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Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
被引:21
作者:

Macaluso, Fabio Salvatore
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Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy

Maida, Marcello
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机构:
S Elia M Raimondi Hosp, Gastroenterol & Endoscopy Unit, Caltanissetta, Italy Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy

Grova, Mauro
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h-index: 0
机构:
Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy
Univ Palermo, Dept Hlth Promot Sci Maternal & Infant Care, Sect Gastroenterol & Hepatol, PROMISE, Palermo, Italy Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy

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Teresi, Giulia
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机构:
Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy

Orlando, Adele
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机构:
Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy

Orlando, Ambrogio
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h-index: 0
机构:
Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy
机构:
[1] Villa Sofia Cervello Hosp, Dept Med, IBD Unit, Viale Strasburgo 233, I-90146 Palermo, Italy
[2] S Elia M Raimondi Hosp, Gastroenterol & Endoscopy Unit, Caltanissetta, Italy
[3] Univ Palermo, Dept Hlth Promot Sci Maternal & Infant Care, Sect Gastroenterol & Hepatol, PROMISE, Palermo, Italy
关键词:
biologicals;
propensity score analysis;
randomized controlled trials;
real-world experience;
CROHNS-DISEASE;
ADALIMUMAB;
INFLIXIMAB;
VEDOLIZUMAB;
D O I:
10.1177/17562848211010668
中图分类号:
R57 [消化系及腹部疾病];
学科分类号:
摘要:
During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.
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页数:11
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Kopylov, Uri
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JOURNAL OF CROHNS & COLITIS,
2018, 12 (02)
:245-257

Engel, Tal
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Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel

Ungar, Bella
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Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel

Yung, Diana E.
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Royal Infirm Edinburgh NHS Trust, Ctr Liver & Digest Disorders, Edinburgh, Midlothian, Scotland Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel

Ben-Horin, Shomron
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Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel

Eliakim, Rami
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Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel

Kopylov, Uri
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Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel Tel Aviv Univ, Gastroenterol Inst, Sackler Sch Med, Sheba Med Ctr Tel Hashomer, Tel Aviv, Israel