Article

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Daily use of an emollient with a prebiotic lysate in the first year of life was safe but did not decrease the risk of developing atopic dermatitis (AD) in high-risk infants.

Major finding: At 2 years, the cumulative incidence of AD among infants receiving general skin care+emollient containing a prebiotic Vitreoscilla filiformis lysate (at least once daily until 1 year of age; intervention group) and general skin care (control group) was comparable (28% and 24%, respectively; adjusted relative risk 1.17; 95% CI 0.46-2.98). No emollient-related adverse events were reported.

Study details: Findings are from the randomized prospective EARLYEmollient study including 50 term-born infants aged 1-21 days with a high risk for AD who were randomly assigned to the intervention (n = 25) or control (n = 25) group.

Disclosures: This study was supported by La Roche-Posay Laboratoire Pharmaceutique, France. Some authors declared serving as lecturers or consultants, receiving institutional grants, or participating in advisory board meetings for various sources.

Source: Harder I et al. Effects of early emollient use in children at high risk of atopic dermatitis: A German pilot study. Acta Derm Venereol. 2023;103:adv5671 (May 29). doi: 10.2340/actadv.v103.5671

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Abrocitinib led to greater and rapid improvements in itch and skin clearance compared with placebo in patients with severe or difficult-to-treat atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients achieved an Investigator’s Global Assessment score of 0 or 1, Eczema Area and Severity Index-75 and -90 responses, and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale score with abrocitinib 200-mg vs placebo across all subgroups (all nominal P < .05).

Study details: This post hoc analysis of the JADE COMPARE trial (n = 837) included a subset of patients with severe or difficult-to-treat AD who were randomly assigned to receive oral abrocitinib (200 or 100 mg), subcutaneous dupilumab (300 mg), or placebo with medicated topical therapy for 16 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared receiving grants or personal fees or serving as consultants, speakers, board members, or investigators for various organizations, including Pfizer. Five authors declared being employees of or shareholders in Pfizer.

Source: Simpson EL et al. Efficacy and safety of abrocitinib in patients with severe and/or difficult‑to‑treat atopic dermatitis: A post hoc analysis of the randomized phase 3 JADE COMPARE trial. Am J Clin Dermatol. 2023 (May 22). doi: 10.1007/s40257-023-00785-5

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: Dupilumab dose was successfully tapered while maintaining controlled disease in the majority of patients with atopic dermatitis (AD) using a patient-centered dosing regimen in a large daily practice cohort study.

Major finding: Dose reduction was successful in 83.3% of patients who prolonged dupilumab interval while maintaining controlled disease, with most patients receiving dupilumab every 3 or 4 weeks. Although a significant small increase was observed in the highest mean Eczema Area and Severity Index and Numeric Rating Scale-Pruritis scores (both P < .001), the scores remained low.

Study details: Findings are from a prospective, multicenter study including 595 adult patients with controlled AD treated with dupilumab for ≥1 yearfrom the BioDay registry, of which 401 patients prolonged the dupilumab interval.

Disclosures: The BioDay registry was sponsored by Sanofi, AbbVie, and others. Some authors declared serving as investigators, speakers, advisors, or consultants for various sources, including the BioDay registry sponsors.

Source: Spekhorst LS, Boesjes CM, et al. Successful tapering of dupilumab in atopic dermatitis patients with low disease activity: A large pragmatic daily practice study from the BioDay registry. Br J Dermatol. 2023 (May 13). doi: 10.1093/bjd/ljad159

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

Disclosures: This study was supported by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Eight authors declared being employees of or holding stock or stock options in AbbVie.

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

Disclosures: This study was supported by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Eight authors declared being employees of or holding stock or stock options in AbbVie.

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), continuous upadacitinib treatment was safe and provided sustained responses through 40 weeks and switch to upadacitinib treatment improved outcomes irrespective of prior dupilumab response.

Major finding: At open-label extension week 16 vs Heads Up week 24, the mean Eczema Area and Severity Index scores were similar with continuous upadacitinib treatment (2.7 vs 2.6) and improved with a switch to upadacitinib from dupilumab (1.09 vs 3.29). Most patients without minimal threshold or adequate response with dupilumab achieved it with upadacitinib. No new safety signals were reported.

Study details: This 16-week interim analysis of a 52-week open-label extension study of the Heads Up trial included adults with moderate-to-severe AD who were assigned to continue receiving upadacitinib (n = 239) or switch to upadacitinib after 24 weeks of dupilumab (n = 245).

Disclosures: This study was supported by AbbVie Inc. Some authors reported ties with various organizations, including AbbVie. Eight authors declared being employees of or holding stock or stock options in AbbVie.

Source: Blauvelt A et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 (May 22). doi: 10.1016/j.jaad.2023.05.033

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Maintenance therapy with once-daily crisaborole is safe and effective in adult and pediatric patients with mild-to-moderate atopic dermatitis (AD) who have previously responded to twice-daily crisaborole treatment.

Major finding: The crisaborole vs vehicle group had a significantly longer median flare-free maintenance time (111 vs 30 days; P = .0034), higher mean number of flare-free days (234.0 vs 199.4 days; P = .0346), and lower mean number of flares (0.95 vs 1.36; P = .0042). No new safety signals were reported.

Study details: This phase 3 study (CrisADe CONTROL) included 270 patients age ≥3 months with mild-to-moderate AD who received twice-daily crisaborole for a maximum of 8 weeks; the responders were randomly assigned to receive once-daily crisaborole 2% ointment (n = 135) or vehicle (n = 135) for 52 weeks.

Disclosures: This study was funded by Pfizer Inc. Some authors declared serving as investigators, speakers, or consultants for or receiving research grants from various sources, including Pfizer. Six authors declared being employees of and shareholders in Pfizer.

Source: Eichenfield LF et al. Once‑daily crisaborole ointment, 2%, as a long‑term maintenance treatment in patients aged ≥ 3 months with mild‑to‑moderate atopic dermatitis: A 52-week clinical study. Am J Clin Dermatol. 2023 (May 15). doi: 10.1007/s40257-023-00780-w

Key clinical point: Adults with atopic dermatitis (AD) have a 1.28-fold increased risk for incident venous thromboembolism (VTE) compared with those without AD.

Major finding: Patients with AD vs control individuals without AD had an increased risk for incident VTE (hazard ratio [HR] 1.28; 95% CI 1.17-1.40), with the risk being elevated for both deep vein thrombosis (HR 1.26; 95% CI 1.14-1.40) and pulmonary embolism (HR 1.30; 95% CI 1.08-1.57).

Study details: The data come from a retrospective cohort study that included 142,429 patients age ≥ 20 years with AD and 142,429 matched control individuals without AD.

Disclosures: This study was funded by Hualien Tzu Chi Hospital, Taiwan. The authors declared no conflicts of interest.

Source: Chen TL et al. Risk of venous thromboembolism among adults with atopic dermatitis. JAMA Dermatol. 2023 (May 31). doi: 10.1001/jamadermatol.2023.1300.

Key clinical point: Adults with atopic dermatitis (AD) have a 1.28-fold increased risk for incident venous thromboembolism (VTE) compared with those without AD.

Major finding: Patients with AD vs control individuals without AD had an increased risk for incident VTE (hazard ratio [HR] 1.28; 95% CI 1.17-1.40), with the risk being elevated for both deep vein thrombosis (HR 1.26; 95% CI 1.14-1.40) and pulmonary embolism (HR 1.30; 95% CI 1.08-1.57).

Study details: The data come from a retrospective cohort study that included 142,429 patients age ≥ 20 years with AD and 142,429 matched control individuals without AD.

Disclosures: This study was funded by Hualien Tzu Chi Hospital, Taiwan. The authors declared no conflicts of interest.

Source: Chen TL et al. Risk of venous thromboembolism among adults with atopic dermatitis. JAMA Dermatol. 2023 (May 31). doi: 10.1001/jamadermatol.2023.1300.

Key clinical point: Adults with atopic dermatitis (AD) have a 1.28-fold increased risk for incident venous thromboembolism (VTE) compared with those without AD.

Major finding: Patients with AD vs control individuals without AD had an increased risk for incident VTE (hazard ratio [HR] 1.28; 95% CI 1.17-1.40), with the risk being elevated for both deep vein thrombosis (HR 1.26; 95% CI 1.14-1.40) and pulmonary embolism (HR 1.30; 95% CI 1.08-1.57).

Study details: The data come from a retrospective cohort study that included 142,429 patients age ≥ 20 years with AD and 142,429 matched control individuals without AD.

Disclosures: This study was funded by Hualien Tzu Chi Hospital, Taiwan. The authors declared no conflicts of interest.

Source: Chen TL et al. Risk of venous thromboembolism among adults with atopic dermatitis. JAMA Dermatol. 2023 (May 31). doi: 10.1001/jamadermatol.2023.1300.

Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.

Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.

Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.

Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or  stock options in AOBiome.

Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002

Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.

Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.

Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.

Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or  stock options in AOBiome.

Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002

Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.

Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.

Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.

Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or  stock options in AOBiome.

Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002

The history and findings in this case are suggestive of leukemic non-nodal mantle cell lymphoma (MCL).

MCL is a rare mature B-cell neoplasm characterized by t(11;14) (q13;q32) and cyclin D1 overexpression in more than 95% of cases. It accounts for approximately 5%-7% of all lymphomas, with an annual incidence of one case per 200,000 people. In North America and Europe, the incidence of MCL is like that of noncutaneous peripheral T-cell lymphomas. MCL occurs more frequently in men than in women (3:1), and the median age at diagnosis ranges from ages 60-70 years. 

In recent years, MCL has been categorized into two major subgroups that have distinct clinical presentation and molecular features: nodal MCL and leukemic non-nodal MCL. Nodal MCL is a common variant with an aggressive disease course. Unmutated IGHV gene rearrangement, SOX11 overexpression, a higher degree of genomic instability (eg, ATM, CDKN2A, chromatin modifier mutations), and other oncogenic mutations and epigenetic modifications are seen in patients with this variant. 

Leukemic non-nodal MCL is seen in 10%-20% of patients with MCL. Patients frequently present with lymphocytosis and splenomegaly. In most cases, it is associated with an indolent disease course and superior outcome. This subtype is largely IGHV mutated and mostly SOX11-negative, with positive expression of CD200, peripheral blood, bone marrow, and splenic involvement, low tumor burden, and a low Ki-67 index.

Recognition of the leukemic non-nodal MCL immunophenotype enables it to be differentiated from other CD5-positive B-cell cancers, particularly classical MCL and chronic lymphocytic leukemia (CLL). The overexpression of cyclin D1, the presence of the t(11;14) translocation, and the absence of chromosomal markers typically present in CLL differentiate leukemic non-nodal MCL from CLL. Moreover, CLL has high expression of CD23 and is negative for SOX11 and CD200.

Pathologic features of MCL include small- to medium-size lymphocytes with scant cytoplasm, clumped chromatin, inconspicuous nucleoli, and prominent nuclear clefts. Observed growth patterns include diffuse, nodular (more vague and less discrete than that found in follicular lymphomas), mantle-zone lymphoma with expansion of mantle zones, and in situ mantle-cell neoplasia [typical cells with the characteristic t(11;14) translocation, scattered in the mantle zone of otherwise normal-appearing lymph nodes]. Cytologic subtypes include classic MCL, the blastoid subtype (large cells, dispersed chromatin, and a high mitotic rate), and the pleomorphic subtype (cells of variable sizes, although many are large, with pale cytoplasm, oval irregular nuclei, and prominent nucleoli). 

MCL is a challenging disease to treat. Despite treatment advances, it is largely incurable, with a median overall survival of 1.8-9.4 years, depending on whether it is aggressive or indolent MCL. The aggressiveness of the disease, the patient's performance status, age, and mantle cell international prognostic index score should all be considered when selecting treatment because there is no standard curative treatment. 

According to the 2023 guidelines from the National Comprehensive Cancer Network (NCCN), for patients with indolent disease (eg, IGHV mutated and mostly SOX11-negative with leukemic and non-nodal presentation), observation is reasonable when patients are asymptomatic and have no indications for treatment. For patients with symptomatic disease or other indications for treatment, induction therapy with aggressive regimens is recommended when patients do not have a TP53 mutation. The optimum approach for patients with TP53 mutation is not yet known; induction therapy followed by high-dose therapy with autologous stem cell transplant or less aggressive regimens could be an option for these patients.

Treatment options for relapsed/refractory MCL include radiotherapy; traditional chemotherapy regimens, with or without rituximab; and newer targeted therapies. These include Bruton tyrosine kinase inhibitors (ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib), lenalidomide, bortezomib, the mammalian target of rapamycin inhibitors temsirolimus and everolimus, the phosphatidylinositol 3–kinase inhibitors idelalisib and umbralisib, and the B-cell lymphoma 2 inhibitor venetoclax. These agents are frequently administered in combination with rituximab or another anti-CD20 antibody.

For comprehensive guidance on the treatment of MCL, consult the complete NCCN guidelines.

Timothy J. Voorhees, MD, MSCR, Assistant Professor of Internal Medicine - Clinical, Division of Hematology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH.

Timothy J. Voorhees, MD, MSCR, has disclosed the following relevant financial relationships:
Received research grant from: AstraZeneca; Morphosys; Incyte; Recordati.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The history and findings in this case are suggestive of leukemic non-nodal mantle cell lymphoma (MCL).

MCL is a rare mature B-cell neoplasm characterized by t(11;14) (q13;q32) and cyclin D1 overexpression in more than 95% of cases. It accounts for approximately 5%-7% of all lymphomas, with an annual incidence of one case per 200,000 people. In North America and Europe, the incidence of MCL is like that of noncutaneous peripheral T-cell lymphomas. MCL occurs more frequently in men than in women (3:1), and the median age at diagnosis ranges from ages 60-70 years. 

In recent years, MCL has been categorized into two major subgroups that have distinct clinical presentation and molecular features: nodal MCL and leukemic non-nodal MCL. Nodal MCL is a common variant with an aggressive disease course. Unmutated IGHV gene rearrangement, SOX11 overexpression, a higher degree of genomic instability (eg, ATM, CDKN2A, chromatin modifier mutations), and other oncogenic mutations and epigenetic modifications are seen in patients with this variant. 

Leukemic non-nodal MCL is seen in 10%-20% of patients with MCL. Patients frequently present with lymphocytosis and splenomegaly. In most cases, it is associated with an indolent disease course and superior outcome. This subtype is largely IGHV mutated and mostly SOX11-negative, with positive expression of CD200, peripheral blood, bone marrow, and splenic involvement, low tumor burden, and a low Ki-67 index.

Recognition of the leukemic non-nodal MCL immunophenotype enables it to be differentiated from other CD5-positive B-cell cancers, particularly classical MCL and chronic lymphocytic leukemia (CLL). The overexpression of cyclin D1, the presence of the t(11;14) translocation, and the absence of chromosomal markers typically present in CLL differentiate leukemic non-nodal MCL from CLL. Moreover, CLL has high expression of CD23 and is negative for SOX11 and CD200.

Pathologic features of MCL include small- to medium-size lymphocytes with scant cytoplasm, clumped chromatin, inconspicuous nucleoli, and prominent nuclear clefts. Observed growth patterns include diffuse, nodular (more vague and less discrete than that found in follicular lymphomas), mantle-zone lymphoma with expansion of mantle zones, and in situ mantle-cell neoplasia [typical cells with the characteristic t(11;14) translocation, scattered in the mantle zone of otherwise normal-appearing lymph nodes]. Cytologic subtypes include classic MCL, the blastoid subtype (large cells, dispersed chromatin, and a high mitotic rate), and the pleomorphic subtype (cells of variable sizes, although many are large, with pale cytoplasm, oval irregular nuclei, and prominent nucleoli). 

MCL is a challenging disease to treat. Despite treatment advances, it is largely incurable, with a median overall survival of 1.8-9.4 years, depending on whether it is aggressive or indolent MCL. The aggressiveness of the disease, the patient's performance status, age, and mantle cell international prognostic index score should all be considered when selecting treatment because there is no standard curative treatment. 

According to the 2023 guidelines from the National Comprehensive Cancer Network (NCCN), for patients with indolent disease (eg, IGHV mutated and mostly SOX11-negative with leukemic and non-nodal presentation), observation is reasonable when patients are asymptomatic and have no indications for treatment. For patients with symptomatic disease or other indications for treatment, induction therapy with aggressive regimens is recommended when patients do not have a TP53 mutation. The optimum approach for patients with TP53 mutation is not yet known; induction therapy followed by high-dose therapy with autologous stem cell transplant or less aggressive regimens could be an option for these patients.

Treatment options for relapsed/refractory MCL include radiotherapy; traditional chemotherapy regimens, with or without rituximab; and newer targeted therapies. These include Bruton tyrosine kinase inhibitors (ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib), lenalidomide, bortezomib, the mammalian target of rapamycin inhibitors temsirolimus and everolimus, the phosphatidylinositol 3–kinase inhibitors idelalisib and umbralisib, and the B-cell lymphoma 2 inhibitor venetoclax. These agents are frequently administered in combination with rituximab or another anti-CD20 antibody.

For comprehensive guidance on the treatment of MCL, consult the complete NCCN guidelines.

Timothy J. Voorhees, MD, MSCR, Assistant Professor of Internal Medicine - Clinical, Division of Hematology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH.

Timothy J. Voorhees, MD, MSCR, has disclosed the following relevant financial relationships:
Received research grant from: AstraZeneca; Morphosys; Incyte; Recordati.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The history and findings in this case are suggestive of leukemic non-nodal mantle cell lymphoma (MCL).

MCL is a rare mature B-cell neoplasm characterized by t(11;14) (q13;q32) and cyclin D1 overexpression in more than 95% of cases. It accounts for approximately 5%-7% of all lymphomas, with an annual incidence of one case per 200,000 people. In North America and Europe, the incidence of MCL is like that of noncutaneous peripheral T-cell lymphomas. MCL occurs more frequently in men than in women (3:1), and the median age at diagnosis ranges from ages 60-70 years. 

In recent years, MCL has been categorized into two major subgroups that have distinct clinical presentation and molecular features: nodal MCL and leukemic non-nodal MCL. Nodal MCL is a common variant with an aggressive disease course. Unmutated IGHV gene rearrangement, SOX11 overexpression, a higher degree of genomic instability (eg, ATM, CDKN2A, chromatin modifier mutations), and other oncogenic mutations and epigenetic modifications are seen in patients with this variant. 

Leukemic non-nodal MCL is seen in 10%-20% of patients with MCL. Patients frequently present with lymphocytosis and splenomegaly. In most cases, it is associated with an indolent disease course and superior outcome. This subtype is largely IGHV mutated and mostly SOX11-negative, with positive expression of CD200, peripheral blood, bone marrow, and splenic involvement, low tumor burden, and a low Ki-67 index.

Recognition of the leukemic non-nodal MCL immunophenotype enables it to be differentiated from other CD5-positive B-cell cancers, particularly classical MCL and chronic lymphocytic leukemia (CLL). The overexpression of cyclin D1, the presence of the t(11;14) translocation, and the absence of chromosomal markers typically present in CLL differentiate leukemic non-nodal MCL from CLL. Moreover, CLL has high expression of CD23 and is negative for SOX11 and CD200.

Pathologic features of MCL include small- to medium-size lymphocytes with scant cytoplasm, clumped chromatin, inconspicuous nucleoli, and prominent nuclear clefts. Observed growth patterns include diffuse, nodular (more vague and less discrete than that found in follicular lymphomas), mantle-zone lymphoma with expansion of mantle zones, and in situ mantle-cell neoplasia [typical cells with the characteristic t(11;14) translocation, scattered in the mantle zone of otherwise normal-appearing lymph nodes]. Cytologic subtypes include classic MCL, the blastoid subtype (large cells, dispersed chromatin, and a high mitotic rate), and the pleomorphic subtype (cells of variable sizes, although many are large, with pale cytoplasm, oval irregular nuclei, and prominent nucleoli). 

MCL is a challenging disease to treat. Despite treatment advances, it is largely incurable, with a median overall survival of 1.8-9.4 years, depending on whether it is aggressive or indolent MCL. The aggressiveness of the disease, the patient's performance status, age, and mantle cell international prognostic index score should all be considered when selecting treatment because there is no standard curative treatment. 

According to the 2023 guidelines from the National Comprehensive Cancer Network (NCCN), for patients with indolent disease (eg, IGHV mutated and mostly SOX11-negative with leukemic and non-nodal presentation), observation is reasonable when patients are asymptomatic and have no indications for treatment. For patients with symptomatic disease or other indications for treatment, induction therapy with aggressive regimens is recommended when patients do not have a TP53 mutation. The optimum approach for patients with TP53 mutation is not yet known; induction therapy followed by high-dose therapy with autologous stem cell transplant or less aggressive regimens could be an option for these patients.

Treatment options for relapsed/refractory MCL include radiotherapy; traditional chemotherapy regimens, with or without rituximab; and newer targeted therapies. These include Bruton tyrosine kinase inhibitors (ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib), lenalidomide, bortezomib, the mammalian target of rapamycin inhibitors temsirolimus and everolimus, the phosphatidylinositol 3–kinase inhibitors idelalisib and umbralisib, and the B-cell lymphoma 2 inhibitor venetoclax. These agents are frequently administered in combination with rituximab or another anti-CD20 antibody.

For comprehensive guidance on the treatment of MCL, consult the complete NCCN guidelines.

Timothy J. Voorhees, MD, MSCR, Assistant Professor of Internal Medicine - Clinical, Division of Hematology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH.

Timothy J. Voorhees, MD, MSCR, has disclosed the following relevant financial relationships:
Received research grant from: AstraZeneca; Morphosys; Incyte; Recordati.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

Kerry Dooley Young

The US Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
 

FDA approves OTC naloxone, but will cost be a barrier?

Alicia Ault

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

Karen Blum

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

Tara Haelle

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

Kerry Dooley Young

The US Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
 

FDA approves OTC naloxone, but will cost be a barrier?

Alicia Ault

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

Karen Blum

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

Tara Haelle

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

Kerry Dooley Young

The US Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
 

FDA approves OTC naloxone, but will cost be a barrier?

Alicia Ault

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

Karen Blum

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

Tara Haelle

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

Climate change has been called the biggest health threat of the 21st century.¹ The health care sector is a huge contributor to global carbon emissions, accounting for almost double the emissions of global aviation. While other industries and countries are implementing mitigation measures to decrease their emissions, health care is currently on track to double its carbon emissions by 2050, even though it should be carbon neutral by that time to comply with the Paris Climate Agreement.² There have been some national efforts to curb health care emissions, including the creation of the Office of Climate Change and Health Equity in 2021 and the passage of the Inflation Reduction Act in 2022.³ These are top-down, administrative approaches, and to be successful we will also need clinicians to understand and address this problem.

The negative impacts of heat, air pollution, and exposure to toxic substances on human health have been well documented in multiple regions across multiple specialties.^4-7 The United States makes up 27% of the global health care carbon footprint—more emissions than the entire United Kingdom as a country—despite having only 4% of the world’s population.² Culture and incentives for an overabundance of single-use supplies, not evidence for patient safety, have led to this uniquely American problem. It is evident that our health care industry is an excellent place to implement mitigation measures for carbon emissions that contribute to climate change and can improve health outcomes.

In this article, we recommend 10 practices that can decrease our carbon footprint in ObGyn. We focus on the classic motto of “Reduce, Reuse, Recycle,” while adding “Remove” and “Reimagine” to classify the ways in which we can reduce emissions while not compromising our care to patients.

Reduce

1. Minimize opened materials and single-use devices in the OR and labor and delivery

Health care is a unique setting where a culture of infection prevention and efficiency has led low-cost, single-use supplies to dominate over reusable items. While single-use items can have inexpensive purchasing costs compared to reusable items, the environmental costs required for the production and disposal of the former are often much greater. In operating rooms (ORs) and labor and delivery (LD) units, single-use items are omnipresent. Over the past decade, researchers and clinicians have started to take a closer look at these items and their carbon footprint. One group evaluated hysterectomy through a waste audit and found that the vast majority of waste from all of the cases was Spunbond Meltblown Spunbond, or SMS; plastic materialthat comprises gowns; blue wraps; and drapes; followed by hard plastic material that comprises trays and packaging.⁸ Moreover, production and manufacturing processes contributed to 95% of the environmental impacts of these items.⁸

In an effort to be time efficient, OR staff will open sterile surgical packs and individual peel-pack items prior to surgery to minimize having to find items during surgery. However, this creates an inordinate amount of waste. One group of neurosurgeons who evaluated their opened but unused supplies found that 85% of their unused items were individually opened items, leading to a waste of $2.9 million per year.⁹ Minor procedures like dilation and curettage, cystoscopy, and hysteroscopy do not need such a large sterile field, as these procedures are also safe to perform in the office. Hand surgeons have been quick to lead in this space, particularly with minor procedures such as carpal tunnel release. One division was able to eliminate 2.8 tons of waste and save $13,000 in a 2-year period by reducing the sterile field.¹⁰ ObGyns can work with OR and LD staff to create custom packs that minimize unused or underutilized items, helping to reduce both the carbon footprint and health care spending.

Bottom line: ObGyns can help foster a culture of having supplies available but not opened until needed during a case.

Continue to: 2. Decrease regulated medical waste...

 

 

2. Decrease regulated medical waste

Health care is unique from other fields in that there are multiple waste streams to consider. Infectious waste and items saturated in blood or capable of causing infection must be placed into regulated medical waste (RMW), or more commonly, red biohazard bags. RMW is autoclaved or incinerated prior to disposal in a landfill. This process is more financially and environmentally costly than general municipal waste (GMW). This process also requires more transport—1 study revealed that GMW traveled 20 km to a landfill for disposal, compared with the 50 km that RMW traveled for sterilized-prior-to-landfill disposal.¹¹

Unfortunately, the vast majority of items placed in RMW are incorrectly triaged and should instead be disposed in GMW.^12,13 One study performed in an emergency department revealed that 85% of waste was incorrectly placed in the RMW.¹²

Bottom line: ObGyns can avoid placing items in RMW that may not qualify and advocate for institution policy changes to remove RMW from places such as waiting rooms, at the patient bedside, or next to scrub sinks.

3. Reduce energy use

ORs and LD units use a lot of energy, and numerous studies have demonstrated that the heating, ventilation, and air conditioning (HVAC) system plays a large role in emissions.^8,11 This can easily be fixed by “HVAC setbacks” and powering down rooms when not in use. One institution powered down ORs when not in use and reduced 234 metric tons of CO₂ emissions and saved $33,000 per year.¹⁴ Transitioning to light-emitting diode (LED) lights reduced energy usage at 1 institution by almost 50%.¹⁵ Finally, computers in clinical offices, examination rooms, and administrative offices can be powered down at the end of the day. One study found that in 1 radiology department, 29 computers left on overnight and on weekends emitted 17.7 tons of CO₂ emissions in 1 year.¹⁶

Bottom line: We as ObGyns can advocate for how energy can be saved outside of surgical cases, including powering down ORs and LD units, transitioning to LED lighting, and powering down workstations.

Reuse

4. Choose reusable equipment

In ObGyn practice, the most commonly used tool is the speculum. Given its omnipresence, the speculum is a great place to start to decrease our carbon footprint. Two studies have evaluated the environmental impact of reusable versus single-use disposable specula, and both demonstrated that the stainless-steel versions have less global warming potential than the acrylic varieties.^17,18 Donahue and colleagues¹⁷ demonstrated that it only took 2 to 3 pelvic examinations for the cost of stainless-steel specula to break even, even when sterilized in a half-filled autoclave tray. Rodriquez, et al¹⁸ revealed that, compared with an acrylic model, the stainless-steel specula had fewer negative impacts in terms of global warming, acidification, respiratory effects, smog, and fossil fuel depletion.¹⁸

Bottom line: Strongly consider using stainless-steel specula to reduce costs and carbon emissions.

In addition to specula, ObGyns can choose reusable equipment in the OR. For example, surgeons can use stainless-steel trocars instead of disposable trocars.¹⁹ In vaginal cases, Breisky-Navratil retractors can be used instead of disposable self-retaining retractors. Plastic basins that often are included in sterile supply packs can be replaced with stainless-steel basins, which could have profound positive effects on the carbon footprint of gynecologic surgery.⁸ One study of ObGyns demonstrated that 95% of physicians supported waste-reduction efforts, and 66% supported utilizing reusable surgical tools instead of disposable tools.²⁰

Bottom line: As surgeons, ObGyns have influence over what they want to use in the OR, and they can petition for reusable options over disposable options.

5. Launder the sterile blue towels

Sterile blue towels, which are made of cotton, have the largest environmental footprint compared with other disposable materials, such as plastics, and contribute greatly to toxicity in human health.^8,11 Although these towels cannot be laundered and sterilized again for use in a sterile surgical field, they can be laundered and repurposed, including by environmental services to clean hospital rooms. Blue towels should be able to be laundered no matter how saturated in body fluids they are.

Bottom line: ObGyns should strive to always launder the blue towels and educate trainees and other staff in the OR to do the same.

Recycle

6. Recycle and reprocess materials and devices

While recycling is immensely important, it requires a large amount of energy to break down a material to its raw components for manufacturing. It likely reduces our carbon footprint from OR procedures by only 5%.⁸ However, recycling is still a good way to divert appropriate materials from landfill, saving costs and emissions at the end of a material’s life. One example is sterile blue wrap, which is a petroleum product with a recycling number of 6 and a filtration rating of N99. Blue wrap can be recycled into plastic pellets, or it can be recreated into other hospital supplies, such as gowns.

Bottom line: ObGyns can petition their hospitals to work with suppliers and waste-processing companies who have recycling programs built into their supply chains.

By contrast, reprocessing can have a much larger impact on carbon emissions. Complex items, such as advanced energy devices that can be reprocessed, result in a greater reduction in carbon emissions due to the reuse of their complex materials and manufacturing when compared with such devices that cannot be reprocessed. Recycling and reprocessing programs are already in place for several devices (TABLE). Authors of a systematic review showed that there is no evidence to support the use of single-use supplies and instruments over reprocessed items when considering instrument function, ease of use, patient safety, transmission of infection, or long-term patient outcomes.²¹

Bottom line: ObGyns can choose to use reprocessed items in ORs instead of single-use devices and educate staff on the safety of these items.

Continue to: Remove...

 

 

Remove

7. Remove desflurane and other volatile gases from formularies

Volatile anesthetic gases, such as desflurane, isoflurane, and nitrous oxide, are themselves potent greenhouse gases, comprising a large portion of the carbon emissions that come from the OR.²² Desflurane was developed to have a rapid onset for induction and quick recovery; however, studies have shown no clinical benefit over other gases.²³ Furthermore, the costs and greenhouse gas potential are substantial. Desflurane costs 2 to 3 times more and has more than 20 times the global warming potential of the other volatile gases (FIGURE).⁸ Using 1 hour of desflurane is equivalent to driving 378 miles in a gas-powered vehicle, while the use of isoflurane and sevoflurane create equivalents of only 15 and 8 miles, respectively.²³

Nitrous oxide is another powerful greenhouse gas that is a direct ozone depletor and can stay in the atmosphere for 114 years.²² Nitrous oxide has limited clinical use in hospitals, but it is often stored in central hospital piping. Most of the impact of nitrous oxide comes through leaks in a poor system design rather than patient delivery. One estimate reveals that more than 13 million liters of nitrous oxide are lost annually from leaks in European hospitals.²² The American Society of Anesthesiologists recommends decommissioning central piping of nitrous oxide in favor of cylinders at the point of care.²⁴

Literature on enhanced recovery after surgery in gynecology promotes the use of propofol over volatile gases for our patients because of the high rate of postoperative nausea and vomiting seen with gases.²⁵ Volatile gases should be a last-choice anesthetic for our patients.

Bottom line: It is critical that ObGyns work with colleagues in anesthesia to develop climate- and patient-friendly protocols for procedures.

8. Remove endocrine-disrupting chemicals from clinical supplies

Endocrine-disrupting chemicals (EDCs) are a type of chemical that alter the hormonal systems of humans, which can result in adverse health effects. Multiple studies and reviews have tied EDCs to reproductive abnormalities, such as the effects of bisphenol A (BPA) on estradiol levels, antral follicle counts, oocyte quality, and implantation rates; phthalates on fibroid burden; triclosan on embryo quality; parabens on live birth rates; and perfluoroalkylsubstances (PFAS or “forever substances”) on hypertensive disorders of pregnancy.^5,26,27

What might be most shocking is that these EDCs are incorporated into medical supplies and pharmaceuticals. For example, BPA is known to line dialysis and ointment tubes, parabens are used for their antimicrobial properties in ultrasound gel and hep-locks, and phthalates are found in up to 40% of medical-use plastics and controlled-release medications. Authors of an observational study found that 74% of patients admitted to an LD unit were exposed to EDCs. In a neonatal intensive care unit (NICU), most of the supplies contained an EDC, and urinary BPA levels were elevated in neonates admitted to a NICU, raising concerns about long-term health risks.⁵

Bottom line: Physicians and health care institutions have an obligation to petition industry partners and suppliers to remove EDCs from their supply chains.

Reimagine

9. Educate

The field of health care sustainability remains in its infancy, but from 2007 to 2019, publications on climate change and health in academia increased by a factor of 8.²⁹ Additionally, through waste audits, quality-improvement projects, and life cycle analyses (analytical tools to evaluate product or process emissions from materials extraction to disposal), we have gained insight into the scope of the problem, with evidence showing that our practices are largely derived from culture. It is time to provide formal education on health care sustainability to medical trainees, staff, and clinicians alike, who desire to see this topic reflected in their formal curricula.³⁰ Start talking about it!

Bottom line: Commentaries, webinars, formal didactics sessions, in-services, and hospital workgroups to introduce this topic are a good way to teach others about the carbon footprint of our care and solutions to minimize it.

10. Engage in advocacy

Physicians have an ethical duty to advocate for change at the local, regional, and national levels if we want to see a better future for our patients, their children, and even ourselves. We should reimagine this work as an important public health initiative.³¹ Surveys of physicians, including ObGyns, reveal a concern about the sustainability of health care and a commitment to addressing this issue.²⁰ ObGyns are on the frontlines of delivering care every day, so we are poised to implement changes that can impact our patients, especially when we can lead and petition hospital or local committees.^20,28,32 There is much to be done, but every voice counts and can make impactful changes at every level. ●

Climate change has been called the biggest health threat of the 21st century.¹ The health care sector is a huge contributor to global carbon emissions, accounting for almost double the emissions of global aviation. While other industries and countries are implementing mitigation measures to decrease their emissions, health care is currently on track to double its carbon emissions by 2050, even though it should be carbon neutral by that time to comply with the Paris Climate Agreement.² There have been some national efforts to curb health care emissions, including the creation of the Office of Climate Change and Health Equity in 2021 and the passage of the Inflation Reduction Act in 2022.³ These are top-down, administrative approaches, and to be successful we will also need clinicians to understand and address this problem.

The negative impacts of heat, air pollution, and exposure to toxic substances on human health have been well documented in multiple regions across multiple specialties.^4-7 The United States makes up 27% of the global health care carbon footprint—more emissions than the entire United Kingdom as a country—despite having only 4% of the world’s population.² Culture and incentives for an overabundance of single-use supplies, not evidence for patient safety, have led to this uniquely American problem. It is evident that our health care industry is an excellent place to implement mitigation measures for carbon emissions that contribute to climate change and can improve health outcomes.

In this article, we recommend 10 practices that can decrease our carbon footprint in ObGyn. We focus on the classic motto of “Reduce, Reuse, Recycle,” while adding “Remove” and “Reimagine” to classify the ways in which we can reduce emissions while not compromising our care to patients.

Reduce

1. Minimize opened materials and single-use devices in the OR and labor and delivery

Health care is a unique setting where a culture of infection prevention and efficiency has led low-cost, single-use supplies to dominate over reusable items. While single-use items can have inexpensive purchasing costs compared to reusable items, the environmental costs required for the production and disposal of the former are often much greater. In operating rooms (ORs) and labor and delivery (LD) units, single-use items are omnipresent. Over the past decade, researchers and clinicians have started to take a closer look at these items and their carbon footprint. One group evaluated hysterectomy through a waste audit and found that the vast majority of waste from all of the cases was Spunbond Meltblown Spunbond, or SMS; plastic materialthat comprises gowns; blue wraps; and drapes; followed by hard plastic material that comprises trays and packaging.⁸ Moreover, production and manufacturing processes contributed to 95% of the environmental impacts of these items.⁸

In an effort to be time efficient, OR staff will open sterile surgical packs and individual peel-pack items prior to surgery to minimize having to find items during surgery. However, this creates an inordinate amount of waste. One group of neurosurgeons who evaluated their opened but unused supplies found that 85% of their unused items were individually opened items, leading to a waste of $2.9 million per year.⁹ Minor procedures like dilation and curettage, cystoscopy, and hysteroscopy do not need such a large sterile field, as these procedures are also safe to perform in the office. Hand surgeons have been quick to lead in this space, particularly with minor procedures such as carpal tunnel release. One division was able to eliminate 2.8 tons of waste and save $13,000 in a 2-year period by reducing the sterile field.¹⁰ ObGyns can work with OR and LD staff to create custom packs that minimize unused or underutilized items, helping to reduce both the carbon footprint and health care spending.

Bottom line: ObGyns can help foster a culture of having supplies available but not opened until needed during a case.

Continue to: 2. Decrease regulated medical waste...

 

 

2. Decrease regulated medical waste

Health care is unique from other fields in that there are multiple waste streams to consider. Infectious waste and items saturated in blood or capable of causing infection must be placed into regulated medical waste (RMW), or more commonly, red biohazard bags. RMW is autoclaved or incinerated prior to disposal in a landfill. This process is more financially and environmentally costly than general municipal waste (GMW). This process also requires more transport—1 study revealed that GMW traveled 20 km to a landfill for disposal, compared with the 50 km that RMW traveled for sterilized-prior-to-landfill disposal.¹¹

Unfortunately, the vast majority of items placed in RMW are incorrectly triaged and should instead be disposed in GMW.^12,13 One study performed in an emergency department revealed that 85% of waste was incorrectly placed in the RMW.¹²

Bottom line: ObGyns can avoid placing items in RMW that may not qualify and advocate for institution policy changes to remove RMW from places such as waiting rooms, at the patient bedside, or next to scrub sinks.

3. Reduce energy use

ORs and LD units use a lot of energy, and numerous studies have demonstrated that the heating, ventilation, and air conditioning (HVAC) system plays a large role in emissions.^8,11 This can easily be fixed by “HVAC setbacks” and powering down rooms when not in use. One institution powered down ORs when not in use and reduced 234 metric tons of CO₂ emissions and saved $33,000 per year.¹⁴ Transitioning to light-emitting diode (LED) lights reduced energy usage at 1 institution by almost 50%.¹⁵ Finally, computers in clinical offices, examination rooms, and administrative offices can be powered down at the end of the day. One study found that in 1 radiology department, 29 computers left on overnight and on weekends emitted 17.7 tons of CO₂ emissions in 1 year.¹⁶

Bottom line: We as ObGyns can advocate for how energy can be saved outside of surgical cases, including powering down ORs and LD units, transitioning to LED lighting, and powering down workstations.

Reuse

4. Choose reusable equipment

In ObGyn practice, the most commonly used tool is the speculum. Given its omnipresence, the speculum is a great place to start to decrease our carbon footprint. Two studies have evaluated the environmental impact of reusable versus single-use disposable specula, and both demonstrated that the stainless-steel versions have less global warming potential than the acrylic varieties.^17,18 Donahue and colleagues¹⁷ demonstrated that it only took 2 to 3 pelvic examinations for the cost of stainless-steel specula to break even, even when sterilized in a half-filled autoclave tray. Rodriquez, et al¹⁸ revealed that, compared with an acrylic model, the stainless-steel specula had fewer negative impacts in terms of global warming, acidification, respiratory effects, smog, and fossil fuel depletion.¹⁸

Bottom line: Strongly consider using stainless-steel specula to reduce costs and carbon emissions.

In addition to specula, ObGyns can choose reusable equipment in the OR. For example, surgeons can use stainless-steel trocars instead of disposable trocars.¹⁹ In vaginal cases, Breisky-Navratil retractors can be used instead of disposable self-retaining retractors. Plastic basins that often are included in sterile supply packs can be replaced with stainless-steel basins, which could have profound positive effects on the carbon footprint of gynecologic surgery.⁸ One study of ObGyns demonstrated that 95% of physicians supported waste-reduction efforts, and 66% supported utilizing reusable surgical tools instead of disposable tools.²⁰

Bottom line: As surgeons, ObGyns have influence over what they want to use in the OR, and they can petition for reusable options over disposable options.

5. Launder the sterile blue towels

Sterile blue towels, which are made of cotton, have the largest environmental footprint compared with other disposable materials, such as plastics, and contribute greatly to toxicity in human health.^8,11 Although these towels cannot be laundered and sterilized again for use in a sterile surgical field, they can be laundered and repurposed, including by environmental services to clean hospital rooms. Blue towels should be able to be laundered no matter how saturated in body fluids they are.

Bottom line: ObGyns should strive to always launder the blue towels and educate trainees and other staff in the OR to do the same.

Recycle

6. Recycle and reprocess materials and devices

While recycling is immensely important, it requires a large amount of energy to break down a material to its raw components for manufacturing. It likely reduces our carbon footprint from OR procedures by only 5%.⁸ However, recycling is still a good way to divert appropriate materials from landfill, saving costs and emissions at the end of a material’s life. One example is sterile blue wrap, which is a petroleum product with a recycling number of 6 and a filtration rating of N99. Blue wrap can be recycled into plastic pellets, or it can be recreated into other hospital supplies, such as gowns.

Bottom line: ObGyns can petition their hospitals to work with suppliers and waste-processing companies who have recycling programs built into their supply chains.

By contrast, reprocessing can have a much larger impact on carbon emissions. Complex items, such as advanced energy devices that can be reprocessed, result in a greater reduction in carbon emissions due to the reuse of their complex materials and manufacturing when compared with such devices that cannot be reprocessed. Recycling and reprocessing programs are already in place for several devices (TABLE). Authors of a systematic review showed that there is no evidence to support the use of single-use supplies and instruments over reprocessed items when considering instrument function, ease of use, patient safety, transmission of infection, or long-term patient outcomes.²¹

Bottom line: ObGyns can choose to use reprocessed items in ORs instead of single-use devices and educate staff on the safety of these items.

Continue to: Remove...

 

 

Remove

7. Remove desflurane and other volatile gases from formularies

Volatile anesthetic gases, such as desflurane, isoflurane, and nitrous oxide, are themselves potent greenhouse gases, comprising a large portion of the carbon emissions that come from the OR.²² Desflurane was developed to have a rapid onset for induction and quick recovery; however, studies have shown no clinical benefit over other gases.²³ Furthermore, the costs and greenhouse gas potential are substantial. Desflurane costs 2 to 3 times more and has more than 20 times the global warming potential of the other volatile gases (FIGURE).⁸ Using 1 hour of desflurane is equivalent to driving 378 miles in a gas-powered vehicle, while the use of isoflurane and sevoflurane create equivalents of only 15 and 8 miles, respectively.²³

Nitrous oxide is another powerful greenhouse gas that is a direct ozone depletor and can stay in the atmosphere for 114 years.²² Nitrous oxide has limited clinical use in hospitals, but it is often stored in central hospital piping. Most of the impact of nitrous oxide comes through leaks in a poor system design rather than patient delivery. One estimate reveals that more than 13 million liters of nitrous oxide are lost annually from leaks in European hospitals.²² The American Society of Anesthesiologists recommends decommissioning central piping of nitrous oxide in favor of cylinders at the point of care.²⁴

Literature on enhanced recovery after surgery in gynecology promotes the use of propofol over volatile gases for our patients because of the high rate of postoperative nausea and vomiting seen with gases.²⁵ Volatile gases should be a last-choice anesthetic for our patients.

Bottom line: It is critical that ObGyns work with colleagues in anesthesia to develop climate- and patient-friendly protocols for procedures.

8. Remove endocrine-disrupting chemicals from clinical supplies

Endocrine-disrupting chemicals (EDCs) are a type of chemical that alter the hormonal systems of humans, which can result in adverse health effects. Multiple studies and reviews have tied EDCs to reproductive abnormalities, such as the effects of bisphenol A (BPA) on estradiol levels, antral follicle counts, oocyte quality, and implantation rates; phthalates on fibroid burden; triclosan on embryo quality; parabens on live birth rates; and perfluoroalkylsubstances (PFAS or “forever substances”) on hypertensive disorders of pregnancy.^5,26,27

What might be most shocking is that these EDCs are incorporated into medical supplies and pharmaceuticals. For example, BPA is known to line dialysis and ointment tubes, parabens are used for their antimicrobial properties in ultrasound gel and hep-locks, and phthalates are found in up to 40% of medical-use plastics and controlled-release medications. Authors of an observational study found that 74% of patients admitted to an LD unit were exposed to EDCs. In a neonatal intensive care unit (NICU), most of the supplies contained an EDC, and urinary BPA levels were elevated in neonates admitted to a NICU, raising concerns about long-term health risks.⁵

Bottom line: Physicians and health care institutions have an obligation to petition industry partners and suppliers to remove EDCs from their supply chains.

Reimagine

9. Educate

The field of health care sustainability remains in its infancy, but from 2007 to 2019, publications on climate change and health in academia increased by a factor of 8.²⁹ Additionally, through waste audits, quality-improvement projects, and life cycle analyses (analytical tools to evaluate product or process emissions from materials extraction to disposal), we have gained insight into the scope of the problem, with evidence showing that our practices are largely derived from culture. It is time to provide formal education on health care sustainability to medical trainees, staff, and clinicians alike, who desire to see this topic reflected in their formal curricula.³⁰ Start talking about it!

Bottom line: Commentaries, webinars, formal didactics sessions, in-services, and hospital workgroups to introduce this topic are a good way to teach others about the carbon footprint of our care and solutions to minimize it.

10. Engage in advocacy

Physicians have an ethical duty to advocate for change at the local, regional, and national levels if we want to see a better future for our patients, their children, and even ourselves. We should reimagine this work as an important public health initiative.³¹ Surveys of physicians, including ObGyns, reveal a concern about the sustainability of health care and a commitment to addressing this issue.²⁰ ObGyns are on the frontlines of delivering care every day, so we are poised to implement changes that can impact our patients, especially when we can lead and petition hospital or local committees.^20,28,32 There is much to be done, but every voice counts and can make impactful changes at every level. ●

Climate change has been called the biggest health threat of the 21st century.¹ The health care sector is a huge contributor to global carbon emissions, accounting for almost double the emissions of global aviation. While other industries and countries are implementing mitigation measures to decrease their emissions, health care is currently on track to double its carbon emissions by 2050, even though it should be carbon neutral by that time to comply with the Paris Climate Agreement.² There have been some national efforts to curb health care emissions, including the creation of the Office of Climate Change and Health Equity in 2021 and the passage of the Inflation Reduction Act in 2022.³ These are top-down, administrative approaches, and to be successful we will also need clinicians to understand and address this problem.

The negative impacts of heat, air pollution, and exposure to toxic substances on human health have been well documented in multiple regions across multiple specialties.^4-7 The United States makes up 27% of the global health care carbon footprint—more emissions than the entire United Kingdom as a country—despite having only 4% of the world’s population.² Culture and incentives for an overabundance of single-use supplies, not evidence for patient safety, have led to this uniquely American problem. It is evident that our health care industry is an excellent place to implement mitigation measures for carbon emissions that contribute to climate change and can improve health outcomes.

In this article, we recommend 10 practices that can decrease our carbon footprint in ObGyn. We focus on the classic motto of “Reduce, Reuse, Recycle,” while adding “Remove” and “Reimagine” to classify the ways in which we can reduce emissions while not compromising our care to patients.

Reduce

1. Minimize opened materials and single-use devices in the OR and labor and delivery

Health care is a unique setting where a culture of infection prevention and efficiency has led low-cost, single-use supplies to dominate over reusable items. While single-use items can have inexpensive purchasing costs compared to reusable items, the environmental costs required for the production and disposal of the former are often much greater. In operating rooms (ORs) and labor and delivery (LD) units, single-use items are omnipresent. Over the past decade, researchers and clinicians have started to take a closer look at these items and their carbon footprint. One group evaluated hysterectomy through a waste audit and found that the vast majority of waste from all of the cases was Spunbond Meltblown Spunbond, or SMS; plastic materialthat comprises gowns; blue wraps; and drapes; followed by hard plastic material that comprises trays and packaging.⁸ Moreover, production and manufacturing processes contributed to 95% of the environmental impacts of these items.⁸

In an effort to be time efficient, OR staff will open sterile surgical packs and individual peel-pack items prior to surgery to minimize having to find items during surgery. However, this creates an inordinate amount of waste. One group of neurosurgeons who evaluated their opened but unused supplies found that 85% of their unused items were individually opened items, leading to a waste of $2.9 million per year.⁹ Minor procedures like dilation and curettage, cystoscopy, and hysteroscopy do not need such a large sterile field, as these procedures are also safe to perform in the office. Hand surgeons have been quick to lead in this space, particularly with minor procedures such as carpal tunnel release. One division was able to eliminate 2.8 tons of waste and save $13,000 in a 2-year period by reducing the sterile field.¹⁰ ObGyns can work with OR and LD staff to create custom packs that minimize unused or underutilized items, helping to reduce both the carbon footprint and health care spending.

Bottom line: ObGyns can help foster a culture of having supplies available but not opened until needed during a case.

Continue to: 2. Decrease regulated medical waste...

 

 

2. Decrease regulated medical waste

Health care is unique from other fields in that there are multiple waste streams to consider. Infectious waste and items saturated in blood or capable of causing infection must be placed into regulated medical waste (RMW), or more commonly, red biohazard bags. RMW is autoclaved or incinerated prior to disposal in a landfill. This process is more financially and environmentally costly than general municipal waste (GMW). This process also requires more transport—1 study revealed that GMW traveled 20 km to a landfill for disposal, compared with the 50 km that RMW traveled for sterilized-prior-to-landfill disposal.¹¹

Unfortunately, the vast majority of items placed in RMW are incorrectly triaged and should instead be disposed in GMW.^12,13 One study performed in an emergency department revealed that 85% of waste was incorrectly placed in the RMW.¹²

Bottom line: ObGyns can avoid placing items in RMW that may not qualify and advocate for institution policy changes to remove RMW from places such as waiting rooms, at the patient bedside, or next to scrub sinks.

3. Reduce energy use

ORs and LD units use a lot of energy, and numerous studies have demonstrated that the heating, ventilation, and air conditioning (HVAC) system plays a large role in emissions.^8,11 This can easily be fixed by “HVAC setbacks” and powering down rooms when not in use. One institution powered down ORs when not in use and reduced 234 metric tons of CO₂ emissions and saved $33,000 per year.¹⁴ Transitioning to light-emitting diode (LED) lights reduced energy usage at 1 institution by almost 50%.¹⁵ Finally, computers in clinical offices, examination rooms, and administrative offices can be powered down at the end of the day. One study found that in 1 radiology department, 29 computers left on overnight and on weekends emitted 17.7 tons of CO₂ emissions in 1 year.¹⁶

Bottom line: We as ObGyns can advocate for how energy can be saved outside of surgical cases, including powering down ORs and LD units, transitioning to LED lighting, and powering down workstations.

Reuse

4. Choose reusable equipment

In ObGyn practice, the most commonly used tool is the speculum. Given its omnipresence, the speculum is a great place to start to decrease our carbon footprint. Two studies have evaluated the environmental impact of reusable versus single-use disposable specula, and both demonstrated that the stainless-steel versions have less global warming potential than the acrylic varieties.^17,18 Donahue and colleagues¹⁷ demonstrated that it only took 2 to 3 pelvic examinations for the cost of stainless-steel specula to break even, even when sterilized in a half-filled autoclave tray. Rodriquez, et al¹⁸ revealed that, compared with an acrylic model, the stainless-steel specula had fewer negative impacts in terms of global warming, acidification, respiratory effects, smog, and fossil fuel depletion.¹⁸

Bottom line: Strongly consider using stainless-steel specula to reduce costs and carbon emissions.

In addition to specula, ObGyns can choose reusable equipment in the OR. For example, surgeons can use stainless-steel trocars instead of disposable trocars.¹⁹ In vaginal cases, Breisky-Navratil retractors can be used instead of disposable self-retaining retractors. Plastic basins that often are included in sterile supply packs can be replaced with stainless-steel basins, which could have profound positive effects on the carbon footprint of gynecologic surgery.⁸ One study of ObGyns demonstrated that 95% of physicians supported waste-reduction efforts, and 66% supported utilizing reusable surgical tools instead of disposable tools.²⁰

Bottom line: As surgeons, ObGyns have influence over what they want to use in the OR, and they can petition for reusable options over disposable options.

5. Launder the sterile blue towels

Sterile blue towels, which are made of cotton, have the largest environmental footprint compared with other disposable materials, such as plastics, and contribute greatly to toxicity in human health.^8,11 Although these towels cannot be laundered and sterilized again for use in a sterile surgical field, they can be laundered and repurposed, including by environmental services to clean hospital rooms. Blue towels should be able to be laundered no matter how saturated in body fluids they are.

Bottom line: ObGyns should strive to always launder the blue towels and educate trainees and other staff in the OR to do the same.

Recycle

6. Recycle and reprocess materials and devices

While recycling is immensely important, it requires a large amount of energy to break down a material to its raw components for manufacturing. It likely reduces our carbon footprint from OR procedures by only 5%.⁸ However, recycling is still a good way to divert appropriate materials from landfill, saving costs and emissions at the end of a material’s life. One example is sterile blue wrap, which is a petroleum product with a recycling number of 6 and a filtration rating of N99. Blue wrap can be recycled into plastic pellets, or it can be recreated into other hospital supplies, such as gowns.

Bottom line: ObGyns can petition their hospitals to work with suppliers and waste-processing companies who have recycling programs built into their supply chains.

By contrast, reprocessing can have a much larger impact on carbon emissions. Complex items, such as advanced energy devices that can be reprocessed, result in a greater reduction in carbon emissions due to the reuse of their complex materials and manufacturing when compared with such devices that cannot be reprocessed. Recycling and reprocessing programs are already in place for several devices (TABLE). Authors of a systematic review showed that there is no evidence to support the use of single-use supplies and instruments over reprocessed items when considering instrument function, ease of use, patient safety, transmission of infection, or long-term patient outcomes.²¹

Bottom line: ObGyns can choose to use reprocessed items in ORs instead of single-use devices and educate staff on the safety of these items.

Continue to: Remove...

 

 

Remove

7. Remove desflurane and other volatile gases from formularies

Volatile anesthetic gases, such as desflurane, isoflurane, and nitrous oxide, are themselves potent greenhouse gases, comprising a large portion of the carbon emissions that come from the OR.²² Desflurane was developed to have a rapid onset for induction and quick recovery; however, studies have shown no clinical benefit over other gases.²³ Furthermore, the costs and greenhouse gas potential are substantial. Desflurane costs 2 to 3 times more and has more than 20 times the global warming potential of the other volatile gases (FIGURE).⁸ Using 1 hour of desflurane is equivalent to driving 378 miles in a gas-powered vehicle, while the use of isoflurane and sevoflurane create equivalents of only 15 and 8 miles, respectively.²³

Nitrous oxide is another powerful greenhouse gas that is a direct ozone depletor and can stay in the atmosphere for 114 years.²² Nitrous oxide has limited clinical use in hospitals, but it is often stored in central hospital piping. Most of the impact of nitrous oxide comes through leaks in a poor system design rather than patient delivery. One estimate reveals that more than 13 million liters of nitrous oxide are lost annually from leaks in European hospitals.²² The American Society of Anesthesiologists recommends decommissioning central piping of nitrous oxide in favor of cylinders at the point of care.²⁴

Literature on enhanced recovery after surgery in gynecology promotes the use of propofol over volatile gases for our patients because of the high rate of postoperative nausea and vomiting seen with gases.²⁵ Volatile gases should be a last-choice anesthetic for our patients.

Bottom line: It is critical that ObGyns work with colleagues in anesthesia to develop climate- and patient-friendly protocols for procedures.

8. Remove endocrine-disrupting chemicals from clinical supplies

Endocrine-disrupting chemicals (EDCs) are a type of chemical that alter the hormonal systems of humans, which can result in adverse health effects. Multiple studies and reviews have tied EDCs to reproductive abnormalities, such as the effects of bisphenol A (BPA) on estradiol levels, antral follicle counts, oocyte quality, and implantation rates; phthalates on fibroid burden; triclosan on embryo quality; parabens on live birth rates; and perfluoroalkylsubstances (PFAS or “forever substances”) on hypertensive disorders of pregnancy.^5,26,27

What might be most shocking is that these EDCs are incorporated into medical supplies and pharmaceuticals. For example, BPA is known to line dialysis and ointment tubes, parabens are used for their antimicrobial properties in ultrasound gel and hep-locks, and phthalates are found in up to 40% of medical-use plastics and controlled-release medications. Authors of an observational study found that 74% of patients admitted to an LD unit were exposed to EDCs. In a neonatal intensive care unit (NICU), most of the supplies contained an EDC, and urinary BPA levels were elevated in neonates admitted to a NICU, raising concerns about long-term health risks.⁵

Bottom line: Physicians and health care institutions have an obligation to petition industry partners and suppliers to remove EDCs from their supply chains.

Reimagine

9. Educate

The field of health care sustainability remains in its infancy, but from 2007 to 2019, publications on climate change and health in academia increased by a factor of 8.²⁹ Additionally, through waste audits, quality-improvement projects, and life cycle analyses (analytical tools to evaluate product or process emissions from materials extraction to disposal), we have gained insight into the scope of the problem, with evidence showing that our practices are largely derived from culture. It is time to provide formal education on health care sustainability to medical trainees, staff, and clinicians alike, who desire to see this topic reflected in their formal curricula.³⁰ Start talking about it!

Bottom line: Commentaries, webinars, formal didactics sessions, in-services, and hospital workgroups to introduce this topic are a good way to teach others about the carbon footprint of our care and solutions to minimize it.

10. Engage in advocacy

Physicians have an ethical duty to advocate for change at the local, regional, and national levels if we want to see a better future for our patients, their children, and even ourselves. We should reimagine this work as an important public health initiative.³¹ Surveys of physicians, including ObGyns, reveal a concern about the sustainability of health care and a commitment to addressing this issue.²⁰ ObGyns are on the frontlines of delivering care every day, so we are poised to implement changes that can impact our patients, especially when we can lead and petition hospital or local committees.^20,28,32 There is much to be done, but every voice counts and can make impactful changes at every level. ●