JAMA Dermatology

<jats:sec><jats:title>Importance</jats:title><jats:p>Current topical treatments for scalp psoriasis are limited by formulation, efficacy, and/or safety.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To assess safety and efficacy of roflumilast foam, 0.3%, in patients with psoriasis of the scalp and body.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>This was a phase 3 double-blinded, vehicle-controlled randomized clinical trial conducted between August 24, 2021, and June 3, 2022, at 49 sites in Canada and the US. Eligible participants were 12 years and older with plaque psoriasis affecting up to 25% of the scalp and body, at least 10% of the scalp, and up to 20% of nonscalp areas, with a minimum Scalp−Investigator Global Assessment (S-IGA) score of 3 (moderate), and minimum Body−IGA (B-IGA) score of 2 (mild). Data analyses were performed from September 9 to December 30, 2022.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Once-daily roflumilast foam, 0.3%, or vehicle for 8 weeks.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>Coprimary end points were S-IGA and B-IGA success (clear [0] or almost clear [1] plus ≥2-grade improvement) at week 8. Secondary end points included S-IGA success at weeks 2 and 4, change in Scalp Itch−Numeric Rating Scale (SI-NRS), and SI-NRS and Worst Itch−NRS (WI-NRS) success (≥4-point improvement in patients with baseline score of ≥4). Safety and tolerability were also assessed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) or vehicle (n = 151). At week 8, 66.4% of the roflumilast group achieved S-IGA success vs 27.8% of the vehicle group (<jats:italic>P</jats:italic> &amp;amp;lt; .001); and 45.5% of the roflumilast group achieved B-IGA success compared with 20.1% of the vehicle group (<jats:italic>P</jats:italic> &amp;amp;lt; .001). Rates for S-IGA success at week 2 and SI-NRS and WI-NRS success at weeks 2, 4, and 8 were significantly higher for roflumilast vs vehicle. Improvements in SI-NRS were greater for the roflumilast vs the vehicle group as early as the first assessment (24 hours after the first application). Both study groups had low rates of adverse events and favorable tolerability profiles.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>This randomized clinical trial found that roflumilast foam, 0.3%, improved signs and symptoms of psoriasis on the scalp and body, including pruritus, with low rates of adverse events in patients 12 years and older. These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/study/NCT05028582">NCT05028582</jats:ext-link></jats:p></jats:sec>

Patient-reported outcome measures as complementary information to clinician-reported outcome measures in patients with psoriasis.

JAMA Dermatol

Treatment burden and the perspectives of patients with psoriasis using topical treatments: results from a national survey of adults with psoriasis in the United States.

J Dermatolog Treat

Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey.

J Am Acad Dermatol

Characterization of patients with psoriasis in challenging-to-treat body areas in the Corrona Psoriasis Registry.

Dermatology

Epidemiology of psoriasis in hard-to-treat body locations: data from the Danish skin cohort.

BMC Dermatol

Psoriasis in special localizations.

Reumatologia

Management of scalp psoriasis: current perspectives.

Psoriasis (Auckl)

Pharmacotherapeutic approaches for treating psoriasis in difficult-to-treat areas.

Expert Opin Pharmacother

Scalp psoriasis: a literature review of effective therapies and updated recommendations for practical management.

Dermatol Ther (Heidelb)

Itch: an under-recognized problem in psoriasis.

J Eur Acad Dermatol Venereol

Pruritus severity in patients with psoriasis is not correlated with psoriasis disease severity.

A multidimensional assessment of the burden of psoriasis: results from a multinational dermatologist and patient survey.

Br J Dermatol

Treatment of skin inflammation with benzoxaborole phosphodiesterase inhibitors: selectivity, cellular activity, and effect on cytokines associated with skin inflammation and skin architecture changes.

J Pharmacol Exp Ther

Chemical, biochemical, and structural similarities and differences of dermatological cAMP phosphodiesterase-IV inhibitors.

J Invest Dermatol

The 3 major types of innate and adaptive cell-mediated effector immunity.

J Allergy Clin Immunol

A putative antipruritic mechanism of the phosphodiesterase-4 inhibitor E6005 by attenuating capsaicin-induced depolarization of C-fibre nerves.

Exp Dermatol

Keratinocytes: an enigmatic factor in atopic dermatitis.

Cells

Long-acting ß(2) adrenergic receptor agonist ameliorates imiquimod-induced psoriasis-like skin lesion by regulating keratinocyte proliferation and apoptosis.

Front Pharmacol

Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials.

JAMA

The safety and efficacy of roflumilast cream 0.15% and 0.05% in patients with atopic dermatitis: randomized, double-blind, phase 2 proof of concept study.

J Drugs Dermatol

Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: a randomized, double-blinded, vehicle-controlled, phase 3 trial.

Roflumilast cream, 0.15%, for atopic dermatitis in adults and children: INTEGUMENT-1 and INTEGUMENT-2 randomized clinical trials.

Long-term safety and efficacy with roflumilast cream 0.15% in patients aged =6 years with atopic dermatitis: a phase 3 open-label extension trial.

Dermatitis

Krafft temperature of surfactants in vehicles for roflumilast and pimecrolimus cream and effects on skin tolerability.

Efficacy of roflumilast foam, 0.3%, in patients with seborrheic dermatitis: a double-blind, vehicle-controlled phase 2a randomized clinical trial.

Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study.

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

The International Conference on Harmonization Good Clinical Practice guideline.

Qual Assur

Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp.

The Worst Itch Numeric Rating Scale for patients with moderate to severe plaque psoriasis or psoriatic arthritis.

Int J Dermatol

The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients.

J Adolesc Health

The PHQ-8 as a measure of current depression in the general population.

J Affect Disord

The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.

Am J Psychiatry

Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO-INSIGHTFUL study.

The clinical relevance and therapeutic benefit of established active ingredients incorporated into advanced foam vehicles: vehicle characteristics can influence and improve patient outcomes.

Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: a 52-week, phase 2, open-label trial.

Current topical treatments for scalp psoriasis are limited by formulation, efficacy, and/or safety.
To assess safety and efficacy of roflumilast foam, 0.3%, in patients with psoriasis of the scalp and body.
This was a phase 3 double-blinded, vehicle-controlled randomized clinical trial conducted between August 24, 2021, and June 3, 2022, at 49 sites in Canada and the US. Eligible participants were 12 years and older with plaque psoriasis affecting up to 25% of the scalp and body, at least 10% of the scalp, and up to 20% of nonscalp areas, with a minimum Scalp-Investigator Global Assessment (S-IGA) score of 3 (moderate), and minimum Body-IGA (B-IGA) score of 2 (mild). Data analyses were performed from September 9 to December 30, 2022.
Once-daily roflumilast foam, 0.3%, or vehicle for 8 weeks.
Coprimary end points were S-IGA and B-IGA success (clear [0] or almost clear [1] plus ≥2-grade improvement) at week 8. Secondary end points included S-IGA success at weeks 2 and 4, change in Scalp Itch-Numeric Rating Scale (SI-NRS), and SI-NRS and Worst Itch-NRS (WI-NRS) success (≥4-point improvement in patients with baseline score of ≥4). Safety and tolerability were also assessed.
A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) or vehicle (n = 151). At week 8, 66.4% of the roflumilast group achieved S-IGA success vs 27.8% of the vehicle group (P < .001); and 45.5% of the roflumilast group achieved B-IGA success compared with 20.1% of the vehicle group (P < .001). Rates for S-IGA success at week 2 and SI-NRS and WI-NRS success at weeks 2, 4, and 8 were significantly higher for roflumilast vs vehicle. Improvements in SI-NRS were greater for the roflumilast vs the vehicle group as early as the first assessment (24 hours after the first application). Both study groups had low rates of adverse events and favorable tolerability profiles.
This randomized clinical trial found that roflumilast foam, 0.3%, improved signs and symptoms of psoriasis on the scalp and body, including pruritus, with low rates of adverse events in patients 12 years and older. These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body.
ClinicalTrials.gov Identifier: NCT05028582.

Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial.

Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body

<jats:sec id="ab-dbr230025-4"><jats:title>Importance</jats:title><jats:p>Laboratory testing for the presence of tuberculosis, hepatitis, and other conditions before starting most systemic immunomodulatory agents is recommended in patients with chronic inflammatory skin diseases (CISD) but current testing patterns in the US are unclear.</jats:p></jats:sec><jats:sec id="ab-dbr230025-5"><jats:title>Objective</jats:title><jats:p>To determine the prevalence of pretreatment testing that is recommended for patients with CISD (psoriasis, hidradenitis suppurativa, or atopic dermatitis).</jats:p></jats:sec><jats:sec id="ab-dbr230025-6"><jats:title>Design, Setting, and Participants</jats:title><jats:p>This descriptive analysis of US commercial insurance claims databases from December 31, 2002, to December 31, 2020, included adult patients with CISD (psoriasis, hidradenitis suppurativa, or atopic dermatitis) who started an immunomodulatory agent, including methotrexate, tumor necrosis factor α inhibitors, interleukin (IL)–17Ai, ustekinumab, IL-23i, dupilumab, or apremilast.</jats:p></jats:sec><jats:sec id="ab-dbr230025-7"><jats:title>Main Outcomes and Measures</jats:title><jats:p>The proportion of patients who underwent the screening tests as suggested by professional societies—including for tuberculosis, hepatitis, and liver function; complete blood cell counts; and lipid panels—were determined within 6 months before and during 2 years after treatment start.</jats:p></jats:sec><jats:sec id="ab-dbr230025-8"><jats:title>Results</jats:title><jats:p>A total of 122 308 patients with CISDs (median [IQR] age, 49 [38-58] years; 63 663 [52.1%] male) starting systemic immunomodulatory treatment in the US were included. Treatment for patients with CISDs comprised methotrexate (28 684), tumor necrosis factor α inhibitors (40 965), ustekinumab (12 841), IL-23i (6116), IL-17Ai (9799), dupilumab (7787), or apremilast (16 116). Complete blood cell count was the most common test, performed in 41% (3161/7787) to 69% (19 659/28 684) of individuals before initiation across treatments. Between 11% (889/7787) and 59% (3613/6116) of patients had tuberculosis screening within 6 months before treatment, and 3% (149/4577) to 26% (1559/6097) had updated tests 1 year later. Between 13% (1006/7787) and 41% (16 728/40 965) had hepatitis panels before treatment. Low pretreatment testing levels before apremilast (15% [2331/16 116] to 45% [7253/16 116]) persisted a year into treatment (9% [816/8496] to 36% [2999/8496]) and were similar to dupilumab (11% [850/7787] to 41% [3161/7787] vs 3% [149/4577] to 25% [1160/4577]).</jats:p></jats:sec><jats:sec id="ab-dbr230025-9"><jats:title>Conclusions and Relevance</jats:title><jats:p>In this descriptive analysis of patients with CISDs starting systemic immunomodulatory treatment in the US, less than 60% received the recommended pretreatment testing. Additional research is required to understand whether variations in testing affect patient outcomes.</jats:p></jats:sec>

Real-world trends in biologic, oral systemic, and phototherapy in US patients with psoriasis or psoriatic arthritis.

Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.

Screening for tuberculosis infection prior to initiation of anti-TNF therapy.

Autoimmun Rev

Graphical depiction of longitudinal study designs in health care databases.

Ann Intern Med

Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.

Nat Commun

Emulation of randomized clinical trials with non-randomized database analyses: results in 32 clinical trials.

Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies.

European guideline (EuroGuiDerm) on atopic eczema: part I—systemic therapy.

Laboratory testing for the presence of tuberculosis, hepatitis, and other conditions before starting most systemic immunomodulatory agents is recommended in patients with chronic inflammatory skin diseases (CISD) but current testing patterns in the US are unclear.
To determine the prevalence of pretreatment testing that is recommended for patients with CISD (psoriasis, hidradenitis suppurativa, or atopic dermatitis).
This descriptive analysis of US commercial insurance claims databases from December 31, 2002, to December 31, 2020, included adult patients with CISD (psoriasis, hidradenitis suppurativa, or atopic dermatitis) who started an immunomodulatory agent, including methotrexate, tumor necrosis factor α inhibitors, interleukin (IL)-17Ai, ustekinumab, IL-23i, dupilumab, or apremilast.
The proportion of patients who underwent the screening tests as suggested by professional societies-including for tuberculosis, hepatitis, and liver function; complete blood cell counts; and lipid panels-were determined within 6 months before and during 2 years after treatment start.
A total of 122 308 patients with CISDs (median [IQR] age, 49 [38-58] years; 63 663 [52.1%] male) starting systemic immunomodulatory treatment in the US were included. Treatment for patients with CISDs comprised methotrexate (28 684), tumor necrosis factor α inhibitors (40 965), ustekinumab (12 841), IL-23i (6116), IL-17Ai (9799), dupilumab (7787), or apremilast (16 116). Complete blood cell count was the most common test, performed in 41% (3161/7787) to 69% (19 659/28 684) of individuals before initiation across treatments. Between 11% (889/7787) and 59% (3613/6116) of patients had tuberculosis screening within 6 months before treatment, and 3% (149/4577) to 26% (1559/6097) had updated tests 1 year later. Between 13% (1006/7787) and 41% (16 728/40 965) had hepatitis panels before treatment. Low pretreatment testing levels before apremilast (15% [2331/16 116] to 45% [7253/16 116]) persisted a year into treatment (9% [816/8496] to 36% [2999/8496]) and were similar to dupilumab (11% [850/7787] to 41% [3161/7787] vs 3% [149/4577] to 25% [1160/4577]).
In this descriptive analysis of patients with CISDs starting systemic immunomodulatory treatment in the US, less than 60% received the recommended pretreatment testing. Additional research is required to understand whether variations in testing affect patient outcomes.

Prevalence of Pretreatment Testing Recommended for Patients With Chronic Inflammatory Skin Diseases.

Prevalence of Pretreatment Testing Recommended for Patients With Chronic Inflammatory Skin Diseases

Journal of the American Academy of Dermatology

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American Academy of Dermatology

Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies

GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations

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GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength

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A randomized double-blind controlled trial to compare a triclosan-containing emollient with vehicle for the treatment of atopic dermatitis

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South Med J

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Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials

Two randomized, double-blind, placebo-controlled studies of fluticasone propionate lotion 0.05% for the treatment of atopic dermatitis in subjects from 3 months of age

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Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies

Association between topical calcineurin inhibitor use and risk of cancer, including lymphoma, keratinocyte carcinoma, and Melanoma: a systematic review and meta-analysis

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Pediatrics

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No evidence of increased cancer incidence in children using topical tacrolimus for atopic dermatitis

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Guidelines of care for the management of atopic dermatitis in adults with topical therapies

PDE-4 Inhibitor in Dermatology Research

Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body

Prevalence of Pretreatment Testing Recommended for Patients With Chronic Inflammatory Skin Diseases

Guidelines of care for the management of atopic dermatitis in adults with topical therapies

Executive summary: American Academy of Dermatology guidelines of care for the management of atopic dermatitis in adults with topical therapies

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