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 [1 ]
Maida, Marcello [2 ]
Grova, Mauro [1 ,3 ]
Crispino, Federica [1 ,3 ]
Teresi, Giulia [1 ]
Orlando, Adele [1 ]
Orlando, Ambrogio [1 ]
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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共 35 条
[1]   MECHANISMS OF DISEASE Inflammatory Bowel Disease [J].
Abraham, Clara ;
Cho, Judy H. .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (21) :2066-2078
[2]   The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti-tumour necrosis factor [J].
Alric, Hadrien ;
Amiot, Aurelien ;
Kirchgesner, Julien ;
Treton, Xavier ;
Allez, Mathieu ;
Bouhnik, Yoram ;
Beaugerie, Laurent ;
Carbonnel, Franck ;
Meyer, Antoine .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 51 (10) :948-957
[3]   An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies [J].
Austin, Peter C. .
MULTIVARIATE BEHAVIORAL RESEARCH, 2011, 46 (03) :399-424
[4]   Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment [J].
Biemans, Vince B. C. ;
van der Woude, C. Janneke ;
Dijkstra, Gerard ;
van der Meulen-de Jong, Andrea E. ;
Lowenberg, Mark ;
de Boer, Nanne K. ;
Oldenburg, Bas ;
Srivastava, Nidhi ;
Jansen, Jeroen M. ;
Bodelier, Alexander G. L. ;
West, Rachel L. ;
de Vries, Annemarie C. ;
Haans, Jeoffrey J. L. ;
de Jong, Dirk ;
Hoentjen, Frank ;
Pierik, Marieke J. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 52 (01) :123-134
[5]   Are propensity scores really superior to standard multivariable analysis? [J].
Biondi-Zoccai, Giuseppe ;
Romagnoli, Enrico ;
Agostoni, Pierfrancesco ;
Capodanno, Davide ;
Castagno, Davide ;
D'Ascenzo, Fabrizio ;
Sangiorgi, Giuseppe ;
Modena, Maria Grazia .
CONTEMPORARY CLINICAL TRIALS, 2011, 32 (05) :731-740
[6]   Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician [J].
Blonde, Lawrence ;
Khunti, Kamlesh ;
Harris, Stewart B. ;
Meizinger, Casey ;
Skolnik, Neil S. .
ADVANCES IN THERAPY, 2018, 35 (11) :1763-1774
[7]   Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn's disease [J].
Bohm, Matthew ;
Xu, Ronghui ;
Zhang, Yiran ;
Varma, Sashidhar ;
Fischer, Monika ;
Kochhar, Gursimran ;
Boland, Brigid ;
Singh, Siddharth ;
Hirten, Robert ;
Ungaro, Ryan ;
Shmidt, Eugenia ;
Lasch, Karen ;
Jairaith, Vipul ;
Hudesman, David ;
Chang, Shannon ;
Lukin, Dana ;
Swaminath, Arun ;
Sands, Bruce E. ;
Colombel, Jean-Frederic ;
Kane, Sunanda ;
Loftus, Edward V., Jr. ;
Shen, Bo ;
Siegel, Corey A. ;
Sandborn, William J. ;
Dulai, Parambir S. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 52 (04) :669-681
[8]   Conceptual and Technical Challenges in Network Meta-analysis [J].
Cipriani, Andrea ;
Higgins, Julian P. T. ;
Geddes, John R. ;
Salanti, Georgia .
ANNALS OF INTERNAL MEDICINE, 2013, 159 (02) :130-W54
[9]   Adalimumab or infliximab as monotherapy, or in combination with an immunomodulator, in the treatment of Crohn's disease [J].
Cosnes, J. ;
Sokol, H. ;
Bourrier, A. ;
Nion-Larmurier, I. ;
Wisniewski, A. ;
Landman, C. ;
Marteau, P. ;
Beaugerie, L. ;
Perez, K. ;
Seksik, P. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2016, 44 (10) :1102-1113
[10]   Vedolizumab in IBD-Lessons From Real-world Experience; A Systematic Review and Pooled Analysis [J].
Engel, Tal ;
Ungar, Bella ;
Yung, Diana E. ;
Ben-Horin, Shomron ;
Eliakim, Rami ;
Kopylov, Uri .
JOURNAL OF CROHNS & COLITIS, 2018, 12 (02) :245-257