Dermatology and Therapy最新文献

Introduction: Melasma is a chronic pigmentary disorder that often recurs after treatment, particularly in people with darker skin who are more prone to pigmentary side effects.

Methods: This prospective study evaluated the efficacy and safety of a 675-nm laser for melasma in individuals with darker skin types. Twenty-eight Thai women with Fitzpatrick skin types (FSTs) III-V underwent three monthly laser sessions using dual Moveo and Standard modes without anesthesia. Clinical severity, pigmentation, patient satisfaction, and safety were assessed up to 6 months after treatment.

Results: The modified Melasma Area and Severity Index (mMASI) showed a 41% improvement at 3 months and 34% at 6 months post-treatment. Antera 3D imaging confirmed progressive melanin reduction, and over 70% of participants reported at least 50% improvement. Adverse effects were mild and transient, including mild erythema or small scabs, with no postinflammatory hyperpigmentation (PIH) observed.

Conclusion: The 675-nm laser achieved sustained lightening of melasma and skin tone improvement with minimal discomfort and no downtime. These findings support the 675-nm laser as a safe and effective treatment for melasma in darker skin types, offering a potential new approach for managing this persistent condition.

Historically, dermatology research and clinical practice in the United States (USA) have overlooked important considerations in the dermatological care of individuals with skin of color (SOC). With growing awareness of the disparities in health outcomes among racial and ethnic groups, it is critical to recognize the existing care gaps and implement initiatives that promote healthcare equity. To identify the unmet dermatological needs of these populations, a literature review was conducted from January 2020 to October 2023, which revealed 18 distinct dermatological care gaps categorized under four root causes: cultural diversity, income status, racial bias, and underrepresentation in medical and research settings. An initiative scan was performed using a similar search and prioritization strategy to assess ongoing activities led by medical societies, pharmaceutical companies, and patient organizations to address these care gaps. Sustaining these evidence-based interventions is essential to reducing racial and ethnic disparities in dermatology and driving meaningful change in the healthcare system within the USA. This review offers a snapshot of the current dermatological care landscape for patients with SOC and proposes a structured framework for evaluating outcomes and guiding future initiatives.

Introduction: While bimekizumab has demonstrated rapid, superior clinical efficacy versus adalimumab and ustekinumab, with sustained responses through 4 years, its comparative and long-term impact on patient-reported outcomes (PROs) remains underexplored. Here, we report PROs with bimekizumab versus adalimumab/ustekinumab/placebo in phase 3 controlled trials, and over 4 years with bimekizumab.

Methods: Data were analyzed from BE SURE, BE VIVID, BE READY (52/56 weeks), and their open-label extension (OLE), BE BRIGHT (144 weeks; 4 years' total treatment). Patients were randomized to bimekizumab/adalimumab/ustekinumab/placebo during comparator-controlled periods; all received bimekizumab during BE BRIGHT. Proportions of patients reporting Psoriasis Symptoms and Impacts Measure (P‑SIM) = 0 and Dermatology Life Quality Index (DLQI) = 0 (both at item-level) were assessed during comparator‑controlled periods using non-responder imputation (NRI). Over 4 years, PROs were analyzed using modified NRI in patients who received continuous bimekizumab from baseline into the OLE.

Results: BE SURE included 478 patients (bimekizumab, 319; adalimumab, 159); BE VIVID included 567 (bimekizumab, 321; ustekinumab, 163; placebo, 83); BE READY included 435 (bimekizumab, 349; placebo, 86). In total, 771 patients received continuous bimekizumab into the OLE. A larger proportion of bimekizumab-treated patients achieved P-SIM = 0 across key items versus adalimumab (week 24; itching, 30.7% vs. 18.9%; skin pain, 43.9% vs. 30.2%; scaling, 39.2% vs. 19.5%), ustekinumab (week 16; itching, 31.2% vs. 17.8%; skin pain, 51.7% vs. 27.6%; scaling, 43.6% vs. 17.2%), and placebo. Similar trends were seen for other P-SIM items and in proportions of bimekizumab-treated patients reporting DLQI = 0 across items versus comparators. The patient-reported benefits of bimekizumab were demonstrated throughout the OLE, with 65.5-94.8% of patients reporting DLQI = 0 across items at 4 years.

Conclusions: Bimekizumab provided greater improvements in PROs versus comparators, with durable effects over 4 years. These findings reinforce bimekizumab's role in effective psoriasis management, linking clinical efficacy with sustained patient-reported benefits.

Trial registration: NCT03412747, NCT03370133, NCT03410992, NCT03598790. A Graphical Abstract is available for this article.

Introduction: Amlitelimab (SAR445229, KY1005), a nondepleting anti-OX40 ligand monoclonal antibody, reduced lesions and pruritus in phase 2a and 2b trials in adults with moderate-to-severe atopic dermatitis (AD). Here, efficacy and durability of amlitelimab across body regions were evaluated, given that unmet needs remain for treatment of head and neck AD.

Methods: STREAM-AD phase 2b trial data were used in this post hoc analysis. Patients were randomized 1:1:1:1:1 to receive amlitelimab subcutaneously (250 mg with 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg) or placebo every 4 weeks from weeks 0 to 24 (part 1). In part 2, clinical responders (patients achieving Investigator Global Assessment 0/1 and/or ≥ 75% reduction in Eczema Area and Severity Index [EASI-75] at week 24) were re-randomized 3:1 to withdraw from amlitelimab or continue their pre-week 24 amlitelimab dose through week 52. EASI subscores and signs were evaluated for head and neck, trunk, lower extremities, and upper extremities.

Results: Part 1 included 390 randomized patients; 190 continued to part 2. In part 1, all EASI body region subscores were reduced with all amlitelimab doses at week 24 (P ≤ 0.01). Additionally, the four EASI signs-erythema, edema, excoriation, and lichenification-were reduced with amlitelimab vs. placebo. Greater proportions of patients achieved EASI-75 per body region with all amlitelimab doses, compared to placebo (P ≤ 0.05). At week 52, clinical responders maintained improvements in each body region achieved in part 1, regardless of treatment continuation or withdrawal.

Conclusion: Improvements in AD signs and severity were observed with amlitelimab across all body regions. Notably, clinical responses were sustained following treatment withdrawal, supporting the potential for extended dosing intervals and durable off-treatment efficacy. Amlitelimab may be a treatment option for hard-to-treat head and neck AD that disproportionately impairs quality of life.

Trial registration: ClinicalTrials.gov Identifier NCT05131477.

Chronic hand eczema (CHE) is a chronic inflammatory skin disease defined as hand eczema that occurs for more than three consecutive months or relapses at least twice per year. For patients with CHE, quality of life can be negatively affected by the severity of symptoms, such as pain and itch, and the appearance of the affected skin on the hands and wrists which are highly visible. This article is coauthored by a patient who shares her lifelong journey with CHE. She details the physical, mental, and social impacts she experienced throughout her life with this chronic disease, as well as her struggles in navigating clinical care and finding an effective treatment. A dermatologist then reflects on the patient's story, highlighting five key lessons to clinicians regarding the burdens of living with CHE and the crucial role of empathy in guiding clinicians to provide more holistic care. Additionally, the current clinical understanding of CHE and treatment options are briefly discussed. Altogether, combining effective treatments with patient-centered holistic care can enhance the quality of life for patients with CHE, by not only improving the physical symptoms of CHE but also their overall well-being.

Introduction: Lebrikizumab, a human monoclonal antibody that targets interleukin-13, is approved for treating moderate to severe atopic dermatitis in many regions. However, real-world data are lacking and are needed to inform its efficacy and safety in broader populations.

Methods: This retrospective study reviewed the Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) at baseline and 16-20 weeks of 84 consecutive patients who received lebrikizumab subcutaneously at the label dose in a tertiary centre.

Results: EASI scores were available at 16-20 weeks for 72 patients. At this timepoint, 80.6% (58/72) achieved EASI 50, 56.9% (41/72) reached EASI 75, and 27.8% (20/72) attained EASI 90. DLQI was reduced by an average of - 1.5 points at 16-20 weeks. No serious adverse events were reported. Ocular adverse events occurred in 21.4% of the cohort (18/84). Eleven out of 14 patients that previously experienced conjunctivitis with dupilumab or tralokinumab had no recurrence with lebrikizumab.

Conclusion: In this real-world cohort of patients with atopic dermatitis, lebrikizumab demonstrated efficacy comparable to that observed in clinical trials. It may provide an alternative treatment option for individuals who have discontinued other biologics as a result of conjunctivitis.

Introduction: Moderate-to-severe plaque psoriasis can be difficult to treat; not all patients respond to treatment. POETYK PSO-1 and PSO-2 were 52-week, phase 3, multinational, double-blinded trials in plaque psoriasis. We determined deucravacitinib efficacy in PSO-1/PSO-2 patients who did not respond to apremilast.

Methods: PSO-1/PSO-2 were conducted between July 2018 and November 2020; this analysis includes data from both trials. Adults with moderate-to-severe plaque psoriasis (baseline Psoriasis Area and Severity Index [PASI] ≥ 12, static Physician Global Assessment [sPGA] ≥ 3, body surface area involvement ≥ 10%) were included and randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Clinical endpoints included ≥ 75%/90% reduction from baseline PASI (PASI 75/90), sPGA score of 0 (clear) or 1 (almost clear) (sPGA 0/1) response rates, and mean percent change from baseline PASI and BSA involvement. Patient-reported outcomes included Dermatology Life Quality Index 0 (no effect) or 1 (little effect) (DLQI 0/1) and mean change from baseline Psoriasis Symptoms and Signs Diary (PSSD) symptom score.

Results: Of 168 (PSO-1) and 254 (PSO-2) patients randomized to apremilast, 54 (32.1% [PSO-1]) and 111 (43.7% [PSO-2]) did not achieve PASI 50 (PSO-1) and PASI 75 (PSO-2) at Week 24 and were switched to deucravacitinib. PASI 75 response rates improved from 0% at Week 24 to 46.3% (PSO-1) and 42.3% (PSO-2) at Week 52. From Weeks 24-52, PASI 90, sPGA 0/1, and DLQI 0/1 response rates increased; mean percent change from baseline PASI decreased by 60% (PSO-1) and 26% (PSO-2); mean change from baseline in PSSD symptom score decreased by ≈20% in both studies; mean percent change from baseline BSA involvement decreased by 65% (PSO-1) and 25% (PSO-2).

Conclusion: Deucravacitinib was efficacious in patients with moderate-to-severe plaque psoriasis who did not respond to apremilast.

Trial registration: ClinicalTrials.gov identifier, NCT03624127, NCT03611751.

Introduction: Tildrakizumab, an anti-interleukin (IL)-23p19 monoclonal antibody, is approved for the treatment of moderate-to-severe plaque psoriasis. Although pivotal clinical trials have shown its sustained efficacy and safety, real-world evidence (RWE) is crucial to assess its performance in routine clinical practice. The aim of this study is to evaluate the real-world effectiveness and safety of tildrakizumab in adult patients with moderate-to-severe plaque psoriasis in the Basque Country, northern Spain.

Methods: We conducted a multicenter, retrospective observational study, including 212 adult patients treated with tildrakizumab across five tertiary hospitals between November 2020 and April 2024. Clinical outcomes, including Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Physician Global Assessment (PGA) scores were collected at baseline and weeks 28, 52, 76, and 100-112. Safety data and reasons for treatment discontinuation were also recorded.

Results: Among the 212 patients (median age 52.7 years, 56.56% male), most had long-standing psoriasis (median duration: 20.9 years) and multiple comorbidities. Over 80% had previously received biologic therapy. At week 52, 68.8% of patients with follow-up achieved PASI ≤ 3, and 72.7% reached a PGA of 0/1. Median PASI decreased from 11.21 at baseline to 2.51 at week 52. No serious treatment-related adverse events were reported. Discontinuation occurred in 41 patients (19.3%), mainly owing to primary or secondary failure and patient decision.

Conclusions: Tildrakizumab demonstrated high effectiveness and a favorable safety profile in this large, real-world multicenter cohort. These findings support its role as a reliable therapeutic option for patients with moderate-to-severe plaque psoriasis in clinical practice.

Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with impaired quality of life and a substantial burden of disease. Lebrikizumab is a monoclonal antibody that selectively binds with high affinity to interleukin-13, thereby inhibiting its cascade signaling and reducing inflammation. Lebrikizumab has demonstrated efficacy and safety in adults and adolescents ≥ 12 years with moderate-to-severe AD in randomized, placebo-controlled, phase 3 clinical trials. Here, we report a case series of four patients with moderate-to-severe AD who transitioned to lebrikizumab treatment in the Czech Republic. All four patients had failed previous targeted therapies (biologics or Janus kinase inhibitors) and/or cyclosporine treatments and presented with associated comorbidities. After 12 to 16 weeks of treatment with lebrikizumab, clinically significant improvements in signs and symptoms (assessed by Eczema Area and Severity Index [EASI], pruritus Numerical Rate Scale, quality of life assessed by the Dermatology Life Quality Index [DLQI], and/or Patient Oriented Eczema Measure [POEM]) were reported. The results of these four clinical cases support the effectiveness observed in randomized clinical trials and suggest that lebrikizumab may be an effective treatment for moderate-severe AD in real-world clinical practice, even in patients with comorbidities who have failed previous advanced treatments.