A Propensity Score-matched Comparison of Infliximab and Adalimumab in Tumour Necrosis Factor-α Inhibitor-naïve and Non-naïve Patients With Crohn’s Disease: Real-Life Data From the Sicilian Network for Inflammatory Bowel Disease

Macaluso, Fabio Salvatore; Fries, Walter; Privitera, A; Cappello, Maria; Siringo, S.; Inserra, G.; Magnano, Antonio; Mitri, Roberto Di; Mocciaro, Filippo; Belluardo, Nunzio; Scarpulla, G.; Magrì, Giovanni; Trovatello, A.; Carroccio, Antonio; Genova, S.; Bertolami, Carmelo; Vassallo, Roberto; Romano, Claudio; Citrano, Michele; Accomando, Salvatore; Ventimiglia, Marco; Renna, Sara; Orlando, R.; Rizzuto, G.; Porcari, Serena; Ferracane, Concetta; Cottone, Mario; Orlando, Ambrogio

doi:10.1093/ecco-jcc/jjy156

Cited by 31 publications

(27 citation statements)

References 18 publications

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“…At both time points, response rates were not significantly different when comparing ADA with IFX (62% vs 65% after 1 year, 41% vs 49% after 2 years, respectively) [14]. These findings are in line with other studies and were recently confirmed in a propensity-score matched comparison in 632 adult CD patients, showing no significant difference in steroid-free remission rate when comparing IFX with ADA after one year in patients who had received other previous therapies (19.1% vs 27.7% respectively, p = 0.350) [15,16,17]. Furthermore, in addition to positive findings with IFX, ADA was recently proven to be effective in children and adolescents with moderately to severely active CD complicated by perianal fistulae in fistula closure [18,19].…”

Section: Resultssupporting

confidence: 86%

“…Certain clinical characteristics are known to predict response to anti-TNF therapy, mainly based on studies with adult patients. For both UC and CD factors associated with a good response are younger age (<40 years) at diagnosis, concomitant use of an immunomodulator and being naïve to anti-TNF therapy [15,43,44,45]. In addition, shorter disease duration [45], isolated colonic disease [46], elevated CRP [47,48], the absence of previous surgery in CD [15] and a hemoglobin >11.5 mg/dL in UC [49] are considered to have predictive value [50].…”

Section: Resultsmentioning

confidence: 99%

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A Review on the Use of Anti-TNF in Children and Adolescents with Inflammatory Bowel Disease

Aardoom

Veereman²,

Ridder

2019

IJMS

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Inflammatory bowel disease (IBD) presents with disabling symptoms and may lead to insufficient growth and late pubertal development in cases of disease onset during childhood or adolescence. During the last decade, the role of anti-tumor necrosis factor (TNF) in the treatment of paediatric-onset IBD has gained more ground. The number of biologicals presently available for children and adolescents with IBD has increased, biosimilars have become available, and practices in adult gastroenterology with regards to anti-TNF have changed. The aim of this study is to review the current evidence on the indications, judicious use, effectiveness and safety of anti-TNF agents in paediatric IBD. A PubMed literature search was performed and included articles published after 2000 using the following terms: child or paediatric, Crohn, ulcerative colitis, inflammatory bowel disease, anti-TNF, TNF alpha inhibitor, infliximab, adalimumab, golimumab and biological. Anti-TNF agents, specifically infliximab and adalimumab, have proven to be effective in moderate and severe paediatric IBD. Therapeutic drug monitoring increases therapy effectiveness and safety. Clinical predictors for anti-TNF response are currently of limited value because of the variation in outcome definitions and follow-ups. Future research should comprise large cohorts and clinical trials comparing groups according to their risk profile in order to provide personalized therapeutic strategies.

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Section: Resultssupporting

confidence: 86%

Section: Resultsmentioning

confidence: 99%

A Review on the Use of Anti-TNF in Children and Adolescents with Inflammatory Bowel Disease

Aardoom

Veereman²,

Ridder

2019

IJMS

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“…Several Western studies have shown no difference in clinical response and remission between these two TNF-α inhibitors. [24][25][26][27] Similar to our results, some studies from Western countries have shown no difference in the risk of surgery, hospitalization, and steroid utilization between IFX and ADA. [9][10][11]13,26,28 A retrospective cohort study using U.S. Medicare data showed no significant difference in the risks of abdominal surgery and hospitalization between IFX-and ADA-treated patients with CD (n=1,459 and n=871, respectively).…”

Section: Discussionsupporting

confidence: 90%

Comparison of Long-term Outcomes of Infliximab versus Adalimumab in 1,488 Biologic-Naive Korean Patients with Crohn’s Disease

et al. 2021

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Background/Aims: Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with Crohn's disease (CD) are rare, particularly for Asian patients. We compared the key clinical outcomes (surgery, hospitalization, and corticosteroid use) of use of these two drugs in biologic-naive Korean patients with CD. Methods: Using National Health Insurance claims, we collected data on patients who were diagnosed with CD and exposed to IFX or ADA between 2010 and 2016. Results: We included 1,488 new users of biologics (1,000 IFX users and 488 ADA users). Over a median follow-up period of 2.1 years after starting biological therapy, no significant differences were found between IFX and ADA users in the risks for surgery (ADA vs IFX: adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 0.81 to 1.84), hospitalization (aHR, 1.02; 95% CI, 0.81 to 1.28), and corticosteroid use (aHR, 0.82; 95% CI, 0.56 to 1.19). These results were unchanged even when only patients who used biologics for over 6 months were analyzed (aHR [95% CI]: surgery, 1.31 [0.82 to 2.11]; hospitalization, 1.02 [0.80 to 1.30]; corticosteroid use, 0.80 [0.54 to 1.18]). Additionally, these results were unchanged in patients treated with biologics as monotherapy or in combination with immunomodulators. Conclusions: In this nationwide population-based study, no significant difference was found in the long-term effectiveness of IFX and ADA in the real-world setting of biologic-naive Korean patients with CD. In the absence of trials to directly compare IFX and ADA, our study indicates that the selection of one of these two biologics can be determined by patient and/or physician preference.

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“…5 Furthermore, the IL-23 receptor is a major susceptibility gene for CD and has led to the development of an anti-p40 immunotherapy that targets this pathway (Ustekinumab). 1,3 TNF-a blockade (e.g.…”

Section: Discussionmentioning

confidence: 99%

“…5 The IL-23 receptor is a major susceptibility gene for CD and has led to the development of an immunotherapy that targets this p40 protein subunit used by both the IL-12 and IL-23 cytokines (Ustekinumab). infliximab and adalimumab) has shown clinical benefit in managing the disease but 20-25% of patients with CD lost therapeutic responses at 12 weeks following commencement of anti-TNF-a therapy and between 30% and 60% lost responses by 12 months.…”

Section: Introductionmentioning

confidence: 99%

Crohn's disease is facilitated by a disturbance of programmed death‐1 ligand 2 on blood dendritic cells

et al. 2019

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Objective Crohn's disease (CD) is characterised by inflammation, predominantly associated with ilea. To investigate the basis for this inflammation in patients with CD, we examined dendritic cells (DC) which are pivotal for maintenance of immunological tolerance in the gut. Methods Ileal biopsies and blood DCs from CD patients and controls were examined by microscopy and flow cytometry for PD‐L1 and PD‐L2 expression, as PD‐L1 has been implicated in colitis but the contribution of PD‐L2 is less clear. In vitro studies, of blood samples from CD patients, were used to demonstrate a functional role for PD‐L2 in disease pathogenesis. Results Quantitative microscopy of CD11c+ DCs in inflamed and noninflamed ilea from CD patient showed > 75% loss of these cells from the villi, lamina propria and Peyer's patches compared with non‐CD controls. Given this loss of DCs from ilia of CD patients, we hypothesised DCs may have migrated to the blood as these patients can have extra‐intestinal symptoms. We thus examined blood DCs from CD patients by flow cytometry and found significant increases in PD‐L1 and PD‐L2 expression compared with control samples. Microscopy revealed an aggregated form of PD‐L2 expression, known to drive Th1 immunity, in CD patients but not in controls. In vitro functional studies with PD‐L2 blockade confirmed PD‐L2 contributes significantly to the secretion of pro‐inflammatory cytokines known to cause disease pathogenesis. Conclusion Taken together, this study shows that PD‐L2 can influence the progression of CD and blockade of PD‐L2 may have therapeutic potential.

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A Propensity Score-matched Comparison of Infliximab and Adalimumab in Tumour Necrosis Factor-α Inhibitor-naïve and Non-naïve Patients With Crohn’s Disease: Real-Life Data From the Sicilian Network for Inflammatory Bowel Disease

Cited by 31 publications

References 18 publications

A Review on the Use of Anti-TNF in Children and Adolescents with Inflammatory Bowel Disease

A Review on the Use of Anti-TNF in Children and Adolescents with Inflammatory Bowel Disease

Comparison of Long-term Outcomes of Infliximab versus Adalimumab in 1,488 Biologic-Naive Korean Patients with Crohn’s Disease

Crohn's disease is facilitated by a disturbance of programmed death‐1 ligand 2 on blood dendritic cells

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