Primary Care/Internal Medicine

NEW YORK – Conventional disease-modifying antirheumatic drugs will not be included among acceptable treatments for enthesitis related to psoriatic arthritis, according to a draft of guidelines being prepared for publication.

"The only controlled trial with a DMARD [disease-modifying antirheumatic drug] for enthesitis was conducted with sulfasalazine, and it was negative," said Dr. Evan L. Siegel, who is in group practice in rheumatology in Rockville, Md. Dr. Siegel led a group of experts preparing psoriatic arthritis enthesitis treatment recommendations to be issued by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In a preliminary report on the planned treatment recommendations, which were delivered at the joint meetings of GRAPPA and the Spondyloarthritis Research & Treatment Network (SPARTAN), Dr. Siegel reported that the new recommendations will recognize only two gradations of enthesitis: mild or moderate/severe.

"It is difficult to differentiate moderate from severe because these have not been treated as distinct entities in the clinical trials," Dr. Siegel said. Patients experience severity in regard to intensity of pain and limitation of function, either or both of which may represent severe enthesitis in any given individual patient, according to Dr. Siegel, who also noted that the number of sites of activity is also generally unhelpful.

"Significant activity at a single site may be sufficient to produce a major functional deficit in one individual, whereas the activity at multiple sites may not produce much symptomatology or functional loss in another," Dr. Siegel said.

Enthesitis, an inflammation at the site where tendons or ligaments attach to bone, has been reported in up to 70% of patients with psoriatic arthritis. In some patients, it is the dominant symptom. However, the number of treatment trials in which control of enthesitis is the primary outcome continues to be limited, according to Dr. Siegel. He acknowledged that many of the proposed treatment recommendations owed more to expert opinion than to data.

This is true of the proposed first-line recommendation, he said, which is the use of nonsteroidal anti-inflammatory drugs and physical therapy. For NSAIDs, the wording of the recommendation will emphasize the need to monitor side effects.

The expert opinion of the GRAPPA consensus group was nearly unanimous that NSAIDs and physical therapy are effective and should be tried initially in both mild and moderate/severe disease, even though Dr. Siegel said that the supportive data from controlled trials are limited.

For those with moderate/severe enthesitis not sufficiently controlled on NSAIDs, alternatives include tumor necrosis factor inhibitors, ustekinumab, and apremilast. Some supportive data are available for each of these options, even though the consensus group concluded that there is not enough comparative evidence "to recommend one over another," he said.

Rather, the consensus group is recommending that the choice of therapies beyond NSAIDs and physical therapy be individualized in relationship to comorbidities, personal preference, and other considerations.

Special wording is being developed in regard to the use of corticosteroid injections. This wording was partly inspired by a meta-analysis that associated corticosteroid injections with an adverse effect on the integrity of tendons. Although there were many criticisms of this report, there was sufficient concern among the consensus group to urge that this treatment be used with caution.

"We think that these injections should only be provided by experienced physicians," Dr. Siegel reported. The wording in the preliminary draft is that adjunctive corticosteroid injections "may be considered on an individual basis."

When published, the enthesitis guidelines will include grading for the quality of the evidence behind each recommendation as well as the relative strength of the recommendation conferred by the expert panel.

Dr. Siegel reported financial relationships with Amgen and AbbVie.

NEW YORK – Conventional disease-modifying antirheumatic drugs will not be included among acceptable treatments for enthesitis related to psoriatic arthritis, according to a draft of guidelines being prepared for publication.

"The only controlled trial with a DMARD [disease-modifying antirheumatic drug] for enthesitis was conducted with sulfasalazine, and it was negative," said Dr. Evan L. Siegel, who is in group practice in rheumatology in Rockville, Md. Dr. Siegel led a group of experts preparing psoriatic arthritis enthesitis treatment recommendations to be issued by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In a preliminary report on the planned treatment recommendations, which were delivered at the joint meetings of GRAPPA and the Spondyloarthritis Research & Treatment Network (SPARTAN), Dr. Siegel reported that the new recommendations will recognize only two gradations of enthesitis: mild or moderate/severe.

"It is difficult to differentiate moderate from severe because these have not been treated as distinct entities in the clinical trials," Dr. Siegel said. Patients experience severity in regard to intensity of pain and limitation of function, either or both of which may represent severe enthesitis in any given individual patient, according to Dr. Siegel, who also noted that the number of sites of activity is also generally unhelpful.

"Significant activity at a single site may be sufficient to produce a major functional deficit in one individual, whereas the activity at multiple sites may not produce much symptomatology or functional loss in another," Dr. Siegel said.

Enthesitis, an inflammation at the site where tendons or ligaments attach to bone, has been reported in up to 70% of patients with psoriatic arthritis. In some patients, it is the dominant symptom. However, the number of treatment trials in which control of enthesitis is the primary outcome continues to be limited, according to Dr. Siegel. He acknowledged that many of the proposed treatment recommendations owed more to expert opinion than to data.

This is true of the proposed first-line recommendation, he said, which is the use of nonsteroidal anti-inflammatory drugs and physical therapy. For NSAIDs, the wording of the recommendation will emphasize the need to monitor side effects.

The expert opinion of the GRAPPA consensus group was nearly unanimous that NSAIDs and physical therapy are effective and should be tried initially in both mild and moderate/severe disease, even though Dr. Siegel said that the supportive data from controlled trials are limited.

For those with moderate/severe enthesitis not sufficiently controlled on NSAIDs, alternatives include tumor necrosis factor inhibitors, ustekinumab, and apremilast. Some supportive data are available for each of these options, even though the consensus group concluded that there is not enough comparative evidence "to recommend one over another," he said.

Rather, the consensus group is recommending that the choice of therapies beyond NSAIDs and physical therapy be individualized in relationship to comorbidities, personal preference, and other considerations.

Special wording is being developed in regard to the use of corticosteroid injections. This wording was partly inspired by a meta-analysis that associated corticosteroid injections with an adverse effect on the integrity of tendons. Although there were many criticisms of this report, there was sufficient concern among the consensus group to urge that this treatment be used with caution.

"We think that these injections should only be provided by experienced physicians," Dr. Siegel reported. The wording in the preliminary draft is that adjunctive corticosteroid injections "may be considered on an individual basis."

When published, the enthesitis guidelines will include grading for the quality of the evidence behind each recommendation as well as the relative strength of the recommendation conferred by the expert panel.

Dr. Siegel reported financial relationships with Amgen and AbbVie.

NEW YORK – Conventional disease-modifying antirheumatic drugs will not be included among acceptable treatments for enthesitis related to psoriatic arthritis, according to a draft of guidelines being prepared for publication.

"The only controlled trial with a DMARD [disease-modifying antirheumatic drug] for enthesitis was conducted with sulfasalazine, and it was negative," said Dr. Evan L. Siegel, who is in group practice in rheumatology in Rockville, Md. Dr. Siegel led a group of experts preparing psoriatic arthritis enthesitis treatment recommendations to be issued by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In a preliminary report on the planned treatment recommendations, which were delivered at the joint meetings of GRAPPA and the Spondyloarthritis Research & Treatment Network (SPARTAN), Dr. Siegel reported that the new recommendations will recognize only two gradations of enthesitis: mild or moderate/severe.

"It is difficult to differentiate moderate from severe because these have not been treated as distinct entities in the clinical trials," Dr. Siegel said. Patients experience severity in regard to intensity of pain and limitation of function, either or both of which may represent severe enthesitis in any given individual patient, according to Dr. Siegel, who also noted that the number of sites of activity is also generally unhelpful.

"Significant activity at a single site may be sufficient to produce a major functional deficit in one individual, whereas the activity at multiple sites may not produce much symptomatology or functional loss in another," Dr. Siegel said.

Enthesitis, an inflammation at the site where tendons or ligaments attach to bone, has been reported in up to 70% of patients with psoriatic arthritis. In some patients, it is the dominant symptom. However, the number of treatment trials in which control of enthesitis is the primary outcome continues to be limited, according to Dr. Siegel. He acknowledged that many of the proposed treatment recommendations owed more to expert opinion than to data.

This is true of the proposed first-line recommendation, he said, which is the use of nonsteroidal anti-inflammatory drugs and physical therapy. For NSAIDs, the wording of the recommendation will emphasize the need to monitor side effects.

The expert opinion of the GRAPPA consensus group was nearly unanimous that NSAIDs and physical therapy are effective and should be tried initially in both mild and moderate/severe disease, even though Dr. Siegel said that the supportive data from controlled trials are limited.

For those with moderate/severe enthesitis not sufficiently controlled on NSAIDs, alternatives include tumor necrosis factor inhibitors, ustekinumab, and apremilast. Some supportive data are available for each of these options, even though the consensus group concluded that there is not enough comparative evidence "to recommend one over another," he said.

Rather, the consensus group is recommending that the choice of therapies beyond NSAIDs and physical therapy be individualized in relationship to comorbidities, personal preference, and other considerations.

Special wording is being developed in regard to the use of corticosteroid injections. This wording was partly inspired by a meta-analysis that associated corticosteroid injections with an adverse effect on the integrity of tendons. Although there were many criticisms of this report, there was sufficient concern among the consensus group to urge that this treatment be used with caution.

"We think that these injections should only be provided by experienced physicians," Dr. Siegel reported. The wording in the preliminary draft is that adjunctive corticosteroid injections "may be considered on an individual basis."

When published, the enthesitis guidelines will include grading for the quality of the evidence behind each recommendation as well as the relative strength of the recommendation conferred by the expert panel.

Dr. Siegel reported financial relationships with Amgen and AbbVie.

COEUR D’ALENE, IDAHO – The 2014 American Academy of Dermatology atopic dermatitis guidelines may already need an update, according to the cochair of the guidelines panel.

The guidelines were based upon studies published through 2012. Since then, new evidence has emerged that raises the level of uncertainty regarding several key questions the panel addressed, Dr. Robert Sidbury observed at the annual meeting of the Society for Pediatric Dermatology. Among these questions: To bathe or not to bathe? Will a child outgrow atopic dermatitis?

©aniaostudio/thinkstockphotos.com

Serving as cochair of the guidelines committee was both a reassuring and daunting experience, according to Dr. Sidbury, chief of the division of dermatology at Seattle Children’s Hospital.

It was reassuring to note that the committee members, who included 17 atopic dermatitis experts from three countries, were free from financial conflicts as they sifted through the published data for evidence-based recommendations to inform practice. But it was daunting to learn how sketchy the supporting evidence is for some of the conventional wisdom regarding atopic dermatitis management, he explained.

By way of providing what he called "a peek behind the curtains" of the guidelines-development process, Dr. Sidbury highlighted the issue of daily bathing followed by application of emollients and moisturizers. This was among the topics the panel struggled with the most, which might come as a surprise to outsiders who consider this to be standard practice, he noted.

"It seems like a very straightforward thing. Almost everyone in this room, to a person, recommends a daily bath followed by moisturizers, yet when we examined the studies we realized that recommendation isn’t based upon much evidence," he said.

Thus, the panel concluded that bathing is "suggested" for atopic dermatitis patients, while adding that "there is no standard" for the duration or frequency of bathing. The panel rated the strength of their recommendation as C, and the level of evidence as III.

"That’s a fairly weak recommendation based upon fairly week evidence," Dr. Sidbury commented.

Moreover, since publication of the guidelines, two new studies have come forth that address the question of whether bathing plus moisturizers is beneficial in atopic dermatitis. The results conflict with each other, making recommendations even more difficult.

Data from a retrospective study of 75 patients with moderate or severe atopic dermatitis suggested that a daily 15- to 20-minute bath followed by a mid-potency topical steroid and moisturizer was indeed beneficial: 79% of subjects showed marked improvement based on Investigator’s Global Assessment at week 3, and 4% were clear (Dermatitis 2014;25:56-9).

By contrast, data from a prospective trial in which 28 children with atopic dermatitis were randomized to a daily vs. twice-weekly bath followed by appropriate care indicated that, while hydration with emollients was important, bathing frequency wasn’t (Clin. Pediatr. 2014;53:677-81).

"This paper makes me feel better about the guidelines not saying, ‘You should bathe every day,’ although that’s still my own recommendation to patients," Dr. Sidbury said.

This year also has brought two conflicting studies regarding the natural history of atopic dermatitis. A large national Taiwanese population-based cohort study of children diagnosed with atopic dermatitis within the first 2 years of life and followed from birth to age 10 years concluded that 70% of these early-onset patients eventually went into remission. A total of 19% of patients did so within the first year, and 49% in less than 4 years. The median disease duration was 4.2 years (Br. J. Dermatol. 2014;170:130-5).

On the other hand, a report from the 7,157-patient, cross-sectional, longitudinal Pediatric Eczema Elective Registry (PEER) found that by age 20, only 50% of the patients had experienced at least one symptom-free period lasting 6 months or more. The investigators concluded that atopic dermatitis is probably a lifelong disease (JAMA Dermatology 2014;150:593-600).

"That’s a provocative conclusion, and a tough thing to tell a parent," Dr. Sidbury observed. "I offer parents realistic but optimistic counsel. I tell them the tendency toward xerosis, irritancy, and infection will persist – the patient in front of you is never going to want to wear a wool sweater for the rest of their life. But the incessant itch, the need for treatment, the impact on quality of life – which is really the issue at hand – hopefully will not persist."

Since the release earlier this year of the first three of the four sections of the atopic dermatitis guidelines, Dr. Sidbury and the other panelists have received considerable feedback that the guidelines didn’t adequately address the topic of topical steroid addiction.

"Some say we missed the boat in not making coherent recommendations to parents about it. We got some very pointed comments," he conceded.

He noted that a systematic review presented at last year’s International Symposium on Atopic Dermatitis concluded that topical steroid withdrawal is a real phenomenon distinct from other topical steroid side effects. It comes in two rosacea-like variants: an erythroedematous form and a papulopustular form. An atopic dermatitis patient’s report of a burning sensation upon cessation of topical steroid therapy is a red flag.

Despite the occasional missed opportunity in drawing up the first AAD atopic guidelines in 10 years, the process was richly rewarding, Dr. Sidbury said. And although experts will continue to debate the unresolved controversies in atopic dermatitis, for him the most important lesson to emerge from the panel’s comprehensive review of the evidence was strikingly clear: "Time and time again, education trumps all. Education of patients and families leads to the best outcomes. I think that’s an important lesson to take home," he said.

Dr. Sidbury had no financial conflicts to disclose.

bjancin@frontlinemedcom.com

COEUR D’ALENE, IDAHO – The 2014 American Academy of Dermatology atopic dermatitis guidelines may already need an update, according to the cochair of the guidelines panel.

The guidelines were based upon studies published through 2012. Since then, new evidence has emerged that raises the level of uncertainty regarding several key questions the panel addressed, Dr. Robert Sidbury observed at the annual meeting of the Society for Pediatric Dermatology. Among these questions: To bathe or not to bathe? Will a child outgrow atopic dermatitis?

©aniaostudio/thinkstockphotos.com

Serving as cochair of the guidelines committee was both a reassuring and daunting experience, according to Dr. Sidbury, chief of the division of dermatology at Seattle Children’s Hospital.

It was reassuring to note that the committee members, who included 17 atopic dermatitis experts from three countries, were free from financial conflicts as they sifted through the published data for evidence-based recommendations to inform practice. But it was daunting to learn how sketchy the supporting evidence is for some of the conventional wisdom regarding atopic dermatitis management, he explained.

By way of providing what he called "a peek behind the curtains" of the guidelines-development process, Dr. Sidbury highlighted the issue of daily bathing followed by application of emollients and moisturizers. This was among the topics the panel struggled with the most, which might come as a surprise to outsiders who consider this to be standard practice, he noted.

"It seems like a very straightforward thing. Almost everyone in this room, to a person, recommends a daily bath followed by moisturizers, yet when we examined the studies we realized that recommendation isn’t based upon much evidence," he said.

Thus, the panel concluded that bathing is "suggested" for atopic dermatitis patients, while adding that "there is no standard" for the duration or frequency of bathing. The panel rated the strength of their recommendation as C, and the level of evidence as III.

"That’s a fairly weak recommendation based upon fairly week evidence," Dr. Sidbury commented.

Moreover, since publication of the guidelines, two new studies have come forth that address the question of whether bathing plus moisturizers is beneficial in atopic dermatitis. The results conflict with each other, making recommendations even more difficult.

Data from a retrospective study of 75 patients with moderate or severe atopic dermatitis suggested that a daily 15- to 20-minute bath followed by a mid-potency topical steroid and moisturizer was indeed beneficial: 79% of subjects showed marked improvement based on Investigator’s Global Assessment at week 3, and 4% were clear (Dermatitis 2014;25:56-9).

By contrast, data from a prospective trial in which 28 children with atopic dermatitis were randomized to a daily vs. twice-weekly bath followed by appropriate care indicated that, while hydration with emollients was important, bathing frequency wasn’t (Clin. Pediatr. 2014;53:677-81).

"This paper makes me feel better about the guidelines not saying, ‘You should bathe every day,’ although that’s still my own recommendation to patients," Dr. Sidbury said.

This year also has brought two conflicting studies regarding the natural history of atopic dermatitis. A large national Taiwanese population-based cohort study of children diagnosed with atopic dermatitis within the first 2 years of life and followed from birth to age 10 years concluded that 70% of these early-onset patients eventually went into remission. A total of 19% of patients did so within the first year, and 49% in less than 4 years. The median disease duration was 4.2 years (Br. J. Dermatol. 2014;170:130-5).

On the other hand, a report from the 7,157-patient, cross-sectional, longitudinal Pediatric Eczema Elective Registry (PEER) found that by age 20, only 50% of the patients had experienced at least one symptom-free period lasting 6 months or more. The investigators concluded that atopic dermatitis is probably a lifelong disease (JAMA Dermatology 2014;150:593-600).

"That’s a provocative conclusion, and a tough thing to tell a parent," Dr. Sidbury observed. "I offer parents realistic but optimistic counsel. I tell them the tendency toward xerosis, irritancy, and infection will persist – the patient in front of you is never going to want to wear a wool sweater for the rest of their life. But the incessant itch, the need for treatment, the impact on quality of life – which is really the issue at hand – hopefully will not persist."

Since the release earlier this year of the first three of the four sections of the atopic dermatitis guidelines, Dr. Sidbury and the other panelists have received considerable feedback that the guidelines didn’t adequately address the topic of topical steroid addiction.

"Some say we missed the boat in not making coherent recommendations to parents about it. We got some very pointed comments," he conceded.

He noted that a systematic review presented at last year’s International Symposium on Atopic Dermatitis concluded that topical steroid withdrawal is a real phenomenon distinct from other topical steroid side effects. It comes in two rosacea-like variants: an erythroedematous form and a papulopustular form. An atopic dermatitis patient’s report of a burning sensation upon cessation of topical steroid therapy is a red flag.

Despite the occasional missed opportunity in drawing up the first AAD atopic guidelines in 10 years, the process was richly rewarding, Dr. Sidbury said. And although experts will continue to debate the unresolved controversies in atopic dermatitis, for him the most important lesson to emerge from the panel’s comprehensive review of the evidence was strikingly clear: "Time and time again, education trumps all. Education of patients and families leads to the best outcomes. I think that’s an important lesson to take home," he said.

Dr. Sidbury had no financial conflicts to disclose.

bjancin@frontlinemedcom.com

COEUR D’ALENE, IDAHO – The 2014 American Academy of Dermatology atopic dermatitis guidelines may already need an update, according to the cochair of the guidelines panel.

The guidelines were based upon studies published through 2012. Since then, new evidence has emerged that raises the level of uncertainty regarding several key questions the panel addressed, Dr. Robert Sidbury observed at the annual meeting of the Society for Pediatric Dermatology. Among these questions: To bathe or not to bathe? Will a child outgrow atopic dermatitis?

©aniaostudio/thinkstockphotos.com

Serving as cochair of the guidelines committee was both a reassuring and daunting experience, according to Dr. Sidbury, chief of the division of dermatology at Seattle Children’s Hospital.

It was reassuring to note that the committee members, who included 17 atopic dermatitis experts from three countries, were free from financial conflicts as they sifted through the published data for evidence-based recommendations to inform practice. But it was daunting to learn how sketchy the supporting evidence is for some of the conventional wisdom regarding atopic dermatitis management, he explained.

By way of providing what he called "a peek behind the curtains" of the guidelines-development process, Dr. Sidbury highlighted the issue of daily bathing followed by application of emollients and moisturizers. This was among the topics the panel struggled with the most, which might come as a surprise to outsiders who consider this to be standard practice, he noted.

"It seems like a very straightforward thing. Almost everyone in this room, to a person, recommends a daily bath followed by moisturizers, yet when we examined the studies we realized that recommendation isn’t based upon much evidence," he said.

Thus, the panel concluded that bathing is "suggested" for atopic dermatitis patients, while adding that "there is no standard" for the duration or frequency of bathing. The panel rated the strength of their recommendation as C, and the level of evidence as III.

"That’s a fairly weak recommendation based upon fairly week evidence," Dr. Sidbury commented.

Moreover, since publication of the guidelines, two new studies have come forth that address the question of whether bathing plus moisturizers is beneficial in atopic dermatitis. The results conflict with each other, making recommendations even more difficult.

Data from a retrospective study of 75 patients with moderate or severe atopic dermatitis suggested that a daily 15- to 20-minute bath followed by a mid-potency topical steroid and moisturizer was indeed beneficial: 79% of subjects showed marked improvement based on Investigator’s Global Assessment at week 3, and 4% were clear (Dermatitis 2014;25:56-9).

By contrast, data from a prospective trial in which 28 children with atopic dermatitis were randomized to a daily vs. twice-weekly bath followed by appropriate care indicated that, while hydration with emollients was important, bathing frequency wasn’t (Clin. Pediatr. 2014;53:677-81).

"This paper makes me feel better about the guidelines not saying, ‘You should bathe every day,’ although that’s still my own recommendation to patients," Dr. Sidbury said.

This year also has brought two conflicting studies regarding the natural history of atopic dermatitis. A large national Taiwanese population-based cohort study of children diagnosed with atopic dermatitis within the first 2 years of life and followed from birth to age 10 years concluded that 70% of these early-onset patients eventually went into remission. A total of 19% of patients did so within the first year, and 49% in less than 4 years. The median disease duration was 4.2 years (Br. J. Dermatol. 2014;170:130-5).

On the other hand, a report from the 7,157-patient, cross-sectional, longitudinal Pediatric Eczema Elective Registry (PEER) found that by age 20, only 50% of the patients had experienced at least one symptom-free period lasting 6 months or more. The investigators concluded that atopic dermatitis is probably a lifelong disease (JAMA Dermatology 2014;150:593-600).

"That’s a provocative conclusion, and a tough thing to tell a parent," Dr. Sidbury observed. "I offer parents realistic but optimistic counsel. I tell them the tendency toward xerosis, irritancy, and infection will persist – the patient in front of you is never going to want to wear a wool sweater for the rest of their life. But the incessant itch, the need for treatment, the impact on quality of life – which is really the issue at hand – hopefully will not persist."

Since the release earlier this year of the first three of the four sections of the atopic dermatitis guidelines, Dr. Sidbury and the other panelists have received considerable feedback that the guidelines didn’t adequately address the topic of topical steroid addiction.

"Some say we missed the boat in not making coherent recommendations to parents about it. We got some very pointed comments," he conceded.

He noted that a systematic review presented at last year’s International Symposium on Atopic Dermatitis concluded that topical steroid withdrawal is a real phenomenon distinct from other topical steroid side effects. It comes in two rosacea-like variants: an erythroedematous form and a papulopustular form. An atopic dermatitis patient’s report of a burning sensation upon cessation of topical steroid therapy is a red flag.

Despite the occasional missed opportunity in drawing up the first AAD atopic guidelines in 10 years, the process was richly rewarding, Dr. Sidbury said. And although experts will continue to debate the unresolved controversies in atopic dermatitis, for him the most important lesson to emerge from the panel’s comprehensive review of the evidence was strikingly clear: "Time and time again, education trumps all. Education of patients and families leads to the best outcomes. I think that’s an important lesson to take home," he said.

Dr. Sidbury had no financial conflicts to disclose.

bjancin@frontlinemedcom.com

NEW YORK – A consensus group has developed evidence-based treatment recommendations for patients with psoriatic arthritis and nail involvement and raised the possibility of issuing them independent of recommendations for the skin, according to a report on the deliberations.

"The suggestion has been made to separate out skin from nail because the assessment is quite different to the point where you can potentially have patients with severe nail disease but limited skin disease," reported Dr. April W. Armstrong, director of the psoriasis program at the University of Colorado, Denver.

The proposal was made in the course of presenting the preliminary evidence-based recommendations on managing psoriatic arthritis (PsA) nail involvement to the full membership of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. GRAPPA is in the process of preparing a new set of PsA treatment recommendations.

The decision to address nails separately from skin was not a unanimous recommendation within the committee, and no conclusion was reached, but Dr. Armstrong brought the issue forward "to be clear about our ambiguity" regarding this specific aspect of how to best outline treatment options useful to clinicians.

Other recommendations, based on evidence, are more assured of making the final version, because they are evidence based. When presented at GRAPPA, which convened its most recent annual meeting jointly with the Spondyloarthritis Research & Treatment Network, each recommendation was graded for the quality of the evidence and strength of the consensus.

For example, the committee found little controlled evidence to support a significant benefit from topical therapies, including those commonly used, such as steroids and vitamin D analogs. Although the consensus committee concluded that the risk of adverse events is low and the costs are low to moderate, the efficacy is only modest. The strength for recommending topical therapies overall was characterized as "weak."

For procedural therapies, such as pulsed-dye laser or intralesional injections, no placebo-controlled trials could be identified by the committee, and the expert opinion of its members was that the efficacy is relatively low in general even if benefit is achieved in some individuals. The cost was characterized as low to moderate. The committee concluded that only a "weak" recommendation should be conferred to these types of interventions for nail involvement.

The proposed recommendation for oral therapies, such a methotrexate, cyclosporine, leflunomide, and acitretin, was considered "stronger than that for topical therapies" when nail involvement is moderate, but the committee also found supportive evidence of benefit to be of "low quality." Again, although recognizing that some PsA patients may benefit, the recommendation for oral therapies overall for nail involvement was characterized as weak.

For biologics, including both tumor necrosis factor (TNF) inhibitors and the interleukin 12/23 inhibitor ustekinumab, the consensus committee reported that there are good quality data showing efficacy in nails, including some studies showing superiority of TNF inhibitors to methotrexate and cyclosporine. For patients with moderate to severe nail involvement warranting the potential risks of these therapies, the preliminary recommendation for these agents was "strong" even if the costs of these therapies were characterized as "high to crazy."

One unresolved issue, however, is which strategy to recommend for placing nail involvement into "mild," "moderate," or "severe" categories. Objective scores, such as Nail Psoriasis Severity Index (NAPSI), were considered by the consensus committee to be helpful but insufficient.

"Perhaps in addition to objective scoring of nail disease, we should also take into account [the impact] on quality of life as well as function," Dr. Armstrong said.

The final GRAPPA treatment recommendations for nail involvement, as well as other aspects of PsA management, will be made after a discussion of the consensus group proposals over the next several months, followed by voting among the GRAPPA membership. As GRAPPA is an international organization, it is intended that final recommendations will be broadly applicable.

Dr. Armstrong reported financial relationships with AbbVie, Amgen, Janssen Biotech, Merck, Novartis, and Pfizer.

NEW YORK – A consensus group has developed evidence-based treatment recommendations for patients with psoriatic arthritis and nail involvement and raised the possibility of issuing them independent of recommendations for the skin, according to a report on the deliberations.

"The suggestion has been made to separate out skin from nail because the assessment is quite different to the point where you can potentially have patients with severe nail disease but limited skin disease," reported Dr. April W. Armstrong, director of the psoriasis program at the University of Colorado, Denver.

The proposal was made in the course of presenting the preliminary evidence-based recommendations on managing psoriatic arthritis (PsA) nail involvement to the full membership of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. GRAPPA is in the process of preparing a new set of PsA treatment recommendations.

The decision to address nails separately from skin was not a unanimous recommendation within the committee, and no conclusion was reached, but Dr. Armstrong brought the issue forward "to be clear about our ambiguity" regarding this specific aspect of how to best outline treatment options useful to clinicians.

Other recommendations, based on evidence, are more assured of making the final version, because they are evidence based. When presented at GRAPPA, which convened its most recent annual meeting jointly with the Spondyloarthritis Research & Treatment Network, each recommendation was graded for the quality of the evidence and strength of the consensus.

For example, the committee found little controlled evidence to support a significant benefit from topical therapies, including those commonly used, such as steroids and vitamin D analogs. Although the consensus committee concluded that the risk of adverse events is low and the costs are low to moderate, the efficacy is only modest. The strength for recommending topical therapies overall was characterized as "weak."

For procedural therapies, such as pulsed-dye laser or intralesional injections, no placebo-controlled trials could be identified by the committee, and the expert opinion of its members was that the efficacy is relatively low in general even if benefit is achieved in some individuals. The cost was characterized as low to moderate. The committee concluded that only a "weak" recommendation should be conferred to these types of interventions for nail involvement.

The proposed recommendation for oral therapies, such a methotrexate, cyclosporine, leflunomide, and acitretin, was considered "stronger than that for topical therapies" when nail involvement is moderate, but the committee also found supportive evidence of benefit to be of "low quality." Again, although recognizing that some PsA patients may benefit, the recommendation for oral therapies overall for nail involvement was characterized as weak.

For biologics, including both tumor necrosis factor (TNF) inhibitors and the interleukin 12/23 inhibitor ustekinumab, the consensus committee reported that there are good quality data showing efficacy in nails, including some studies showing superiority of TNF inhibitors to methotrexate and cyclosporine. For patients with moderate to severe nail involvement warranting the potential risks of these therapies, the preliminary recommendation for these agents was "strong" even if the costs of these therapies were characterized as "high to crazy."

One unresolved issue, however, is which strategy to recommend for placing nail involvement into "mild," "moderate," or "severe" categories. Objective scores, such as Nail Psoriasis Severity Index (NAPSI), were considered by the consensus committee to be helpful but insufficient.

"Perhaps in addition to objective scoring of nail disease, we should also take into account [the impact] on quality of life as well as function," Dr. Armstrong said.

The final GRAPPA treatment recommendations for nail involvement, as well as other aspects of PsA management, will be made after a discussion of the consensus group proposals over the next several months, followed by voting among the GRAPPA membership. As GRAPPA is an international organization, it is intended that final recommendations will be broadly applicable.

Dr. Armstrong reported financial relationships with AbbVie, Amgen, Janssen Biotech, Merck, Novartis, and Pfizer.

NEW YORK – A consensus group has developed evidence-based treatment recommendations for patients with psoriatic arthritis and nail involvement and raised the possibility of issuing them independent of recommendations for the skin, according to a report on the deliberations.

"The suggestion has been made to separate out skin from nail because the assessment is quite different to the point where you can potentially have patients with severe nail disease but limited skin disease," reported Dr. April W. Armstrong, director of the psoriasis program at the University of Colorado, Denver.

The proposal was made in the course of presenting the preliminary evidence-based recommendations on managing psoriatic arthritis (PsA) nail involvement to the full membership of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. GRAPPA is in the process of preparing a new set of PsA treatment recommendations.

The decision to address nails separately from skin was not a unanimous recommendation within the committee, and no conclusion was reached, but Dr. Armstrong brought the issue forward "to be clear about our ambiguity" regarding this specific aspect of how to best outline treatment options useful to clinicians.

Other recommendations, based on evidence, are more assured of making the final version, because they are evidence based. When presented at GRAPPA, which convened its most recent annual meeting jointly with the Spondyloarthritis Research & Treatment Network, each recommendation was graded for the quality of the evidence and strength of the consensus.

For example, the committee found little controlled evidence to support a significant benefit from topical therapies, including those commonly used, such as steroids and vitamin D analogs. Although the consensus committee concluded that the risk of adverse events is low and the costs are low to moderate, the efficacy is only modest. The strength for recommending topical therapies overall was characterized as "weak."

For procedural therapies, such as pulsed-dye laser or intralesional injections, no placebo-controlled trials could be identified by the committee, and the expert opinion of its members was that the efficacy is relatively low in general even if benefit is achieved in some individuals. The cost was characterized as low to moderate. The committee concluded that only a "weak" recommendation should be conferred to these types of interventions for nail involvement.

The proposed recommendation for oral therapies, such a methotrexate, cyclosporine, leflunomide, and acitretin, was considered "stronger than that for topical therapies" when nail involvement is moderate, but the committee also found supportive evidence of benefit to be of "low quality." Again, although recognizing that some PsA patients may benefit, the recommendation for oral therapies overall for nail involvement was characterized as weak.

For biologics, including both tumor necrosis factor (TNF) inhibitors and the interleukin 12/23 inhibitor ustekinumab, the consensus committee reported that there are good quality data showing efficacy in nails, including some studies showing superiority of TNF inhibitors to methotrexate and cyclosporine. For patients with moderate to severe nail involvement warranting the potential risks of these therapies, the preliminary recommendation for these agents was "strong" even if the costs of these therapies were characterized as "high to crazy."

One unresolved issue, however, is which strategy to recommend for placing nail involvement into "mild," "moderate," or "severe" categories. Objective scores, such as Nail Psoriasis Severity Index (NAPSI), were considered by the consensus committee to be helpful but insufficient.

"Perhaps in addition to objective scoring of nail disease, we should also take into account [the impact] on quality of life as well as function," Dr. Armstrong said.

The final GRAPPA treatment recommendations for nail involvement, as well as other aspects of PsA management, will be made after a discussion of the consensus group proposals over the next several months, followed by voting among the GRAPPA membership. As GRAPPA is an international organization, it is intended that final recommendations will be broadly applicable.

Dr. Armstrong reported financial relationships with AbbVie, Amgen, Janssen Biotech, Merck, Novartis, and Pfizer.

NEW YORK – For the first time, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis is preparing evidence-based treatment recommendations for the diagnosis and management of the comorbidities associated with psoriatic arthritis.

"I am really excited that we are taking the initiative to treat and manage the psoriatic arthritis [PsA] patient as a whole," reported Dr. Elaine Husni, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. The guidelines are meant to be a "platform on which to raise awareness" and foster education.

An initial set of guidelines on comorbidities was drafted at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Dr. Husni led the consensus group and fielded questions about key recommendations.

The first of these recommendations, which will undergo a process of discussion and review prior to formal adoption, states that all patients with PsA should be evaluated for cardiovascular (CV) disease. The consensus group labeled this recommendation "strong" even while conferring it with grade D evidence.

"The grade D was based on the fact that there are no outcomes data specifically in patients with psoriatic arthritis," observed Dr. Alexis R. Ogdie-Beatty, director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia. A member of the consensus group, Dr. Ogdie-Beatty suggested that benefit from CV screening is still a reasonable expectation "given the growing evidence that patients with PsA are at increased risk."

Similar "strong" recommendations but grade D evidence were given for screening for ophthalmic complications and inflammatory bowel disease. In these cases, there is good evidence for an association with PsA but limited evidence that screening will lead to improved outcome. The exception was obesity for which the group gave a B rating to the evidence for benefit from diagnosis and treatment.

Screening for diabetes was also included among recommendations, but it was given a "weak" rating and a grade D for supportive evidence.

Most of the other recommendations involved screening for various infections, such as hepatitis C virus (HCV), HIV, and tuberculosis, prior to initiating immunosuppressant therapies, particularly biologics. The level of evidence for these recommendations typically ranged between B and C even though all were given strong recommendations.

The consensus recommendations are not expected to include much detail about the specific management of comorbidities. The reason is concern about their applicability across various settings of care. It was thought that GRAPPA, as an international organization, should accommodate different types of practice. For example, the group cautioned against outlining steps of CV risk management, which may be managed by rheumatologists in some areas of the world but by specialists in others.

"We want to stay away from being minicardiologists," Dr. Husni explained. She indicated that the goal of the recommendations is to simply identify the specific types of comorbidity screening that should be considered "core recommendations" in the approach to PsA.

However, there is interest in creating a table regarding the use of specific medications for PsA treatment in the context of comorbidities. In a color-coded draft presented at the GRAPPA and SPARTAN meeting, some examples included caution in the use of NSAIDs in patients with CV disease, a need for monitoring when using cyclosporine in patients with chronic kidney disease, and a preference for etanercept over other tumor necrosis factor inhibitors in patients with HCV infection.

Overall, recommendations for comorbidities were identified as an important step in defining optimal care for PsA. According to Dr. Ogdie-Beatty, "the most important point may be to raise awareness." As these recommendations wend their way through an approval process at the organizational level, Dr. Ogdie-Beatty expressed hope that the final wording is specific enough to encourage attention to comorbidities without restricting a variety of valid approaches.

Dr. Husni reported a financial relationship with Celgene. Dr. Ogdie-Beatty had no potential conflicts of interest to report.

NEW YORK – For the first time, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis is preparing evidence-based treatment recommendations for the diagnosis and management of the comorbidities associated with psoriatic arthritis.

"I am really excited that we are taking the initiative to treat and manage the psoriatic arthritis [PsA] patient as a whole," reported Dr. Elaine Husni, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. The guidelines are meant to be a "platform on which to raise awareness" and foster education.

An initial set of guidelines on comorbidities was drafted at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Dr. Husni led the consensus group and fielded questions about key recommendations.

The first of these recommendations, which will undergo a process of discussion and review prior to formal adoption, states that all patients with PsA should be evaluated for cardiovascular (CV) disease. The consensus group labeled this recommendation "strong" even while conferring it with grade D evidence.

"The grade D was based on the fact that there are no outcomes data specifically in patients with psoriatic arthritis," observed Dr. Alexis R. Ogdie-Beatty, director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia. A member of the consensus group, Dr. Ogdie-Beatty suggested that benefit from CV screening is still a reasonable expectation "given the growing evidence that patients with PsA are at increased risk."

Similar "strong" recommendations but grade D evidence were given for screening for ophthalmic complications and inflammatory bowel disease. In these cases, there is good evidence for an association with PsA but limited evidence that screening will lead to improved outcome. The exception was obesity for which the group gave a B rating to the evidence for benefit from diagnosis and treatment.

Screening for diabetes was also included among recommendations, but it was given a "weak" rating and a grade D for supportive evidence.

Most of the other recommendations involved screening for various infections, such as hepatitis C virus (HCV), HIV, and tuberculosis, prior to initiating immunosuppressant therapies, particularly biologics. The level of evidence for these recommendations typically ranged between B and C even though all were given strong recommendations.

The consensus recommendations are not expected to include much detail about the specific management of comorbidities. The reason is concern about their applicability across various settings of care. It was thought that GRAPPA, as an international organization, should accommodate different types of practice. For example, the group cautioned against outlining steps of CV risk management, which may be managed by rheumatologists in some areas of the world but by specialists in others.

"We want to stay away from being minicardiologists," Dr. Husni explained. She indicated that the goal of the recommendations is to simply identify the specific types of comorbidity screening that should be considered "core recommendations" in the approach to PsA.

However, there is interest in creating a table regarding the use of specific medications for PsA treatment in the context of comorbidities. In a color-coded draft presented at the GRAPPA and SPARTAN meeting, some examples included caution in the use of NSAIDs in patients with CV disease, a need for monitoring when using cyclosporine in patients with chronic kidney disease, and a preference for etanercept over other tumor necrosis factor inhibitors in patients with HCV infection.

Overall, recommendations for comorbidities were identified as an important step in defining optimal care for PsA. According to Dr. Ogdie-Beatty, "the most important point may be to raise awareness." As these recommendations wend their way through an approval process at the organizational level, Dr. Ogdie-Beatty expressed hope that the final wording is specific enough to encourage attention to comorbidities without restricting a variety of valid approaches.

Dr. Husni reported a financial relationship with Celgene. Dr. Ogdie-Beatty had no potential conflicts of interest to report.

NEW YORK – For the first time, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis is preparing evidence-based treatment recommendations for the diagnosis and management of the comorbidities associated with psoriatic arthritis.

"I am really excited that we are taking the initiative to treat and manage the psoriatic arthritis [PsA] patient as a whole," reported Dr. Elaine Husni, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. The guidelines are meant to be a "platform on which to raise awareness" and foster education.

An initial set of guidelines on comorbidities was drafted at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Dr. Husni led the consensus group and fielded questions about key recommendations.

The first of these recommendations, which will undergo a process of discussion and review prior to formal adoption, states that all patients with PsA should be evaluated for cardiovascular (CV) disease. The consensus group labeled this recommendation "strong" even while conferring it with grade D evidence.

"The grade D was based on the fact that there are no outcomes data specifically in patients with psoriatic arthritis," observed Dr. Alexis R. Ogdie-Beatty, director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia. A member of the consensus group, Dr. Ogdie-Beatty suggested that benefit from CV screening is still a reasonable expectation "given the growing evidence that patients with PsA are at increased risk."

Similar "strong" recommendations but grade D evidence were given for screening for ophthalmic complications and inflammatory bowel disease. In these cases, there is good evidence for an association with PsA but limited evidence that screening will lead to improved outcome. The exception was obesity for which the group gave a B rating to the evidence for benefit from diagnosis and treatment.

Screening for diabetes was also included among recommendations, but it was given a "weak" rating and a grade D for supportive evidence.

Most of the other recommendations involved screening for various infections, such as hepatitis C virus (HCV), HIV, and tuberculosis, prior to initiating immunosuppressant therapies, particularly biologics. The level of evidence for these recommendations typically ranged between B and C even though all were given strong recommendations.

The consensus recommendations are not expected to include much detail about the specific management of comorbidities. The reason is concern about their applicability across various settings of care. It was thought that GRAPPA, as an international organization, should accommodate different types of practice. For example, the group cautioned against outlining steps of CV risk management, which may be managed by rheumatologists in some areas of the world but by specialists in others.

"We want to stay away from being minicardiologists," Dr. Husni explained. She indicated that the goal of the recommendations is to simply identify the specific types of comorbidity screening that should be considered "core recommendations" in the approach to PsA.

However, there is interest in creating a table regarding the use of specific medications for PsA treatment in the context of comorbidities. In a color-coded draft presented at the GRAPPA and SPARTAN meeting, some examples included caution in the use of NSAIDs in patients with CV disease, a need for monitoring when using cyclosporine in patients with chronic kidney disease, and a preference for etanercept over other tumor necrosis factor inhibitors in patients with HCV infection.

Overall, recommendations for comorbidities were identified as an important step in defining optimal care for PsA. According to Dr. Ogdie-Beatty, "the most important point may be to raise awareness." As these recommendations wend their way through an approval process at the organizational level, Dr. Ogdie-Beatty expressed hope that the final wording is specific enough to encourage attention to comorbidities without restricting a variety of valid approaches.

Dr. Husni reported a financial relationship with Celgene. Dr. Ogdie-Beatty had no potential conflicts of interest to report.

The absolute 20-year survival benefit from contralateral prophylactic mastectomy stands at less than 1%, regardless of age, estrogen receptor status, and cancer stage, a decision analysis demonstrated.

"Long-term survival in women with unilateral breast cancer treated with or without CPM depends upon several factors, including mortality of the primary breast cancer, risk of CBC [contralateral breast cancer], stage and mortality of the CBC, and the individual patient’s overall life expectancy," wrote Dr. Pamela R. Portschy of the University of Minnesota, Minneapolis.

The report was published July 16 in the Journal of the National Cancer Institute.

"Prospective randomized trials comparing CPM with no CPM are not feasible. Retrospective studies evaluating a potential survival benefit with CPM are limited by short follow-up, potential selection bias, and lack of important clinical information," noted Dr. Portschy and her associates.

They limited their analysis to women with stage I and II breast cancer without BRCA mutations. They developed a Markov model to simulate survival outcomes among those who did and did not have contralateral prophylactic mastectomy (CPM), and they used published studies to estimate probabilities for developing CBC, dying from CBC, dying from primary breast cancer, and age-specific mortality rates. Data were extracted from numerous sources including Surveillance, Epidemiology, and End Results (SEER), the Early Breast Cancer Trialists’ Collaborative Group, and the Oregon State Cancer Registry.

The researchers estimated the 20-year overall survival and life expectancy, but not quality of life or cost, and their analysis considered variation in age, estrogen receptor status, and cancer stage (J. Natl. Cancer Inst. 2014 July 16 [doi:10.1093/jnci/dju160]).

The predicted life expectancy gain from CPM ranged from .13 to .59 years for women with stage I breast cancer, and .08 to .29 years for those with stage II breast cancer. CPM conferred a life expectancy benefit among younger women and among those who had stage I and estrogen receptor–positive disease. "The potential benefit of CPM was consistently lower for patients with stage II breast cancer because of the worse prognosis associated with the primary breast cancer," the researchers wrote. "Similarly, the potential benefits of CPM are more modest for older women because they have relatively fewer years remaining of [life expectancy]."

Dr. Portschy and her associates could not identify any cohort of women that had a greater than 1% absolute survival difference at 20 years. In fact, the predicted 20-year survival differences ranged from .56 to .94% for women with stage I breast cancer and .36 to .61% for those with stage II breast cancer.

The researchers acknowledged limitations of the study, including the fact that the results "do not apply to BRCA gene mutation carriers with unilateral breast cancer who have a cumulative 10-year risk of CBC of approximately 30% to 40%," they wrote. "The outcomes of this analysis were limited to overall and disease-specific survival; we did not evaluate other important outcomes such as surgical complications and quality of life. Also, we assumed the mortality of CBC was the same as the mortality of the index cancer reported by SEER."

They also noted that survival is not the only potential benefit of a cancer risk reduction strategy. "Effects on cancer-related anxiety, cosmesis, and self-image are also important in the decision-making process," they wrote. "For some women, the negative impact of CPM on quality of life may outweigh a potential survival benefit. For others who are very anxious about CBC, CPM may result in a psychological benefit even if survival benefits are minimal."

They concluded that the survival estimates from their Markov model "may be useful for physicians and breast cancer patients to arrive at evidence-based informed decisions regarding CPM. Moreover, the use of accurate and easily understood decision aids may reverse some of the mastectomy trends recently observed in the United States."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The absolute 20-year survival benefit from contralateral prophylactic mastectomy stands at less than 1%, regardless of age, estrogen receptor status, and cancer stage, a decision analysis demonstrated.

"Long-term survival in women with unilateral breast cancer treated with or without CPM depends upon several factors, including mortality of the primary breast cancer, risk of CBC [contralateral breast cancer], stage and mortality of the CBC, and the individual patient’s overall life expectancy," wrote Dr. Pamela R. Portschy of the University of Minnesota, Minneapolis.

The report was published July 16 in the Journal of the National Cancer Institute.

"Prospective randomized trials comparing CPM with no CPM are not feasible. Retrospective studies evaluating a potential survival benefit with CPM are limited by short follow-up, potential selection bias, and lack of important clinical information," noted Dr. Portschy and her associates.

They limited their analysis to women with stage I and II breast cancer without BRCA mutations. They developed a Markov model to simulate survival outcomes among those who did and did not have contralateral prophylactic mastectomy (CPM), and they used published studies to estimate probabilities for developing CBC, dying from CBC, dying from primary breast cancer, and age-specific mortality rates. Data were extracted from numerous sources including Surveillance, Epidemiology, and End Results (SEER), the Early Breast Cancer Trialists’ Collaborative Group, and the Oregon State Cancer Registry.

The researchers estimated the 20-year overall survival and life expectancy, but not quality of life or cost, and their analysis considered variation in age, estrogen receptor status, and cancer stage (J. Natl. Cancer Inst. 2014 July 16 [doi:10.1093/jnci/dju160]).

The predicted life expectancy gain from CPM ranged from .13 to .59 years for women with stage I breast cancer, and .08 to .29 years for those with stage II breast cancer. CPM conferred a life expectancy benefit among younger women and among those who had stage I and estrogen receptor–positive disease. "The potential benefit of CPM was consistently lower for patients with stage II breast cancer because of the worse prognosis associated with the primary breast cancer," the researchers wrote. "Similarly, the potential benefits of CPM are more modest for older women because they have relatively fewer years remaining of [life expectancy]."

Dr. Portschy and her associates could not identify any cohort of women that had a greater than 1% absolute survival difference at 20 years. In fact, the predicted 20-year survival differences ranged from .56 to .94% for women with stage I breast cancer and .36 to .61% for those with stage II breast cancer.

The researchers acknowledged limitations of the study, including the fact that the results "do not apply to BRCA gene mutation carriers with unilateral breast cancer who have a cumulative 10-year risk of CBC of approximately 30% to 40%," they wrote. "The outcomes of this analysis were limited to overall and disease-specific survival; we did not evaluate other important outcomes such as surgical complications and quality of life. Also, we assumed the mortality of CBC was the same as the mortality of the index cancer reported by SEER."

They also noted that survival is not the only potential benefit of a cancer risk reduction strategy. "Effects on cancer-related anxiety, cosmesis, and self-image are also important in the decision-making process," they wrote. "For some women, the negative impact of CPM on quality of life may outweigh a potential survival benefit. For others who are very anxious about CBC, CPM may result in a psychological benefit even if survival benefits are minimal."

They concluded that the survival estimates from their Markov model "may be useful for physicians and breast cancer patients to arrive at evidence-based informed decisions regarding CPM. Moreover, the use of accurate and easily understood decision aids may reverse some of the mastectomy trends recently observed in the United States."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The absolute 20-year survival benefit from contralateral prophylactic mastectomy stands at less than 1%, regardless of age, estrogen receptor status, and cancer stage, a decision analysis demonstrated.

"Long-term survival in women with unilateral breast cancer treated with or without CPM depends upon several factors, including mortality of the primary breast cancer, risk of CBC [contralateral breast cancer], stage and mortality of the CBC, and the individual patient’s overall life expectancy," wrote Dr. Pamela R. Portschy of the University of Minnesota, Minneapolis.

The report was published July 16 in the Journal of the National Cancer Institute.

"Prospective randomized trials comparing CPM with no CPM are not feasible. Retrospective studies evaluating a potential survival benefit with CPM are limited by short follow-up, potential selection bias, and lack of important clinical information," noted Dr. Portschy and her associates.

They limited their analysis to women with stage I and II breast cancer without BRCA mutations. They developed a Markov model to simulate survival outcomes among those who did and did not have contralateral prophylactic mastectomy (CPM), and they used published studies to estimate probabilities for developing CBC, dying from CBC, dying from primary breast cancer, and age-specific mortality rates. Data were extracted from numerous sources including Surveillance, Epidemiology, and End Results (SEER), the Early Breast Cancer Trialists’ Collaborative Group, and the Oregon State Cancer Registry.

The researchers estimated the 20-year overall survival and life expectancy, but not quality of life or cost, and their analysis considered variation in age, estrogen receptor status, and cancer stage (J. Natl. Cancer Inst. 2014 July 16 [doi:10.1093/jnci/dju160]).

The predicted life expectancy gain from CPM ranged from .13 to .59 years for women with stage I breast cancer, and .08 to .29 years for those with stage II breast cancer. CPM conferred a life expectancy benefit among younger women and among those who had stage I and estrogen receptor–positive disease. "The potential benefit of CPM was consistently lower for patients with stage II breast cancer because of the worse prognosis associated with the primary breast cancer," the researchers wrote. "Similarly, the potential benefits of CPM are more modest for older women because they have relatively fewer years remaining of [life expectancy]."

Dr. Portschy and her associates could not identify any cohort of women that had a greater than 1% absolute survival difference at 20 years. In fact, the predicted 20-year survival differences ranged from .56 to .94% for women with stage I breast cancer and .36 to .61% for those with stage II breast cancer.

The researchers acknowledged limitations of the study, including the fact that the results "do not apply to BRCA gene mutation carriers with unilateral breast cancer who have a cumulative 10-year risk of CBC of approximately 30% to 40%," they wrote. "The outcomes of this analysis were limited to overall and disease-specific survival; we did not evaluate other important outcomes such as surgical complications and quality of life. Also, we assumed the mortality of CBC was the same as the mortality of the index cancer reported by SEER."

They also noted that survival is not the only potential benefit of a cancer risk reduction strategy. "Effects on cancer-related anxiety, cosmesis, and self-image are also important in the decision-making process," they wrote. "For some women, the negative impact of CPM on quality of life may outweigh a potential survival benefit. For others who are very anxious about CBC, CPM may result in a psychological benefit even if survival benefits are minimal."

They concluded that the survival estimates from their Markov model "may be useful for physicians and breast cancer patients to arrive at evidence-based informed decisions regarding CPM. Moreover, the use of accurate and easily understood decision aids may reverse some of the mastectomy trends recently observed in the United States."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The new pelvic exam guidelines from the American College of Physicians may be a relief for women who would prefer to forgo the annual ritual, but they could also lead to variation in well-woman care, depending on which type of specialist provides that care.

The guidelines advise physicians to skip annual pelvic examinations in otherwise healthy, asymptomatic women who are not pregnant (Ann. Intern. Med. 2014;161:67-72).

The evidence-based clinical practice guidelines recommend that cervical cancer screening be limited to the visual inspection of the cervix and cervical swabs for cancer and human papillomavirus. They recommend against performing a speculum examination of the vagina and cervix, and a bimanual examination of the adnexa, uterus, ovaries, and bladder. The recommendation does not apply to using the Pap smear to screen for cervical cancer.

The diagnostic accuracy of the pelvic exam in detecting gynecologic cancer or infections is low, the ACP said, and carries the risk of false positives that can lead to unnecessary testing and procedures. The embarrassment and discomfort of the exam may also keep some women from seeking care, the ACP stated in the guidelines.

But that advice conflicts with an August 2012 policy statement from the American College of Obstetricians and Gynecologists, which recommends that pelvic exams be performed in asymptomatic adults as part of an annual well-woman visit. However, citing a lack of evidence, the opinion leaves the decision about when and how often to perform the exams in the hands of physicians and patients (Obstet. Gynecol. 2012;120:421-4).

Following the release of the ACP guidelines, ACOG issued a statement renewing its support for the pelvic exam, but saying that the ACOG policy was a "complement" to the new ACP recommendations. ACOG said that the use of the exam is "supported by the clinical experiences of gynecologists treating their patients."

It’s a position shared by Dr. Jill Rabin, professor of obstetrics and gynecology at Hofstra North Shore–LIJ School of Medicine and head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y. She currently performs a full pelvic exam during the well-woman visit and plans to continue doing so.

"I want every woman to get a full exam every year and whoever does it, they should do a good job," Dr. Rabin said.

She praised the ACP guideline, saying that she agreed that there was a lack of evidence and that the exams can create anxiety and embarrassment. But pelvic exams are also essential in uncovering conditions such as pelvic floor weakness, fibroids, and vulvovaginal atrophy, Dr. Rabin said. And the exam provides a unique opportunity for women to bring up concerns that they might not raise during a history taking, she said, such as symptoms of incontinence.

As for the lack of evidence, Dr. Rabin said researchers should begin those studies even if they take decades to provide complete answers.

"There’s a lot that we do in life where we don’t have the studies," she said. "But lack of the evidence doesn’t mean that there’s lack of value."

And Dr. Rabin isn’t alone in doing a full pelvic exam. A recent survey of ob.gyns. found that nearly all perform bimanual pelvic examinations in asymptomatic women for a variety of reasons including patient reassurance, detection of ovarian cancer, or identification of benign uterine and ovarian conditions (Am. J. Obstet. Gynecol. 2013;208:109.e1-7).

Dr. Molly Cooke, the ACP’s immediate past president and a member of the group’s Clinical Practice Guidelines Committee, said that for years she performed pelvic exams in asymptomatic patients mainly out of "habit," rather than evidence. But with the ACP’s new guidelines, she plans to change her approach.

Going forward, Dr. Cooke said she will discuss the utility of the pelvic exam with patients and explain that the evidence indicates that the bimanual exam does not produce meaningful information and could lead them astray. She said she expects that most patients will agree to forgo the pelvic exam when presented with the evidence.

As for ob.gyns. who may continue to perform pelvic exams routinely in asymptomatic patients, Dr. Cooke said that they are essentially making a "faith-based" assertion about the usefulness of the exam.

Dr. Cooke said the ACP recommendations are meant to apply to all clinicians who provide well-woman care. "We don’t see any reason why the guideline isn’t as useful and applicable to a nurse practitioner, a gynecologist, a family physician, and an internist," she said.

The new ACP guidelines are being well received by some internists and family physicians who are feeling the pressure to cram more and more preventive care into a short visit.

"You really have to think about the opportunity cost here," said Dr. Giang Nguyen of the Hospital of the University of Pennsylvania, Philadelphia.

"When we take those extra minutes out of a visit, which might only be 15 minutes long, you’re preventing the patient and the provider from using that time for things that we have strong evidence for, like counseling about weight management, talking about smoking cessation, reviewing other parts of their sexual history that maybe would be useful to talk about in order to prevent future illness," he added.

Given the shortage of primary care physicians, Dr. Nguyen said spending visit time on screenings that aren’t evidence based essentially reduces access to care.

The American Academy of Family Physicians doesn’t have a recommendation for or against performing screening pelvic exams. As part of the Choosing Wisely campaign, the AAFP issued a clinical recommendation against requiring a pelvic exam or other physical exam to prescribe oral contraceptives.

mschneider@frontlinemedcom.com

On Twitter @MaryEllenNY

The new pelvic exam guidelines from the American College of Physicians may be a relief for women who would prefer to forgo the annual ritual, but they could also lead to variation in well-woman care, depending on which type of specialist provides that care.

The guidelines advise physicians to skip annual pelvic examinations in otherwise healthy, asymptomatic women who are not pregnant (Ann. Intern. Med. 2014;161:67-72).

The evidence-based clinical practice guidelines recommend that cervical cancer screening be limited to the visual inspection of the cervix and cervical swabs for cancer and human papillomavirus. They recommend against performing a speculum examination of the vagina and cervix, and a bimanual examination of the adnexa, uterus, ovaries, and bladder. The recommendation does not apply to using the Pap smear to screen for cervical cancer.

The diagnostic accuracy of the pelvic exam in detecting gynecologic cancer or infections is low, the ACP said, and carries the risk of false positives that can lead to unnecessary testing and procedures. The embarrassment and discomfort of the exam may also keep some women from seeking care, the ACP stated in the guidelines.

But that advice conflicts with an August 2012 policy statement from the American College of Obstetricians and Gynecologists, which recommends that pelvic exams be performed in asymptomatic adults as part of an annual well-woman visit. However, citing a lack of evidence, the opinion leaves the decision about when and how often to perform the exams in the hands of physicians and patients (Obstet. Gynecol. 2012;120:421-4).

Following the release of the ACP guidelines, ACOG issued a statement renewing its support for the pelvic exam, but saying that the ACOG policy was a "complement" to the new ACP recommendations. ACOG said that the use of the exam is "supported by the clinical experiences of gynecologists treating their patients."

It’s a position shared by Dr. Jill Rabin, professor of obstetrics and gynecology at Hofstra North Shore–LIJ School of Medicine and head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y. She currently performs a full pelvic exam during the well-woman visit and plans to continue doing so.

"I want every woman to get a full exam every year and whoever does it, they should do a good job," Dr. Rabin said.

She praised the ACP guideline, saying that she agreed that there was a lack of evidence and that the exams can create anxiety and embarrassment. But pelvic exams are also essential in uncovering conditions such as pelvic floor weakness, fibroids, and vulvovaginal atrophy, Dr. Rabin said. And the exam provides a unique opportunity for women to bring up concerns that they might not raise during a history taking, she said, such as symptoms of incontinence.

As for the lack of evidence, Dr. Rabin said researchers should begin those studies even if they take decades to provide complete answers.

"There’s a lot that we do in life where we don’t have the studies," she said. "But lack of the evidence doesn’t mean that there’s lack of value."

And Dr. Rabin isn’t alone in doing a full pelvic exam. A recent survey of ob.gyns. found that nearly all perform bimanual pelvic examinations in asymptomatic women for a variety of reasons including patient reassurance, detection of ovarian cancer, or identification of benign uterine and ovarian conditions (Am. J. Obstet. Gynecol. 2013;208:109.e1-7).

Dr. Molly Cooke, the ACP’s immediate past president and a member of the group’s Clinical Practice Guidelines Committee, said that for years she performed pelvic exams in asymptomatic patients mainly out of "habit," rather than evidence. But with the ACP’s new guidelines, she plans to change her approach.

Going forward, Dr. Cooke said she will discuss the utility of the pelvic exam with patients and explain that the evidence indicates that the bimanual exam does not produce meaningful information and could lead them astray. She said she expects that most patients will agree to forgo the pelvic exam when presented with the evidence.

As for ob.gyns. who may continue to perform pelvic exams routinely in asymptomatic patients, Dr. Cooke said that they are essentially making a "faith-based" assertion about the usefulness of the exam.

Dr. Cooke said the ACP recommendations are meant to apply to all clinicians who provide well-woman care. "We don’t see any reason why the guideline isn’t as useful and applicable to a nurse practitioner, a gynecologist, a family physician, and an internist," she said.

The new ACP guidelines are being well received by some internists and family physicians who are feeling the pressure to cram more and more preventive care into a short visit.

"You really have to think about the opportunity cost here," said Dr. Giang Nguyen of the Hospital of the University of Pennsylvania, Philadelphia.

"When we take those extra minutes out of a visit, which might only be 15 minutes long, you’re preventing the patient and the provider from using that time for things that we have strong evidence for, like counseling about weight management, talking about smoking cessation, reviewing other parts of their sexual history that maybe would be useful to talk about in order to prevent future illness," he added.

Given the shortage of primary care physicians, Dr. Nguyen said spending visit time on screenings that aren’t evidence based essentially reduces access to care.

The American Academy of Family Physicians doesn’t have a recommendation for or against performing screening pelvic exams. As part of the Choosing Wisely campaign, the AAFP issued a clinical recommendation against requiring a pelvic exam or other physical exam to prescribe oral contraceptives.

mschneider@frontlinemedcom.com

On Twitter @MaryEllenNY

The new pelvic exam guidelines from the American College of Physicians may be a relief for women who would prefer to forgo the annual ritual, but they could also lead to variation in well-woman care, depending on which type of specialist provides that care.

The guidelines advise physicians to skip annual pelvic examinations in otherwise healthy, asymptomatic women who are not pregnant (Ann. Intern. Med. 2014;161:67-72).

The evidence-based clinical practice guidelines recommend that cervical cancer screening be limited to the visual inspection of the cervix and cervical swabs for cancer and human papillomavirus. They recommend against performing a speculum examination of the vagina and cervix, and a bimanual examination of the adnexa, uterus, ovaries, and bladder. The recommendation does not apply to using the Pap smear to screen for cervical cancer.

The diagnostic accuracy of the pelvic exam in detecting gynecologic cancer or infections is low, the ACP said, and carries the risk of false positives that can lead to unnecessary testing and procedures. The embarrassment and discomfort of the exam may also keep some women from seeking care, the ACP stated in the guidelines.

But that advice conflicts with an August 2012 policy statement from the American College of Obstetricians and Gynecologists, which recommends that pelvic exams be performed in asymptomatic adults as part of an annual well-woman visit. However, citing a lack of evidence, the opinion leaves the decision about when and how often to perform the exams in the hands of physicians and patients (Obstet. Gynecol. 2012;120:421-4).

Following the release of the ACP guidelines, ACOG issued a statement renewing its support for the pelvic exam, but saying that the ACOG policy was a "complement" to the new ACP recommendations. ACOG said that the use of the exam is "supported by the clinical experiences of gynecologists treating their patients."

It’s a position shared by Dr. Jill Rabin, professor of obstetrics and gynecology at Hofstra North Shore–LIJ School of Medicine and head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y. She currently performs a full pelvic exam during the well-woman visit and plans to continue doing so.

"I want every woman to get a full exam every year and whoever does it, they should do a good job," Dr. Rabin said.

She praised the ACP guideline, saying that she agreed that there was a lack of evidence and that the exams can create anxiety and embarrassment. But pelvic exams are also essential in uncovering conditions such as pelvic floor weakness, fibroids, and vulvovaginal atrophy, Dr. Rabin said. And the exam provides a unique opportunity for women to bring up concerns that they might not raise during a history taking, she said, such as symptoms of incontinence.

As for the lack of evidence, Dr. Rabin said researchers should begin those studies even if they take decades to provide complete answers.

"There’s a lot that we do in life where we don’t have the studies," she said. "But lack of the evidence doesn’t mean that there’s lack of value."

And Dr. Rabin isn’t alone in doing a full pelvic exam. A recent survey of ob.gyns. found that nearly all perform bimanual pelvic examinations in asymptomatic women for a variety of reasons including patient reassurance, detection of ovarian cancer, or identification of benign uterine and ovarian conditions (Am. J. Obstet. Gynecol. 2013;208:109.e1-7).

Dr. Molly Cooke, the ACP’s immediate past president and a member of the group’s Clinical Practice Guidelines Committee, said that for years she performed pelvic exams in asymptomatic patients mainly out of "habit," rather than evidence. But with the ACP’s new guidelines, she plans to change her approach.

Going forward, Dr. Cooke said she will discuss the utility of the pelvic exam with patients and explain that the evidence indicates that the bimanual exam does not produce meaningful information and could lead them astray. She said she expects that most patients will agree to forgo the pelvic exam when presented with the evidence.

As for ob.gyns. who may continue to perform pelvic exams routinely in asymptomatic patients, Dr. Cooke said that they are essentially making a "faith-based" assertion about the usefulness of the exam.

Dr. Cooke said the ACP recommendations are meant to apply to all clinicians who provide well-woman care. "We don’t see any reason why the guideline isn’t as useful and applicable to a nurse practitioner, a gynecologist, a family physician, and an internist," she said.

The new ACP guidelines are being well received by some internists and family physicians who are feeling the pressure to cram more and more preventive care into a short visit.

"You really have to think about the opportunity cost here," said Dr. Giang Nguyen of the Hospital of the University of Pennsylvania, Philadelphia.

"When we take those extra minutes out of a visit, which might only be 15 minutes long, you’re preventing the patient and the provider from using that time for things that we have strong evidence for, like counseling about weight management, talking about smoking cessation, reviewing other parts of their sexual history that maybe would be useful to talk about in order to prevent future illness," he added.

Given the shortage of primary care physicians, Dr. Nguyen said spending visit time on screenings that aren’t evidence based essentially reduces access to care.

The American Academy of Family Physicians doesn’t have a recommendation for or against performing screening pelvic exams. As part of the Choosing Wisely campaign, the AAFP issued a clinical recommendation against requiring a pelvic exam or other physical exam to prescribe oral contraceptives.

mschneider@frontlinemedcom.com

On Twitter @MaryEllenNY