MDedge Dermatology

Key clinical point: Long-term proactive management (PM) of psoriasis with calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) vs reactive management (RM) benefitted all patients irrespective of baseline characteristics, with greater benefits observed in patients with more severe disease.

Major finding: Effect of treatment on time to first relapse was consistent across all baseline parameters, with treatment group (PM vs RM; hazard ratio [HR], 0.56; P less than .001), baseline Physician Global Assessment (severe vs mild; HR, 2.32; P = .003), and modified Psoriasis Area Severity Index (severe vs mild; HR, 1.77; P = .002) having a significant impact.

Study details: This was a post hoc analysis of phase 3 PSO LONG trial which included a 52-week maintenance phase where patients with psoriasis were randomly assigned to Cal/BD twice weekly (PM) or vehicle foam (RM).

Disclosures: This study was supported by LEO Pharma, Ballerup, Denmark. MG Lebwohl, KA Papp, and RB Warren declared receiving research funds, honoraria for advisory board, speaker, and/or consultant services from various sources including LEO Pharma. MH Mørch and MYJ Bernasconi declared being employees of LEO Pharma.

Source: Lebwohl MG et al. Dermatol Ther (Heidelb). 2021 Aug 2. doi: 10.1007/s13555-021-00585-x.

Key clinical point: Long-term proactive management (PM) of psoriasis with calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) vs reactive management (RM) benefitted all patients irrespective of baseline characteristics, with greater benefits observed in patients with more severe disease.

Major finding: Effect of treatment on time to first relapse was consistent across all baseline parameters, with treatment group (PM vs RM; hazard ratio [HR], 0.56; P less than .001), baseline Physician Global Assessment (severe vs mild; HR, 2.32; P = .003), and modified Psoriasis Area Severity Index (severe vs mild; HR, 1.77; P = .002) having a significant impact.

Study details: This was a post hoc analysis of phase 3 PSO LONG trial which included a 52-week maintenance phase where patients with psoriasis were randomly assigned to Cal/BD twice weekly (PM) or vehicle foam (RM).

Disclosures: This study was supported by LEO Pharma, Ballerup, Denmark. MG Lebwohl, KA Papp, and RB Warren declared receiving research funds, honoraria for advisory board, speaker, and/or consultant services from various sources including LEO Pharma. MH Mørch and MYJ Bernasconi declared being employees of LEO Pharma.

Source: Lebwohl MG et al. Dermatol Ther (Heidelb). 2021 Aug 2. doi: 10.1007/s13555-021-00585-x.

Key clinical point: Long-term proactive management (PM) of psoriasis with calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) vs reactive management (RM) benefitted all patients irrespective of baseline characteristics, with greater benefits observed in patients with more severe disease.

Major finding: Effect of treatment on time to first relapse was consistent across all baseline parameters, with treatment group (PM vs RM; hazard ratio [HR], 0.56; P less than .001), baseline Physician Global Assessment (severe vs mild; HR, 2.32; P = .003), and modified Psoriasis Area Severity Index (severe vs mild; HR, 1.77; P = .002) having a significant impact.

Study details: This was a post hoc analysis of phase 3 PSO LONG trial which included a 52-week maintenance phase where patients with psoriasis were randomly assigned to Cal/BD twice weekly (PM) or vehicle foam (RM).

Disclosures: This study was supported by LEO Pharma, Ballerup, Denmark. MG Lebwohl, KA Papp, and RB Warren declared receiving research funds, honoraria for advisory board, speaker, and/or consultant services from various sources including LEO Pharma. MH Mørch and MYJ Bernasconi declared being employees of LEO Pharma.

Source: Lebwohl MG et al. Dermatol Ther (Heidelb). 2021 Aug 2. doi: 10.1007/s13555-021-00585-x.

Key clinical point: Dimethyl fumarate may be considered a first-line systemic treatment option to manage psoriasis in the elderly. However, long-term safety, particularly lymphocytopenia, should be closely monitored.

Major finding: The Psoriasis Area and Severity Index score ranged from 3.7 to -24.0 (mean, 9.8±4.1) at week 0, which changed to 4.3±3.2 at week 16 and 2.7±3.2 at week 24 after dimethyl fumarate administration. Overall, 72.8% of adverse events were reported, with the most common being gastrointestinal complaints (29.6%), flushes (12.3%), and lymphocytopenia (12.35%).

Study details: Findings are from a retrospective study including 81 elderly patients with moderate-to-severe psoriasis, aged 65 years and older, treated with dimethyl fumarate for up to 24 weeks.

Disclosures: No source of funding was declared. The authors declared no potential conflict of interests.

Source: Ricceri F et al. J Dermatolo Treat. 2021 Aug 11. doi: 10.1080/09546634.2021.1962000.

Key clinical point: Dimethyl fumarate may be considered a first-line systemic treatment option to manage psoriasis in the elderly. However, long-term safety, particularly lymphocytopenia, should be closely monitored.

Major finding: The Psoriasis Area and Severity Index score ranged from 3.7 to -24.0 (mean, 9.8±4.1) at week 0, which changed to 4.3±3.2 at week 16 and 2.7±3.2 at week 24 after dimethyl fumarate administration. Overall, 72.8% of adverse events were reported, with the most common being gastrointestinal complaints (29.6%), flushes (12.3%), and lymphocytopenia (12.35%).

Study details: Findings are from a retrospective study including 81 elderly patients with moderate-to-severe psoriasis, aged 65 years and older, treated with dimethyl fumarate for up to 24 weeks.

Disclosures: No source of funding was declared. The authors declared no potential conflict of interests.

Source: Ricceri F et al. J Dermatolo Treat. 2021 Aug 11. doi: 10.1080/09546634.2021.1962000.

Key clinical point: Dimethyl fumarate may be considered a first-line systemic treatment option to manage psoriasis in the elderly. However, long-term safety, particularly lymphocytopenia, should be closely monitored.

Major finding: The Psoriasis Area and Severity Index score ranged from 3.7 to -24.0 (mean, 9.8±4.1) at week 0, which changed to 4.3±3.2 at week 16 and 2.7±3.2 at week 24 after dimethyl fumarate administration. Overall, 72.8% of adverse events were reported, with the most common being gastrointestinal complaints (29.6%), flushes (12.3%), and lymphocytopenia (12.35%).

Study details: Findings are from a retrospective study including 81 elderly patients with moderate-to-severe psoriasis, aged 65 years and older, treated with dimethyl fumarate for up to 24 weeks.

Disclosures: No source of funding was declared. The authors declared no potential conflict of interests.

Source: Ricceri F et al. J Dermatolo Treat. 2021 Aug 11. doi: 10.1080/09546634.2021.1962000.

Key clinical point: Among patients with at least mild psoriasis, calcipotriol/betamethasone (Cal/BD) aerosol foam appeared to be beneficial with substantial itch relief and improvement in itch-related sleep loss, itch severity, and quality of life (QoL).

Major finding: The proportion of patients with itch and itch-related sleep loss reduced from 89.3% at baseline to 43.5% at week 4, and 93.4% of patients reported a 30% or more reduction in itch severity. The mean change in Dermatology Life Quality Index score at week 4 was −5.9±4.7, with 76.3% of patients achieving a score of 5 or lesser indicating no/small effect on QoL.

Study details: Findings are from CELSUS, a noninterventional prospective study including 400 patients with plaque psoriasis treated with Cal/BD aerosol foam.

Disclosures: This study was supported by LEO Pharma. Dr. Rigopoulos, Dr. Lazaridou, Dr. Georgiou, Dr. Chasapi, and Dr. Ioannides reported receiving personal fees from various sources including LEO Pharma, outside the submitted work.

Source: Rigopoulos D et al. J Eur Acad Dermatol Venereol. 2021 Aug 9. doi: 10.1111/jdv.17593.

Key clinical point: Among patients with at least mild psoriasis, calcipotriol/betamethasone (Cal/BD) aerosol foam appeared to be beneficial with substantial itch relief and improvement in itch-related sleep loss, itch severity, and quality of life (QoL).

Major finding: The proportion of patients with itch and itch-related sleep loss reduced from 89.3% at baseline to 43.5% at week 4, and 93.4% of patients reported a 30% or more reduction in itch severity. The mean change in Dermatology Life Quality Index score at week 4 was −5.9±4.7, with 76.3% of patients achieving a score of 5 or lesser indicating no/small effect on QoL.

Study details: Findings are from CELSUS, a noninterventional prospective study including 400 patients with plaque psoriasis treated with Cal/BD aerosol foam.

Disclosures: This study was supported by LEO Pharma. Dr. Rigopoulos, Dr. Lazaridou, Dr. Georgiou, Dr. Chasapi, and Dr. Ioannides reported receiving personal fees from various sources including LEO Pharma, outside the submitted work.

Source: Rigopoulos D et al. J Eur Acad Dermatol Venereol. 2021 Aug 9. doi: 10.1111/jdv.17593.

Key clinical point: Among patients with at least mild psoriasis, calcipotriol/betamethasone (Cal/BD) aerosol foam appeared to be beneficial with substantial itch relief and improvement in itch-related sleep loss, itch severity, and quality of life (QoL).

Major finding: The proportion of patients with itch and itch-related sleep loss reduced from 89.3% at baseline to 43.5% at week 4, and 93.4% of patients reported a 30% or more reduction in itch severity. The mean change in Dermatology Life Quality Index score at week 4 was −5.9±4.7, with 76.3% of patients achieving a score of 5 or lesser indicating no/small effect on QoL.

Study details: Findings are from CELSUS, a noninterventional prospective study including 400 patients with plaque psoriasis treated with Cal/BD aerosol foam.

Disclosures: This study was supported by LEO Pharma. Dr. Rigopoulos, Dr. Lazaridou, Dr. Georgiou, Dr. Chasapi, and Dr. Ioannides reported receiving personal fees from various sources including LEO Pharma, outside the submitted work.

Source: Rigopoulos D et al. J Eur Acad Dermatol Venereol. 2021 Aug 9. doi: 10.1111/jdv.17593.

Key clinical point: Prevalence of subclinical atherosclerosis is higher among patients with psoriasis and nonalcoholic fatty liver disease (NAFLD). Additionally, those with elevated hepatic inflammation had a higher burden of coronary atherosclerosis.

Major finding: Among patients with psoriasis, the prevalence of subclinical atherosclerosis was higher among those with vs without NAFLD (61% vs 23%; P = .006). Uptake of 2-[fluorine-18]fluoro-2-deoxy-D-glucose was significantly associated with noncalcified (β, 0.28; P < .001), fibrofatty (β, 0.49; P less than 001), and lipid-rich necrotic core (β, 0.28; P = .003) coronary burden.

Study details: Findings are from a 2-cohort cross-sectional study including 314 patients with psoriasis. The European cohort consisted of 76 patients with psoriasis and 76 control patients and the United States cohort consisted of 162 patients with psoriasis.

Disclosures: This study was funded by National Heart, Lung, and Blood Institute Intramural Research Program. Dr. Mehta, Dr. Gelfand, Dr. González-Cantero, and Dr. Prussick declared serving as a consultant and/or speaker and receiving research grants and personal fees from various sources.

Source: Gonzalez-Cantero A et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.05.034.

Key clinical point: Prevalence of subclinical atherosclerosis is higher among patients with psoriasis and nonalcoholic fatty liver disease (NAFLD). Additionally, those with elevated hepatic inflammation had a higher burden of coronary atherosclerosis.

Major finding: Among patients with psoriasis, the prevalence of subclinical atherosclerosis was higher among those with vs without NAFLD (61% vs 23%; P = .006). Uptake of 2-[fluorine-18]fluoro-2-deoxy-D-glucose was significantly associated with noncalcified (β, 0.28; P < .001), fibrofatty (β, 0.49; P less than 001), and lipid-rich necrotic core (β, 0.28; P = .003) coronary burden.

Study details: Findings are from a 2-cohort cross-sectional study including 314 patients with psoriasis. The European cohort consisted of 76 patients with psoriasis and 76 control patients and the United States cohort consisted of 162 patients with psoriasis.

Disclosures: This study was funded by National Heart, Lung, and Blood Institute Intramural Research Program. Dr. Mehta, Dr. Gelfand, Dr. González-Cantero, and Dr. Prussick declared serving as a consultant and/or speaker and receiving research grants and personal fees from various sources.

Source: Gonzalez-Cantero A et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.05.034.

Key clinical point: Prevalence of subclinical atherosclerosis is higher among patients with psoriasis and nonalcoholic fatty liver disease (NAFLD). Additionally, those with elevated hepatic inflammation had a higher burden of coronary atherosclerosis.

Major finding: Among patients with psoriasis, the prevalence of subclinical atherosclerosis was higher among those with vs without NAFLD (61% vs 23%; P = .006). Uptake of 2-[fluorine-18]fluoro-2-deoxy-D-glucose was significantly associated with noncalcified (β, 0.28; P < .001), fibrofatty (β, 0.49; P less than 001), and lipid-rich necrotic core (β, 0.28; P = .003) coronary burden.

Study details: Findings are from a 2-cohort cross-sectional study including 314 patients with psoriasis. The European cohort consisted of 76 patients with psoriasis and 76 control patients and the United States cohort consisted of 162 patients with psoriasis.

Disclosures: This study was funded by National Heart, Lung, and Blood Institute Intramural Research Program. Dr. Mehta, Dr. Gelfand, Dr. González-Cantero, and Dr. Prussick declared serving as a consultant and/or speaker and receiving research grants and personal fees from various sources.

Source: Gonzalez-Cantero A et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.05.034.

Key clinical point: Compared with the general population, patients with moderate-to-severe plaque psoriasis were at an increased risk for lympho-hematological malignancies (LHM) and lymphoma, particularly cutaneous T-cell lymphoma (CTCL).

Major finding: Patients with moderate-to-severe plaque psoriasis vs general population had significantly higher risk for LHM (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.24-2.94) and lymphoma (HR, 1.27; 95% CI, 1.08-1.50). The risk for CTCL was markedly augmented in patients with psoriasis (HR, 6.22; 95% CI, 3.39-11.42).

Study details: Findings are from a meta-analysis of 25 observational studies including 2,501,652 study subjects. Most of the studies included patients with moderate-to-severe psoriasis.

Disclosures: The study did not receive any funding. P Gisondi and G Girolomoni declared serving as a consultant and/or speaker for various sources.

Source: Bellinato F et al. J Am Acad Dermatol. 2021 Aug 3. doi: 10.1016/j.jaad.2021.07.050.

Key clinical point: Compared with the general population, patients with moderate-to-severe plaque psoriasis were at an increased risk for lympho-hematological malignancies (LHM) and lymphoma, particularly cutaneous T-cell lymphoma (CTCL).

Major finding: Patients with moderate-to-severe plaque psoriasis vs general population had significantly higher risk for LHM (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.24-2.94) and lymphoma (HR, 1.27; 95% CI, 1.08-1.50). The risk for CTCL was markedly augmented in patients with psoriasis (HR, 6.22; 95% CI, 3.39-11.42).

Study details: Findings are from a meta-analysis of 25 observational studies including 2,501,652 study subjects. Most of the studies included patients with moderate-to-severe psoriasis.

Disclosures: The study did not receive any funding. P Gisondi and G Girolomoni declared serving as a consultant and/or speaker for various sources.

Source: Bellinato F et al. J Am Acad Dermatol. 2021 Aug 3. doi: 10.1016/j.jaad.2021.07.050.

Key clinical point: Compared with the general population, patients with moderate-to-severe plaque psoriasis were at an increased risk for lympho-hematological malignancies (LHM) and lymphoma, particularly cutaneous T-cell lymphoma (CTCL).

Major finding: Patients with moderate-to-severe plaque psoriasis vs general population had significantly higher risk for LHM (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.24-2.94) and lymphoma (HR, 1.27; 95% CI, 1.08-1.50). The risk for CTCL was markedly augmented in patients with psoriasis (HR, 6.22; 95% CI, 3.39-11.42).

Study details: Findings are from a meta-analysis of 25 observational studies including 2,501,652 study subjects. Most of the studies included patients with moderate-to-severe psoriasis.

Disclosures: The study did not receive any funding. P Gisondi and G Girolomoni declared serving as a consultant and/or speaker for various sources.

Source: Bellinato F et al. J Am Acad Dermatol. 2021 Aug 3. doi: 10.1016/j.jaad.2021.07.050.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

Most over-the-counter (OTC) products for molluscum contagiosum (MC) do not include sufficient information about their plant-based ingredients or appropriate dosing, according to an analysis of eight such products available to U.S. consumers

“It’s important for clinicians who see children with molluscum to be aware of the many products marketed to patients and to be able to provide objective information about them,” senior author Elaine Siegfried, MD, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session.

In the text of their abstract, Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and coauthors Isaac Hoft, of Open Mind Holistics in Ft. Collins, Colo., and Samantha K. Ong, BA, a student at SLU, noted that MC primarily infects children, with an annual incidence of 8%. “Although the disease is self-limited, associated symptoms, contagion and an average 1-year duration prompt concern and frequent medical visits,” they wrote.

The optimal treatment for MC has not been defined and there is currently no approved medication approved for the condition, although three products are in development: VP-102 (cantharidin) by Verrica Pharmaceuticals; SB206, a topical antiviral by Novan; and 10%-15% KOH formulation by the Gurina Foundation.

But many OTC products have been marketed to treat the condition. To identify the OTC products and to assess accompanying information related to safety, efficacy, and cost, the researchers performed an internet search using the terms “molluscum” plus “treatment,” “treatment at home,” “relief,” and “medication.” Eight products were identified for analysis: Conzerol (Elroselabs), Molleave (Innovative Med), Mollenol (Jeva Laboratories), MolluscumBLAST (Revitalize Life Organics), Molluscum Away Patches (Molluscum Away), Naturasil (Nature’s Innovation), Terrasil (Advanced Skincare % Topical Solutions), and Zymaderm (Naturopathix). Package sizes ranged from 0.78 to 1.5 ounces, and prices ranged from about $19 to almost $55.

Dr. Siegfried and colleagues found that all products provided instructions on application and use but most package labels did not include sufficient information about their plant-based ingredients or appropriate dosing. Six of the eight products contained Thuja occidentalis (Arbor vitae), a coniferous cedar whose essential oil has been used in homeopathic products for its anti-inflammatory and antiviral properties. Lemon extract, tea tree oil, and other botanicals were present in no more than three products each. Only two of the products provided information about the number of lesions that could be treated per package.

“The lack of national oversight as well as robust methods for high-level data analysis make safety and efficacy unclear for a Thuja extract marketed to treat MC,” the researchers wrote. “Numerous adverse drug events and positive intradermal skin tests related to Thuja have been reported.”

Dr. Siegfried added that many OTC products offer a money-back guarantee, “so when seeing a patient who failed to respond to one of these products, encourage them, at least, to request a refund, but to also submit a comment about lack of efficacy, in order to provide more balanced Internet information.”

Dr. Siegfried disclosed that she has served as an investigator and consultant for Verrica Pharmaceuticals, and as a consultant and Data Safety Monitoring board member for Novan, two of the companies currently developing drugs to treat molluscum. Her coauthors had no conflicts of interest to disclose.

[email protected]

Most over-the-counter (OTC) products for molluscum contagiosum (MC) do not include sufficient information about their plant-based ingredients or appropriate dosing, according to an analysis of eight such products available to U.S. consumers

“It’s important for clinicians who see children with molluscum to be aware of the many products marketed to patients and to be able to provide objective information about them,” senior author Elaine Siegfried, MD, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session.

In the text of their abstract, Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and coauthors Isaac Hoft, of Open Mind Holistics in Ft. Collins, Colo., and Samantha K. Ong, BA, a student at SLU, noted that MC primarily infects children, with an annual incidence of 8%. “Although the disease is self-limited, associated symptoms, contagion and an average 1-year duration prompt concern and frequent medical visits,” they wrote.

The optimal treatment for MC has not been defined and there is currently no approved medication approved for the condition, although three products are in development: VP-102 (cantharidin) by Verrica Pharmaceuticals; SB206, a topical antiviral by Novan; and 10%-15% KOH formulation by the Gurina Foundation.

But many OTC products have been marketed to treat the condition. To identify the OTC products and to assess accompanying information related to safety, efficacy, and cost, the researchers performed an internet search using the terms “molluscum” plus “treatment,” “treatment at home,” “relief,” and “medication.” Eight products were identified for analysis: Conzerol (Elroselabs), Molleave (Innovative Med), Mollenol (Jeva Laboratories), MolluscumBLAST (Revitalize Life Organics), Molluscum Away Patches (Molluscum Away), Naturasil (Nature’s Innovation), Terrasil (Advanced Skincare % Topical Solutions), and Zymaderm (Naturopathix). Package sizes ranged from 0.78 to 1.5 ounces, and prices ranged from about $19 to almost $55.

Dr. Siegfried and colleagues found that all products provided instructions on application and use but most package labels did not include sufficient information about their plant-based ingredients or appropriate dosing. Six of the eight products contained Thuja occidentalis (Arbor vitae), a coniferous cedar whose essential oil has been used in homeopathic products for its anti-inflammatory and antiviral properties. Lemon extract, tea tree oil, and other botanicals were present in no more than three products each. Only two of the products provided information about the number of lesions that could be treated per package.

“The lack of national oversight as well as robust methods for high-level data analysis make safety and efficacy unclear for a Thuja extract marketed to treat MC,” the researchers wrote. “Numerous adverse drug events and positive intradermal skin tests related to Thuja have been reported.”

Dr. Siegfried added that many OTC products offer a money-back guarantee, “so when seeing a patient who failed to respond to one of these products, encourage them, at least, to request a refund, but to also submit a comment about lack of efficacy, in order to provide more balanced Internet information.”

Dr. Siegfried disclosed that she has served as an investigator and consultant for Verrica Pharmaceuticals, and as a consultant and Data Safety Monitoring board member for Novan, two of the companies currently developing drugs to treat molluscum. Her coauthors had no conflicts of interest to disclose.

[email protected]

Most over-the-counter (OTC) products for molluscum contagiosum (MC) do not include sufficient information about their plant-based ingredients or appropriate dosing, according to an analysis of eight such products available to U.S. consumers

“It’s important for clinicians who see children with molluscum to be aware of the many products marketed to patients and to be able to provide objective information about them,” senior author Elaine Siegfried, MD, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session.

In the text of their abstract, Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and coauthors Isaac Hoft, of Open Mind Holistics in Ft. Collins, Colo., and Samantha K. Ong, BA, a student at SLU, noted that MC primarily infects children, with an annual incidence of 8%. “Although the disease is self-limited, associated symptoms, contagion and an average 1-year duration prompt concern and frequent medical visits,” they wrote.

The optimal treatment for MC has not been defined and there is currently no approved medication approved for the condition, although three products are in development: VP-102 (cantharidin) by Verrica Pharmaceuticals; SB206, a topical antiviral by Novan; and 10%-15% KOH formulation by the Gurina Foundation.

But many OTC products have been marketed to treat the condition. To identify the OTC products and to assess accompanying information related to safety, efficacy, and cost, the researchers performed an internet search using the terms “molluscum” plus “treatment,” “treatment at home,” “relief,” and “medication.” Eight products were identified for analysis: Conzerol (Elroselabs), Molleave (Innovative Med), Mollenol (Jeva Laboratories), MolluscumBLAST (Revitalize Life Organics), Molluscum Away Patches (Molluscum Away), Naturasil (Nature’s Innovation), Terrasil (Advanced Skincare % Topical Solutions), and Zymaderm (Naturopathix). Package sizes ranged from 0.78 to 1.5 ounces, and prices ranged from about $19 to almost $55.

Dr. Siegfried and colleagues found that all products provided instructions on application and use but most package labels did not include sufficient information about their plant-based ingredients or appropriate dosing. Six of the eight products contained Thuja occidentalis (Arbor vitae), a coniferous cedar whose essential oil has been used in homeopathic products for its anti-inflammatory and antiviral properties. Lemon extract, tea tree oil, and other botanicals were present in no more than three products each. Only two of the products provided information about the number of lesions that could be treated per package.

“The lack of national oversight as well as robust methods for high-level data analysis make safety and efficacy unclear for a Thuja extract marketed to treat MC,” the researchers wrote. “Numerous adverse drug events and positive intradermal skin tests related to Thuja have been reported.”

Dr. Siegfried added that many OTC products offer a money-back guarantee, “so when seeing a patient who failed to respond to one of these products, encourage them, at least, to request a refund, but to also submit a comment about lack of efficacy, in order to provide more balanced Internet information.”

Dr. Siegfried disclosed that she has served as an investigator and consultant for Verrica Pharmaceuticals, and as a consultant and Data Safety Monitoring board member for Novan, two of the companies currently developing drugs to treat molluscum. Her coauthors had no conflicts of interest to disclose.

[email protected]