MDedge Dermatology

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: Ruxolitinib cream demonstrated rapid and sustained improvement in itch in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream achieved ≥2-point reduction in itch numerical rating scale (NRS2) score as rapidly as within 12 hours (16.3% and 13.1% vs 6.9%; P < .05), with further improvements at week 8 (58.3% and 65.1% vs 29.4%; P < .0001). In patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream, time to achieve itch NRS2 score was shorter (5 and 4 vs 17 days).

Study details: Findings are from a pooled analysis of two phase 3 trials, TRuE-AD1 and TRuE-AD2, including 1249 patients with mild-to-moderate AD who were randomly assigned to receive ruxolitinib (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants or receiving research grants and honoraria from several sources.

Source: Blauvelt A et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2022 (Sep 6). Doi: 10.1111/jdv.18571

Key clinical point: Ruxolitinib cream demonstrated rapid and sustained improvement in itch in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream achieved ≥2-point reduction in itch numerical rating scale (NRS2) score as rapidly as within 12 hours (16.3% and 13.1% vs 6.9%; P < .05), with further improvements at week 8 (58.3% and 65.1% vs 29.4%; P < .0001). In patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream, time to achieve itch NRS2 score was shorter (5 and 4 vs 17 days).

Study details: Findings are from a pooled analysis of two phase 3 trials, TRuE-AD1 and TRuE-AD2, including 1249 patients with mild-to-moderate AD who were randomly assigned to receive ruxolitinib (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants or receiving research grants and honoraria from several sources.

Source: Blauvelt A et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2022 (Sep 6). Doi: 10.1111/jdv.18571

Key clinical point: Ruxolitinib cream demonstrated rapid and sustained improvement in itch in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream achieved ≥2-point reduction in itch numerical rating scale (NRS2) score as rapidly as within 12 hours (16.3% and 13.1% vs 6.9%; P < .05), with further improvements at week 8 (58.3% and 65.1% vs 29.4%; P < .0001). In patients receiving ruxolitinib (0.75% or 1.5%) vs vehicle cream, time to achieve itch NRS2 score was shorter (5 and 4 vs 17 days).

Study details: Findings are from a pooled analysis of two phase 3 trials, TRuE-AD1 and TRuE-AD2, including 1249 patients with mild-to-moderate AD who were randomly assigned to receive ruxolitinib (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants or receiving research grants and honoraria from several sources.

Source: Blauvelt A et al. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2022 (Sep 6). Doi: 10.1111/jdv.18571

Key clinical point: Topical brepocitinib cream showed significant efficacy in reducing disease severity and was well-tolerated in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: The reduction in the mean Eczema Area and Severity Index at week 6 was significantly higher with 1% brepocitinib cream once daily (QD) vs vehicle QD (−70.1% vs −44.4%) and 1% brepocitinib  cream twice daily (BID) vs vehicle BID (−75.0% vs −47.6%; both P < .05). No serious adverse events or deaths were reported.

Study details: Findings are from a double-blind, dose-ranging, phase 2 study including 292 patients with mild-to-moderate AD who were randomly assigned to receive brepocitinib (0.1% QD, 0.3% QD or BID, 1.0% QD or BID, or 3.0% QD) or vehicle (QD or BID).

Disclosures: This study was sponsored by Pfizer Inc. Nine authors declared being shareholders and current or former employees of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Landis MN et al. Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: A phase IIb, randomised, double-blind, vehicle-controlled, dose-ranging, and parallel-group study. Br J Dermatol. 2022 (Aug 20). Doi: 10.1111/bjd.21826

Key clinical point: Topical brepocitinib cream showed significant efficacy in reducing disease severity and was well-tolerated in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: The reduction in the mean Eczema Area and Severity Index at week 6 was significantly higher with 1% brepocitinib cream once daily (QD) vs vehicle QD (−70.1% vs −44.4%) and 1% brepocitinib  cream twice daily (BID) vs vehicle BID (−75.0% vs −47.6%; both P < .05). No serious adverse events or deaths were reported.

Study details: Findings are from a double-blind, dose-ranging, phase 2 study including 292 patients with mild-to-moderate AD who were randomly assigned to receive brepocitinib (0.1% QD, 0.3% QD or BID, 1.0% QD or BID, or 3.0% QD) or vehicle (QD or BID).

Disclosures: This study was sponsored by Pfizer Inc. Nine authors declared being shareholders and current or former employees of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Landis MN et al. Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: A phase IIb, randomised, double-blind, vehicle-controlled, dose-ranging, and parallel-group study. Br J Dermatol. 2022 (Aug 20). Doi: 10.1111/bjd.21826

Key clinical point: Topical brepocitinib cream showed significant efficacy in reducing disease severity and was well-tolerated in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: The reduction in the mean Eczema Area and Severity Index at week 6 was significantly higher with 1% brepocitinib cream once daily (QD) vs vehicle QD (−70.1% vs −44.4%) and 1% brepocitinib  cream twice daily (BID) vs vehicle BID (−75.0% vs −47.6%; both P < .05). No serious adverse events or deaths were reported.

Study details: Findings are from a double-blind, dose-ranging, phase 2 study including 292 patients with mild-to-moderate AD who were randomly assigned to receive brepocitinib (0.1% QD, 0.3% QD or BID, 1.0% QD or BID, or 3.0% QD) or vehicle (QD or BID).

Disclosures: This study was sponsored by Pfizer Inc. Nine authors declared being shareholders and current or former employees of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Landis MN et al. Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: A phase IIb, randomised, double-blind, vehicle-controlled, dose-ranging, and parallel-group study. Br J Dermatol. 2022 (Aug 20). Doi: 10.1111/bjd.21826

Key clinical point: The results of this meta-analysis do not demonstrate an elevated risk for incident venous thromboembolism (VTE) in patients with atopic dermatitis (AD), particularly among those receiving treatment with Janus kinase (JAK) inhibitors.

Major finding: The risk for incident VTE was similar among participants with vs without AD (pooled hazard ratio 0.95; 95% CI 0.62-1.45). Among patients with AD who received JAK inhibitors vs placebo /dupilumab, 0.05% vs 0.03% reported VTE (Mantel-Haenszel risk difference 0; 95% CI 0-0).

Study details: Findings are from a meta-analysis of two cohort studies including 458,206 participants with (n = 229,103) and without AD (n = 229,103) and 15 randomized controlled trials including 8787 patients with AD who received an interventional treatment with JAK inhibitors or a control treatment with dupilumab or placebo.

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

Source: Chen TL et al. Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: A systematic review and meta-analysis. JAMA Dermatol. 2022;e223516 (Aug 24). Doi: 10.1001/jamadermatol.2022.3516

Key clinical point: The results of this meta-analysis do not demonstrate an elevated risk for incident venous thromboembolism (VTE) in patients with atopic dermatitis (AD), particularly among those receiving treatment with Janus kinase (JAK) inhibitors.

Major finding: The risk for incident VTE was similar among participants with vs without AD (pooled hazard ratio 0.95; 95% CI 0.62-1.45). Among patients with AD who received JAK inhibitors vs placebo /dupilumab, 0.05% vs 0.03% reported VTE (Mantel-Haenszel risk difference 0; 95% CI 0-0).

Study details: Findings are from a meta-analysis of two cohort studies including 458,206 participants with (n = 229,103) and without AD (n = 229,103) and 15 randomized controlled trials including 8787 patients with AD who received an interventional treatment with JAK inhibitors or a control treatment with dupilumab or placebo.

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

Source: Chen TL et al. Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: A systematic review and meta-analysis. JAMA Dermatol. 2022;e223516 (Aug 24). Doi: 10.1001/jamadermatol.2022.3516

Key clinical point: The results of this meta-analysis do not demonstrate an elevated risk for incident venous thromboembolism (VTE) in patients with atopic dermatitis (AD), particularly among those receiving treatment with Janus kinase (JAK) inhibitors.

Major finding: The risk for incident VTE was similar among participants with vs without AD (pooled hazard ratio 0.95; 95% CI 0.62-1.45). Among patients with AD who received JAK inhibitors vs placebo /dupilumab, 0.05% vs 0.03% reported VTE (Mantel-Haenszel risk difference 0; 95% CI 0-0).

Study details: Findings are from a meta-analysis of two cohort studies including 458,206 participants with (n = 229,103) and without AD (n = 229,103) and 15 randomized controlled trials including 8787 patients with AD who received an interventional treatment with JAK inhibitors or a control treatment with dupilumab or placebo.

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

Source: Chen TL et al. Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: A systematic review and meta-analysis. JAMA Dermatol. 2022;e223516 (Aug 24). Doi: 10.1001/jamadermatol.2022.3516

Key clinical point: Dupilumab demonstrated good overall drug survival for up to 3 years in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab showed good overall drug survival rates at 1-year (90.3%), 2-year (85.9%), and 3-year (78.6%). The use of immunosuppressant drugs at baseline was associated with shorter drug survival owing to ineffectiveness (hazard ratio [HR] 2.64; 95% CI 1.10-6.37) and adverse events (HR 2.69; 95% CI 1.32-5.48).

Study details: Findings are from an analysis of the BioDay registry data of 715 adult patients with moderate-to-severe AD who received dupilumab and were followed-up for ≥4 weeks.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. The authors declared receiving grants, personal fees, speaking fees, financial support or nonfinancial support from several sources.

Source: Spekhorst LS et al. Dupilumab drug survival and associated predictors in patients with moderate to severe atopic dermatitis: Long-term results from the daily practice BioDay registry. JAMA Dermatol. 2022;e223014 (Aug 10). Doi: 10.1001/jamadermatol.2022.3014

Key clinical point: Dupilumab demonstrated good overall drug survival for up to 3 years in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab showed good overall drug survival rates at 1-year (90.3%), 2-year (85.9%), and 3-year (78.6%). The use of immunosuppressant drugs at baseline was associated with shorter drug survival owing to ineffectiveness (hazard ratio [HR] 2.64; 95% CI 1.10-6.37) and adverse events (HR 2.69; 95% CI 1.32-5.48).

Study details: Findings are from an analysis of the BioDay registry data of 715 adult patients with moderate-to-severe AD who received dupilumab and were followed-up for ≥4 weeks.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. The authors declared receiving grants, personal fees, speaking fees, financial support or nonfinancial support from several sources.

Source: Spekhorst LS et al. Dupilumab drug survival and associated predictors in patients with moderate to severe atopic dermatitis: Long-term results from the daily practice BioDay registry. JAMA Dermatol. 2022;e223014 (Aug 10). Doi: 10.1001/jamadermatol.2022.3014

Key clinical point: Dupilumab demonstrated good overall drug survival for up to 3 years in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Dupilumab showed good overall drug survival rates at 1-year (90.3%), 2-year (85.9%), and 3-year (78.6%). The use of immunosuppressant drugs at baseline was associated with shorter drug survival owing to ineffectiveness (hazard ratio [HR] 2.64; 95% CI 1.10-6.37) and adverse events (HR 2.69; 95% CI 1.32-5.48).

Study details: Findings are from an analysis of the BioDay registry data of 715 adult patients with moderate-to-severe AD who received dupilumab and were followed-up for ≥4 weeks.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. The authors declared receiving grants, personal fees, speaking fees, financial support or nonfinancial support from several sources.

Source: Spekhorst LS et al. Dupilumab drug survival and associated predictors in patients with moderate to severe atopic dermatitis: Long-term results from the daily practice BioDay registry. JAMA Dermatol. 2022;e223014 (Aug 10). Doi: 10.1001/jamadermatol.2022.3014

The psoriasis clinical trials listed below are all phase 3 and recruiting participants as of July 19, 2022. For additional information on the study design, eligibility criteria, and contacts/locations, visit ClinicalTrials.gov.

GENERALIZED PUSTULAR PSORIASIS

Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI2)

ClinicalTrials.gov Identifier: NCT05366855

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

ClinicalTrials.gov Identifier: NCT05200247

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have No Other Treatment Options

ClinicalTrials.gov Identifier: NCT05239039

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

ClinicalTrials.gov Identifier: NCT05352893

NAIL PSORIASIS

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

ClinicalTrials.gov Identifier: NCT03897075

PALMOPLANTAR PUSTULOSIS

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

ClinicalTrials.gov Identifier: NCT05174065

PLAQUE PSORIASIS

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04175613

A Phase III Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04839328

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

ClinicalTrials.gov Identifier: NCT04435600

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04772079

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

ClinicalTrials.gov Identifier: NCT05203315

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04728360

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT05020249

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

ClinicalTrials.gov Identifier: NCT05335356

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)(CIMcare)

ClinicalTrials.gov Identifier: NCT04123795

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT03997786

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

ClinicalTrials.gov Identifier: NCT05172726

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR)

ClinicalTrials.gov Identifier: NCT03451851

PSORIATIC ARTHRITIS

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

ClinicalTrials.gov Identifier: NCT05092269

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ClinicalTrials.gov Identifier: NCT05083182

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT05046431

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04991116

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04957550

PSORIATIC ARTHRITIS (continued)

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

ClinicalTrials.gov Identifier: NCT04936308

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov Identifier: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT04908189

A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX) ClinicalTrials.gov Identifier: NCT04882098 Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

ClinicalTrials.gov Identifier: NCT04804553

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04610476

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04527380

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

ClinicalTrials.gov Identifier: NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti- TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov Identifier: NCT04314531

The psoriasis clinical trials listed below are all phase 3 and recruiting participants as of July 19, 2022. For additional information on the study design, eligibility criteria, and contacts/locations, visit ClinicalTrials.gov.

GENERALIZED PUSTULAR PSORIASIS

Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI2)

ClinicalTrials.gov Identifier: NCT05366855

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

ClinicalTrials.gov Identifier: NCT05200247

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have No Other Treatment Options

ClinicalTrials.gov Identifier: NCT05239039

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

ClinicalTrials.gov Identifier: NCT05352893

NAIL PSORIASIS

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

ClinicalTrials.gov Identifier: NCT03897075

PALMOPLANTAR PUSTULOSIS

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

ClinicalTrials.gov Identifier: NCT05174065

PLAQUE PSORIASIS

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04175613

A Phase III Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04839328

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

ClinicalTrials.gov Identifier: NCT04435600

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04772079

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

ClinicalTrials.gov Identifier: NCT05203315

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04728360

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT05020249

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

ClinicalTrials.gov Identifier: NCT05335356

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)(CIMcare)

ClinicalTrials.gov Identifier: NCT04123795

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT03997786

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

ClinicalTrials.gov Identifier: NCT05172726

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR)

ClinicalTrials.gov Identifier: NCT03451851

PSORIATIC ARTHRITIS

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

ClinicalTrials.gov Identifier: NCT05092269

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ClinicalTrials.gov Identifier: NCT05083182

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT05046431

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04991116

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04957550

PSORIATIC ARTHRITIS (continued)

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

ClinicalTrials.gov Identifier: NCT04936308

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov Identifier: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT04908189

A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX) ClinicalTrials.gov Identifier: NCT04882098 Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

ClinicalTrials.gov Identifier: NCT04804553

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04610476

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04527380

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

ClinicalTrials.gov Identifier: NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti- TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov Identifier: NCT04314531

The psoriasis clinical trials listed below are all phase 3 and recruiting participants as of July 19, 2022. For additional information on the study design, eligibility criteria, and contacts/locations, visit ClinicalTrials.gov.

GENERALIZED PUSTULAR PSORIASIS

Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI2)

ClinicalTrials.gov Identifier: NCT05366855

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

ClinicalTrials.gov Identifier: NCT05200247

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have No Other Treatment Options

ClinicalTrials.gov Identifier: NCT05239039

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

ClinicalTrials.gov Identifier: NCT05352893

NAIL PSORIASIS

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

ClinicalTrials.gov Identifier: NCT03897075

PALMOPLANTAR PUSTULOSIS

Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

ClinicalTrials.gov Identifier: NCT05174065

PLAQUE PSORIASIS

A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04175613

A Phase III Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04839328

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

ClinicalTrials.gov Identifier: NCT04435600

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Adolescent Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04772079

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

ClinicalTrials.gov Identifier: NCT05203315

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT04728360

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT05020249

Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

ClinicalTrials.gov Identifier: NCT05335356

A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)(CIMcare)

ClinicalTrials.gov Identifier: NCT04123795

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

ClinicalTrials.gov Identifier: NCT03997786

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

ClinicalTrials.gov Identifier: NCT05172726

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PROTOSTAR)

ClinicalTrials.gov Identifier: NCT03451851

PSORIATIC ARTHRITIS

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

ClinicalTrials.gov Identifier: NCT04632927

A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

ClinicalTrials.gov Identifier: NCT05092269

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

ClinicalTrials.gov Identifier: NCT05083182

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT05046431

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04991116

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04957550

PSORIATIC ARTHRITIS (continued)

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

ClinicalTrials.gov Identifier: NCT04936308

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

ClinicalTrials.gov Identifier: NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

ClinicalTrials.gov Identifier: NCT04908189

A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX) ClinicalTrials.gov Identifier: NCT04882098 Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

ClinicalTrials.gov Identifier: NCT04804553

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04610476

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04527380

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

ClinicalTrials.gov Identifier: NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti- TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov Identifier: NCT04314531

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

Additional hidradenitis suppurativa (HS) treatments could be on the horizon with the news that both secukinumab and the investigational drug brepocitinib reduced the effects of the chronic and painful skin condition in separate trials.

Around 40%-50% of patients exhibited a clinical response to these agents at 16 weeks, a leading HS expert reported at the annual congress of the European Academy of Dermatology and Venereology.
 

Time in the spotlight for HS

Research into HS is “an incredibly active field at this moment,” said Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, and president and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston.

It’s “been great for advancing our understanding of the biology and the treatments that we will be able to use,” she said.

During the late-breaking sessions at the annual EADV Congress, Dr. Kimball presented data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety and tolerability of the interleukin (IL) 17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS.

“This is only the second phase 3 program we have ever seen in HS and the first one since 2016,” Dr. Kimball said of the trials. It’s also the largest trial program in HS conducted to date, she added, “so it really is a milestone.”

The last big development was when adalimumab, a tumor necrosis factor (TNF) blocker, gained regulatory approval for HS in 2016, observed Neil Patel, PhD, MRCP, who leads the HS service at Imperial College Healthcare NHS Trust in London.

“Adalimumab has been very helpful for many patients, but not all patients respond, and others may respond initially but then the treatment starts to fail after a year or 2,” Dr. Patel said in an interview with this news organization.

“There is definitely a huge need for alternative medication for this condition, which still has a lack of effective treatment options,” added Dr. Patel, who was not involved in either of the studies.

“One major upside for secukinumab is that its safety profile is generally very good and familiarity in the dermatologic community is already well established,” Christopher Sayed, MD, said in a separate interview.

“This will make most providers very comfortable offering it as a potential treatment option sooner rather than later given that its efficacy has now been demonstrated in phase 3 trials,” added Dr. Sayed, associate professor of dermatology at the University of North Carolina at Chapel Hill.
 

Two identically designed trials

Altogether, SUNSHINE and SUNRISE enrolled just over 1,000 patients at 219 sites in 33 countries. Both trials were identical in their design: A 4-week run-in phase before a randomized, double-blind treatment phase that tested two dosing regimens of secukinumab (300 mg administered subcutaneously) every 2 or 4 weeks vs. placebo for 16 weeks. The trial continued after this time, with patients in the placebo arm re–randomly assigned to treatment with one of the two secukinumab regimens out to a year.

The primary endpoint was the percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment, with key secondary endpoints, which were abscess and inflammatory nodule (AN) count, occurrence of flares, and at least a 30% reduction in Patient’s Global Assessment of Skin Pain assessed using a numeric rating scale (NPRS30).
 

Secukinumab superior to placebo

The HiSCR is defined as at least a 50% decrease in AN count with no increase in the number of abscesses or in the number of draining fistulas relative to baseline. This was achieved by about 42%-45% of patients who received secukinumab every 2 weeks, about 42%-46% of those who received secukinumab every 4 weeks, and about 31%-33% of those on placebo in both studies.

Of note, fewer patients treated with secukinumab (about 15%-20% among those treated every 2 weeks, and about 15% to 23% among those treated every 4 weeks) than those on placebo (27%-29%) experienced flares, defined as at least a 25% increase in AN count and at least a two-point increase relative to baseline values.

Improvement in HS pain can be a difficult parameter to meet, Dr. Kimball noted. “Pain is such an important feature of this disease as it so debilitating for the patients.” More than one-third (almost 36%-39%) of patients given secukinumab vs. just over a quarter (26.9%) given placebo achieved at least a 30% reduction in NPRS30 ratings, she reported. The difference between active and placebo treatment was significant only when secukinumab was given every 2 weeks, however.

“The placebo rates that we see in these studies are exactly parallel to what we saw in other studies, and other disease states when we had a 50% bar of improvement,” Dr. Kimball said when questioned about these results.

“HS is a highly variable disease; it’s maybe not so much the placebo rate or the scoring system used but maybe the 50% bar set for improvement is too low. It’s likely, as data start to mature and a 75% HiSCR can be calculated, that the placebo rates will drop,” she said.

There were no surprises when it came to the safety of secukinumab, being an old player in a new game, she noted. It was “well tolerated” and tolerability was “consistent with the known safety profile,” Dr. Kimball said, “so we expect it to be a new, safe, and effective add to our armamentarium in treating this disease.”

This research involves “basically borrowing drugs from other areas and trying them in HS to see what effect they may have,” Dr. Patel said, noting that drugs such as adalimumab and secukinumab already had a proven track record in other diseases, such as psoriasis. “These early data for secukinumab definitely are very exciting, but we would need to see real-life results” in patients with HS who are not enrolled in trials to see the benefits, he added.

‘Tipping point’ for HS research

“I think we will look back on this meeting and realize that it was an incredibly important tipping point for the treatment of this incredibly debilitating disease,” Dr. Kimball said.

Elsewhere at the meeting, she had presented findings from a phase 2a study that pitted three different kinase inhibitors with different modes of action against each other and compared them with placebo. 

The three agents evaluated are an IL-1 receptor–associated kinase 4 inhibitor known as PF-06650833, a tyrosine kinase 2 (TYK2) JAK1 inhibitor brepocitinib, and the TYK2 inhibitor PF-06826647.

“This technique has been used in oncology,” Dr. Kimball said, noting that the ability to test multiple drugs at the same time “means we can really much more efficiently test two different things at the same time, and also put fewer patients at risk for potential problems if drugs don’t work.”
 

Positive signs for brepocitinib, not the other kinases tested

The results showed that though brepocitinib worked in HS, the other two novel compounds did not appear to have beneficial effects. Just over half (52%) of the 52 patients treated with brepocitinib achieved an HiSCR at 16 weeks, compared with around one-third of those given placebo, PF-06650833, or PF-06826647.

A similar benefit was seen in terms of reduction in flares for brepocitinib but not the other agents, although there was no difference between them all in terms of NPRS30 pain reduction.

“We’ve been able to test three different modalities. This tells us some things about the pathophysiology for HS, which is a very profoundly intensive inflammatory process,” which, Dr. Kimball said, “may require multiple modalities of action to get it under control.” In addition, these “general modalities seem to safe and well tolerated,” she added.
 

Take-homes for practice and future research

“While it is disappointing that two of the drugs tested did not clearly demonstrate efficacy, it is very possible that these mechanisms of action may be successful targets in the future as new dosing strategies and drugs targeting these pathways are developed,” Dr. Sayed said.

A case in point, he added, was that “adalimumab did not meet treatment endpoints at a dose of 40 mg every other week, but clearly has made a major impact at 40 mg weekly.”

The bottom line is that “both secukinumab and beprocitinib demonstrated efficacy over placebo and are likely to be helpful for a significant number of patients with HS,” Dr. Sayed said. “Hopefully, we’ll see head-to-head trials and more data regarding proportions of patients with deeper responses using criteria such as HiSCR75 and HiSCR90.”

Moreover, “having a larger number of drugs with a range of mechanisms of action is extraordinarily helpful given how difficult the disease can be to manage. We will hopefully continue to see creative approaches and further successes in the current wave of phase 1, 2, and 3 trials that are already underway.”

The SUNSHINE and SUNRISE studies were funded by Novartis Pharma AG, Basel, Switzerland. The phase 2A study Dr. Kimball presented was sponsored by Pfizer.

Dr. Kimball disclosed ties to both Novartis and Pfizer and acts as a consultant and investigator to AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, and UCB. She is an investigator for Incyte and AnaptysBio; acts as a consultant to Bayer, Boehringer Ingelheim, Ventyz, Moonlake, Lily, Concert, EvoImmune, Sonoma Bio, and Sanofi; receives fellowship funding from Janssen, and serves on the Board of Directors for Almirall.

Dr. Patel had no conflicts of interest to disclose. Dr. Sayed is the director of the HS Foundation, a nonprofit organization, and has acted as an adviser or consultant to, speaker for, and received research funding from multiple drug companies including AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.

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

Additional hidradenitis suppurativa (HS) treatments could be on the horizon with the news that both secukinumab and the investigational drug brepocitinib reduced the effects of the chronic and painful skin condition in separate trials.

Around 40%-50% of patients exhibited a clinical response to these agents at 16 weeks, a leading HS expert reported at the annual congress of the European Academy of Dermatology and Venereology.
 

Time in the spotlight for HS

Research into HS is “an incredibly active field at this moment,” said Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, and president and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston.

It’s “been great for advancing our understanding of the biology and the treatments that we will be able to use,” she said.

During the late-breaking sessions at the annual EADV Congress, Dr. Kimball presented data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety and tolerability of the interleukin (IL) 17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS.

“This is only the second phase 3 program we have ever seen in HS and the first one since 2016,” Dr. Kimball said of the trials. It’s also the largest trial program in HS conducted to date, she added, “so it really is a milestone.”

The last big development was when adalimumab, a tumor necrosis factor (TNF) blocker, gained regulatory approval for HS in 2016, observed Neil Patel, PhD, MRCP, who leads the HS service at Imperial College Healthcare NHS Trust in London.

“Adalimumab has been very helpful for many patients, but not all patients respond, and others may respond initially but then the treatment starts to fail after a year or 2,” Dr. Patel said in an interview with this news organization.

“There is definitely a huge need for alternative medication for this condition, which still has a lack of effective treatment options,” added Dr. Patel, who was not involved in either of the studies.

“One major upside for secukinumab is that its safety profile is generally very good and familiarity in the dermatologic community is already well established,” Christopher Sayed, MD, said in a separate interview.

“This will make most providers very comfortable offering it as a potential treatment option sooner rather than later given that its efficacy has now been demonstrated in phase 3 trials,” added Dr. Sayed, associate professor of dermatology at the University of North Carolina at Chapel Hill.
 

Two identically designed trials

Altogether, SUNSHINE and SUNRISE enrolled just over 1,000 patients at 219 sites in 33 countries. Both trials were identical in their design: A 4-week run-in phase before a randomized, double-blind treatment phase that tested two dosing regimens of secukinumab (300 mg administered subcutaneously) every 2 or 4 weeks vs. placebo for 16 weeks. The trial continued after this time, with patients in the placebo arm re–randomly assigned to treatment with one of the two secukinumab regimens out to a year.

The primary endpoint was the percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment, with key secondary endpoints, which were abscess and inflammatory nodule (AN) count, occurrence of flares, and at least a 30% reduction in Patient’s Global Assessment of Skin Pain assessed using a numeric rating scale (NPRS30).
 

Secukinumab superior to placebo

The HiSCR is defined as at least a 50% decrease in AN count with no increase in the number of abscesses or in the number of draining fistulas relative to baseline. This was achieved by about 42%-45% of patients who received secukinumab every 2 weeks, about 42%-46% of those who received secukinumab every 4 weeks, and about 31%-33% of those on placebo in both studies.

Of note, fewer patients treated with secukinumab (about 15%-20% among those treated every 2 weeks, and about 15% to 23% among those treated every 4 weeks) than those on placebo (27%-29%) experienced flares, defined as at least a 25% increase in AN count and at least a two-point increase relative to baseline values.

Improvement in HS pain can be a difficult parameter to meet, Dr. Kimball noted. “Pain is such an important feature of this disease as it so debilitating for the patients.” More than one-third (almost 36%-39%) of patients given secukinumab vs. just over a quarter (26.9%) given placebo achieved at least a 30% reduction in NPRS30 ratings, she reported. The difference between active and placebo treatment was significant only when secukinumab was given every 2 weeks, however.

“The placebo rates that we see in these studies are exactly parallel to what we saw in other studies, and other disease states when we had a 50% bar of improvement,” Dr. Kimball said when questioned about these results.

“HS is a highly variable disease; it’s maybe not so much the placebo rate or the scoring system used but maybe the 50% bar set for improvement is too low. It’s likely, as data start to mature and a 75% HiSCR can be calculated, that the placebo rates will drop,” she said.

There were no surprises when it came to the safety of secukinumab, being an old player in a new game, she noted. It was “well tolerated” and tolerability was “consistent with the known safety profile,” Dr. Kimball said, “so we expect it to be a new, safe, and effective add to our armamentarium in treating this disease.”

This research involves “basically borrowing drugs from other areas and trying them in HS to see what effect they may have,” Dr. Patel said, noting that drugs such as adalimumab and secukinumab already had a proven track record in other diseases, such as psoriasis. “These early data for secukinumab definitely are very exciting, but we would need to see real-life results” in patients with HS who are not enrolled in trials to see the benefits, he added.

‘Tipping point’ for HS research

“I think we will look back on this meeting and realize that it was an incredibly important tipping point for the treatment of this incredibly debilitating disease,” Dr. Kimball said.

Elsewhere at the meeting, she had presented findings from a phase 2a study that pitted three different kinase inhibitors with different modes of action against each other and compared them with placebo. 

The three agents evaluated are an IL-1 receptor–associated kinase 4 inhibitor known as PF-06650833, a tyrosine kinase 2 (TYK2) JAK1 inhibitor brepocitinib, and the TYK2 inhibitor PF-06826647.

“This technique has been used in oncology,” Dr. Kimball said, noting that the ability to test multiple drugs at the same time “means we can really much more efficiently test two different things at the same time, and also put fewer patients at risk for potential problems if drugs don’t work.”
 

Positive signs for brepocitinib, not the other kinases tested

The results showed that though brepocitinib worked in HS, the other two novel compounds did not appear to have beneficial effects. Just over half (52%) of the 52 patients treated with brepocitinib achieved an HiSCR at 16 weeks, compared with around one-third of those given placebo, PF-06650833, or PF-06826647.

A similar benefit was seen in terms of reduction in flares for brepocitinib but not the other agents, although there was no difference between them all in terms of NPRS30 pain reduction.

“We’ve been able to test three different modalities. This tells us some things about the pathophysiology for HS, which is a very profoundly intensive inflammatory process,” which, Dr. Kimball said, “may require multiple modalities of action to get it under control.” In addition, these “general modalities seem to safe and well tolerated,” she added.
 

Take-homes for practice and future research

“While it is disappointing that two of the drugs tested did not clearly demonstrate efficacy, it is very possible that these mechanisms of action may be successful targets in the future as new dosing strategies and drugs targeting these pathways are developed,” Dr. Sayed said.

A case in point, he added, was that “adalimumab did not meet treatment endpoints at a dose of 40 mg every other week, but clearly has made a major impact at 40 mg weekly.”

The bottom line is that “both secukinumab and beprocitinib demonstrated efficacy over placebo and are likely to be helpful for a significant number of patients with HS,” Dr. Sayed said. “Hopefully, we’ll see head-to-head trials and more data regarding proportions of patients with deeper responses using criteria such as HiSCR75 and HiSCR90.”

Moreover, “having a larger number of drugs with a range of mechanisms of action is extraordinarily helpful given how difficult the disease can be to manage. We will hopefully continue to see creative approaches and further successes in the current wave of phase 1, 2, and 3 trials that are already underway.”

The SUNSHINE and SUNRISE studies were funded by Novartis Pharma AG, Basel, Switzerland. The phase 2A study Dr. Kimball presented was sponsored by Pfizer.

Dr. Kimball disclosed ties to both Novartis and Pfizer and acts as a consultant and investigator to AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, and UCB. She is an investigator for Incyte and AnaptysBio; acts as a consultant to Bayer, Boehringer Ingelheim, Ventyz, Moonlake, Lily, Concert, EvoImmune, Sonoma Bio, and Sanofi; receives fellowship funding from Janssen, and serves on the Board of Directors for Almirall.

Dr. Patel had no conflicts of interest to disclose. Dr. Sayed is the director of the HS Foundation, a nonprofit organization, and has acted as an adviser or consultant to, speaker for, and received research funding from multiple drug companies including AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.

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

Additional hidradenitis suppurativa (HS) treatments could be on the horizon with the news that both secukinumab and the investigational drug brepocitinib reduced the effects of the chronic and painful skin condition in separate trials.

Around 40%-50% of patients exhibited a clinical response to these agents at 16 weeks, a leading HS expert reported at the annual congress of the European Academy of Dermatology and Venereology.
 

Time in the spotlight for HS

Research into HS is “an incredibly active field at this moment,” said Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, and president and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston.

It’s “been great for advancing our understanding of the biology and the treatments that we will be able to use,” she said.

During the late-breaking sessions at the annual EADV Congress, Dr. Kimball presented data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety and tolerability of the interleukin (IL) 17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS.

“This is only the second phase 3 program we have ever seen in HS and the first one since 2016,” Dr. Kimball said of the trials. It’s also the largest trial program in HS conducted to date, she added, “so it really is a milestone.”

The last big development was when adalimumab, a tumor necrosis factor (TNF) blocker, gained regulatory approval for HS in 2016, observed Neil Patel, PhD, MRCP, who leads the HS service at Imperial College Healthcare NHS Trust in London.

“Adalimumab has been very helpful for many patients, but not all patients respond, and others may respond initially but then the treatment starts to fail after a year or 2,” Dr. Patel said in an interview with this news organization.

“There is definitely a huge need for alternative medication for this condition, which still has a lack of effective treatment options,” added Dr. Patel, who was not involved in either of the studies.

“One major upside for secukinumab is that its safety profile is generally very good and familiarity in the dermatologic community is already well established,” Christopher Sayed, MD, said in a separate interview.

“This will make most providers very comfortable offering it as a potential treatment option sooner rather than later given that its efficacy has now been demonstrated in phase 3 trials,” added Dr. Sayed, associate professor of dermatology at the University of North Carolina at Chapel Hill.
 

Two identically designed trials

Altogether, SUNSHINE and SUNRISE enrolled just over 1,000 patients at 219 sites in 33 countries. Both trials were identical in their design: A 4-week run-in phase before a randomized, double-blind treatment phase that tested two dosing regimens of secukinumab (300 mg administered subcutaneously) every 2 or 4 weeks vs. placebo for 16 weeks. The trial continued after this time, with patients in the placebo arm re–randomly assigned to treatment with one of the two secukinumab regimens out to a year.

The primary endpoint was the percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment, with key secondary endpoints, which were abscess and inflammatory nodule (AN) count, occurrence of flares, and at least a 30% reduction in Patient’s Global Assessment of Skin Pain assessed using a numeric rating scale (NPRS30).
 

Secukinumab superior to placebo

The HiSCR is defined as at least a 50% decrease in AN count with no increase in the number of abscesses or in the number of draining fistulas relative to baseline. This was achieved by about 42%-45% of patients who received secukinumab every 2 weeks, about 42%-46% of those who received secukinumab every 4 weeks, and about 31%-33% of those on placebo in both studies.

Of note, fewer patients treated with secukinumab (about 15%-20% among those treated every 2 weeks, and about 15% to 23% among those treated every 4 weeks) than those on placebo (27%-29%) experienced flares, defined as at least a 25% increase in AN count and at least a two-point increase relative to baseline values.

Improvement in HS pain can be a difficult parameter to meet, Dr. Kimball noted. “Pain is such an important feature of this disease as it so debilitating for the patients.” More than one-third (almost 36%-39%) of patients given secukinumab vs. just over a quarter (26.9%) given placebo achieved at least a 30% reduction in NPRS30 ratings, she reported. The difference between active and placebo treatment was significant only when secukinumab was given every 2 weeks, however.

“The placebo rates that we see in these studies are exactly parallel to what we saw in other studies, and other disease states when we had a 50% bar of improvement,” Dr. Kimball said when questioned about these results.

“HS is a highly variable disease; it’s maybe not so much the placebo rate or the scoring system used but maybe the 50% bar set for improvement is too low. It’s likely, as data start to mature and a 75% HiSCR can be calculated, that the placebo rates will drop,” she said.

There were no surprises when it came to the safety of secukinumab, being an old player in a new game, she noted. It was “well tolerated” and tolerability was “consistent with the known safety profile,” Dr. Kimball said, “so we expect it to be a new, safe, and effective add to our armamentarium in treating this disease.”

This research involves “basically borrowing drugs from other areas and trying them in HS to see what effect they may have,” Dr. Patel said, noting that drugs such as adalimumab and secukinumab already had a proven track record in other diseases, such as psoriasis. “These early data for secukinumab definitely are very exciting, but we would need to see real-life results” in patients with HS who are not enrolled in trials to see the benefits, he added.

‘Tipping point’ for HS research

“I think we will look back on this meeting and realize that it was an incredibly important tipping point for the treatment of this incredibly debilitating disease,” Dr. Kimball said.

Elsewhere at the meeting, she had presented findings from a phase 2a study that pitted three different kinase inhibitors with different modes of action against each other and compared them with placebo. 

The three agents evaluated are an IL-1 receptor–associated kinase 4 inhibitor known as PF-06650833, a tyrosine kinase 2 (TYK2) JAK1 inhibitor brepocitinib, and the TYK2 inhibitor PF-06826647.

“This technique has been used in oncology,” Dr. Kimball said, noting that the ability to test multiple drugs at the same time “means we can really much more efficiently test two different things at the same time, and also put fewer patients at risk for potential problems if drugs don’t work.”
 

Positive signs for brepocitinib, not the other kinases tested

The results showed that though brepocitinib worked in HS, the other two novel compounds did not appear to have beneficial effects. Just over half (52%) of the 52 patients treated with brepocitinib achieved an HiSCR at 16 weeks, compared with around one-third of those given placebo, PF-06650833, or PF-06826647.

A similar benefit was seen in terms of reduction in flares for brepocitinib but not the other agents, although there was no difference between them all in terms of NPRS30 pain reduction.

“We’ve been able to test three different modalities. This tells us some things about the pathophysiology for HS, which is a very profoundly intensive inflammatory process,” which, Dr. Kimball said, “may require multiple modalities of action to get it under control.” In addition, these “general modalities seem to safe and well tolerated,” she added.
 

Take-homes for practice and future research

“While it is disappointing that two of the drugs tested did not clearly demonstrate efficacy, it is very possible that these mechanisms of action may be successful targets in the future as new dosing strategies and drugs targeting these pathways are developed,” Dr. Sayed said.

A case in point, he added, was that “adalimumab did not meet treatment endpoints at a dose of 40 mg every other week, but clearly has made a major impact at 40 mg weekly.”

The bottom line is that “both secukinumab and beprocitinib demonstrated efficacy over placebo and are likely to be helpful for a significant number of patients with HS,” Dr. Sayed said. “Hopefully, we’ll see head-to-head trials and more data regarding proportions of patients with deeper responses using criteria such as HiSCR75 and HiSCR90.”

Moreover, “having a larger number of drugs with a range of mechanisms of action is extraordinarily helpful given how difficult the disease can be to manage. We will hopefully continue to see creative approaches and further successes in the current wave of phase 1, 2, and 3 trials that are already underway.”

The SUNSHINE and SUNRISE studies were funded by Novartis Pharma AG, Basel, Switzerland. The phase 2A study Dr. Kimball presented was sponsored by Pfizer.

Dr. Kimball disclosed ties to both Novartis and Pfizer and acts as a consultant and investigator to AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, and UCB. She is an investigator for Incyte and AnaptysBio; acts as a consultant to Bayer, Boehringer Ingelheim, Ventyz, Moonlake, Lily, Concert, EvoImmune, Sonoma Bio, and Sanofi; receives fellowship funding from Janssen, and serves on the Board of Directors for Almirall.

Dr. Patel had no conflicts of interest to disclose. Dr. Sayed is the director of the HS Foundation, a nonprofit organization, and has acted as an adviser or consultant to, speaker for, and received research funding from multiple drug companies including AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.

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

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].