Key clinical point: Obesity was associated with a higher disease activity and poorer quality of life (QoL) in patients with psoriatic arthritis (PsA), thus emphasizing the need to consider obesity during the management of patients with PsA.

Major finding: Patients with obesity had a significantly higher PsA QoL questionnaire and psychological status measured by the Hospital Anxiety and Depression Scale compared with nonobese patients (P < .001). Even the disease activity index for PsA score was higher in patients with obesity (P < .05), whereas Psoriasis Area and Severity Index was similar between both groups (P = .154).

Study details: Findings are from a cross-sectional study including 1,033 patients with PsA, of which 62.9% of patients were nonobese and 37.1% were obese.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Gok K et al. Rheumatol Int. 2021 Aug 28. doi: 10.1007/s00296-021-04971-8.

Key clinical point: Obesity was associated with a higher disease activity and poorer quality of life (QoL) in patients with psoriatic arthritis (PsA), thus emphasizing the need to consider obesity during the management of patients with PsA.

Major finding: Patients with obesity had a significantly higher PsA QoL questionnaire and psychological status measured by the Hospital Anxiety and Depression Scale compared with nonobese patients (P < .001). Even the disease activity index for PsA score was higher in patients with obesity (P < .05), whereas Psoriasis Area and Severity Index was similar between both groups (P = .154).

Study details: Findings are from a cross-sectional study including 1,033 patients with PsA, of which 62.9% of patients were nonobese and 37.1% were obese.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Gok K et al. Rheumatol Int. 2021 Aug 28. doi: 10.1007/s00296-021-04971-8.

Key clinical point: Obesity was associated with a higher disease activity and poorer quality of life (QoL) in patients with psoriatic arthritis (PsA), thus emphasizing the need to consider obesity during the management of patients with PsA.

Major finding: Patients with obesity had a significantly higher PsA QoL questionnaire and psychological status measured by the Hospital Anxiety and Depression Scale compared with nonobese patients (P < .001). Even the disease activity index for PsA score was higher in patients with obesity (P < .05), whereas Psoriasis Area and Severity Index was similar between both groups (P = .154).

Study details: Findings are from a cross-sectional study including 1,033 patients with PsA, of which 62.9% of patients were nonobese and 37.1% were obese.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Gok K et al. Rheumatol Int. 2021 Aug 28. doi: 10.1007/s00296-021-04971-8.

Key clinical point: Endothelial dysfunction (ED) was inversely correlated with the severity of depressive symptoms in patients with psoriatic arthritis (PsA).

Major finding: Overall, 40% of PsA patients experienced depressive symptoms according to the Hospital Anxiety and Depression Scale (HDS). ED as measured by flow-mediated dilatation was negatively correlated with HDS score (Pearson’s coefficient [ρ] −0.339; P = .016), intensity of pain, and disease activity in PsA score (both ρ, −0.507; P = .001).

Study details: Findings are from a cross-sectional study including 50 patients with PsA between 30 and 75 years of age and without any previous history of heart disease or diabetes.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: De Lorenzis E et al. Front Med. 2021 Aug 27. doi: 10.3389/fmed.2021.669397.

Key clinical point: Endothelial dysfunction (ED) was inversely correlated with the severity of depressive symptoms in patients with psoriatic arthritis (PsA).

Major finding: Overall, 40% of PsA patients experienced depressive symptoms according to the Hospital Anxiety and Depression Scale (HDS). ED as measured by flow-mediated dilatation was negatively correlated with HDS score (Pearson’s coefficient [ρ] −0.339; P = .016), intensity of pain, and disease activity in PsA score (both ρ, −0.507; P = .001).

Study details: Findings are from a cross-sectional study including 50 patients with PsA between 30 and 75 years of age and without any previous history of heart disease or diabetes.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: De Lorenzis E et al. Front Med. 2021 Aug 27. doi: 10.3389/fmed.2021.669397.

Key clinical point: Endothelial dysfunction (ED) was inversely correlated with the severity of depressive symptoms in patients with psoriatic arthritis (PsA).

Major finding: Overall, 40% of PsA patients experienced depressive symptoms according to the Hospital Anxiety and Depression Scale (HDS). ED as measured by flow-mediated dilatation was negatively correlated with HDS score (Pearson’s coefficient [ρ] −0.339; P = .016), intensity of pain, and disease activity in PsA score (both ρ, −0.507; P = .001).

Study details: Findings are from a cross-sectional study including 50 patients with PsA between 30 and 75 years of age and without any previous history of heart disease or diabetes.

Disclosures: No information on funding was available. The authors declared no conflicts of interest.

Source: De Lorenzis E et al. Front Med. 2021 Aug 27. doi: 10.3389/fmed.2021.669397.

Key clinical point: Treatment modification was frequently observed in a cohort of patients with psoriatic arthritis (PsA) receiving disease-modifying antirheumatic drugs (DMARD), highlighting the need for more effective therapies.

Major finding: Overall, 57.3% of patients were treated with biologic DMARDs either as monotherapy or in combination with conventional synthetic DMARDs (csDMARD), whereas 37.7% and 4.4% of patients were treated with csDMARDs and targeted synthetic DMARDs, respectively. Treatment modifications in the previous year were reported by 48.4% of patients, with major reasons being lack of efficacy (38%) and remission or major improvement in the disease (14%).

Study details: Findings are from a retrospective observational cross-sectional study including 316 adults with established PsA and psoriasis who received DMARD treatment for at least 183 days in the previous year.

Disclosures: This work was funded by Bristol Myers Squibb, Germany. Some of the authors declared receiving speaker’s fees and compensation for consultancy or board memberships from Bristol Myers Squibb. Dr. Daamen and Dr. Rothnie declared being current or previous employees of Bristol Myers Squibb.

Source: Behrens F et al. Mod Rheumatol. 2021 Aug 26. doi: 10.1080/14397595.2020.1816597.

Key clinical point: Treatment modification was frequently observed in a cohort of patients with psoriatic arthritis (PsA) receiving disease-modifying antirheumatic drugs (DMARD), highlighting the need for more effective therapies.

Major finding: Overall, 57.3% of patients were treated with biologic DMARDs either as monotherapy or in combination with conventional synthetic DMARDs (csDMARD), whereas 37.7% and 4.4% of patients were treated with csDMARDs and targeted synthetic DMARDs, respectively. Treatment modifications in the previous year were reported by 48.4% of patients, with major reasons being lack of efficacy (38%) and remission or major improvement in the disease (14%).

Study details: Findings are from a retrospective observational cross-sectional study including 316 adults with established PsA and psoriasis who received DMARD treatment for at least 183 days in the previous year.

Disclosures: This work was funded by Bristol Myers Squibb, Germany. Some of the authors declared receiving speaker’s fees and compensation for consultancy or board memberships from Bristol Myers Squibb. Dr. Daamen and Dr. Rothnie declared being current or previous employees of Bristol Myers Squibb.

Source: Behrens F et al. Mod Rheumatol. 2021 Aug 26. doi: 10.1080/14397595.2020.1816597.

Key clinical point: Treatment modification was frequently observed in a cohort of patients with psoriatic arthritis (PsA) receiving disease-modifying antirheumatic drugs (DMARD), highlighting the need for more effective therapies.

Major finding: Overall, 57.3% of patients were treated with biologic DMARDs either as monotherapy or in combination with conventional synthetic DMARDs (csDMARD), whereas 37.7% and 4.4% of patients were treated with csDMARDs and targeted synthetic DMARDs, respectively. Treatment modifications in the previous year were reported by 48.4% of patients, with major reasons being lack of efficacy (38%) and remission or major improvement in the disease (14%).

Study details: Findings are from a retrospective observational cross-sectional study including 316 adults with established PsA and psoriasis who received DMARD treatment for at least 183 days in the previous year.

Disclosures: This work was funded by Bristol Myers Squibb, Germany. Some of the authors declared receiving speaker’s fees and compensation for consultancy or board memberships from Bristol Myers Squibb. Dr. Daamen and Dr. Rothnie declared being current or previous employees of Bristol Myers Squibb.

Source: Behrens F et al. Mod Rheumatol. 2021 Aug 26. doi: 10.1080/14397595.2020.1816597.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: The chances of counseling or education for modifiable lifestyle risk factors were rare during psoriatic arthritis (PsA) or psoriasis outpatient visits, with rates being even lower among dermatologists compared to nondermatologists.

Major finding: Overall, low rates of counseling were observed for any modifiable lifestyle risk factor (11.1%; 95% CI 7.9%-15.3%), tobacco (4.8%; 95% CI 2.8%-8.0%), and obesity (2.8%; 95% CI 1.7%-4.5%). Moreover, counseling rates for any modifiable risk factor were lower for dermatologists compared to nondermatologists visits (0.9% vs. 22.6%; P < .001).

Study details: This study used the National Ambulatory Medical Care Survey (2002-2016) and the National Hospital Ambulatory Medical Care Survey (2002-2011) conducted in the United States to assess the frequency of education/counseling for modifiable risk factors in an estimated 41.8 million psoriasis or PsA outpatient visits.

Disclosures: Dr. Barbieri is supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and receives partial support from Pfizer. The authors declared no conflicts of interest.

Source: Taylor MT et al. J Am Acad Dermatol. 2021 Aug 24. doi: 10.1016/j.jaad.2021.08.034.

Key clinical point: The chances of counseling or education for modifiable lifestyle risk factors were rare during psoriatic arthritis (PsA) or psoriasis outpatient visits, with rates being even lower among dermatologists compared to nondermatologists.

Major finding: Overall, low rates of counseling were observed for any modifiable lifestyle risk factor (11.1%; 95% CI 7.9%-15.3%), tobacco (4.8%; 95% CI 2.8%-8.0%), and obesity (2.8%; 95% CI 1.7%-4.5%). Moreover, counseling rates for any modifiable risk factor were lower for dermatologists compared to nondermatologists visits (0.9% vs. 22.6%; P < .001).

Study details: This study used the National Ambulatory Medical Care Survey (2002-2016) and the National Hospital Ambulatory Medical Care Survey (2002-2011) conducted in the United States to assess the frequency of education/counseling for modifiable risk factors in an estimated 41.8 million psoriasis or PsA outpatient visits.

Disclosures: Dr. Barbieri is supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and receives partial support from Pfizer. The authors declared no conflicts of interest.

Source: Taylor MT et al. J Am Acad Dermatol. 2021 Aug 24. doi: 10.1016/j.jaad.2021.08.034.

Key clinical point: The chances of counseling or education for modifiable lifestyle risk factors were rare during psoriatic arthritis (PsA) or psoriasis outpatient visits, with rates being even lower among dermatologists compared to nondermatologists.

Major finding: Overall, low rates of counseling were observed for any modifiable lifestyle risk factor (11.1%; 95% CI 7.9%-15.3%), tobacco (4.8%; 95% CI 2.8%-8.0%), and obesity (2.8%; 95% CI 1.7%-4.5%). Moreover, counseling rates for any modifiable risk factor were lower for dermatologists compared to nondermatologists visits (0.9% vs. 22.6%; P < .001).

Study details: This study used the National Ambulatory Medical Care Survey (2002-2016) and the National Hospital Ambulatory Medical Care Survey (2002-2011) conducted in the United States to assess the frequency of education/counseling for modifiable risk factors in an estimated 41.8 million psoriasis or PsA outpatient visits.

Disclosures: Dr. Barbieri is supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and receives partial support from Pfizer. The authors declared no conflicts of interest.

Source: Taylor MT et al. J Am Acad Dermatol. 2021 Aug 24. doi: 10.1016/j.jaad.2021.08.034.

Key clinical point: Patients with psoriasis with higher vs. lower affected body surface area (BSA) were at an increased risk of developing psoriatic arthritis (PsA).

Major finding: During a mean follow-up of 4.2 years, the incidence of PsA was 5.4 cases per 1,000 person years. Compared with BSA < 3%, BSA > 10% (hazard ratio [HR] 2.01; 95% CI 1.29-3.13) and BSA = 3%-10% (HR 1.44; 95% CI 1.02-2.03) were associated with incident PsA.

Study details: Findings are from a prospective, population-based cohort study including 9,056 patients with at least 1 code for psoriasis (mild to severe) and 90,547 matched general population controls.

Disclosures: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Heart, Lung, and Blood Institute of the National Institutes of Health. Some authors declared serving as consultant or co-patent holder or receiving grants, honoraria, or payments for medical education from several sources.

Source: Ogdie A et al. Rheumatology. 2021 Sep 11. doi: 10.1093/rheumatology/keab622.

Key clinical point: Patients with psoriasis with higher vs. lower affected body surface area (BSA) were at an increased risk of developing psoriatic arthritis (PsA).

Major finding: During a mean follow-up of 4.2 years, the incidence of PsA was 5.4 cases per 1,000 person years. Compared with BSA < 3%, BSA > 10% (hazard ratio [HR] 2.01; 95% CI 1.29-3.13) and BSA = 3%-10% (HR 1.44; 95% CI 1.02-2.03) were associated with incident PsA.

Study details: Findings are from a prospective, population-based cohort study including 9,056 patients with at least 1 code for psoriasis (mild to severe) and 90,547 matched general population controls.

Disclosures: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Heart, Lung, and Blood Institute of the National Institutes of Health. Some authors declared serving as consultant or co-patent holder or receiving grants, honoraria, or payments for medical education from several sources.

Source: Ogdie A et al. Rheumatology. 2021 Sep 11. doi: 10.1093/rheumatology/keab622.

Key clinical point: Patients with psoriasis with higher vs. lower affected body surface area (BSA) were at an increased risk of developing psoriatic arthritis (PsA).

Major finding: During a mean follow-up of 4.2 years, the incidence of PsA was 5.4 cases per 1,000 person years. Compared with BSA < 3%, BSA > 10% (hazard ratio [HR] 2.01; 95% CI 1.29-3.13) and BSA = 3%-10% (HR 1.44; 95% CI 1.02-2.03) were associated with incident PsA.

Study details: Findings are from a prospective, population-based cohort study including 9,056 patients with at least 1 code for psoriasis (mild to severe) and 90,547 matched general population controls.

Disclosures: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Heart, Lung, and Blood Institute of the National Institutes of Health. Some authors declared serving as consultant or co-patent holder or receiving grants, honoraria, or payments for medical education from several sources.

Source: Ogdie A et al. Rheumatology. 2021 Sep 11. doi: 10.1093/rheumatology/keab622.

Key clinical point: Treating skin manifestations with biologics significantly reduced the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: The risk of developing PsA was significantly higher in patients who did not receive treatment with biologics vs. the biological treatment group (adjusted hazard ratio 1.39; 95% CI 1.03-1.87).

Study details: Findings are from a retrospective cohort including 1,326 patients with psoriasis without PsA, of which 663 patients received biological treatment and 663 patients did not receive biological treatment.

Disclosures: This study did not report any external funding. Dr. Pavlovsky declared serving as investigator, advisor, consultant, and invited lecturer for various sources.

Source: Rosenthal YS et al. Arthritis Rheumatol. 2021 Aug 23. doi: 10.1002/art.41946.

Key clinical point: Treating skin manifestations with biologics significantly reduced the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: The risk of developing PsA was significantly higher in patients who did not receive treatment with biologics vs. the biological treatment group (adjusted hazard ratio 1.39; 95% CI 1.03-1.87).

Study details: Findings are from a retrospective cohort including 1,326 patients with psoriasis without PsA, of which 663 patients received biological treatment and 663 patients did not receive biological treatment.

Disclosures: This study did not report any external funding. Dr. Pavlovsky declared serving as investigator, advisor, consultant, and invited lecturer for various sources.

Source: Rosenthal YS et al. Arthritis Rheumatol. 2021 Aug 23. doi: 10.1002/art.41946.

Key clinical point: Treating skin manifestations with biologics significantly reduced the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: The risk of developing PsA was significantly higher in patients who did not receive treatment with biologics vs. the biological treatment group (adjusted hazard ratio 1.39; 95% CI 1.03-1.87).

Study details: Findings are from a retrospective cohort including 1,326 patients with psoriasis without PsA, of which 663 patients received biological treatment and 663 patients did not receive biological treatment.

Disclosures: This study did not report any external funding. Dr. Pavlovsky declared serving as investigator, advisor, consultant, and invited lecturer for various sources.

Source: Rosenthal YS et al. Arthritis Rheumatol. 2021 Aug 23. doi: 10.1002/art.41946.

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

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

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

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

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

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

Federal efforts to improve the quality, safety, and efficacy of over-the-counter sunscreens took a step forward today with the release of two orders aimed at updating regulatory requirements for most sunscreen products in the United States.

“We see it as a key public health priority and our regulatory obligation to make sure that marketed sunscreen products offer protection from the sun’s effects and that they deliver on those promises to consumers,” Theresa Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said during a media briefing.

When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of amending a sunscreen monograph through the previous rule-making process, and the agency had issued a proposed rule for sunscreens in February of 2019. The CARES Act provided the FDA with new authority related to OTC drugs including sunscreens.

It also established a deemed final order for sunscreens, which set the current requirements for OTC sunscreen products marketed without an application. The deemed final order, released on Sept. 24, “essentially preserves the pre-CARES Act status quo marketing conditions for these sunscreens,” Dr. Michele explained. “Before the CARES Act was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the agency believes that most sunscreens on the market today are already in compliance with this order.”

The CARES Act also required the FDA to issue a proposed order by Sept. 27 to amend and revise the deemed final order. Dr. Michele described the proposed order, which was released on Sept. 24, as “a vehicle to effectively transition our ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rule-making process to this new order process. The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens. With this proposed order, we’re proposing new requirements to improve the quality, safety, and efficacy of sunscreens that Americans use every day.”

The order proposes to update the generally recognized as safe (GRASE) status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, professor and chair of dermatology at George Washington University, Washington, emphasized that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad-spectrum sunscreens with an SPF of 15 and higher play an important role in this. This should not be lost amidst the proposed order.”

Changes between the deemed and proposed order that he highlighted include a maximum SPF of 60+ (though up to 80 might be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for community input,” he said.

Other changes between the deemed and proposed order are that PABA and trolamine salicylate are not GRASE and that broad-spectrum testing will be mandatory. In addition, Dr. Friedman said, “sprays will be considered for GRASE so long as properly tested, labeling should be clearer (and a warning will be applied to those sunscreens not shown to prevent all the bad stuff with UVR [ultraviolet radiation]), and bug spray–sunscreen combos are a no-go.”

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we’ll consider all timely comments submitted both in response to the February 2019 proposed rule and to the current proposed order,” Dr. Michele said.

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

[email protected]

Federal efforts to improve the quality, safety, and efficacy of over-the-counter sunscreens took a step forward today with the release of two orders aimed at updating regulatory requirements for most sunscreen products in the United States.

“We see it as a key public health priority and our regulatory obligation to make sure that marketed sunscreen products offer protection from the sun’s effects and that they deliver on those promises to consumers,” Theresa Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said during a media briefing.

When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of amending a sunscreen monograph through the previous rule-making process, and the agency had issued a proposed rule for sunscreens in February of 2019. The CARES Act provided the FDA with new authority related to OTC drugs including sunscreens.

It also established a deemed final order for sunscreens, which set the current requirements for OTC sunscreen products marketed without an application. The deemed final order, released on Sept. 24, “essentially preserves the pre-CARES Act status quo marketing conditions for these sunscreens,” Dr. Michele explained. “Before the CARES Act was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the agency believes that most sunscreens on the market today are already in compliance with this order.”

The CARES Act also required the FDA to issue a proposed order by Sept. 27 to amend and revise the deemed final order. Dr. Michele described the proposed order, which was released on Sept. 24, as “a vehicle to effectively transition our ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rule-making process to this new order process. The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens. With this proposed order, we’re proposing new requirements to improve the quality, safety, and efficacy of sunscreens that Americans use every day.”

The order proposes to update the generally recognized as safe (GRASE) status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, professor and chair of dermatology at George Washington University, Washington, emphasized that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad-spectrum sunscreens with an SPF of 15 and higher play an important role in this. This should not be lost amidst the proposed order.”

Changes between the deemed and proposed order that he highlighted include a maximum SPF of 60+ (though up to 80 might be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for community input,” he said.

Other changes between the deemed and proposed order are that PABA and trolamine salicylate are not GRASE and that broad-spectrum testing will be mandatory. In addition, Dr. Friedman said, “sprays will be considered for GRASE so long as properly tested, labeling should be clearer (and a warning will be applied to those sunscreens not shown to prevent all the bad stuff with UVR [ultraviolet radiation]), and bug spray–sunscreen combos are a no-go.”

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we’ll consider all timely comments submitted both in response to the February 2019 proposed rule and to the current proposed order,” Dr. Michele said.

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

[email protected]

Federal efforts to improve the quality, safety, and efficacy of over-the-counter sunscreens took a step forward today with the release of two orders aimed at updating regulatory requirements for most sunscreen products in the United States.

“We see it as a key public health priority and our regulatory obligation to make sure that marketed sunscreen products offer protection from the sun’s effects and that they deliver on those promises to consumers,” Theresa Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said during a media briefing.

When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of amending a sunscreen monograph through the previous rule-making process, and the agency had issued a proposed rule for sunscreens in February of 2019. The CARES Act provided the FDA with new authority related to OTC drugs including sunscreens.

It also established a deemed final order for sunscreens, which set the current requirements for OTC sunscreen products marketed without an application. The deemed final order, released on Sept. 24, “essentially preserves the pre-CARES Act status quo marketing conditions for these sunscreens,” Dr. Michele explained. “Before the CARES Act was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the agency believes that most sunscreens on the market today are already in compliance with this order.”

The CARES Act also required the FDA to issue a proposed order by Sept. 27 to amend and revise the deemed final order. Dr. Michele described the proposed order, which was released on Sept. 24, as “a vehicle to effectively transition our ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rule-making process to this new order process. The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens. With this proposed order, we’re proposing new requirements to improve the quality, safety, and efficacy of sunscreens that Americans use every day.”

The order proposes to update the generally recognized as safe (GRASE) status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, professor and chair of dermatology at George Washington University, Washington, emphasized that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad-spectrum sunscreens with an SPF of 15 and higher play an important role in this. This should not be lost amidst the proposed order.”

Changes between the deemed and proposed order that he highlighted include a maximum SPF of 60+ (though up to 80 might be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for community input,” he said.

Other changes between the deemed and proposed order are that PABA and trolamine salicylate are not GRASE and that broad-spectrum testing will be mandatory. In addition, Dr. Friedman said, “sprays will be considered for GRASE so long as properly tested, labeling should be clearer (and a warning will be applied to those sunscreens not shown to prevent all the bad stuff with UVR [ultraviolet radiation]), and bug spray–sunscreen combos are a no-go.”

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we’ll consider all timely comments submitted both in response to the February 2019 proposed rule and to the current proposed order,” Dr. Michele said.

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

[email protected]