2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T782,Chronic obstructive pulmonary disease (COPD) is a leading cause of hospitalization and death, particularly among patients with chronic bronchitis and frequent exacerbations. Results of placebo-controlled clinical trials indicate that treatment escalation with either long-term oral roflumilast or azithromycin can reduce COPD exacerbations. However, head-to-head comparative data from clinical trials are lacking, so the relative harms and benefits of these treatments are unclear. The RELIANCE (RofLumilast or Azithromycin to preveNt COPD Exacerbations) study is an investigator-initiated, multicenter, randomized, pragmatic clinical trial embedded in clinical practice to evaluate the effectiveness of treatment escalation with long-term azithromycin versus roflumilast in patients with COPD and chronic bronchitis. We solicited preferences from patients, clinicians, and other stakeholders during the design and implementation phases of the study, including feedback that informed modifications related to the COVID-19 pandemic. Eligibility criteria did not require assessments outside of clinical practice, with exclusions principally for safety. The composite endpoint of first all-cause hospitalization or death served as the primary outcome. Enrollment was initially through university-affiliated Clinical Centers but was subsequently expanded to recruit patients in community-based practices who might not otherwise participate in research. We employed human-centered design principles to improve the usability of study activities from the perspective of participants, study staff, and treating clinicians. The final study design offered the option for patients with COPD and chronic bronchitis at high-risk of hospitalization or death to be remotely consented, prescribed a medication according to the randomized treatment allocation, and complete virtual follow-up study visits in a decentralized clinical trial.31:T926,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: NCT05028582.32:Tc8f,ImportanceCurrent topical treatments for scalp psoriasis are limited by formulation, efficacy, and/or safety.ObjectiveTo assess safety and efficacy of roflumilast foam, 0.3%, in patients with psoriasis of the scalp and body.Design, Setting, and ParticipantsThis 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.InterventionsOnce-daily roflumilast foam, 0.3%, or vehicle for 8 weeks.Main Outcomes and MeasuresCoprimary 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.ResultsA 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 &lt; .001); and 45.5% of the roflumilast group achieved B-IGA success compared with 20.1% of the vehicle group (P &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.Conclusions and RelevanceThis 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.Trial RegistrationClinicalTrials.gov Identifier: NCT0502858233:T725,Efficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2-5 years with AD. Patients aged 2-5 years with mild-to-moderate AD were treated with once-daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA-AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2-grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) and Worst Itch-Numeric Rating Score (WI-NRS) Success (≥ 4-point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed. Among 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week-4 vIGA-AD Success (25.4% vs. 10.7%; p < 0.0001), EASI-75 (39.4% vs. 20.6%; p < 0.0001), and WI-NRS Success (35.3% vs. 18.0%; nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment-emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group. In this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle. ClinicalTrials.gov: NCT04845620.34:T9b5,ABSTRACTBackground/ObjectivesEfficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel‐group, double‐blind trial (INTEGUMENT‐PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2–5 years with AD.MethodsPatients aged 2–5 years with mild‐to‐moderate AD were treated with once‐daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA‐AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2‐grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI‐75) and Worst Itch‐Numeric Rating Score (WI‐NRS) Success (≥ 4‐point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed.ResultsAmong 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week‐4 vIGA‐AD Success (25.4% vs. 10.7%; p < 0.0001), EASI‐75 (39.4% vs. 20.6%; p < 0.0001), and WI‐NRS Success (35.3% vs. 18.0%; nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment‐emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group.ConclusionsIn this Phase 3 trial, once‐daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2–5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle. 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Synthetic DMARD","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"IL-12/23 Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"IL-17 Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"IL-23 Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"JAK Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"NSAID","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"PDE4 Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"Retinoid","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"TNF-Alpha Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"modality","value":"TYK2 Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"study_design","value":"Narrative Review","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"warning","value":"Corresponding author (Tsen-Fang Tsai) has disclosed extensive consultant relationships with manufacturers of many drugs discussed in the review.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"warning","value":"Level of evidence assigned as 5 (narrative review/expert opinion) due to absence of PRISMA methodology, risk-of-bias tools, or meta-analytic synthesis, even though individual cited studies range from Level 1 to Level 5.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"warning","value":"Several drug-AD associations cited are from studies in rheumatoid arthritis populations, not specifically psoriasis patients; generalizability to psoriatic disease may be limited.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01761-7","tag_type":"warning","value":"This is a narrative review without formal systematic methods; findings are hypothesis-generating and subject to selection bias in included studies.","value_numeric":null}],"summaries":{"what_studied":"This narrative review examined whether systemic drugs used for psoriatic disease (NSAIDs, methotrexate, cyclosporin, retinoids, PDE4 inhibitors, JAK inhibitors, TYK2 inhibitors, and biologics targeting TNF-α, IL-12/23, IL-17, and IL-23) influence the risk or progression of Alzheimer's disease (AD), using AD as a model for dementia. Literature from PubMed (2015–2025) was synthesized across preclinical, observational, and RCT-level evidence.","key_result":"Most preclinical and observational data suggest antipsoriatic therapies may reduce AD risk. The strongest clinical signal comes from a propensity score–matched cohort (n=1,766) showing biologic therapy for psoriasis was associated with a **53% lower risk of incident dementia** vs. conventional systemic therapy alone. In a large EHR-based study (56 million records), TNF inhibitors (etanercept, adalimumab, infliximab) were linked to markedly reduced AD odds (ORs 0.34, 0.28, and 0.52, respectively; all P<0.0001). However, several large observational studies found the psoriasis–dementia association attenuated or disappeared after adjusting for comorbidities.","limitations":"- Narrative (not systematic) review with no PRISMA flow, risk-of-bias assessment, or quantitative synthesis, limiting reproducibility.\n- Most mechanistic evidence comes from preclinical models (Level 5), with very few adequately powered RCTs in humans.\n- Residual confounding by disease severity, metabolic comorbidities, and medication use cannot be excluded in observational studies.","practice_takeaway":"For older patients with psoriasis, consider early cognitive screening, as shared inflammatory mechanisms may raise dementia risk—especially in those with metabolic comorbidities. Biologic therapy, particularly TNF inhibitors, shows the most consistent signal for possible neuroprotection, but current evidence is hypothesis-generating and should not yet change prescribing solely for dementia prevention."}},{"doi":"10.1016/j.jaad.2026.02.113","pmid":"41949508","title":"Guidelines of care for the management of atopic dermatitis in pediatric patients","journal_title":"Journal of the American Academy of Dermatology","journal_issn":"0190-9622","published_at":"2026-04-07T00:00:00.000Z","url":"https://doi.org/10.1016/j.jaad.2026.02.113","source_score":103,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-07T17:34:05.456Z","updated_at":"2026-05-07T17:34:05.456Z","tags":[{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"age_group","value":"pediatric","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Adbry","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Cibinqo","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Ebglyss","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Eucrisa","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Olumiant","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Opzelura","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Rinvoq","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"brand","value":"Vtama","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"category","value":"Dermatology","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"condition","value":"Atopic Dermatitis","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"abrocitinib","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"azathioprine","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"baricitinib","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"crisaborole","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"cyclosporine","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"lebrikizumab","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"methotrexate","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"mycophenolate mofetil","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"nemolizumab","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"roflumilast","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"ruxolitinib","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"tapinarof","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"tralokinumab","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"generic","value":"upadacitinib","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"Biologic","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"Conventional Immunosuppressant","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"JAK Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"PDE4 Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"Phototherapy","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"Topical Calcineurin Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"modality","value":"Topical Corticosteroid","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"study_design","value":"Clinical Practice Guideline","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"warning","value":"Brand name for nemolizumab (Nemluvio) and lebrikizumab (Ebglyss) inclusion is based on known drug-brand mapping; verify current approvals for pediatric indications.","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"warning","value":"Brand name for roflumilast cream (Zoryve) was not explicitly stated in the abstract; brand tag was omitted to avoid speculation.","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"warning","value":"No total sample size is reported — this is a guideline/systematic review, not a single trial; sample_size tag was omitted.","value_numeric":null},{"paper_doi":"10.1016/j.jaad.2026.02.113","tag_type":"warning","value":"The DOI publication date (2026-04-07) is in the future relative to the 2014 AAD guidelines it updates, consistent with today's date of May 7, 2026.","value_numeric":null}],"summaries":{"what_studied":"A multidisciplinary AAD workgroup evaluated topical, phototherapy, and systemic treatments for atopic dermatitis (AD) in children and adolescents, using a systematic review and GRADE methodology to update the 2014 AAD guidelines.","key_result":"27 evidence-based recommendations were developed. Strong recommendations support moisturizers, topical corticosteroids, topical calcineurin inhibitors, crisaborole, roflumilast, ruxolitinib, tapinarof, dupilumab, tralokinumab, lebrikizumab, nemolizumab (with topical therapy), upadacitinib, abrocitinib, and baricitinib. Conditional recommendations favor bathing, bleach baths, wet dressings, phototherapy, methotrexate, mycophenolate mofetil, azathioprine, and cyclosporine. Systemic corticosteroids are strongly recommended against.","limitations":"Most RCTs for AD therapies are short in duration, limiting conclusions about long-term efficacy and safety. Evidence is based on best available data at time of review only.","practice_takeaway":"Multiple biologic and JAK inhibitor options now carry strong recommendations for pediatric AD — clinicians should prioritize these over systemic corticosteroids, which are strongly discouraged. 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TEAEs were low and 98.9% were mild or moderate; application-site stinging/burning causing definite discomfort was reported by ≤0.7% with roflumilast.","limitations":"Short treatment duration (4 weeks); no active comparator; WI-NRS is not validated for ages 2–5 years.","practice_takeaway":"In toddlers with mild-to-moderate atopic dermatitis, once-daily roflumilast 0.05% improved signs and itch by Week 4—and as early as 24 hours—while showing low rates of mostly mild AEs and local tolerability comparable to vehicle over 4 weeks."}}],"initialOffset":6,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"generic","value":"roflumilast"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Generics","href":"/hub/tag/generic"},{"name":"roflumilast"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"generic","hub_tag_value":"roflumilast"}}}]]

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