MDedge Dermatology

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[email protected]

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

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

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

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

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

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

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

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

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

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

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

[email protected]

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

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

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

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

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

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

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

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

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

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

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

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Two new cases of a mysterious virus have been reported by the Alaska Department of Health and Social Services. Both people were diagnosed after receiving urgent care in a Fairbanks-area clinic. One was a child with a sore on the left elbow, along with fever and swollen lymph nodes. And the other was an unrelated middle-aged woman with a pox mark on her leg, swollen lymph nodes, and joint pain. In both cases, symptoms improved within 3 weeks.

This isn’t the first time the so-called Alaskapox virus has been detected in the region. In 2015, a woman living near Fairbanks turned up at her doctor’s office with a single reddened pox-like mark on her upper arm and a feeling of fatigue.

Sampling of the pox mark showed that it was caused by a previously unidentified virus of the same family as smallpox and cowpox.

Five years later, another woman showed up with similar signs and symptoms, and her pox also proved to be the result of what public health experts started calling the Alaskapox virus.

In both cases, the women recovered completely.
 

Smallpox-like illness

Public health sleuths figured out that in three of the four cases, the patients lived in a home with a cat or cats, and one of these cats was known to hunt small animals.

Experts already knew that cats mingling in cow pastures and sickened by cattle virus had helped cowpox make the leap from bovines to humans. And just as in the case of cowpox, they suspected that cats might again be spreading this new virus to people, too.

All four of the infected people lived in sparsely populated areas amid forests. Officials laid animal traps where some of the affected people lived and identified the virus in several species of small wild animals.

The animals that turned up most often with Alaskapox were small mouse-like voles. The rodents with rounded muzzles are known for burrowing in the region. And scientists suspect the Alaskapox virus makes its way from these wild animals to humans through their pet cats or possibly by direct exposure outdoors.

None of the four people identified so far with Alaskapox knew each other or interacted, so officials also suspect that there are more cases going unrecognized, possibly because the symptoms are mild or nonexistent.

There are no documented cases of person-to-person transmission of Alaskapox, according to public health officials monitoring the small number of cases. But other pox viruses can spread by direct contact with skin lesions, so clinicians are recommending that people cover wounds with bandages. Three of the people with Alaskapox mistook their lesions at first for a bite from a spider or insect.

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

Two new cases of a mysterious virus have been reported by the Alaska Department of Health and Social Services. Both people were diagnosed after receiving urgent care in a Fairbanks-area clinic. One was a child with a sore on the left elbow, along with fever and swollen lymph nodes. And the other was an unrelated middle-aged woman with a pox mark on her leg, swollen lymph nodes, and joint pain. In both cases, symptoms improved within 3 weeks.

This isn’t the first time the so-called Alaskapox virus has been detected in the region. In 2015, a woman living near Fairbanks turned up at her doctor’s office with a single reddened pox-like mark on her upper arm and a feeling of fatigue.

Sampling of the pox mark showed that it was caused by a previously unidentified virus of the same family as smallpox and cowpox.

Five years later, another woman showed up with similar signs and symptoms, and her pox also proved to be the result of what public health experts started calling the Alaskapox virus.

In both cases, the women recovered completely.
 

Smallpox-like illness

Public health sleuths figured out that in three of the four cases, the patients lived in a home with a cat or cats, and one of these cats was known to hunt small animals.

Experts already knew that cats mingling in cow pastures and sickened by cattle virus had helped cowpox make the leap from bovines to humans. And just as in the case of cowpox, they suspected that cats might again be spreading this new virus to people, too.

All four of the infected people lived in sparsely populated areas amid forests. Officials laid animal traps where some of the affected people lived and identified the virus in several species of small wild animals.

The animals that turned up most often with Alaskapox were small mouse-like voles. The rodents with rounded muzzles are known for burrowing in the region. And scientists suspect the Alaskapox virus makes its way from these wild animals to humans through their pet cats or possibly by direct exposure outdoors.

None of the four people identified so far with Alaskapox knew each other or interacted, so officials also suspect that there are more cases going unrecognized, possibly because the symptoms are mild or nonexistent.

There are no documented cases of person-to-person transmission of Alaskapox, according to public health officials monitoring the small number of cases. But other pox viruses can spread by direct contact with skin lesions, so clinicians are recommending that people cover wounds with bandages. Three of the people with Alaskapox mistook their lesions at first for a bite from a spider or insect.

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

Two new cases of a mysterious virus have been reported by the Alaska Department of Health and Social Services. Both people were diagnosed after receiving urgent care in a Fairbanks-area clinic. One was a child with a sore on the left elbow, along with fever and swollen lymph nodes. And the other was an unrelated middle-aged woman with a pox mark on her leg, swollen lymph nodes, and joint pain. In both cases, symptoms improved within 3 weeks.

This isn’t the first time the so-called Alaskapox virus has been detected in the region. In 2015, a woman living near Fairbanks turned up at her doctor’s office with a single reddened pox-like mark on her upper arm and a feeling of fatigue.

Sampling of the pox mark showed that it was caused by a previously unidentified virus of the same family as smallpox and cowpox.

Five years later, another woman showed up with similar signs and symptoms, and her pox also proved to be the result of what public health experts started calling the Alaskapox virus.

In both cases, the women recovered completely.
 

Smallpox-like illness

Public health sleuths figured out that in three of the four cases, the patients lived in a home with a cat or cats, and one of these cats was known to hunt small animals.

Experts already knew that cats mingling in cow pastures and sickened by cattle virus had helped cowpox make the leap from bovines to humans. And just as in the case of cowpox, they suspected that cats might again be spreading this new virus to people, too.

All four of the infected people lived in sparsely populated areas amid forests. Officials laid animal traps where some of the affected people lived and identified the virus in several species of small wild animals.

The animals that turned up most often with Alaskapox were small mouse-like voles. The rodents with rounded muzzles are known for burrowing in the region. And scientists suspect the Alaskapox virus makes its way from these wild animals to humans through their pet cats or possibly by direct exposure outdoors.

None of the four people identified so far with Alaskapox knew each other or interacted, so officials also suspect that there are more cases going unrecognized, possibly because the symptoms are mild or nonexistent.

There are no documented cases of person-to-person transmission of Alaskapox, according to public health officials monitoring the small number of cases. But other pox viruses can spread by direct contact with skin lesions, so clinicians are recommending that people cover wounds with bandages. Three of the people with Alaskapox mistook their lesions at first for a bite from a spider or insect.

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