Dr. Mishra, and none have looked at whether CDT improves patient survival, compared with standard treatments. The largest report on CDT treatment of PE came from a single-arm, uncontrolled study with 150 patients who received ultrasound-facilitated CDT (JACC Cardiovasc Interv. 2015 Aug;8[10]:1382-92).

To better document the incremental benefit from CDT, Dr. Mishra and his associates used data collected by the Nationwide Readmissions Database during 2013 and 2014, both before and after a CDT device became available for U.S. use. From among 4,426 patients hospitalized with a primary diagnosis of PE and treated with thrombolytic therapy, they used propensity score matching to compare 2,256 patients treated with systemic thrombolysis with 1,128 matched patients treated with CDT using tissue plasminogen activator.

The analysis showed that in-hospital death was 15% in the systemic patients and 6% in the CDT group, a relative risk reduction of 63%, and 30-day readmissions occurred in 11% of the systemic patients and in 8% of those treated with CDT, a 30% relative risk reduction. Both were statistically significant differences for the study’s two primary endpoints, Dr. Mishra reported at the meeting. Rates of intracerebral hemorrhage and gastrointestinal bleeds were both numerically lower with CDT, and significantly lower for gastrointestinal bleeds.

The researchers also ran a multivariate analysis on their data that showed CDT was linked with significant relative reductions of about 60% for both in-hospital death and 30-day readmissions, compared with patients on systemic therapy. The results Dr. Mishra reported also appeared in a published report (Am J Cardiol. 2017 Nov 1;120[9]:1653-61).

These findings help buttress the case for using CDT for at least some PE patients. “The key is which patients need it. What is the best way to stratify patients?” commented Victor F. Tapson, MD, a pulmonologist at Cedars-Sinai Medical Center in Los Angeles.

“Patients with PE and a normal right ventricle generally don’t need anything more aggressive than anticoagulation, and really sick patients with massive PE need systemic thrombolytics. Intermediate-risk patients” are best suited to CDT, but “the problem is that intermediate-risk patients are heterogeneous,” Dr. Tapson said in a video interview. Future studies should establish a more specific subgroup of intermediate-risk patients who benefit from routinely employed CDT, he suggested.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

– Catheter-directed thrombolysis of pulmonary embolism using an ultrasound-assisted device led to significantly better outcomes in patients hospitalized for pulmonary embolism, compared with conventional systemic thrombolytic treatment, in a propensity score–adjusted analysis of nearly 3,400 patients.

Catheter-directed thrombolysis (CDT) “represents an opportunity to locally treat pulmonary embolism with significant thrombus burden with lower bleeding complications,” Abhishek Mishra, MD, said at the CHEST annual meeting. “I think we are underusing CDT,” said Dr. Mishra, a cardiovascular disease physician at Guthrie Robert Packer Hospital in Sayre, Pa.

Although one CDT device, the EKOS endovascular system that uses ultrasound to facilitate pulmonary embolism (PE) thrombolysis, received Food & Drug Administration approval for U.S. marketing in 2014, the trials that have compared it with systemic thrombolysis have been small, noted Dr. Mishra, and none have looked at whether CDT improves patient survival, compared with standard treatments. The largest report on CDT treatment of PE came from a single-arm, uncontrolled study with 150 patients who received ultrasound-facilitated CDT (JACC Cardiovasc Interv. 2015 Aug;8[10]:1382-92).

To better document the incremental benefit from CDT, Dr. Mishra and his associates used data collected by the Nationwide Readmissions Database during 2013 and 2014, both before and after a CDT device became available for U.S. use. From among 4,426 patients hospitalized with a primary diagnosis of PE and treated with thrombolytic therapy, they used propensity score matching to compare 2,256 patients treated with systemic thrombolysis with 1,128 matched patients treated with CDT using tissue plasminogen activator.

The analysis showed that in-hospital death was 15% in the systemic patients and 6% in the CDT group, a relative risk reduction of 63%, and 30-day readmissions occurred in 11% of the systemic patients and in 8% of those treated with CDT, a 30% relative risk reduction. Both were statistically significant differences for the study’s two primary endpoints, Dr. Mishra reported at the meeting. Rates of intracerebral hemorrhage and gastrointestinal bleeds were both numerically lower with CDT, and significantly lower for gastrointestinal bleeds.

The researchers also ran a multivariate analysis on their data that showed CDT was linked with significant relative reductions of about 60% for both in-hospital death and 30-day readmissions, compared with patients on systemic therapy. The results Dr. Mishra reported also appeared in a published report (Am J Cardiol. 2017 Nov 1;120[9]:1653-61).

These findings help buttress the case for using CDT for at least some PE patients. “The key is which patients need it. What is the best way to stratify patients?” commented Victor F. Tapson, MD, a pulmonologist at Cedars-Sinai Medical Center in Los Angeles.

“Patients with PE and a normal right ventricle generally don’t need anything more aggressive than anticoagulation, and really sick patients with massive PE need systemic thrombolytics. Intermediate-risk patients” are best suited to CDT, but “the problem is that intermediate-risk patients are heterogeneous,” Dr. Tapson said in a video interview. Future studies should establish a more specific subgroup of intermediate-risk patients who benefit from routinely employed CDT, he suggested.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

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Key clinical point: Hospitalized patients with pulmonary embolism had significantly reduced rates of both in-hospital death and 30-day readmission when treated with catheter-directed thrombolysis, compared with systemic treatment.

Major finding: Catheter-directed thrombolysis cut in-hospital mortality by 63%, compared with conventional systemic thrombolysis.

Data source: The National Readmission Database, which included 4,426 patients hospitalized during 2013 and 2014 with primary pulmonary embolism and treated with thrombolysis.

Disclosures: Dr. Mishra had no disclosures. Dr. Tapson has been a consultant to and had received research funding from Ekos/BTG, a company that markets a catheter-directed thrombolysis device. He has also ties to Daiichi Sankyo, Inari, Janssen, and Portola.

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VIDEO: New PsA guideline expected in 2018

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Tue, 02/07/2023 - 16:56

– For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News
From left, Dr. Alexis Ogdie, Dr. Dafna D. Gladman, and Dr. Jasvinder Singh
Dr. Gladman, professor of medicine at the University of Toronto, was a member of the core oversight team that assembled the guideline, which was a joint effort of the American College of Rheumatology and the National Psoriasis Foundation. It also marked the first PsA guideline to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for rheumatoid arthritis and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

“At first, I wasn’t a big fan of the idea of the GRADE guidelines because the number of questions blows up so fast, [but] it really makes you focus on what the most common [clinical] settings are,” said another core oversight team member, Alexis Ogdie, MD, a rheumatologist at the University of Pennsylvania, Philadelphia. “These guidelines also reveal the major gap of no head-to-head studies. I think we’ve known that, but this really called that out as important. When we’re making a treatment decision between [drugs] A and B, we need those studies to be able to better understand how to treat our patients, rather than using the data from one trial to make a decision. ... For my patients, I’m excited that I can now use a TNF inhibitor as a first-line agent. When we have patients come in with very severe disease, occasionally they also have severe psoriasis, so we’ve been able to use TNF inhibitors as first-line treatment in some of our patients in Pennsylvania. This differs state by state. But the exciting thing is that they get better so fast and you don’t have to tell them to wait 12 weeks for methotrexate to work.”

The ACR/NPF guideline is currently under peer review and is expected to be published in Arthritis & Rheumatology, Arthritis Care & Research, and the Journal of Psoriasis and Psoriatic Arthritis in the spring or summer of 2018. It focuses on common PsA patients, not exceptional cases. It includes recommendations on the management of patients with active PsA that is defined by the patients’ self-report and judged by the examining clinician to be caused by PsA, based on the on the presence of at least one of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; active skin and/or nail involvement; and/or extra-articular manifestations such as uveitis or inflammatory bowel disease. Authors of the guideline considered cost as one of many possible factors affecting the use of the recommendations, but explicit cost-effectiveness analyses were not conducted. Also, since the NPF and the American Academy of Dermatology are concurrently developing a psoriasis treatment guideline, the treatment of skin psoriasis was not included in the guideline.

According to the guideline’s principal investigator Jasvinder Singh, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, the guideline will include 80 recommendations, 75 (94%) that are rated as “conditional,” and 5 (6%) that are rated as “strong,” based on the quality of evidence in the existing medical literature. “Most of our treatment guidelines rely on very low-to-moderate quality evidence, which means that there needs to be an active discussion between the physician and the patient with regard to which treatment to choose,” said Dr. Singh, who is also a staff rheumatologist at the Birmingham Veterans Affairs Medical Center and who led development of the 2012 and 2015 ACR treatment guidelines for RA. “When you’re not choosing the preferred treatment, there are defined specific recommendations under which that second treatment may be preferred over the first treatment.”

During a separate session at the meeting, Dr. Singh unveiled a few of the draft recommendations. One calls for using a treat-to-target strategy over not using one. In the setting of immunizing patients who are receiving a biologic, another recommendation calls for clinicians to start the indicated biologic and administer killed vaccines (as indicated) in patients with active PsA rather than delaying the biologic to give the killed vaccines. In addition, delaying the start of the indicated biologic is recommended over not delaying in order to administer a live attenuated vaccine in patients with active PsA. When patients continue to have with active PsA despite being on a TNF inhibitor, the draft guideline recommends switching to a different TNF inhibitor rather than an IL-17 inhibitor, an IL-12/IL-23 inhibitor, abatacept (Orencia), tofacitinib (Xeljanz), or adding methotrexate. If PsA is still active, the guideline recommends switching to an IL-17 inhibitor instead of an IL-12/IL-23 inhibitor, abatacept, or tofacitinib. If PsA is still active, the guideline recommends switching to an IL-12/IL-23 inhibitor over abatacept or tofacitinib.

The guideline also includes suggestions for nonpharmacologic treatments, including recommending low-impact exercise over high-impact exercise, occupational therapy, physical therapy, and weight loss. It also includes a strong recommendation to provide smoking cessation advice to patients.

Dr. Singh acknowledged significant research gaps in the current PsA medical literature, including no head-to-head comparisons of treatments. He said that the field also could benefit from specific studies for enthesitis, axial disease, and arthritis mutilans; randomized trials of nonpharmacologic interventions; more trials of monotherapy vs. combination therapy; vaccination trials for live attenuated vaccines; trials and registry studies of patients with common comorbidities, and studies of NSAIDs and glucocorticoids, to define their role.

Possible topics for future PsA guidelines, he continued, include treatment options for patients for whom biologic medication is not an option; use of therapies in pregnancy and conception; incorporation of high-quality cost or cost-effectiveness analysis into recommendations; and the role of other comorbidities, such as fibromyalgia, hepatitis, depression/anxiety, malignancy, and cardiovascular disease.

“Evidence-based medicine needs to be practiced, even in situations where it’s difficult to get a drug,” Dr. Gladman said. “One of the things we hope will happen in the near future is that companies will start doing head-to-head studies, to help us support evidence-based recommendations in the future.”

None of the speakers reported having relevant financial disclosures.

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– For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News
From left, Dr. Alexis Ogdie, Dr. Dafna D. Gladman, and Dr. Jasvinder Singh
Dr. Gladman, professor of medicine at the University of Toronto, was a member of the core oversight team that assembled the guideline, which was a joint effort of the American College of Rheumatology and the National Psoriasis Foundation. It also marked the first PsA guideline to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for rheumatoid arthritis and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

“At first, I wasn’t a big fan of the idea of the GRADE guidelines because the number of questions blows up so fast, [but] it really makes you focus on what the most common [clinical] settings are,” said another core oversight team member, Alexis Ogdie, MD, a rheumatologist at the University of Pennsylvania, Philadelphia. “These guidelines also reveal the major gap of no head-to-head studies. I think we’ve known that, but this really called that out as important. When we’re making a treatment decision between [drugs] A and B, we need those studies to be able to better understand how to treat our patients, rather than using the data from one trial to make a decision. ... For my patients, I’m excited that I can now use a TNF inhibitor as a first-line agent. When we have patients come in with very severe disease, occasionally they also have severe psoriasis, so we’ve been able to use TNF inhibitors as first-line treatment in some of our patients in Pennsylvania. This differs state by state. But the exciting thing is that they get better so fast and you don’t have to tell them to wait 12 weeks for methotrexate to work.”

The ACR/NPF guideline is currently under peer review and is expected to be published in Arthritis & Rheumatology, Arthritis Care & Research, and the Journal of Psoriasis and Psoriatic Arthritis in the spring or summer of 2018. It focuses on common PsA patients, not exceptional cases. It includes recommendations on the management of patients with active PsA that is defined by the patients’ self-report and judged by the examining clinician to be caused by PsA, based on the on the presence of at least one of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; active skin and/or nail involvement; and/or extra-articular manifestations such as uveitis or inflammatory bowel disease. Authors of the guideline considered cost as one of many possible factors affecting the use of the recommendations, but explicit cost-effectiveness analyses were not conducted. Also, since the NPF and the American Academy of Dermatology are concurrently developing a psoriasis treatment guideline, the treatment of skin psoriasis was not included in the guideline.

According to the guideline’s principal investigator Jasvinder Singh, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, the guideline will include 80 recommendations, 75 (94%) that are rated as “conditional,” and 5 (6%) that are rated as “strong,” based on the quality of evidence in the existing medical literature. “Most of our treatment guidelines rely on very low-to-moderate quality evidence, which means that there needs to be an active discussion between the physician and the patient with regard to which treatment to choose,” said Dr. Singh, who is also a staff rheumatologist at the Birmingham Veterans Affairs Medical Center and who led development of the 2012 and 2015 ACR treatment guidelines for RA. “When you’re not choosing the preferred treatment, there are defined specific recommendations under which that second treatment may be preferred over the first treatment.”

During a separate session at the meeting, Dr. Singh unveiled a few of the draft recommendations. One calls for using a treat-to-target strategy over not using one. In the setting of immunizing patients who are receiving a biologic, another recommendation calls for clinicians to start the indicated biologic and administer killed vaccines (as indicated) in patients with active PsA rather than delaying the biologic to give the killed vaccines. In addition, delaying the start of the indicated biologic is recommended over not delaying in order to administer a live attenuated vaccine in patients with active PsA. When patients continue to have with active PsA despite being on a TNF inhibitor, the draft guideline recommends switching to a different TNF inhibitor rather than an IL-17 inhibitor, an IL-12/IL-23 inhibitor, abatacept (Orencia), tofacitinib (Xeljanz), or adding methotrexate. If PsA is still active, the guideline recommends switching to an IL-17 inhibitor instead of an IL-12/IL-23 inhibitor, abatacept, or tofacitinib. If PsA is still active, the guideline recommends switching to an IL-12/IL-23 inhibitor over abatacept or tofacitinib.

The guideline also includes suggestions for nonpharmacologic treatments, including recommending low-impact exercise over high-impact exercise, occupational therapy, physical therapy, and weight loss. It also includes a strong recommendation to provide smoking cessation advice to patients.

Dr. Singh acknowledged significant research gaps in the current PsA medical literature, including no head-to-head comparisons of treatments. He said that the field also could benefit from specific studies for enthesitis, axial disease, and arthritis mutilans; randomized trials of nonpharmacologic interventions; more trials of monotherapy vs. combination therapy; vaccination trials for live attenuated vaccines; trials and registry studies of patients with common comorbidities, and studies of NSAIDs and glucocorticoids, to define their role.

Possible topics for future PsA guidelines, he continued, include treatment options for patients for whom biologic medication is not an option; use of therapies in pregnancy and conception; incorporation of high-quality cost or cost-effectiveness analysis into recommendations; and the role of other comorbidities, such as fibromyalgia, hepatitis, depression/anxiety, malignancy, and cardiovascular disease.

“Evidence-based medicine needs to be practiced, even in situations where it’s difficult to get a drug,” Dr. Gladman said. “One of the things we hope will happen in the near future is that companies will start doing head-to-head studies, to help us support evidence-based recommendations in the future.”

None of the speakers reported having relevant financial disclosures.

– For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News
From left, Dr. Alexis Ogdie, Dr. Dafna D. Gladman, and Dr. Jasvinder Singh
Dr. Gladman, professor of medicine at the University of Toronto, was a member of the core oversight team that assembled the guideline, which was a joint effort of the American College of Rheumatology and the National Psoriasis Foundation. It also marked the first PsA guideline to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for rheumatoid arthritis and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

“At first, I wasn’t a big fan of the idea of the GRADE guidelines because the number of questions blows up so fast, [but] it really makes you focus on what the most common [clinical] settings are,” said another core oversight team member, Alexis Ogdie, MD, a rheumatologist at the University of Pennsylvania, Philadelphia. “These guidelines also reveal the major gap of no head-to-head studies. I think we’ve known that, but this really called that out as important. When we’re making a treatment decision between [drugs] A and B, we need those studies to be able to better understand how to treat our patients, rather than using the data from one trial to make a decision. ... For my patients, I’m excited that I can now use a TNF inhibitor as a first-line agent. When we have patients come in with very severe disease, occasionally they also have severe psoriasis, so we’ve been able to use TNF inhibitors as first-line treatment in some of our patients in Pennsylvania. This differs state by state. But the exciting thing is that they get better so fast and you don’t have to tell them to wait 12 weeks for methotrexate to work.”

The ACR/NPF guideline is currently under peer review and is expected to be published in Arthritis & Rheumatology, Arthritis Care & Research, and the Journal of Psoriasis and Psoriatic Arthritis in the spring or summer of 2018. It focuses on common PsA patients, not exceptional cases. It includes recommendations on the management of patients with active PsA that is defined by the patients’ self-report and judged by the examining clinician to be caused by PsA, based on the on the presence of at least one of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; active skin and/or nail involvement; and/or extra-articular manifestations such as uveitis or inflammatory bowel disease. Authors of the guideline considered cost as one of many possible factors affecting the use of the recommendations, but explicit cost-effectiveness analyses were not conducted. Also, since the NPF and the American Academy of Dermatology are concurrently developing a psoriasis treatment guideline, the treatment of skin psoriasis was not included in the guideline.

According to the guideline’s principal investigator Jasvinder Singh, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, the guideline will include 80 recommendations, 75 (94%) that are rated as “conditional,” and 5 (6%) that are rated as “strong,” based on the quality of evidence in the existing medical literature. “Most of our treatment guidelines rely on very low-to-moderate quality evidence, which means that there needs to be an active discussion between the physician and the patient with regard to which treatment to choose,” said Dr. Singh, who is also a staff rheumatologist at the Birmingham Veterans Affairs Medical Center and who led development of the 2012 and 2015 ACR treatment guidelines for RA. “When you’re not choosing the preferred treatment, there are defined specific recommendations under which that second treatment may be preferred over the first treatment.”

During a separate session at the meeting, Dr. Singh unveiled a few of the draft recommendations. One calls for using a treat-to-target strategy over not using one. In the setting of immunizing patients who are receiving a biologic, another recommendation calls for clinicians to start the indicated biologic and administer killed vaccines (as indicated) in patients with active PsA rather than delaying the biologic to give the killed vaccines. In addition, delaying the start of the indicated biologic is recommended over not delaying in order to administer a live attenuated vaccine in patients with active PsA. When patients continue to have with active PsA despite being on a TNF inhibitor, the draft guideline recommends switching to a different TNF inhibitor rather than an IL-17 inhibitor, an IL-12/IL-23 inhibitor, abatacept (Orencia), tofacitinib (Xeljanz), or adding methotrexate. If PsA is still active, the guideline recommends switching to an IL-17 inhibitor instead of an IL-12/IL-23 inhibitor, abatacept, or tofacitinib. If PsA is still active, the guideline recommends switching to an IL-12/IL-23 inhibitor over abatacept or tofacitinib.

The guideline also includes suggestions for nonpharmacologic treatments, including recommending low-impact exercise over high-impact exercise, occupational therapy, physical therapy, and weight loss. It also includes a strong recommendation to provide smoking cessation advice to patients.

Dr. Singh acknowledged significant research gaps in the current PsA medical literature, including no head-to-head comparisons of treatments. He said that the field also could benefit from specific studies for enthesitis, axial disease, and arthritis mutilans; randomized trials of nonpharmacologic interventions; more trials of monotherapy vs. combination therapy; vaccination trials for live attenuated vaccines; trials and registry studies of patients with common comorbidities, and studies of NSAIDs and glucocorticoids, to define their role.

Possible topics for future PsA guidelines, he continued, include treatment options for patients for whom biologic medication is not an option; use of therapies in pregnancy and conception; incorporation of high-quality cost or cost-effectiveness analysis into recommendations; and the role of other comorbidities, such as fibromyalgia, hepatitis, depression/anxiety, malignancy, and cardiovascular disease.

“Evidence-based medicine needs to be practiced, even in situations where it’s difficult to get a drug,” Dr. Gladman said. “One of the things we hope will happen in the near future is that companies will start doing head-to-head studies, to help us support evidence-based recommendations in the future.”

None of the speakers reported having relevant financial disclosures.

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VIDEO: Consider depression in patients with psoriasis

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Mon, 07/01/2019 - 11:12

 

LAS VEGAS– When treating patients with psoriasis, “it is very important for us to treat the entire patient,” and consider the comorbidities, including depression, associated with psoriasis, Jeffrey M. Sobell, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Depression can be a particular concern for younger patients with more severe psoriasis, said Dr. Sobell of Tufts University, Boston.

When he sees patients aged 18-35 years with significant psoriasis in his practice, he has made it a habit to ask them about depression “and if they’ve ever had thoughts of hurting themselves,” and arranges for mental health follow-up visits for patients about whom he is concerned. “It’s something that’s hard to talk about, but so important,” he said.

Dr. Sobell disclosed relationships with multiple companies including AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Regeneron, Sanofi, and Sun Pharma.

SDEF and this news organization are owned by the same parent company.

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LAS VEGAS– When treating patients with psoriasis, “it is very important for us to treat the entire patient,” and consider the comorbidities, including depression, associated with psoriasis, Jeffrey M. Sobell, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Depression can be a particular concern for younger patients with more severe psoriasis, said Dr. Sobell of Tufts University, Boston.

When he sees patients aged 18-35 years with significant psoriasis in his practice, he has made it a habit to ask them about depression “and if they’ve ever had thoughts of hurting themselves,” and arranges for mental health follow-up visits for patients about whom he is concerned. “It’s something that’s hard to talk about, but so important,” he said.

Dr. Sobell disclosed relationships with multiple companies including AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Regeneron, Sanofi, and Sun Pharma.

SDEF and this news organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

LAS VEGAS– When treating patients with psoriasis, “it is very important for us to treat the entire patient,” and consider the comorbidities, including depression, associated with psoriasis, Jeffrey M. Sobell, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Depression can be a particular concern for younger patients with more severe psoriasis, said Dr. Sobell of Tufts University, Boston.

When he sees patients aged 18-35 years with significant psoriasis in his practice, he has made it a habit to ask them about depression “and if they’ve ever had thoughts of hurting themselves,” and arranges for mental health follow-up visits for patients about whom he is concerned. “It’s something that’s hard to talk about, but so important,” he said.

Dr. Sobell disclosed relationships with multiple companies including AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Regeneron, Sanofi, and Sun Pharma.

SDEF and this news organization are owned by the same parent company.

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VIDEO: Biologic use during pregnancy had no impact on serious infection risks in infants

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Fri, 01/18/2019 - 17:09

 

– Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.

“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.

In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.

Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.

In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).

“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.

Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

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– Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.

“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.

In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.

Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.

In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).

“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.

Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Researchers found no evidence of increased risk of serious or opportunistic infections in infants born to pregnant women who were treated with biologic medication for their rheumatoid arthritis, according to a cohort study.

“These data add to what we’re beginning to learn about these medications that are so commonly used in women of reproductive age, and who have concerns about whether they can use them safely or not during pregnancy,” lead study author Christina D. Chambers, PhD, MPH, said during a press briefing at the annual meeting of the American College of Rheumatology. To date, theoretical concern exists that the use of biologics could interfere with postnatal immune function in the infant, said Dr. Chambers, a perinatal epidemiologist and teratologist at the University of California, San Diego. “The theory has been that because of the size of the molecule, little placental transfer is thought to take place early in pregnancy, but later in pregnancy, more placental transfer may be possible,” she said.

In an effort to investigate the risk of serious or opportunistic infections for infants whose mothers used biologics during pregnancy, the researchers conducted an observational cohort study from pregnant women participating in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project from 2004 through 2016. Mothers fell into one of three groups: 502 pregnancies where the mother with RA was treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy (group A); 231 pregnancies where the mother had RA but did not use any biologics during pregnancy (group B), and 423 pregnancies where the mother had no chronic diseases at all (group C). The investigators defined the serious or opportunistic infections as a list of 16 infections that included X-ray proven pneumonia, septic arthritis, osteomyelitis, tuberculosis, herpes, listeria, legionella, mycobacteria, systemic cytomegalovirus and abscess. The one-year follow-up data was collected from medical records and corroborated with maternal reports.

Among the pregnant mothers in group A, 43% took their last dose in the first or second trimester, and 57% percent took their last dose in the third trimester. Dr. Chambers reported that 20 of the 502 infants in group A developed at least one serious or opportunistic infection, for a rate of 4%, while the rates among infants in groups B and C were 2.6% and 2.1%, respectively. The most common infections seen were X-ray proven pneumonia, sepsis, bacteremia, meningitis, and abscess. Between 11% and 19% of infants had more than one infection over the one-year period.

In a subset analysis of 285 women in group A who had third trimester exposure to one of the biologics, 10 infants had at least one serious or opportunistic infection, for a rate of 3.5%, which was statistically similar to that of groups B and C (2.6% and 2.1%, respectively).

“These data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than take them off the drug during that period of time,” Dr. Chambers said. She acknowledged certain limitations of the study, including the fact that the researchers did not examine risk of less serious infections, such as more frequent colds or ear infections in the infants, and they did not have any direct measure of their immune function.

Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

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Key clinical point: Use of biologics during pregnancy had no impact on opportunistic infection risks in infants.

Major finding: Infections occurred in 4% of infants born to mothers with RA treated with a biologic with or without other disease modifying anti-rheumatic medications during her pregnancy.

Study details: An observational cohort study of 1,156 pregnant women with RA.

Disclosures: Dr. Chambers disclosed having received research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen Pharmaceutica Products, L.P., Pfizer Inc, Roche Pharmaceuticals, Seqirus, GSK, UCB, and Sanofi-Aventis.

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MACRA Monday: Poor HbA1c control

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Tue, 05/03/2022 - 15:21

 

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Measure #1: Diabetes: HbA1c Poor Control

The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.

What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.

Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.

• Those who have Medicare Part B allowed charges of $30,000 or less.

• Those who have 100 or fewer Medicare Part B patients.

• Those who are significantly participating in an Advanced Alternative Payment Model (APM).


 

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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Measure #1: Diabetes: HbA1c Poor Control

The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.

What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.

Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.

• Those who have Medicare Part B allowed charges of $30,000 or less.

• Those who have 100 or fewer Medicare Part B patients.

• Those who are significantly participating in an Advanced Alternative Payment Model (APM).


 

 

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Measure #1: Diabetes: HbA1c Poor Control

The measure is aimed at capturing the percentage of patients aged 18-75 years with diabetes who had a hemoglobin A1c greater than 9.0%. For this inverse measure, a lower performance rate indicates better clinical care.

What you need to do: Document the patient’s most recent HbA1c level that was performed during the last 12 months.

Eligible cases include patients aged 18-75 years on the date of the encounter who had a documented diagnosis of diabetes. One of the following services must be performed at the visit (CPT or HCPCS): 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99217, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99238, 99239, 99281, 99282, 99283, 99284, 99285, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0270, G0271, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or that you had a good reason for not doing so. For instance, CPT II 3046F indicates that the most recent hemoglobin A1c level was greater than 9.0%, CPT II 3044F indicates that the most recent HbA1c level was less than 7.0%, and CPT II 3045F indicates that the most recent HbA1c level was between 7.0% and 9.0%.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association also has created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.

• Those who have Medicare Part B allowed charges of $30,000 or less.

• Those who have 100 or fewer Medicare Part B patients.

• Those who are significantly participating in an Advanced Alternative Payment Model (APM).


 

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VIDEO: Obesity linked to worse outcomes in axial spondyloarthropathy

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Sat, 12/08/2018 - 14:35

 

– Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.

“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.

“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”

Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.

Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”

The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”

She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”

ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.

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– Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.

“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.

“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”

Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.

Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”

The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”

She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”

ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Among patients with axial spondyloarthropathy, higher BMI and obesity independently predicts worse disease outcomes, according to results from a registry study.

“Obesity is one of the biggest public health challenges facing us in the 21st century,” lead study author Gillian Fitzgerald, MD, said in an interview in advance of the annual meeting of the American College of Rheumatology.

“Traditionally, we have a perception of patients with axial SpA being of normal or even thin body habitus. However, recent studies have indicated that this is not the case and that obesity is prevalent in axial SpA patients. The negative consequences of obesity in the general population are well documented, with affected patients suffering greater morbidity and mortality.”

Dr. Fitzgerald, of St. James’s Hospital, Dublin, Ireland, noted that research to date in axial SpA indicates that disease outcomes may be worse in obese patients. However, existing literature looking at obesity in axial SpA is relatively sparse. In an effort to clarify this issue, she and her associates evaluated 683 patients from the Ankylosing Spondylitis Registry of Ireland (ASRI), which is designed to provide descriptive epidemiological data on the Irish axSpA population via standardized clinical assessments and structured interviews. The mean age of the 683 patients enrolled as of June 2017 was 46, the majority (77%) were men, their mean disease duration was 19 years, and their mean delay to diagnosis was nine years. Most (79%) fulfilled Modified New York modified criteria, their mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 3.9, their mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 3.6, their mean Bath Ankylosing Spondylitis Functional Index (BASFI) was 3.6 and their mean Health Assessment Questionnaire (HAQ) was 0.52.

Based on WHO criteria, the cohort’s mean BMI was 27.8 kg/m2. Of these, 38.9% were overweight and 28.4% were obese. “Indeed, only 32% of the cohort have a healthy BMI,” Dr. Fitzgerald commented. “When we looked at the relationship between BMI and disease outcomes, we found that obese patients had more severe disease than their normal weight and overweight counterparts, with higher measures of disease activity, quality of life, disability and function, as well as worse spinal mobility.”

The researchers also observed that the prevalence of smoking was lower in obese patients, compared with normal weight patients (18% vs. 38, respectively). In univariable linear regression, BMI and obesity were associated with higher BASDAI, BASMI, BASFI and HAQ scores. In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

“As clinicians, we are always looking for ways to reduce the burden of disease that patients carry and to improve outcomes,” Dr. Fitzgerald said. “In this study, we demonstrated that over two-thirds of our axial SpA patients are either overweight or obese, and that these patients have more severe disease. Further research is needed to clarify this relationship between obesity and disease severity; in particular, the effect of losing weight on disease outcomes needs to be clarified. However, when devising treatment plans for axial SpA patients, this study provides rheumatologists with a strong rationale to include strategies to actively control weight.”

She acknowledged that the study’s cross-sectional design is a limitation. “This means cause and effect can’t be determined exclusively from this study; therefore, prospective studies are required to further clarify this relationship that we have noted between obesity and disease outcomes.”

ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Key clinical point: Obese patients with axial spondyloarthropathy have worse disease outcomes.

Major finding: In multivariable regression analysis, only obesity remained an independent predictor of higher disease activity and worse function (P less than .01).

Study details: A cross-sectional study of 683 patients with axial spondyloarthropathy.

Disclosures: ASRI is funded by an unrestricted grant from AbbVie and Pfizer. Dr. Fitzgerald disclosed having received research support from AbbVie Hopkins.

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VIDEO: Treating vascular lesions in children

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LAS VEGAS– Clinicians should not shy away from light-based treatment of vascular lesions in children, for reasons that include achieving better results when treated early, according to Kristen M. Kelly, MD.

Special considerations include addressing children’s fears. “One of the strategies we use is we have child life specialists who help us” create a friendly and welcoming environment, Dr. Kelly said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. Consequently, “many of our children actually come in, they’re excited about their visit ... and are looking forward to seeing us at the next visit,” she noted.

Which type of anesthesia to use is another important consideration when treating children, said Dr. Kelly of the University of California, Irvine, in Orange. “For a larger procedure ... one definitely could consider general anesthesia,” but there are risks and benefits to general anesthesia in very young children, and options should be discussed with patients and their families, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

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LAS VEGAS– Clinicians should not shy away from light-based treatment of vascular lesions in children, for reasons that include achieving better results when treated early, according to Kristen M. Kelly, MD.

Special considerations include addressing children’s fears. “One of the strategies we use is we have child life specialists who help us” create a friendly and welcoming environment, Dr. Kelly said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. Consequently, “many of our children actually come in, they’re excited about their visit ... and are looking forward to seeing us at the next visit,” she noted.

Which type of anesthesia to use is another important consideration when treating children, said Dr. Kelly of the University of California, Irvine, in Orange. “For a larger procedure ... one definitely could consider general anesthesia,” but there are risks and benefits to general anesthesia in very young children, and options should be discussed with patients and their families, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS– Clinicians should not shy away from light-based treatment of vascular lesions in children, for reasons that include achieving better results when treated early, according to Kristen M. Kelly, MD.

Special considerations include addressing children’s fears. “One of the strategies we use is we have child life specialists who help us” create a friendly and welcoming environment, Dr. Kelly said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. Consequently, “many of our children actually come in, they’re excited about their visit ... and are looking forward to seeing us at the next visit,” she noted.

Which type of anesthesia to use is another important consideration when treating children, said Dr. Kelly of the University of California, Irvine, in Orange. “For a larger procedure ... one definitely could consider general anesthesia,” but there are risks and benefits to general anesthesia in very young children, and options should be discussed with patients and their families, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

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