PURPOSE:Ruxolitinib cream (Janus kinase [JAK]1/JAK2 inhibitor) was effective and well tolerated in clinical trials of patients with atopic dermatitis (AD). We examined real-world outcomes among patients with moderate AD treated with ruxolitinib cream or systemic therapies. METHODS:Physician-reported data for adults with moderate AD (physician assessed at current treatment initiation) from the Adelphi AD Disease Specific Programme™ (August 2022-March 2023) were analyzed descriptively. Patients treated with ruxolitinib cream, traditional systemic immunosuppressants, oral JAK inhibitors, or biologics comprised 4 mutually exclusive cohorts. RESULTS:Among 619 patients (mean age, 39.1 y; 50% female; 79% White), mean affected body surface area (BSA) was reduced from treatment initiation by 49% with ruxolitinib cream, 35% with systemic immunosuppressants, 61% with oral JAK inhibitors, and 55% with biologics. Nearly half of patients (48.4%) had reduced physician-reported disease severity with ruxolitinib cream versus 6.3%, 51.5%, and 46.4% with systemic immunosuppressants, oral JAK inhibitors, and biologics, respectively. Results were similar among patients with baseline affected BSA ≤20%. CONCLUSIONS:Physician-reported outcomes show that ruxolitinib cream monotherapy substantially reduced the extent and severity of moderate AD, suggesting that it provides an effective topical treatment option in these specific populations.
Objectives Urticaria pigmentosa (UP) is the most common form of cutaneous mastocytosis. UP presents with pruritic, red-brown macules and papules, and can be associated with systemic involvement. Currently, there is no cure for UP. Treatment options have been historically limited to antihistamines, which are effective for symptoms but not cosmesis of the lesions. While phototherapy is a recognized treatment for cutaneous mastocytosis, there is sparse evidence addressing the efficacy of narrowband UVB (NB-UVB) phototherapy for UP specifically. We describe three cases of long-standing UP successfully treated with NB-UVB.Methods A retrospective chart review was performed to collect demographic characteristics, disease features, prior treatments, phototherapy parameters, adverse events, pruritus severity, and clinical response using investigator global assessment.Results All three patients demonstrated clinical improvement with NB-UVB despite differences in disease duration, prior treatment history, and phototherapy adherence. Pruritus resolved during therapy for all patients, and two patients had documented improvement in lesion appearance. Treatment was well tolerated, with adverse events limited to mild, transient erythema in two patients and no severe or long-term complications documented.Conclusions These cases support NB-UVB as a durable and well-tolerated treatment option for selected adult patients with UP, particularly those with inadequate response to conventional therapies or need for adjunctive treatment.
OBJECTIVES:Non-segmental vitiligo (NSV) is a chronic skin disease characterized by progressive, bilateral skin depigmentation that can impact health-related quality of life and psychosocial well-being. To assess emerging and new NSV treatments, patient-reported outcomes (PROs) that capture patient-valued treatment outcomes and meaningful changes are needed. Two common aspects of NSV are vitiligo noticeability and sun sensitivity. Thus, PRO items assessing vitiligo noticeability and sun sensitivity were developed. This study aimed to evaluate the content validity and interpretability of the NSV noticeability and sun sensitivity PRO items. METHODS:In this cross-sectional, qualitative interview study, the NSV noticeability and sun sensitivity PRO items were tested in iterative hybrid concept confirmation and cognitive debriefing interviews with 24 adults (≥18 years) and 13 adolescents (12 to ≤17 years) with confirmed NSV. RESULTS:Among the participants, approximately 73% stated noticeability was an important aspect of their vitiligo. Of those who reported sun sensitivity (n = 23), 73.9% noted this symptom was important. Following cognitive debriefing, item wording was simplified, and each item was split to separately assess facial vitiligo and body vitiligo. CONCLUSIONS:Combined, these findings underscore the importance of vitiligo noticeability and sun sensitivity among patients with NSV. The revised noticeability and sun sensitivity items, separately assessing the face and body, may provide a more comprehensive assessment of these outcomes experienced by people with NSV.
Purpose: Janus kinase (JAK) inhibitors are a promising therapeutic option for vitiligo, but previous meta-analyses have focused mainly on topical ruxolitinib versus placebo. Newer randomized controlled trials (RCTs) evaluating oral agents and head-to-head comparisons with active treatments have not been comprehensively synthesized. Materials and methods: We searched PubMed, Embase, the Cochrane Library, and Web of Science to 11 March 2026. Eligible RCTs evaluated JAK inhibitor monotherapy versus placebo or active comparators. Two reviewers screened records, extracted data, and assessed risk of bias using RoB 2.0. The primary outcome was F-VASI75. Meta-analyses used fixed-effect or random-effects models. GRADE assessed certainty of evidence. Results: Nine RCTs (1826 patients) were included. JAK inhibitors increased F-VASI75 versus placebo (RR 4.59, 95% CI 3.20-6.59; p < 0.001). For F-VASI50, they were superior to tacrolimus (RR 1.88, 95% CI 1.02-3.45) but not significantly different from dexamethasone (RR 2.17, 95% CI 0.95-4.94). Serious adverse events were comparable between groups (RR 1.15, 95% CI 0.57-2.33). Evidence certainty was moderate. Conclusions: JAK inhibitors are effective and well tolerated for vitiligo. Topical ruxolitinib is supported as a first-line option for limited facial disease; oral agents show promise but require longer-term safety data.
BACKGROUND:Adalimumab is widely used for hidradenitis suppurativa (HS), but treatment durability varies and predictors of sustained benefit remain uncertain. OBJECTIVE:To identify clinical and laboratory factors associated with adalimumab treatment durability in HS. METHODS:We retrospectively studied 135 adults with HS who initiated adalimumab as first biologic therapy across three academic centers from 2013 to 2023. Outcomes were categorized as primary failure (12-24 weeks), secondary failure (24 weeks-2 years), or sustained response (>2 years) based on discontinuation for inefficacy. Predictors of treatment durability were evaluated using ordinal logistic regression. RESULTS:In univariable analyses, Hurley stage 3, higher body mass index, diabetes, and lower hemoglobin were associated with lower adalimumab durability. In the multivariable model, Hurley stage 3 remained independently associated with less favorable durability (adjusted odds ratio 0.37, 95% confidence interval 0.17-0.81). Comorbid psoriasis was not significantly associated with durability (adjusted odds ratio 2.84, 95% confidence interval 0.96-8.39). Baseline laboratory parameters, including leukocyte and monocyte counts and albumin, did not predict outcome. Age at disease onset, disease duration, and other demographic characteristics were also not associated with durability. CONCLUSION:Hurley stage 3 was independently associated with lower adalimumab durability, while routinely available laboratory measures did not identify additional predictors of long-term treatment outcome.
BACKGROUND:Baseline clinical factors may help estimate early response in psoriasis, but real world evidence across biologics, methotrexate, and phototherapy remains limited. We used SPEECH registry data to evaluate factors associated with Physician Global Assessment (PGA) ≤ 1 at week 12. METHODS:Patients initiating biologics, methotrexate, or phototherapy with week 12 PGA data were included. The primary endpoint was week 12 PGA ≤ 1. Separate multivariable logistic regression models evaluated baseline factors, and restricted cubic spline (RCS) models evaluated associations between body mass index (BMI) and response. RESULTS:Among 998 patients, 478 received biologics, 262 methotrexate, and 258 phototherapy. Response rates were 70.1%, 45.8%, and 54.7%, respectively. Obesity was associated with lower response odds in biologics and methotrexate, but not clearly in phototherapy. In biologics, family history was associated with higher response odds, whereas prior biologic treatment was associated with lower odds. Higher baseline PGA was associated with lower response odds in phototherapy. RCS analysis suggested that associations between BMI and response were most evident in biologics, borderline in methotrexate, and not apparent in phototherapy. CONCLUSIONS:Baseline predictors differed across treatment groups. Obesity/BMI appeared more relevant to response in biologics and methotrexate, whereas baseline PGA appeared more relevant in phototherapy.
OBJECTIVE:To summarize recent literature evaluating treatment outcomes in adults with plaque psoriasis who switched to brodalumab from a different biologic because of treatment failure (inadequate initial response/loss of an adequate initial response) and/or adverse events. METHODS:Relevant published evidence from real-world studies and clinical trials that met defined criteria was identified through targeted searches of PubMed, supplemented by manual reviews of reference lists and input from authors. RESULTS:In real-world studies of patients with treatment failure on anti-IL-17 agents (secukinumab and/or ixekizumab), brodalumab achieved PASI 75, PASI 90, and PASI 100 in 47.8%-81.7%, 40.0%-58.9%, and 28.0%-50.0% of patients, respectively, after 12-16 weeks of treatment. PASI 100 was achieved by 45.5%-63.6% of patients with 26 weeks of brodalumab therapy after anti-IL-12/23, anti-IL-23, or anti-tumor necrosis factor alpha agents in a phase 4 study. Studies with longer-term follow-up have suggested that responses to brodalumab are durable in biologic-experienced patients. CONCLUSIONS:Literature evaluated in this narrative review positions brodalumab as a rational, safe, and effective treatment option for adults with moderate to severe plaque psoriasis who have an inadequate response/loss of an initial response to their existing biologic agent.
BACKGROUND:Characterized by severe pruritus and nodular lesions, prurigo nodularis (PN) is a chronic, inflammatory skin condition that significantly impairs quality of life. Few treatments are specifically approved for PN, and limited evidence exists on patient needs and preferences. OBJECTIVE:To quantify treatment preferences among adults with moderate to severe PN. METHODS:An online discrete choice experiment was administered to 150 adults in the UK (N = 75) and US (N = 75) including 7 attributes: onset of itch reduction, onset of skin lesions/nodules reduction, probability of no itch at 16 weeks, probability of skin healing at 16 weeks, adverse events, special warnings, and administration frequency. Data analysis was conducted using random parameter logit models. RESULTS:Onset of itch reduction was the most important attribute, with a conditional relative importance (CRI: 36.91) 7.4 times greater than onset of skin lesions/nodules reduction (CRI: 5.02) and nearly twice as important as the probability of achieving skin healing (CRI: 22.05) or no itch at 16 weeks (CRI: 20.54). Attributes related to safety and administration frequency had CRIs between 6.3 and 3.9. CONCLUSION:Patients with PN prioritize rapid itch relief over long-term outcomes and safety considerations, underscoring the importance of incorporating patient preferences into clinical and payer decision-making.
Background For patients with stable psoriasis or atopic dermatitis (AD) receiving systemic treatment, telemedicine may offer a viable alternative to in-person consultations. However, perspectives of these patients and dermatological care providers (DCPs) regarding telemedicine are underexplored, yet essential for successful implementation.Objectives To explore experiences, preferences, and perspectives of patients and DCPs regarding telemedicine for patients with psoriasis or AD on systemic treatment.Methods A mixed-methods study was conducted using surveys and semi-structured interviews with patients and DCPs.Results Surveys were completed by 162 patients and 152 DCPs, and interviews by 12 patients and 5 DCPs. Both groups expressed positive attitudes toward telemedicine, provided stable disease. Patients valued telemedicine for practical benefits, including time/cost savings, but emphasized the importance of an established relationship with DCPs before its initiation. DCPs identified key enablers including improved ICT-support, user-friendly systems, and adequate reimbursement. The majority of patients and DCPs supported telemedicine implementation, with telephonic consultations as preferred method. Many DCPs believed ≥50% of consultations could be conducted through telemedicine. Additionally, telemedicine leads to substantial CO2-equivalent emission reduction.Conclusion Patients and DCPs supported further implementation of telemedicine in patients with stable psoriasis or AD on systemic treatment and identified practical, financial and societal facilitators.
BACKGROUND:Palmoplantar pustulosis (PPP) is an uncommon paradoxical reaction associated with biologic therapy. However, secukinumab-induced PPP remains poorly characterized, particularly in biologic-naïve patients with plaque psoriasis. OBJECTIVE:To describe the clinical features, laboratory findings, management, and outcomes of biologic-naïve patients who developed PPP during secukinumab therapy. METHODS:We conducted a retrospective case series of biologic-naïve adults with moderate-to-severe plaque psoriasis who developed new-onset PPP during secukinumab treatment. Clinical characteristics, laboratory findings, treatment modifications, and outcomes were reviewed. RESULTS:Seven biologic-naïve patients were identified. PPP developed after a median of 10 weeks following secukinumab initiation. All patients developed de novo palmoplantar pustular lesions without a prior history of PPP. Peripheral neutrophilia was observed in all patients and was accompanied by significant increases in neutrophil and white blood cell counts compared with baseline, without evidence of infection. Secukinumab was discontinued in all cases. Clinical improvement occurred in six patients, and complete resolution was achieved in two patients after switching to tildrakizumab. CONCLUSIONS:PPP may occur as a paradoxical adverse event during secukinumab therapy, even in biologic-naïve patients. Early recognition and appropriate treatment modification are important for optimal management.
BACKGROUND:JADE REAL was a global, prospective, multicenter, open-label expanded access protocol study that integrated the rigorous follow-up, safety, and efficacy assessments of a clinical trial with dosing flexibility and ability to use concomitant topical therapies to simulate real-world management of atopic dermatitis (AD). OBJECTIVE:The study aimed to provide access to abrocitinib for patients with moderate-to-severe AD without adequate treatments available. METHODS:Eligible patients received abrocitinib 100 mg or 200 mg once daily per investigator's discretion. Dose could be adjusted during treatment. Safety and exploratory efficacy endpoints were assessed. RESULTS:Of 312 patients, 120 (38.5%) and 192 (61.5%) received an initial dose of abrocitinib 100 mg and 200 mg, respectively. TEAEs were reported in 78.2% of patients. TEAEs led to dose change in 39 patients (12.5%); 12 (3.8%) had a dose escalation and 27 (8.7%) had a dose reduction. Rapid improvements in AD severity progressed up to 72 weeks among observed patients. CONCLUSION:Most patients continued their initial dose of abrocitinib. TEAEs accounted for a minority of documented dose reductions; instead, investigators may have determined that the patients' disease could be maintained at a lower dose. These findings support clinical decision-making around dose selection and modification. TRIAL REGISTRATION:NCT04564755.
Objectives Adalimumab was among the first biologics to face widespread biosimilar competition following US market entry of multiple adalimumab biosimilars in 2023. However, Medicare Part D formulary adoption of these products and their associated specialty-tier cost-sharing requirements remain unknown.Methods To evaluate adalimumab biosimilar adoption and associated cost-sharing patterns across Medicare Part D formularies, Centers for Medicare & Medicaid Services (CMS) Medicare Part D Formulary and Plan Benefit Package files were analyzed. Plans were categorized as covering originator adalimumab-only, both originator and biosimilar products (dual coverage), or biosimilars-only.Results In 2023, all Medicare Part D plans covering adalimumab listed only the originator product. By 2024, 52.5% of plans provided dual coverage, increasing to 79.9% in 2025. Biosimilar-exclusive coverage increased from 8.6% of plans in 2025 to 45.9% in 2026, while originator-only coverage declined to 0.8%. Median specialty-tier coinsurance differed according to coverage strategy. In 2026, median specialty-tier coinsurance was 33% among originator-only plans, 27% among dual-coverage plans, and 25% among biosimilar-only plans.Conclusions Medicare Part D formularies rapidly included adalimumab biosimilars following market entry, with substantial growth in biosimilar-exclusive coverage by 2026. Specialty tier coinsurance varied by medication coverage type, suggesting that evolving formulary strategies may influence beneficiary cost-sharing requirements.
BACKGROUND:Extramammary Paget's disease (EMPD) is a rare intraepithelial adenocarcinoma for which surgical excision often causes functional/cosmetic impairment. Photodynamic therapy (PDT) offers a noninvasive alternative, but data on its efficacy and influencing factors remain limited. OBJECTIVE:To evaluate efficacy of 5‑aminolevulinic acid (ALA)‑PDT monotherapy for localized EMPD over one year, and identify baseline predictors of response. METHODS:This retrospective study included 31 patients with histologically confirmed localized EMPD treated with ALA‑PDT alone. Responses were assessed at 3, 6, and 12 months. Objective response rate (ORR), disease control rate (DCR), and associated response factors were analyzed by Fisher's exact test. RESULTS:At 3 months, ORR was 90.3% (28/31) and DCR 100% (31/31), with no complete responses (CR). At 6 months, CR was 19.4% (6/31), ORR 67.7% (21/31), DCR 83.9% (26/31). At 12 months (n = 30), CR remained 19.4% (6/30), ORR declined to 36.7% (11/30), and DCR to 56.7% (17/30). Lesion diameter ≤5 cm and absence of exudation predicted better 6‑month response (p = 0.020 and p = 0.006); diameter ≤5 cm remained significant at 12 months (p = 0.002). CONCLUSIONS:ALA-PDT monotherapy achieves high short‑term responses in localized EMPD, but efficacy declines substantially by 12 months. Lesion diameter ≤5 cm and non-exudative morphology predict better responses.
OBJECTIVE:To evaluate the effect of obesity on biologic efficacy in psoriasis across different drug classes. METHODS:PubMed, Embase, Web of Science, and Cochrane Library were searched from inception to March 2026. Studies reporting obesity‑stratified outcomes of biologics for psoriasis were included. Primary outcome was PASI90 (Psoriasis Area and Severity Index); secondary outcomes were PASI75 and PASI100. Random‑effects model was used to calculate pooled relative risks (RRs). Subgroup analyses and meta‑regression explored heterogeneity. RESULTS:Twelve studies (4200 patients) were included. Obese patients had lower PASI90 response (RR = 0.64; 95% confidence interval (CI): 0.55-0.76; I2 = 72%), but publication bias was present (Egger p < 0.001); after trim‑and‑fill correction, RR = 0.79 (95% CI: 0.58-1.08). This finding should therefore be interpreted with caution. Significant negative effects were seen for interleukin (IL)‑17 inhibitors (RR = 0.57) and IL‑12/23 inhibitors (RR = 0.43) in subgroup analyses, but not for tumor necrosis factor‑alpha (TNF‑α) or IL‑23 inhibitors, although the small number of studies for some classes limits the robustness of these estimates. PASI75 (RR = 0.52) and PASI100 (RR = 0.42) were also lower in obese patients. Biologic class, study design, region, mean body mass index (BMI), and obesity proportion were major sources of heterogeneity. CONCLUSIONS:Obesity may be associated with reduced response to biologics in psoriasis, although the PASI90 result was affected by publication bias and became non‑significant after correction. The impact appeared to differ by class, with significant effects for IL‑17 and IL‑12/23 inhibitors in subgroup analyses, but these findings require confirmation in larger studies. Weight status should be considered as one of multiple factors when selecting biologics, but current evidence does not support treatment selection based solely on obesity.
BACKGROUND:The picosecond Nd:YAG laser is a standard treatment for freckles. However, factors such as cost and technology barriers may limit accessibility, necessitating evaluation of alternative systems. OBJECTIVES:To evaluate the noninferiority and safety of a novel 532-nm picosecond Nd:YAG laser versus an established system for treating freckles. METHODS:In this randomized, evaluator-blinded, split-face trial, 84 participants received a single treatment session. Contralateral facial sides were randomly assigned to the investigational or control device in a 1:1 ratio. The primary endpoint was the response rate at week 8. Secondary endpoints included the cure rate, investigator-assessed improvement, patient satisfaction and procedural tolerability. Safety was assessed by adverse events monitoring. RESULTS:The investigational device demonstrated noninferiority to the control (response rates: 97.6% vs. 97.6%; difference, 0.0%; 95% confidence interval: -3.30% to 3.30%) with comparable cure rates (13.1% vs. 9.5%, p = .527). Participant satisfaction was significantly higher with the investigational device (72.6% vs. 58.3%, p = .001). Treatment duration suggested an association with superior efficacy (OR = 2.07, 95% CI: 1.14-3.76, p = .016). No serious adverse effects occurred. CONCLUSION:The novel 532-nm picosecond Nd:YAG laser is noninferior to the established system, with comparable short-term efficacy and safety. Further studies are needed to assess long-term safety.
INTRODUCTION:Vitiligo is an acquired depigmenting disorder characterized by white macules resulting from the loss of functional melanocytes. MATERIAL AND METHODS:This multicenter, real-life observational study evaluated the efficacy of topical Ruxolitinib (15 mg/g) in 100 patients with non-segmental facial vitiligo treated twice daily for three months, combining clinical scales and noninvasive imaging techniques. Assessments at baseline, 30 days, and 90 days included Facial Vitiligo Area Scoring Index (F-VASI), Facial Vitiligo Extent Score - Body Surface Area (F-VES BSA), Vitiligo Extent Score (VES) grade, Physician's and Patient's Global Vitiligo Assessments, and Dermatology Life Quality Index. RESULTS:Significant improvements were observed across most clinical indices, with marked reductions in disease extent and severity scores (p < 0.0001). Quality of life also improved substantially, as reflected by DLQI reduction. Although F-VASI showed a smaller mean change, it remained statistically significant. DISCUSSION:Instrumental evaluation, including VISIA imaging, Wood's lamp examination, reflectance confocal microscopy, and LC-OCT, confirmed clinical findings by demonstrating repigmentation and a reduction in affected areas. Overall, topical Ruxolitinib proved effective in reducing facial vitiligo lesions and improving patient-reported outcomes. CONCLUSIONS:These findings support the therapeutic potential of JAK inhibitors, although further controlled studies are warranted to confirm long-term efficacy and safety.
BACKGROUND:Non-segmental vitiligo is an autoimmune disorder causing melanocyte loss and depigmentation. The 308-nm excimer laser is effective but achieving sustained repigmentation is challenging. Crisaborole, a PDE-4 inhibitor, may synergize with laser therapy. This study evaluates crisaborole 2% ointment plus laser vs. laser monotherapy with vehicle using an intra-patient left-right controlled design. METHODS:This is a single-center, randomized, double-blind, intra-patient controlled trial. Eligible adults (18-65 years) with stable NSV and at least two comparable symmetrical lesions will be enrolled. Lesions will be randomly assigned to receive either crisaborole + 308-nm excimer laser or vehicle + 308-nm excimer laser. Laser treatment will be administered twice weekly, and ointments applied twice daily over 24 weeks. The primary endpoint is the proportion of lesions achieving ≥75% improvement in the Vitiligo Area Scoring Index (VASI/F-VASI) at the end of treatment. Secondary endpoints include mean percentage change in VASI/F-VASI, time to first repigmentation, recurrence at three months post-treatment, and patient-reported satisfaction. Adverse events will be monitored throughout the study. CONCLUSION:This trial aims to provide high-quality evidence regarding the potential synergistic effect of crisaborole combined with excimer laser therapy, potentially establishing a more effective and safe treatment option for NSV. CLINICAL TRIAL NUMBER:ChiCTR2600124948.
