Publications by authors named "Gooderham M"

Trial Design: This two-part, double-blinded trial assessed the truncated retinoic acid-related orphan receptor γ (RORγt) inhibitor BI 730357 in plaque psoriasis.

Methods: Part 1: patients were randomized 2:2:2:2:1 to BI 730357 25, 50, 100, 200 mg, or placebo once daily (qd; fasting conditions); non-responders switched to higher doses. Part 2: a separate patient set was randomized 4:4:1 to BI 730357 400 mg qd, 200 mg twice daily, or placebo (fed conditions).

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Background: Generalised pustular psoriasis (GPP) is a chronic, systemic, neutrophilic inflammatory disease. A previous Delphi panel established areas of consensus on GPP, although patient perspectives were not included, and aspects of treatment goals remain unclear.

Objectives: To identify and achieve consensus on refined, specific treatment goals for GPP treatment via a Delphi panel with patient participation.

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Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.

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In atopic dermatitis (AD), the real-world impact of achieving itch and skin lesion treatment targets compared to partial improvement remains unclear. We assessed the relationship between itch relief (reduction in Worst Itch Numeric Rating Scale [WI-NRS]) and skin clearance (Investigator Global Assessment [IGA] 0/1) with other patient-reported outcomes. Using TARGET-DERM AD registry data on adults receiving standard-of-care treatment, we described and modeled the relationship of itch severity (Worst Itch Numeric Rating Scale [WI-NRS]) and skin lesion severity (IGA) outcomes with patient-reported (quality of life ([DLQI)], AD severity [(POEM]), sleep ([Sleep-NRS]), and skin pain [(Pain-NRS]).

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Introduction: Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials.

Methods: High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE).

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Introduction: In adults with moderate-to-severe atopic dermatitis (AD), rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo. This post hoc analysis of a phase 2b study was undertaken to understand the disease burden and to assess the impact of rocatinlimab on patient-reported outcomes (PROs).

Methods: This analysis used baseline data from a multicenter, randomized, double-blind study of adults with moderate-to-severe AD, who completed a Worst Pruritus numerical rating scale (NRS), Sleep Disturbance NRS, and the Dermatology Life Quality Index (DLQI).

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  • Treg impairment is linked to chronic inflammatory diseases, and the study explores the use of a new medication, rezpegaldesleukin (REZPEG), for restoring Tregs in patients with atopic dermatitis and psoriasis.
  • Two trials showed that REZPEG is safe and well-tolerated, with effective dosing leading to significant improvements in disease severity scores after treatment.
  • Patients who received the higher dose exhibited lasting benefits, such as significant EASI score improvements and sustained Treg increases, indicating the potential for long-term control of these skin conditions without ongoing treatment.
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  • The study examines the effectiveness and safety of risankizumab for treating moderate-to-severe plaque psoriasis, focusing on racial and ethnic disparities in diagnosis and representation in clinical trials.
  • A total of 897 patients participated, with significant reductions in psoriasis severity and improvements in quality of life reported, particularly among Black or African American and Hispanic or Latino patients.
  • Results suggest that risankizumab shows similar efficacy across different racial and ethnic groups without any new safety concerns arising during the treatment.
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  • Safe and effective long-term topical treatments for atopic dermatitis (AD) are limited, leading to low adherence rates among patients.
  • The study aimed to assess the efficacy and safety of once-daily roflumilast cream (0.15%) compared to a vehicle cream in patients aged 6 and older with mild to moderate AD across two phase 3 trials.
  • Results showed that a significantly higher percentage of patients using roflumilast achieved treatment success and a notable reduction in eczema severity compared to those using the vehicle cream.
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Background: Janus kinase inhibitors (JAKi) have the potential to alter the landscape of atopic dermatitis (AD) management dramatically, owing to promising efficacy results from phase III trials and their rapid onset of action. However, JAKi are not without risk, and their use is not appropriate for all patients with AD, making this a medication class that dermatologists should understand and consider when treating patients with moderate-to-severe AD.

Objectives: To provide a consensus expert opinion statement from the International Eczema Council (IEC) that provides a pragmatic approach to prescribing JAKi, including choosing appropriate patients and dosing, clinical and laboratory monitoring and advice about long-term use.

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  • Generalized pustular psoriasis (GPP) is a rare skin disease that causes painful bumps and redness all over the body, and it can be really serious if not treated.
  • GPP can come and go, but sometimes the symptoms can last a long time, and it's important for doctors to know about it.
  • This paper wants to help more people recognize GPP so that it can be diagnosed and treated faster.
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Chronic spontaneous urticaria (CSU) should be on every dermatology practitioner's radar. CSU is a skin disorder marked by wheals, angioedema, or both for more than 6 weeks. Patients with CSU experience unexplained, itchy wheals that appear and disappear, traveling around the body and lasting less than 24 hours per area.

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Importance: New, effective, and well-tolerated oral therapies are needed for treating psoriasis. Zasocitinib, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, is a potential new oral treatment for this disease.

Objective: To assess the efficacy, safety, and tolerability of zasocitinib in patients with moderate to severe plaque psoriasis.

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Oral Janus kinase inhibitors (JAKi), a class of advanced targeted systemic therapy, have demonstrated efficacy and safety in the treatment of moderate-to-severe atopic dermatitis (AD). Like other small molecules, oral JAKi have the potential for off-target effects including laboratory-related adverse events (AEs). Product labels for oral JAKi recommend an initial laboratory assessment and follow-up 4-12 weeks later to monitor for potential changes, based on evidence from clinical trials across therapeutic indications for oral JAKi, which may not reflect a population of moderate-to-severe AD patients typically seen in routine clinical practice.

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  • - The study focused on atopic dermatitis (AD) and evaluated how much time patients spent with clear skin and minimal itch while being treated with upadacitinib compared to a placebo and dupilumab.
  • - Researchers analyzed data from three phase 3 studies involving nearly 2,400 patients, with treatments lasting from 16 to 24 weeks and assessed using established skin severity and itch scales.
  • - Results showed that patients on upadacitinib experienced significantly more days with better skin conditions and reduced itching compared to those on placebo or dupilumab.
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  • * Data from a 5-year trial (UNCOVER-3) shows that most patients, regardless of whether they had initial issues in these challenging areas, achieved similar levels of clear skin and overall improvement.
  • * A notable finding is that patients without nail involvement had a significant advantage in overall percentage improvement, but overall efficacy was largely comparable across both groups.
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  • Chronic hand eczema is a painful, inflammatory condition affecting the hands and wrists, impacting patients' quality of life and ability to work; the DELTA 1 and DELTA 2 trials aimed to evaluate the effectiveness and safety of delgocitinib cream against a placebo.* -
  • Both studies were randomized, double-blind, and involved adult participants with moderate to severe chronic hand eczema, comparing the effects of twice-daily applications of delgocitinib cream to a placebo for 16 weeks, focusing on achieving a clear or almost clear skin condition.* -
  • Results showed that significantly more patients treated with delgocitinib achieved treatment success compared to the placebo group, with notable differences observed in both trials
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  • Current treatment recommendations for atopic dermatitis (AD) may not adequately address patients' needs and goals, prompting the development of new strategies for management.
  • An international team of dermatology experts created the Aiming High in Eczema/Atopic Dermatitis (AHEAD) recommendations, incorporating patient input and utilizing a modified voting process to achieve consensus on treatment targets.
  • The AHEAD approach emphasizes shared decision-making with patients selecting troublesome symptoms while clinicians assess severity; it aims for minimal disease activity as a goal, achieving significant agreement among experts on the proposed guidelines.
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  • - Abrocitinib is an FDA-approved oral medication for treating moderate-to-severe atopic dermatitis (AD) in both adults and adolescents, and it has proven to be effective in clinical trials with a good safety profile over time.
  • - A 200-mg daily dose of abrocitinib offers quicker relief from itching and better skin improvement compared to dupilumab, but monitoring for potential side effects is crucial due to risks associated with all oral JAK inhibitors.
  • - The use of abrocitinib is appropriate for qualified patients needing systemic AD therapy, though caution is advised for specific populations such as older adults and those with certain health risks, with a recommendation to start with a lower 100-mg dose in
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Aim: In the global phase 3 POETYK PSO-1 and PSO-2 trials, significantly greater proportions of deucravacitinib-treated patients met the coprimary endpoints (PASI 75, sPGA 0/1) at Week 16 versus placebo or apremilast-treated patients. This analysis evaluated onset of action and maintenance of response in patients randomized to deucravacitinib and placebo only.

Methods: Adults with moderate to severe plaque psoriasis at baseline were randomized 1:2:1 to oral placebo, deucravacitinib, or apremilast.

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The objective was to study a large, international, ethnically diverse population of patients with atopic dermatitis (AD) to support the creation of patient-centric recommendations for AD management. Qualitative data were generated from 45-min, 1:1 telephone interviews conducted across 15 countries in each patient's native language. Interviews explored the impact of AD on patients' lives, patients' most important symptoms, treatment expectations, and treatment decision-making.

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Secukinumab is a fully human IgG1 antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin-17A. Secukinumab is an effective and well-tolerated treatment for plaque psoriasis. There is a limited real-word evidence for dose optimisation of secukinumab based on clinical response.

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Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease resulting from the complex interplay of genetic and environmental factors, meriting exploration using temporally dynamic biomarkers. DNA methylation-based algorithms have been trained to accurately estimate biological age, and deviation of predicted age from true age (epigenetic age acceleration) has been implicated in several inflammatory diseases, including asthma.

Objective: We sought to determine the role of epigenetic and biological aging, telomere length, and epigenetically inferred abundance of 7 inflammatory biomarkers in AD.

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