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1.
JAMA Dermatol ; 157(11): 1306-1315, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34643650

RESUMO

IMPORTANCE: Psoriasis relapse may involve compensatory T-cell activation pathways in the presence of CD28-CD80/CD86 blockade with abatacept. OBJECTIVE: To determine whether costimulatory signaling blockade with abatacept prevents psoriasis relapse after ustekinumab withdrawal. DESIGN, SETTING, AND PARTICIPANTS: Psoriasis Treatment with Abatacept and Ustekinumab: a Study of Efficacy (PAUSE), a parallel-design, double-blind, placebo-controlled randomized clinical trial, was conducted at 10 sites in the US and Canada. Participant enrollment opened on March 19, 2014, and concluded on April 11, 2016. Participants were adults with moderate to severe plaque psoriasis and received ustekinumab in a lead-in phase. Those who responded to ustekinumab at week 12 were randomized 1:1 to either the continued with ustekinumab group (ustekinumab group) or the switched to abatacept group (abatacept group). Treatment was discontinued at week 39, and participants were followed up for psoriasis relapse until week 88. Statistical analyses were performed in the intention-to-treat (ITT) and safety samples from May 3, 2018, to July 6, 2021. INTERVENTIONS: Participants received subcutaneous ustekinumab at weeks 0 and 4 (45 mg per dose for those ≤100 kg; 90 mg per dose for those >100 kg). Participants randomized to the abatacept group at week 12 received subcutaneous abatacept, 125 mg weekly, from weeks 12 to 39 and ustekinumab placebo at weeks 16 and 28. Participants randomized to the ustekinumab group received ustekinumab at weeks 16 and 28 and abatacept placebo weekly from weeks 12 to 39. MAIN OUTCOMES AND MEASURES: The primary end point was the proportion of participants with psoriasis relapse (loss of ≥50% of the initial Psoriasis Area and Severity Index improvement) between weeks 12 and 88. Secondary end points included time to psoriasis relapse, proportion of participants with psoriasis relapse between weeks 12 and 40, and adverse events. The psoriasis transcriptome and serum cytokines were evaluated. RESULTS: A total of 108 participants (mean [SD] age, 46.1 [12.1] years; 73 [67.6%] men) were treated with open-label ustekinumab; 91 were randomized to blinded treatment. Similar proportions of participants in the abatacept group and the ustekinumab group relapsed between weeks 12 and 88 (41 of 45 [91.1%] vs 40 of 46 [87.0%]; P = .41). Median time to relapse from the last dose of ustekinumab was similar between groups as well: 36 weeks (95% CI, 36-48 weeks) in the abatacept group vs 32 weeks (95% CI, 28-40 weeks) in the ustekinumab group. Similar numbers and rates of adverse events occurred. Abatacept did not maintain suppression of the pathogenic IL-23-mediated psoriasis molecular signature in lesions after ustekinumab withdrawal, and serum IL-19 levels increased. CONCLUSIONS AND RELEVANCE: This parallel-design, double-blind randomized clinical trial found that abatacept did not prevent psoriasis relapse that occurred after ustekinumab withdrawal because it did not completely block the pathogenic psoriasis molecular pathways that led to relapse. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01999868.


Assuntos
Psoríase , Ustekinumab , Abatacepte/efeitos adversos , Adulto , Método Duplo-Cego , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/tratamento farmacológico , Psoríase/induzido quimicamente , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do Tratamento , Ustekinumab/uso terapêutico
6.
J Am Acad Dermatol ; 54(3): 416-9, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16488291

RESUMO

BACKGROUND: Little is known about the psychologic status of cosmetically oriented dermatology patients. OBJECTIVE: We sought to determine the prevalence of psychotropic medication use among such patients to offer insight into the rates of psychopathology in this group. METHODS: We conducted a retrospective chart review of patients seeking consultation at a cosmetic dermatology practice, recorded patients' use of psychotropic medicines, and compared this with data from a control group of medical dermatology patients. RESULTS: Both groups reported rates of psychotropic medication use above those expected in the general population. There was no statistically significant difference in the prevalence of psychotropic drug use between cosmetic (18%) and medical (17%) dermatology patients. LIMITATIONS: There is not a one-to-one correspondence between psychotropic medication use and the presence of psychopathology. Data are based on patient health histories and, thus, may be subject to underreporting. CONCLUSIONS: There is a relatively high rate of psychotropic drug use among all patients seeking care from dermatologists, but this does not appear to be more common among patients interested in undergoing cosmetic procedures.


Assuntos
Técnicas Cosméticas/psicologia , Transtornos Mentais/complicações , Transtornos Mentais/tratamento farmacológico , Psicotrópicos/uso terapêutico , Dermatopatias/complicações , Dermatopatias/psicologia , Adulto , Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
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