Psoriasis

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.

Bimekizumab has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults, according to a statement from the manufacturer.

Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F, the statement from UCB said.

In the United States, the Food and Drug Administration is expected to make a decision on approval of bimekizumab for treating psoriasis on Oct. 15.

Approval in the EU was based on data from three phase 3 trials including a total of 1,480 adult patients with moderate to severe psoriasis, which found that those treated with bimekizumab experienced significantly greater skin clearance, compared with placebo, ustekinumab, and adalimumab, with a favorable safety profile, according to the company.

In all three studies (BE VIVID, BE READY, and BE SURE), more than 80% of patients treated with bimekizumab showed improved skin clearance after 16 weeks, significantly more than those treated with ustekinumab, placebo, or adalimumab, based on an improvement of at least 90% in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). In all three studies, these clinical responses persisted after 1 year.

The recommended dose of bimekizumab is 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks. However, for “some patients” weighing 120 kg or more who have not achieved complete skin clearance at 16 weeks, 320 mg every 4 weeks after that time may improve response to treatment, according to the company statement.

The most common treatment-related adverse events in the studies were upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.

Results of BE READY and BE VIVID were published in The Lancet. Results of the BE SURE study were published in The New England Journal of Medicine.

Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance. More details on bimekizumab are available on the website of the European Medicines Agency.

Bimekizumab has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults, according to a statement from the manufacturer.

Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F, the statement from UCB said.

In the United States, the Food and Drug Administration is expected to make a decision on approval of bimekizumab for treating psoriasis on Oct. 15.

Approval in the EU was based on data from three phase 3 trials including a total of 1,480 adult patients with moderate to severe psoriasis, which found that those treated with bimekizumab experienced significantly greater skin clearance, compared with placebo, ustekinumab, and adalimumab, with a favorable safety profile, according to the company.

In all three studies (BE VIVID, BE READY, and BE SURE), more than 80% of patients treated with bimekizumab showed improved skin clearance after 16 weeks, significantly more than those treated with ustekinumab, placebo, or adalimumab, based on an improvement of at least 90% in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). In all three studies, these clinical responses persisted after 1 year.

The recommended dose of bimekizumab is 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks. However, for “some patients” weighing 120 kg or more who have not achieved complete skin clearance at 16 weeks, 320 mg every 4 weeks after that time may improve response to treatment, according to the company statement.

The most common treatment-related adverse events in the studies were upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.

Results of BE READY and BE VIVID were published in The Lancet. Results of the BE SURE study were published in The New England Journal of Medicine.

Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance. More details on bimekizumab are available on the website of the European Medicines Agency.

Bimekizumab has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults, according to a statement from the manufacturer.

Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F, the statement from UCB said.

In the United States, the Food and Drug Administration is expected to make a decision on approval of bimekizumab for treating psoriasis on Oct. 15.

Approval in the EU was based on data from three phase 3 trials including a total of 1,480 adult patients with moderate to severe psoriasis, which found that those treated with bimekizumab experienced significantly greater skin clearance, compared with placebo, ustekinumab, and adalimumab, with a favorable safety profile, according to the company.

In all three studies (BE VIVID, BE READY, and BE SURE), more than 80% of patients treated with bimekizumab showed improved skin clearance after 16 weeks, significantly more than those treated with ustekinumab, placebo, or adalimumab, based on an improvement of at least 90% in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). In all three studies, these clinical responses persisted after 1 year.

The recommended dose of bimekizumab is 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks. However, for “some patients” weighing 120 kg or more who have not achieved complete skin clearance at 16 weeks, 320 mg every 4 weeks after that time may improve response to treatment, according to the company statement.

The most common treatment-related adverse events in the studies were upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.

Results of BE READY and BE VIVID were published in The Lancet. Results of the BE SURE study were published in The New England Journal of Medicine.

Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance. More details on bimekizumab are available on the website of the European Medicines Agency.

Annual health care costs for patients with psoriatic arthritis rose over recent 5-year periods across all categories of resource use to a significantly greater extent than among patients with psoriasis only or those without any psoriatic disease diagnoses, according to commercial insurance claims data.

Thinkstock Photos

Using an IBM MarketScan Commercial Database, researchers examined claims data for 208,434 patients with psoriasis, 47,274 with PsA, and 255,708 controls who had neither psoriasis nor PsA. Controls were matched for age and sex. Those with RA, ankylosing spondylitis, Crohn’s disease, or ulcerative colitis were excluded.

The investigators examined data for 2009-2020, following patients for 5 years within that period. They looked at hospitalizations, outpatient and pharmacy services, lab services, and office visits, Steven Peterson, director of market access for rheumatology at Janssen Pharmaceuticals, said in his presentation of the data at the Pan American League of Associations for Rheumatology 2021 annual meeting, held recently as a virtual event.

The research was also published online May 2, 2021, in Clinical Rheumatology.

Big differences between the groups were seen in the first year, when the average health care costs for the PsA group were $28,322, about half of which was outpatient drug costs. That compared with $12,039 for the psoriasis group and $6,672 for the control group.

The differences tended to widen over time. By the fifth year, average costs for the PsA group were $34,290, nearly 60% of which were drug costs. That compared with $12,877 for the psoriasis group and $8,569 for the control group. In each year examined, outpatient drug costs accounted for less than half of the expenses for the psoriasis group and about a quarter for the control group.

Researchers found that the PsA group needed 28.7 prescriptions per person per year, compared with 17.0 and 12.7 in the psoriasis and control groups, respectively, Mr. Peterson said. He also noted that patients with PsA and psoriasis tended to have higher rates of hypertension, depression, and anxiety.

“The cost and resource utilization disparity between these patient groups demonstrates the high remaining unmet medical need for patients with psoriasis and psoriatic arthritis,” Mr. Peterson said during the virtual proceedings.

Do findings reflect treatment advances?

Elaine Husni, MD, MPH, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic, where she studies health outcomes in PsA, said the findings are helpful in pointing to a trend across a large sample. But she added it’s important to remember that the increasing costs could reflect recent advances in PsA treatment, which include costly biologic drugs.

“There’s a ton more treatments for psoriasis and psoriatic arthritis than there were even just 5 years ago,” she said in an interview. She was not involved in the research.

Dr. Husni would like to see a more detailed look at the costs, from the categories of expenses to the patients who are incurring the highest costs.  

“Is it just a couple of percent of really sick patients that are driving the psoriatic arthritis group?” she wondered.

She also pointed out that PsA is going to be more expensive by its very nature. PsA tends to develop 3-10 years after psoriasis, adding to the costs for someone who already has psoriasis and at a time when they are older and likely have higher health care costs because of comorbidities that develop with age.

Dr. Husni said she does think about treatment costs, in that a less expensive first-line drug might be more appropriate than going straight to a more expensive biologic, especially because they also tend to be safer. She said it’s not just a simple question of curbing costs.

“Is there a way that we can personalize medicine?” she asked. “Is there a way that we can be more accurate about which people may need the more expensive drugs, and which patients may need the less expensive drugs? Are we getting better at monitoring so we can avoid high-cost events?”

Mr. Peterson is an employee of Janssen Pharmaceuticals. Dr. Husni reported serving as a consultant to AbbVie, Amgen, Bristol-Myers Squibb, UCB, Novartis, Lilly, and Pfizer.

* Update, 9/28/21: The headline and parts of this story were updated to better reflect the study on which it reports.

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

Annual health care costs for patients with psoriatic arthritis rose over recent 5-year periods across all categories of resource use to a significantly greater extent than among patients with psoriasis only or those without any psoriatic disease diagnoses, according to commercial insurance claims data.

Thinkstock Photos

Using an IBM MarketScan Commercial Database, researchers examined claims data for 208,434 patients with psoriasis, 47,274 with PsA, and 255,708 controls who had neither psoriasis nor PsA. Controls were matched for age and sex. Those with RA, ankylosing spondylitis, Crohn’s disease, or ulcerative colitis were excluded.

The investigators examined data for 2009-2020, following patients for 5 years within that period. They looked at hospitalizations, outpatient and pharmacy services, lab services, and office visits, Steven Peterson, director of market access for rheumatology at Janssen Pharmaceuticals, said in his presentation of the data at the Pan American League of Associations for Rheumatology 2021 annual meeting, held recently as a virtual event.

The research was also published online May 2, 2021, in Clinical Rheumatology.

Big differences between the groups were seen in the first year, when the average health care costs for the PsA group were $28,322, about half of which was outpatient drug costs. That compared with $12,039 for the psoriasis group and $6,672 for the control group.

The differences tended to widen over time. By the fifth year, average costs for the PsA group were $34,290, nearly 60% of which were drug costs. That compared with $12,877 for the psoriasis group and $8,569 for the control group. In each year examined, outpatient drug costs accounted for less than half of the expenses for the psoriasis group and about a quarter for the control group.

Researchers found that the PsA group needed 28.7 prescriptions per person per year, compared with 17.0 and 12.7 in the psoriasis and control groups, respectively, Mr. Peterson said. He also noted that patients with PsA and psoriasis tended to have higher rates of hypertension, depression, and anxiety.

“The cost and resource utilization disparity between these patient groups demonstrates the high remaining unmet medical need for patients with psoriasis and psoriatic arthritis,” Mr. Peterson said during the virtual proceedings.

Do findings reflect treatment advances?

Elaine Husni, MD, MPH, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic, where she studies health outcomes in PsA, said the findings are helpful in pointing to a trend across a large sample. But she added it’s important to remember that the increasing costs could reflect recent advances in PsA treatment, which include costly biologic drugs.

“There’s a ton more treatments for psoriasis and psoriatic arthritis than there were even just 5 years ago,” she said in an interview. She was not involved in the research.

Dr. Husni would like to see a more detailed look at the costs, from the categories of expenses to the patients who are incurring the highest costs.  

“Is it just a couple of percent of really sick patients that are driving the psoriatic arthritis group?” she wondered.

She also pointed out that PsA is going to be more expensive by its very nature. PsA tends to develop 3-10 years after psoriasis, adding to the costs for someone who already has psoriasis and at a time when they are older and likely have higher health care costs because of comorbidities that develop with age.

Dr. Husni said she does think about treatment costs, in that a less expensive first-line drug might be more appropriate than going straight to a more expensive biologic, especially because they also tend to be safer. She said it’s not just a simple question of curbing costs.

“Is there a way that we can personalize medicine?” she asked. “Is there a way that we can be more accurate about which people may need the more expensive drugs, and which patients may need the less expensive drugs? Are we getting better at monitoring so we can avoid high-cost events?”

Mr. Peterson is an employee of Janssen Pharmaceuticals. Dr. Husni reported serving as a consultant to AbbVie, Amgen, Bristol-Myers Squibb, UCB, Novartis, Lilly, and Pfizer.

* Update, 9/28/21: The headline and parts of this story were updated to better reflect the study on which it reports.

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

Annual health care costs for patients with psoriatic arthritis rose over recent 5-year periods across all categories of resource use to a significantly greater extent than among patients with psoriasis only or those without any psoriatic disease diagnoses, according to commercial insurance claims data.

Thinkstock Photos

Using an IBM MarketScan Commercial Database, researchers examined claims data for 208,434 patients with psoriasis, 47,274 with PsA, and 255,708 controls who had neither psoriasis nor PsA. Controls were matched for age and sex. Those with RA, ankylosing spondylitis, Crohn’s disease, or ulcerative colitis were excluded.

The investigators examined data for 2009-2020, following patients for 5 years within that period. They looked at hospitalizations, outpatient and pharmacy services, lab services, and office visits, Steven Peterson, director of market access for rheumatology at Janssen Pharmaceuticals, said in his presentation of the data at the Pan American League of Associations for Rheumatology 2021 annual meeting, held recently as a virtual event.

The research was also published online May 2, 2021, in Clinical Rheumatology.

Big differences between the groups were seen in the first year, when the average health care costs for the PsA group were $28,322, about half of which was outpatient drug costs. That compared with $12,039 for the psoriasis group and $6,672 for the control group.

The differences tended to widen over time. By the fifth year, average costs for the PsA group were $34,290, nearly 60% of which were drug costs. That compared with $12,877 for the psoriasis group and $8,569 for the control group. In each year examined, outpatient drug costs accounted for less than half of the expenses for the psoriasis group and about a quarter for the control group.

Researchers found that the PsA group needed 28.7 prescriptions per person per year, compared with 17.0 and 12.7 in the psoriasis and control groups, respectively, Mr. Peterson said. He also noted that patients with PsA and psoriasis tended to have higher rates of hypertension, depression, and anxiety.

“The cost and resource utilization disparity between these patient groups demonstrates the high remaining unmet medical need for patients with psoriasis and psoriatic arthritis,” Mr. Peterson said during the virtual proceedings.

Do findings reflect treatment advances?

Elaine Husni, MD, MPH, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic, where she studies health outcomes in PsA, said the findings are helpful in pointing to a trend across a large sample. But she added it’s important to remember that the increasing costs could reflect recent advances in PsA treatment, which include costly biologic drugs.

“There’s a ton more treatments for psoriasis and psoriatic arthritis than there were even just 5 years ago,” she said in an interview. She was not involved in the research.

Dr. Husni would like to see a more detailed look at the costs, from the categories of expenses to the patients who are incurring the highest costs.  

“Is it just a couple of percent of really sick patients that are driving the psoriatic arthritis group?” she wondered.

She also pointed out that PsA is going to be more expensive by its very nature. PsA tends to develop 3-10 years after psoriasis, adding to the costs for someone who already has psoriasis and at a time when they are older and likely have higher health care costs because of comorbidities that develop with age.

Dr. Husni said she does think about treatment costs, in that a less expensive first-line drug might be more appropriate than going straight to a more expensive biologic, especially because they also tend to be safer. She said it’s not just a simple question of curbing costs.

“Is there a way that we can personalize medicine?” she asked. “Is there a way that we can be more accurate about which people may need the more expensive drugs, and which patients may need the less expensive drugs? Are we getting better at monitoring so we can avoid high-cost events?”

Mr. Peterson is an employee of Janssen Pharmaceuticals. Dr. Husni reported serving as a consultant to AbbVie, Amgen, Bristol-Myers Squibb, UCB, Novartis, Lilly, and Pfizer.

* Update, 9/28/21: The headline and parts of this story were updated to better reflect the study on which it reports.

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