Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F18%3A10380063" target="_blank" >RIV/00216208:11110/18:10380063 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064165:_____/18:10380063

Výsledek na webu

<a href="https://doi.org/10.1080/14712598.2018.1504918" target="_blank" >https://doi.org/10.1080/14712598.2018.1504918</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/14712598.2018.1504918" target="_blank" >10.1080/14712598.2018.1504918</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus

Popis výsledku v původním jazyce

Introduction: Treatment of systemic lupus erythematosus (SLE) represents a challenge due to variable disease manifestations, clinical course, and outcome. Long-term outcome in SLE remain unsatisfactory and a search for new therapeutic options is definitely warranted. Despite expectations, most clinical trials performed in SLE and lupus nephritis in the last decade did not reach primary outcome, and the only drug that has been licensed is belimumab. Areas covered: Results of negative trials testing monoclonal antibodies and other biologic agents in SLE are briefly summarized. Reasons for the failure of the trials are listed and discussed. Expert opinion: Future studies should recruit patients with similar organ involvement, better defined disease manifestations, higher activity, and similar severity. In addition to testing higher efficacy if given as add-on treatment to standard-of-care, the trials should be aimed at reducing dosing, or completely eliminating some parts of the current standard treatment, especially corticosteroids. Median follow-up of the patients should be longer. Moreover, specific biomarkers are needed to help to identify eligible patients and to better define response to treatment. An urgent unmet need is testing these new drugs in patients with severe SLE (including those refractory to current treatment).

Název v anglickém jazyce

Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus

Popis výsledku anglicky

Introduction: Treatment of systemic lupus erythematosus (SLE) represents a challenge due to variable disease manifestations, clinical course, and outcome. Long-term outcome in SLE remain unsatisfactory and a search for new therapeutic options is definitely warranted. Despite expectations, most clinical trials performed in SLE and lupus nephritis in the last decade did not reach primary outcome, and the only drug that has been licensed is belimumab. Areas covered: Results of negative trials testing monoclonal antibodies and other biologic agents in SLE are briefly summarized. Reasons for the failure of the trials are listed and discussed. Expert opinion: Future studies should recruit patients with similar organ involvement, better defined disease manifestations, higher activity, and similar severity. In addition to testing higher efficacy if given as add-on treatment to standard-of-care, the trials should be aimed at reducing dosing, or completely eliminating some parts of the current standard treatment, especially corticosteroids. Median follow-up of the patients should be longer. Moreover, specific biomarkers are needed to help to identify eligible patients and to better define response to treatment. An urgent unmet need is testing these new drugs in patients with severe SLE (including those refractory to current treatment).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30217 - Urology and nephrology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Expert Opinion on Biological Therapy

ISSN

1471-2598

e-ISSN

—

Svazek periodika

18

Číslo periodika v rámci svazku

9

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

989-996

Kód UT WoS článku

000443869300007

EID výsledku v databázi Scopus

2-s2.0-85052934799