AVT02 as effective as reference adalimumab in moderate-to-severe plaque psoriasis

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Key clinical point: The biosimilar AVT02 is as efficacious, safe, and immunogenic as its originator, adalimumab, in moderate-to-severe chronic plaque psoriasis.

Major finding: At week 16, AVT02 and originator adalimumab induced comparable percentage improvement in Psoriasis Area Severity Index (91.6% and 89.6%, respectively), with the difference in percentage improvement within the predefined equivalence margins of ±10% (90% CI, −0.76 to 5.29), along with similar safety, tolerability, and immunogenicity profiles, which lasted through week 50.

Study details: This was a phase 3 study including 413 adult patients with moderate-to-severe chronic plaque psoriasis who were initially assigned to receive AVT02 or adalimumab; at week 16, the latter were randomly reassigned to continue receiving adalimumab or switch to AVT02 until week 48.

Disclosures: The study was sponsored by Alvotech Swiss AG. SR Feldman and R Kay disclosed receiving research grants, speaker honoraria, or consultancy fees from various sources, including Alvotech, and some of the authors declared being employees of Alvotech.

Source: Feldman SR et al. BioDrugs. 2021 Oct 16. doi: 10.1007/s40259-021-00502-w.

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Key clinical point: The biosimilar AVT02 is as efficacious, safe, and immunogenic as its originator, adalimumab, in moderate-to-severe chronic plaque psoriasis.

Major finding: At week 16, AVT02 and originator adalimumab induced comparable percentage improvement in Psoriasis Area Severity Index (91.6% and 89.6%, respectively), with the difference in percentage improvement within the predefined equivalence margins of ±10% (90% CI, −0.76 to 5.29), along with similar safety, tolerability, and immunogenicity profiles, which lasted through week 50.

Study details: This was a phase 3 study including 413 adult patients with moderate-to-severe chronic plaque psoriasis who were initially assigned to receive AVT02 or adalimumab; at week 16, the latter were randomly reassigned to continue receiving adalimumab or switch to AVT02 until week 48.

Disclosures: The study was sponsored by Alvotech Swiss AG. SR Feldman and R Kay disclosed receiving research grants, speaker honoraria, or consultancy fees from various sources, including Alvotech, and some of the authors declared being employees of Alvotech.

Source: Feldman SR et al. BioDrugs. 2021 Oct 16. doi: 10.1007/s40259-021-00502-w.

Key clinical point: The biosimilar AVT02 is as efficacious, safe, and immunogenic as its originator, adalimumab, in moderate-to-severe chronic plaque psoriasis.

Major finding: At week 16, AVT02 and originator adalimumab induced comparable percentage improvement in Psoriasis Area Severity Index (91.6% and 89.6%, respectively), with the difference in percentage improvement within the predefined equivalence margins of ±10% (90% CI, −0.76 to 5.29), along with similar safety, tolerability, and immunogenicity profiles, which lasted through week 50.

Study details: This was a phase 3 study including 413 adult patients with moderate-to-severe chronic plaque psoriasis who were initially assigned to receive AVT02 or adalimumab; at week 16, the latter were randomly reassigned to continue receiving adalimumab or switch to AVT02 until week 48.

Disclosures: The study was sponsored by Alvotech Swiss AG. SR Feldman and R Kay disclosed receiving research grants, speaker honoraria, or consultancy fees from various sources, including Alvotech, and some of the authors declared being employees of Alvotech.

Source: Feldman SR et al. BioDrugs. 2021 Oct 16. doi: 10.1007/s40259-021-00502-w.

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Ixekizumab bests secukinumab in the real-world race against psoriasis

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Key clinical point: Compared with secukinumab, ixekizumab concorded with significantly increased adherence rates and decreased nonpersistence, discontinuation, and switching in biologic-experienced patients with psoriasis.

Major finding: After 18 months of follow-up, ixekizumab was associated with significantly higher rates of high treatment adherence (42% vs 35%; P = .019) and persistence (44.9% vs 36.9%; P = .007) and lower discontinuation (48.4% vs 56.0%; P = .018) and switching (26.6% vs 34.0%; P = .009) rates than secukinumab.

Study details: Findings are from a retrospective observational study consisting of prior biologic-experienced adult patients with psoriasis now receiving either secukinumab (n=780) or ixekizumab (n=411).

Disclosures: The study was supported by Eli Lilly and Company, USA. The lead author declared serving as a scientific advisor/clinical study investigator for various companies including Eli Lilly. Some of the authors are full-time employees or stakeholders of Eli Lilly, and a few others work for an alternative employer, which received compensation from Eli Lilly.

Source: Blauvelt A et al. Dermatol Ther (Heidelb). 2021 Oct 15. doi: 10.1007/s13555-021-00627-4.

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Key clinical point: Compared with secukinumab, ixekizumab concorded with significantly increased adherence rates and decreased nonpersistence, discontinuation, and switching in biologic-experienced patients with psoriasis.

Major finding: After 18 months of follow-up, ixekizumab was associated with significantly higher rates of high treatment adherence (42% vs 35%; P = .019) and persistence (44.9% vs 36.9%; P = .007) and lower discontinuation (48.4% vs 56.0%; P = .018) and switching (26.6% vs 34.0%; P = .009) rates than secukinumab.

Study details: Findings are from a retrospective observational study consisting of prior biologic-experienced adult patients with psoriasis now receiving either secukinumab (n=780) or ixekizumab (n=411).

Disclosures: The study was supported by Eli Lilly and Company, USA. The lead author declared serving as a scientific advisor/clinical study investigator for various companies including Eli Lilly. Some of the authors are full-time employees or stakeholders of Eli Lilly, and a few others work for an alternative employer, which received compensation from Eli Lilly.

Source: Blauvelt A et al. Dermatol Ther (Heidelb). 2021 Oct 15. doi: 10.1007/s13555-021-00627-4.

Key clinical point: Compared with secukinumab, ixekizumab concorded with significantly increased adherence rates and decreased nonpersistence, discontinuation, and switching in biologic-experienced patients with psoriasis.

Major finding: After 18 months of follow-up, ixekizumab was associated with significantly higher rates of high treatment adherence (42% vs 35%; P = .019) and persistence (44.9% vs 36.9%; P = .007) and lower discontinuation (48.4% vs 56.0%; P = .018) and switching (26.6% vs 34.0%; P = .009) rates than secukinumab.

Study details: Findings are from a retrospective observational study consisting of prior biologic-experienced adult patients with psoriasis now receiving either secukinumab (n=780) or ixekizumab (n=411).

Disclosures: The study was supported by Eli Lilly and Company, USA. The lead author declared serving as a scientific advisor/clinical study investigator for various companies including Eli Lilly. Some of the authors are full-time employees or stakeholders of Eli Lilly, and a few others work for an alternative employer, which received compensation from Eli Lilly.

Source: Blauvelt A et al. Dermatol Ther (Heidelb). 2021 Oct 15. doi: 10.1007/s13555-021-00627-4.

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Tapinarof cream 1% QD efficacious against extensive plaque psoriasis in phase 2a

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Key clinical point: Tapinarof cream 1% applied once daily (QD) displayed significant efficacy after 4 weeks along with good tolerability and limited systemic exposure in patients with extensive plaque psoriasis.

Major finding: At day 29, the mean Psoriasis Area Severity Index score changed significantly with a mean percentage change from baseline of −59.56% (95% CI, −73.53% to −45.59%) and the tapinarof plasma concentration remained below the quantification level (< 50 pg/mL) in the majority (67.9%) of patients; 17 patients reported no irritation and 2 had mild irritation at the application site.

Study details: Findings are from a phase 2a trial involving 21 adult patients with extensive plaque psoriasis (20% or more body surface area involvement) who applied tapinarof cream 1% QD for 29 days.

Disclosures: The study was supported by Dermavant Sciences, Inc. Some of the authors, including the lead author, declared serving as an employee or investigator for Dermavant Sciences, Inc.

Source: Jett JE et al. Am J Clin Dermatol. 2021 Oct 28. doi: 10.1007/s40257-021-00641-4.

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Key clinical point: Tapinarof cream 1% applied once daily (QD) displayed significant efficacy after 4 weeks along with good tolerability and limited systemic exposure in patients with extensive plaque psoriasis.

Major finding: At day 29, the mean Psoriasis Area Severity Index score changed significantly with a mean percentage change from baseline of −59.56% (95% CI, −73.53% to −45.59%) and the tapinarof plasma concentration remained below the quantification level (< 50 pg/mL) in the majority (67.9%) of patients; 17 patients reported no irritation and 2 had mild irritation at the application site.

Study details: Findings are from a phase 2a trial involving 21 adult patients with extensive plaque psoriasis (20% or more body surface area involvement) who applied tapinarof cream 1% QD for 29 days.

Disclosures: The study was supported by Dermavant Sciences, Inc. Some of the authors, including the lead author, declared serving as an employee or investigator for Dermavant Sciences, Inc.

Source: Jett JE et al. Am J Clin Dermatol. 2021 Oct 28. doi: 10.1007/s40257-021-00641-4.

Key clinical point: Tapinarof cream 1% applied once daily (QD) displayed significant efficacy after 4 weeks along with good tolerability and limited systemic exposure in patients with extensive plaque psoriasis.

Major finding: At day 29, the mean Psoriasis Area Severity Index score changed significantly with a mean percentage change from baseline of −59.56% (95% CI, −73.53% to −45.59%) and the tapinarof plasma concentration remained below the quantification level (< 50 pg/mL) in the majority (67.9%) of patients; 17 patients reported no irritation and 2 had mild irritation at the application site.

Study details: Findings are from a phase 2a trial involving 21 adult patients with extensive plaque psoriasis (20% or more body surface area involvement) who applied tapinarof cream 1% QD for 29 days.

Disclosures: The study was supported by Dermavant Sciences, Inc. Some of the authors, including the lead author, declared serving as an employee or investigator for Dermavant Sciences, Inc.

Source: Jett JE et al. Am J Clin Dermatol. 2021 Oct 28. doi: 10.1007/s40257-021-00641-4.

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Is beta-blocker use in hypertension linked with psoriasis development?

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Key clinical point: Clinical avoidance of beta-blockers (BBs) should not be considered a prerequisite for solely avoiding the onset of de novo psoriasis in patients with hypertension.

Major finding: Overall, 0.2% and 0.4% of patients developed de novo psoriasis in the first and second years after BB initiation, which was not significantly different from patients without exposure to BB (P = .77 and P = .96; respectively). The odds of de novo psoriasis were not significantly higher in patients with exposure to BB than those unexposed (odds ratio, 1.00; 95% CI, 0.60-1.67).

Study details: Findings are from a nationwide population-based retrospective cohort study including 105,529 patients aged 19 years or above with hypertension who had not been diagnosed with psoriasis.

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

Source: Kim YE et al. J Eur Acad Dermatol Venereol. 2021 Oct 9. doi: 10.1111/jdv.17733.

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Key clinical point: Clinical avoidance of beta-blockers (BBs) should not be considered a prerequisite for solely avoiding the onset of de novo psoriasis in patients with hypertension.

Major finding: Overall, 0.2% and 0.4% of patients developed de novo psoriasis in the first and second years after BB initiation, which was not significantly different from patients without exposure to BB (P = .77 and P = .96; respectively). The odds of de novo psoriasis were not significantly higher in patients with exposure to BB than those unexposed (odds ratio, 1.00; 95% CI, 0.60-1.67).

Study details: Findings are from a nationwide population-based retrospective cohort study including 105,529 patients aged 19 years or above with hypertension who had not been diagnosed with psoriasis.

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

Source: Kim YE et al. J Eur Acad Dermatol Venereol. 2021 Oct 9. doi: 10.1111/jdv.17733.

Key clinical point: Clinical avoidance of beta-blockers (BBs) should not be considered a prerequisite for solely avoiding the onset of de novo psoriasis in patients with hypertension.

Major finding: Overall, 0.2% and 0.4% of patients developed de novo psoriasis in the first and second years after BB initiation, which was not significantly different from patients without exposure to BB (P = .77 and P = .96; respectively). The odds of de novo psoriasis were not significantly higher in patients with exposure to BB than those unexposed (odds ratio, 1.00; 95% CI, 0.60-1.67).

Study details: Findings are from a nationwide population-based retrospective cohort study including 105,529 patients aged 19 years or above with hypertension who had not been diagnosed with psoriasis.

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

Source: Kim YE et al. J Eur Acad Dermatol Venereol. 2021 Oct 9. doi: 10.1111/jdv.17733.

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Phase 2a supports infrequent bimekizumab dosing for plaque psoriasis maintenance

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Key clinical point: Bimekizumab may be dosed every 8 weeks during maintenance therapy for plaque psoriasis in contrast to the 4-week dosing regimen typically adopted for anti-interleukin-17A biologics.

Major finding: The absolute change in Psoriasis Area Severity Index (PASI) at week 28 in patients receiving an additional bimekizumab dose vs placebo was −19.7 (95% CI, −24.2 to −15.2) vs −10.8 (95% CI, −13.5 to −8.0). Patients receiving placebo vs bimekizumab at week 16 showed a higher reduction in PASI 100 (−34.4% vs −11.7%) and Investigator's Global Assessment 0/1 (−62.5% vs 0.0%) response rates between weeks 16 and 28.

Study details: This was a prospective phase 2a study including 49 patients with moderate-to-severe plaque psoriasis who received bimekizumab at weeks 0 and 4 and were subsequently randomly assigned to receive either placebo or bimekizumab third dose at week 16.

Disclosures: The study was sponsored by UCB Pharma. Most of the authors including the lead author declared serving as employees of UCB Pharma, and some received research grants or consultation fees from various sources including UCB Pharma.

Source: Oliver R et al. Br J Dermatol. 2021 Oct 23. doi: 10.1111/bjd.20827.

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Key clinical point: Bimekizumab may be dosed every 8 weeks during maintenance therapy for plaque psoriasis in contrast to the 4-week dosing regimen typically adopted for anti-interleukin-17A biologics.

Major finding: The absolute change in Psoriasis Area Severity Index (PASI) at week 28 in patients receiving an additional bimekizumab dose vs placebo was −19.7 (95% CI, −24.2 to −15.2) vs −10.8 (95% CI, −13.5 to −8.0). Patients receiving placebo vs bimekizumab at week 16 showed a higher reduction in PASI 100 (−34.4% vs −11.7%) and Investigator's Global Assessment 0/1 (−62.5% vs 0.0%) response rates between weeks 16 and 28.

Study details: This was a prospective phase 2a study including 49 patients with moderate-to-severe plaque psoriasis who received bimekizumab at weeks 0 and 4 and were subsequently randomly assigned to receive either placebo or bimekizumab third dose at week 16.

Disclosures: The study was sponsored by UCB Pharma. Most of the authors including the lead author declared serving as employees of UCB Pharma, and some received research grants or consultation fees from various sources including UCB Pharma.

Source: Oliver R et al. Br J Dermatol. 2021 Oct 23. doi: 10.1111/bjd.20827.

Key clinical point: Bimekizumab may be dosed every 8 weeks during maintenance therapy for plaque psoriasis in contrast to the 4-week dosing regimen typically adopted for anti-interleukin-17A biologics.

Major finding: The absolute change in Psoriasis Area Severity Index (PASI) at week 28 in patients receiving an additional bimekizumab dose vs placebo was −19.7 (95% CI, −24.2 to −15.2) vs −10.8 (95% CI, −13.5 to −8.0). Patients receiving placebo vs bimekizumab at week 16 showed a higher reduction in PASI 100 (−34.4% vs −11.7%) and Investigator's Global Assessment 0/1 (−62.5% vs 0.0%) response rates between weeks 16 and 28.

Study details: This was a prospective phase 2a study including 49 patients with moderate-to-severe plaque psoriasis who received bimekizumab at weeks 0 and 4 and were subsequently randomly assigned to receive either placebo or bimekizumab third dose at week 16.

Disclosures: The study was sponsored by UCB Pharma. Most of the authors including the lead author declared serving as employees of UCB Pharma, and some received research grants or consultation fees from various sources including UCB Pharma.

Source: Oliver R et al. Br J Dermatol. 2021 Oct 23. doi: 10.1111/bjd.20827.

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Novel CAL/BDP PAD-cream outshines the conventional counterpart

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Key clinical point: The novel calcipotriol (CAL)/betamethasone dipropionate (BDP) PAD-cream offered greater benefits than the currently available topical suspension/gel (CAL/BDP TS) in terms of efficacy and patient quality of life along with favorable safety in plaque psoriasis.

Major finding: At 8 weeks, CAL/BDP PAD-cream vs CAL/BDP TS was associated with a significantly higher Physician's Global Assessment success rate (43.2% vs 31.9%; P < .0001), mean percent reduction in modified Psoriasis Area Severity Index (64.6% vs 56.4%; P < .0001), and Dermatology Life Quality Index 0/1 response rate (43.8% vs 34.2%; P = .0005) and no adverse drug reaction with a frequency greater than 1%.

Study details: This is a pooled analysis of 2 phase 3 trials consisting of a combined 1,271 patients with mild-to-moderate plaque psoriasis, treated with either CAL/BDP PAD-cream (n=551), CAL/BDP TS (n=542), or vehicle (n=178).

Disclosures: Both trials were sponsored by MC2 Therapeutics, Denmark. Some of the authors including the lead author received investigator honoraria for phase 3 trials from MC2, and the rest are employees of MC2.

Source: Pinter A et al. J Eur Acad Dermatol Venereol. 2021 Oct 10. doi: 10.1111/jdv.17734.

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Key clinical point: The novel calcipotriol (CAL)/betamethasone dipropionate (BDP) PAD-cream offered greater benefits than the currently available topical suspension/gel (CAL/BDP TS) in terms of efficacy and patient quality of life along with favorable safety in plaque psoriasis.

Major finding: At 8 weeks, CAL/BDP PAD-cream vs CAL/BDP TS was associated with a significantly higher Physician's Global Assessment success rate (43.2% vs 31.9%; P < .0001), mean percent reduction in modified Psoriasis Area Severity Index (64.6% vs 56.4%; P < .0001), and Dermatology Life Quality Index 0/1 response rate (43.8% vs 34.2%; P = .0005) and no adverse drug reaction with a frequency greater than 1%.

Study details: This is a pooled analysis of 2 phase 3 trials consisting of a combined 1,271 patients with mild-to-moderate plaque psoriasis, treated with either CAL/BDP PAD-cream (n=551), CAL/BDP TS (n=542), or vehicle (n=178).

Disclosures: Both trials were sponsored by MC2 Therapeutics, Denmark. Some of the authors including the lead author received investigator honoraria for phase 3 trials from MC2, and the rest are employees of MC2.

Source: Pinter A et al. J Eur Acad Dermatol Venereol. 2021 Oct 10. doi: 10.1111/jdv.17734.

Key clinical point: The novel calcipotriol (CAL)/betamethasone dipropionate (BDP) PAD-cream offered greater benefits than the currently available topical suspension/gel (CAL/BDP TS) in terms of efficacy and patient quality of life along with favorable safety in plaque psoriasis.

Major finding: At 8 weeks, CAL/BDP PAD-cream vs CAL/BDP TS was associated with a significantly higher Physician's Global Assessment success rate (43.2% vs 31.9%; P < .0001), mean percent reduction in modified Psoriasis Area Severity Index (64.6% vs 56.4%; P < .0001), and Dermatology Life Quality Index 0/1 response rate (43.8% vs 34.2%; P = .0005) and no adverse drug reaction with a frequency greater than 1%.

Study details: This is a pooled analysis of 2 phase 3 trials consisting of a combined 1,271 patients with mild-to-moderate plaque psoriasis, treated with either CAL/BDP PAD-cream (n=551), CAL/BDP TS (n=542), or vehicle (n=178).

Disclosures: Both trials were sponsored by MC2 Therapeutics, Denmark. Some of the authors including the lead author received investigator honoraria for phase 3 trials from MC2, and the rest are employees of MC2.

Source: Pinter A et al. J Eur Acad Dermatol Venereol. 2021 Oct 10. doi: 10.1111/jdv.17734.

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Preventing psoriasis relapse after ustekinumab withdrawal using abatacept: A failed attempt

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Key clinical point: Abatacept-mediated CD28-CD80/CD86 blockade was inept at averting psoriasis relapse following ustekinumab withdrawal in patients with moderate-to-severe plaque psoriasis.

Major finding: Between weeks 12 and 88, abatacept vs ustekinumab groups displayed similar relapse rates (91.1% vs 87.0%; P = .41) and median time to relapse from the last dose of ustekinumab (36 weeks [95% CI, 36-48] vs 32 weeks [95% CI, 28-40]).

Study details: The data come from the PAUSE trial, including 91 adult patients with moderate-to-severe plaque psoriasis who achieved Psoriasis Area Severity Index 75 at week 12 of receiving ustekinumab and who were randomly assigned to either continued ustekinumab or switch to abatacept until week 39.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and Eli Lilly and Co. Some of the authors declared receiving research/institutional grants and/or personal fees from various sources, including Eli Lilly.

Source: Harris KM et al. JAMA Dermatol. 2021 Oct 13. doi: 10.1001/jamadermatol.2021.3492.

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Key clinical point: Abatacept-mediated CD28-CD80/CD86 blockade was inept at averting psoriasis relapse following ustekinumab withdrawal in patients with moderate-to-severe plaque psoriasis.

Major finding: Between weeks 12 and 88, abatacept vs ustekinumab groups displayed similar relapse rates (91.1% vs 87.0%; P = .41) and median time to relapse from the last dose of ustekinumab (36 weeks [95% CI, 36-48] vs 32 weeks [95% CI, 28-40]).

Study details: The data come from the PAUSE trial, including 91 adult patients with moderate-to-severe plaque psoriasis who achieved Psoriasis Area Severity Index 75 at week 12 of receiving ustekinumab and who were randomly assigned to either continued ustekinumab or switch to abatacept until week 39.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and Eli Lilly and Co. Some of the authors declared receiving research/institutional grants and/or personal fees from various sources, including Eli Lilly.

Source: Harris KM et al. JAMA Dermatol. 2021 Oct 13. doi: 10.1001/jamadermatol.2021.3492.

Key clinical point: Abatacept-mediated CD28-CD80/CD86 blockade was inept at averting psoriasis relapse following ustekinumab withdrawal in patients with moderate-to-severe plaque psoriasis.

Major finding: Between weeks 12 and 88, abatacept vs ustekinumab groups displayed similar relapse rates (91.1% vs 87.0%; P = .41) and median time to relapse from the last dose of ustekinumab (36 weeks [95% CI, 36-48] vs 32 weeks [95% CI, 28-40]).

Study details: The data come from the PAUSE trial, including 91 adult patients with moderate-to-severe plaque psoriasis who achieved Psoriasis Area Severity Index 75 at week 12 of receiving ustekinumab and who were randomly assigned to either continued ustekinumab or switch to abatacept until week 39.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and Eli Lilly and Co. Some of the authors declared receiving research/institutional grants and/or personal fees from various sources, including Eli Lilly.

Source: Harris KM et al. JAMA Dermatol. 2021 Oct 13. doi: 10.1001/jamadermatol.2021.3492.

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mCRPC: Survival with enzalutamide and abiraterone improved in Blacks vs Whites

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Key clinical point: A significant improvement in overall survival is seen in chemotherapy-naïve Black vs White patients with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone or enzalutamide.

Major finding: The median follow-up was 19.0 and 18.7 months in Black and White patients, respectively. The overall survival was significantly longer in Black vs White patients (hazard ratio, 0.67; P <.0001).

Study details: A retrospective study of 2,910 patients with mCRPC from the Veterans Health Administration database who received enzalutamide or abiraterone after castration between April 2014 and March 2017.

Disclosures: This study was sponsored by Pfizer Inc. and Astellas Pharma, Inc. The authors received grants, personal/consulting fees, and nonfinancial support outside this work. Some authors were being employed and/or held stocks in various pharmaceutical companies.

Source: George DJ et al. Prostate Cancer Prostatic Dis. 2021 Nov 3. doi: 10.1038/s41391-021-00463-9.

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Key clinical point: A significant improvement in overall survival is seen in chemotherapy-naïve Black vs White patients with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone or enzalutamide.

Major finding: The median follow-up was 19.0 and 18.7 months in Black and White patients, respectively. The overall survival was significantly longer in Black vs White patients (hazard ratio, 0.67; P <.0001).

Study details: A retrospective study of 2,910 patients with mCRPC from the Veterans Health Administration database who received enzalutamide or abiraterone after castration between April 2014 and March 2017.

Disclosures: This study was sponsored by Pfizer Inc. and Astellas Pharma, Inc. The authors received grants, personal/consulting fees, and nonfinancial support outside this work. Some authors were being employed and/or held stocks in various pharmaceutical companies.

Source: George DJ et al. Prostate Cancer Prostatic Dis. 2021 Nov 3. doi: 10.1038/s41391-021-00463-9.

Key clinical point: A significant improvement in overall survival is seen in chemotherapy-naïve Black vs White patients with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone or enzalutamide.

Major finding: The median follow-up was 19.0 and 18.7 months in Black and White patients, respectively. The overall survival was significantly longer in Black vs White patients (hazard ratio, 0.67; P <.0001).

Study details: A retrospective study of 2,910 patients with mCRPC from the Veterans Health Administration database who received enzalutamide or abiraterone after castration between April 2014 and March 2017.

Disclosures: This study was sponsored by Pfizer Inc. and Astellas Pharma, Inc. The authors received grants, personal/consulting fees, and nonfinancial support outside this work. Some authors were being employed and/or held stocks in various pharmaceutical companies.

Source: George DJ et al. Prostate Cancer Prostatic Dis. 2021 Nov 3. doi: 10.1038/s41391-021-00463-9.

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mCRPC: ARamp is a biomarker candidate for hormone therapy response

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Key clinical point: Androgen receptor amplification (ARamp) status is associated with clinical outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) who receive novel hormonal treatment (NHT) but not in those treated with taxanes.

Major finding: Patients with ARamp or PTEN aberrations (PTENalt) vs those without had worse relative PSA response with NHT vs taxanes. The presence of ARamp, PTENalt, or RB1 aberrations was associated with worse time to next treatment and overall survival with NHT without affecting clinical benefit from taxane therapy.

Study details: A retrospective study of 308 patients with mCRPC who received treatment between 2011 and 2020.

Disclosures: This work was sponsored by Foundation Medicine. Some authors disclosed employment with Foundation Medicine and/or stock ownership in Roche. The authors received speaker/consulting/ advisory fees, research funding, and/or honoraria outside this work.

Source: Graf RP et al. Eur Urol. 2021 Oct 26. doi: 10.1016/j.eururo.2021.09.030.

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Key clinical point: Androgen receptor amplification (ARamp) status is associated with clinical outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) who receive novel hormonal treatment (NHT) but not in those treated with taxanes.

Major finding: Patients with ARamp or PTEN aberrations (PTENalt) vs those without had worse relative PSA response with NHT vs taxanes. The presence of ARamp, PTENalt, or RB1 aberrations was associated with worse time to next treatment and overall survival with NHT without affecting clinical benefit from taxane therapy.

Study details: A retrospective study of 308 patients with mCRPC who received treatment between 2011 and 2020.

Disclosures: This work was sponsored by Foundation Medicine. Some authors disclosed employment with Foundation Medicine and/or stock ownership in Roche. The authors received speaker/consulting/ advisory fees, research funding, and/or honoraria outside this work.

Source: Graf RP et al. Eur Urol. 2021 Oct 26. doi: 10.1016/j.eururo.2021.09.030.

Key clinical point: Androgen receptor amplification (ARamp) status is associated with clinical outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) who receive novel hormonal treatment (NHT) but not in those treated with taxanes.

Major finding: Patients with ARamp or PTEN aberrations (PTENalt) vs those without had worse relative PSA response with NHT vs taxanes. The presence of ARamp, PTENalt, or RB1 aberrations was associated with worse time to next treatment and overall survival with NHT without affecting clinical benefit from taxane therapy.

Study details: A retrospective study of 308 patients with mCRPC who received treatment between 2011 and 2020.

Disclosures: This work was sponsored by Foundation Medicine. Some authors disclosed employment with Foundation Medicine and/or stock ownership in Roche. The authors received speaker/consulting/ advisory fees, research funding, and/or honoraria outside this work.

Source: Graf RP et al. Eur Urol. 2021 Oct 26. doi: 10.1016/j.eururo.2021.09.030.

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Prostate cancer: Surgery lowers mortality risk in high-risk group

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Key clinical point: Radical prostatectomy vs external beam radiotherapy (EBRT) is associated with significant improvement in cancer-specific mortality in patients with National Comprehensive Cancer Network (NCCN) high-risk and Johns Hopkins University (JH) very high-risk prostate cancer.

Major finding: Cancer-specific mortality (CSM) was significantly lower with radical prostatectomy vs EBRT in NCCN high-risk combined group (2.3% vs 4.1%; hazard ratio [HR], 0.68; P < .001) and JH very high-risk subgroup (3.5% vs 6.0%; HR, 0.58; P < .001). There was no significant difference in CSM between 2 treatments in JH high-risk patient subgroup (P = .2).

Study details: Study of 24,407 NCCN high-risk patients with prostate cancer identified from the Surveillance, Epidemiology, and End Results database between 2010 and 2016. Patients were subcategorized into JH high-risk and very high-risk groups.

Disclosures: No funding source was identified for this work. The authors declared no conflict of interests.

Source: Cheirigo F et al. J Urol. 2021 Sep 24. doi: 10.1097/JU.0000000000002250.

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Key clinical point: Radical prostatectomy vs external beam radiotherapy (EBRT) is associated with significant improvement in cancer-specific mortality in patients with National Comprehensive Cancer Network (NCCN) high-risk and Johns Hopkins University (JH) very high-risk prostate cancer.

Major finding: Cancer-specific mortality (CSM) was significantly lower with radical prostatectomy vs EBRT in NCCN high-risk combined group (2.3% vs 4.1%; hazard ratio [HR], 0.68; P < .001) and JH very high-risk subgroup (3.5% vs 6.0%; HR, 0.58; P < .001). There was no significant difference in CSM between 2 treatments in JH high-risk patient subgroup (P = .2).

Study details: Study of 24,407 NCCN high-risk patients with prostate cancer identified from the Surveillance, Epidemiology, and End Results database between 2010 and 2016. Patients were subcategorized into JH high-risk and very high-risk groups.

Disclosures: No funding source was identified for this work. The authors declared no conflict of interests.

Source: Cheirigo F et al. J Urol. 2021 Sep 24. doi: 10.1097/JU.0000000000002250.

Key clinical point: Radical prostatectomy vs external beam radiotherapy (EBRT) is associated with significant improvement in cancer-specific mortality in patients with National Comprehensive Cancer Network (NCCN) high-risk and Johns Hopkins University (JH) very high-risk prostate cancer.

Major finding: Cancer-specific mortality (CSM) was significantly lower with radical prostatectomy vs EBRT in NCCN high-risk combined group (2.3% vs 4.1%; hazard ratio [HR], 0.68; P < .001) and JH very high-risk subgroup (3.5% vs 6.0%; HR, 0.58; P < .001). There was no significant difference in CSM between 2 treatments in JH high-risk patient subgroup (P = .2).

Study details: Study of 24,407 NCCN high-risk patients with prostate cancer identified from the Surveillance, Epidemiology, and End Results database between 2010 and 2016. Patients were subcategorized into JH high-risk and very high-risk groups.

Disclosures: No funding source was identified for this work. The authors declared no conflict of interests.

Source: Cheirigo F et al. J Urol. 2021 Sep 24. doi: 10.1097/JU.0000000000002250.

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