ImportanceLebrikizumab (LEB), a high-affinity monoclonal antibody targeting interleukin (IL)-13, demonstrated efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) during 16 weeks of monotherapy in a phase 2b trial, and two 52-week phase 3 trials.ObjectiveTo evaluate efficacy and safety of LEB combined with low- to mid-potency topical corticosteroids (TCS) in patients with moderate-to-severe AD.Design, Setting, and ParticipantsThe ADhere trial was a 16-week randomized, double-blinded, placebo (PBO)-controlled, multicenter, phase 3 clinical trial conducted from February 3, 2020, to September 16, 2021. The study was conducted at 54 outpatient sites across Germany, Poland, Canada, and the US and included adolescent (aged ≥12 to <18 years weighing ≥40 kg) and adult patients with moderate-to-severe AD. The treatment allocation ratio was 2:1 (LEB:PBO).InterventionsOverall, 211 patients were randomized to subcutaneous LEB (loading dose of 500 mg at baseline and week 2, followed by 250 mg every 2 weeks [Q2W] thereafter) or PBO Q2W in combination with TCS for 16 weeks.Main Outcomes and MeasuresEfficacy analyses at week 16 included proportions of patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA [0,1]) with 2 or more points improvement from baseline, and 75% improvement in the Eczema Area and Severity Index (EASI-75). Key secondary end points included evaluation of itch, itch interference on sleep, and quality of life. Safety assessments included monitoring adverse events (AEs).ResultsThe mean (SD) age of patients was 37.2 (19.3) years, 103 (48.8%) patients were women, 31 (14.7%) patients were Asian, and 28 (13.3%) patients were Black/African American. At week 16, IGA (0,1) was achieved by 145 (41.2%) patients in the LEB+TCS group vs 66 (22.1%) receiving PBO+TCS (P = .01); corresponding proportions of patients achieving EASI-75 were 69.5% vs 42.2% (P < .001). The LEB+TCS group showed statistically significant improvements in all key secondary end points. Most treatment-emergent adverse events (TEAEs) were nonserious, mild or moderate in severity, and did not lead to study discontinuation. The TEAEs frequently reported in the LEB+TCS group included conjunctivitis (7 [4.8%]), headache (7 [4.8%]), hypertension (4 [2.8%]), injection site reactions (4 [2.8%]), and herpes infection (5 [3.4%]) vs 1.5% or less patient-reported frequencies in the PBO+TCS group. Similar frequencies of patient-reported serious AEs following LEB+TCS (n = 2, 1.4%) and PBO+TCS (n = 1, 1.5%).Conclusions and RelevanceIn this randomized phase 3 clinical trial, LEB+TCS was associated with improved outcomes in adolescents and adults with moderate-to-severe AD compared with TCS alone, and safety was consistent with previously reported AD trials.Trial RegistrationClinicalTrials.gov Identifier: NCT04250337
Background: Pimecrolimus is indicated for treatment of atopic dermatitis and has been evaluated in many other disorders.Objective: To review the efficacy of pimecrolimus in treatment of disorders other than atopic dermatitis.Methods: We performed a PubMed search of the English-language literature using the key word ''pimecrolimus.'' We reviewed articles reporting the use of pimecrolimus in disorders other than atopic dermatitis and classified them by the type of study used to evaluate efficacy.Results: Randomized, double-blind studies have shown that pimecrolimus is superior to vehicle in treatment of seborrheic dermatitis, hand dermatitis, and asteatotic eczema but have yielded conflicting results regarding intertriginous psoriasis and vitiligo.Open-label studies involving four or more patients have shown favorable results in many disorders, including contact dermatitis, rosacea, lichen sclerosus, and oral and genital lichen planus. Case reports have shown that topical pimecrolimus may be useful in cutaneous graft-versus-host disease, lichen striatus, cutaneous lichen planus, and many other disorders.Conclusions: Topical pimecrolimus appears to be an effective treatment for many disorders other than atopic dermatitis, especially seborrheic dermatitis, hand dermatitis, and asteatoic eczema. It may be effective in many other disorders, but its role in these disorders remains to be clarified by additional studies.Anté cé dents: Le pimé crolimus est indiqué dans le traitement des dermatites atopiques et a é té é valué dans le traitement de nombreuses autres affections.Objectif: Passer en revue l'efficacité du pimé crolimus dans le traitement des conditions autres que la dermatite atopique.Mé thode: Nous avons effectué une recherche au moyen de PubMed dans les publications de langue anglaise en utilisant le terme clé pimé crolimus. Nous avons passé en revue des articles qui mentionnent l'usage de pimé crolimus dans le traitement de conditions outre les dermatites atopiques, et les avons classé s par type d'é tudes utilisé es pour en é valuer l'efficacité .Ré sultats: Les é tudes randomisé es à double insu ont montré que le pimé crolimus é tait plus efficace que le vé hicule dans le traitement de la dermatite sé borrhé ique, de la dermatite sur les mains, et de l'eczé ma asté atotique, mais que les ré sultats é taient contradictoires dans les cas du psoriasis intertrigineux et de vitiligo. Les é tudes ouvertes regroupant quatre patients ou plus ont montré des ré sultats favorables dans le traitement de plusieurs conditions, notamment les dermatites de contact, la rosacé e, le lichen sclé reux, et le lichen plan buccal et gé nital. Les rapports de cas ont montré que le pimé crolimus topique pourrait ê tre utile dans les cas de rejet de greffe cutané e, de lichen striatus, de lichen plan cutané , et de nombreuses autres maladies.Conclusion: Le pimé crolimus topique semble un traitement efficace contre de nombreuses conditions en plus de la dermatite atopique, surtout la dermatite sé borrhé ique, la dermatite sur les mai...
The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, proposed criteria for Internet gaming disorder (IGD) share similar symptomology with substance use disorders (SUDs), so counselors have adopted individual, cognitive-behavioral models from SUD research to apply to IGD. Studies of these cognitive-behavioral treatments reveal that symptoms return as clients leave treatment. Systemic interventions lower rates of relapse in SUD. Thus, it shall be proposed that Steinglass's systemic-motivational therapy, designed initially for treatment of SUD, could have similar effects on relapse rates when applied to an analogous issue of IGD.
Five percent liposomal lidocaine cream significantly reduces the pain associated with the skin penetration phase of lumbosacral diagnostic blocks but does not change the pain associated with the deep phase or the injection procedure overall. Its usefulness for this application is questionable.
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