Acne in women: What new insights tell us

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– When it comes to acne in adult women, look past the jawline, beyond traditional medications, and toward greater control. That’s the message of a dermatologist who spoke at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

Dr. Linda F. Stein Gold

“We should be aiming to get our patients to clear or almost clear, and we have the tools necessary to help that happen,” said Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital in Detroit.

Research suggests that acne is more common in adult women than in men, a gap that widens after age 29 years, she noted. Acne appears to affect 51% of women aged 20-29 years, she said, and prevalence dips to 15% in women older than 50 years.

About 80% of cases continue from adolescence, compared with about 20% that are new-onset during adulthood, she said. According to studies, she added, “most adult women have acne on multiple different areas of their face, not just the jawline. It’s similar to what we see in the adolescent population.”

Dr. Stein Gold offered these tips about treatment in this group of patients:
 

Inflammation

Researchers now consider that “all acne is inflammatory acne.” Be aggressive with anti-inflammatory treatment, and “continue even after the lesion is resolved” if needed to prevent scarring.

Oral contraceptives (OCs)

OCs can be helpful, but “we have to proceed with caution,” she said. A 2012 Cochrane Library review of 31 trials found that six combination OCs (COCs) “evaluated in placebo-controlled trials are effective in reducing inflammatory and noninflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne,” the review concluded (Cochrane Database Syst Rev. 2012 Jul 11;[7]:CD004425).

Results take time, however, and it “can take 3 months to see an effect, and 6 months for full effect,” Dr. Stein Gold noted.

There are multiple contraindications to the use of OCs, and they’ve been linked – controversially – to an increased risk of blood clots and breast cancer. However, risk of thrombosis also spikes – to significantly higher levels than with OC use – during pregnancy and the postpartum period, she said.
 

Spironolactone

This antihypertensive drug can be helpful, Dr. Stein Gold noted, although the one study in a 2009 Cochrane review that had acne as an outcome failed to find evidence of efficacy versus placebo (Cochrane Database Syst Rev. 2009 Apr 15;[2]:CD000194). Be aware of the boxed warning about links to cancer in rat studies, and consider the risk of potassium elevation in certain populations, she added. Watch the dose: fewer side effects are seen at 50-100 mg daily, although they’re still common, and it can take 3 months or more for improvements to appear, she said.

Truncal acne

Patients may be hesitant to mention they have acne on their chest and back. “They may not tell you about it, and you may not ask about it but [some patients] expect you to know about it and treat it,” Dr. Stein Gold said. She referred to trifarotene, a topical retinoid cream that, although not yet approved, appears to be safe and effective in treating acne on the face and trunk in phase 3 studies.

“Some people will say the trunk will get too irritated if you put a retinoid on it. But it absolutely can be used on the chest and back. The first thing I say to my patients is to expect to have redness and scaling for first 2 weeks. People pay money for that. It’s a chemical peel! It’s okay to have some sloughing; use an oil-free moisturizer.”

Dr. Stein Gold disclosed relationships with Galderma, Foamix, and Sol Gel (investigator, consultant); Valeant (consultant, speaker); and Dermira (investigator, speaker).

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

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– When it comes to acne in adult women, look past the jawline, beyond traditional medications, and toward greater control. That’s the message of a dermatologist who spoke at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

Dr. Linda F. Stein Gold

“We should be aiming to get our patients to clear or almost clear, and we have the tools necessary to help that happen,” said Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital in Detroit.

Research suggests that acne is more common in adult women than in men, a gap that widens after age 29 years, she noted. Acne appears to affect 51% of women aged 20-29 years, she said, and prevalence dips to 15% in women older than 50 years.

About 80% of cases continue from adolescence, compared with about 20% that are new-onset during adulthood, she said. According to studies, she added, “most adult women have acne on multiple different areas of their face, not just the jawline. It’s similar to what we see in the adolescent population.”

Dr. Stein Gold offered these tips about treatment in this group of patients:
 

Inflammation

Researchers now consider that “all acne is inflammatory acne.” Be aggressive with anti-inflammatory treatment, and “continue even after the lesion is resolved” if needed to prevent scarring.

Oral contraceptives (OCs)

OCs can be helpful, but “we have to proceed with caution,” she said. A 2012 Cochrane Library review of 31 trials found that six combination OCs (COCs) “evaluated in placebo-controlled trials are effective in reducing inflammatory and noninflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne,” the review concluded (Cochrane Database Syst Rev. 2012 Jul 11;[7]:CD004425).

Results take time, however, and it “can take 3 months to see an effect, and 6 months for full effect,” Dr. Stein Gold noted.

There are multiple contraindications to the use of OCs, and they’ve been linked – controversially – to an increased risk of blood clots and breast cancer. However, risk of thrombosis also spikes – to significantly higher levels than with OC use – during pregnancy and the postpartum period, she said.
 

Spironolactone

This antihypertensive drug can be helpful, Dr. Stein Gold noted, although the one study in a 2009 Cochrane review that had acne as an outcome failed to find evidence of efficacy versus placebo (Cochrane Database Syst Rev. 2009 Apr 15;[2]:CD000194). Be aware of the boxed warning about links to cancer in rat studies, and consider the risk of potassium elevation in certain populations, she added. Watch the dose: fewer side effects are seen at 50-100 mg daily, although they’re still common, and it can take 3 months or more for improvements to appear, she said.

Truncal acne

Patients may be hesitant to mention they have acne on their chest and back. “They may not tell you about it, and you may not ask about it but [some patients] expect you to know about it and treat it,” Dr. Stein Gold said. She referred to trifarotene, a topical retinoid cream that, although not yet approved, appears to be safe and effective in treating acne on the face and trunk in phase 3 studies.

“Some people will say the trunk will get too irritated if you put a retinoid on it. But it absolutely can be used on the chest and back. The first thing I say to my patients is to expect to have redness and scaling for first 2 weeks. People pay money for that. It’s a chemical peel! It’s okay to have some sloughing; use an oil-free moisturizer.”

Dr. Stein Gold disclosed relationships with Galderma, Foamix, and Sol Gel (investigator, consultant); Valeant (consultant, speaker); and Dermira (investigator, speaker).

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

– When it comes to acne in adult women, look past the jawline, beyond traditional medications, and toward greater control. That’s the message of a dermatologist who spoke at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

Dr. Linda F. Stein Gold

“We should be aiming to get our patients to clear or almost clear, and we have the tools necessary to help that happen,” said Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital in Detroit.

Research suggests that acne is more common in adult women than in men, a gap that widens after age 29 years, she noted. Acne appears to affect 51% of women aged 20-29 years, she said, and prevalence dips to 15% in women older than 50 years.

About 80% of cases continue from adolescence, compared with about 20% that are new-onset during adulthood, she said. According to studies, she added, “most adult women have acne on multiple different areas of their face, not just the jawline. It’s similar to what we see in the adolescent population.”

Dr. Stein Gold offered these tips about treatment in this group of patients:
 

Inflammation

Researchers now consider that “all acne is inflammatory acne.” Be aggressive with anti-inflammatory treatment, and “continue even after the lesion is resolved” if needed to prevent scarring.

Oral contraceptives (OCs)

OCs can be helpful, but “we have to proceed with caution,” she said. A 2012 Cochrane Library review of 31 trials found that six combination OCs (COCs) “evaluated in placebo-controlled trials are effective in reducing inflammatory and noninflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne,” the review concluded (Cochrane Database Syst Rev. 2012 Jul 11;[7]:CD004425).

Results take time, however, and it “can take 3 months to see an effect, and 6 months for full effect,” Dr. Stein Gold noted.

There are multiple contraindications to the use of OCs, and they’ve been linked – controversially – to an increased risk of blood clots and breast cancer. However, risk of thrombosis also spikes – to significantly higher levels than with OC use – during pregnancy and the postpartum period, she said.
 

Spironolactone

This antihypertensive drug can be helpful, Dr. Stein Gold noted, although the one study in a 2009 Cochrane review that had acne as an outcome failed to find evidence of efficacy versus placebo (Cochrane Database Syst Rev. 2009 Apr 15;[2]:CD000194). Be aware of the boxed warning about links to cancer in rat studies, and consider the risk of potassium elevation in certain populations, she added. Watch the dose: fewer side effects are seen at 50-100 mg daily, although they’re still common, and it can take 3 months or more for improvements to appear, she said.

Truncal acne

Patients may be hesitant to mention they have acne on their chest and back. “They may not tell you about it, and you may not ask about it but [some patients] expect you to know about it and treat it,” Dr. Stein Gold said. She referred to trifarotene, a topical retinoid cream that, although not yet approved, appears to be safe and effective in treating acne on the face and trunk in phase 3 studies.

“Some people will say the trunk will get too irritated if you put a retinoid on it. But it absolutely can be used on the chest and back. The first thing I say to my patients is to expect to have redness and scaling for first 2 weeks. People pay money for that. It’s a chemical peel! It’s okay to have some sloughing; use an oil-free moisturizer.”

Dr. Stein Gold disclosed relationships with Galderma, Foamix, and Sol Gel (investigator, consultant); Valeant (consultant, speaker); and Dermira (investigator, speaker).

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

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Tildrakizumab shows positive effects in active psoriatic arthritis

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MADRID – Tildrakizumab, a high-affinity anti–interleukin-23p19 monoclonal antibody, significantly improved joint and skin manifestations in patients with psoriatic arthritis in an ongoing phase 2b study.

Sara Freeman/MDedge News
Dr. Philip J. Mease

“By week 24, all four doses of tildrakizumab were significantly more efficacious than placebo,” Philip J. Mease, MD, director of the division of rheumatology clinical research at Swedish Medical Center, Seattle, reported at the European Congress of Rheumatology. This included patient-rated pain, he observed.

Furthermore, “there was a clear separation between tildrakizumab and placebo as early as 8 weeks” for the trial’s primary endpoint, a 20% response rate on American College of Rheumatology criteria (ACR20) at 24 weeks.

The study (NCT02980692), which is projected to complete next year, was conducted to demonstrate the safety and efficacy of tildrakizumab in patients with active psoriatic arthritis. Tildrakizumab is already approved for the treatment of moderate to severe plaque psoriasis in multiple countries, Dr. Mease pointed out. Indeed, the drug – which is marketed as Ilumya in the United States and as Ilumetri in the Europe Union – was approved by the Food and Drug Administration in March last year based on the positive results of the phase 3 reSURFACE clinical trials program (Drugs. 2018;78[8]:845-9).

In presenting interim findings from the study, Dr. Mease observed that “it looked like shortening the dosing interval from Q12 to Q4 weeks for the 200-mg dose did not result in a measurable difference in skin or joint responses.”

The trial included 391 of 500 adult patients who were screened and then randomized to one of four tildrakizumab dosing groups or placebo; there were 78 patients treated with tildrakizumab 200 mg once every 4 weeks (Q4W) and 79 who were treated with tildrakizumab 200 mg once every 12 weeks (Q12W). A further 77 patients were treated with a 100 mg tildrakizumab dose Q12W, 78 patients with a 20 mg tildrakizumab dose Q12W, and 79 patients were treated with a placebo Q4W.

The mean age of patients included in the study was around 48 years. A total of 55% were female, and more than 96% were white. Across the groups, patients had a median of 7-8 tender joints and about 14-19 swollen joints, and 53%-70% had at least 3% psoriasis body surface area involvement.

The primary endpoint of ACR20 at 24 weeks was met by 79.5%, 77.2%, 71.4%, and 73.1% of patients in the tildrakizumab 200-mg Q4W, 200-mg Q12W, 100-mg Q12W, and 20-mg Q12W groups, and by 50.6% of the placebo-treated patients. “So even the very low dose had an effect,” Dr. Mease observed, also acknowledging the “very high placebo response.”

An ACR50 response was achieved by a respective 53.6%, 50.6%, 45.5%, 39.7%, 19.7%, and 24.1% of patients. ACR70 response rates were also “proportionately lower” than the ACR20 responses at around 25%-29% for the tildrakizumab groups and 16% for placebo.

“The skin scores were as expected quite high,” Dr. Mease said. The Psoriasis Area and Severity Index (PASI) 75 response rate was 79.6% in the tildrakizumab 200-mg Q12W group, 64.2% in the 200-mg Q4W group, 55.6% in the 100-mg Q12W group, 46.3% in the 20-mg Q12W group, and just 16.7% in the placebo group. The respective percentages of patients achieving a PASI 90 response rate were 50%, 47.2%, 38.9%, 36.6%, and 7.1%.

Patient pain assessment showed a clear reduction with tildrakizumab versus placebo treatment. “We see statistical separation between all of the tildrakizumab arms and placebo,” Dr. Mease said. “A greater than 50% response in pain is considered major clinical improvement, and that was achieved by all of the tildrakizumab arms.”

As for enthesitis, the mean change in Leeds Enthesitis Scores from baseline to week 24 were greater with all tildrakizumab doses than with placebo, although a high placebo response was again apparent.

“In general, the safety profile was very good for this agent,” Dr. Mease said. Any treatment-emergent adverse event (TEAE) occurred in 156 of 317 (49%) tildrakizumab-treated patients and in 34 of 70 (49%) placebo-treated patients. The rates of any severe TEAE were 2.2% for the tildrakizumab arms and 2.5% for placebo. Any TEAE related to treatment occurred in a respective 11.2% and 12.7%, but there were no discontinuations because of adverse events, nor were there any major cardiac adverse events, cases of malignancy, or deaths caused by TEAEs. There was a single serious infection, a case of tonsillitis, which occurred with tildrakizumab treatment.

In response to a question after his presentation, Dr. Measure noted: “In the psoriasis trials with this agent, even a single dose yielded a fairly meaningful PASI 75 responses out for extremely long periods of time, 6–12 months. So, it looks like the Q12 dosing is going to be reasonable and convenient for patients”. He also agreed with a comment that the more frequent dosing seemed to be linked to inferior responses in the skin.

The study was sponsored by Sun Pharmaceutical Industries. Dr. Mease has received research grants, consulting fees, and/or speaker fees from 15 pharmaceutical companies, including Sun Pharmaceutical Industries.

 

 

SOURCE: Mease PJ et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-9. Abstract LB0002, doi: 10.1136/annrheumdis-2019-eular.8669

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MADRID – Tildrakizumab, a high-affinity anti–interleukin-23p19 monoclonal antibody, significantly improved joint and skin manifestations in patients with psoriatic arthritis in an ongoing phase 2b study.

Sara Freeman/MDedge News
Dr. Philip J. Mease

“By week 24, all four doses of tildrakizumab were significantly more efficacious than placebo,” Philip J. Mease, MD, director of the division of rheumatology clinical research at Swedish Medical Center, Seattle, reported at the European Congress of Rheumatology. This included patient-rated pain, he observed.

Furthermore, “there was a clear separation between tildrakizumab and placebo as early as 8 weeks” for the trial’s primary endpoint, a 20% response rate on American College of Rheumatology criteria (ACR20) at 24 weeks.

The study (NCT02980692), which is projected to complete next year, was conducted to demonstrate the safety and efficacy of tildrakizumab in patients with active psoriatic arthritis. Tildrakizumab is already approved for the treatment of moderate to severe plaque psoriasis in multiple countries, Dr. Mease pointed out. Indeed, the drug – which is marketed as Ilumya in the United States and as Ilumetri in the Europe Union – was approved by the Food and Drug Administration in March last year based on the positive results of the phase 3 reSURFACE clinical trials program (Drugs. 2018;78[8]:845-9).

In presenting interim findings from the study, Dr. Mease observed that “it looked like shortening the dosing interval from Q12 to Q4 weeks for the 200-mg dose did not result in a measurable difference in skin or joint responses.”

The trial included 391 of 500 adult patients who were screened and then randomized to one of four tildrakizumab dosing groups or placebo; there were 78 patients treated with tildrakizumab 200 mg once every 4 weeks (Q4W) and 79 who were treated with tildrakizumab 200 mg once every 12 weeks (Q12W). A further 77 patients were treated with a 100 mg tildrakizumab dose Q12W, 78 patients with a 20 mg tildrakizumab dose Q12W, and 79 patients were treated with a placebo Q4W.

The mean age of patients included in the study was around 48 years. A total of 55% were female, and more than 96% were white. Across the groups, patients had a median of 7-8 tender joints and about 14-19 swollen joints, and 53%-70% had at least 3% psoriasis body surface area involvement.

The primary endpoint of ACR20 at 24 weeks was met by 79.5%, 77.2%, 71.4%, and 73.1% of patients in the tildrakizumab 200-mg Q4W, 200-mg Q12W, 100-mg Q12W, and 20-mg Q12W groups, and by 50.6% of the placebo-treated patients. “So even the very low dose had an effect,” Dr. Mease observed, also acknowledging the “very high placebo response.”

An ACR50 response was achieved by a respective 53.6%, 50.6%, 45.5%, 39.7%, 19.7%, and 24.1% of patients. ACR70 response rates were also “proportionately lower” than the ACR20 responses at around 25%-29% for the tildrakizumab groups and 16% for placebo.

“The skin scores were as expected quite high,” Dr. Mease said. The Psoriasis Area and Severity Index (PASI) 75 response rate was 79.6% in the tildrakizumab 200-mg Q12W group, 64.2% in the 200-mg Q4W group, 55.6% in the 100-mg Q12W group, 46.3% in the 20-mg Q12W group, and just 16.7% in the placebo group. The respective percentages of patients achieving a PASI 90 response rate were 50%, 47.2%, 38.9%, 36.6%, and 7.1%.

Patient pain assessment showed a clear reduction with tildrakizumab versus placebo treatment. “We see statistical separation between all of the tildrakizumab arms and placebo,” Dr. Mease said. “A greater than 50% response in pain is considered major clinical improvement, and that was achieved by all of the tildrakizumab arms.”

As for enthesitis, the mean change in Leeds Enthesitis Scores from baseline to week 24 were greater with all tildrakizumab doses than with placebo, although a high placebo response was again apparent.

“In general, the safety profile was very good for this agent,” Dr. Mease said. Any treatment-emergent adverse event (TEAE) occurred in 156 of 317 (49%) tildrakizumab-treated patients and in 34 of 70 (49%) placebo-treated patients. The rates of any severe TEAE were 2.2% for the tildrakizumab arms and 2.5% for placebo. Any TEAE related to treatment occurred in a respective 11.2% and 12.7%, but there were no discontinuations because of adverse events, nor were there any major cardiac adverse events, cases of malignancy, or deaths caused by TEAEs. There was a single serious infection, a case of tonsillitis, which occurred with tildrakizumab treatment.

In response to a question after his presentation, Dr. Measure noted: “In the psoriasis trials with this agent, even a single dose yielded a fairly meaningful PASI 75 responses out for extremely long periods of time, 6–12 months. So, it looks like the Q12 dosing is going to be reasonable and convenient for patients”. He also agreed with a comment that the more frequent dosing seemed to be linked to inferior responses in the skin.

The study was sponsored by Sun Pharmaceutical Industries. Dr. Mease has received research grants, consulting fees, and/or speaker fees from 15 pharmaceutical companies, including Sun Pharmaceutical Industries.

 

 

SOURCE: Mease PJ et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-9. Abstract LB0002, doi: 10.1136/annrheumdis-2019-eular.8669

 

MADRID – Tildrakizumab, a high-affinity anti–interleukin-23p19 monoclonal antibody, significantly improved joint and skin manifestations in patients with psoriatic arthritis in an ongoing phase 2b study.

Sara Freeman/MDedge News
Dr. Philip J. Mease

“By week 24, all four doses of tildrakizumab were significantly more efficacious than placebo,” Philip J. Mease, MD, director of the division of rheumatology clinical research at Swedish Medical Center, Seattle, reported at the European Congress of Rheumatology. This included patient-rated pain, he observed.

Furthermore, “there was a clear separation between tildrakizumab and placebo as early as 8 weeks” for the trial’s primary endpoint, a 20% response rate on American College of Rheumatology criteria (ACR20) at 24 weeks.

The study (NCT02980692), which is projected to complete next year, was conducted to demonstrate the safety and efficacy of tildrakizumab in patients with active psoriatic arthritis. Tildrakizumab is already approved for the treatment of moderate to severe plaque psoriasis in multiple countries, Dr. Mease pointed out. Indeed, the drug – which is marketed as Ilumya in the United States and as Ilumetri in the Europe Union – was approved by the Food and Drug Administration in March last year based on the positive results of the phase 3 reSURFACE clinical trials program (Drugs. 2018;78[8]:845-9).

In presenting interim findings from the study, Dr. Mease observed that “it looked like shortening the dosing interval from Q12 to Q4 weeks for the 200-mg dose did not result in a measurable difference in skin or joint responses.”

The trial included 391 of 500 adult patients who were screened and then randomized to one of four tildrakizumab dosing groups or placebo; there were 78 patients treated with tildrakizumab 200 mg once every 4 weeks (Q4W) and 79 who were treated with tildrakizumab 200 mg once every 12 weeks (Q12W). A further 77 patients were treated with a 100 mg tildrakizumab dose Q12W, 78 patients with a 20 mg tildrakizumab dose Q12W, and 79 patients were treated with a placebo Q4W.

The mean age of patients included in the study was around 48 years. A total of 55% were female, and more than 96% were white. Across the groups, patients had a median of 7-8 tender joints and about 14-19 swollen joints, and 53%-70% had at least 3% psoriasis body surface area involvement.

The primary endpoint of ACR20 at 24 weeks was met by 79.5%, 77.2%, 71.4%, and 73.1% of patients in the tildrakizumab 200-mg Q4W, 200-mg Q12W, 100-mg Q12W, and 20-mg Q12W groups, and by 50.6% of the placebo-treated patients. “So even the very low dose had an effect,” Dr. Mease observed, also acknowledging the “very high placebo response.”

An ACR50 response was achieved by a respective 53.6%, 50.6%, 45.5%, 39.7%, 19.7%, and 24.1% of patients. ACR70 response rates were also “proportionately lower” than the ACR20 responses at around 25%-29% for the tildrakizumab groups and 16% for placebo.

“The skin scores were as expected quite high,” Dr. Mease said. The Psoriasis Area and Severity Index (PASI) 75 response rate was 79.6% in the tildrakizumab 200-mg Q12W group, 64.2% in the 200-mg Q4W group, 55.6% in the 100-mg Q12W group, 46.3% in the 20-mg Q12W group, and just 16.7% in the placebo group. The respective percentages of patients achieving a PASI 90 response rate were 50%, 47.2%, 38.9%, 36.6%, and 7.1%.

Patient pain assessment showed a clear reduction with tildrakizumab versus placebo treatment. “We see statistical separation between all of the tildrakizumab arms and placebo,” Dr. Mease said. “A greater than 50% response in pain is considered major clinical improvement, and that was achieved by all of the tildrakizumab arms.”

As for enthesitis, the mean change in Leeds Enthesitis Scores from baseline to week 24 were greater with all tildrakizumab doses than with placebo, although a high placebo response was again apparent.

“In general, the safety profile was very good for this agent,” Dr. Mease said. Any treatment-emergent adverse event (TEAE) occurred in 156 of 317 (49%) tildrakizumab-treated patients and in 34 of 70 (49%) placebo-treated patients. The rates of any severe TEAE were 2.2% for the tildrakizumab arms and 2.5% for placebo. Any TEAE related to treatment occurred in a respective 11.2% and 12.7%, but there were no discontinuations because of adverse events, nor were there any major cardiac adverse events, cases of malignancy, or deaths caused by TEAEs. There was a single serious infection, a case of tonsillitis, which occurred with tildrakizumab treatment.

In response to a question after his presentation, Dr. Measure noted: “In the psoriasis trials with this agent, even a single dose yielded a fairly meaningful PASI 75 responses out for extremely long periods of time, 6–12 months. So, it looks like the Q12 dosing is going to be reasonable and convenient for patients”. He also agreed with a comment that the more frequent dosing seemed to be linked to inferior responses in the skin.

The study was sponsored by Sun Pharmaceutical Industries. Dr. Mease has received research grants, consulting fees, and/or speaker fees from 15 pharmaceutical companies, including Sun Pharmaceutical Industries.

 

 

SOURCE: Mease PJ et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-9. Abstract LB0002, doi: 10.1136/annrheumdis-2019-eular.8669

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Key clinical point: Tildrakizumab (Ilumya) significantly improved joint and skin manifestations in patients with psoriatic arthritis.

Major finding: At 24 weeks, more than 70% of patients treated with tildrakizumab versus 50% of those given placebo achieved an American College of Rheumatology (ACR) 20 response.

Study details: Randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of tildrakizumab in patients with active psoriatic arthritis.

Disclosures: The study was sponsored by Sun Pharmaceutical Industries. Dr. Mease has received research grants, consulting fees, speaker fees, or all, from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Genentech, Gilead, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, UCB, and Sun Pharmaceutical Industries.

Source: Mease PJ et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-9. Abstract LB0002, doi: 10.1136/annrheumdis-2019-eular.8669

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Metformin linked to lower dementia risk in black patients

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Black individuals who develop type 2 diabetes are more likely than their white counterparts to develop dementia. Now, findings from a new study point to a possible preventive strategy: Putting older patients on metformin when they are diagnosed could reduce their risk for dementia by as much as 40%, whereas sulfonylureas do not seem to have such an effect.

The researchers did not examine cause and effect, so their findings are not conclusive, and very few women were included in the study. Still, the authors said that their data showing a 29% lower risk of dementia associated with metformin use in black patients aged 65-74 years, and a 40% lower risk in those aged 50-64 years, suggested that “this inexpensive, widely available treatment could be broadly prescribed to substantially reduce the risk of dementia in younger [black] patients with [type 2 diabetes]” (Ann Fam Med. 2019;17:352-62).

Previous findings have suggested that black patients with type 2 diabetes face a 10%-18% higher risk of dementia, compared with white patients (Diabetes Care. 2014; 37[4]:1009-15). Another study linked type 2 diabetes in middle-aged black patients to a 41% decrease in cognition per test results over 14 years. There was no such decrease in white patients (Neuroepidemiology. 2014;43[3-4]: 220-7).

For the new study, researchers led by Jeffrey F. Scherrer, PhD, of Saint Louis University tracked 73,761 patients aged 50 years or older from 2000-2001 (when they were free of dementia and not taking diabetes) to 2015. Among the patients, 86% were white and 14% were black. In the white and black groups, 97% and 95% were men, respectively, and 61% and 55% were obese, respectively.

All participants began metformin (76%) or sulfonylurea (24%) monotherapy after the baseline period. Guidelines recommend metformin as a first-line treatment for type 2 diabetes, whereas sulfonylureas are considered second-line drugs that should be added to metformin.

After adjustment for confounders such as socioeconomic status and other medical conditions, the researchers found a significantly lower risk of dementia in black patients who took metformin, compared with those taking a sulfonylurea (hazard ratio, 0.73; 95% confidence interval, 0.6-0.89). There was no difference between the drugs among white patients (HR, 0.96; 95% CI, 0.9-1.03, both P = .008)

The results were not statistically significant among age groups, but there were trends. In black patients, the dementia-lowering benefit was largest among those aged 50-64 years (HR, 0.6; 95% CI, 0.45-0.81), followed by those aged 65-74 years (HR, 0.71; 95% CI, 0.53-0.94), and there was no benefit among those aged at least 75 (HR, 1.17; 95% CI, 0.73-1.85) all P = .055. There was a slight benefit among white patients in one of the age groups – 65-74 years (HR, 0.9; 95% CI, 0.82-0.99; P = .315).

The authors suggested that the findings could have been the result of an effect of metformin to reduce vascular disease and chronic inflammation in black patients.

They also noted that further research is needed to identify the demographic and clinical subgroups in which metformin is most strongly associated with a reduction in the risk of dementia. In addition, they emphasized that clinical trials are needed to confirm the study findings.

The National Institutes of Health funded the study. The authors report no relevant disclosures.

SOURCE: Scherrer JF et al. Ann Fam Med. 2019;17:352-62.

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Black individuals who develop type 2 diabetes are more likely than their white counterparts to develop dementia. Now, findings from a new study point to a possible preventive strategy: Putting older patients on metformin when they are diagnosed could reduce their risk for dementia by as much as 40%, whereas sulfonylureas do not seem to have such an effect.

The researchers did not examine cause and effect, so their findings are not conclusive, and very few women were included in the study. Still, the authors said that their data showing a 29% lower risk of dementia associated with metformin use in black patients aged 65-74 years, and a 40% lower risk in those aged 50-64 years, suggested that “this inexpensive, widely available treatment could be broadly prescribed to substantially reduce the risk of dementia in younger [black] patients with [type 2 diabetes]” (Ann Fam Med. 2019;17:352-62).

Previous findings have suggested that black patients with type 2 diabetes face a 10%-18% higher risk of dementia, compared with white patients (Diabetes Care. 2014; 37[4]:1009-15). Another study linked type 2 diabetes in middle-aged black patients to a 41% decrease in cognition per test results over 14 years. There was no such decrease in white patients (Neuroepidemiology. 2014;43[3-4]: 220-7).

For the new study, researchers led by Jeffrey F. Scherrer, PhD, of Saint Louis University tracked 73,761 patients aged 50 years or older from 2000-2001 (when they were free of dementia and not taking diabetes) to 2015. Among the patients, 86% were white and 14% were black. In the white and black groups, 97% and 95% were men, respectively, and 61% and 55% were obese, respectively.

All participants began metformin (76%) or sulfonylurea (24%) monotherapy after the baseline period. Guidelines recommend metformin as a first-line treatment for type 2 diabetes, whereas sulfonylureas are considered second-line drugs that should be added to metformin.

After adjustment for confounders such as socioeconomic status and other medical conditions, the researchers found a significantly lower risk of dementia in black patients who took metformin, compared with those taking a sulfonylurea (hazard ratio, 0.73; 95% confidence interval, 0.6-0.89). There was no difference between the drugs among white patients (HR, 0.96; 95% CI, 0.9-1.03, both P = .008)

The results were not statistically significant among age groups, but there were trends. In black patients, the dementia-lowering benefit was largest among those aged 50-64 years (HR, 0.6; 95% CI, 0.45-0.81), followed by those aged 65-74 years (HR, 0.71; 95% CI, 0.53-0.94), and there was no benefit among those aged at least 75 (HR, 1.17; 95% CI, 0.73-1.85) all P = .055. There was a slight benefit among white patients in one of the age groups – 65-74 years (HR, 0.9; 95% CI, 0.82-0.99; P = .315).

The authors suggested that the findings could have been the result of an effect of metformin to reduce vascular disease and chronic inflammation in black patients.

They also noted that further research is needed to identify the demographic and clinical subgroups in which metformin is most strongly associated with a reduction in the risk of dementia. In addition, they emphasized that clinical trials are needed to confirm the study findings.

The National Institutes of Health funded the study. The authors report no relevant disclosures.

SOURCE: Scherrer JF et al. Ann Fam Med. 2019;17:352-62.

 

Black individuals who develop type 2 diabetes are more likely than their white counterparts to develop dementia. Now, findings from a new study point to a possible preventive strategy: Putting older patients on metformin when they are diagnosed could reduce their risk for dementia by as much as 40%, whereas sulfonylureas do not seem to have such an effect.

The researchers did not examine cause and effect, so their findings are not conclusive, and very few women were included in the study. Still, the authors said that their data showing a 29% lower risk of dementia associated with metformin use in black patients aged 65-74 years, and a 40% lower risk in those aged 50-64 years, suggested that “this inexpensive, widely available treatment could be broadly prescribed to substantially reduce the risk of dementia in younger [black] patients with [type 2 diabetes]” (Ann Fam Med. 2019;17:352-62).

Previous findings have suggested that black patients with type 2 diabetes face a 10%-18% higher risk of dementia, compared with white patients (Diabetes Care. 2014; 37[4]:1009-15). Another study linked type 2 diabetes in middle-aged black patients to a 41% decrease in cognition per test results over 14 years. There was no such decrease in white patients (Neuroepidemiology. 2014;43[3-4]: 220-7).

For the new study, researchers led by Jeffrey F. Scherrer, PhD, of Saint Louis University tracked 73,761 patients aged 50 years or older from 2000-2001 (when they were free of dementia and not taking diabetes) to 2015. Among the patients, 86% were white and 14% were black. In the white and black groups, 97% and 95% were men, respectively, and 61% and 55% were obese, respectively.

All participants began metformin (76%) or sulfonylurea (24%) monotherapy after the baseline period. Guidelines recommend metformin as a first-line treatment for type 2 diabetes, whereas sulfonylureas are considered second-line drugs that should be added to metformin.

After adjustment for confounders such as socioeconomic status and other medical conditions, the researchers found a significantly lower risk of dementia in black patients who took metformin, compared with those taking a sulfonylurea (hazard ratio, 0.73; 95% confidence interval, 0.6-0.89). There was no difference between the drugs among white patients (HR, 0.96; 95% CI, 0.9-1.03, both P = .008)

The results were not statistically significant among age groups, but there were trends. In black patients, the dementia-lowering benefit was largest among those aged 50-64 years (HR, 0.6; 95% CI, 0.45-0.81), followed by those aged 65-74 years (HR, 0.71; 95% CI, 0.53-0.94), and there was no benefit among those aged at least 75 (HR, 1.17; 95% CI, 0.73-1.85) all P = .055. There was a slight benefit among white patients in one of the age groups – 65-74 years (HR, 0.9; 95% CI, 0.82-0.99; P = .315).

The authors suggested that the findings could have been the result of an effect of metformin to reduce vascular disease and chronic inflammation in black patients.

They also noted that further research is needed to identify the demographic and clinical subgroups in which metformin is most strongly associated with a reduction in the risk of dementia. In addition, they emphasized that clinical trials are needed to confirm the study findings.

The National Institutes of Health funded the study. The authors report no relevant disclosures.

SOURCE: Scherrer JF et al. Ann Fam Med. 2019;17:352-62.

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Key clinical point: Metformin – but not sulfonylurea – monotherapy may help reduce the risk of dementia in adult black patients with type 2 diabetes.

Major finding: Metformin monotherapy, compared with sulfonylurea monotherapy, was linked to a significantly lower risk for dementia in black patients (HR, 0.73; 95% CI, 0.6-0.89), but not in white patients (HR, 0.96; 95% CI, 0.9-1.03; P = .008).

Study details: Retrospective analysis of 73,761 patients aged 50 years or older in the Veterans Health Administration system who were tracked from 2000-2001 to 2015 and began metformin or sulfonylurea monotherapy after baseline.

Disclosures: The National Institutes of Health funded the study. The authors report no relevant disclosures.

Source: Scherrer JF et al. Ann Fam Med. 2019;17:352-62.
 

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Study: Most patients hospitalized with pneumonia receive excessive antibiotics

Clinicians should adopt “shorter is better” mantra
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Two-thirds of patients hospitalized with pneumonia received an excess duration of antibiotics, according to a recent study of more than 6,000 patients.

Longer antibiotic courses did not increase the survival rate or prevent any subsequent health care utilization, authors said; instead, they increased the risk of patient-reported adverse events.

The findings bolster a growing body of evidence showing that short-course therapy for pneumonia is safe and that longer durations are not only unnecessary, but “potentially harmful,” said Valerie M. Vaughn, MD, assistant professor of medicine at the University of Michigan, Ann Arbor, and coinvestigators.

“Reducing excess treatment durations should be a top priority for antibiotic stewardship nationally,” the investigators wrote in their report, which appears in the Annals of Internal Medicine.

The primary analysis of their retrospective cohort study included 6,481 individuals with pneumonia treated at 43 hospitals participating in a statewide quality initiative designed to improve care for hospitalized medical patients at risk of adverse events. About half of the patients were women, and the median age was 70 years. Nearly 60% had severe pneumonia.

The primary outcome of the study was the rate of excess antibiotic therapy duration beyond the shortest expected treatment duration consistent with guidelines. Patients with community-acquired pneumonia (CAP), representing about three-quarters of the study cohort, were expected to have a treatment duration of at least 5 days, while patients with health care–acquired pneumonia (HCAP) were expected to have at least 7 days of treatment.

Overall, 4,391 patients (67.8%) had antibiotic courses longer than the shortest effective duration, with a median duration of 8 days, and a median excess duration of 2 days, the researchers noted.

The great majority of excess days (93.2%) were due to antibiotic prescribed at discharge, according to Dr. Vaughn and colleagues.

Excess treatment duration was not linked to any improvement in 30-day mortality, readmission rates, or subsequent emergency department visits, they found.

In a telephone call at 30 days, 38% of patients treated to excess said they had gone to the doctor for an antibiotic-associated adverse event, compared with 31% who received appropriate-length courses (P = .003).

Odds of a patient-reported adverse event were increased by 5% for every excess treatment day, the investigators wrote.

Taken together, these findings have implications for patient care, research efforts, and future guidelines, according to Dr. Vaughn and coinvestigators.

“The next iteration of CAP and HCAP guidelines should explicitly recommend (rather than imply) that providers prescribe the shortest effective duration,” they said in a discussion of their study results.

Dr. Vaughn reported no disclosures related to the study. Coauthors reported grants from Blue Cross Blue Shield of Michigan and the Agency for Healthcare Research and Quality, personal fees from Wiley Publishing, and royalties from Wolters Kluwer Publishing and Oxford University Press, among other disclosures.

SOURCE: Vaughn VM et al. Ann Intern Med. 2019;171:153-63. doi: 10.7326/M18-3640.

Body

This study by Vaughn and colleagues adds “valuable insight” to an already considerable body of evidence showing that shorter durations of antibiotic therapy are effective and limit potential harm due to adverse effects, authors of an accompanying editorial said.

“After dozens of randomized, controlled trials and more than a decade since the initial clarion call to move to short-course therapy, it is time to adapt clinical practice for diseases that have been studied and adopt the mantra ‘shorter is better,’ ” Brad Spellberg, MD, and Louis B. Rice, MD, wrote in their editorial.

“It is time for regulatory agencies, payers, and professional societies to align themselves with the overwhelming data and assist in converting practice patterns to short-course therapy,” the authors said.
 

Brad Spellberg, MD, is with the Los Angeles County–University of Southern California Medical Center, and Louis B. Rice, MD, is with Rhode Island Hospital, Brown University, Providence, R.I. Their editorial appears in Annals of Internal Medicine. The authors reported disclosures outside the submitted work from Alexion, Paratek, TheoremDx, Acurx, Shionogi, Merck, Motif, BioAIM, Mycomed, and ExBaq (Dr. Spellberg); and Zavante Pharmaceuticals and Macrolide (Dr. Rice).

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Body

This study by Vaughn and colleagues adds “valuable insight” to an already considerable body of evidence showing that shorter durations of antibiotic therapy are effective and limit potential harm due to adverse effects, authors of an accompanying editorial said.

“After dozens of randomized, controlled trials and more than a decade since the initial clarion call to move to short-course therapy, it is time to adapt clinical practice for diseases that have been studied and adopt the mantra ‘shorter is better,’ ” Brad Spellberg, MD, and Louis B. Rice, MD, wrote in their editorial.

“It is time for regulatory agencies, payers, and professional societies to align themselves with the overwhelming data and assist in converting practice patterns to short-course therapy,” the authors said.
 

Brad Spellberg, MD, is with the Los Angeles County–University of Southern California Medical Center, and Louis B. Rice, MD, is with Rhode Island Hospital, Brown University, Providence, R.I. Their editorial appears in Annals of Internal Medicine. The authors reported disclosures outside the submitted work from Alexion, Paratek, TheoremDx, Acurx, Shionogi, Merck, Motif, BioAIM, Mycomed, and ExBaq (Dr. Spellberg); and Zavante Pharmaceuticals and Macrolide (Dr. Rice).

Body

This study by Vaughn and colleagues adds “valuable insight” to an already considerable body of evidence showing that shorter durations of antibiotic therapy are effective and limit potential harm due to adverse effects, authors of an accompanying editorial said.

“After dozens of randomized, controlled trials and more than a decade since the initial clarion call to move to short-course therapy, it is time to adapt clinical practice for diseases that have been studied and adopt the mantra ‘shorter is better,’ ” Brad Spellberg, MD, and Louis B. Rice, MD, wrote in their editorial.

“It is time for regulatory agencies, payers, and professional societies to align themselves with the overwhelming data and assist in converting practice patterns to short-course therapy,” the authors said.
 

Brad Spellberg, MD, is with the Los Angeles County–University of Southern California Medical Center, and Louis B. Rice, MD, is with Rhode Island Hospital, Brown University, Providence, R.I. Their editorial appears in Annals of Internal Medicine. The authors reported disclosures outside the submitted work from Alexion, Paratek, TheoremDx, Acurx, Shionogi, Merck, Motif, BioAIM, Mycomed, and ExBaq (Dr. Spellberg); and Zavante Pharmaceuticals and Macrolide (Dr. Rice).

Title
Clinicians should adopt “shorter is better” mantra
Clinicians should adopt “shorter is better” mantra

Two-thirds of patients hospitalized with pneumonia received an excess duration of antibiotics, according to a recent study of more than 6,000 patients.

Longer antibiotic courses did not increase the survival rate or prevent any subsequent health care utilization, authors said; instead, they increased the risk of patient-reported adverse events.

The findings bolster a growing body of evidence showing that short-course therapy for pneumonia is safe and that longer durations are not only unnecessary, but “potentially harmful,” said Valerie M. Vaughn, MD, assistant professor of medicine at the University of Michigan, Ann Arbor, and coinvestigators.

“Reducing excess treatment durations should be a top priority for antibiotic stewardship nationally,” the investigators wrote in their report, which appears in the Annals of Internal Medicine.

The primary analysis of their retrospective cohort study included 6,481 individuals with pneumonia treated at 43 hospitals participating in a statewide quality initiative designed to improve care for hospitalized medical patients at risk of adverse events. About half of the patients were women, and the median age was 70 years. Nearly 60% had severe pneumonia.

The primary outcome of the study was the rate of excess antibiotic therapy duration beyond the shortest expected treatment duration consistent with guidelines. Patients with community-acquired pneumonia (CAP), representing about three-quarters of the study cohort, were expected to have a treatment duration of at least 5 days, while patients with health care–acquired pneumonia (HCAP) were expected to have at least 7 days of treatment.

Overall, 4,391 patients (67.8%) had antibiotic courses longer than the shortest effective duration, with a median duration of 8 days, and a median excess duration of 2 days, the researchers noted.

The great majority of excess days (93.2%) were due to antibiotic prescribed at discharge, according to Dr. Vaughn and colleagues.

Excess treatment duration was not linked to any improvement in 30-day mortality, readmission rates, or subsequent emergency department visits, they found.

In a telephone call at 30 days, 38% of patients treated to excess said they had gone to the doctor for an antibiotic-associated adverse event, compared with 31% who received appropriate-length courses (P = .003).

Odds of a patient-reported adverse event were increased by 5% for every excess treatment day, the investigators wrote.

Taken together, these findings have implications for patient care, research efforts, and future guidelines, according to Dr. Vaughn and coinvestigators.

“The next iteration of CAP and HCAP guidelines should explicitly recommend (rather than imply) that providers prescribe the shortest effective duration,” they said in a discussion of their study results.

Dr. Vaughn reported no disclosures related to the study. Coauthors reported grants from Blue Cross Blue Shield of Michigan and the Agency for Healthcare Research and Quality, personal fees from Wiley Publishing, and royalties from Wolters Kluwer Publishing and Oxford University Press, among other disclosures.

SOURCE: Vaughn VM et al. Ann Intern Med. 2019;171:153-63. doi: 10.7326/M18-3640.

Two-thirds of patients hospitalized with pneumonia received an excess duration of antibiotics, according to a recent study of more than 6,000 patients.

Longer antibiotic courses did not increase the survival rate or prevent any subsequent health care utilization, authors said; instead, they increased the risk of patient-reported adverse events.

The findings bolster a growing body of evidence showing that short-course therapy for pneumonia is safe and that longer durations are not only unnecessary, but “potentially harmful,” said Valerie M. Vaughn, MD, assistant professor of medicine at the University of Michigan, Ann Arbor, and coinvestigators.

“Reducing excess treatment durations should be a top priority for antibiotic stewardship nationally,” the investigators wrote in their report, which appears in the Annals of Internal Medicine.

The primary analysis of their retrospective cohort study included 6,481 individuals with pneumonia treated at 43 hospitals participating in a statewide quality initiative designed to improve care for hospitalized medical patients at risk of adverse events. About half of the patients were women, and the median age was 70 years. Nearly 60% had severe pneumonia.

The primary outcome of the study was the rate of excess antibiotic therapy duration beyond the shortest expected treatment duration consistent with guidelines. Patients with community-acquired pneumonia (CAP), representing about three-quarters of the study cohort, were expected to have a treatment duration of at least 5 days, while patients with health care–acquired pneumonia (HCAP) were expected to have at least 7 days of treatment.

Overall, 4,391 patients (67.8%) had antibiotic courses longer than the shortest effective duration, with a median duration of 8 days, and a median excess duration of 2 days, the researchers noted.

The great majority of excess days (93.2%) were due to antibiotic prescribed at discharge, according to Dr. Vaughn and colleagues.

Excess treatment duration was not linked to any improvement in 30-day mortality, readmission rates, or subsequent emergency department visits, they found.

In a telephone call at 30 days, 38% of patients treated to excess said they had gone to the doctor for an antibiotic-associated adverse event, compared with 31% who received appropriate-length courses (P = .003).

Odds of a patient-reported adverse event were increased by 5% for every excess treatment day, the investigators wrote.

Taken together, these findings have implications for patient care, research efforts, and future guidelines, according to Dr. Vaughn and coinvestigators.

“The next iteration of CAP and HCAP guidelines should explicitly recommend (rather than imply) that providers prescribe the shortest effective duration,” they said in a discussion of their study results.

Dr. Vaughn reported no disclosures related to the study. Coauthors reported grants from Blue Cross Blue Shield of Michigan and the Agency for Healthcare Research and Quality, personal fees from Wiley Publishing, and royalties from Wolters Kluwer Publishing and Oxford University Press, among other disclosures.

SOURCE: Vaughn VM et al. Ann Intern Med. 2019;171:153-63. doi: 10.7326/M18-3640.

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Key clinical point: Excessive antibiotic therapy was common among patients hospitalized with pneumonia and linked to an increase in patient-reported adverse events.

Major finding: Two-thirds (67.8%) of patients had antibiotic courses longer than the shortest effective duration.

Study details: Retrospective cohort study of 6,481 individuals with pneumonia treated at 43 hospitals participating in a statewide quality initiative.

Disclosures: Study authors reported grants from Blue Cross Blue Shield of Michigan and the Agency for Healthcare Research and Quality, personal fees from Wiley Publishing, and royalties from Wolters Kluwer Publishing and Oxford University Press, among other disclosures.

Source: Vaughn VM et al. Ann Intern Med. 2019;171:153-63. doi: 10.7326/M18-3640.

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Lupus pregnancy outcomes show marked improvement in past 20 years

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Pregnancy management and outcomes have improved markedly for women with SLE over the past 2 decades, but there’s still progress to be made, research shows.

A retrospective cohort study led by rheumatologist Bella Mehta, MBBS, of the Hospital for Special Surgery in New York, and colleagues looked at data from the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

The results showed that over the 18-year study period, in-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Fetal mortality declined both for patients with SLE (268 deaths per 10,000 deliveries in 1998-2000 vs. 153 in 2013-2015) and those without SLE (72 deaths per 10,000 deliveries in 1998-2000 vs. 66 in 2013-2015).

“Although the decrease in fetal mortality seems somewhat greater in patients with SLE than those without it, the difference in trends is not statistically significant (P = .064),” the study authors noted in their paper, published in Annals of Internal Medicine.

Although patients with SLE in their study showed greater progress in rates of preeclampsia or eclampsia and length of stay, they still had worse outcomes in all measures when compared against women without SLE, the authors noted.

“Our study provides nationwide evidence that SLE pregnancy outcomes have become markedly better in the past 2 decades and continue to improve. However, SLE pregnancy risks remain high, and more work is needed to ensure good pregnancy outcomes among women with SLE,” they concluded.



Writing in an accompanying editorial, Megan E.B. Clowse, MD, of Duke University, Durham, N.C., noted that although the study findings of a progressive reduction in maternal mortality seemed very likely, the absolute decrease seen – from 140 maternal deaths per 100,000 births to fewer than 50 in 2013-2015 – warranted some reflection (Ann Intern Med. 2019;171:212-3. doi: 10.7326/M19-1667).

“SLE pregnancy management has not advanced within the past 5 years to an extent great enough to explain such a large drop in mortality,” she wrote.

There were also question marks around whether the NIS data should be used to analyze very rare events, such as maternal deaths in women with SLE. The SLE diagnosis in the database may also have included pregnancies in women who did not have SLE but instead had an elevated level of antinuclear antibody or lupus anticoagulant, which “may have diluted the frequency of poor outcomes,” Dr. Clowse wrote.

“For these reasons, I am concerned that the observed decline in maternal mortality may be an artifact, underestimating the ongoing risk of pregnancy for women with SLE,” Dr. Clowse wrote.

She added that recent analyses demonstrated that the use of hydroxychloroquine and aspirin in SLE pregnancy was not widespread.

“The inaugural reproductive health guidelines soon to be published by the American College of Rheumatology will have the potential to help expand state-of-the-art approaches to the management of pregnant women with SLE seen in everyday practice,” she concluded.

The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment Award. Dr. Clowse reported grants from GlaxoSmithKline and personal fees from UCB, both outside the submitted work.

SOURCE: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

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Pregnancy management and outcomes have improved markedly for women with SLE over the past 2 decades, but there’s still progress to be made, research shows.

A retrospective cohort study led by rheumatologist Bella Mehta, MBBS, of the Hospital for Special Surgery in New York, and colleagues looked at data from the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

The results showed that over the 18-year study period, in-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Fetal mortality declined both for patients with SLE (268 deaths per 10,000 deliveries in 1998-2000 vs. 153 in 2013-2015) and those without SLE (72 deaths per 10,000 deliveries in 1998-2000 vs. 66 in 2013-2015).

“Although the decrease in fetal mortality seems somewhat greater in patients with SLE than those without it, the difference in trends is not statistically significant (P = .064),” the study authors noted in their paper, published in Annals of Internal Medicine.

Although patients with SLE in their study showed greater progress in rates of preeclampsia or eclampsia and length of stay, they still had worse outcomes in all measures when compared against women without SLE, the authors noted.

“Our study provides nationwide evidence that SLE pregnancy outcomes have become markedly better in the past 2 decades and continue to improve. However, SLE pregnancy risks remain high, and more work is needed to ensure good pregnancy outcomes among women with SLE,” they concluded.



Writing in an accompanying editorial, Megan E.B. Clowse, MD, of Duke University, Durham, N.C., noted that although the study findings of a progressive reduction in maternal mortality seemed very likely, the absolute decrease seen – from 140 maternal deaths per 100,000 births to fewer than 50 in 2013-2015 – warranted some reflection (Ann Intern Med. 2019;171:212-3. doi: 10.7326/M19-1667).

“SLE pregnancy management has not advanced within the past 5 years to an extent great enough to explain such a large drop in mortality,” she wrote.

There were also question marks around whether the NIS data should be used to analyze very rare events, such as maternal deaths in women with SLE. The SLE diagnosis in the database may also have included pregnancies in women who did not have SLE but instead had an elevated level of antinuclear antibody or lupus anticoagulant, which “may have diluted the frequency of poor outcomes,” Dr. Clowse wrote.

“For these reasons, I am concerned that the observed decline in maternal mortality may be an artifact, underestimating the ongoing risk of pregnancy for women with SLE,” Dr. Clowse wrote.

She added that recent analyses demonstrated that the use of hydroxychloroquine and aspirin in SLE pregnancy was not widespread.

“The inaugural reproductive health guidelines soon to be published by the American College of Rheumatology will have the potential to help expand state-of-the-art approaches to the management of pregnant women with SLE seen in everyday practice,” she concluded.

The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment Award. Dr. Clowse reported grants from GlaxoSmithKline and personal fees from UCB, both outside the submitted work.

SOURCE: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

 

Pregnancy management and outcomes have improved markedly for women with SLE over the past 2 decades, but there’s still progress to be made, research shows.

A retrospective cohort study led by rheumatologist Bella Mehta, MBBS, of the Hospital for Special Surgery in New York, and colleagues looked at data from the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

The results showed that over the 18-year study period, in-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Fetal mortality declined both for patients with SLE (268 deaths per 10,000 deliveries in 1998-2000 vs. 153 in 2013-2015) and those without SLE (72 deaths per 10,000 deliveries in 1998-2000 vs. 66 in 2013-2015).

“Although the decrease in fetal mortality seems somewhat greater in patients with SLE than those without it, the difference in trends is not statistically significant (P = .064),” the study authors noted in their paper, published in Annals of Internal Medicine.

Although patients with SLE in their study showed greater progress in rates of preeclampsia or eclampsia and length of stay, they still had worse outcomes in all measures when compared against women without SLE, the authors noted.

“Our study provides nationwide evidence that SLE pregnancy outcomes have become markedly better in the past 2 decades and continue to improve. However, SLE pregnancy risks remain high, and more work is needed to ensure good pregnancy outcomes among women with SLE,” they concluded.



Writing in an accompanying editorial, Megan E.B. Clowse, MD, of Duke University, Durham, N.C., noted that although the study findings of a progressive reduction in maternal mortality seemed very likely, the absolute decrease seen – from 140 maternal deaths per 100,000 births to fewer than 50 in 2013-2015 – warranted some reflection (Ann Intern Med. 2019;171:212-3. doi: 10.7326/M19-1667).

“SLE pregnancy management has not advanced within the past 5 years to an extent great enough to explain such a large drop in mortality,” she wrote.

There were also question marks around whether the NIS data should be used to analyze very rare events, such as maternal deaths in women with SLE. The SLE diagnosis in the database may also have included pregnancies in women who did not have SLE but instead had an elevated level of antinuclear antibody or lupus anticoagulant, which “may have diluted the frequency of poor outcomes,” Dr. Clowse wrote.

“For these reasons, I am concerned that the observed decline in maternal mortality may be an artifact, underestimating the ongoing risk of pregnancy for women with SLE,” Dr. Clowse wrote.

She added that recent analyses demonstrated that the use of hydroxychloroquine and aspirin in SLE pregnancy was not widespread.

“The inaugural reproductive health guidelines soon to be published by the American College of Rheumatology will have the potential to help expand state-of-the-art approaches to the management of pregnant women with SLE seen in everyday practice,” she concluded.

The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment Award. Dr. Clowse reported grants from GlaxoSmithKline and personal fees from UCB, both outside the submitted work.

SOURCE: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

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Key clinical point: In-hospital maternal mortality and outcomes have improved markedly among women with SLE but improvements are still needed.

Major finding: In-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Study details: A retrospective cohort study using the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

Disclosure: The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment award.

Source: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

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Repeated ANA testing after negative result of little diagnostic value

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– Repeated antinuclear antibody testing after a negative result has limited use for the diagnosis of ANA-associated rheumatologic conditions, according to data from a multicenter, retrospective analysis that considered a 7-year period.

Sara Freeman/MDEdge News
Dr. Ai Li Yeo

Considering more than 7,875 repeated ANA tests in 4,887 patients, “the vast majority of results didn’t change,” Ai Li Yeo, MBBS, a PhD candidate, rheumatologist, and infectious disease fellow at Monash University, Melbourne, reported at the European Congress of Rheumatology.

ANA tests were repeated between 2 and as many as 45 times in individual patients, she reported, but the results of 79% of these tests remained unchanged – 45% of tests were persistently negative and 34% persistently positive using a cutoff titer of 1:160.

“Our study showed that there was a very low yield in repeating an ANA test for the diagnosis of ANA-associated rheumatological conditions unless there was evidence of evolving multisystem clinical features,” Dr. Yeo said.

Indeed, the positive predictive value was just 0.01. “So for a hundred patients staring off with a negative ANA results that on repeat testing became positive, the probability is that one patient will have a new ANA-associated rheumatological condition diagnosis,” Dr. Yeo said.

“ANA testing is frequently performed and is part of the classification criteria for autoimmune conditions such as lupus and scleroderma,” she observed. However, the test provides no information on the severity or activity of the disease, and the value of serial monitoring for such conditions is unclear.

“Minimizing unnecessary tests is a global health economic priority,” Dr. Yeo said. She noted that there are multiple initiatives in place to try to open a dialog about using health care resources most effectively, such as ‘Choosing Wisely’ set up by the American Board of Internal Medicine (ABIM) Foundation.

The aim of the present analysis was to calculate the cost of repeated ANA testing and to see if any change in the ANA result was associated with new diagnoses of ANA-associated rheumatological conditions.

The analysis considered more than 36,700 tests that were performed on samples from more than 28,800 patients within the Monash Health tertiary health network between 2011 and 2018. Of these, 22,657 (62%) had given a negative result and 14,058 (38%) had given a positive result.



“Not surprisingly, the age of those who tested positive was significantly higher than those who tested negative,” Dr. Yeo said (52.6 vs. 48.9 years; P less than .001). There was also a higher number of women than men tested, and women more often tested positive.

Around one-fifth of tests performed were repeat tests, of which 511 (6.5%) changed from being negative to positive over a median of 1.71 years.

“A small percentage of people alternated between results,” Dr. Yeo acknowledged, with 9.4% of people going from a positive to a negative result; 10.5% moving from a negative to a positive result, and 1.9% going from positive to negative to positive.

With repeated tests, just five new diagnoses of ANA-associated rheumatologic conditions were made: two cases of systemic lupus erythematosus (SLE), one case of scleroderma, and two cases of undifferentiated connective tissue disease. There was a range of ANA titers and patterns and evolving clinical features of a multisystem disease.

Based on the direct costs of ANA testing in her health care system, not performing repeated tests could yield significant savings, Dr. Yeo said, a 21.4% reduction, in fact, based on this analysis. The cost of an ANA test in Australia ranges from 15 to 46 euros, making the cost of all tests in this analysis 564,745 euros. Taking away the cost of all the single ANA tests performed (443,209 euros) gives a potential cost saving of more than 121,000 euros, she said.

“We now have an opportunity to prevent unnecessary ANA testing, Dr. Yeo said. “Ultimately, our aim is to change behavior at the start of the ordering cycle by educating medical students and doctors about inappropriate test ordering.”

The majority of repeated tests had been ordered by nonrheumatologists (82% of cases), and Dr. Yeo said that rheumatologists ordered repeat tests in 11% of cases. However, there was little information available in this retrospective analysis as to why the tests had been repeated.

The research was picked as one of the six best clinical abstracts at the meeting, out of a total of almost 5,000 submitted abstracts.

Dr. Yeo reported having no conflicts of interest.

SOURCE: Yeo AL et al. Ann Rheum Dis. Jun 2019;78(suppl 2):76-7, Abstract OP0020. doi: 10.1136/annrheumdis-2019-eular.4517.

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– Repeated antinuclear antibody testing after a negative result has limited use for the diagnosis of ANA-associated rheumatologic conditions, according to data from a multicenter, retrospective analysis that considered a 7-year period.

Sara Freeman/MDEdge News
Dr. Ai Li Yeo

Considering more than 7,875 repeated ANA tests in 4,887 patients, “the vast majority of results didn’t change,” Ai Li Yeo, MBBS, a PhD candidate, rheumatologist, and infectious disease fellow at Monash University, Melbourne, reported at the European Congress of Rheumatology.

ANA tests were repeated between 2 and as many as 45 times in individual patients, she reported, but the results of 79% of these tests remained unchanged – 45% of tests were persistently negative and 34% persistently positive using a cutoff titer of 1:160.

“Our study showed that there was a very low yield in repeating an ANA test for the diagnosis of ANA-associated rheumatological conditions unless there was evidence of evolving multisystem clinical features,” Dr. Yeo said.

Indeed, the positive predictive value was just 0.01. “So for a hundred patients staring off with a negative ANA results that on repeat testing became positive, the probability is that one patient will have a new ANA-associated rheumatological condition diagnosis,” Dr. Yeo said.

“ANA testing is frequently performed and is part of the classification criteria for autoimmune conditions such as lupus and scleroderma,” she observed. However, the test provides no information on the severity or activity of the disease, and the value of serial monitoring for such conditions is unclear.

“Minimizing unnecessary tests is a global health economic priority,” Dr. Yeo said. She noted that there are multiple initiatives in place to try to open a dialog about using health care resources most effectively, such as ‘Choosing Wisely’ set up by the American Board of Internal Medicine (ABIM) Foundation.

The aim of the present analysis was to calculate the cost of repeated ANA testing and to see if any change in the ANA result was associated with new diagnoses of ANA-associated rheumatological conditions.

The analysis considered more than 36,700 tests that were performed on samples from more than 28,800 patients within the Monash Health tertiary health network between 2011 and 2018. Of these, 22,657 (62%) had given a negative result and 14,058 (38%) had given a positive result.



“Not surprisingly, the age of those who tested positive was significantly higher than those who tested negative,” Dr. Yeo said (52.6 vs. 48.9 years; P less than .001). There was also a higher number of women than men tested, and women more often tested positive.

Around one-fifth of tests performed were repeat tests, of which 511 (6.5%) changed from being negative to positive over a median of 1.71 years.

“A small percentage of people alternated between results,” Dr. Yeo acknowledged, with 9.4% of people going from a positive to a negative result; 10.5% moving from a negative to a positive result, and 1.9% going from positive to negative to positive.

With repeated tests, just five new diagnoses of ANA-associated rheumatologic conditions were made: two cases of systemic lupus erythematosus (SLE), one case of scleroderma, and two cases of undifferentiated connective tissue disease. There was a range of ANA titers and patterns and evolving clinical features of a multisystem disease.

Based on the direct costs of ANA testing in her health care system, not performing repeated tests could yield significant savings, Dr. Yeo said, a 21.4% reduction, in fact, based on this analysis. The cost of an ANA test in Australia ranges from 15 to 46 euros, making the cost of all tests in this analysis 564,745 euros. Taking away the cost of all the single ANA tests performed (443,209 euros) gives a potential cost saving of more than 121,000 euros, she said.

“We now have an opportunity to prevent unnecessary ANA testing, Dr. Yeo said. “Ultimately, our aim is to change behavior at the start of the ordering cycle by educating medical students and doctors about inappropriate test ordering.”

The majority of repeated tests had been ordered by nonrheumatologists (82% of cases), and Dr. Yeo said that rheumatologists ordered repeat tests in 11% of cases. However, there was little information available in this retrospective analysis as to why the tests had been repeated.

The research was picked as one of the six best clinical abstracts at the meeting, out of a total of almost 5,000 submitted abstracts.

Dr. Yeo reported having no conflicts of interest.

SOURCE: Yeo AL et al. Ann Rheum Dis. Jun 2019;78(suppl 2):76-7, Abstract OP0020. doi: 10.1136/annrheumdis-2019-eular.4517.

 

– Repeated antinuclear antibody testing after a negative result has limited use for the diagnosis of ANA-associated rheumatologic conditions, according to data from a multicenter, retrospective analysis that considered a 7-year period.

Sara Freeman/MDEdge News
Dr. Ai Li Yeo

Considering more than 7,875 repeated ANA tests in 4,887 patients, “the vast majority of results didn’t change,” Ai Li Yeo, MBBS, a PhD candidate, rheumatologist, and infectious disease fellow at Monash University, Melbourne, reported at the European Congress of Rheumatology.

ANA tests were repeated between 2 and as many as 45 times in individual patients, she reported, but the results of 79% of these tests remained unchanged – 45% of tests were persistently negative and 34% persistently positive using a cutoff titer of 1:160.

“Our study showed that there was a very low yield in repeating an ANA test for the diagnosis of ANA-associated rheumatological conditions unless there was evidence of evolving multisystem clinical features,” Dr. Yeo said.

Indeed, the positive predictive value was just 0.01. “So for a hundred patients staring off with a negative ANA results that on repeat testing became positive, the probability is that one patient will have a new ANA-associated rheumatological condition diagnosis,” Dr. Yeo said.

“ANA testing is frequently performed and is part of the classification criteria for autoimmune conditions such as lupus and scleroderma,” she observed. However, the test provides no information on the severity or activity of the disease, and the value of serial monitoring for such conditions is unclear.

“Minimizing unnecessary tests is a global health economic priority,” Dr. Yeo said. She noted that there are multiple initiatives in place to try to open a dialog about using health care resources most effectively, such as ‘Choosing Wisely’ set up by the American Board of Internal Medicine (ABIM) Foundation.

The aim of the present analysis was to calculate the cost of repeated ANA testing and to see if any change in the ANA result was associated with new diagnoses of ANA-associated rheumatological conditions.

The analysis considered more than 36,700 tests that were performed on samples from more than 28,800 patients within the Monash Health tertiary health network between 2011 and 2018. Of these, 22,657 (62%) had given a negative result and 14,058 (38%) had given a positive result.



“Not surprisingly, the age of those who tested positive was significantly higher than those who tested negative,” Dr. Yeo said (52.6 vs. 48.9 years; P less than .001). There was also a higher number of women than men tested, and women more often tested positive.

Around one-fifth of tests performed were repeat tests, of which 511 (6.5%) changed from being negative to positive over a median of 1.71 years.

“A small percentage of people alternated between results,” Dr. Yeo acknowledged, with 9.4% of people going from a positive to a negative result; 10.5% moving from a negative to a positive result, and 1.9% going from positive to negative to positive.

With repeated tests, just five new diagnoses of ANA-associated rheumatologic conditions were made: two cases of systemic lupus erythematosus (SLE), one case of scleroderma, and two cases of undifferentiated connective tissue disease. There was a range of ANA titers and patterns and evolving clinical features of a multisystem disease.

Based on the direct costs of ANA testing in her health care system, not performing repeated tests could yield significant savings, Dr. Yeo said, a 21.4% reduction, in fact, based on this analysis. The cost of an ANA test in Australia ranges from 15 to 46 euros, making the cost of all tests in this analysis 564,745 euros. Taking away the cost of all the single ANA tests performed (443,209 euros) gives a potential cost saving of more than 121,000 euros, she said.

“We now have an opportunity to prevent unnecessary ANA testing, Dr. Yeo said. “Ultimately, our aim is to change behavior at the start of the ordering cycle by educating medical students and doctors about inappropriate test ordering.”

The majority of repeated tests had been ordered by nonrheumatologists (82% of cases), and Dr. Yeo said that rheumatologists ordered repeat tests in 11% of cases. However, there was little information available in this retrospective analysis as to why the tests had been repeated.

The research was picked as one of the six best clinical abstracts at the meeting, out of a total of almost 5,000 submitted abstracts.

Dr. Yeo reported having no conflicts of interest.

SOURCE: Yeo AL et al. Ann Rheum Dis. Jun 2019;78(suppl 2):76-7, Abstract OP0020. doi: 10.1136/annrheumdis-2019-eular.4517.

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Women express low decision regret after preimplantation testing for aneuploidy

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The decision to undergo preimplantation genetic testing for aneuploidy is associated with a small but not unimportant amount of regret among some patients undergoing fertility treatment, research suggests.

In a report published in Human Reproduction, researchers did an anonymous survey of 69 patients undergoing their first cycle of autologous preimplantation genetic testing for aneuploidy (PGT-A) at a single fertility center.

“Despite the known distress associated with many aspects of assisted reproductive technology (ART) and the many opportunities for distress among patients pursuing PGT-A, little is known about the associated patient experience and psychological risks,” wrote Dr. Kara N. Goldman of New York University Langone Fertility Center, and coauthors.

“A ‘failure’ after PGT-A can present in many forms well before other IVF losses may be experienced: Embryos may not meet criteria for biopsy, PGT-A may result in an all-aneuploid embryo cohort, or a euploid embryo may fail to implant,” the authors continued.

The mean overall decision regret scale score was 8.5 on a scale of 0-100 – with a median of 0 – and 61% of respondents said they had no regrets about undergoing preimplantation genetic testing for aneuploidy; the remaining 39% reported “any degree of regret.”

This “one-third of respondents reported some degree of regret, suggesting an important opportunity for pretest counseling and support among patients pursuing PGT-A,” Dr. Goldman and associates emphasized.

Of the respondents who then underwent euploid embryo transfer, and who had a known pregnancy outcome, the 36 with an ongoing or delivered pregnancy had significantly less decision regret than the 24 who experienced a negative pregnancy test or a miscarriage.

The study found no differences in decision regret between those aged under or over 35 years of age, those with different levels of educational attainment, or between patients who paid exclusively out of pocket compared with those with any insurance coverage.

However, greater levels of decision regret were seen in patients who had experienced a longer time since retrieval of oocytes and those who said they would consider pregnancy with donor oocytes if they were unsuccessful with IVF and PGT-A.

“Completing a cycle of IVF with PGT-A and obtaining no usable, euploid embryos results in distress, but this distress must be weighed against the alternative scenario in which a patient invests valuable time, energy, and resources into a futile embryo transfer cycle resulting in a negative pregnancy test, miscarriage, or aneuploid gestation,” the authors wrote.

When assessing the dependence of the decision regret score on demographic factors, the researchers found that patients who had learned about PGT-A from their physicians, rather than from other sources such as friends or the Internet, had the highest levels of decision regret.

There was no external funding. One coauthor declared personal fees and other support from the fertility and pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Goldman KN et al. Hum Reprod. 2019 Jun 21. doi: 10.1093/humrep/dez080.

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The decision to undergo preimplantation genetic testing for aneuploidy is associated with a small but not unimportant amount of regret among some patients undergoing fertility treatment, research suggests.

In a report published in Human Reproduction, researchers did an anonymous survey of 69 patients undergoing their first cycle of autologous preimplantation genetic testing for aneuploidy (PGT-A) at a single fertility center.

“Despite the known distress associated with many aspects of assisted reproductive technology (ART) and the many opportunities for distress among patients pursuing PGT-A, little is known about the associated patient experience and psychological risks,” wrote Dr. Kara N. Goldman of New York University Langone Fertility Center, and coauthors.

“A ‘failure’ after PGT-A can present in many forms well before other IVF losses may be experienced: Embryos may not meet criteria for biopsy, PGT-A may result in an all-aneuploid embryo cohort, or a euploid embryo may fail to implant,” the authors continued.

The mean overall decision regret scale score was 8.5 on a scale of 0-100 – with a median of 0 – and 61% of respondents said they had no regrets about undergoing preimplantation genetic testing for aneuploidy; the remaining 39% reported “any degree of regret.”

This “one-third of respondents reported some degree of regret, suggesting an important opportunity for pretest counseling and support among patients pursuing PGT-A,” Dr. Goldman and associates emphasized.

Of the respondents who then underwent euploid embryo transfer, and who had a known pregnancy outcome, the 36 with an ongoing or delivered pregnancy had significantly less decision regret than the 24 who experienced a negative pregnancy test or a miscarriage.

The study found no differences in decision regret between those aged under or over 35 years of age, those with different levels of educational attainment, or between patients who paid exclusively out of pocket compared with those with any insurance coverage.

However, greater levels of decision regret were seen in patients who had experienced a longer time since retrieval of oocytes and those who said they would consider pregnancy with donor oocytes if they were unsuccessful with IVF and PGT-A.

“Completing a cycle of IVF with PGT-A and obtaining no usable, euploid embryos results in distress, but this distress must be weighed against the alternative scenario in which a patient invests valuable time, energy, and resources into a futile embryo transfer cycle resulting in a negative pregnancy test, miscarriage, or aneuploid gestation,” the authors wrote.

When assessing the dependence of the decision regret score on demographic factors, the researchers found that patients who had learned about PGT-A from their physicians, rather than from other sources such as friends or the Internet, had the highest levels of decision regret.

There was no external funding. One coauthor declared personal fees and other support from the fertility and pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Goldman KN et al. Hum Reprod. 2019 Jun 21. doi: 10.1093/humrep/dez080.

The decision to undergo preimplantation genetic testing for aneuploidy is associated with a small but not unimportant amount of regret among some patients undergoing fertility treatment, research suggests.

In a report published in Human Reproduction, researchers did an anonymous survey of 69 patients undergoing their first cycle of autologous preimplantation genetic testing for aneuploidy (PGT-A) at a single fertility center.

“Despite the known distress associated with many aspects of assisted reproductive technology (ART) and the many opportunities for distress among patients pursuing PGT-A, little is known about the associated patient experience and psychological risks,” wrote Dr. Kara N. Goldman of New York University Langone Fertility Center, and coauthors.

“A ‘failure’ after PGT-A can present in many forms well before other IVF losses may be experienced: Embryos may not meet criteria for biopsy, PGT-A may result in an all-aneuploid embryo cohort, or a euploid embryo may fail to implant,” the authors continued.

The mean overall decision regret scale score was 8.5 on a scale of 0-100 – with a median of 0 – and 61% of respondents said they had no regrets about undergoing preimplantation genetic testing for aneuploidy; the remaining 39% reported “any degree of regret.”

This “one-third of respondents reported some degree of regret, suggesting an important opportunity for pretest counseling and support among patients pursuing PGT-A,” Dr. Goldman and associates emphasized.

Of the respondents who then underwent euploid embryo transfer, and who had a known pregnancy outcome, the 36 with an ongoing or delivered pregnancy had significantly less decision regret than the 24 who experienced a negative pregnancy test or a miscarriage.

The study found no differences in decision regret between those aged under or over 35 years of age, those with different levels of educational attainment, or between patients who paid exclusively out of pocket compared with those with any insurance coverage.

However, greater levels of decision regret were seen in patients who had experienced a longer time since retrieval of oocytes and those who said they would consider pregnancy with donor oocytes if they were unsuccessful with IVF and PGT-A.

“Completing a cycle of IVF with PGT-A and obtaining no usable, euploid embryos results in distress, but this distress must be weighed against the alternative scenario in which a patient invests valuable time, energy, and resources into a futile embryo transfer cycle resulting in a negative pregnancy test, miscarriage, or aneuploid gestation,” the authors wrote.

When assessing the dependence of the decision regret score on demographic factors, the researchers found that patients who had learned about PGT-A from their physicians, rather than from other sources such as friends or the Internet, had the highest levels of decision regret.

There was no external funding. One coauthor declared personal fees and other support from the fertility and pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Goldman KN et al. Hum Reprod. 2019 Jun 21. doi: 10.1093/humrep/dez080.

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July: An important month for pediatric hospital medicine

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National conferences and grassroots initiatives

 

Each July, the largest gathering of pediatric hospitalists occurs, and 2019 is no different! This year, hospitalists who care for children will gather at Pediatric Hospital Medicine (PHM) in Seattle from July 25 to 28, with the goal of enhancing participants’ knowledge and competence in the areas of innovation, clinical medicine, education, health services, practice management, quality improvement, and research.

Dr. Kris Rehm

But what makes this year particularly special is the launch of the subspecialty exam for certification in pediatric hospital medicine coming later this fall, solidifying its growth and importance within hospital medicine and the entire health care landscape. The American Board of Pediatrics (ABP) has approved PHM as the newest board subspecialty with a 2-year fellowship accredited by the Accreditation Council for Graduate Medical Education (ACGME). This conference will be a great opportunity to join with others to review competencies for board review, as well as to network with those who are also navigating the road ahead.

During 2019, the Pediatric Hospitalist Special Interest Group (SIG) of SHM has been working tirelessly on several initiatives, including a revision of the Pediatric Hospital Medicine Core Competencies as well as additional work to develop Choosing Wisely 2.0 recommendations. These will help us ensure we are developing the best curricula for the next generation of pediatric hospitalists, while cutting back on unnecessary tests and procedures for those practicing today. Each of these initiatives, as well as the July conference, highlights the opportunities that we have within SHM to work with other like-minded providers who care for children. While we partner with all professionals across many organizations, like the American Academy of Pediatrics and the Academic Pediatric Association to name a few, I wanted to share my reflections on SHM and my appreciation for the “big tent” philosophy that has served us so well thus far.

Having an opportunity to sit on the board of SHM has allowed me a chance to really appreciate the efforts that this organization invests in all who care for patients in the hospital; we have an active group of advanced-practice providers, practice administrators, residents, students, academic hospitalists, and the list goes on and on. We collaborate with a number of spectacular societies dedicated to medical specialties, and we are always open to new ways of improving the methods of delivering care to patients, in hospitals, post-acute care facilities, homes – you name it! As health care delivery models continue to evolve, I believe we are well positioned to be leaders in the delivery of acute care medicine in the hospital and beyond.

I have also learned of happenings at the grassroots level by attending SHM chapter meetings across the United States. For example, the Hampton Roads Chapter led a great Point-of-Care Ultrasound (POCUS) workshop, and influenced by that, I shared an idea at home in Nashville – borrowing my son as a model to demonstrate ultrasound techniques that hospitalists can use to assist in clinical care. I hope you, as pediatric hospitalists, will see if you have a local chapter and attend a meeting; whether you are a member of SHM or not, you can mingle with those who provide acute care treatments to all your communities and share best practices. If you don’t see an SHM chapter close by, let’s get one going! SHM is here to help launch a chapter that can help bring your community together and provide education and networking closer to home.

If you can’t attend PHM in Seattle this year, I hope you will make every effort to be at PHM 2020, where our own SIG leader, Dr. Jeffrey Grill from Louisville, Ky., will be chairing the next rendition of this amazing conference. The SHM Meetings team led by Michelle Kann will be working tirelessly to make it a great event with continued growth in content and attendance.

Dr. Rehm is associate professor, pediatrics, and director, division of pediatric outreach medicine at Vanderbilt University and Monroe Carell Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn. She is also a member of the SHM board of directors.

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National conferences and grassroots initiatives

National conferences and grassroots initiatives

 

Each July, the largest gathering of pediatric hospitalists occurs, and 2019 is no different! This year, hospitalists who care for children will gather at Pediatric Hospital Medicine (PHM) in Seattle from July 25 to 28, with the goal of enhancing participants’ knowledge and competence in the areas of innovation, clinical medicine, education, health services, practice management, quality improvement, and research.

Dr. Kris Rehm

But what makes this year particularly special is the launch of the subspecialty exam for certification in pediatric hospital medicine coming later this fall, solidifying its growth and importance within hospital medicine and the entire health care landscape. The American Board of Pediatrics (ABP) has approved PHM as the newest board subspecialty with a 2-year fellowship accredited by the Accreditation Council for Graduate Medical Education (ACGME). This conference will be a great opportunity to join with others to review competencies for board review, as well as to network with those who are also navigating the road ahead.

During 2019, the Pediatric Hospitalist Special Interest Group (SIG) of SHM has been working tirelessly on several initiatives, including a revision of the Pediatric Hospital Medicine Core Competencies as well as additional work to develop Choosing Wisely 2.0 recommendations. These will help us ensure we are developing the best curricula for the next generation of pediatric hospitalists, while cutting back on unnecessary tests and procedures for those practicing today. Each of these initiatives, as well as the July conference, highlights the opportunities that we have within SHM to work with other like-minded providers who care for children. While we partner with all professionals across many organizations, like the American Academy of Pediatrics and the Academic Pediatric Association to name a few, I wanted to share my reflections on SHM and my appreciation for the “big tent” philosophy that has served us so well thus far.

Having an opportunity to sit on the board of SHM has allowed me a chance to really appreciate the efforts that this organization invests in all who care for patients in the hospital; we have an active group of advanced-practice providers, practice administrators, residents, students, academic hospitalists, and the list goes on and on. We collaborate with a number of spectacular societies dedicated to medical specialties, and we are always open to new ways of improving the methods of delivering care to patients, in hospitals, post-acute care facilities, homes – you name it! As health care delivery models continue to evolve, I believe we are well positioned to be leaders in the delivery of acute care medicine in the hospital and beyond.

I have also learned of happenings at the grassroots level by attending SHM chapter meetings across the United States. For example, the Hampton Roads Chapter led a great Point-of-Care Ultrasound (POCUS) workshop, and influenced by that, I shared an idea at home in Nashville – borrowing my son as a model to demonstrate ultrasound techniques that hospitalists can use to assist in clinical care. I hope you, as pediatric hospitalists, will see if you have a local chapter and attend a meeting; whether you are a member of SHM or not, you can mingle with those who provide acute care treatments to all your communities and share best practices. If you don’t see an SHM chapter close by, let’s get one going! SHM is here to help launch a chapter that can help bring your community together and provide education and networking closer to home.

If you can’t attend PHM in Seattle this year, I hope you will make every effort to be at PHM 2020, where our own SIG leader, Dr. Jeffrey Grill from Louisville, Ky., will be chairing the next rendition of this amazing conference. The SHM Meetings team led by Michelle Kann will be working tirelessly to make it a great event with continued growth in content and attendance.

Dr. Rehm is associate professor, pediatrics, and director, division of pediatric outreach medicine at Vanderbilt University and Monroe Carell Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn. She is also a member of the SHM board of directors.

 

Each July, the largest gathering of pediatric hospitalists occurs, and 2019 is no different! This year, hospitalists who care for children will gather at Pediatric Hospital Medicine (PHM) in Seattle from July 25 to 28, with the goal of enhancing participants’ knowledge and competence in the areas of innovation, clinical medicine, education, health services, practice management, quality improvement, and research.

Dr. Kris Rehm

But what makes this year particularly special is the launch of the subspecialty exam for certification in pediatric hospital medicine coming later this fall, solidifying its growth and importance within hospital medicine and the entire health care landscape. The American Board of Pediatrics (ABP) has approved PHM as the newest board subspecialty with a 2-year fellowship accredited by the Accreditation Council for Graduate Medical Education (ACGME). This conference will be a great opportunity to join with others to review competencies for board review, as well as to network with those who are also navigating the road ahead.

During 2019, the Pediatric Hospitalist Special Interest Group (SIG) of SHM has been working tirelessly on several initiatives, including a revision of the Pediatric Hospital Medicine Core Competencies as well as additional work to develop Choosing Wisely 2.0 recommendations. These will help us ensure we are developing the best curricula for the next generation of pediatric hospitalists, while cutting back on unnecessary tests and procedures for those practicing today. Each of these initiatives, as well as the July conference, highlights the opportunities that we have within SHM to work with other like-minded providers who care for children. While we partner with all professionals across many organizations, like the American Academy of Pediatrics and the Academic Pediatric Association to name a few, I wanted to share my reflections on SHM and my appreciation for the “big tent” philosophy that has served us so well thus far.

Having an opportunity to sit on the board of SHM has allowed me a chance to really appreciate the efforts that this organization invests in all who care for patients in the hospital; we have an active group of advanced-practice providers, practice administrators, residents, students, academic hospitalists, and the list goes on and on. We collaborate with a number of spectacular societies dedicated to medical specialties, and we are always open to new ways of improving the methods of delivering care to patients, in hospitals, post-acute care facilities, homes – you name it! As health care delivery models continue to evolve, I believe we are well positioned to be leaders in the delivery of acute care medicine in the hospital and beyond.

I have also learned of happenings at the grassroots level by attending SHM chapter meetings across the United States. For example, the Hampton Roads Chapter led a great Point-of-Care Ultrasound (POCUS) workshop, and influenced by that, I shared an idea at home in Nashville – borrowing my son as a model to demonstrate ultrasound techniques that hospitalists can use to assist in clinical care. I hope you, as pediatric hospitalists, will see if you have a local chapter and attend a meeting; whether you are a member of SHM or not, you can mingle with those who provide acute care treatments to all your communities and share best practices. If you don’t see an SHM chapter close by, let’s get one going! SHM is here to help launch a chapter that can help bring your community together and provide education and networking closer to home.

If you can’t attend PHM in Seattle this year, I hope you will make every effort to be at PHM 2020, where our own SIG leader, Dr. Jeffrey Grill from Louisville, Ky., will be chairing the next rendition of this amazing conference. The SHM Meetings team led by Michelle Kann will be working tirelessly to make it a great event with continued growth in content and attendance.

Dr. Rehm is associate professor, pediatrics, and director, division of pediatric outreach medicine at Vanderbilt University and Monroe Carell Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn. She is also a member of the SHM board of directors.

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Racial, age disparities confirmed in triple-negative breast cancer

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Odds of triple-negative breast cancer (TNBC) are elevated for minority women and younger women, results of a nationwide cross-sectional cohort study of more than a million breast cancer cases confirm.

Previous studies have suggested certain sociodemographic groups are disproportionately affected by TNBC, but have been limited by the population studied, size, and characteristics assessed, note the investigators, who were led by Lia C. Scott, PhD, MPH, of the division of epidemiology and biostatistics at the School of Public Health, Georgia State University, Atlanta. “It is imperative that cancer research identify factors that drive disparities and focus on prevention,” they wrote in Cancer.

Dr. Scott and coinvestigators used the United States Cancer Statistics database to identify 1,151,724 cases of breast cancer diagnosed during 2010-2014 in 39 states having the necessary data. TNBC accounted for roughly 8.4% of all cases.

In unadjusted analyses using non-Hispanic white women as the comparator, odds of TNBC were significantly higher for non-Hispanic black women (odds ratio, 2.27), Hispanic women (OR, 1.22), and American Indian/Alaska Native women (OR, 1.26). On the other hand, odds were lower for Asian women (OR, 0.92).

By age group, compared with women 50-64 years old, women younger than 40 years were most likely to have the TNBC phenotype (OR, 1.95), while women aged 75 or older were least likely (OR, 0.75). Odds of TNBC were also significantly elevated for women whose cancer was diagnosed at stage III or higher (OR, 1.69) or at stage IV (OR, 1.47).

Findings were essentially the same in analyses simultaneously adjusted for age, race, and stage.

“The results of the current study demonstrated that there is a significant burden of disease in TNBC diagnosed among women of color, specifically non-Hispanic black women, and younger women,” Dr. Scott and coinvestigators write. “Given the large sample size and geospatial coverage of the data, these results are somewhat different from and also more generalizable, compared with data from previous studies.”

“With the advent and availability of more comprehensive cancer data, such as the United States Cancer Statistics database, it is important that we continue to explore disparities in order to better inform practice and policy around screenable cancers like breast cancer,” she further commented in a statement. “We hope that this update on the epidemiology of triple-negative breast cancer can provide a basis to further explore contributing factors in future research.”

Dr. Scott disclosed that she received a Dissertation Training Grant (F31-Diversity) from the National Institutes of Health. The study was funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health; the Centers for Disease Control and Prevention’s National Program of Cancer Registries contributed funds to cover the standard research data center fees for researchers conducting analyses under approved research projects.

SOURCE: Scott LC et al. Cancer. 2019 Jul 8. doi: 10.1002/cncr.32207.

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Odds of triple-negative breast cancer (TNBC) are elevated for minority women and younger women, results of a nationwide cross-sectional cohort study of more than a million breast cancer cases confirm.

Previous studies have suggested certain sociodemographic groups are disproportionately affected by TNBC, but have been limited by the population studied, size, and characteristics assessed, note the investigators, who were led by Lia C. Scott, PhD, MPH, of the division of epidemiology and biostatistics at the School of Public Health, Georgia State University, Atlanta. “It is imperative that cancer research identify factors that drive disparities and focus on prevention,” they wrote in Cancer.

Dr. Scott and coinvestigators used the United States Cancer Statistics database to identify 1,151,724 cases of breast cancer diagnosed during 2010-2014 in 39 states having the necessary data. TNBC accounted for roughly 8.4% of all cases.

In unadjusted analyses using non-Hispanic white women as the comparator, odds of TNBC were significantly higher for non-Hispanic black women (odds ratio, 2.27), Hispanic women (OR, 1.22), and American Indian/Alaska Native women (OR, 1.26). On the other hand, odds were lower for Asian women (OR, 0.92).

By age group, compared with women 50-64 years old, women younger than 40 years were most likely to have the TNBC phenotype (OR, 1.95), while women aged 75 or older were least likely (OR, 0.75). Odds of TNBC were also significantly elevated for women whose cancer was diagnosed at stage III or higher (OR, 1.69) or at stage IV (OR, 1.47).

Findings were essentially the same in analyses simultaneously adjusted for age, race, and stage.

“The results of the current study demonstrated that there is a significant burden of disease in TNBC diagnosed among women of color, specifically non-Hispanic black women, and younger women,” Dr. Scott and coinvestigators write. “Given the large sample size and geospatial coverage of the data, these results are somewhat different from and also more generalizable, compared with data from previous studies.”

“With the advent and availability of more comprehensive cancer data, such as the United States Cancer Statistics database, it is important that we continue to explore disparities in order to better inform practice and policy around screenable cancers like breast cancer,” she further commented in a statement. “We hope that this update on the epidemiology of triple-negative breast cancer can provide a basis to further explore contributing factors in future research.”

Dr. Scott disclosed that she received a Dissertation Training Grant (F31-Diversity) from the National Institutes of Health. The study was funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health; the Centers for Disease Control and Prevention’s National Program of Cancer Registries contributed funds to cover the standard research data center fees for researchers conducting analyses under approved research projects.

SOURCE: Scott LC et al. Cancer. 2019 Jul 8. doi: 10.1002/cncr.32207.

 

Odds of triple-negative breast cancer (TNBC) are elevated for minority women and younger women, results of a nationwide cross-sectional cohort study of more than a million breast cancer cases confirm.

Previous studies have suggested certain sociodemographic groups are disproportionately affected by TNBC, but have been limited by the population studied, size, and characteristics assessed, note the investigators, who were led by Lia C. Scott, PhD, MPH, of the division of epidemiology and biostatistics at the School of Public Health, Georgia State University, Atlanta. “It is imperative that cancer research identify factors that drive disparities and focus on prevention,” they wrote in Cancer.

Dr. Scott and coinvestigators used the United States Cancer Statistics database to identify 1,151,724 cases of breast cancer diagnosed during 2010-2014 in 39 states having the necessary data. TNBC accounted for roughly 8.4% of all cases.

In unadjusted analyses using non-Hispanic white women as the comparator, odds of TNBC were significantly higher for non-Hispanic black women (odds ratio, 2.27), Hispanic women (OR, 1.22), and American Indian/Alaska Native women (OR, 1.26). On the other hand, odds were lower for Asian women (OR, 0.92).

By age group, compared with women 50-64 years old, women younger than 40 years were most likely to have the TNBC phenotype (OR, 1.95), while women aged 75 or older were least likely (OR, 0.75). Odds of TNBC were also significantly elevated for women whose cancer was diagnosed at stage III or higher (OR, 1.69) or at stage IV (OR, 1.47).

Findings were essentially the same in analyses simultaneously adjusted for age, race, and stage.

“The results of the current study demonstrated that there is a significant burden of disease in TNBC diagnosed among women of color, specifically non-Hispanic black women, and younger women,” Dr. Scott and coinvestigators write. “Given the large sample size and geospatial coverage of the data, these results are somewhat different from and also more generalizable, compared with data from previous studies.”

“With the advent and availability of more comprehensive cancer data, such as the United States Cancer Statistics database, it is important that we continue to explore disparities in order to better inform practice and policy around screenable cancers like breast cancer,” she further commented in a statement. “We hope that this update on the epidemiology of triple-negative breast cancer can provide a basis to further explore contributing factors in future research.”

Dr. Scott disclosed that she received a Dissertation Training Grant (F31-Diversity) from the National Institutes of Health. The study was funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health; the Centers for Disease Control and Prevention’s National Program of Cancer Registries contributed funds to cover the standard research data center fees for researchers conducting analyses under approved research projects.

SOURCE: Scott LC et al. Cancer. 2019 Jul 8. doi: 10.1002/cncr.32207.

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Grouped Erythematous Papules and Plaques on the Trunk

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Grouped Erythematous Papules and Plaques on the Trunk

The Diagnosis: Cutaneous B-Cell Lymphoma, Follicle Center Subtype 

A 4-mm punch biopsy through the center of the largest lesion on the right posterior shoulder demonstrated a superficial and deep dermal atypical lymphoid infiltrate composed predominantly of small mature lymphocytes with interspersed intermediate-sized cells with irregular to cleaved nuclei, dispersed chromatin, one or more distinct nucleoli, occasional mitoses, and small amounts of cytoplasm (Figure, A). Immunoperoxidase studies showed the infiltrate to be a mixture of CD3+ T cells and CD20+ B cells (Figure, B). The B cells coexpressed B-cell lymphoma (Bcl) 6 protein (Figure, C) but were negative for multiple myeloma 1/interferon regulatory factor 4 and CD10; Bcl2 protein was positive in T cells but inconclusive for staining in B cells. Very few plasma cells were seen with CD138 stain. Fluorescence in situ hybridization studies were negative for IgH and BCL2 gene rearrangement. Molecular diagnostic studies for IgH and κ light chain gene rearrangement were positive for a clonal population. A clonal T-cell receptor γ chain gene rearrangement was not identified. The overall morphologic, immunophenotypic, and molecular findings were consistent with cutaneous involvement by a B-cell lymphoproliferative disorder, favoring primary cutaneous follicle center lymphoma (PCFCL). 

Histopathology of primary cutaneous follicle center lymphoma. A, A superficial and deep dermal atypical lymphoid infiltrate was composed predominantly of small mature lymphocytes with interspersed intermediate-sized cells with irregular to cleaved nuclei, dispersed chromatin, one or more distinct nucleoli, occasional mitoses, and small amounts of cytoplasm (H&E, original magnification ×20 [inset, original magnification ×100). B, Immunoperoxidase study showed CD20+ B cells (original magnification ×20). C, The B cells were coexpressed on B-cell lymphoma 6 immunoperoxidase stain (original magnification ×40).

The patient was referred to our cancer center for further workup consisting of a complete blood cell count with differential; comprehensive metabolic panel; lactate dehydrogenase; serum protein electrophoresis; peripheral blood flow cytometry; and computed tomography of the chest, abdomen, and pelvis. The analysis was unremarkable, supporting primary cutaneous disease. Additional studies suggested in the National Comprehensive Cancer Network (NCCN) Guidelines for primary cutaneous B-cell lymphomas include hepatitis B testing if the patient is being considered for immunotherapy and/or chemotherapy due to risk of reactivation, pregnancy testing in women of childbearing age, and human immunodeficiency virus testing.1 These tests were not performed in our patient because he did not have any risk factors for hepatitis B or human immunodeficiency virus. 

Primary cutaneous B-cell lymphomas originate in the skin without evidence of extracutaneous disease at presentation. They account for approximately 25% of primary cutaneous lymphomas in the United States, with primary cutaneous T-cell lymphoma being most common.2 The revised 2017 World Health Organization classification system defines 3 major subtypes of primary cutaneous B-cell lymphoma (Table).3-9 Primary cutaneous follicle center lymphoma is the most common subtype, accounting for approximately 60% of cases. In Europe, an association with Borrelia burgdorferi has been reported.10 The extent of skin involvement determines the T portion of TNM staging for PCFCL. It is based on the size and location of affected body regions that are delineated, such as the head and neck, chest, abdomen/genitalia, upper back, lower back/buttocks, each upper arm, each lower arm/hand, each upper leg, and each lower leg/foot. T1 is for solitary skin involvement in which the lesion is 5 cm or less in diameter (T1a) or greater than 5 cm (T1b). T2 is for regional skin involvement limited to 1 or 2 contiguous body regions, whereas T2a has all lesions confined to an area 15 cm or less in diameter, T2b has lesions confined to an area greater than 15 cm up to 30 cm in diameter, and the area for T2c is greater than 30 cm in diameter. Finally, T3 is generalized skin involvement, whereas T3a has multiple lesions in 2 noncontiguous body regions, and T3b has multiple lesions on 3 or more regions.11 At presentation, our patient was considered T2cN0M0, as his lesions were present on only 2 contiguous regions extending beyond 30 cm without any evidence of lymph node involvement or metastasis.  

Treatment of PCFCL is tailored to each case, as there is a paucity of randomized data in this rare entity. It is guided by the number and location of cutaneous lesions, associated skin symptoms, age of the patient, and performance status. Local disease can be treated with intralesional corticosteroids, excision, or close monitoring if the patient is asymptomatic. Low-dose radiation therapy may be used as primary treatment or for local recurrence.12 Patients with more extensive skin lesions can relapse after clearing; those with refractory disease can be managed with single-agent rituximab.13 Our patient underwent low-dose radiation therapy with good response and has not experienced recurrence. 

Lymphocytoma cutis, also known as benign reactive lymphoid hyperplasia, can be idiopathic or can arise after arthropod assault, penetrative skin trauma, drugs, or infections. In granuloma annulare, small dermal papules may present in isolation or coalesce to form annular plaques. It is a benign inflammatory disorder of unknown cause, can have mild pruritus, and usually is self-limited. Pyogenic granuloma is a benign vascular proliferation of unknown etiology. Sarcoidosis is an immune-mediated systemic disorder with granuloma formation that has a predilection for the lungs and the skin. 

References
  1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Primary Cutaneous B-Cell Lymphomas. Version 2.2018. https://oncolife.com.ua/doc/nccn/Primary_Cutaneous_B-Cell_Lymphomas.pdf. Published January 10, 2018. Accessed June 21, 2019.  
  2. Dores GM, Anderson WF, Devesa SS. Cutaneous lymphomas reported to the National Cancer Institute's surveillance, epidemiology, and end results program: applying the new WHO-European Organisation for Research and Treatment of Cancer classification system. J Clin Oncol. 2005;23:7246-7248. 
  3. Swerdlow SH, Campo E, Harris NL, et al, eds. World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. Lyon, France: IARC; 2017. 
  4. Surveillance, Epidemiology, and End Results Program. National Cancer Institute website. https://seer.cancer.gov/. Accessed June 26, 2019. 
  5. Cerroni L. B-cell lymphomas of the skin. In: Bolognia JL, Schaffer JV, Cerroni L, eds. Dermatology. 4th ed. China: Elsevier; 2018:2113-2126. 
  6. Jacobsen E, Freedman AS, Willemze R. Primary cutaneous follicle center lymphoma. UpToDate website. https://www.uptodate.com/contents/primary-cutaneous-follicle-center-lymphoma. Updated February 7, 2018. Accessed June 26, 2019. 
  7. Jacobsen E, Freedman AS, Willemze R. Primary cutaneous marginal zone lymphoma. UpToDate website. https://www.uptodate.com/contents/primary-cutaneous-marginal-zone-lymphoma. Updated March 6, 2019. Accessed June 26, 2019. 
  8. Jacobsen E, Freedman AS, Willemze R. Primary cutaneous large B cell lymphoma, leg type. UpToDate website. https://www.uptodate.com/contents/primary-cutaneous-large-b-cell-lymphoma-leg-type. Updated July 3, 2017. Accessed June 26, 2019. 
  9. Suárez AL, Pulitzer M, Horwitz S, et al. Primary cutaneous B-cell lymphomas: part I. clinical features, diagnosis, and classification. J Am Acad Dermatol. 2013;69:329.e1-13; quiz 241-342. 
  10. Goodlad JR, Davidson MM, Hollowood K, et al. Primary cutaneous B-cell lymphoma and Borrelia burgdorferi infection in patients from the Highlands of Scotand. Am J Surg Pathol. 2000;24:1279-1285. 
  11. Kim YH, Willemze R, Pimpinelli N, et al. TNM classification system for primary cutaneous lymphomas other than mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the Cutaneous Lymphoma Task Force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110:479-484. 
  12. Wilcon RA. Cutaneous B-cell lymphomas: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91:1052-1055. 
  13. Morales AV, Advani R, Horwitz SM, et al. Indolent primary cutaneous B-cell lymphoma: experience using systemic rituximab. J Am Acad Dermatol. 2008;59:953-957.
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From Roger Williams Medical Center, Providence, Rhode Island. Drs. George and Fischer are from the Division of Dermatology, and Drs. Almardini and Breen are from the Department of Pathology.

The authors report no conflict of interest.

Correspondence: Dean David George, MD, Division of Dermatology, Roger Williams Medical Center, 50 Maude St, 1st Floor, Providence, RI 02908 (ddgeorge@bu.edu).

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The authors report no conflict of interest.

Correspondence: Dean David George, MD, Division of Dermatology, Roger Williams Medical Center, 50 Maude St, 1st Floor, Providence, RI 02908 (ddgeorge@bu.edu).

Author and Disclosure Information

From Roger Williams Medical Center, Providence, Rhode Island. Drs. George and Fischer are from the Division of Dermatology, and Drs. Almardini and Breen are from the Department of Pathology.

The authors report no conflict of interest.

Correspondence: Dean David George, MD, Division of Dermatology, Roger Williams Medical Center, 50 Maude St, 1st Floor, Providence, RI 02908 (ddgeorge@bu.edu).

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The Diagnosis: Cutaneous B-Cell Lymphoma, Follicle Center Subtype 

A 4-mm punch biopsy through the center of the largest lesion on the right posterior shoulder demonstrated a superficial and deep dermal atypical lymphoid infiltrate composed predominantly of small mature lymphocytes with interspersed intermediate-sized cells with irregular to cleaved nuclei, dispersed chromatin, one or more distinct nucleoli, occasional mitoses, and small amounts of cytoplasm (Figure, A). Immunoperoxidase studies showed the infiltrate to be a mixture of CD3+ T cells and CD20+ B cells (Figure, B). The B cells coexpressed B-cell lymphoma (Bcl) 6 protein (Figure, C) but were negative for multiple myeloma 1/interferon regulatory factor 4 and CD10; Bcl2 protein was positive in T cells but inconclusive for staining in B cells. Very few plasma cells were seen with CD138 stain. Fluorescence in situ hybridization studies were negative for IgH and BCL2 gene rearrangement. Molecular diagnostic studies for IgH and κ light chain gene rearrangement were positive for a clonal population. A clonal T-cell receptor γ chain gene rearrangement was not identified. The overall morphologic, immunophenotypic, and molecular findings were consistent with cutaneous involvement by a B-cell lymphoproliferative disorder, favoring primary cutaneous follicle center lymphoma (PCFCL). 

Histopathology of primary cutaneous follicle center lymphoma. A, A superficial and deep dermal atypical lymphoid infiltrate was composed predominantly of small mature lymphocytes with interspersed intermediate-sized cells with irregular to cleaved nuclei, dispersed chromatin, one or more distinct nucleoli, occasional mitoses, and small amounts of cytoplasm (H&E, original magnification ×20 [inset, original magnification ×100). B, Immunoperoxidase study showed CD20+ B cells (original magnification ×20). C, The B cells were coexpressed on B-cell lymphoma 6 immunoperoxidase stain (original magnification ×40).

The patient was referred to our cancer center for further workup consisting of a complete blood cell count with differential; comprehensive metabolic panel; lactate dehydrogenase; serum protein electrophoresis; peripheral blood flow cytometry; and computed tomography of the chest, abdomen, and pelvis. The analysis was unremarkable, supporting primary cutaneous disease. Additional studies suggested in the National Comprehensive Cancer Network (NCCN) Guidelines for primary cutaneous B-cell lymphomas include hepatitis B testing if the patient is being considered for immunotherapy and/or chemotherapy due to risk of reactivation, pregnancy testing in women of childbearing age, and human immunodeficiency virus testing.1 These tests were not performed in our patient because he did not have any risk factors for hepatitis B or human immunodeficiency virus. 

Primary cutaneous B-cell lymphomas originate in the skin without evidence of extracutaneous disease at presentation. They account for approximately 25% of primary cutaneous lymphomas in the United States, with primary cutaneous T-cell lymphoma being most common.2 The revised 2017 World Health Organization classification system defines 3 major subtypes of primary cutaneous B-cell lymphoma (Table).3-9 Primary cutaneous follicle center lymphoma is the most common subtype, accounting for approximately 60% of cases. In Europe, an association with Borrelia burgdorferi has been reported.10 The extent of skin involvement determines the T portion of TNM staging for PCFCL. It is based on the size and location of affected body regions that are delineated, such as the head and neck, chest, abdomen/genitalia, upper back, lower back/buttocks, each upper arm, each lower arm/hand, each upper leg, and each lower leg/foot. T1 is for solitary skin involvement in which the lesion is 5 cm or less in diameter (T1a) or greater than 5 cm (T1b). T2 is for regional skin involvement limited to 1 or 2 contiguous body regions, whereas T2a has all lesions confined to an area 15 cm or less in diameter, T2b has lesions confined to an area greater than 15 cm up to 30 cm in diameter, and the area for T2c is greater than 30 cm in diameter. Finally, T3 is generalized skin involvement, whereas T3a has multiple lesions in 2 noncontiguous body regions, and T3b has multiple lesions on 3 or more regions.11 At presentation, our patient was considered T2cN0M0, as his lesions were present on only 2 contiguous regions extending beyond 30 cm without any evidence of lymph node involvement or metastasis.  

Treatment of PCFCL is tailored to each case, as there is a paucity of randomized data in this rare entity. It is guided by the number and location of cutaneous lesions, associated skin symptoms, age of the patient, and performance status. Local disease can be treated with intralesional corticosteroids, excision, or close monitoring if the patient is asymptomatic. Low-dose radiation therapy may be used as primary treatment or for local recurrence.12 Patients with more extensive skin lesions can relapse after clearing; those with refractory disease can be managed with single-agent rituximab.13 Our patient underwent low-dose radiation therapy with good response and has not experienced recurrence. 

Lymphocytoma cutis, also known as benign reactive lymphoid hyperplasia, can be idiopathic or can arise after arthropod assault, penetrative skin trauma, drugs, or infections. In granuloma annulare, small dermal papules may present in isolation or coalesce to form annular plaques. It is a benign inflammatory disorder of unknown cause, can have mild pruritus, and usually is self-limited. Pyogenic granuloma is a benign vascular proliferation of unknown etiology. Sarcoidosis is an immune-mediated systemic disorder with granuloma formation that has a predilection for the lungs and the skin. 

The Diagnosis: Cutaneous B-Cell Lymphoma, Follicle Center Subtype 

A 4-mm punch biopsy through the center of the largest lesion on the right posterior shoulder demonstrated a superficial and deep dermal atypical lymphoid infiltrate composed predominantly of small mature lymphocytes with interspersed intermediate-sized cells with irregular to cleaved nuclei, dispersed chromatin, one or more distinct nucleoli, occasional mitoses, and small amounts of cytoplasm (Figure, A). Immunoperoxidase studies showed the infiltrate to be a mixture of CD3+ T cells and CD20+ B cells (Figure, B). The B cells coexpressed B-cell lymphoma (Bcl) 6 protein (Figure, C) but were negative for multiple myeloma 1/interferon regulatory factor 4 and CD10; Bcl2 protein was positive in T cells but inconclusive for staining in B cells. Very few plasma cells were seen with CD138 stain. Fluorescence in situ hybridization studies were negative for IgH and BCL2 gene rearrangement. Molecular diagnostic studies for IgH and κ light chain gene rearrangement were positive for a clonal population. A clonal T-cell receptor γ chain gene rearrangement was not identified. The overall morphologic, immunophenotypic, and molecular findings were consistent with cutaneous involvement by a B-cell lymphoproliferative disorder, favoring primary cutaneous follicle center lymphoma (PCFCL). 

Histopathology of primary cutaneous follicle center lymphoma. A, A superficial and deep dermal atypical lymphoid infiltrate was composed predominantly of small mature lymphocytes with interspersed intermediate-sized cells with irregular to cleaved nuclei, dispersed chromatin, one or more distinct nucleoli, occasional mitoses, and small amounts of cytoplasm (H&E, original magnification ×20 [inset, original magnification ×100). B, Immunoperoxidase study showed CD20+ B cells (original magnification ×20). C, The B cells were coexpressed on B-cell lymphoma 6 immunoperoxidase stain (original magnification ×40).

The patient was referred to our cancer center for further workup consisting of a complete blood cell count with differential; comprehensive metabolic panel; lactate dehydrogenase; serum protein electrophoresis; peripheral blood flow cytometry; and computed tomography of the chest, abdomen, and pelvis. The analysis was unremarkable, supporting primary cutaneous disease. Additional studies suggested in the National Comprehensive Cancer Network (NCCN) Guidelines for primary cutaneous B-cell lymphomas include hepatitis B testing if the patient is being considered for immunotherapy and/or chemotherapy due to risk of reactivation, pregnancy testing in women of childbearing age, and human immunodeficiency virus testing.1 These tests were not performed in our patient because he did not have any risk factors for hepatitis B or human immunodeficiency virus. 

Primary cutaneous B-cell lymphomas originate in the skin without evidence of extracutaneous disease at presentation. They account for approximately 25% of primary cutaneous lymphomas in the United States, with primary cutaneous T-cell lymphoma being most common.2 The revised 2017 World Health Organization classification system defines 3 major subtypes of primary cutaneous B-cell lymphoma (Table).3-9 Primary cutaneous follicle center lymphoma is the most common subtype, accounting for approximately 60% of cases. In Europe, an association with Borrelia burgdorferi has been reported.10 The extent of skin involvement determines the T portion of TNM staging for PCFCL. It is based on the size and location of affected body regions that are delineated, such as the head and neck, chest, abdomen/genitalia, upper back, lower back/buttocks, each upper arm, each lower arm/hand, each upper leg, and each lower leg/foot. T1 is for solitary skin involvement in which the lesion is 5 cm or less in diameter (T1a) or greater than 5 cm (T1b). T2 is for regional skin involvement limited to 1 or 2 contiguous body regions, whereas T2a has all lesions confined to an area 15 cm or less in diameter, T2b has lesions confined to an area greater than 15 cm up to 30 cm in diameter, and the area for T2c is greater than 30 cm in diameter. Finally, T3 is generalized skin involvement, whereas T3a has multiple lesions in 2 noncontiguous body regions, and T3b has multiple lesions on 3 or more regions.11 At presentation, our patient was considered T2cN0M0, as his lesions were present on only 2 contiguous regions extending beyond 30 cm without any evidence of lymph node involvement or metastasis.  

Treatment of PCFCL is tailored to each case, as there is a paucity of randomized data in this rare entity. It is guided by the number and location of cutaneous lesions, associated skin symptoms, age of the patient, and performance status. Local disease can be treated with intralesional corticosteroids, excision, or close monitoring if the patient is asymptomatic. Low-dose radiation therapy may be used as primary treatment or for local recurrence.12 Patients with more extensive skin lesions can relapse after clearing; those with refractory disease can be managed with single-agent rituximab.13 Our patient underwent low-dose radiation therapy with good response and has not experienced recurrence. 

Lymphocytoma cutis, also known as benign reactive lymphoid hyperplasia, can be idiopathic or can arise after arthropod assault, penetrative skin trauma, drugs, or infections. In granuloma annulare, small dermal papules may present in isolation or coalesce to form annular plaques. It is a benign inflammatory disorder of unknown cause, can have mild pruritus, and usually is self-limited. Pyogenic granuloma is a benign vascular proliferation of unknown etiology. Sarcoidosis is an immune-mediated systemic disorder with granuloma formation that has a predilection for the lungs and the skin. 

References
  1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Primary Cutaneous B-Cell Lymphomas. Version 2.2018. https://oncolife.com.ua/doc/nccn/Primary_Cutaneous_B-Cell_Lymphomas.pdf. Published January 10, 2018. Accessed June 21, 2019.  
  2. Dores GM, Anderson WF, Devesa SS. Cutaneous lymphomas reported to the National Cancer Institute's surveillance, epidemiology, and end results program: applying the new WHO-European Organisation for Research and Treatment of Cancer classification system. J Clin Oncol. 2005;23:7246-7248. 
  3. Swerdlow SH, Campo E, Harris NL, et al, eds. World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. Lyon, France: IARC; 2017. 
  4. Surveillance, Epidemiology, and End Results Program. National Cancer Institute website. https://seer.cancer.gov/. Accessed June 26, 2019. 
  5. Cerroni L. B-cell lymphomas of the skin. In: Bolognia JL, Schaffer JV, Cerroni L, eds. Dermatology. 4th ed. China: Elsevier; 2018:2113-2126. 
  6. Jacobsen E, Freedman AS, Willemze R. Primary cutaneous follicle center lymphoma. UpToDate website. https://www.uptodate.com/contents/primary-cutaneous-follicle-center-lymphoma. Updated February 7, 2018. Accessed June 26, 2019. 
  7. Jacobsen E, Freedman AS, Willemze R. Primary cutaneous marginal zone lymphoma. UpToDate website. https://www.uptodate.com/contents/primary-cutaneous-marginal-zone-lymphoma. Updated March 6, 2019. Accessed June 26, 2019. 
  8. Jacobsen E, Freedman AS, Willemze R. Primary cutaneous large B cell lymphoma, leg type. UpToDate website. https://www.uptodate.com/contents/primary-cutaneous-large-b-cell-lymphoma-leg-type. Updated July 3, 2017. Accessed June 26, 2019. 
  9. Suárez AL, Pulitzer M, Horwitz S, et al. Primary cutaneous B-cell lymphomas: part I. clinical features, diagnosis, and classification. J Am Acad Dermatol. 2013;69:329.e1-13; quiz 241-342. 
  10. Goodlad JR, Davidson MM, Hollowood K, et al. Primary cutaneous B-cell lymphoma and Borrelia burgdorferi infection in patients from the Highlands of Scotand. Am J Surg Pathol. 2000;24:1279-1285. 
  11. Kim YH, Willemze R, Pimpinelli N, et al. TNM classification system for primary cutaneous lymphomas other than mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the Cutaneous Lymphoma Task Force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110:479-484. 
  12. Wilcon RA. Cutaneous B-cell lymphomas: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91:1052-1055. 
  13. Morales AV, Advani R, Horwitz SM, et al. Indolent primary cutaneous B-cell lymphoma: experience using systemic rituximab. J Am Acad Dermatol. 2008;59:953-957.
References
  1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Primary Cutaneous B-Cell Lymphomas. Version 2.2018. https://oncolife.com.ua/doc/nccn/Primary_Cutaneous_B-Cell_Lymphomas.pdf. Published January 10, 2018. Accessed June 21, 2019.  
  2. Dores GM, Anderson WF, Devesa SS. Cutaneous lymphomas reported to the National Cancer Institute's surveillance, epidemiology, and end results program: applying the new WHO-European Organisation for Research and Treatment of Cancer classification system. J Clin Oncol. 2005;23:7246-7248. 
  3. Swerdlow SH, Campo E, Harris NL, et al, eds. World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. Lyon, France: IARC; 2017. 
  4. Surveillance, Epidemiology, and End Results Program. National Cancer Institute website. https://seer.cancer.gov/. Accessed June 26, 2019. 
  5. Cerroni L. B-cell lymphomas of the skin. In: Bolognia JL, Schaffer JV, Cerroni L, eds. Dermatology. 4th ed. China: Elsevier; 2018:2113-2126. 
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Issue
Cutis - 104(1)
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Cutis - 104(1)
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25, 30-32
Page Number
25, 30-32
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Grouped Erythematous Papules and Plaques on the Trunk
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Grouped Erythematous Papules and Plaques on the Trunk
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A 34-year-old man presented to the outpatient dermatology clinic with 3 groups of mildly pruritic, erythematous papules and plaques. The most prominent group appeared on the right posterior shoulder and had been slowly enlarging in size over the last 12 months (quiz image). A similar thinner group appeared on the left mid-back 6 months prior, and a third smaller group appeared over the left serratus anterior muscle 2 months prior. The patient reported having similar episodes dating back to his early 20s. In those instances, the lesions presented without an inciting incident, became more pronounced, and persisted for months to years before resolving. Previously affected areas included the upper and lateral back, flanks, and posterior upper arms. The patient used triamcinolone cream 0.1% up to 3 times daily on active lesions, which improved the pruritus and seemed to make the lesions resolve more quickly. He denied fever, chills, night sweats, anorexia, weight loss, fatigue, cough, and shortness of breath. His only medication was ranitidine 150 mg twice daily for gastroesophageal reflux disease. Physical examination revealed no palpable lymphadenopathy.

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