MDedge Rheumatology

Key clinical point: Among patients with psoriatic arthritis (PsA), sonographic enthesitis was more prevalent in men than women.

Major finding: Compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005), as reflected by higher hypoechogenicity, thickening, and enthesophytes (P < .05), with the male sex being associated with a significantly higher ultrasound inflammatory enthesitis score (P = .02).

Study details: Findings are from a prospective study including 158 patients with PsA, of which 70 patients were men and 88 were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Furer V et al. Sex-based differences in sonographic and clinical findings among patients with psoriatic arthritis. J Rheumatol. 2022 (Oct 15). Doi: 10.3899/jrheum.220547

Key clinical point: Among patients with psoriatic arthritis (PsA), sonographic enthesitis was more prevalent in men than women.

Major finding: Compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005), as reflected by higher hypoechogenicity, thickening, and enthesophytes (P < .05), with the male sex being associated with a significantly higher ultrasound inflammatory enthesitis score (P = .02).

Study details: Findings are from a prospective study including 158 patients with PsA, of which 70 patients were men and 88 were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Furer V et al. Sex-based differences in sonographic and clinical findings among patients with psoriatic arthritis. J Rheumatol. 2022 (Oct 15). Doi: 10.3899/jrheum.220547

Key clinical point: Among patients with psoriatic arthritis (PsA), sonographic enthesitis was more prevalent in men than women.

Major finding: Compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005), as reflected by higher hypoechogenicity, thickening, and enthesophytes (P < .05), with the male sex being associated with a significantly higher ultrasound inflammatory enthesitis score (P = .02).

Study details: Findings are from a prospective study including 158 patients with PsA, of which 70 patients were men and 88 were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Furer V et al. Sex-based differences in sonographic and clinical findings among patients with psoriatic arthritis. J Rheumatol. 2022 (Oct 15). Doi: 10.3899/jrheum.220547

Key clinical point: Patients with psoriatic arthritis (PsA) experienced a slowing of radiographic progression during treatment with etanercept.

Major finding: In patients with available pre-etanercept radiographic data, the annualized radiographic progression was significantly lower with etanercept during the first 18 months than during the pre-etanercept treatment period (P < .005), and a higher proportion of patients showed no progression during etanercept treatment (61.7%) than during the pre-etanercept period (55.3%).

Study details: Findings are from a real-world, noninterventional study including 1821 participants who started treatment with etanercept, of which 1378 patients had rheumatoid arthritis and 440 patients had PsA.

Disclosures: This study was funded by Pfizer. Five authors declared being current or former employees of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Wassenberg S et al. Etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: Final results from a German non-interventional study (PRERA). Rheumatol Ther. 2022 (Oct 17). Doi: 10.1007/s40744-022-00491-4

Key clinical point: Patients with psoriatic arthritis (PsA) experienced a slowing of radiographic progression during treatment with etanercept.

Major finding: In patients with available pre-etanercept radiographic data, the annualized radiographic progression was significantly lower with etanercept during the first 18 months than during the pre-etanercept treatment period (P < .005), and a higher proportion of patients showed no progression during etanercept treatment (61.7%) than during the pre-etanercept period (55.3%).

Study details: Findings are from a real-world, noninterventional study including 1821 participants who started treatment with etanercept, of which 1378 patients had rheumatoid arthritis and 440 patients had PsA.

Disclosures: This study was funded by Pfizer. Five authors declared being current or former employees of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Wassenberg S et al. Etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: Final results from a German non-interventional study (PRERA). Rheumatol Ther. 2022 (Oct 17). Doi: 10.1007/s40744-022-00491-4

Key clinical point: Patients with psoriatic arthritis (PsA) experienced a slowing of radiographic progression during treatment with etanercept.

Major finding: In patients with available pre-etanercept radiographic data, the annualized radiographic progression was significantly lower with etanercept during the first 18 months than during the pre-etanercept treatment period (P < .005), and a higher proportion of patients showed no progression during etanercept treatment (61.7%) than during the pre-etanercept period (55.3%).

Study details: Findings are from a real-world, noninterventional study including 1821 participants who started treatment with etanercept, of which 1378 patients had rheumatoid arthritis and 440 patients had PsA.

Disclosures: This study was funded by Pfizer. Five authors declared being current or former employees of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Wassenberg S et al. Etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: Final results from a German non-interventional study (PRERA). Rheumatol Ther. 2022 (Oct 17). Doi: 10.1007/s40744-022-00491-4

Key clinical point: Compared with adalimumab, both 15 mg and 30 mg upadacitinib showed similar or better efficacy through 2 years and a similar safety profile in patients with psoriatic arthritis (PsA).

Major finding: At week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥20% improvement in the American College of Rheumatology criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable.

Study details: Findings are from an exploratory analysis of the SELECT-PsA 1 study including 1704 patients with active PsA and inadequate response/intolerance to ≥1 non-biologic disease-modifying antirheumatic drug who were randomly assigned to receive upadacitinib (15 or 30 mg) or adalimumab.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Efficacy and safety of upadacitinib in patients with psoriatic arthritis: 2-year results from the phase 3 SELECT-PsA 1 study. Rheumatol Ther. 2022 (Oct 15). Doi: 10.1007/s40744-022-00499-w

Key clinical point: Compared with adalimumab, both 15 mg and 30 mg upadacitinib showed similar or better efficacy through 2 years and a similar safety profile in patients with psoriatic arthritis (PsA).

Major finding: At week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥20% improvement in the American College of Rheumatology criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable.

Study details: Findings are from an exploratory analysis of the SELECT-PsA 1 study including 1704 patients with active PsA and inadequate response/intolerance to ≥1 non-biologic disease-modifying antirheumatic drug who were randomly assigned to receive upadacitinib (15 or 30 mg) or adalimumab.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Efficacy and safety of upadacitinib in patients with psoriatic arthritis: 2-year results from the phase 3 SELECT-PsA 1 study. Rheumatol Ther. 2022 (Oct 15). Doi: 10.1007/s40744-022-00499-w

Key clinical point: Compared with adalimumab, both 15 mg and 30 mg upadacitinib showed similar or better efficacy through 2 years and a similar safety profile in patients with psoriatic arthritis (PsA).

Major finding: At week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥20% improvement in the American College of Rheumatology criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable.

Study details: Findings are from an exploratory analysis of the SELECT-PsA 1 study including 1704 patients with active PsA and inadequate response/intolerance to ≥1 non-biologic disease-modifying antirheumatic drug who were randomly assigned to receive upadacitinib (15 or 30 mg) or adalimumab.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Efficacy and safety of upadacitinib in patients with psoriatic arthritis: 2-year results from the phase 3 SELECT-PsA 1 study. Rheumatol Ther. 2022 (Oct 15). Doi: 10.1007/s40744-022-00499-w

Key clinical point: Singleton pregnant women with psoriatic arthritis (PsA) had a significantly higher risk for preeclampsia than matched control pregnant women without PsA.

Major finding: Compared with control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13).

Study details: Findings are from an analysis of a register-based cohort study including singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively.

Disclosures: This study was supported by NordForsk and other sources. Some authors declared serving on speakers’ bureaus, receiving research grants, or receiving  consulting fees from several sources.

Source: Secher AEP et al. Risk of pre-eclampsia and impact of disease activity and antirheumatic treatment in women with rheumatoid arthritis, axial spondylarthritis and psoriatic arthritis: A collaborative matched cohort study from Sweden and Denmark. RMD Open. 2022;8:e002445 (Nov 3). Doi: 10.1136/rmdopen-2022-002445

Key clinical point: Singleton pregnant women with psoriatic arthritis (PsA) had a significantly higher risk for preeclampsia than matched control pregnant women without PsA.

Major finding: Compared with control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13).

Study details: Findings are from an analysis of a register-based cohort study including singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively.

Disclosures: This study was supported by NordForsk and other sources. Some authors declared serving on speakers’ bureaus, receiving research grants, or receiving  consulting fees from several sources.

Source: Secher AEP et al. Risk of pre-eclampsia and impact of disease activity and antirheumatic treatment in women with rheumatoid arthritis, axial spondylarthritis and psoriatic arthritis: A collaborative matched cohort study from Sweden and Denmark. RMD Open. 2022;8:e002445 (Nov 3). Doi: 10.1136/rmdopen-2022-002445

Key clinical point: Singleton pregnant women with psoriatic arthritis (PsA) had a significantly higher risk for preeclampsia than matched control pregnant women without PsA.

Major finding: Compared with control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13).

Study details: Findings are from an analysis of a register-based cohort study including singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively.

Disclosures: This study was supported by NordForsk and other sources. Some authors declared serving on speakers’ bureaus, receiving research grants, or receiving  consulting fees from several sources.

Source: Secher AEP et al. Risk of pre-eclampsia and impact of disease activity and antirheumatic treatment in women with rheumatoid arthritis, axial spondylarthritis and psoriatic arthritis: A collaborative matched cohort study from Sweden and Denmark. RMD Open. 2022;8:e002445 (Nov 3). Doi: 10.1136/rmdopen-2022-002445

Key clinical point: Risankizumab demonstrated long-term (52 weeks) efficacy in reducing disease severity and showed a consistent safety profile in patients with psoriatic arthritis (PsA) and previous inadequate response or intolerance to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).

Major finding: Among patients who received risankizumab continuously, those achieving ≥20% improvement in American College of Rheumatology (ACR20) response increased from 57.3% at week 24 to 70.0% at week 52; meanwhile, 63.0% of patients who switched from placebo to risankizumab achieved ACR20 at week 52. No new safety signals were identified.

Study details: Findings are from the ongoing phase 3 KEEPsAKE 1 study including 964 patients with active PsA who were csDMARD-IR and were randomly assigned to receive risankizumab or placebo for 24 weeks, of which 940 patients were eligible to receive open-label risankizumab through 208 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stock options in AbbVie, and the other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2022 (Oct 25). Doi: 10.1093/rheumatology/keac607

Key clinical point: Risankizumab demonstrated long-term (52 weeks) efficacy in reducing disease severity and showed a consistent safety profile in patients with psoriatic arthritis (PsA) and previous inadequate response or intolerance to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).

Major finding: Among patients who received risankizumab continuously, those achieving ≥20% improvement in American College of Rheumatology (ACR20) response increased from 57.3% at week 24 to 70.0% at week 52; meanwhile, 63.0% of patients who switched from placebo to risankizumab achieved ACR20 at week 52. No new safety signals were identified.

Study details: Findings are from the ongoing phase 3 KEEPsAKE 1 study including 964 patients with active PsA who were csDMARD-IR and were randomly assigned to receive risankizumab or placebo for 24 weeks, of which 940 patients were eligible to receive open-label risankizumab through 208 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stock options in AbbVie, and the other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2022 (Oct 25). Doi: 10.1093/rheumatology/keac607

Key clinical point: Risankizumab demonstrated long-term (52 weeks) efficacy in reducing disease severity and showed a consistent safety profile in patients with psoriatic arthritis (PsA) and previous inadequate response or intolerance to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).

Major finding: Among patients who received risankizumab continuously, those achieving ≥20% improvement in American College of Rheumatology (ACR20) response increased from 57.3% at week 24 to 70.0% at week 52; meanwhile, 63.0% of patients who switched from placebo to risankizumab achieved ACR20 at week 52. No new safety signals were identified.

Study details: Findings are from the ongoing phase 3 KEEPsAKE 1 study including 964 patients with active PsA who were csDMARD-IR and were randomly assigned to receive risankizumab or placebo for 24 weeks, of which 940 patients were eligible to receive open-label risankizumab through 208 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stock options in AbbVie, and the other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2022 (Oct 25). Doi: 10.1093/rheumatology/keac607

After recovery from acute infection with SARS-CoV-2, major stressful life events such as the death of a loved one or financial insecurity can have a significant impact on the development of long COVID symptoms, new research suggests.

Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.

These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.

The findings were published online in the Journal of the Neurological Sciences.
 

Major stressful events common

Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points. 

Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.

In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8. 

The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.

Long-term sequelae of COVID are increasingly recognized as major public health issues. 

It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work. 
 

Holistic approach

Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”

She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”

Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.

She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.

“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.

“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.

The study had no commercial funding. The investigators reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After recovery from acute infection with SARS-CoV-2, major stressful life events such as the death of a loved one or financial insecurity can have a significant impact on the development of long COVID symptoms, new research suggests.

Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.

These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.

The findings were published online in the Journal of the Neurological Sciences.
 

Major stressful events common

Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points. 

Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.

In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8. 

The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.

Long-term sequelae of COVID are increasingly recognized as major public health issues. 

It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work. 
 

Holistic approach

Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”

She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”

Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.

She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.

“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.

“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.

The study had no commercial funding. The investigators reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After recovery from acute infection with SARS-CoV-2, major stressful life events such as the death of a loved one or financial insecurity can have a significant impact on the development of long COVID symptoms, new research suggests.

Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.

These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.

The findings were published online in the Journal of the Neurological Sciences.
 

Major stressful events common

Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points. 

Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.

In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8. 

The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.

Long-term sequelae of COVID are increasingly recognized as major public health issues. 

It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work. 
 

Holistic approach

Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”

She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”

Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.

She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.

“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.

“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.

The study had no commercial funding. The investigators reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

A version of this article first appeared on Medscape.com.

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

A version of this article first appeared on Medscape.com.

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

A version of this article first appeared on Medscape.com.

PHILADELPHIA – Patients with gout who underwent an intensive treat-to-target regimen of monthly up-titration of urate-lowering therapy (ULT) to reach a target serum urate level were significantly more likely to reach that goal at 1 year than were patients who received conventional gout management in a randomized, controlled trial.

These results came from the TICOG (Tight Control of Gout) trial, one of a handful of recent trials to test a treat-to-target strategy with ULT in the management of gout. Beyond the primary outcome of reaching target serum urate level of < 5 mg/dL (< 300 micromol/L), the results also showed that the tight-control strategy significantly lowered urate to a greater extent than conventional management, reduced tophus size in the first metatarsophalangeal (MTP) joint, and improved gray scale synovitis on ultrasound significantly more than with conventional management, Sarah Black, MBBS, a rheumatology trainee at Musgrave Park Hospital, Belfast, Northern Ireland, reported at the American College of Rheumatology annual meeting.

“Based on these outcomes, we question whether gout is best managed in primary or secondary care. We think there is an argument for establishing specialist gout clinics with more time to focus on patient education to help improve outcomes. These clinics could be led by allied health care professionals, such as specialist nurses and pharmacists,” Dr. Black said at the meeting.

Gout management guidelines issued by the British Society for Rheumatology in 2017 call for a target serum urate level of < 5 mg/dL, whereas the ACR’s 2020 guideline for the management of gout endorses a treat-to-target management strategy that aims for a serum urate level of < 6 mg/dL.

The single-center, nonblinded trial recruited 110 patients aged 18-85 years over a 3-year period to take ULT with allopurinol as first-line therapy starting at 100 mg/day. Everyone received the same advice regarding ULT up-titration, lifestyle changes, and gout education at baseline. The second-line agent for ULT was febuxostat (Uloric) 80 mg daily, with uricosuric drugs as third-line agents. All patients received colchicine or NSAID prophylaxis for gout flares for the first 6 months, depending on their comorbidities.

The trial excluded patients who had been treated with ULT within the past 6 months or had experienced prior hypersensitivity to ULT, severe renal impairment (creatinine clearance < 30 mL/min as measured by estimated glomerular filtration rate), significant liver impairment, or any other significant medical disease affecting life expectancy shorter than 1 year.

Conventional management consisted of urate level review at 0, 6, and 12 months with up-titration at each visit and primary care management of ULT between reviews until the target serum urate level was reached. In the tight-control group, monthly up-titrations occurred at the Musgrave Park Hospital at visits with the study team that were led by a rheumatologist and a specialist pharmacist.

A total of 48 patients in the conventional arm and 47 in the tight-control arm completed the trial. At baseline, monosodium urate crystals were detected in joint aspirates in 56% of patients receiving tight control and in 58.5% of those receiving conventional management. The mean serum urate level was 490 micromol/L (8.24 mg/dL) for tight-control patients and 470 micromol/L (7.9 mg/dL) for conventionally managed patients.

By 1 year, 89.4% of patients in the tight-control group had achieved the target urate level, compared with 39.6% in the conventional-management group (P < .001). At 6 months, serum urate had declined by 37.6% with tight control vs. 18% with conventional management. By the end of the trial, the median allopurinol dose was 400 mg with tight control (range, 200-900 mg) and 200 mg with conventional management (range, 0-400 mg). A total of 89% of patients were taking allopurinol at the end of the trial.

As expected, tight control led to more flares per month on average (0.35 vs. 0.13) in the 79 patients for whom complete data on flare frequency were available.

On blinded ultrasound evaluations, the median diameter of the first MTP tophus declined significantly more with tight control than with conventional management (–4.65 mm vs. –0.30 mm; P = .003). Gray scale synovitis in the knee improved in 63% of patients undergoing tight control, compared with 14% of conventionally managed patients (P = .043). The researchers observed no difference in resolution of the double-contour sign or in the number of erosions between the groups, although the 1-year time frame may not have been long enough to see resolution and improvement, Dr. Black said.

Dr. Black said that a follow-up study is planned with the same patient cohort at 3 years.

When asked about the feasibility of monthly ULT titration visits for gout management, audience member Tuhina Neogi, MD, professor of epidemiology at Boston University and chief of rheumatology at Boston Medical Center, told this news organization, “We don’t have a lot of data to guide us in that regard, and I also think it depends on what the increment of the dose titration is, but we generally do recognize that therapeutic inertia is bad – keeping someone on a dose for a long time. For me, I don’t think monthly is unreasonable if you have good prophylaxis [against acute flares].”

Dr. Neogi also noted that such monthly assessments don’t have to take place at a hospital. “I think there are many different practice models in which it could be implemented [that are not physician-driven].”

The study had no outside funding. Dr. Black has disclosed no relevant financial relationships. Dr. Neogi has received consulting fees from a variety of pharmaceutical companies, including Alnylam, Regeneron, Eli Lilly, EMD Serono, Novartis, Pfizer, and GlaxoSmithKline.

A version of this article first appeared on Medscape.com.

PHILADELPHIA – Patients with gout who underwent an intensive treat-to-target regimen of monthly up-titration of urate-lowering therapy (ULT) to reach a target serum urate level were significantly more likely to reach that goal at 1 year than were patients who received conventional gout management in a randomized, controlled trial.

These results came from the TICOG (Tight Control of Gout) trial, one of a handful of recent trials to test a treat-to-target strategy with ULT in the management of gout. Beyond the primary outcome of reaching target serum urate level of < 5 mg/dL (< 300 micromol/L), the results also showed that the tight-control strategy significantly lowered urate to a greater extent than conventional management, reduced tophus size in the first metatarsophalangeal (MTP) joint, and improved gray scale synovitis on ultrasound significantly more than with conventional management, Sarah Black, MBBS, a rheumatology trainee at Musgrave Park Hospital, Belfast, Northern Ireland, reported at the American College of Rheumatology annual meeting.

“Based on these outcomes, we question whether gout is best managed in primary or secondary care. We think there is an argument for establishing specialist gout clinics with more time to focus on patient education to help improve outcomes. These clinics could be led by allied health care professionals, such as specialist nurses and pharmacists,” Dr. Black said at the meeting.

Gout management guidelines issued by the British Society for Rheumatology in 2017 call for a target serum urate level of < 5 mg/dL, whereas the ACR’s 2020 guideline for the management of gout endorses a treat-to-target management strategy that aims for a serum urate level of < 6 mg/dL.

The single-center, nonblinded trial recruited 110 patients aged 18-85 years over a 3-year period to take ULT with allopurinol as first-line therapy starting at 100 mg/day. Everyone received the same advice regarding ULT up-titration, lifestyle changes, and gout education at baseline. The second-line agent for ULT was febuxostat (Uloric) 80 mg daily, with uricosuric drugs as third-line agents. All patients received colchicine or NSAID prophylaxis for gout flares for the first 6 months, depending on their comorbidities.

The trial excluded patients who had been treated with ULT within the past 6 months or had experienced prior hypersensitivity to ULT, severe renal impairment (creatinine clearance < 30 mL/min as measured by estimated glomerular filtration rate), significant liver impairment, or any other significant medical disease affecting life expectancy shorter than 1 year.

Conventional management consisted of urate level review at 0, 6, and 12 months with up-titration at each visit and primary care management of ULT between reviews until the target serum urate level was reached. In the tight-control group, monthly up-titrations occurred at the Musgrave Park Hospital at visits with the study team that were led by a rheumatologist and a specialist pharmacist.

A total of 48 patients in the conventional arm and 47 in the tight-control arm completed the trial. At baseline, monosodium urate crystals were detected in joint aspirates in 56% of patients receiving tight control and in 58.5% of those receiving conventional management. The mean serum urate level was 490 micromol/L (8.24 mg/dL) for tight-control patients and 470 micromol/L (7.9 mg/dL) for conventionally managed patients.

By 1 year, 89.4% of patients in the tight-control group had achieved the target urate level, compared with 39.6% in the conventional-management group (P < .001). At 6 months, serum urate had declined by 37.6% with tight control vs. 18% with conventional management. By the end of the trial, the median allopurinol dose was 400 mg with tight control (range, 200-900 mg) and 200 mg with conventional management (range, 0-400 mg). A total of 89% of patients were taking allopurinol at the end of the trial.

As expected, tight control led to more flares per month on average (0.35 vs. 0.13) in the 79 patients for whom complete data on flare frequency were available.

On blinded ultrasound evaluations, the median diameter of the first MTP tophus declined significantly more with tight control than with conventional management (–4.65 mm vs. –0.30 mm; P = .003). Gray scale synovitis in the knee improved in 63% of patients undergoing tight control, compared with 14% of conventionally managed patients (P = .043). The researchers observed no difference in resolution of the double-contour sign or in the number of erosions between the groups, although the 1-year time frame may not have been long enough to see resolution and improvement, Dr. Black said.

Dr. Black said that a follow-up study is planned with the same patient cohort at 3 years.

When asked about the feasibility of monthly ULT titration visits for gout management, audience member Tuhina Neogi, MD, professor of epidemiology at Boston University and chief of rheumatology at Boston Medical Center, told this news organization, “We don’t have a lot of data to guide us in that regard, and I also think it depends on what the increment of the dose titration is, but we generally do recognize that therapeutic inertia is bad – keeping someone on a dose for a long time. For me, I don’t think monthly is unreasonable if you have good prophylaxis [against acute flares].”

Dr. Neogi also noted that such monthly assessments don’t have to take place at a hospital. “I think there are many different practice models in which it could be implemented [that are not physician-driven].”

The study had no outside funding. Dr. Black has disclosed no relevant financial relationships. Dr. Neogi has received consulting fees from a variety of pharmaceutical companies, including Alnylam, Regeneron, Eli Lilly, EMD Serono, Novartis, Pfizer, and GlaxoSmithKline.

A version of this article first appeared on Medscape.com.

PHILADELPHIA – Patients with gout who underwent an intensive treat-to-target regimen of monthly up-titration of urate-lowering therapy (ULT) to reach a target serum urate level were significantly more likely to reach that goal at 1 year than were patients who received conventional gout management in a randomized, controlled trial.

These results came from the TICOG (Tight Control of Gout) trial, one of a handful of recent trials to test a treat-to-target strategy with ULT in the management of gout. Beyond the primary outcome of reaching target serum urate level of < 5 mg/dL (< 300 micromol/L), the results also showed that the tight-control strategy significantly lowered urate to a greater extent than conventional management, reduced tophus size in the first metatarsophalangeal (MTP) joint, and improved gray scale synovitis on ultrasound significantly more than with conventional management, Sarah Black, MBBS, a rheumatology trainee at Musgrave Park Hospital, Belfast, Northern Ireland, reported at the American College of Rheumatology annual meeting.

“Based on these outcomes, we question whether gout is best managed in primary or secondary care. We think there is an argument for establishing specialist gout clinics with more time to focus on patient education to help improve outcomes. These clinics could be led by allied health care professionals, such as specialist nurses and pharmacists,” Dr. Black said at the meeting.

Gout management guidelines issued by the British Society for Rheumatology in 2017 call for a target serum urate level of < 5 mg/dL, whereas the ACR’s 2020 guideline for the management of gout endorses a treat-to-target management strategy that aims for a serum urate level of < 6 mg/dL.

The single-center, nonblinded trial recruited 110 patients aged 18-85 years over a 3-year period to take ULT with allopurinol as first-line therapy starting at 100 mg/day. Everyone received the same advice regarding ULT up-titration, lifestyle changes, and gout education at baseline. The second-line agent for ULT was febuxostat (Uloric) 80 mg daily, with uricosuric drugs as third-line agents. All patients received colchicine or NSAID prophylaxis for gout flares for the first 6 months, depending on their comorbidities.

The trial excluded patients who had been treated with ULT within the past 6 months or had experienced prior hypersensitivity to ULT, severe renal impairment (creatinine clearance < 30 mL/min as measured by estimated glomerular filtration rate), significant liver impairment, or any other significant medical disease affecting life expectancy shorter than 1 year.

Conventional management consisted of urate level review at 0, 6, and 12 months with up-titration at each visit and primary care management of ULT between reviews until the target serum urate level was reached. In the tight-control group, monthly up-titrations occurred at the Musgrave Park Hospital at visits with the study team that were led by a rheumatologist and a specialist pharmacist.

A total of 48 patients in the conventional arm and 47 in the tight-control arm completed the trial. At baseline, monosodium urate crystals were detected in joint aspirates in 56% of patients receiving tight control and in 58.5% of those receiving conventional management. The mean serum urate level was 490 micromol/L (8.24 mg/dL) for tight-control patients and 470 micromol/L (7.9 mg/dL) for conventionally managed patients.

By 1 year, 89.4% of patients in the tight-control group had achieved the target urate level, compared with 39.6% in the conventional-management group (P < .001). At 6 months, serum urate had declined by 37.6% with tight control vs. 18% with conventional management. By the end of the trial, the median allopurinol dose was 400 mg with tight control (range, 200-900 mg) and 200 mg with conventional management (range, 0-400 mg). A total of 89% of patients were taking allopurinol at the end of the trial.

As expected, tight control led to more flares per month on average (0.35 vs. 0.13) in the 79 patients for whom complete data on flare frequency were available.

On blinded ultrasound evaluations, the median diameter of the first MTP tophus declined significantly more with tight control than with conventional management (–4.65 mm vs. –0.30 mm; P = .003). Gray scale synovitis in the knee improved in 63% of patients undergoing tight control, compared with 14% of conventionally managed patients (P = .043). The researchers observed no difference in resolution of the double-contour sign or in the number of erosions between the groups, although the 1-year time frame may not have been long enough to see resolution and improvement, Dr. Black said.

Dr. Black said that a follow-up study is planned with the same patient cohort at 3 years.

When asked about the feasibility of monthly ULT titration visits for gout management, audience member Tuhina Neogi, MD, professor of epidemiology at Boston University and chief of rheumatology at Boston Medical Center, told this news organization, “We don’t have a lot of data to guide us in that regard, and I also think it depends on what the increment of the dose titration is, but we generally do recognize that therapeutic inertia is bad – keeping someone on a dose for a long time. For me, I don’t think monthly is unreasonable if you have good prophylaxis [against acute flares].”

Dr. Neogi also noted that such monthly assessments don’t have to take place at a hospital. “I think there are many different practice models in which it could be implemented [that are not physician-driven].”

The study had no outside funding. Dr. Black has disclosed no relevant financial relationships. Dr. Neogi has received consulting fees from a variety of pharmaceutical companies, including Alnylam, Regeneron, Eli Lilly, EMD Serono, Novartis, Pfizer, and GlaxoSmithKline.

A version of this article first appeared on Medscape.com.

PHILADELPHIA – A draft update of criteria for classifying antiphospholipid syndrome (APS) incorporates a much broader spectrum of disease signs and symptoms, such as kidney disease and more variables for pregnancy, and meets a higher level of specificity than the existing Sapporo criteria, although at the expense of lower sensitivity.

Richard Mark Kirkner/MDedge News

Three members of the core planning group that wrote the update, jointly commissioned by the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR), reviewed the proposed criteria at the annual meeting of the ACR.

If ACR and EULAR adopt the new criteria, it would be an update to the Sapporo classification criteria for APS, which was last updated in 2006. The pending criteria consist of the following eight domains encompassing clinical findings and laboratory test results:

• Macrovascular – venous thromboembolism (VTE) with and without high VTE risk profile.
• Macrovascular – arterial thrombosis with and without a high cardiovascular disease risk profile.
• Microvascular – additional categories for kidney disease, pulmonary embolism, and other conditions for both suspected and established APS.
• Obstetric – expanded definitions to account for the absence or presence of preeclampsia or premature birth with or without fetal death.
• Cardiac valve – accounts for thickening and vegetation.
• Hematologic – includes thrombocytopenia (defined as the lowest platelet count, 20-130 x 10⁹/L).
• Antiphospholipid (aPL) test – coagulation-based functional assay, assigning greater weight to persistent over one-time positive test results.
• aPL test by solid-phase assay – includes anticardiolipin enzyme-linked immunosorbent assay (aCL ELISA), and aCL/anti-beta 2 glycoprotein-I (aCL/anti-beta 2 GPI) tests, with greater weight assigned for moderate-to-high positive results depending on isotype, whether immunoglobulin G or M.

Changes from Sapporo criteria

The existing Sapporo criteria include two clinical categories, vascular thrombosis and pregnancy morbidity; and three laboratory categories, positive lupus anticoagulant, medium or high antibody titers, and high aCL/anti-beta 2 GPI measured by ELISA. All of these are included in the draft criteria under two domains.

“These novel clinical features will help us better stratify patients according to the risk factor profile,” Stéphane Zuily, MD, PhD, a vascular specialist and European co-principal investigator of the planning group, said in explaining the proposed updated domains.

“We well-defined the microvascular domain items further than the aPL nephropathy; we redefined pregnancy morbidities; we added cardiac valve disease and thrombocytopenia; and, through gathering novel laboratory features, we were able to quantify single, double, and triple aPL positivity based on different domains and weights,” said Dr. Zuily, professor of medicine at Lorraine University in Nancy, France.

Also noteworthy is the separation of aCL/anti-beta 2 GPI testing by IgG and IgM isotypes. “And we were also able to identify different thresholds in terms of aPL positivity,” Dr. Zuily said.
 

Rationale and methodology

Planning group member Medha Barbhaiya, MD, MPH, an attending physician at the Hospital for Special Surgery and assistant professor at Weill Cornell Medicine in New York, explained the rationale for the update. “The existing criteria were drafted in 1999 and updated in 2006 and require one clinical criterion, either vascular thrombosis event or pregnancy morbidity along with antiphospholipid antibodies,” she said.

Those 16-year-old criteria also ignored heterogeneous manifestations such as heart valve disease or thrombocytopenia, failed to stratify thrombotic events as risk factors, and used an outdated definition of pregnancy morbidity related to APS, she said.

“These findings helped to support our rationale for new criteria development, along with the fact that over the last 1 to 2 decades there have been important advancements in the methodology of classification criteria development,” she said. ACR and EULAR both endorsed the new methodology for developing the classification criteria, Dr. Barbhaiya added.

That methodology involved multidisciplinary international panels of experts and data-driven efforts, with the goal of identifying patients with a high likelihood of APS for research purposes. The planning group collected 568 cases from 29 international centers, dividing them into two validation cohorts of 284 cases each.
 

How classification criteria work

Doruk Erkan, MD, MPH, coprincipal investigator representing the United States on the planning group, an attending physician at the Hospital for Special Surgery in New York, and a professor at Weill Cornell Medicine in New York, explained how the classification system works. “If you have a patient that you are considering for APS classification, the story starts with entry criteria, which are one documented clinical criterion plus a positive aPL [antiphospholipid] test within 3 years of observation of the clinical criteria,” he said.

Once the entry criteria for APS are met, there are the clinical and laboratory domains. Dr. Erkan explained that weighted point values are assigned to individual categories under each domain. For example, in the macrovascular VTE domain, VTE with a high VTE risk profile is worth 1 point, but VTE without a high VTE risk profile is worth 3 points.

“APS classification will be achieved with at least three points from clinical domains and at least three points from the laboratory domains,” he said.

The planning group conducted a sensitivity and specificity analysis of the draft classification system using the two validation cohorts. “Our goal was very high specificity to improve the homogeneity in APS research, and we achieved this in both cohorts with 99% specificity,” Dr. Erkan said. That compares to sensitivity of 91% and 86% of the Sapporo criteria in the validation cohorts.

“Our sensitivity was 83% and 84% capturing a broad spectrum of patients assessed with APS suspicion,” he added, vs. 100% and 99% with the Sapporo criteria.

These criteria are not absolute and are structured to permit future modifications, Dr. Erkan said. “When this work is completed, another chapter will start,” he said. “If a case doesn’t meet APS classification criteria, the case may still be uncertain or equivocal rather than not APS. Uncertain or controversial cases should be studied separately to guide future updates of the new criteria.”
 

Comment: Why these updates are needed

April Jorge, MD, a rheumatologist at Massachusetts General Hospital in Boston and moderator of the session on the draft APS criteria, explained why these updated criteria are needed. “It’s very important to get the updated criteria because, as the speakers mentioned, the prior Sapporo criteria were limited to just large-vessel venous thrombosis or pregnancy complications, and so that makes it difficult to study the disease in other manifestations, such as kidney manifestations, if they’re not part of the criteria.”

She added, “I think there was a need for clear classification criteria that was thought to be highly specific for the disease so that future studies can be done in this population.”

Dr. Jorge called the 99% specificity described in the analysis “impressive” and “promising.”

Dr. Barbhaiya and Dr. Zuily have no relevant disclosures. Dr. Erkan disclosed relationships with Aurinia, Eli Lilly, Exagen, and GlaxoSmithKline. Dr. Jorge has no relevant disclosures.
 

PHILADELPHIA – A draft update of criteria for classifying antiphospholipid syndrome (APS) incorporates a much broader spectrum of disease signs and symptoms, such as kidney disease and more variables for pregnancy, and meets a higher level of specificity than the existing Sapporo criteria, although at the expense of lower sensitivity.

Richard Mark Kirkner/MDedge News

Three members of the core planning group that wrote the update, jointly commissioned by the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR), reviewed the proposed criteria at the annual meeting of the ACR.

If ACR and EULAR adopt the new criteria, it would be an update to the Sapporo classification criteria for APS, which was last updated in 2006. The pending criteria consist of the following eight domains encompassing clinical findings and laboratory test results:

• Macrovascular – venous thromboembolism (VTE) with and without high VTE risk profile.
• Macrovascular – arterial thrombosis with and without a high cardiovascular disease risk profile.
• Microvascular – additional categories for kidney disease, pulmonary embolism, and other conditions for both suspected and established APS.
• Obstetric – expanded definitions to account for the absence or presence of preeclampsia or premature birth with or without fetal death.
• Cardiac valve – accounts for thickening and vegetation.
• Hematologic – includes thrombocytopenia (defined as the lowest platelet count, 20-130 x 10⁹/L).
• Antiphospholipid (aPL) test – coagulation-based functional assay, assigning greater weight to persistent over one-time positive test results.
• aPL test by solid-phase assay – includes anticardiolipin enzyme-linked immunosorbent assay (aCL ELISA), and aCL/anti-beta 2 glycoprotein-I (aCL/anti-beta 2 GPI) tests, with greater weight assigned for moderate-to-high positive results depending on isotype, whether immunoglobulin G or M.

Changes from Sapporo criteria

The existing Sapporo criteria include two clinical categories, vascular thrombosis and pregnancy morbidity; and three laboratory categories, positive lupus anticoagulant, medium or high antibody titers, and high aCL/anti-beta 2 GPI measured by ELISA. All of these are included in the draft criteria under two domains.

“These novel clinical features will help us better stratify patients according to the risk factor profile,” Stéphane Zuily, MD, PhD, a vascular specialist and European co-principal investigator of the planning group, said in explaining the proposed updated domains.

“We well-defined the microvascular domain items further than the aPL nephropathy; we redefined pregnancy morbidities; we added cardiac valve disease and thrombocytopenia; and, through gathering novel laboratory features, we were able to quantify single, double, and triple aPL positivity based on different domains and weights,” said Dr. Zuily, professor of medicine at Lorraine University in Nancy, France.

Also noteworthy is the separation of aCL/anti-beta 2 GPI testing by IgG and IgM isotypes. “And we were also able to identify different thresholds in terms of aPL positivity,” Dr. Zuily said.
 

Rationale and methodology

Planning group member Medha Barbhaiya, MD, MPH, an attending physician at the Hospital for Special Surgery and assistant professor at Weill Cornell Medicine in New York, explained the rationale for the update. “The existing criteria were drafted in 1999 and updated in 2006 and require one clinical criterion, either vascular thrombosis event or pregnancy morbidity along with antiphospholipid antibodies,” she said.

Those 16-year-old criteria also ignored heterogeneous manifestations such as heart valve disease or thrombocytopenia, failed to stratify thrombotic events as risk factors, and used an outdated definition of pregnancy morbidity related to APS, she said.

“These findings helped to support our rationale for new criteria development, along with the fact that over the last 1 to 2 decades there have been important advancements in the methodology of classification criteria development,” she said. ACR and EULAR both endorsed the new methodology for developing the classification criteria, Dr. Barbhaiya added.

That methodology involved multidisciplinary international panels of experts and data-driven efforts, with the goal of identifying patients with a high likelihood of APS for research purposes. The planning group collected 568 cases from 29 international centers, dividing them into two validation cohorts of 284 cases each.
 

How classification criteria work

Doruk Erkan, MD, MPH, coprincipal investigator representing the United States on the planning group, an attending physician at the Hospital for Special Surgery in New York, and a professor at Weill Cornell Medicine in New York, explained how the classification system works. “If you have a patient that you are considering for APS classification, the story starts with entry criteria, which are one documented clinical criterion plus a positive aPL [antiphospholipid] test within 3 years of observation of the clinical criteria,” he said.

Once the entry criteria for APS are met, there are the clinical and laboratory domains. Dr. Erkan explained that weighted point values are assigned to individual categories under each domain. For example, in the macrovascular VTE domain, VTE with a high VTE risk profile is worth 1 point, but VTE without a high VTE risk profile is worth 3 points.

“APS classification will be achieved with at least three points from clinical domains and at least three points from the laboratory domains,” he said.

The planning group conducted a sensitivity and specificity analysis of the draft classification system using the two validation cohorts. “Our goal was very high specificity to improve the homogeneity in APS research, and we achieved this in both cohorts with 99% specificity,” Dr. Erkan said. That compares to sensitivity of 91% and 86% of the Sapporo criteria in the validation cohorts.

“Our sensitivity was 83% and 84% capturing a broad spectrum of patients assessed with APS suspicion,” he added, vs. 100% and 99% with the Sapporo criteria.

These criteria are not absolute and are structured to permit future modifications, Dr. Erkan said. “When this work is completed, another chapter will start,” he said. “If a case doesn’t meet APS classification criteria, the case may still be uncertain or equivocal rather than not APS. Uncertain or controversial cases should be studied separately to guide future updates of the new criteria.”
 

Comment: Why these updates are needed

April Jorge, MD, a rheumatologist at Massachusetts General Hospital in Boston and moderator of the session on the draft APS criteria, explained why these updated criteria are needed. “It’s very important to get the updated criteria because, as the speakers mentioned, the prior Sapporo criteria were limited to just large-vessel venous thrombosis or pregnancy complications, and so that makes it difficult to study the disease in other manifestations, such as kidney manifestations, if they’re not part of the criteria.”

She added, “I think there was a need for clear classification criteria that was thought to be highly specific for the disease so that future studies can be done in this population.”

Dr. Jorge called the 99% specificity described in the analysis “impressive” and “promising.”

Dr. Barbhaiya and Dr. Zuily have no relevant disclosures. Dr. Erkan disclosed relationships with Aurinia, Eli Lilly, Exagen, and GlaxoSmithKline. Dr. Jorge has no relevant disclosures.
 

PHILADELPHIA – A draft update of criteria for classifying antiphospholipid syndrome (APS) incorporates a much broader spectrum of disease signs and symptoms, such as kidney disease and more variables for pregnancy, and meets a higher level of specificity than the existing Sapporo criteria, although at the expense of lower sensitivity.

Richard Mark Kirkner/MDedge News

Three members of the core planning group that wrote the update, jointly commissioned by the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR), reviewed the proposed criteria at the annual meeting of the ACR.

If ACR and EULAR adopt the new criteria, it would be an update to the Sapporo classification criteria for APS, which was last updated in 2006. The pending criteria consist of the following eight domains encompassing clinical findings and laboratory test results:

• Macrovascular – venous thromboembolism (VTE) with and without high VTE risk profile.
• Macrovascular – arterial thrombosis with and without a high cardiovascular disease risk profile.
• Microvascular – additional categories for kidney disease, pulmonary embolism, and other conditions for both suspected and established APS.
• Obstetric – expanded definitions to account for the absence or presence of preeclampsia or premature birth with or without fetal death.
• Cardiac valve – accounts for thickening and vegetation.
• Hematologic – includes thrombocytopenia (defined as the lowest platelet count, 20-130 x 10⁹/L).
• Antiphospholipid (aPL) test – coagulation-based functional assay, assigning greater weight to persistent over one-time positive test results.
• aPL test by solid-phase assay – includes anticardiolipin enzyme-linked immunosorbent assay (aCL ELISA), and aCL/anti-beta 2 glycoprotein-I (aCL/anti-beta 2 GPI) tests, with greater weight assigned for moderate-to-high positive results depending on isotype, whether immunoglobulin G or M.

Changes from Sapporo criteria

The existing Sapporo criteria include two clinical categories, vascular thrombosis and pregnancy morbidity; and three laboratory categories, positive lupus anticoagulant, medium or high antibody titers, and high aCL/anti-beta 2 GPI measured by ELISA. All of these are included in the draft criteria under two domains.

“These novel clinical features will help us better stratify patients according to the risk factor profile,” Stéphane Zuily, MD, PhD, a vascular specialist and European co-principal investigator of the planning group, said in explaining the proposed updated domains.

“We well-defined the microvascular domain items further than the aPL nephropathy; we redefined pregnancy morbidities; we added cardiac valve disease and thrombocytopenia; and, through gathering novel laboratory features, we were able to quantify single, double, and triple aPL positivity based on different domains and weights,” said Dr. Zuily, professor of medicine at Lorraine University in Nancy, France.

Also noteworthy is the separation of aCL/anti-beta 2 GPI testing by IgG and IgM isotypes. “And we were also able to identify different thresholds in terms of aPL positivity,” Dr. Zuily said.
 

Rationale and methodology

Planning group member Medha Barbhaiya, MD, MPH, an attending physician at the Hospital for Special Surgery and assistant professor at Weill Cornell Medicine in New York, explained the rationale for the update. “The existing criteria were drafted in 1999 and updated in 2006 and require one clinical criterion, either vascular thrombosis event or pregnancy morbidity along with antiphospholipid antibodies,” she said.

Those 16-year-old criteria also ignored heterogeneous manifestations such as heart valve disease or thrombocytopenia, failed to stratify thrombotic events as risk factors, and used an outdated definition of pregnancy morbidity related to APS, she said.

“These findings helped to support our rationale for new criteria development, along with the fact that over the last 1 to 2 decades there have been important advancements in the methodology of classification criteria development,” she said. ACR and EULAR both endorsed the new methodology for developing the classification criteria, Dr. Barbhaiya added.

That methodology involved multidisciplinary international panels of experts and data-driven efforts, with the goal of identifying patients with a high likelihood of APS for research purposes. The planning group collected 568 cases from 29 international centers, dividing them into two validation cohorts of 284 cases each.
 

How classification criteria work

Doruk Erkan, MD, MPH, coprincipal investigator representing the United States on the planning group, an attending physician at the Hospital for Special Surgery in New York, and a professor at Weill Cornell Medicine in New York, explained how the classification system works. “If you have a patient that you are considering for APS classification, the story starts with entry criteria, which are one documented clinical criterion plus a positive aPL [antiphospholipid] test within 3 years of observation of the clinical criteria,” he said.

Once the entry criteria for APS are met, there are the clinical and laboratory domains. Dr. Erkan explained that weighted point values are assigned to individual categories under each domain. For example, in the macrovascular VTE domain, VTE with a high VTE risk profile is worth 1 point, but VTE without a high VTE risk profile is worth 3 points.

“APS classification will be achieved with at least three points from clinical domains and at least three points from the laboratory domains,” he said.

The planning group conducted a sensitivity and specificity analysis of the draft classification system using the two validation cohorts. “Our goal was very high specificity to improve the homogeneity in APS research, and we achieved this in both cohorts with 99% specificity,” Dr. Erkan said. That compares to sensitivity of 91% and 86% of the Sapporo criteria in the validation cohorts.

“Our sensitivity was 83% and 84% capturing a broad spectrum of patients assessed with APS suspicion,” he added, vs. 100% and 99% with the Sapporo criteria.

These criteria are not absolute and are structured to permit future modifications, Dr. Erkan said. “When this work is completed, another chapter will start,” he said. “If a case doesn’t meet APS classification criteria, the case may still be uncertain or equivocal rather than not APS. Uncertain or controversial cases should be studied separately to guide future updates of the new criteria.”
 

Comment: Why these updates are needed

April Jorge, MD, a rheumatologist at Massachusetts General Hospital in Boston and moderator of the session on the draft APS criteria, explained why these updated criteria are needed. “It’s very important to get the updated criteria because, as the speakers mentioned, the prior Sapporo criteria were limited to just large-vessel venous thrombosis or pregnancy complications, and so that makes it difficult to study the disease in other manifestations, such as kidney manifestations, if they’re not part of the criteria.”

She added, “I think there was a need for clear classification criteria that was thought to be highly specific for the disease so that future studies can be done in this population.”

Dr. Jorge called the 99% specificity described in the analysis “impressive” and “promising.”

Dr. Barbhaiya and Dr. Zuily have no relevant disclosures. Dr. Erkan disclosed relationships with Aurinia, Eli Lilly, Exagen, and GlaxoSmithKline. Dr. Jorge has no relevant disclosures.
 

PHILADELPHIA – An international group of researchers has proposed the first classification criteria for chronic nonbacterial osteomyelitis (CNO) and a severe form of it, chronic recurrent multifocal osteomyelitis (CRMO).

CNO/CRMO most frequently affect children and adolescents and can significantly affect quality of life.

Yongdong (Dan) Zhao, MD, PhD, a pediatric rheumatologist at Seattle Children’s Hospital, Seattle, Washington, and Seza Ozen, MD, MSc, medical faculty head at Hacettepe University in Ankara, Turkey – members of the expert panel for criteria development – explained the proposed criteria, developed over 6 years, at the American College of Rheumatology 2022 Annual Meeting.

They gave examples of the point system that will help researchers correctly classify CNO/CRMO if the criteria are approved by ACR and the European Alliance of Associations for Rheumatology (EULAR).

Melissa S. Oliver, MD, a pediatric rheumatologist at Riley Children’s Hospital and Indiana University, Indianapolis, told this news organization: “This proposal is important because CNO/CRMO has primarily been a diagnosis of exclusion. There are no specific tests or biomarkers for this disease. It can mimic malignancy and infectious osteomyelitis in its presentation, and these must be ruled out thoroughly first.”

However, she noted, this can be challenging and can delay diagnosis and treatment.

The classification criteria are novel, she said, because an international collaborative group used a consensus process involving physicians managing CNO and patients or caregivers of children with CNO.
 

Findings for and against CNO

Dr. Ozen summarized some examples of findings for and against a CNO/CRMO classification.

Statistically significant findings in favor of CNO/CRMO, she said, include intermittent bone pain; bone pain in upper torso; swelling of upper torso; presence of symmetric lesions; and presence of adaptive immune cell and/or fibrosis in biopsy.

Conversely, findings against CNO/CRMO include fever; signs of infection by labs; signs of cancer by biopsy; specific abnormal x-ray/CT scan; specific abnormal MRI; or pain resolved with antibiotics alone.

Dr. Zhao described a point system with a threshold of 55 points for classification of CNO/CRMO.

He gave actual examples from the registry to demonstrate high and low probability of CNO/CRMO.
 

Pro-CNO example

The first was a boy, aged 7 years 10 months, who had a year and a half of pain in his back and legs, but no fever. Pain was constant, waxing and waning. He had a personal and family history of psoriasis and was tender to palpation at multiple sites. Labs were normal and bone biopsy and vitamin C tests were not done; imaging findings showed multiple bones were affected. There was no antibiotic treatment.

That patient was scored 81, much higher than the threshold of 55, and would be classified as having CNO.
 

Non-CNO example

Conversely, the following example of a patient would score 47 – under the threshold – and would not be classified as having CNO.

That patient was an 11-year-old boy who had 2 months of pain in his right thigh with no fever. The pain was constantly waxing and waning. He was tender to palpation at only his right thigh without swelling. Labs were normal. He had no coexisting conditions. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were not measured, and no vitamin C test was performed. Imaging showed one right femur lesion on a PET-CT scan. There was no antibiotic treatment, and a bone biopsy culture showed malignancy but no inflammation or fibrosis.

Dr. Zhao said the mimickers most likely to be misclassified are vitamin C deficiency; hypophosphatasia; benign bone tumor, such as osteogenic osteoma; and a malignancy with normal labs and multifocal pattern of bone lesions.

The classification criteria will be “extremely helpful to diagnose patients with CNO/CRMO earlier,” said Dr. Oliver, who helped develop the criteria.

“The goal is that the proposed classification criteria will be used by all physicians to diagnose suspected CNO patients earlier and refer to a rheumatologist earlier so that appropriate therapies will not be delayed.”

The group will seek ACR and EULAR endorsement, and if granted, work toward widespread implementation. The criteria will allow researchers to have a more homogeneous study population for future clinical trials, Dr. Zhao said.

Dr. Zhao, Dr. Ozen, and Dr. Oliver declared no relevant financial relationships. Dr. Oliver helped develop the proposed guidelines.

A version of this article first appeared on Medscape.com.

PHILADELPHIA – An international group of researchers has proposed the first classification criteria for chronic nonbacterial osteomyelitis (CNO) and a severe form of it, chronic recurrent multifocal osteomyelitis (CRMO).

CNO/CRMO most frequently affect children and adolescents and can significantly affect quality of life.

Yongdong (Dan) Zhao, MD, PhD, a pediatric rheumatologist at Seattle Children’s Hospital, Seattle, Washington, and Seza Ozen, MD, MSc, medical faculty head at Hacettepe University in Ankara, Turkey – members of the expert panel for criteria development – explained the proposed criteria, developed over 6 years, at the American College of Rheumatology 2022 Annual Meeting.

They gave examples of the point system that will help researchers correctly classify CNO/CRMO if the criteria are approved by ACR and the European Alliance of Associations for Rheumatology (EULAR).

Melissa S. Oliver, MD, a pediatric rheumatologist at Riley Children’s Hospital and Indiana University, Indianapolis, told this news organization: “This proposal is important because CNO/CRMO has primarily been a diagnosis of exclusion. There are no specific tests or biomarkers for this disease. It can mimic malignancy and infectious osteomyelitis in its presentation, and these must be ruled out thoroughly first.”

However, she noted, this can be challenging and can delay diagnosis and treatment.

The classification criteria are novel, she said, because an international collaborative group used a consensus process involving physicians managing CNO and patients or caregivers of children with CNO.
 

Findings for and against CNO

Dr. Ozen summarized some examples of findings for and against a CNO/CRMO classification.

Statistically significant findings in favor of CNO/CRMO, she said, include intermittent bone pain; bone pain in upper torso; swelling of upper torso; presence of symmetric lesions; and presence of adaptive immune cell and/or fibrosis in biopsy.

Conversely, findings against CNO/CRMO include fever; signs of infection by labs; signs of cancer by biopsy; specific abnormal x-ray/CT scan; specific abnormal MRI; or pain resolved with antibiotics alone.

Dr. Zhao described a point system with a threshold of 55 points for classification of CNO/CRMO.

He gave actual examples from the registry to demonstrate high and low probability of CNO/CRMO.
 

Pro-CNO example

The first was a boy, aged 7 years 10 months, who had a year and a half of pain in his back and legs, but no fever. Pain was constant, waxing and waning. He had a personal and family history of psoriasis and was tender to palpation at multiple sites. Labs were normal and bone biopsy and vitamin C tests were not done; imaging findings showed multiple bones were affected. There was no antibiotic treatment.

That patient was scored 81, much higher than the threshold of 55, and would be classified as having CNO.
 

Non-CNO example

Conversely, the following example of a patient would score 47 – under the threshold – and would not be classified as having CNO.

That patient was an 11-year-old boy who had 2 months of pain in his right thigh with no fever. The pain was constantly waxing and waning. He was tender to palpation at only his right thigh without swelling. Labs were normal. He had no coexisting conditions. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were not measured, and no vitamin C test was performed. Imaging showed one right femur lesion on a PET-CT scan. There was no antibiotic treatment, and a bone biopsy culture showed malignancy but no inflammation or fibrosis.

Dr. Zhao said the mimickers most likely to be misclassified are vitamin C deficiency; hypophosphatasia; benign bone tumor, such as osteogenic osteoma; and a malignancy with normal labs and multifocal pattern of bone lesions.

The classification criteria will be “extremely helpful to diagnose patients with CNO/CRMO earlier,” said Dr. Oliver, who helped develop the criteria.

“The goal is that the proposed classification criteria will be used by all physicians to diagnose suspected CNO patients earlier and refer to a rheumatologist earlier so that appropriate therapies will not be delayed.”

The group will seek ACR and EULAR endorsement, and if granted, work toward widespread implementation. The criteria will allow researchers to have a more homogeneous study population for future clinical trials, Dr. Zhao said.

Dr. Zhao, Dr. Ozen, and Dr. Oliver declared no relevant financial relationships. Dr. Oliver helped develop the proposed guidelines.

A version of this article first appeared on Medscape.com.

PHILADELPHIA – An international group of researchers has proposed the first classification criteria for chronic nonbacterial osteomyelitis (CNO) and a severe form of it, chronic recurrent multifocal osteomyelitis (CRMO).

CNO/CRMO most frequently affect children and adolescents and can significantly affect quality of life.

Yongdong (Dan) Zhao, MD, PhD, a pediatric rheumatologist at Seattle Children’s Hospital, Seattle, Washington, and Seza Ozen, MD, MSc, medical faculty head at Hacettepe University in Ankara, Turkey – members of the expert panel for criteria development – explained the proposed criteria, developed over 6 years, at the American College of Rheumatology 2022 Annual Meeting.

They gave examples of the point system that will help researchers correctly classify CNO/CRMO if the criteria are approved by ACR and the European Alliance of Associations for Rheumatology (EULAR).

Melissa S. Oliver, MD, a pediatric rheumatologist at Riley Children’s Hospital and Indiana University, Indianapolis, told this news organization: “This proposal is important because CNO/CRMO has primarily been a diagnosis of exclusion. There are no specific tests or biomarkers for this disease. It can mimic malignancy and infectious osteomyelitis in its presentation, and these must be ruled out thoroughly first.”

However, she noted, this can be challenging and can delay diagnosis and treatment.

The classification criteria are novel, she said, because an international collaborative group used a consensus process involving physicians managing CNO and patients or caregivers of children with CNO.
 

Findings for and against CNO

Dr. Ozen summarized some examples of findings for and against a CNO/CRMO classification.

Statistically significant findings in favor of CNO/CRMO, she said, include intermittent bone pain; bone pain in upper torso; swelling of upper torso; presence of symmetric lesions; and presence of adaptive immune cell and/or fibrosis in biopsy.

Conversely, findings against CNO/CRMO include fever; signs of infection by labs; signs of cancer by biopsy; specific abnormal x-ray/CT scan; specific abnormal MRI; or pain resolved with antibiotics alone.

Dr. Zhao described a point system with a threshold of 55 points for classification of CNO/CRMO.

He gave actual examples from the registry to demonstrate high and low probability of CNO/CRMO.
 

Pro-CNO example

The first was a boy, aged 7 years 10 months, who had a year and a half of pain in his back and legs, but no fever. Pain was constant, waxing and waning. He had a personal and family history of psoriasis and was tender to palpation at multiple sites. Labs were normal and bone biopsy and vitamin C tests were not done; imaging findings showed multiple bones were affected. There was no antibiotic treatment.

That patient was scored 81, much higher than the threshold of 55, and would be classified as having CNO.
 

Non-CNO example

Conversely, the following example of a patient would score 47 – under the threshold – and would not be classified as having CNO.

That patient was an 11-year-old boy who had 2 months of pain in his right thigh with no fever. The pain was constantly waxing and waning. He was tender to palpation at only his right thigh without swelling. Labs were normal. He had no coexisting conditions. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were not measured, and no vitamin C test was performed. Imaging showed one right femur lesion on a PET-CT scan. There was no antibiotic treatment, and a bone biopsy culture showed malignancy but no inflammation or fibrosis.

Dr. Zhao said the mimickers most likely to be misclassified are vitamin C deficiency; hypophosphatasia; benign bone tumor, such as osteogenic osteoma; and a malignancy with normal labs and multifocal pattern of bone lesions.

The classification criteria will be “extremely helpful to diagnose patients with CNO/CRMO earlier,” said Dr. Oliver, who helped develop the criteria.

“The goal is that the proposed classification criteria will be used by all physicians to diagnose suspected CNO patients earlier and refer to a rheumatologist earlier so that appropriate therapies will not be delayed.”

The group will seek ACR and EULAR endorsement, and if granted, work toward widespread implementation. The criteria will allow researchers to have a more homogeneous study population for future clinical trials, Dr. Zhao said.

Dr. Zhao, Dr. Ozen, and Dr. Oliver declared no relevant financial relationships. Dr. Oliver helped develop the proposed guidelines.

A version of this article first appeared on Medscape.com.