Lais(Lais) - 在研适应症：超敏反应_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

LAIS、monomeric allergoid vaccine (Lofarma)

靶点-

作用方式-

作用机制-

治疗领域

免疫系统疾病

在研适应症

超敏反应

非在研适应症-

原研机构

Lofarma SpA

在研机构

Lofarma SpA

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

意大利 (2001-05-17),

超敏反应

最高研发阶段(中国)-

特殊审评-

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关联

7

项与 Lais 相关的临床试验

EUCTR2019-001532-65-IT

/ Not yet recruiting临床3期

A prospective, multicenter, double-blind, placebo-controlled randomized study to assess efficacy and safety of LAIS® Grass pollen tablets in patients with seasonal grass pollen-induced allergic rhinoconjunctivitis - LAIS® Grass pollen tablets in seasonal grass pollen-induced allergic rhinoconjunctivitis

开始日期2019-09-12

申办/合作机构-

EUCTR2017-005079-21-DE

/ Not yet recruiting临床2期

A Prospective, Multicenter, Double-Blind, Placebo-Controlled, Dose-Finding Phase-II Study for the Efficacy and Safety of LAIS® House Dust Mites Sublingual Tablets in Patients with Mite-Induced Allergic RhinoConjunctivitis Without or With Controlled Asthma using a Titrated Nasal Provocation Test model.

开始日期2018-08-23

申办/合作机构-

EUCTR2016-003439-39-DE

/ Unknown status临床2期

A Prospective, Multicenter, Double-Blind, Placebo-Controlled, Dose-Finding Phase-II Study for the Efficacy and Safety of LAIS® House Dust Mites Sublingual Tablets in Patients with Mite-Induced Allergic Rhino-Conjunctivitis Without or With Controlled Asthma in an Allergen Exposure Chamber (AEC)

开始日期2017-05-22

申办/合作机构-

100 项与 Lais 相关的临床结果

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100 项与 Lais 相关的转化医学

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100 项与 Lais 相关的专利（医药）

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153

项与 Lais 相关的文献（医药）

2025-06-01·Psychiatry Research

Real-world outcomes and practice patterns among patients with schizophrenia when switched from oral antipsychotics to long-acting injectable formulations after hospitalization

Article

作者: Casciano, Julian ; Thompson, Stephen ; Kane, John M ; Dotiwala, Zenobia ; Philbin, Michael J ; Franzenburg, Kelli R ; Iii, Rolf T Hansen ; Rubio, Jose M

This study compared rehospitalization and practice patterns among patients with schizophrenia in the United States prescribed oral antipsychotics (OAs), alone or with long-acting injectable antipsychotics (LAIs) at hospital discharge. Data came from a hospital-based payer database from December 2019-June 2021. At discharge, 23,336 (84 %) patients were prescribed OAs and 4293 (16 %) were prescribed LAIs±OAs (first-generation LAIs±OAs, 2990/4293 [70 %]; second-generation LAIs±OAs, 1303/4293 [30 %]). The most prescribed OA and LAI±OA were risperidone (26 %) and haloperidol (37 %), respectively. Significantly greater proportions of patients were rehospitalized within 30, 60, or 90 days after discharge with OAs (11 %, 15 %, and 18 %, respectively) vs LAIs±OAs (8 %, 12 %, and 15 %; numbers needed to treat [NNTs], 37, 35, and 38), and with first-generation (9 %, 13 %, 16 %) vs second-generation (7 %, 10 %, 13 %) LAIs (p < 0.05 for all). Significantly greater proportions prescribed LAIs dosed once every 2 weeks vs monthly were rehospitalized within 60 days (15 % vs 11 %, respectively; NNT 33) and 90 days (18 % vs 14 %; NNT 26) (p < 0.05 for all). Prescriptions were based on clinical characteristics at discharge; those prescribed LAIs±OAs may have had less favorable prognoses. However, these results suggest that prescribing second-generation LAIs±OAs with less frequent dosing at discharge may lower rehospitalization risk for patients with schizophrenia.

2025-04-01·Psychiatry Research

Latent variable analysis of adherence to antipsychotics among South Carolina medicaid beneficiaries with schizophrenia or schizoaffective disorder

Article

作者: Benson, Carmela ; Cai, Chao ; Patel, Charmi ; Kozma, Chris ; Yunusa, Ismaeel ; Zhao, Pujing ; Reeder, Gene

Schizophrenia and schizoaffective disorder are chronic mental illnesses that may lead to positive symptoms, negative symptoms, or cognitive symptoms. This study examined latent classes within medication adherence profiles for long-acting injectable antipsychotics (LAIs) and oral antipsychotics (OAPs). Latent profile analysis (LPA) and multinomial logistic regression models were used to explore the association between patient characteristics and latent class membership. Four latent classes were identified using LPA with observed adherence measures. The classes were labeled as "best adherent", "intermittent adherent", "early drop-off", and "worst adherent", with their respective estimated prevalences of 58 %, 17 %, 9 %, and 16 %. Multinomial logistic regression showed that patients on LAIs were more likely to belong to the "best adherent" group than to the non-adherent groups ("intermittent adherent", "early drop-off", and "worst adherent") when compared to those on OAPs. These findings may contribute to the development of strategies for medication prescription and disease management for people with schizophrenia or schizoaffective disorder.

2025-03-01·Journal of Child and Adolescent Psychopharmacology

Long-Acting Injectable Antipsychotic Medication Use in Youth: A Systematic Review of the Literature Along with MedWatch Safety Data and Prescriber Attitudes

Review

作者: Sieracki, Rita ; Mireski, Sarah J. ; Scharko, Alexander M.

Objectives: Long-acting injectable (LAI) antipsychotic medications are being prescribed to children and adolescents along a broad age range from 2 to 17 years old. However, there is no U.S. Food and Drug Administration (FDA) approved indication for the use of any LAI in a pediatric population. The goal of this article is to perform a systematic literature review regarding the use of LAIs in a pediatric population, to obtain pediatric LAI safety data, and to survey prescriber attitudes regarding LAI use in youth. Methods: A search for relevant articles between June 1986 and June 2021 was conducted. Safety data were obtained from FDA MedWatch postmarketing adverse event reports regarding LAI use in children and adolescents. A survey of practicing Child and Adolescent Psychiatrists in Wisconsin was done regarding the use of LAIs in youth. Results: The predominant reasons for LAI use in youth were illness severity and treatment noncompliance. Twenty-six of 30 identified studies and reports favored LAI use in youth, but were of low to very low quality. Overall, 587 FDA MedWatch reports between June 1986 and June 2021 were identified. Most adverse events occurred in modest numbers. Extrapyramidal symptoms accounted for 18% of all MedWatch reports, neuroleptic malignant syndrome accounted for 3% of all reports, and deaths accounted for 2% of all reports. The concern for safety was reflected in prescriber survey results along with a recognition that LAIs can be helpful to target severe psychiatric symptoms and address treatment noncompliance. Conclusions: No randomized controlled studies were found. Identified published studies and reports were of low to very low quality. However, it appeared reasonable that the use of LAIs in a select group of pediatric patients can be helpful to target severe psychiatric symptoms and to enhance treatment compliance.

100 项与 Lais 相关的药物交易

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