To the Editor:

Because the SARS-CoV-2 virus is constantly changing, routine vaccination to prevent COVID-19 infection is recommended. The messenger RNA (mRNA) vaccines from Pfizer-BioNTech and Moderna as well as the Ad26.COV2.S (Johnson & Johnson) and NVX-CoV2373 (Novavax) vaccines are the most commonly used COVID-19 vaccines in the United States. Adverse effects following vaccination against SARS-CoV-2 are well documented; recent studies report a small incidence of adverse effects in the general population, with most being minor (eg, headache, fever, muscle pain).^1,2 Interestingly, reports of exacerbation of psoriasis and new-onset psoriasis following COVID-19 vaccination suggest a potential association.^3,4 However, the literature investigating the vaccine adverse effect profile in this demographic is scarce. We examined the incidence of adverse effects from SARS-CoV-2 vaccines in patients with psoriasis.

This retrospective cohort study used the COVID-19 Research Database (https://covid19researchdatabase.org/) to examine the adverse effects following the first and second doses of the mRNA vaccines in patients with and without psoriasis. The sample size for the Ad26.COV2.S vaccine was too small to analyze.

Claims were evaluated from August to October 2021 for 2 diagnoses of psoriasis prior to January 1, 2020, using the International Classification of Diseases, Tenth Revision (ICD-10) code L40.9 to increase the positive predictive value and ensure that the diagnosis preceded the COVID-19 pandemic. Patients younger than 18 years and those who did not receive 2 doses of a SARS-CoV-2 vaccine were excluded. Controls who did not have a diagnosis of psoriasis were matched for age, sex, and hypertension at a 4:1 ratio. Hypertension represented the most common comorbidity that could feasibly be controlled for in this study population. Other comorbidities recorded included obesity, type 2 diabetes mellitus, congestive heart failure, asthma, chronic obstructive pulmonary disease, chronic ischemic heart disease, rhinitis, and chronic kidney disease.

Common adverse effects as long as 30 days after vaccination were identified using ICD-10 codes. Adverse effects of interest were anaphylactic reaction, initial encounter of adverse effect of viral vaccines, fever, allergic urticaria, weakness, altered mental status, malaise, allergic reaction, chest pain, symptoms involving circulatory or respiratory systems, localized rash, axillary lymphadenopathy, infection, and myocarditis.⁵ Poisson regression was performed using Stata 17 analytical software.

We identified 4273 patients with psoriasis and 17,092 controls who received mRNA COVID-19 vaccines (Table). Adjusted odds ratios (aORs) for doses 1 and 2 were calculated for each vaccine (eTable). Adverse effects with sufficient data to generate an aOR included weakness, altered mental status, malaise, chest pain, and symptoms involving the circulatory or respiratory system. The aORs for allergic urticaria and initial encounter of adverse effect of viral vaccines were only calculated for the Moderna mRNA vaccine due to low sample size.

This study demonstrated that patients with psoriasis do not appear to have a significantly increased risk of adverse effects from mRNA SARS-CoV-2 vaccines. Although the ORs in this study were not significant, most recorded adverse effects demonstrated an aOR less than 1, suggesting that there might be a lower risk of certain adverse effects in psoriasis patients. This could be explained by the immunomodulatory effects of certain systemic psoriasis treatments that might influence the adverse effect presentation.

The study is limited by the lack of treatment data, small sample size, and the fact that it did not assess flares or worsening of psoriasis with the vaccines. Underreporting of adverse effects by patients and underdiagnosis of adverse effects secondary to SARS-CoV-2 vaccines due to its novel nature, incompletely understood consequences, and limited ICD-10 codes associated with adverse effects all contributed to the small sample size.

Our findings suggest that the risk for immediate adverse effects from the mRNA SARS-CoV-2 vaccines is not increased among psoriasis patients. However, the impact of immunomodulatory agents on vaccine efficacy and expected adverse effects should be investigated. As more individuals receive the COVID-19 vaccine, the adverse effect profile in patients with psoriasis is an important area of investigation.

To the Editor:

Because the SARS-CoV-2 virus is constantly changing, routine vaccination to prevent COVID-19 infection is recommended. The messenger RNA (mRNA) vaccines from Pfizer-BioNTech and Moderna as well as the Ad26.COV2.S (Johnson & Johnson) and NVX-CoV2373 (Novavax) vaccines are the most commonly used COVID-19 vaccines in the United States. Adverse effects following vaccination against SARS-CoV-2 are well documented; recent studies report a small incidence of adverse effects in the general population, with most being minor (eg, headache, fever, muscle pain).^1,2 Interestingly, reports of exacerbation of psoriasis and new-onset psoriasis following COVID-19 vaccination suggest a potential association.^3,4 However, the literature investigating the vaccine adverse effect profile in this demographic is scarce. We examined the incidence of adverse effects from SARS-CoV-2 vaccines in patients with psoriasis.

This retrospective cohort study used the COVID-19 Research Database (https://covid19researchdatabase.org/) to examine the adverse effects following the first and second doses of the mRNA vaccines in patients with and without psoriasis. The sample size for the Ad26.COV2.S vaccine was too small to analyze.

Claims were evaluated from August to October 2021 for 2 diagnoses of psoriasis prior to January 1, 2020, using the International Classification of Diseases, Tenth Revision (ICD-10) code L40.9 to increase the positive predictive value and ensure that the diagnosis preceded the COVID-19 pandemic. Patients younger than 18 years and those who did not receive 2 doses of a SARS-CoV-2 vaccine were excluded. Controls who did not have a diagnosis of psoriasis were matched for age, sex, and hypertension at a 4:1 ratio. Hypertension represented the most common comorbidity that could feasibly be controlled for in this study population. Other comorbidities recorded included obesity, type 2 diabetes mellitus, congestive heart failure, asthma, chronic obstructive pulmonary disease, chronic ischemic heart disease, rhinitis, and chronic kidney disease.

Common adverse effects as long as 30 days after vaccination were identified using ICD-10 codes. Adverse effects of interest were anaphylactic reaction, initial encounter of adverse effect of viral vaccines, fever, allergic urticaria, weakness, altered mental status, malaise, allergic reaction, chest pain, symptoms involving circulatory or respiratory systems, localized rash, axillary lymphadenopathy, infection, and myocarditis.⁵ Poisson regression was performed using Stata 17 analytical software.

We identified 4273 patients with psoriasis and 17,092 controls who received mRNA COVID-19 vaccines (Table). Adjusted odds ratios (aORs) for doses 1 and 2 were calculated for each vaccine (eTable). Adverse effects with sufficient data to generate an aOR included weakness, altered mental status, malaise, chest pain, and symptoms involving the circulatory or respiratory system. The aORs for allergic urticaria and initial encounter of adverse effect of viral vaccines were only calculated for the Moderna mRNA vaccine due to low sample size.

This study demonstrated that patients with psoriasis do not appear to have a significantly increased risk of adverse effects from mRNA SARS-CoV-2 vaccines. Although the ORs in this study were not significant, most recorded adverse effects demonstrated an aOR less than 1, suggesting that there might be a lower risk of certain adverse effects in psoriasis patients. This could be explained by the immunomodulatory effects of certain systemic psoriasis treatments that might influence the adverse effect presentation.

The study is limited by the lack of treatment data, small sample size, and the fact that it did not assess flares or worsening of psoriasis with the vaccines. Underreporting of adverse effects by patients and underdiagnosis of adverse effects secondary to SARS-CoV-2 vaccines due to its novel nature, incompletely understood consequences, and limited ICD-10 codes associated with adverse effects all contributed to the small sample size.

Our findings suggest that the risk for immediate adverse effects from the mRNA SARS-CoV-2 vaccines is not increased among psoriasis patients. However, the impact of immunomodulatory agents on vaccine efficacy and expected adverse effects should be investigated. As more individuals receive the COVID-19 vaccine, the adverse effect profile in patients with psoriasis is an important area of investigation.

To the Editor:

Because the SARS-CoV-2 virus is constantly changing, routine vaccination to prevent COVID-19 infection is recommended. The messenger RNA (mRNA) vaccines from Pfizer-BioNTech and Moderna as well as the Ad26.COV2.S (Johnson & Johnson) and NVX-CoV2373 (Novavax) vaccines are the most commonly used COVID-19 vaccines in the United States. Adverse effects following vaccination against SARS-CoV-2 are well documented; recent studies report a small incidence of adverse effects in the general population, with most being minor (eg, headache, fever, muscle pain).^1,2 Interestingly, reports of exacerbation of psoriasis and new-onset psoriasis following COVID-19 vaccination suggest a potential association.^3,4 However, the literature investigating the vaccine adverse effect profile in this demographic is scarce. We examined the incidence of adverse effects from SARS-CoV-2 vaccines in patients with psoriasis.

This retrospective cohort study used the COVID-19 Research Database (https://covid19researchdatabase.org/) to examine the adverse effects following the first and second doses of the mRNA vaccines in patients with and without psoriasis. The sample size for the Ad26.COV2.S vaccine was too small to analyze.

Claims were evaluated from August to October 2021 for 2 diagnoses of psoriasis prior to January 1, 2020, using the International Classification of Diseases, Tenth Revision (ICD-10) code L40.9 to increase the positive predictive value and ensure that the diagnosis preceded the COVID-19 pandemic. Patients younger than 18 years and those who did not receive 2 doses of a SARS-CoV-2 vaccine were excluded. Controls who did not have a diagnosis of psoriasis were matched for age, sex, and hypertension at a 4:1 ratio. Hypertension represented the most common comorbidity that could feasibly be controlled for in this study population. Other comorbidities recorded included obesity, type 2 diabetes mellitus, congestive heart failure, asthma, chronic obstructive pulmonary disease, chronic ischemic heart disease, rhinitis, and chronic kidney disease.

Common adverse effects as long as 30 days after vaccination were identified using ICD-10 codes. Adverse effects of interest were anaphylactic reaction, initial encounter of adverse effect of viral vaccines, fever, allergic urticaria, weakness, altered mental status, malaise, allergic reaction, chest pain, symptoms involving circulatory or respiratory systems, localized rash, axillary lymphadenopathy, infection, and myocarditis.⁵ Poisson regression was performed using Stata 17 analytical software.

We identified 4273 patients with psoriasis and 17,092 controls who received mRNA COVID-19 vaccines (Table). Adjusted odds ratios (aORs) for doses 1 and 2 were calculated for each vaccine (eTable). Adverse effects with sufficient data to generate an aOR included weakness, altered mental status, malaise, chest pain, and symptoms involving the circulatory or respiratory system. The aORs for allergic urticaria and initial encounter of adverse effect of viral vaccines were only calculated for the Moderna mRNA vaccine due to low sample size.

This study demonstrated that patients with psoriasis do not appear to have a significantly increased risk of adverse effects from mRNA SARS-CoV-2 vaccines. Although the ORs in this study were not significant, most recorded adverse effects demonstrated an aOR less than 1, suggesting that there might be a lower risk of certain adverse effects in psoriasis patients. This could be explained by the immunomodulatory effects of certain systemic psoriasis treatments that might influence the adverse effect presentation.

The study is limited by the lack of treatment data, small sample size, and the fact that it did not assess flares or worsening of psoriasis with the vaccines. Underreporting of adverse effects by patients and underdiagnosis of adverse effects secondary to SARS-CoV-2 vaccines due to its novel nature, incompletely understood consequences, and limited ICD-10 codes associated with adverse effects all contributed to the small sample size.

Our findings suggest that the risk for immediate adverse effects from the mRNA SARS-CoV-2 vaccines is not increased among psoriasis patients. However, the impact of immunomodulatory agents on vaccine efficacy and expected adverse effects should be investigated. As more individuals receive the COVID-19 vaccine, the adverse effect profile in patients with psoriasis is an important area of investigation.

Consultations and referrals are an important component of many dermatology practices. There are several families of consultation codes that can be utilized based on the setting and format of the patient encounter. In this article, I describe appropriate use of 3 families of consultation codes and recent updates in these areas.

Consultation Definitions

For all of these code sets, the same definition of consultationapplies—namely that the encounter is provided at the request of another physician, other qualified health care professional, or other appropriate source (eg, nonclinical social worker, educator, lawyer, insurance company) for a specific condition or problem. Importantly, a consultation initiated by a patient or family, or both, and not requested by one of the professionals listed above is not reported using a consultation code.¹

The consultant’s opinion and any services that were ordered or performed also must be communicated to the requesting provider. The type of communication required varies based on the consultation code set in question.

Outpatient Consultation Codes

Outpatient consultation CPT (Current Procedural Terminology) codes (99241-99245) are a family of codes that can be utilized for evaluation of a new patient or an existing patient with a new problem in the outpatient setting. These codes are not reimbursed by the Centers for Medicare & Medicaid Services, but some private payers do recognize and reimburse for them.²

The consultant’s opinion and any services that were ordered or performed must be communicated by written report to the requesting physician, other qualified health care professional, or other appropriate source. If a consultation is mandated (eg, by a third-party payer), then modifier -32 also should be reported.¹ Modifier -32 should not be used for a second request by a patient or a patient’s family.¹

This family of codes has been revised in tandem with other evaluation and management (E/M) code sets; changes went into effect January 1, 2023. These updates are part of the ongoing effort to update code wording and structures to reflect guiding principles of the American Medical Association when redesigning E/M codes. These principles include decreasing administrative burden and the need for audits, decreasing unnecessary documentation that is not needed for patient care, and ensuring that payment for E/M is resource based.³ Updated code language and payment structure is found in Table 1.^1,2 The main updates to these codes include:

• Code 99241 was deleted. This was in line with removal of 99201 from the outpatient E/M family set.

• Level of service is now based solely on either time on the date of encounter or medical decision-making.

• Definitions regarding medical decision-making are in line with those utilized for outpatient E/M codes.

• If coding by time and the maximum amount of time has been exceeded by 15 or more minutes, prolonged services code 99417 can be utilized.

Inpatient Consultation Codes

Similar to the outpatient consultation codes, the inpatient consultation codes also have been revised as part of E/M updates; revisions went into effect January 1, 2023. Also, as with the outpatient consultation codes, the consultant’s opinion and any services that were ordered or performed must be communicated by written report to the requesting physician, other qualified health care professional, or other appropriate source. If a consultation is mandated (eg, by a third-party payer), then modifier -32 also should be reported.¹

When inpatient consultations are performed, 2 code families generally are utilized. For initial consultation, initial inpatient consultation codes (99251-99255) are used; for any follow-up encounters performed while the patient is an inpatient, subsequent inpatient consultation codes (99231-99233) are used. The subsequent code family is the same that is utilized for all subsequent care within the inpatient or observation care setting, regardless of how the care was initiated.¹

“Initial service” is when the patient has not received any professional services from either the physician or other qualified health care professional or from another physician or other qualified health care professional ofthe exact same specialty and subspecialty who belongs to the same group practice during the inpatient, observation, or nursing facility admission and stay. “Subsequent service” is when the patient has received professional service(s) from either the physician or other qualified health care professional or from another physician or other qualified health care professional.¹ Updated code language and payment structure is found in Table 2.^1,2 Major changes include:

• Code 99251 was deleted. This is in line with deletion of a new low-level patient encounter in the outpatient E/M family set and consultation code family set, as noted above.

• Level of service is now based solely on either time on the date of encounter or medical decision-making.

• Definitions regarding medical decision-making are in line with those utilized for outpatient E/M codes.

• If coding by time and the maximum amount of time has been exceeded by 15 or more minutes, prolonged services code 993X0 can be utilized.

Interprofessional Consultation Codes

An additional code family that can be utilized for consultations is the interprofessional consultation codes. These codes can be utilized when assisting in the diagnosis or management, or both, of a patient without face-to-face contact. These codes are listed in Table 3.^2,4 For all of these codes, the consultation is performed by telephone, internet or electronic health record, or a combination of these means. The consultation can be for a new problem or a worsening existing problem. The patient can be a new or established patient to the consultant. Documentation should be performed in the patient’s medical record, including the reason for the request.

To bill for interprofessional consultation, the consultant should not have seen the patient in a face-to-face encounter within the prior 14 days or see them in the following 14 days. The codes should not be reported more than once in a 7-day period or more than once in a 14-day period in the case of code 99452.⁴ For codes 99446 to 99449, more than 50% of the time spent by the consulting physician must be devoted to verbal or internet discussion, or both, with the referring physician. For code 99451, service time is based on total review and interprofessional communication time.⁴ The correct code is chosen based on the following parameters:

• 99446-99449: Describes interprofessional consultation services, which include both a written and a verbal report to the patient’s treating or requesting physician or qualified health care professional. These codes can be utilized by a consulting physician. The correct code is chosen based on time spent by the consulting physician.

• 99451: Describes an interprofessional consultation service, which includes a written report to the patient’s treating or requesting physician or qualified health care professional. This code can be utilized by a consulting physician once 5 minutes of consultative discussion and review has been performed.

• 99452: Describes an interprofessional consultation service provided by the requesting physician. This code can be utilized when a requesting physician spends 16 to 30 minutes in medical consultative discussion and review.

Final Thoughts

Consultation codes can be an important part of a dermatologist’s practice. Differences exist between consultation code sets based on the encounter setting and whether the encounter was performed with or without face-to-face contact. In addition, updates to the E/M inpatient and outpatient consultation codes went into effect January 1, 2023. It is important to understand those changes to correctly bill for these encounters.

Consultations and referrals are an important component of many dermatology practices. There are several families of consultation codes that can be utilized based on the setting and format of the patient encounter. In this article, I describe appropriate use of 3 families of consultation codes and recent updates in these areas.

Consultation Definitions

For all of these code sets, the same definition of consultationapplies—namely that the encounter is provided at the request of another physician, other qualified health care professional, or other appropriate source (eg, nonclinical social worker, educator, lawyer, insurance company) for a specific condition or problem. Importantly, a consultation initiated by a patient or family, or both, and not requested by one of the professionals listed above is not reported using a consultation code.¹

The consultant’s opinion and any services that were ordered or performed also must be communicated to the requesting provider. The type of communication required varies based on the consultation code set in question.

Outpatient Consultation Codes

Outpatient consultation CPT (Current Procedural Terminology) codes (99241-99245) are a family of codes that can be utilized for evaluation of a new patient or an existing patient with a new problem in the outpatient setting. These codes are not reimbursed by the Centers for Medicare & Medicaid Services, but some private payers do recognize and reimburse for them.²

The consultant’s opinion and any services that were ordered or performed must be communicated by written report to the requesting physician, other qualified health care professional, or other appropriate source. If a consultation is mandated (eg, by a third-party payer), then modifier -32 also should be reported.¹ Modifier -32 should not be used for a second request by a patient or a patient’s family.¹

This family of codes has been revised in tandem with other evaluation and management (E/M) code sets; changes went into effect January 1, 2023. These updates are part of the ongoing effort to update code wording and structures to reflect guiding principles of the American Medical Association when redesigning E/M codes. These principles include decreasing administrative burden and the need for audits, decreasing unnecessary documentation that is not needed for patient care, and ensuring that payment for E/M is resource based.³ Updated code language and payment structure is found in Table 1.^1,2 The main updates to these codes include:

• Code 99241 was deleted. This was in line with removal of 99201 from the outpatient E/M family set.

• Level of service is now based solely on either time on the date of encounter or medical decision-making.

• Definitions regarding medical decision-making are in line with those utilized for outpatient E/M codes.

• If coding by time and the maximum amount of time has been exceeded by 15 or more minutes, prolonged services code 99417 can be utilized.

Inpatient Consultation Codes

Similar to the outpatient consultation codes, the inpatient consultation codes also have been revised as part of E/M updates; revisions went into effect January 1, 2023. Also, as with the outpatient consultation codes, the consultant’s opinion and any services that were ordered or performed must be communicated by written report to the requesting physician, other qualified health care professional, or other appropriate source. If a consultation is mandated (eg, by a third-party payer), then modifier -32 also should be reported.¹

When inpatient consultations are performed, 2 code families generally are utilized. For initial consultation, initial inpatient consultation codes (99251-99255) are used; for any follow-up encounters performed while the patient is an inpatient, subsequent inpatient consultation codes (99231-99233) are used. The subsequent code family is the same that is utilized for all subsequent care within the inpatient or observation care setting, regardless of how the care was initiated.¹

“Initial service” is when the patient has not received any professional services from either the physician or other qualified health care professional or from another physician or other qualified health care professional ofthe exact same specialty and subspecialty who belongs to the same group practice during the inpatient, observation, or nursing facility admission and stay. “Subsequent service” is when the patient has received professional service(s) from either the physician or other qualified health care professional or from another physician or other qualified health care professional.¹ Updated code language and payment structure is found in Table 2.^1,2 Major changes include:

• Code 99251 was deleted. This is in line with deletion of a new low-level patient encounter in the outpatient E/M family set and consultation code family set, as noted above.

• Level of service is now based solely on either time on the date of encounter or medical decision-making.

• Definitions regarding medical decision-making are in line with those utilized for outpatient E/M codes.

• If coding by time and the maximum amount of time has been exceeded by 15 or more minutes, prolonged services code 993X0 can be utilized.

Interprofessional Consultation Codes

An additional code family that can be utilized for consultations is the interprofessional consultation codes. These codes can be utilized when assisting in the diagnosis or management, or both, of a patient without face-to-face contact. These codes are listed in Table 3.^2,4 For all of these codes, the consultation is performed by telephone, internet or electronic health record, or a combination of these means. The consultation can be for a new problem or a worsening existing problem. The patient can be a new or established patient to the consultant. Documentation should be performed in the patient’s medical record, including the reason for the request.

To bill for interprofessional consultation, the consultant should not have seen the patient in a face-to-face encounter within the prior 14 days or see them in the following 14 days. The codes should not be reported more than once in a 7-day period or more than once in a 14-day period in the case of code 99452.⁴ For codes 99446 to 99449, more than 50% of the time spent by the consulting physician must be devoted to verbal or internet discussion, or both, with the referring physician. For code 99451, service time is based on total review and interprofessional communication time.⁴ The correct code is chosen based on the following parameters:

• 99446-99449: Describes interprofessional consultation services, which include both a written and a verbal report to the patient’s treating or requesting physician or qualified health care professional. These codes can be utilized by a consulting physician. The correct code is chosen based on time spent by the consulting physician.

• 99451: Describes an interprofessional consultation service, which includes a written report to the patient’s treating or requesting physician or qualified health care professional. This code can be utilized by a consulting physician once 5 minutes of consultative discussion and review has been performed.

• 99452: Describes an interprofessional consultation service provided by the requesting physician. This code can be utilized when a requesting physician spends 16 to 30 minutes in medical consultative discussion and review.

Final Thoughts

Consultation codes can be an important part of a dermatologist’s practice. Differences exist between consultation code sets based on the encounter setting and whether the encounter was performed with or without face-to-face contact. In addition, updates to the E/M inpatient and outpatient consultation codes went into effect January 1, 2023. It is important to understand those changes to correctly bill for these encounters.

Consultations and referrals are an important component of many dermatology practices. There are several families of consultation codes that can be utilized based on the setting and format of the patient encounter. In this article, I describe appropriate use of 3 families of consultation codes and recent updates in these areas.

Consultation Definitions

For all of these code sets, the same definition of consultationapplies—namely that the encounter is provided at the request of another physician, other qualified health care professional, or other appropriate source (eg, nonclinical social worker, educator, lawyer, insurance company) for a specific condition or problem. Importantly, a consultation initiated by a patient or family, or both, and not requested by one of the professionals listed above is not reported using a consultation code.¹

The consultant’s opinion and any services that were ordered or performed also must be communicated to the requesting provider. The type of communication required varies based on the consultation code set in question.

Outpatient Consultation Codes

Outpatient consultation CPT (Current Procedural Terminology) codes (99241-99245) are a family of codes that can be utilized for evaluation of a new patient or an existing patient with a new problem in the outpatient setting. These codes are not reimbursed by the Centers for Medicare & Medicaid Services, but some private payers do recognize and reimburse for them.²

The consultant’s opinion and any services that were ordered or performed must be communicated by written report to the requesting physician, other qualified health care professional, or other appropriate source. If a consultation is mandated (eg, by a third-party payer), then modifier -32 also should be reported.¹ Modifier -32 should not be used for a second request by a patient or a patient’s family.¹

This family of codes has been revised in tandem with other evaluation and management (E/M) code sets; changes went into effect January 1, 2023. These updates are part of the ongoing effort to update code wording and structures to reflect guiding principles of the American Medical Association when redesigning E/M codes. These principles include decreasing administrative burden and the need for audits, decreasing unnecessary documentation that is not needed for patient care, and ensuring that payment for E/M is resource based.³ Updated code language and payment structure is found in Table 1.^1,2 The main updates to these codes include:

• Code 99241 was deleted. This was in line with removal of 99201 from the outpatient E/M family set.

• Level of service is now based solely on either time on the date of encounter or medical decision-making.

• Definitions regarding medical decision-making are in line with those utilized for outpatient E/M codes.

• If coding by time and the maximum amount of time has been exceeded by 15 or more minutes, prolonged services code 99417 can be utilized.

Inpatient Consultation Codes

Similar to the outpatient consultation codes, the inpatient consultation codes also have been revised as part of E/M updates; revisions went into effect January 1, 2023. Also, as with the outpatient consultation codes, the consultant’s opinion and any services that were ordered or performed must be communicated by written report to the requesting physician, other qualified health care professional, or other appropriate source. If a consultation is mandated (eg, by a third-party payer), then modifier -32 also should be reported.¹

When inpatient consultations are performed, 2 code families generally are utilized. For initial consultation, initial inpatient consultation codes (99251-99255) are used; for any follow-up encounters performed while the patient is an inpatient, subsequent inpatient consultation codes (99231-99233) are used. The subsequent code family is the same that is utilized for all subsequent care within the inpatient or observation care setting, regardless of how the care was initiated.¹

“Initial service” is when the patient has not received any professional services from either the physician or other qualified health care professional or from another physician or other qualified health care professional ofthe exact same specialty and subspecialty who belongs to the same group practice during the inpatient, observation, or nursing facility admission and stay. “Subsequent service” is when the patient has received professional service(s) from either the physician or other qualified health care professional or from another physician or other qualified health care professional.¹ Updated code language and payment structure is found in Table 2.^1,2 Major changes include:

• Code 99251 was deleted. This is in line with deletion of a new low-level patient encounter in the outpatient E/M family set and consultation code family set, as noted above.

• Level of service is now based solely on either time on the date of encounter or medical decision-making.

• Definitions regarding medical decision-making are in line with those utilized for outpatient E/M codes.

• If coding by time and the maximum amount of time has been exceeded by 15 or more minutes, prolonged services code 993X0 can be utilized.

Interprofessional Consultation Codes

An additional code family that can be utilized for consultations is the interprofessional consultation codes. These codes can be utilized when assisting in the diagnosis or management, or both, of a patient without face-to-face contact. These codes are listed in Table 3.^2,4 For all of these codes, the consultation is performed by telephone, internet or electronic health record, or a combination of these means. The consultation can be for a new problem or a worsening existing problem. The patient can be a new or established patient to the consultant. Documentation should be performed in the patient’s medical record, including the reason for the request.

To bill for interprofessional consultation, the consultant should not have seen the patient in a face-to-face encounter within the prior 14 days or see them in the following 14 days. The codes should not be reported more than once in a 7-day period or more than once in a 14-day period in the case of code 99452.⁴ For codes 99446 to 99449, more than 50% of the time spent by the consulting physician must be devoted to verbal or internet discussion, or both, with the referring physician. For code 99451, service time is based on total review and interprofessional communication time.⁴ The correct code is chosen based on the following parameters:

• 99446-99449: Describes interprofessional consultation services, which include both a written and a verbal report to the patient’s treating or requesting physician or qualified health care professional. These codes can be utilized by a consulting physician. The correct code is chosen based on time spent by the consulting physician.

• 99451: Describes an interprofessional consultation service, which includes a written report to the patient’s treating or requesting physician or qualified health care professional. This code can be utilized by a consulting physician once 5 minutes of consultative discussion and review has been performed.

• 99452: Describes an interprofessional consultation service provided by the requesting physician. This code can be utilized when a requesting physician spends 16 to 30 minutes in medical consultative discussion and review.

Final Thoughts

Consultation codes can be an important part of a dermatologist’s practice. Differences exist between consultation code sets based on the encounter setting and whether the encounter was performed with or without face-to-face contact. In addition, updates to the E/M inpatient and outpatient consultation codes went into effect January 1, 2023. It is important to understand those changes to correctly bill for these encounters.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

New treatments for psoriasis constitute an embarrassment of riches compared to any other area of dermatology. Despite the many advances over the last 25 years, additional topical and systemic treatments have recently become available. Gosh, it’s great!

In May 2022, once-daily tapinarof cream 1% was approved for the topical treatment of plaque psoriasis in adults.¹ Tapinarof was identified as a metabolite made by bacteria symbiotic to a nematode, allowing the nematode to infect insects.² Tapinarof’s anti-inflammatory effect extends to mammals. The drug works by activating the aryl hydrocarbon receptor, downregulating proinflammatory cytokines such as IL-17, and normalizing the expression of skin barrier proteins such as filaggrin.² In two 12-week, phase 3, randomized trials with 510 and 515 patients, respectively, 35% to 40% of tapinarof-treated psoriasis patients were clear or almost clear compared with only 6% of patients in the placebo group. The drug appears safe; common adverse events (AEs) included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.³

A second new topical treatment for plaque psoriasis was approved in July 2022—once-daily roflumilast 0.3% cream—for patients 12 years and older.⁴ Similar to apremilast, roflumilast is a phosphodiesterase 4 inhibitor that blocks the degradation of cAMP and reduces the downstream production of inflammatory molecules implicated in psoriasis.⁵ In two 8-week, phase 3 clinical trials (ClinicalTrials.gov Identifiers NCT04211363 and NCT04211389)(N=881), approximately 40% of roflumilast-treated patients were clear or almost clear vs approximately 6% in the placebo group. Topical roflumilast was well-tolerated; the most common AEs included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.⁶

We have so many patients—and many more people with psoriasis who are not yet patients—with limited psoriasis who would be amenable to topical treatment but who are not responding to current treatments. There is considerable enthusiasm for the new topicals, but it is still questionable how much they will help our patients. The main reason the current topicals fail is poor adherence to the treatment. If we give these new treatments to patients who used existing topicals and failed, thereby inadvertently selecting patients with poor adherence to topicals, it will be surprising if the new treatments live up to expectations. Perhaps tapinarof and roflumilast will revolutionize the management of localized psoriasis; perhaps their impact will be similar to topical crisaborole— exciting in trials and less practical in real life. It may be that apremilast, which is now approved for psoriasis of any severity, will make a bigger difference for patients who can access it for limited psoriasis.

Deucravacitinib is a once-daily oral selective tyrosine kinase 2 inhibitor that blocks IL-23 and type I interferon signaling. It was approved for adults with moderate to severe plaque psoriasis in September 2021.⁷ We know patients want oral treatment; they ask for apremilast even though injections may be much more potent. In a 16-week, phase 3 clinical trial comparing daily deucravacitinib (n=332), apremilast (n=168), and placebo (n=166), rates of clear or almost clear were approximately 55% in the deucravacitinib group, 32% in the apremilast group, and 7% with placebo. The most common AEs included nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea.⁸ Although deucravacitinib is much more effective than apremilast, deucravacitinib will require monitoring and may have some risk for viral reactivation of herpes simplex and zoster (and hopefully not much else). Whether physicians view it as a replacement for apremilast, which requires no laboratory monitoring, remains to be seen.

Bimekizumab, a humanized monoclonal IgG1 antibody expected to receive US Food and Drug Administration approval in the coming months, inhibits both IL-17A and IL-17F and may become our most effective treatment of psoriasis. Although we are probably not hungering for a more effective psoriasis treatment (given our current embarrassment of riches), bimekizumab’s remarkably high efficacy for psoriatic arthritis may be a quantum leap forward, especially if no new safety signals are identified; bimekizumab treatment is associated with a higher risk of oral candidiasis than other currently available IL-17 antagonists.⁹ Biosimilars may reduce the cost of psoriasis management to the health system, but it seems unlikely that biosimilars will allow us to help patients who we cannot already help with the existing extensive psoriasis treatment armamentarium.

New treatments for psoriasis constitute an embarrassment of riches compared to any other area of dermatology. Despite the many advances over the last 25 years, additional topical and systemic treatments have recently become available. Gosh, it’s great!

In May 2022, once-daily tapinarof cream 1% was approved for the topical treatment of plaque psoriasis in adults.¹ Tapinarof was identified as a metabolite made by bacteria symbiotic to a nematode, allowing the nematode to infect insects.² Tapinarof’s anti-inflammatory effect extends to mammals. The drug works by activating the aryl hydrocarbon receptor, downregulating proinflammatory cytokines such as IL-17, and normalizing the expression of skin barrier proteins such as filaggrin.² In two 12-week, phase 3, randomized trials with 510 and 515 patients, respectively, 35% to 40% of tapinarof-treated psoriasis patients were clear or almost clear compared with only 6% of patients in the placebo group. The drug appears safe; common adverse events (AEs) included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.³

A second new topical treatment for plaque psoriasis was approved in July 2022—once-daily roflumilast 0.3% cream—for patients 12 years and older.⁴ Similar to apremilast, roflumilast is a phosphodiesterase 4 inhibitor that blocks the degradation of cAMP and reduces the downstream production of inflammatory molecules implicated in psoriasis.⁵ In two 8-week, phase 3 clinical trials (ClinicalTrials.gov Identifiers NCT04211363 and NCT04211389)(N=881), approximately 40% of roflumilast-treated patients were clear or almost clear vs approximately 6% in the placebo group. Topical roflumilast was well-tolerated; the most common AEs included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.⁶

We have so many patients—and many more people with psoriasis who are not yet patients—with limited psoriasis who would be amenable to topical treatment but who are not responding to current treatments. There is considerable enthusiasm for the new topicals, but it is still questionable how much they will help our patients. The main reason the current topicals fail is poor adherence to the treatment. If we give these new treatments to patients who used existing topicals and failed, thereby inadvertently selecting patients with poor adherence to topicals, it will be surprising if the new treatments live up to expectations. Perhaps tapinarof and roflumilast will revolutionize the management of localized psoriasis; perhaps their impact will be similar to topical crisaborole— exciting in trials and less practical in real life. It may be that apremilast, which is now approved for psoriasis of any severity, will make a bigger difference for patients who can access it for limited psoriasis.

Deucravacitinib is a once-daily oral selective tyrosine kinase 2 inhibitor that blocks IL-23 and type I interferon signaling. It was approved for adults with moderate to severe plaque psoriasis in September 2021.⁷ We know patients want oral treatment; they ask for apremilast even though injections may be much more potent. In a 16-week, phase 3 clinical trial comparing daily deucravacitinib (n=332), apremilast (n=168), and placebo (n=166), rates of clear or almost clear were approximately 55% in the deucravacitinib group, 32% in the apremilast group, and 7% with placebo. The most common AEs included nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea.⁸ Although deucravacitinib is much more effective than apremilast, deucravacitinib will require monitoring and may have some risk for viral reactivation of herpes simplex and zoster (and hopefully not much else). Whether physicians view it as a replacement for apremilast, which requires no laboratory monitoring, remains to be seen.

Bimekizumab, a humanized monoclonal IgG1 antibody expected to receive US Food and Drug Administration approval in the coming months, inhibits both IL-17A and IL-17F and may become our most effective treatment of psoriasis. Although we are probably not hungering for a more effective psoriasis treatment (given our current embarrassment of riches), bimekizumab’s remarkably high efficacy for psoriatic arthritis may be a quantum leap forward, especially if no new safety signals are identified; bimekizumab treatment is associated with a higher risk of oral candidiasis than other currently available IL-17 antagonists.⁹ Biosimilars may reduce the cost of psoriasis management to the health system, but it seems unlikely that biosimilars will allow us to help patients who we cannot already help with the existing extensive psoriasis treatment armamentarium.

New treatments for psoriasis constitute an embarrassment of riches compared to any other area of dermatology. Despite the many advances over the last 25 years, additional topical and systemic treatments have recently become available. Gosh, it’s great!

In May 2022, once-daily tapinarof cream 1% was approved for the topical treatment of plaque psoriasis in adults.¹ Tapinarof was identified as a metabolite made by bacteria symbiotic to a nematode, allowing the nematode to infect insects.² Tapinarof’s anti-inflammatory effect extends to mammals. The drug works by activating the aryl hydrocarbon receptor, downregulating proinflammatory cytokines such as IL-17, and normalizing the expression of skin barrier proteins such as filaggrin.² In two 12-week, phase 3, randomized trials with 510 and 515 patients, respectively, 35% to 40% of tapinarof-treated psoriasis patients were clear or almost clear compared with only 6% of patients in the placebo group. The drug appears safe; common adverse events (AEs) included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.³

A second new topical treatment for plaque psoriasis was approved in July 2022—once-daily roflumilast 0.3% cream—for patients 12 years and older.⁴ Similar to apremilast, roflumilast is a phosphodiesterase 4 inhibitor that blocks the degradation of cAMP and reduces the downstream production of inflammatory molecules implicated in psoriasis.⁵ In two 8-week, phase 3 clinical trials (ClinicalTrials.gov Identifiers NCT04211363 and NCT04211389)(N=881), approximately 40% of roflumilast-treated patients were clear or almost clear vs approximately 6% in the placebo group. Topical roflumilast was well-tolerated; the most common AEs included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.⁶

We have so many patients—and many more people with psoriasis who are not yet patients—with limited psoriasis who would be amenable to topical treatment but who are not responding to current treatments. There is considerable enthusiasm for the new topicals, but it is still questionable how much they will help our patients. The main reason the current topicals fail is poor adherence to the treatment. If we give these new treatments to patients who used existing topicals and failed, thereby inadvertently selecting patients with poor adherence to topicals, it will be surprising if the new treatments live up to expectations. Perhaps tapinarof and roflumilast will revolutionize the management of localized psoriasis; perhaps their impact will be similar to topical crisaborole— exciting in trials and less practical in real life. It may be that apremilast, which is now approved for psoriasis of any severity, will make a bigger difference for patients who can access it for limited psoriasis.

Deucravacitinib is a once-daily oral selective tyrosine kinase 2 inhibitor that blocks IL-23 and type I interferon signaling. It was approved for adults with moderate to severe plaque psoriasis in September 2021.⁷ We know patients want oral treatment; they ask for apremilast even though injections may be much more potent. In a 16-week, phase 3 clinical trial comparing daily deucravacitinib (n=332), apremilast (n=168), and placebo (n=166), rates of clear or almost clear were approximately 55% in the deucravacitinib group, 32% in the apremilast group, and 7% with placebo. The most common AEs included nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea.⁸ Although deucravacitinib is much more effective than apremilast, deucravacitinib will require monitoring and may have some risk for viral reactivation of herpes simplex and zoster (and hopefully not much else). Whether physicians view it as a replacement for apremilast, which requires no laboratory monitoring, remains to be seen.

Bimekizumab, a humanized monoclonal IgG1 antibody expected to receive US Food and Drug Administration approval in the coming months, inhibits both IL-17A and IL-17F and may become our most effective treatment of psoriasis. Although we are probably not hungering for a more effective psoriasis treatment (given our current embarrassment of riches), bimekizumab’s remarkably high efficacy for psoriatic arthritis may be a quantum leap forward, especially if no new safety signals are identified; bimekizumab treatment is associated with a higher risk of oral candidiasis than other currently available IL-17 antagonists.⁹ Biosimilars may reduce the cost of psoriasis management to the health system, but it seems unlikely that biosimilars will allow us to help patients who we cannot already help with the existing extensive psoriasis treatment armamentarium.

The landscape of psoriasis treatments has undergone rapid change within the last decade, and the dizzying speed of drug development has not slowed, with 4 notable entries into the psoriasis treatment armamentarium within the last year: tapinarof, roflumilast, deucravacitinib, and spesolimab. Several others are in late-stage development, and these therapies represent new mechanisms, pathways, and delivery systems that will meaningfully broaden the spectrum of treatment choices for our patients. However, it can be quite difficult to keep track of all of the medication options. This review aims to present the mechanisms and data on both newly available therapeutics for psoriasis and products in the pipeline that may have a major impact on our treatment paradigm for psoriasis in the near future.

Topical Treatments

Tapinarof—Tapinarof is a topical aryl hydrocarbon receptor (AhR)–modulating agent derived from a secondary metabolite produced by a bacterial symbiont of entomopathogenic nematodes.¹ Tapinarof binds and activates AhR, inducing a signaling cascade that suppresses the expression of helper T cells T_H17 and T_H22, upregulates skin barrier protein expression, and reduces epidermal oxidative stress.² This is a familiar mechanism, as AhR agonism is one of the pathways modulated by coal tar. Tapinarof’s overall effects on immune function, skin barrier integrity, and antioxidant activity show great promise for the treatment of plaque psoriasis.

Two phase 3 trials (N=1025) evaluated the efficacy and safety of once-daily tapinarof cream 1% for plaque psoriasis.³ A physician global assessment (PGA) score of 0/1 occurred in 35.4% to 40.2% of patients in the tapinarof group and in 6.0% of patients in the vehicle group. At week 12, 36.1% to 47.6% of patients treated with daily applications of tapinarof cream achieved a 75% reduction in their baseline psoriasis area and severity index (PASI 75) score compared with 6.9% to 10.2% in the vehicle group.³ In a long-term extension study, a substantial remittive effect of at least 4 months off tapinarof therapy was observed in patients who achieved complete clearance (PGA=0).⁴ Use of tapinarof cream was associated with folliculitis in up to 23.5% of patients.^3,4

Roflumilast—Phosphodiesterase 4 (PDE-4) is an intracellular enzyme involved in the regulation of cell proliferation, differentiation, and immune responses.⁵ The inhibition of PDE-4 decreases the expression of proinflammatory cytokines implicated in the pathogenesis of plaque psoriasis, such as tumor necrosis factor α, IFN-γ, and IL-2, IL-12, and IL-23.⁶ Phosphodiesterase 4–targeted therapies have been thoroughly explored to treat various inflammatory conditions, including atopic dermatitis and plaque psoriasis. The oral PDE-4 inhibitor apremilast was shown to achieve PASI 75 in approximately 30% of 562 patients, accompanied by severe gastrointestinal adverse events (AEs) including diarrhea and nausea associated with treatment.⁷ Local irritation from the topical PDE-4 inhibitor crisaborole for atopic dermatitis and psoriasis (where it only completed phase 2 trials) limits its widespread use. The lack of tolerable and effective treatment alternatives for psoriasis prompted the investigation of new PDE-4–targeted therapies.

Topical roflumilast is a selective, highly potent PDE-4 inhibitor with greater affinity for PDE-4 compared to crisaborole and apremilast.⁸ Two phase 3 trials (N=881) evaluated the efficacy and safety profile of roflumilast cream for plaque psoriasis, with a particular interest in its use for intertriginous areas.⁹ At week 8, 37.5% to 42.4% of roflumilast-treated patients achieved investigator global assessment (IGA) success compared with 6.1% to 6.9% of vehicle-treated patients. Intertriginous IGA success was observed in 68.1% to 71.2% of patients treated with roflumilast cream compared with 13.8% to 18.5% of vehicle-treated patients. At 8-week follow-up, 39.0% to 41.6% of roflumilast-treated patients achieved PASI 75 vs 5.3% to 7.6% of patients in the vehicle group. Few stinging, burning, or application-site reactions were reported with roflumilast, along with rare instances of gastrointestinal AEs (<4%).⁹

Oral Therapy

Deucravacitinib—Tyrosine kinase 2 (TYK2) mediates the intracellular signaling of the T_H17 and T_H1 inflammatory cytokines IL-12/IL-23 and type I interferons, respectively, the former of which are critical in the development of psoriasis via the Janus kinase (JAK) signal transducer and activator of transcription pathway.¹⁰ Deucravacitinib is an oral selective TYK2 allosteric inhibitor that binds to the regulatory domain of the enzyme rather than the active catalytic domain, where other TYK2 and JAK1, JAK2, and JAK3 inhibitors bind.¹¹ This unique inhibitory mechanism accounts for the high functional selectivity of deucravacitinib for TYK2 vs the closely related JAK1, JAK2, and JAK3 kinases, thus avoiding the pitfall of prior JAK inhibitors that were associated with major AEs, including an increased risk for serious infections, malignancies, and thrombosis.¹² The selective suppression of the inflammatory TYK2 pathway has the potential to shift future therapeutic targets to a narrower range of receptors that may contribute to favorable benefit-risk profiles.

Two phase 3 trials (N=1686) compared the efficacy and safety of deucravacitinib vs placebo and apremilast in adults with moderate to severe plaque psoriasis.^13,14 At week 16, 53.0% to 58.4% of deucravacitinib-treated patients achieved PASI 75 compared with 35.1% to 39.8% of apremilast-treated patients. At 16-week follow-up, static PGA response was observed in 49.5% to 53.6% of patients in the deucravacitinib group and 32.1% to 33.9% of the apremilast group. The most frequent AEs associated with deucravacitinib therapy were nasopharyngitis and upper respiratory tract infection, whereas headache, diarrhea, and nausea were more common with apremilast. Treatment with deucravacitinib caused no meaningful changes in laboratory parameters, which are known to change with JAK1, JAK2, and JAK3 inhibitors.^13,14 A long-term extension study demonstrated that deucravacitinib had persistent efficacy and consistent safety for up to 2 years.¹⁵

Novel oral allosteric TYK2 inhibitors—VTX958 and NDI-034858—and the competitive TYK2 inhibitor PF-06826647 are being developed. Theoretically, these new allosteric inhibitors possess unique structural properties to provide greater TYK2 suppression while bypassing JAK1, JAK2, and JAK3 pathways that may contribute to improved efficacy and safety profiles compared with other TYK2 inhibitors such as deucravacitinib. The results of a phase 1b trial (ClinicalTrials.gov Identifier NCT04999839) showed a dose-dependent reduction of disease severity associated with NDI-034858 treatment for patients with moderate to severe plaque psoriasis, albeit in only 26 patients. At week 4, PASI 50 was achieved in 13%, 57%, and 40% of patients in the 5-, 10-, and 30-mg groups, respectively, compared with 0% in the placebo group.¹⁶ In a phase 2 trial of 179 patients, 46.5% and 33.0% of patients treated with 400 and 200 mg of PF-06826647, respectively, achieved PASI 90 at week 16. Conversely, dose-dependent laboratory abnormalities were observed with PF-06826647, including anemia, neutropenia, and increases in creatine phosphokinase.¹⁷ At high concentrations, PF-06826647 may disrupt JAK signaling pathways involved in hematopoiesis and renal functions owing to its mode of action as a competitive inhibitor. Overall, these agents are much farther from market, and long-term studies with larger diverse patient cohorts are required to adequately assess the efficacy and safety data of these novel oral TYK2 inhibitors for patients with psoriasis.

EDP1815—EDP1815 is an oral preparation of a single strain of Prevotella histicola being developed for the treatment of inflammatory diseases, including psoriasis. EDP1815 interacts with host intestinal immune cells through the small intestinal axis (SINTAX) to suppress systemic inflammation across the T_H1, T_H2, and T_H17 pathways. Therapy triggers broad immunomodulatory effects without causing systemic absorption, colonic colonization, or modification of the gut microbiome.¹⁸ In a phase 2 study (NCT04603027), the primary end point analysis, mean percentage change in PASI between treatment and placebo, demonstrated that at week 16, EDP1815 was superior to placebo with 80% to 90% probability across each cohort. At week 16, 25% to 32% of patients across the 3 cohorts treated with EDP1815 achieved PASI 50 compared with 12% of patients receiving placebo. Gastrointestinal AEs were comparable between treatment and placebo groups. These results suggest that SINTAX-targeted therapies may provide efficacious and safe immunomodulatory effects for patients with mild to moderate psoriasis, who often have limited treatment options. Although improvements may be mild, SINTAX-targeted therapies can be seen as a particularly attractive adjunctive treatment for patients with severe psoriasis taking other medications or as part of a treatment approach for a patient with milder psoriasis.

Biologics

Bimekizumab—Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17A and IL-17F. Although IL-17A is a more potent cytokine, IL-17F may be more highly expressed in psoriatic lesional skin and independently contribute to the activation of proinflammatory signaling pathways implicated in the pathophysiology of psoriasis.¹⁹ Evidence suggests that dual inhibition of IL-17A and IL-17F may provide more complete suppression of inflammation and improved clinical responses than IL-17A inhibition alone.²⁰

Prior bimekizumab phase 3 clinical studies have shown both rapid and durable clinical improvements in skin clearance compared with placebo.²¹ Three phase 3 trials—BE VIVID (N=567),²² BE SURE (N=478),²³ and BE RADIANT (N=743)²⁴—assessed the efficacy and safety of bimekizumab vs the IL-12/IL-23 inhibitor ustekinumab, the tumor necrosis factor inhibitor adalimumab, and the selective IL-17A inhibitor secukinumab, respectively. At week 4, significantly more patients treated with bimekizumab (71%–77%) achieved PASI 75 than patients treated with ustekinumab (15%; P<.0001), adalimumab (31.4%; P<.001), or secukinumab (47.3%; P<.001).^22-24 After 16 weeks of treatment, PASI 90 was achieved by 85% to 86.2%, 50%, and 47.2% of patients treated with bimekizumab, ustekinumab, and adalimumab, respectively.^22,23 At week 16, PASI 100 was observed in 59% to 61.7%, 21%, 23.9%, and 48.9% of patients treated with bimekizumab, ustekinumab, adalimumab, and secukinumab, respectively. An IGA response (score of 0/1) at week 16 was achieved by 84% to 85.5%, 53%, 57.2%, and 78.6% of patients receiving bimekizumab, ustekinumab, adalimumab, and secukinumab, respectively.^22-24

The most common AEs in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.^22-24 The dual inhibition of IL-17A and IL-17F suppresses host defenses against Candida at the oral mucosa, increasing the incidence of bimekizumab-associated oral candidiasis.²⁵ Despite the increased risk of Candida infections, these data suggest that inhibition of both IL-17A and IL-17F with bimekizumab may provide faster and greater clinical benefit for patients with moderate to severe plaque psoriasis than inhibition of IL-17A alone and other biologic therapies, as the PASI 100 clearance rates across the multiple comparator trials and the placebo-controlled pivotal trial are consistently the highest among any biologic for the treatment of psoriasis.

Spesolimab—The IL-36 pathway and IL-36 receptor genes have been linked to the pathogenesis of generalized pustular psoriasis.²⁶ In a phase 2 trial, 19 of 35 patients (54%) receiving an intravenous dose of spesolimab, an IL-36 receptor inhibitor, had a generalized pustular psoriasis PGA pustulation subscore of 0 (no visible pustules) at the end of week 1 vs 6% of patients in the placebo group.²⁷ A generalized pustular psoriasis PGA total score of 0 or 1 was observed in 43% (15/35) of spesolimab-treated patients compared with 11% (2/18) of patients in the placebo group. The most common AEs in patients treated with spesolimab were minor infections.²⁷ Two open-label phase 3 trials—NCT05200247 and NCT05239039—are underway to determine the long-term efficacy and safety of spesolimab in patients with generalized pustular psoriasis.

Conclusion

Although we have seen a renaissance in psoriasis therapies with the advent of biologics in the last 20 years, recent evidence shows that more innovation is underway. Just in the last year, 2 new mechanisms for treating psoriasis topically without steroids have come to fruition, and there have not been truly novel mechanisms for treating psoriasis topically since approvals for tazarotene and calcipotriene in the 1990s. An entirely new class—TYK2 inhibitors—was developed and landed in psoriasis first, greatly improving the efficacy measures attained with oral medications in general. Finally, an orphan diagnosis got its due with an ambitiously designed study looking at a previously unheard-of 1-week end point, but it comes for one of the few true dermatologic emergencies we encounter, generalized pustular psoriasis. We are fortunate to have so many meaningful new treatments available to us, and it is invigorating to see that even more efficacious biologics and treatments are coming, along with novel concepts such as a treatment affecting the microbiome. Now, we just need to make sure that our patients have the access they deserve to the wide array of available treatments.

The landscape of psoriasis treatments has undergone rapid change within the last decade, and the dizzying speed of drug development has not slowed, with 4 notable entries into the psoriasis treatment armamentarium within the last year: tapinarof, roflumilast, deucravacitinib, and spesolimab. Several others are in late-stage development, and these therapies represent new mechanisms, pathways, and delivery systems that will meaningfully broaden the spectrum of treatment choices for our patients. However, it can be quite difficult to keep track of all of the medication options. This review aims to present the mechanisms and data on both newly available therapeutics for psoriasis and products in the pipeline that may have a major impact on our treatment paradigm for psoriasis in the near future.

Topical Treatments

Tapinarof—Tapinarof is a topical aryl hydrocarbon receptor (AhR)–modulating agent derived from a secondary metabolite produced by a bacterial symbiont of entomopathogenic nematodes.¹ Tapinarof binds and activates AhR, inducing a signaling cascade that suppresses the expression of helper T cells T_H17 and T_H22, upregulates skin barrier protein expression, and reduces epidermal oxidative stress.² This is a familiar mechanism, as AhR agonism is one of the pathways modulated by coal tar. Tapinarof’s overall effects on immune function, skin barrier integrity, and antioxidant activity show great promise for the treatment of plaque psoriasis.

Two phase 3 trials (N=1025) evaluated the efficacy and safety of once-daily tapinarof cream 1% for plaque psoriasis.³ A physician global assessment (PGA) score of 0/1 occurred in 35.4% to 40.2% of patients in the tapinarof group and in 6.0% of patients in the vehicle group. At week 12, 36.1% to 47.6% of patients treated with daily applications of tapinarof cream achieved a 75% reduction in their baseline psoriasis area and severity index (PASI 75) score compared with 6.9% to 10.2% in the vehicle group.³ In a long-term extension study, a substantial remittive effect of at least 4 months off tapinarof therapy was observed in patients who achieved complete clearance (PGA=0).⁴ Use of tapinarof cream was associated with folliculitis in up to 23.5% of patients.^3,4

Roflumilast—Phosphodiesterase 4 (PDE-4) is an intracellular enzyme involved in the regulation of cell proliferation, differentiation, and immune responses.⁵ The inhibition of PDE-4 decreases the expression of proinflammatory cytokines implicated in the pathogenesis of plaque psoriasis, such as tumor necrosis factor α, IFN-γ, and IL-2, IL-12, and IL-23.⁶ Phosphodiesterase 4–targeted therapies have been thoroughly explored to treat various inflammatory conditions, including atopic dermatitis and plaque psoriasis. The oral PDE-4 inhibitor apremilast was shown to achieve PASI 75 in approximately 30% of 562 patients, accompanied by severe gastrointestinal adverse events (AEs) including diarrhea and nausea associated with treatment.⁷ Local irritation from the topical PDE-4 inhibitor crisaborole for atopic dermatitis and psoriasis (where it only completed phase 2 trials) limits its widespread use. The lack of tolerable and effective treatment alternatives for psoriasis prompted the investigation of new PDE-4–targeted therapies.

Topical roflumilast is a selective, highly potent PDE-4 inhibitor with greater affinity for PDE-4 compared to crisaborole and apremilast.⁸ Two phase 3 trials (N=881) evaluated the efficacy and safety profile of roflumilast cream for plaque psoriasis, with a particular interest in its use for intertriginous areas.⁹ At week 8, 37.5% to 42.4% of roflumilast-treated patients achieved investigator global assessment (IGA) success compared with 6.1% to 6.9% of vehicle-treated patients. Intertriginous IGA success was observed in 68.1% to 71.2% of patients treated with roflumilast cream compared with 13.8% to 18.5% of vehicle-treated patients. At 8-week follow-up, 39.0% to 41.6% of roflumilast-treated patients achieved PASI 75 vs 5.3% to 7.6% of patients in the vehicle group. Few stinging, burning, or application-site reactions were reported with roflumilast, along with rare instances of gastrointestinal AEs (<4%).⁹

Oral Therapy

Deucravacitinib—Tyrosine kinase 2 (TYK2) mediates the intracellular signaling of the T_H17 and T_H1 inflammatory cytokines IL-12/IL-23 and type I interferons, respectively, the former of which are critical in the development of psoriasis via the Janus kinase (JAK) signal transducer and activator of transcription pathway.¹⁰ Deucravacitinib is an oral selective TYK2 allosteric inhibitor that binds to the regulatory domain of the enzyme rather than the active catalytic domain, where other TYK2 and JAK1, JAK2, and JAK3 inhibitors bind.¹¹ This unique inhibitory mechanism accounts for the high functional selectivity of deucravacitinib for TYK2 vs the closely related JAK1, JAK2, and JAK3 kinases, thus avoiding the pitfall of prior JAK inhibitors that were associated with major AEs, including an increased risk for serious infections, malignancies, and thrombosis.¹² The selective suppression of the inflammatory TYK2 pathway has the potential to shift future therapeutic targets to a narrower range of receptors that may contribute to favorable benefit-risk profiles.

Two phase 3 trials (N=1686) compared the efficacy and safety of deucravacitinib vs placebo and apremilast in adults with moderate to severe plaque psoriasis.^13,14 At week 16, 53.0% to 58.4% of deucravacitinib-treated patients achieved PASI 75 compared with 35.1% to 39.8% of apremilast-treated patients. At 16-week follow-up, static PGA response was observed in 49.5% to 53.6% of patients in the deucravacitinib group and 32.1% to 33.9% of the apremilast group. The most frequent AEs associated with deucravacitinib therapy were nasopharyngitis and upper respiratory tract infection, whereas headache, diarrhea, and nausea were more common with apremilast. Treatment with deucravacitinib caused no meaningful changes in laboratory parameters, which are known to change with JAK1, JAK2, and JAK3 inhibitors.^13,14 A long-term extension study demonstrated that deucravacitinib had persistent efficacy and consistent safety for up to 2 years.¹⁵

Novel oral allosteric TYK2 inhibitors—VTX958 and NDI-034858—and the competitive TYK2 inhibitor PF-06826647 are being developed. Theoretically, these new allosteric inhibitors possess unique structural properties to provide greater TYK2 suppression while bypassing JAK1, JAK2, and JAK3 pathways that may contribute to improved efficacy and safety profiles compared with other TYK2 inhibitors such as deucravacitinib. The results of a phase 1b trial (ClinicalTrials.gov Identifier NCT04999839) showed a dose-dependent reduction of disease severity associated with NDI-034858 treatment for patients with moderate to severe plaque psoriasis, albeit in only 26 patients. At week 4, PASI 50 was achieved in 13%, 57%, and 40% of patients in the 5-, 10-, and 30-mg groups, respectively, compared with 0% in the placebo group.¹⁶ In a phase 2 trial of 179 patients, 46.5% and 33.0% of patients treated with 400 and 200 mg of PF-06826647, respectively, achieved PASI 90 at week 16. Conversely, dose-dependent laboratory abnormalities were observed with PF-06826647, including anemia, neutropenia, and increases in creatine phosphokinase.¹⁷ At high concentrations, PF-06826647 may disrupt JAK signaling pathways involved in hematopoiesis and renal functions owing to its mode of action as a competitive inhibitor. Overall, these agents are much farther from market, and long-term studies with larger diverse patient cohorts are required to adequately assess the efficacy and safety data of these novel oral TYK2 inhibitors for patients with psoriasis.

EDP1815—EDP1815 is an oral preparation of a single strain of Prevotella histicola being developed for the treatment of inflammatory diseases, including psoriasis. EDP1815 interacts with host intestinal immune cells through the small intestinal axis (SINTAX) to suppress systemic inflammation across the T_H1, T_H2, and T_H17 pathways. Therapy triggers broad immunomodulatory effects without causing systemic absorption, colonic colonization, or modification of the gut microbiome.¹⁸ In a phase 2 study (NCT04603027), the primary end point analysis, mean percentage change in PASI between treatment and placebo, demonstrated that at week 16, EDP1815 was superior to placebo with 80% to 90% probability across each cohort. At week 16, 25% to 32% of patients across the 3 cohorts treated with EDP1815 achieved PASI 50 compared with 12% of patients receiving placebo. Gastrointestinal AEs were comparable between treatment and placebo groups. These results suggest that SINTAX-targeted therapies may provide efficacious and safe immunomodulatory effects for patients with mild to moderate psoriasis, who often have limited treatment options. Although improvements may be mild, SINTAX-targeted therapies can be seen as a particularly attractive adjunctive treatment for patients with severe psoriasis taking other medications or as part of a treatment approach for a patient with milder psoriasis.

Biologics

Bimekizumab—Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17A and IL-17F. Although IL-17A is a more potent cytokine, IL-17F may be more highly expressed in psoriatic lesional skin and independently contribute to the activation of proinflammatory signaling pathways implicated in the pathophysiology of psoriasis.¹⁹ Evidence suggests that dual inhibition of IL-17A and IL-17F may provide more complete suppression of inflammation and improved clinical responses than IL-17A inhibition alone.²⁰

Prior bimekizumab phase 3 clinical studies have shown both rapid and durable clinical improvements in skin clearance compared with placebo.²¹ Three phase 3 trials—BE VIVID (N=567),²² BE SURE (N=478),²³ and BE RADIANT (N=743)²⁴—assessed the efficacy and safety of bimekizumab vs the IL-12/IL-23 inhibitor ustekinumab, the tumor necrosis factor inhibitor adalimumab, and the selective IL-17A inhibitor secukinumab, respectively. At week 4, significantly more patients treated with bimekizumab (71%–77%) achieved PASI 75 than patients treated with ustekinumab (15%; P<.0001), adalimumab (31.4%; P<.001), or secukinumab (47.3%; P<.001).^22-24 After 16 weeks of treatment, PASI 90 was achieved by 85% to 86.2%, 50%, and 47.2% of patients treated with bimekizumab, ustekinumab, and adalimumab, respectively.^22,23 At week 16, PASI 100 was observed in 59% to 61.7%, 21%, 23.9%, and 48.9% of patients treated with bimekizumab, ustekinumab, adalimumab, and secukinumab, respectively. An IGA response (score of 0/1) at week 16 was achieved by 84% to 85.5%, 53%, 57.2%, and 78.6% of patients receiving bimekizumab, ustekinumab, adalimumab, and secukinumab, respectively.^22-24

The most common AEs in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.^22-24 The dual inhibition of IL-17A and IL-17F suppresses host defenses against Candida at the oral mucosa, increasing the incidence of bimekizumab-associated oral candidiasis.²⁵ Despite the increased risk of Candida infections, these data suggest that inhibition of both IL-17A and IL-17F with bimekizumab may provide faster and greater clinical benefit for patients with moderate to severe plaque psoriasis than inhibition of IL-17A alone and other biologic therapies, as the PASI 100 clearance rates across the multiple comparator trials and the placebo-controlled pivotal trial are consistently the highest among any biologic for the treatment of psoriasis.

Spesolimab—The IL-36 pathway and IL-36 receptor genes have been linked to the pathogenesis of generalized pustular psoriasis.²⁶ In a phase 2 trial, 19 of 35 patients (54%) receiving an intravenous dose of spesolimab, an IL-36 receptor inhibitor, had a generalized pustular psoriasis PGA pustulation subscore of 0 (no visible pustules) at the end of week 1 vs 6% of patients in the placebo group.²⁷ A generalized pustular psoriasis PGA total score of 0 or 1 was observed in 43% (15/35) of spesolimab-treated patients compared with 11% (2/18) of patients in the placebo group. The most common AEs in patients treated with spesolimab were minor infections.²⁷ Two open-label phase 3 trials—NCT05200247 and NCT05239039—are underway to determine the long-term efficacy and safety of spesolimab in patients with generalized pustular psoriasis.

Conclusion

Although we have seen a renaissance in psoriasis therapies with the advent of biologics in the last 20 years, recent evidence shows that more innovation is underway. Just in the last year, 2 new mechanisms for treating psoriasis topically without steroids have come to fruition, and there have not been truly novel mechanisms for treating psoriasis topically since approvals for tazarotene and calcipotriene in the 1990s. An entirely new class—TYK2 inhibitors—was developed and landed in psoriasis first, greatly improving the efficacy measures attained with oral medications in general. Finally, an orphan diagnosis got its due with an ambitiously designed study looking at a previously unheard-of 1-week end point, but it comes for one of the few true dermatologic emergencies we encounter, generalized pustular psoriasis. We are fortunate to have so many meaningful new treatments available to us, and it is invigorating to see that even more efficacious biologics and treatments are coming, along with novel concepts such as a treatment affecting the microbiome. Now, we just need to make sure that our patients have the access they deserve to the wide array of available treatments.

The landscape of psoriasis treatments has undergone rapid change within the last decade, and the dizzying speed of drug development has not slowed, with 4 notable entries into the psoriasis treatment armamentarium within the last year: tapinarof, roflumilast, deucravacitinib, and spesolimab. Several others are in late-stage development, and these therapies represent new mechanisms, pathways, and delivery systems that will meaningfully broaden the spectrum of treatment choices for our patients. However, it can be quite difficult to keep track of all of the medication options. This review aims to present the mechanisms and data on both newly available therapeutics for psoriasis and products in the pipeline that may have a major impact on our treatment paradigm for psoriasis in the near future.

Topical Treatments

Tapinarof—Tapinarof is a topical aryl hydrocarbon receptor (AhR)–modulating agent derived from a secondary metabolite produced by a bacterial symbiont of entomopathogenic nematodes.¹ Tapinarof binds and activates AhR, inducing a signaling cascade that suppresses the expression of helper T cells T_H17 and T_H22, upregulates skin barrier protein expression, and reduces epidermal oxidative stress.² This is a familiar mechanism, as AhR agonism is one of the pathways modulated by coal tar. Tapinarof’s overall effects on immune function, skin barrier integrity, and antioxidant activity show great promise for the treatment of plaque psoriasis.

Two phase 3 trials (N=1025) evaluated the efficacy and safety of once-daily tapinarof cream 1% for plaque psoriasis.³ A physician global assessment (PGA) score of 0/1 occurred in 35.4% to 40.2% of patients in the tapinarof group and in 6.0% of patients in the vehicle group. At week 12, 36.1% to 47.6% of patients treated with daily applications of tapinarof cream achieved a 75% reduction in their baseline psoriasis area and severity index (PASI 75) score compared with 6.9% to 10.2% in the vehicle group.³ In a long-term extension study, a substantial remittive effect of at least 4 months off tapinarof therapy was observed in patients who achieved complete clearance (PGA=0).⁴ Use of tapinarof cream was associated with folliculitis in up to 23.5% of patients.^3,4

Roflumilast—Phosphodiesterase 4 (PDE-4) is an intracellular enzyme involved in the regulation of cell proliferation, differentiation, and immune responses.⁵ The inhibition of PDE-4 decreases the expression of proinflammatory cytokines implicated in the pathogenesis of plaque psoriasis, such as tumor necrosis factor α, IFN-γ, and IL-2, IL-12, and IL-23.⁶ Phosphodiesterase 4–targeted therapies have been thoroughly explored to treat various inflammatory conditions, including atopic dermatitis and plaque psoriasis. The oral PDE-4 inhibitor apremilast was shown to achieve PASI 75 in approximately 30% of 562 patients, accompanied by severe gastrointestinal adverse events (AEs) including diarrhea and nausea associated with treatment.⁷ Local irritation from the topical PDE-4 inhibitor crisaborole for atopic dermatitis and psoriasis (where it only completed phase 2 trials) limits its widespread use. The lack of tolerable and effective treatment alternatives for psoriasis prompted the investigation of new PDE-4–targeted therapies.

Topical roflumilast is a selective, highly potent PDE-4 inhibitor with greater affinity for PDE-4 compared to crisaborole and apremilast.⁸ Two phase 3 trials (N=881) evaluated the efficacy and safety profile of roflumilast cream for plaque psoriasis, with a particular interest in its use for intertriginous areas.⁹ At week 8, 37.5% to 42.4% of roflumilast-treated patients achieved investigator global assessment (IGA) success compared with 6.1% to 6.9% of vehicle-treated patients. Intertriginous IGA success was observed in 68.1% to 71.2% of patients treated with roflumilast cream compared with 13.8% to 18.5% of vehicle-treated patients. At 8-week follow-up, 39.0% to 41.6% of roflumilast-treated patients achieved PASI 75 vs 5.3% to 7.6% of patients in the vehicle group. Few stinging, burning, or application-site reactions were reported with roflumilast, along with rare instances of gastrointestinal AEs (<4%).⁹

Oral Therapy

Deucravacitinib—Tyrosine kinase 2 (TYK2) mediates the intracellular signaling of the T_H17 and T_H1 inflammatory cytokines IL-12/IL-23 and type I interferons, respectively, the former of which are critical in the development of psoriasis via the Janus kinase (JAK) signal transducer and activator of transcription pathway.¹⁰ Deucravacitinib is an oral selective TYK2 allosteric inhibitor that binds to the regulatory domain of the enzyme rather than the active catalytic domain, where other TYK2 and JAK1, JAK2, and JAK3 inhibitors bind.¹¹ This unique inhibitory mechanism accounts for the high functional selectivity of deucravacitinib for TYK2 vs the closely related JAK1, JAK2, and JAK3 kinases, thus avoiding the pitfall of prior JAK inhibitors that were associated with major AEs, including an increased risk for serious infections, malignancies, and thrombosis.¹² The selective suppression of the inflammatory TYK2 pathway has the potential to shift future therapeutic targets to a narrower range of receptors that may contribute to favorable benefit-risk profiles.

Two phase 3 trials (N=1686) compared the efficacy and safety of deucravacitinib vs placebo and apremilast in adults with moderate to severe plaque psoriasis.^13,14 At week 16, 53.0% to 58.4% of deucravacitinib-treated patients achieved PASI 75 compared with 35.1% to 39.8% of apremilast-treated patients. At 16-week follow-up, static PGA response was observed in 49.5% to 53.6% of patients in the deucravacitinib group and 32.1% to 33.9% of the apremilast group. The most frequent AEs associated with deucravacitinib therapy were nasopharyngitis and upper respiratory tract infection, whereas headache, diarrhea, and nausea were more common with apremilast. Treatment with deucravacitinib caused no meaningful changes in laboratory parameters, which are known to change with JAK1, JAK2, and JAK3 inhibitors.^13,14 A long-term extension study demonstrated that deucravacitinib had persistent efficacy and consistent safety for up to 2 years.¹⁵

Novel oral allosteric TYK2 inhibitors—VTX958 and NDI-034858—and the competitive TYK2 inhibitor PF-06826647 are being developed. Theoretically, these new allosteric inhibitors possess unique structural properties to provide greater TYK2 suppression while bypassing JAK1, JAK2, and JAK3 pathways that may contribute to improved efficacy and safety profiles compared with other TYK2 inhibitors such as deucravacitinib. The results of a phase 1b trial (ClinicalTrials.gov Identifier NCT04999839) showed a dose-dependent reduction of disease severity associated with NDI-034858 treatment for patients with moderate to severe plaque psoriasis, albeit in only 26 patients. At week 4, PASI 50 was achieved in 13%, 57%, and 40% of patients in the 5-, 10-, and 30-mg groups, respectively, compared with 0% in the placebo group.¹⁶ In a phase 2 trial of 179 patients, 46.5% and 33.0% of patients treated with 400 and 200 mg of PF-06826647, respectively, achieved PASI 90 at week 16. Conversely, dose-dependent laboratory abnormalities were observed with PF-06826647, including anemia, neutropenia, and increases in creatine phosphokinase.¹⁷ At high concentrations, PF-06826647 may disrupt JAK signaling pathways involved in hematopoiesis and renal functions owing to its mode of action as a competitive inhibitor. Overall, these agents are much farther from market, and long-term studies with larger diverse patient cohorts are required to adequately assess the efficacy and safety data of these novel oral TYK2 inhibitors for patients with psoriasis.

EDP1815—EDP1815 is an oral preparation of a single strain of Prevotella histicola being developed for the treatment of inflammatory diseases, including psoriasis. EDP1815 interacts with host intestinal immune cells through the small intestinal axis (SINTAX) to suppress systemic inflammation across the T_H1, T_H2, and T_H17 pathways. Therapy triggers broad immunomodulatory effects without causing systemic absorption, colonic colonization, or modification of the gut microbiome.¹⁸ In a phase 2 study (NCT04603027), the primary end point analysis, mean percentage change in PASI between treatment and placebo, demonstrated that at week 16, EDP1815 was superior to placebo with 80% to 90% probability across each cohort. At week 16, 25% to 32% of patients across the 3 cohorts treated with EDP1815 achieved PASI 50 compared with 12% of patients receiving placebo. Gastrointestinal AEs were comparable between treatment and placebo groups. These results suggest that SINTAX-targeted therapies may provide efficacious and safe immunomodulatory effects for patients with mild to moderate psoriasis, who often have limited treatment options. Although improvements may be mild, SINTAX-targeted therapies can be seen as a particularly attractive adjunctive treatment for patients with severe psoriasis taking other medications or as part of a treatment approach for a patient with milder psoriasis.

Biologics

Bimekizumab—Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17A and IL-17F. Although IL-17A is a more potent cytokine, IL-17F may be more highly expressed in psoriatic lesional skin and independently contribute to the activation of proinflammatory signaling pathways implicated in the pathophysiology of psoriasis.¹⁹ Evidence suggests that dual inhibition of IL-17A and IL-17F may provide more complete suppression of inflammation and improved clinical responses than IL-17A inhibition alone.²⁰

Prior bimekizumab phase 3 clinical studies have shown both rapid and durable clinical improvements in skin clearance compared with placebo.²¹ Three phase 3 trials—BE VIVID (N=567),²² BE SURE (N=478),²³ and BE RADIANT (N=743)²⁴—assessed the efficacy and safety of bimekizumab vs the IL-12/IL-23 inhibitor ustekinumab, the tumor necrosis factor inhibitor adalimumab, and the selective IL-17A inhibitor secukinumab, respectively. At week 4, significantly more patients treated with bimekizumab (71%–77%) achieved PASI 75 than patients treated with ustekinumab (15%; P<.0001), adalimumab (31.4%; P<.001), or secukinumab (47.3%; P<.001).^22-24 After 16 weeks of treatment, PASI 90 was achieved by 85% to 86.2%, 50%, and 47.2% of patients treated with bimekizumab, ustekinumab, and adalimumab, respectively.^22,23 At week 16, PASI 100 was observed in 59% to 61.7%, 21%, 23.9%, and 48.9% of patients treated with bimekizumab, ustekinumab, adalimumab, and secukinumab, respectively. An IGA response (score of 0/1) at week 16 was achieved by 84% to 85.5%, 53%, 57.2%, and 78.6% of patients receiving bimekizumab, ustekinumab, adalimumab, and secukinumab, respectively.^22-24

The most common AEs in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.^22-24 The dual inhibition of IL-17A and IL-17F suppresses host defenses against Candida at the oral mucosa, increasing the incidence of bimekizumab-associated oral candidiasis.²⁵ Despite the increased risk of Candida infections, these data suggest that inhibition of both IL-17A and IL-17F with bimekizumab may provide faster and greater clinical benefit for patients with moderate to severe plaque psoriasis than inhibition of IL-17A alone and other biologic therapies, as the PASI 100 clearance rates across the multiple comparator trials and the placebo-controlled pivotal trial are consistently the highest among any biologic for the treatment of psoriasis.

Spesolimab—The IL-36 pathway and IL-36 receptor genes have been linked to the pathogenesis of generalized pustular psoriasis.²⁶ In a phase 2 trial, 19 of 35 patients (54%) receiving an intravenous dose of spesolimab, an IL-36 receptor inhibitor, had a generalized pustular psoriasis PGA pustulation subscore of 0 (no visible pustules) at the end of week 1 vs 6% of patients in the placebo group.²⁷ A generalized pustular psoriasis PGA total score of 0 or 1 was observed in 43% (15/35) of spesolimab-treated patients compared with 11% (2/18) of patients in the placebo group. The most common AEs in patients treated with spesolimab were minor infections.²⁷ Two open-label phase 3 trials—NCT05200247 and NCT05239039—are underway to determine the long-term efficacy and safety of spesolimab in patients with generalized pustular psoriasis.

Conclusion

Although we have seen a renaissance in psoriasis therapies with the advent of biologics in the last 20 years, recent evidence shows that more innovation is underway. Just in the last year, 2 new mechanisms for treating psoriasis topically without steroids have come to fruition, and there have not been truly novel mechanisms for treating psoriasis topically since approvals for tazarotene and calcipotriene in the 1990s. An entirely new class—TYK2 inhibitors—was developed and landed in psoriasis first, greatly improving the efficacy measures attained with oral medications in general. Finally, an orphan diagnosis got its due with an ambitiously designed study looking at a previously unheard-of 1-week end point, but it comes for one of the few true dermatologic emergencies we encounter, generalized pustular psoriasis. We are fortunate to have so many meaningful new treatments available to us, and it is invigorating to see that even more efficacious biologics and treatments are coming, along with novel concepts such as a treatment affecting the microbiome. Now, we just need to make sure that our patients have the access they deserve to the wide array of available treatments.

The Centers for Disease Control and Prevention (CDC) recently published updated guidelines on prescribing opioids for pain that stress the need for a flexible and individual approach to pain management.¹ New recommendations emphasize the use of nonopioid therapies whenever appropriate, support consideration of opioid therapy for patients with acute pain when the benefits are expected to outweigh the risks, and urge clinicians to work with patients receiving opioid therapy to determine whether it should be continued or tapered.

This revision to the agency’s 2016 guidelines is aimed at primary care clinicians who prescribe opioids to adult outpatients for treatment of pain. The recommendations are not meant for patients with sickle-cell disease or cancer-related pain, or those receiving palliative and end-of-life care.

Why an update was needed. In 2021, more than 107,000 Americans died of a drug overdose.² Although prescription opioids caused only about 16% of these deaths, they account for a population death rate of 4:100,000—which, despite national efforts, has not changed much since 2013.^3,4

Following publication of the CDC’s 2016 guidelines on prescribing opioids for chronic pain,⁵ there was a decline in opioid prescribing but not in related deaths. Furthermore, there appeared to have been some negative effects of reduced prescribing, including untreated and undertreated pain, and rapid tapering or sudden discontinuation of opioids in chronic users, causing withdrawal symptoms and psychological distress in these patients. To address these issues, the CDC published the new guideline in 2022.¹

Categories of pain. The guideline panel classified pain into 3 categories: acute pain (duration of < 1 month), subacute pain (duration of 1-3 months), and chronic pain (duration of > 3 months).

When to prescribe opioids. The guidelines recommend a new approach to deciding whether to prescribe opioid therapy. In most cases, nonopioid options—such as nonsteroidal anti-inflammatory drugs (NSAIDs) and exercise—should be tried first, since they are as effective as opioids for many types of acute, subacute, and chronic pain. Opioids should be considered if these options fail and the potential benefits outweigh the risks. In moderate-to-severe acute pain, opioids are an option if NSAIDs are unlikely to be effective or are contraindicated.¹

How to prescribe opioids. Before prescribing opioids, clinicians should discuss with the patient the known risks and benefits and offer an accompanying prescription for naloxone. Opioids should be prescribed at the lowest effective dose and for a time period limited to the expected duration of the pain. When starting opioids, immediate-release opioids should be prescribed instead of extended-release or long-acting opioids.¹

Precautionary measures. Clinicians should review the patient’s history of controlled substance prescriptions via their state’s prescription drug monitoring program and consider the use of toxicology testing to determine whether the patient is receiving high-risk opioid dosages or combinations. Clinicians should be especially cautious about prescribing opioids and benzodiazepines concurrently.¹

Continue or stop opioid treatment? A new recommendation advises clinicians to individually assess the benefits and risks of continuing therapy for patients who have been receiving opioids chronically. Whenever the decision is made to stop or reduce treatment, remember that opioid therapy should not be stopped abruptly or reduced quickly. The guideline panel suggests tapering by 10% per month.¹

Finally, patients with opioid use disorder should be offered or referred for treatment with medications. Detoxification alone, without medication, is not recommended.¹

The Centers for Disease Control and Prevention (CDC) recently published updated guidelines on prescribing opioids for pain that stress the need for a flexible and individual approach to pain management.¹ New recommendations emphasize the use of nonopioid therapies whenever appropriate, support consideration of opioid therapy for patients with acute pain when the benefits are expected to outweigh the risks, and urge clinicians to work with patients receiving opioid therapy to determine whether it should be continued or tapered.

This revision to the agency’s 2016 guidelines is aimed at primary care clinicians who prescribe opioids to adult outpatients for treatment of pain. The recommendations are not meant for patients with sickle-cell disease or cancer-related pain, or those receiving palliative and end-of-life care.

Why an update was needed. In 2021, more than 107,000 Americans died of a drug overdose.² Although prescription opioids caused only about 16% of these deaths, they account for a population death rate of 4:100,000—which, despite national efforts, has not changed much since 2013.^3,4

Following publication of the CDC’s 2016 guidelines on prescribing opioids for chronic pain,⁵ there was a decline in opioid prescribing but not in related deaths. Furthermore, there appeared to have been some negative effects of reduced prescribing, including untreated and undertreated pain, and rapid tapering or sudden discontinuation of opioids in chronic users, causing withdrawal symptoms and psychological distress in these patients. To address these issues, the CDC published the new guideline in 2022.¹

Categories of pain. The guideline panel classified pain into 3 categories: acute pain (duration of < 1 month), subacute pain (duration of 1-3 months), and chronic pain (duration of > 3 months).

When to prescribe opioids. The guidelines recommend a new approach to deciding whether to prescribe opioid therapy. In most cases, nonopioid options—such as nonsteroidal anti-inflammatory drugs (NSAIDs) and exercise—should be tried first, since they are as effective as opioids for many types of acute, subacute, and chronic pain. Opioids should be considered if these options fail and the potential benefits outweigh the risks. In moderate-to-severe acute pain, opioids are an option if NSAIDs are unlikely to be effective or are contraindicated.¹

How to prescribe opioids. Before prescribing opioids, clinicians should discuss with the patient the known risks and benefits and offer an accompanying prescription for naloxone. Opioids should be prescribed at the lowest effective dose and for a time period limited to the expected duration of the pain. When starting opioids, immediate-release opioids should be prescribed instead of extended-release or long-acting opioids.¹

Precautionary measures. Clinicians should review the patient’s history of controlled substance prescriptions via their state’s prescription drug monitoring program and consider the use of toxicology testing to determine whether the patient is receiving high-risk opioid dosages or combinations. Clinicians should be especially cautious about prescribing opioids and benzodiazepines concurrently.¹

Continue or stop opioid treatment? A new recommendation advises clinicians to individually assess the benefits and risks of continuing therapy for patients who have been receiving opioids chronically. Whenever the decision is made to stop or reduce treatment, remember that opioid therapy should not be stopped abruptly or reduced quickly. The guideline panel suggests tapering by 10% per month.¹

Finally, patients with opioid use disorder should be offered or referred for treatment with medications. Detoxification alone, without medication, is not recommended.¹

The Centers for Disease Control and Prevention (CDC) recently published updated guidelines on prescribing opioids for pain that stress the need for a flexible and individual approach to pain management.¹ New recommendations emphasize the use of nonopioid therapies whenever appropriate, support consideration of opioid therapy for patients with acute pain when the benefits are expected to outweigh the risks, and urge clinicians to work with patients receiving opioid therapy to determine whether it should be continued or tapered.

This revision to the agency’s 2016 guidelines is aimed at primary care clinicians who prescribe opioids to adult outpatients for treatment of pain. The recommendations are not meant for patients with sickle-cell disease or cancer-related pain, or those receiving palliative and end-of-life care.

Why an update was needed. In 2021, more than 107,000 Americans died of a drug overdose.² Although prescription opioids caused only about 16% of these deaths, they account for a population death rate of 4:100,000—which, despite national efforts, has not changed much since 2013.^3,4

Following publication of the CDC’s 2016 guidelines on prescribing opioids for chronic pain,⁵ there was a decline in opioid prescribing but not in related deaths. Furthermore, there appeared to have been some negative effects of reduced prescribing, including untreated and undertreated pain, and rapid tapering or sudden discontinuation of opioids in chronic users, causing withdrawal symptoms and psychological distress in these patients. To address these issues, the CDC published the new guideline in 2022.¹

Categories of pain. The guideline panel classified pain into 3 categories: acute pain (duration of < 1 month), subacute pain (duration of 1-3 months), and chronic pain (duration of > 3 months).

When to prescribe opioids. The guidelines recommend a new approach to deciding whether to prescribe opioid therapy. In most cases, nonopioid options—such as nonsteroidal anti-inflammatory drugs (NSAIDs) and exercise—should be tried first, since they are as effective as opioids for many types of acute, subacute, and chronic pain. Opioids should be considered if these options fail and the potential benefits outweigh the risks. In moderate-to-severe acute pain, opioids are an option if NSAIDs are unlikely to be effective or are contraindicated.¹

How to prescribe opioids. Before prescribing opioids, clinicians should discuss with the patient the known risks and benefits and offer an accompanying prescription for naloxone. Opioids should be prescribed at the lowest effective dose and for a time period limited to the expected duration of the pain. When starting opioids, immediate-release opioids should be prescribed instead of extended-release or long-acting opioids.¹

Precautionary measures. Clinicians should review the patient’s history of controlled substance prescriptions via their state’s prescription drug monitoring program and consider the use of toxicology testing to determine whether the patient is receiving high-risk opioid dosages or combinations. Clinicians should be especially cautious about prescribing opioids and benzodiazepines concurrently.¹

Continue or stop opioid treatment? A new recommendation advises clinicians to individually assess the benefits and risks of continuing therapy for patients who have been receiving opioids chronically. Whenever the decision is made to stop or reduce treatment, remember that opioid therapy should not be stopped abruptly or reduced quickly. The guideline panel suggests tapering by 10% per month.¹

Finally, patients with opioid use disorder should be offered or referred for treatment with medications. Detoxification alone, without medication, is not recommended.¹

People with diabetes who adhere to a healthy diet, exercise regularly, and follow other healthy lifestyle practices have a significantly lower risk of microvascular complications from the disease, such as diabetic neuropathy, retinopathy, and nephropathy, as well as foot disorders, than counterparts with diabetes who don’t, a prospective cohort study of more than 7,000 patients with type 2 diabetes has found.

“We believe this is one of the first large-scale analyses among diabetes patients that specifically examined an overall healthy lifestyle in relation to the risk of developing microvascular complications,” senior study author Qi Sun, MD, ScD, said in an interview. “The results are not surprising that the healthy lifestyle is associated with lower risk of developing these complications and the enhanced adherence to the healthy lifestyle is associated with lower risk as well. And these findings bear lots of public health significance as they suggest the important role of living a healthy lifestyle in the prevention of diabetes complications, on top of the clinical treatment.”

Dr. Sun is an associate professor of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health, Boston.

The study stated that the findings “lend support” for the American Diabetes Association guidelines for healthy lifestyle practices in people with diabetes.

The study used a cohort from two large prospective cohort studies, the Nurses’ Health Study (NHS) and the Health Professionals Follow-up Study (HPFS), comprising 4,982 women and 2,095 men who were diagnosed with type 2 diabetes during follow-up. They had no cardiovascular disease or cancer at the time of their diabetes diagnosis. Both NHS and HPFS used validated questionnaires to gather information on diet, lifestyle, medical history, and newly diagnosed diseases every 2-4 years. The latter study included NHS and HPFS participants who also completed supplementary questionnaires about their diabetes.

The latest study took into account five modifiable lifestyle-related factors: diet, body weight, smoking status, alcohol, and physical activity. For diet, both large studies used the 2010 Alternate Healthy Eating Index to assess diet quality; those in the upper 40th percentile of the study population were defined as healthy diet. Healthy body weight was defined at a body mass index of 18.5-25 kg/m².

Among the latter study cohort, 2,878 incident cases of diabetic microvascular complications were documented during follow-up. Patients who adhered to a healthy lifestyle before their diabetes diagnosis, defined as having four or more low-risk lifestyle factors, had a 27% lower relative risk of developing any microvascular complication than counterparts with no low-risk lifestyle factors (relative risk, 0.73; 95% confidence interval, 0.35-1; P = .006).

The study found similar outcomes for those who adopted a healthy lifestyle after their diabetes diagnosis, with a 32% reduction in relative risk compared with those who didn’t adopt any healthy lifestyle practices (RR, 0.68; 95% CI, 0.55-0.83; P < .001).

Dr. Sun noted what was noteworthy about his group’s cohort study. “The unique design is truly the prospective follow-up over time so that we could examine the lifestyle at diabetes diagnosis as well as changes in lifestyle before and after diabetes in relation to the future risk of developing the complications,” he said.

A randomized trial would be a more rigorous way to evaluate the impact of a healthy lifestyle, he added, “although it’s much more expensive than a cohort study like what we did with this investigation.”

As for future research, Dr. Sun said, “It will be interesting to understand mechanisms underlying these observations. It’s also critical to understand why certain diabetes patients may not benefit from a healthy lifestyle, since some of them, even when living a healthy lifestyle, still develop the complications.”

This trial shows in a new light the benefits of healthy lifestyle practices on microvascular complications of type 2 diabetes, Paul S. Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., and a professor at the University of Miami, said in a comment. “These benefits have always been surmised and demonstrated in a limited way in previous trials, but not subject to the level of analysis seen in this prospective cohort trial.”

He called the study design “excellent,” adding, “ ‘Validated’ self-reported questionnaires were used widely, although minimal detail is provided about the validation process.” One limitation, he noted, was “the homogeneity of the participants; all were health professionals.”

The study “affirms” and “quantitates” the benefits of a healthy lifestyle in type 2 diabetes. “The issue is not unawareness but rather application,” Dr. Jellinger said. “Modifying long-held lifestyle habits is a real challenge. Perhaps by ‘quantitating’ the benefit, as shown in this trial and hopefully additional studies, impetus will be provided to refocus on this approach, which is too often simply given lip service.”

The National Institutes of Health provided funding for the study. Dr. Sun has no relevant disclosures. Dr. Jellinger disclosed relationships with Amgen and Esperion.
 

People with diabetes who adhere to a healthy diet, exercise regularly, and follow other healthy lifestyle practices have a significantly lower risk of microvascular complications from the disease, such as diabetic neuropathy, retinopathy, and nephropathy, as well as foot disorders, than counterparts with diabetes who don’t, a prospective cohort study of more than 7,000 patients with type 2 diabetes has found.

“We believe this is one of the first large-scale analyses among diabetes patients that specifically examined an overall healthy lifestyle in relation to the risk of developing microvascular complications,” senior study author Qi Sun, MD, ScD, said in an interview. “The results are not surprising that the healthy lifestyle is associated with lower risk of developing these complications and the enhanced adherence to the healthy lifestyle is associated with lower risk as well. And these findings bear lots of public health significance as they suggest the important role of living a healthy lifestyle in the prevention of diabetes complications, on top of the clinical treatment.”

Dr. Sun is an associate professor of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health, Boston.

The study stated that the findings “lend support” for the American Diabetes Association guidelines for healthy lifestyle practices in people with diabetes.

The study used a cohort from two large prospective cohort studies, the Nurses’ Health Study (NHS) and the Health Professionals Follow-up Study (HPFS), comprising 4,982 women and 2,095 men who were diagnosed with type 2 diabetes during follow-up. They had no cardiovascular disease or cancer at the time of their diabetes diagnosis. Both NHS and HPFS used validated questionnaires to gather information on diet, lifestyle, medical history, and newly diagnosed diseases every 2-4 years. The latter study included NHS and HPFS participants who also completed supplementary questionnaires about their diabetes.

The latest study took into account five modifiable lifestyle-related factors: diet, body weight, smoking status, alcohol, and physical activity. For diet, both large studies used the 2010 Alternate Healthy Eating Index to assess diet quality; those in the upper 40th percentile of the study population were defined as healthy diet. Healthy body weight was defined at a body mass index of 18.5-25 kg/m².

Among the latter study cohort, 2,878 incident cases of diabetic microvascular complications were documented during follow-up. Patients who adhered to a healthy lifestyle before their diabetes diagnosis, defined as having four or more low-risk lifestyle factors, had a 27% lower relative risk of developing any microvascular complication than counterparts with no low-risk lifestyle factors (relative risk, 0.73; 95% confidence interval, 0.35-1; P = .006).

The study found similar outcomes for those who adopted a healthy lifestyle after their diabetes diagnosis, with a 32% reduction in relative risk compared with those who didn’t adopt any healthy lifestyle practices (RR, 0.68; 95% CI, 0.55-0.83; P < .001).

Dr. Sun noted what was noteworthy about his group’s cohort study. “The unique design is truly the prospective follow-up over time so that we could examine the lifestyle at diabetes diagnosis as well as changes in lifestyle before and after diabetes in relation to the future risk of developing the complications,” he said.

A randomized trial would be a more rigorous way to evaluate the impact of a healthy lifestyle, he added, “although it’s much more expensive than a cohort study like what we did with this investigation.”

As for future research, Dr. Sun said, “It will be interesting to understand mechanisms underlying these observations. It’s also critical to understand why certain diabetes patients may not benefit from a healthy lifestyle, since some of them, even when living a healthy lifestyle, still develop the complications.”

This trial shows in a new light the benefits of healthy lifestyle practices on microvascular complications of type 2 diabetes, Paul S. Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., and a professor at the University of Miami, said in a comment. “These benefits have always been surmised and demonstrated in a limited way in previous trials, but not subject to the level of analysis seen in this prospective cohort trial.”

He called the study design “excellent,” adding, “ ‘Validated’ self-reported questionnaires were used widely, although minimal detail is provided about the validation process.” One limitation, he noted, was “the homogeneity of the participants; all were health professionals.”

The study “affirms” and “quantitates” the benefits of a healthy lifestyle in type 2 diabetes. “The issue is not unawareness but rather application,” Dr. Jellinger said. “Modifying long-held lifestyle habits is a real challenge. Perhaps by ‘quantitating’ the benefit, as shown in this trial and hopefully additional studies, impetus will be provided to refocus on this approach, which is too often simply given lip service.”

The National Institutes of Health provided funding for the study. Dr. Sun has no relevant disclosures. Dr. Jellinger disclosed relationships with Amgen and Esperion.
 

People with diabetes who adhere to a healthy diet, exercise regularly, and follow other healthy lifestyle practices have a significantly lower risk of microvascular complications from the disease, such as diabetic neuropathy, retinopathy, and nephropathy, as well as foot disorders, than counterparts with diabetes who don’t, a prospective cohort study of more than 7,000 patients with type 2 diabetes has found.

“We believe this is one of the first large-scale analyses among diabetes patients that specifically examined an overall healthy lifestyle in relation to the risk of developing microvascular complications,” senior study author Qi Sun, MD, ScD, said in an interview. “The results are not surprising that the healthy lifestyle is associated with lower risk of developing these complications and the enhanced adherence to the healthy lifestyle is associated with lower risk as well. And these findings bear lots of public health significance as they suggest the important role of living a healthy lifestyle in the prevention of diabetes complications, on top of the clinical treatment.”

Dr. Sun is an associate professor of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health, Boston.

The study stated that the findings “lend support” for the American Diabetes Association guidelines for healthy lifestyle practices in people with diabetes.

The study used a cohort from two large prospective cohort studies, the Nurses’ Health Study (NHS) and the Health Professionals Follow-up Study (HPFS), comprising 4,982 women and 2,095 men who were diagnosed with type 2 diabetes during follow-up. They had no cardiovascular disease or cancer at the time of their diabetes diagnosis. Both NHS and HPFS used validated questionnaires to gather information on diet, lifestyle, medical history, and newly diagnosed diseases every 2-4 years. The latter study included NHS and HPFS participants who also completed supplementary questionnaires about their diabetes.

The latest study took into account five modifiable lifestyle-related factors: diet, body weight, smoking status, alcohol, and physical activity. For diet, both large studies used the 2010 Alternate Healthy Eating Index to assess diet quality; those in the upper 40th percentile of the study population were defined as healthy diet. Healthy body weight was defined at a body mass index of 18.5-25 kg/m².

Among the latter study cohort, 2,878 incident cases of diabetic microvascular complications were documented during follow-up. Patients who adhered to a healthy lifestyle before their diabetes diagnosis, defined as having four or more low-risk lifestyle factors, had a 27% lower relative risk of developing any microvascular complication than counterparts with no low-risk lifestyle factors (relative risk, 0.73; 95% confidence interval, 0.35-1; P = .006).

The study found similar outcomes for those who adopted a healthy lifestyle after their diabetes diagnosis, with a 32% reduction in relative risk compared with those who didn’t adopt any healthy lifestyle practices (RR, 0.68; 95% CI, 0.55-0.83; P < .001).

Dr. Sun noted what was noteworthy about his group’s cohort study. “The unique design is truly the prospective follow-up over time so that we could examine the lifestyle at diabetes diagnosis as well as changes in lifestyle before and after diabetes in relation to the future risk of developing the complications,” he said.

A randomized trial would be a more rigorous way to evaluate the impact of a healthy lifestyle, he added, “although it’s much more expensive than a cohort study like what we did with this investigation.”

As for future research, Dr. Sun said, “It will be interesting to understand mechanisms underlying these observations. It’s also critical to understand why certain diabetes patients may not benefit from a healthy lifestyle, since some of them, even when living a healthy lifestyle, still develop the complications.”

This trial shows in a new light the benefits of healthy lifestyle practices on microvascular complications of type 2 diabetes, Paul S. Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., and a professor at the University of Miami, said in a comment. “These benefits have always been surmised and demonstrated in a limited way in previous trials, but not subject to the level of analysis seen in this prospective cohort trial.”

He called the study design “excellent,” adding, “ ‘Validated’ self-reported questionnaires were used widely, although minimal detail is provided about the validation process.” One limitation, he noted, was “the homogeneity of the participants; all were health professionals.”

The study “affirms” and “quantitates” the benefits of a healthy lifestyle in type 2 diabetes. “The issue is not unawareness but rather application,” Dr. Jellinger said. “Modifying long-held lifestyle habits is a real challenge. Perhaps by ‘quantitating’ the benefit, as shown in this trial and hopefully additional studies, impetus will be provided to refocus on this approach, which is too often simply given lip service.”

The National Institutes of Health provided funding for the study. Dr. Sun has no relevant disclosures. Dr. Jellinger disclosed relationships with Amgen and Esperion.
 

In 2021, Eugene Kim, MD, division director of pediatric surgery and vice chair in the department of surgery at Cedars-Sinai Medical Center, Los Angeles, gave his presidential address to the Association for Academic Surgery.

“Presidents tend to give a message of hope or inspiration; I probably took it in a different way,” he said.

Dr. Kim told the story of one of his clinical partners, Eveline Shue, who, after five rounds of in vitro fertilization (IVF), became pregnant with twins. A high-achiever in her field, Ms. Shue continued working the grueling hours required by her job throughout pregnancy until she noticed concerning symptoms – musculoskeletal issues, extreme swelling, and more. She and her group decided that she should step back from work in her third trimester. A few days later, Ms. Shue suffered a stroke. She was rushed to the hospital where her babies were delivered by emergency C-section. Ms. Shue underwent brain surgery but later recovered and is still practicing in Southern California.

“I remember being at her bedside thinking, ‘How could we have let this happen? How could we have prevented this?’ ”

Dr. Kim’s speech kicked off a firestorm of awareness about pregnancy complications among physicians. “I got scores of emails from women around the country, surgeons in particular, who felt like their issues had been seen. The conversation was long overdue,” he said.

Family planning issues, pregnancy complications, infertility, and pregnancy loss are common, pervasive, and often silent issues in medicine. In July 2021, Dr. Kim and a group of other researchers published a study in JAMA Surgery. It revealed staggering truths: When compared to non-surgeons, female surgeons were more likely to delay pregnancy, use assisted reproductive technology such as IVF, have non-elective C-sections, and suffer pregnancy loss. In the study, 42% of surgeons had experienced pregnancy loss – more than double the rate of the general population. Almost half had serious pregnancy complications.

Research has found that female physicians in general have a significantly greater incidence of miscarriage, infertility, and pregnancy complications than the general population. According to a 2016 survey in the Journal of Women’s Health, the infertility rate for physicians is nearly 1 in 4, about double the rate of the general public.
 

The barriers to starting a family

Physicians face significant professional barriers that impact family planning. Demanding jobs with exhausting and often unpredictable hours contribute to a culture that, traditionally, has been far from family friendly. As a result, many physicians start families later. “For a pediatric surgeon, you finish training at age 35 – minimum,” says Dr. Kim. “Simply being a surgeon makes you a high-risk pregnancy candidate just because of the career.”

In 2020, Ariela L. Marshall, MD, an associate professor of clinical medicine at the University of Pennsylvania’s Perelman school of medicine, co-authored a commentary article in Academic Medicine titled “Physician Fertility: A Call to Action” which was based on her own experiences with infertility. Dr. Marshall was 34 when she and her husband decided to start a family, and she says her infertility diagnosis “came as a shock.”

“I never stopped to think about the consequences of a career path where I’m not going to be established until my 30s,” Dr. Marshall says. “I never thought about how long hours, overnight shifts, or working all the time could impact my fertility.”

It would take four cycles of IVF egg retrieval to create embryos and one failed implantation before Dr. Marshall became pregnant with her son.

When it comes to the timing of pregnancy, medical culture also plays a role. “There’s a lot of messaging around when it’s appropriate to carry a baby – and it’s not until after training is done,” says Arghavan Salles, MD, PhD, a clinical associate professor and special advisor for DEI programs at Stanford (Calif.) University’s department of medicine.

There are always exceptions. Some institutions are more flexible than others about pregnancy during residency. But Dr. Salles notes that this attitude is “not universal,” partly because of the lack of a comprehensive approach to pregnancy or parenthood in the United States. “There’s no federal paid parental leave in this country,” reminds Dr. Salles. “That signals that we don’t value parenting.”

The trickle-down effect of this in medicine is more like a waterfall. Some physicians complain when other physicians are out on leave. There’s an additional burden of work when people take time away, and there are often no support structures in place for backup or fill-in care. Dr. Salles said doctors often tell her that they were responsible for finding coverage for any time off during pregnancy or after becoming a parent. A paper of hers published in JAMA Surgery found that, for physicians, a fear of burdening others was a major barrier to getting pregnant during residency in the first place.
 

The physical consequences

Although research supports the benefits of physical activity throughout pregnancy, a job such as surgery that requires being on your feet for long periods of time “is not the same as exercise,” explains Erika Lu Rangel, MD, a gastrointestinal surgeon at Brigham and Women’s Hospital, Boston, and Dr. Kim’s lead author on the JAMA Surgery article.

Surgeons operating for more than 12 hours a week are at higher risk for pregnancy complications, the study found. Dr. Rangel also cites data suggesting that night shifts or swing shifts (the hours between day and night) put women at higher risk for pregnancy complications.

Equally alarming: Medical trainees appear to have “almost as high a rate of pregnancy complications as surgeons who have already completed their training,” said Dr. Rangel. It is a concerning finding since, as a younger cohort, they should have lower complication rates based on their age. But doctors in training may be on their feet even more than surgeons during long shifts.

Like Dr. Salles, Dr. Rangel sees these issues as part of a pervasive culture of “presenteeism” in medicine, and she points out that many surgeons don’t even take time off to grieve pregnancy loss or physically recover from it. “We work even when we’re sick and even when it’s not good for our health,” she said. “I think that’s an unhealthy behavior that we cultivate from the time that we’re trainees, and we carry it on through when we’re in practice.”

Penn Medicine’s Dr. Marshall remembers that her own maternity leave was “not an easy process to navigate.” From her hospital room on a magnesium drip for preeclampsia, she still attended Zoom meetings with her colleagues. “Nobody says, ‘Oh, you have to do this,’ ” Dr. Marshall explains, “but you wind up feeling guilty if you’re not there at all moments for everyone. That’s also something that needs to change.” 

Dr. Rangel was pregnant with her oldest son as a fourth-year surgery resident. The day she gave birth to him she remembers waking up with a flu-like illness and a fever. She went to work anyway, because “you don’t call in sick as a resident.” She was barely able to complete her rounds and then had to lie down between cases. A co-resident found her and took her to labor and delivery. She had gone into premature labor at 37 weeks, and her son went into the NICU with complications.

“I remember feeling this enormous guilt,” says Dr. Rangel. “I’d been a mom for just a few minutes, and I felt like I had already failed him because I had prioritized what the residency thought of me above what I knew was necessary for his health.”
 

Hope for the future

Disturbed by the status quo, many physicians are pushing for change. “I think there’s a really important and positive conversation going on in the medical community right now about ways that we need to support new parent physicians,” said Dr. Rangel.

Parental leave is a key part of that support. Last year, The American Board of Medical Specialties enacted a mandate that all specialty boards 2 years or more in duration must provide at least 6 weeks of parental and caregiver leave. In 2023, the Accreditation Council for Graduate Medical Education (ACGME) required that all training programs match that policy. “This sends a message to policymakers and leaders in American medicine that this is a priority,” said Dr. Rangel.

In January 2022, a group from the University of Michigan also published an article in the Annals of Surgery called “Safe and Supported Pregnancy: A Call to Action for Surgery Chairs and Program Directors”. The essay urged leading groups such as the ACGME and the American Board of Surgery to “directly address the health and safety of pregnant trainees” and specifically, to “allow for further flexibility during training for pregnancy and peripartum periods,” calling these “fundamental necessities for cultural progress.”

Others have recommended allowing pregnant trainees more flexibility in their schedules or front-loading certain parts of the training that may be more difficult as a pregnancy progresses. Insurance coverage for fertility preservation and reproductive endocrinology services, and support for reentry (including lactation and childcare) are also issues that must be addressed, says Dr. Salles.

A new paper of Dr. Rangel’s, published in JAMA Surgery, suggests that things like mentorship for residents from faculty can also be important pieces of the puzzle.

Education about reproductive health must start earlier, too – as early as medical school. Research suggests only 8% of physicians receive education on the risks of delaying pregnancy. Those who do are significantly less likely to experience pregnancy loss or seek infertility treatment.

Dr. Salles recalls sitting in a classroom learning about advanced maternal age at a time when age 35 seemed unimaginably distant. “It was never taught – at least to my recollection – in a way that was like, ‘this could be your future,’ ” Dr. Salles says.” It was more like this abstract patient who might have advanced maternal age and what the consequences would be. Maybe some of my colleagues put two and two together, but I definitely didn’t.”

Dr. Marshall is the curriculum chair for the IGNITEMed Initiative, which aims to educate medical students about issues not discussed in traditional medical school curricula. Dr. Marshall and her colleague Julia Files, MD, talk with IGNITEMed students about reproductive life planning.

“Raising awareness is a very big thing. That’s not just true for medical students but for professionals at every level of medicine,” Dr. Marshall said. “Residency and fellowship training program directors, department chairs, and hospital CEOs all need to understand that these issues are very common in the people they oversee – and that they are medical issues, like any other medical issue, where people need time off and support.”

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

In 2021, Eugene Kim, MD, division director of pediatric surgery and vice chair in the department of surgery at Cedars-Sinai Medical Center, Los Angeles, gave his presidential address to the Association for Academic Surgery.

“Presidents tend to give a message of hope or inspiration; I probably took it in a different way,” he said.

Dr. Kim told the story of one of his clinical partners, Eveline Shue, who, after five rounds of in vitro fertilization (IVF), became pregnant with twins. A high-achiever in her field, Ms. Shue continued working the grueling hours required by her job throughout pregnancy until she noticed concerning symptoms – musculoskeletal issues, extreme swelling, and more. She and her group decided that she should step back from work in her third trimester. A few days later, Ms. Shue suffered a stroke. She was rushed to the hospital where her babies were delivered by emergency C-section. Ms. Shue underwent brain surgery but later recovered and is still practicing in Southern California.

“I remember being at her bedside thinking, ‘How could we have let this happen? How could we have prevented this?’ ”

Dr. Kim’s speech kicked off a firestorm of awareness about pregnancy complications among physicians. “I got scores of emails from women around the country, surgeons in particular, who felt like their issues had been seen. The conversation was long overdue,” he said.

Family planning issues, pregnancy complications, infertility, and pregnancy loss are common, pervasive, and often silent issues in medicine. In July 2021, Dr. Kim and a group of other researchers published a study in JAMA Surgery. It revealed staggering truths: When compared to non-surgeons, female surgeons were more likely to delay pregnancy, use assisted reproductive technology such as IVF, have non-elective C-sections, and suffer pregnancy loss. In the study, 42% of surgeons had experienced pregnancy loss – more than double the rate of the general population. Almost half had serious pregnancy complications.

Research has found that female physicians in general have a significantly greater incidence of miscarriage, infertility, and pregnancy complications than the general population. According to a 2016 survey in the Journal of Women’s Health, the infertility rate for physicians is nearly 1 in 4, about double the rate of the general public.
 

The barriers to starting a family

Physicians face significant professional barriers that impact family planning. Demanding jobs with exhausting and often unpredictable hours contribute to a culture that, traditionally, has been far from family friendly. As a result, many physicians start families later. “For a pediatric surgeon, you finish training at age 35 – minimum,” says Dr. Kim. “Simply being a surgeon makes you a high-risk pregnancy candidate just because of the career.”

In 2020, Ariela L. Marshall, MD, an associate professor of clinical medicine at the University of Pennsylvania’s Perelman school of medicine, co-authored a commentary article in Academic Medicine titled “Physician Fertility: A Call to Action” which was based on her own experiences with infertility. Dr. Marshall was 34 when she and her husband decided to start a family, and she says her infertility diagnosis “came as a shock.”

“I never stopped to think about the consequences of a career path where I’m not going to be established until my 30s,” Dr. Marshall says. “I never thought about how long hours, overnight shifts, or working all the time could impact my fertility.”

It would take four cycles of IVF egg retrieval to create embryos and one failed implantation before Dr. Marshall became pregnant with her son.

When it comes to the timing of pregnancy, medical culture also plays a role. “There’s a lot of messaging around when it’s appropriate to carry a baby – and it’s not until after training is done,” says Arghavan Salles, MD, PhD, a clinical associate professor and special advisor for DEI programs at Stanford (Calif.) University’s department of medicine.

There are always exceptions. Some institutions are more flexible than others about pregnancy during residency. But Dr. Salles notes that this attitude is “not universal,” partly because of the lack of a comprehensive approach to pregnancy or parenthood in the United States. “There’s no federal paid parental leave in this country,” reminds Dr. Salles. “That signals that we don’t value parenting.”

The trickle-down effect of this in medicine is more like a waterfall. Some physicians complain when other physicians are out on leave. There’s an additional burden of work when people take time away, and there are often no support structures in place for backup or fill-in care. Dr. Salles said doctors often tell her that they were responsible for finding coverage for any time off during pregnancy or after becoming a parent. A paper of hers published in JAMA Surgery found that, for physicians, a fear of burdening others was a major barrier to getting pregnant during residency in the first place.
 

The physical consequences

Although research supports the benefits of physical activity throughout pregnancy, a job such as surgery that requires being on your feet for long periods of time “is not the same as exercise,” explains Erika Lu Rangel, MD, a gastrointestinal surgeon at Brigham and Women’s Hospital, Boston, and Dr. Kim’s lead author on the JAMA Surgery article.

Surgeons operating for more than 12 hours a week are at higher risk for pregnancy complications, the study found. Dr. Rangel also cites data suggesting that night shifts or swing shifts (the hours between day and night) put women at higher risk for pregnancy complications.

Equally alarming: Medical trainees appear to have “almost as high a rate of pregnancy complications as surgeons who have already completed their training,” said Dr. Rangel. It is a concerning finding since, as a younger cohort, they should have lower complication rates based on their age. But doctors in training may be on their feet even more than surgeons during long shifts.

Like Dr. Salles, Dr. Rangel sees these issues as part of a pervasive culture of “presenteeism” in medicine, and she points out that many surgeons don’t even take time off to grieve pregnancy loss or physically recover from it. “We work even when we’re sick and even when it’s not good for our health,” she said. “I think that’s an unhealthy behavior that we cultivate from the time that we’re trainees, and we carry it on through when we’re in practice.”

Penn Medicine’s Dr. Marshall remembers that her own maternity leave was “not an easy process to navigate.” From her hospital room on a magnesium drip for preeclampsia, she still attended Zoom meetings with her colleagues. “Nobody says, ‘Oh, you have to do this,’ ” Dr. Marshall explains, “but you wind up feeling guilty if you’re not there at all moments for everyone. That’s also something that needs to change.” 

Dr. Rangel was pregnant with her oldest son as a fourth-year surgery resident. The day she gave birth to him she remembers waking up with a flu-like illness and a fever. She went to work anyway, because “you don’t call in sick as a resident.” She was barely able to complete her rounds and then had to lie down between cases. A co-resident found her and took her to labor and delivery. She had gone into premature labor at 37 weeks, and her son went into the NICU with complications.

“I remember feeling this enormous guilt,” says Dr. Rangel. “I’d been a mom for just a few minutes, and I felt like I had already failed him because I had prioritized what the residency thought of me above what I knew was necessary for his health.”
 

Hope for the future

Disturbed by the status quo, many physicians are pushing for change. “I think there’s a really important and positive conversation going on in the medical community right now about ways that we need to support new parent physicians,” said Dr. Rangel.

Parental leave is a key part of that support. Last year, The American Board of Medical Specialties enacted a mandate that all specialty boards 2 years or more in duration must provide at least 6 weeks of parental and caregiver leave. In 2023, the Accreditation Council for Graduate Medical Education (ACGME) required that all training programs match that policy. “This sends a message to policymakers and leaders in American medicine that this is a priority,” said Dr. Rangel.

In January 2022, a group from the University of Michigan also published an article in the Annals of Surgery called “Safe and Supported Pregnancy: A Call to Action for Surgery Chairs and Program Directors”. The essay urged leading groups such as the ACGME and the American Board of Surgery to “directly address the health and safety of pregnant trainees” and specifically, to “allow for further flexibility during training for pregnancy and peripartum periods,” calling these “fundamental necessities for cultural progress.”

Others have recommended allowing pregnant trainees more flexibility in their schedules or front-loading certain parts of the training that may be more difficult as a pregnancy progresses. Insurance coverage for fertility preservation and reproductive endocrinology services, and support for reentry (including lactation and childcare) are also issues that must be addressed, says Dr. Salles.

A new paper of Dr. Rangel’s, published in JAMA Surgery, suggests that things like mentorship for residents from faculty can also be important pieces of the puzzle.

Education about reproductive health must start earlier, too – as early as medical school. Research suggests only 8% of physicians receive education on the risks of delaying pregnancy. Those who do are significantly less likely to experience pregnancy loss or seek infertility treatment.

Dr. Salles recalls sitting in a classroom learning about advanced maternal age at a time when age 35 seemed unimaginably distant. “It was never taught – at least to my recollection – in a way that was like, ‘this could be your future,’ ” Dr. Salles says.” It was more like this abstract patient who might have advanced maternal age and what the consequences would be. Maybe some of my colleagues put two and two together, but I definitely didn’t.”

Dr. Marshall is the curriculum chair for the IGNITEMed Initiative, which aims to educate medical students about issues not discussed in traditional medical school curricula. Dr. Marshall and her colleague Julia Files, MD, talk with IGNITEMed students about reproductive life planning.

“Raising awareness is a very big thing. That’s not just true for medical students but for professionals at every level of medicine,” Dr. Marshall said. “Residency and fellowship training program directors, department chairs, and hospital CEOs all need to understand that these issues are very common in the people they oversee – and that they are medical issues, like any other medical issue, where people need time off and support.”

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

In 2021, Eugene Kim, MD, division director of pediatric surgery and vice chair in the department of surgery at Cedars-Sinai Medical Center, Los Angeles, gave his presidential address to the Association for Academic Surgery.

“Presidents tend to give a message of hope or inspiration; I probably took it in a different way,” he said.

Dr. Kim told the story of one of his clinical partners, Eveline Shue, who, after five rounds of in vitro fertilization (IVF), became pregnant with twins. A high-achiever in her field, Ms. Shue continued working the grueling hours required by her job throughout pregnancy until she noticed concerning symptoms – musculoskeletal issues, extreme swelling, and more. She and her group decided that she should step back from work in her third trimester. A few days later, Ms. Shue suffered a stroke. She was rushed to the hospital where her babies were delivered by emergency C-section. Ms. Shue underwent brain surgery but later recovered and is still practicing in Southern California.

“I remember being at her bedside thinking, ‘How could we have let this happen? How could we have prevented this?’ ”

Dr. Kim’s speech kicked off a firestorm of awareness about pregnancy complications among physicians. “I got scores of emails from women around the country, surgeons in particular, who felt like their issues had been seen. The conversation was long overdue,” he said.

Family planning issues, pregnancy complications, infertility, and pregnancy loss are common, pervasive, and often silent issues in medicine. In July 2021, Dr. Kim and a group of other researchers published a study in JAMA Surgery. It revealed staggering truths: When compared to non-surgeons, female surgeons were more likely to delay pregnancy, use assisted reproductive technology such as IVF, have non-elective C-sections, and suffer pregnancy loss. In the study, 42% of surgeons had experienced pregnancy loss – more than double the rate of the general population. Almost half had serious pregnancy complications.

Research has found that female physicians in general have a significantly greater incidence of miscarriage, infertility, and pregnancy complications than the general population. According to a 2016 survey in the Journal of Women’s Health, the infertility rate for physicians is nearly 1 in 4, about double the rate of the general public.
 

The barriers to starting a family

Physicians face significant professional barriers that impact family planning. Demanding jobs with exhausting and often unpredictable hours contribute to a culture that, traditionally, has been far from family friendly. As a result, many physicians start families later. “For a pediatric surgeon, you finish training at age 35 – minimum,” says Dr. Kim. “Simply being a surgeon makes you a high-risk pregnancy candidate just because of the career.”

In 2020, Ariela L. Marshall, MD, an associate professor of clinical medicine at the University of Pennsylvania’s Perelman school of medicine, co-authored a commentary article in Academic Medicine titled “Physician Fertility: A Call to Action” which was based on her own experiences with infertility. Dr. Marshall was 34 when she and her husband decided to start a family, and she says her infertility diagnosis “came as a shock.”

“I never stopped to think about the consequences of a career path where I’m not going to be established until my 30s,” Dr. Marshall says. “I never thought about how long hours, overnight shifts, or working all the time could impact my fertility.”

It would take four cycles of IVF egg retrieval to create embryos and one failed implantation before Dr. Marshall became pregnant with her son.

When it comes to the timing of pregnancy, medical culture also plays a role. “There’s a lot of messaging around when it’s appropriate to carry a baby – and it’s not until after training is done,” says Arghavan Salles, MD, PhD, a clinical associate professor and special advisor for DEI programs at Stanford (Calif.) University’s department of medicine.

There are always exceptions. Some institutions are more flexible than others about pregnancy during residency. But Dr. Salles notes that this attitude is “not universal,” partly because of the lack of a comprehensive approach to pregnancy or parenthood in the United States. “There’s no federal paid parental leave in this country,” reminds Dr. Salles. “That signals that we don’t value parenting.”

The trickle-down effect of this in medicine is more like a waterfall. Some physicians complain when other physicians are out on leave. There’s an additional burden of work when people take time away, and there are often no support structures in place for backup or fill-in care. Dr. Salles said doctors often tell her that they were responsible for finding coverage for any time off during pregnancy or after becoming a parent. A paper of hers published in JAMA Surgery found that, for physicians, a fear of burdening others was a major barrier to getting pregnant during residency in the first place.
 

The physical consequences

Although research supports the benefits of physical activity throughout pregnancy, a job such as surgery that requires being on your feet for long periods of time “is not the same as exercise,” explains Erika Lu Rangel, MD, a gastrointestinal surgeon at Brigham and Women’s Hospital, Boston, and Dr. Kim’s lead author on the JAMA Surgery article.

Surgeons operating for more than 12 hours a week are at higher risk for pregnancy complications, the study found. Dr. Rangel also cites data suggesting that night shifts or swing shifts (the hours between day and night) put women at higher risk for pregnancy complications.

Equally alarming: Medical trainees appear to have “almost as high a rate of pregnancy complications as surgeons who have already completed their training,” said Dr. Rangel. It is a concerning finding since, as a younger cohort, they should have lower complication rates based on their age. But doctors in training may be on their feet even more than surgeons during long shifts.

Like Dr. Salles, Dr. Rangel sees these issues as part of a pervasive culture of “presenteeism” in medicine, and she points out that many surgeons don’t even take time off to grieve pregnancy loss or physically recover from it. “We work even when we’re sick and even when it’s not good for our health,” she said. “I think that’s an unhealthy behavior that we cultivate from the time that we’re trainees, and we carry it on through when we’re in practice.”

Penn Medicine’s Dr. Marshall remembers that her own maternity leave was “not an easy process to navigate.” From her hospital room on a magnesium drip for preeclampsia, she still attended Zoom meetings with her colleagues. “Nobody says, ‘Oh, you have to do this,’ ” Dr. Marshall explains, “but you wind up feeling guilty if you’re not there at all moments for everyone. That’s also something that needs to change.” 

Dr. Rangel was pregnant with her oldest son as a fourth-year surgery resident. The day she gave birth to him she remembers waking up with a flu-like illness and a fever. She went to work anyway, because “you don’t call in sick as a resident.” She was barely able to complete her rounds and then had to lie down between cases. A co-resident found her and took her to labor and delivery. She had gone into premature labor at 37 weeks, and her son went into the NICU with complications.

“I remember feeling this enormous guilt,” says Dr. Rangel. “I’d been a mom for just a few minutes, and I felt like I had already failed him because I had prioritized what the residency thought of me above what I knew was necessary for his health.”
 

Hope for the future

Disturbed by the status quo, many physicians are pushing for change. “I think there’s a really important and positive conversation going on in the medical community right now about ways that we need to support new parent physicians,” said Dr. Rangel.

Parental leave is a key part of that support. Last year, The American Board of Medical Specialties enacted a mandate that all specialty boards 2 years or more in duration must provide at least 6 weeks of parental and caregiver leave. In 2023, the Accreditation Council for Graduate Medical Education (ACGME) required that all training programs match that policy. “This sends a message to policymakers and leaders in American medicine that this is a priority,” said Dr. Rangel.

In January 2022, a group from the University of Michigan also published an article in the Annals of Surgery called “Safe and Supported Pregnancy: A Call to Action for Surgery Chairs and Program Directors”. The essay urged leading groups such as the ACGME and the American Board of Surgery to “directly address the health and safety of pregnant trainees” and specifically, to “allow for further flexibility during training for pregnancy and peripartum periods,” calling these “fundamental necessities for cultural progress.”

Others have recommended allowing pregnant trainees more flexibility in their schedules or front-loading certain parts of the training that may be more difficult as a pregnancy progresses. Insurance coverage for fertility preservation and reproductive endocrinology services, and support for reentry (including lactation and childcare) are also issues that must be addressed, says Dr. Salles.

A new paper of Dr. Rangel’s, published in JAMA Surgery, suggests that things like mentorship for residents from faculty can also be important pieces of the puzzle.

Education about reproductive health must start earlier, too – as early as medical school. Research suggests only 8% of physicians receive education on the risks of delaying pregnancy. Those who do are significantly less likely to experience pregnancy loss or seek infertility treatment.

Dr. Salles recalls sitting in a classroom learning about advanced maternal age at a time when age 35 seemed unimaginably distant. “It was never taught – at least to my recollection – in a way that was like, ‘this could be your future,’ ” Dr. Salles says.” It was more like this abstract patient who might have advanced maternal age and what the consequences would be. Maybe some of my colleagues put two and two together, but I definitely didn’t.”

Dr. Marshall is the curriculum chair for the IGNITEMed Initiative, which aims to educate medical students about issues not discussed in traditional medical school curricula. Dr. Marshall and her colleague Julia Files, MD, talk with IGNITEMed students about reproductive life planning.

“Raising awareness is a very big thing. That’s not just true for medical students but for professionals at every level of medicine,” Dr. Marshall said. “Residency and fellowship training program directors, department chairs, and hospital CEOs all need to understand that these issues are very common in the people they oversee – and that they are medical issues, like any other medical issue, where people need time off and support.”

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

The U.S. Surgeon General says 13 years old is too young to begin using social media.

Most social media platforms including TikTok, Snapchat, Instagram, and Facebook allow users to create accounts if they say they are at least 13 years old.

“I, personally, based on the data I’ve seen, believe that 13 is too early. ... It’s a time where it’s really important for us to be thoughtful about what’s going into how they think about their own self-worth and their relationships, and the skewed and often distorted environment of social media often does a disservice to many of those children,” U.S. Surgeon General Vivek Murthy, MD, told CNN.

Research has shown that teens are susceptible to cyberbullying and serious mental health impacts from social media usage and online activity during an era when the influence of the Internet has become everywhere for young people.

According to the Pew Research Center, 95% of teens age 13 and up have a smartphone, and 97% of teens say they use the Internet daily. Among 13- and 14-year-olds, 61% say they use TikTok and 51% say they use Snapchat. Older teens ages 15-17 use those social media platforms at higher rates, with 71% saying they use TikTok and 65% using Snapchat.

“If parents can band together and say you know, as a group, we’re not going to allow our kids to use social media until 16 or 17 or 18 or whatever age they choose, that’s a much more effective strategy in making sure your kids don’t get exposed to harm early,” Dr. Murthy said.

A version of this article originally appeared on WebMD.com.

The U.S. Surgeon General says 13 years old is too young to begin using social media.

Most social media platforms including TikTok, Snapchat, Instagram, and Facebook allow users to create accounts if they say they are at least 13 years old.

“I, personally, based on the data I’ve seen, believe that 13 is too early. ... It’s a time where it’s really important for us to be thoughtful about what’s going into how they think about their own self-worth and their relationships, and the skewed and often distorted environment of social media often does a disservice to many of those children,” U.S. Surgeon General Vivek Murthy, MD, told CNN.

Research has shown that teens are susceptible to cyberbullying and serious mental health impacts from social media usage and online activity during an era when the influence of the Internet has become everywhere for young people.

According to the Pew Research Center, 95% of teens age 13 and up have a smartphone, and 97% of teens say they use the Internet daily. Among 13- and 14-year-olds, 61% say they use TikTok and 51% say they use Snapchat. Older teens ages 15-17 use those social media platforms at higher rates, with 71% saying they use TikTok and 65% using Snapchat.

“If parents can band together and say you know, as a group, we’re not going to allow our kids to use social media until 16 or 17 or 18 or whatever age they choose, that’s a much more effective strategy in making sure your kids don’t get exposed to harm early,” Dr. Murthy said.

A version of this article originally appeared on WebMD.com.

The U.S. Surgeon General says 13 years old is too young to begin using social media.

Most social media platforms including TikTok, Snapchat, Instagram, and Facebook allow users to create accounts if they say they are at least 13 years old.

“I, personally, based on the data I’ve seen, believe that 13 is too early. ... It’s a time where it’s really important for us to be thoughtful about what’s going into how they think about their own self-worth and their relationships, and the skewed and often distorted environment of social media often does a disservice to many of those children,” U.S. Surgeon General Vivek Murthy, MD, told CNN.

Research has shown that teens are susceptible to cyberbullying and serious mental health impacts from social media usage and online activity during an era when the influence of the Internet has become everywhere for young people.

According to the Pew Research Center, 95% of teens age 13 and up have a smartphone, and 97% of teens say they use the Internet daily. Among 13- and 14-year-olds, 61% say they use TikTok and 51% say they use Snapchat. Older teens ages 15-17 use those social media platforms at higher rates, with 71% saying they use TikTok and 65% using Snapchat.

“If parents can band together and say you know, as a group, we’re not going to allow our kids to use social media until 16 or 17 or 18 or whatever age they choose, that’s a much more effective strategy in making sure your kids don’t get exposed to harm early,” Dr. Murthy said.

A version of this article originally appeared on WebMD.com.

Montrouge, France – Whether you are a cisgender woman or a transgender man who has kept his uterus, regardless of the sex of your partner, and even if you are a woman who is no longer sexually active, you must take part in cervical cancer screening. This is the reminder issued by Julia Maruani, MD, a medical gynecologist in Marseille, France, at a press conference ahead of the 46th meeting of the French Colposcopy and Cervical-Vaginal Diseases Society (SFCPCV).

Cervical screening currently targets asymptomatic, immunocompetent, and sexually active women between ages 25 and 65 years. During her presentation, Dr. Maruani insisted that screening should not discriminate based on a patient’s sexual activity.
 

Sex between women

There is a widely held belief that only men can transmit human papillomavirus (HPV). “If you are in a sexual relationship with a man, then yes, you can get HPV from him. But it’s also possible for HPV to be transmitted in a sexual relationship between two women via touch, bodily fluids, or sex toys,” said Dr. Maruani, who pointed out that 20% of lesbians and 30% of bisexual women are HPV carriers.

Because women who have sexual relationships with other women have the mistaken view that their demographic is less affected, they are less likely to take part in cervical screening. They also present more often with advanced lesions and with cancer because of the lack of screening in this group.
 

Transgender men

Dr. Maruani defines transgender men as “women who have changed gender and who have become men.” Why are they affected by cervical screening? Not all of them are. Those who’ve had their uterus removed no longer have a cervix, so this screening doesn’t affect them. But hysterectomies are rarely performed, as they’re not required in most European countries to legally change gender.

The figures are concerning: 27% of transgender men are screened versus 60% of cisgender females.

“For this demographic, specialist gynecology appointments are hard to come by. Sitting in a women’s waiting room is not easy,” said Dr. Maruani, recalling that often discussion about the transition phase takes up the entire appointment time. It’s also usually the case that any medical problems or health care prevention issues not related to the topic of transitioning are not discussed.

Moreover, the online appointment-booking software doesn’t allow transgender men who have kept their cervix and legally identify as men to make an appointment. “Gynecologists must disable this default option,” said Dr. Maruani.

Likewise, transgender men will not receive an invitation to take part in cervical or breast cancer screening, as they are identified as male by social security services and screening sites. Furthermore, in what Dr. Maruani referred to as an “administrative head-scratcher that needs to change,” some medical procedures are not funded for men.

Yet the risk of contracting HPV is higher among transgender men than in the rest of the population because of different sexual practices in this demographic, as well as the propensity to have multiple sexual partners. The risk of finding abnormalities on cytology screening is greater.

Although data regarding cancer are lacking, “if screening is inadequate but the risk of infection with HPV is great, logic tells us that there will be more lesions, more cancer” in this demographic, said Dr. Maruani.
 

Celibate women

Nowadays, screening drops with age in women, especially after menopause. This is especially true for women who are no longer sexually active. Another preconceived notion to be addressed is that women who are no longer sexually active no longer need screening. But this concept completely goes against the natural history of HPV infection. “There are years, at least 5, between infection and the development of precancerous lesions. There is a further 5 years between a precancerous lesion and cancer,” said Dr. Maruani.

A woman could still be at risk even 20 years after contracting HPV. Approximately 80% of women are exposed to HPV, and 5%-10% have a persistent infection that could lead to the development of precancerous lesions.

“So, a woman who is no longer sexually active can’t stop participating in cervical screening, especially since there aren’t any symptoms until a fairly advanced stage of cancer.” No longer having sex does not mean that screening can be stopped.

What treatment is appropriate for partners of a woman who is no longer sexually active? None. During the press conference, the specialists agreed that a positive HPV test would be of importance to her partner. Even so, they recalled that the infection would generally be an old one and that the woman’s partner (whether male or female) would therefore have probably already been exposed to it. Patients should also be reminded that, in the past, cytology testing did not look for HPV, so the virus could already have been there. According to these specialists, you don’t need to change your sexual habits, just continue to monitor yourself.

This article was translated from the Medscape French edition and a version first appeared on Medscape.com.

Montrouge, France – Whether you are a cisgender woman or a transgender man who has kept his uterus, regardless of the sex of your partner, and even if you are a woman who is no longer sexually active, you must take part in cervical cancer screening. This is the reminder issued by Julia Maruani, MD, a medical gynecologist in Marseille, France, at a press conference ahead of the 46th meeting of the French Colposcopy and Cervical-Vaginal Diseases Society (SFCPCV).

Cervical screening currently targets asymptomatic, immunocompetent, and sexually active women between ages 25 and 65 years. During her presentation, Dr. Maruani insisted that screening should not discriminate based on a patient’s sexual activity.
 

Sex between women

There is a widely held belief that only men can transmit human papillomavirus (HPV). “If you are in a sexual relationship with a man, then yes, you can get HPV from him. But it’s also possible for HPV to be transmitted in a sexual relationship between two women via touch, bodily fluids, or sex toys,” said Dr. Maruani, who pointed out that 20% of lesbians and 30% of bisexual women are HPV carriers.

Because women who have sexual relationships with other women have the mistaken view that their demographic is less affected, they are less likely to take part in cervical screening. They also present more often with advanced lesions and with cancer because of the lack of screening in this group.
 

Transgender men

Dr. Maruani defines transgender men as “women who have changed gender and who have become men.” Why are they affected by cervical screening? Not all of them are. Those who’ve had their uterus removed no longer have a cervix, so this screening doesn’t affect them. But hysterectomies are rarely performed, as they’re not required in most European countries to legally change gender.

The figures are concerning: 27% of transgender men are screened versus 60% of cisgender females.

“For this demographic, specialist gynecology appointments are hard to come by. Sitting in a women’s waiting room is not easy,” said Dr. Maruani, recalling that often discussion about the transition phase takes up the entire appointment time. It’s also usually the case that any medical problems or health care prevention issues not related to the topic of transitioning are not discussed.

Moreover, the online appointment-booking software doesn’t allow transgender men who have kept their cervix and legally identify as men to make an appointment. “Gynecologists must disable this default option,” said Dr. Maruani.

Likewise, transgender men will not receive an invitation to take part in cervical or breast cancer screening, as they are identified as male by social security services and screening sites. Furthermore, in what Dr. Maruani referred to as an “administrative head-scratcher that needs to change,” some medical procedures are not funded for men.

Yet the risk of contracting HPV is higher among transgender men than in the rest of the population because of different sexual practices in this demographic, as well as the propensity to have multiple sexual partners. The risk of finding abnormalities on cytology screening is greater.

Although data regarding cancer are lacking, “if screening is inadequate but the risk of infection with HPV is great, logic tells us that there will be more lesions, more cancer” in this demographic, said Dr. Maruani.
 

Celibate women

Nowadays, screening drops with age in women, especially after menopause. This is especially true for women who are no longer sexually active. Another preconceived notion to be addressed is that women who are no longer sexually active no longer need screening. But this concept completely goes against the natural history of HPV infection. “There are years, at least 5, between infection and the development of precancerous lesions. There is a further 5 years between a precancerous lesion and cancer,” said Dr. Maruani.

A woman could still be at risk even 20 years after contracting HPV. Approximately 80% of women are exposed to HPV, and 5%-10% have a persistent infection that could lead to the development of precancerous lesions.

“So, a woman who is no longer sexually active can’t stop participating in cervical screening, especially since there aren’t any symptoms until a fairly advanced stage of cancer.” No longer having sex does not mean that screening can be stopped.

What treatment is appropriate for partners of a woman who is no longer sexually active? None. During the press conference, the specialists agreed that a positive HPV test would be of importance to her partner. Even so, they recalled that the infection would generally be an old one and that the woman’s partner (whether male or female) would therefore have probably already been exposed to it. Patients should also be reminded that, in the past, cytology testing did not look for HPV, so the virus could already have been there. According to these specialists, you don’t need to change your sexual habits, just continue to monitor yourself.

This article was translated from the Medscape French edition and a version first appeared on Medscape.com.

Montrouge, France – Whether you are a cisgender woman or a transgender man who has kept his uterus, regardless of the sex of your partner, and even if you are a woman who is no longer sexually active, you must take part in cervical cancer screening. This is the reminder issued by Julia Maruani, MD, a medical gynecologist in Marseille, France, at a press conference ahead of the 46th meeting of the French Colposcopy and Cervical-Vaginal Diseases Society (SFCPCV).

Cervical screening currently targets asymptomatic, immunocompetent, and sexually active women between ages 25 and 65 years. During her presentation, Dr. Maruani insisted that screening should not discriminate based on a patient’s sexual activity.
 

Sex between women

There is a widely held belief that only men can transmit human papillomavirus (HPV). “If you are in a sexual relationship with a man, then yes, you can get HPV from him. But it’s also possible for HPV to be transmitted in a sexual relationship between two women via touch, bodily fluids, or sex toys,” said Dr. Maruani, who pointed out that 20% of lesbians and 30% of bisexual women are HPV carriers.

Because women who have sexual relationships with other women have the mistaken view that their demographic is less affected, they are less likely to take part in cervical screening. They also present more often with advanced lesions and with cancer because of the lack of screening in this group.
 

Transgender men

Dr. Maruani defines transgender men as “women who have changed gender and who have become men.” Why are they affected by cervical screening? Not all of them are. Those who’ve had their uterus removed no longer have a cervix, so this screening doesn’t affect them. But hysterectomies are rarely performed, as they’re not required in most European countries to legally change gender.

The figures are concerning: 27% of transgender men are screened versus 60% of cisgender females.

“For this demographic, specialist gynecology appointments are hard to come by. Sitting in a women’s waiting room is not easy,” said Dr. Maruani, recalling that often discussion about the transition phase takes up the entire appointment time. It’s also usually the case that any medical problems or health care prevention issues not related to the topic of transitioning are not discussed.

Moreover, the online appointment-booking software doesn’t allow transgender men who have kept their cervix and legally identify as men to make an appointment. “Gynecologists must disable this default option,” said Dr. Maruani.

Likewise, transgender men will not receive an invitation to take part in cervical or breast cancer screening, as they are identified as male by social security services and screening sites. Furthermore, in what Dr. Maruani referred to as an “administrative head-scratcher that needs to change,” some medical procedures are not funded for men.

Yet the risk of contracting HPV is higher among transgender men than in the rest of the population because of different sexual practices in this demographic, as well as the propensity to have multiple sexual partners. The risk of finding abnormalities on cytology screening is greater.

Although data regarding cancer are lacking, “if screening is inadequate but the risk of infection with HPV is great, logic tells us that there will be more lesions, more cancer” in this demographic, said Dr. Maruani.
 

Celibate women

Nowadays, screening drops with age in women, especially after menopause. This is especially true for women who are no longer sexually active. Another preconceived notion to be addressed is that women who are no longer sexually active no longer need screening. But this concept completely goes against the natural history of HPV infection. “There are years, at least 5, between infection and the development of precancerous lesions. There is a further 5 years between a precancerous lesion and cancer,” said Dr. Maruani.

A woman could still be at risk even 20 years after contracting HPV. Approximately 80% of women are exposed to HPV, and 5%-10% have a persistent infection that could lead to the development of precancerous lesions.

“So, a woman who is no longer sexually active can’t stop participating in cervical screening, especially since there aren’t any symptoms until a fairly advanced stage of cancer.” No longer having sex does not mean that screening can be stopped.

What treatment is appropriate for partners of a woman who is no longer sexually active? None. During the press conference, the specialists agreed that a positive HPV test would be of importance to her partner. Even so, they recalled that the infection would generally be an old one and that the woman’s partner (whether male or female) would therefore have probably already been exposed to it. Patients should also be reminded that, in the past, cytology testing did not look for HPV, so the virus could already have been there. According to these specialists, you don’t need to change your sexual habits, just continue to monitor yourself.

This article was translated from the Medscape French edition and a version first appeared on Medscape.com.