The Effect of Early vs Delayed Initiation of Adalimumab on Remission Rates in Patients With Crohn’s Disease With Poor Prognostic Factors: The MODIFY Study

Mantzaris, Gerassimos J.; Zeglinas, Christos; Theodoropoulou, Anǵeliki; Koutroubakis, Ioannis Ε.; Orfanoudaki, Eleni; Κατσάνος, Κωνσταντίνος; Christodoulou, Dimitrios; Michalopoulos, Georgios; Tzouvala, Maria; Moschovis, Dimitrios; Michopoulos, Spyridon; Zampeli, Evanthia; Soufleris, Konstantinos; Ilias, A.; Chatzievangelinou, Christina; Kyriakakis, Antonios; Antachopoulou, Konstantia; Karmiris, Konstantinos

doi:10.1093/crocol/otab064

Cited by 3 publications

(1 citation statement)

References 37 publications

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“…Disease duration: The analysis of pooled data from CD studies indicates that CD with a shorter disease duration is associated with a superior early response[ 49 ]. In the MODIFY study, patients who received early adalimumab achieved a higher clinical response and remission rate at week 26 than those who received delayed treatment[ 50 ]. This correlation has also been confirmed by a recent meta-analysis[ 51 ].…”

Section: Predictors Of Pnrmentioning

confidence: 99%

Predictors and optimal management of tumor necrosis factor antagonist nonresponse in inflammatory bowel disease: A literature review

Wang¹,

Chen²,

He³

et al. 2023

World J Gastroenterol

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Tumor necrosis factor-α (TNF-α) antagonists, the first biologics approved for treating patients with inflammatory bowel disease (IBD), are effective for the induction and maintenance of remission and significantly improving prognosis. However, up to one-third of treated patients show primary nonresponse (PNR) to anti-TNF-α therapies, and 23%-50% of IBD patients experience loss of response (LOR) to these biologics during subsequent treatment. There is still no recognized predictor for evaluating the efficacy of anti-TNF drugs. This review summarizes the existing predictors of PNR and LOR to anti-TNF in IBD patients. Most predictors remain controversial, and only previous surgical history, disease manifestations, drug concentrations, antidrug antibodies, serum albumin, some biologic markers, and some genetic markers may be potentially predictive. In addition, we also discuss the next steps of treatment for patients with PNR or LOR to TNF antagonists. Therapeutic drug monitoring plays an important role in treatment selection. Dose escalation, combination therapy, switching to a different anti-TNF drug, or switching to a biologic with a different mechanism of action can be selected based on the concentration of the drug and/or antidrug antibodies.

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Section: Predictors Of Pnrmentioning

confidence: 99%

Predictors and optimal management of tumor necrosis factor antagonist nonresponse in inflammatory bowel disease: A literature review

Wang¹,

Chen²,

He³

et al. 2023

World J Gastroenterol

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Early Biologic Treatment Decreases Risk of Surgery in Crohn’s Disease but not in Ulcerative Colitis: Systematic Review and Meta-Analysis

Law,

Tkachuk,

Lieto

et al. 2023

Inflammatory Bowel Diseases

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Background and Aims Inflammatory bowel disease (IBD) can lead to long-term complications that significantly impact patients’ quality of life and healthcare resource utilization. Prior studies have demonstrated improved short-term outcomes to early exposure of biologics in patients with Crohn’s disease (CD) but not in patients with ulcerative colitis (UC). However, there are conflicting data on impact of early intervention on longer-term adverse events. Therefore, we conducted a systematic review and meta-analysis assessing the impact of early biologic treatment on rates of IBD-related surgery. Methods A systematic search was conducted in April 2022. Studies were included if biologic initiation was compared between patients starting early (<3 years of diagnosis or top-down treatment) vs later (>3 years of diagnosis or step-up treatment). Studies with <1 year of follow-up were excluded. The outcomes were colectomy and CD-related surgery for patients with UC and CD, respectively. Random-effects analyses were conducted to compare rates of IBD surgery between early and late biologic treatment. Results Eighteen studies were included in the meta-analysis. Three studies included patients with UC and 15 studies included patients with CD. In patients with CD, early biologic therapy was associated with lower odds of surgery (odds ratio, 0.63; 95% confidence interval, 0.48-0.84) compared with late treatment. Conversely, in patients with UC, the odds of colectomy were increased (odds ratio, 2.86; 95% confidence interval, 1.30-6.30). Conclusions Early biologic treatment is associated with lower rates of surgery in patients with CD. In contrast, early biologic therapy appears to be associated with higher rates of colectomy in patients with UC, which may be confounded by disease severity.

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Real-world Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-naive Patients With Crohn’s Disease

Yarur,

Bressler,

Brett

et al. 2024

Journal of Clinical Gastroenterology

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Goals: This study evaluated the real-world effectiveness and safety of vedolizumab versus adalimumab over 12 months of treatment in biologic-naive patients with Crohn’s disease (CD), using data from the EVOLVE study. Background: A comparison of vedolizumab and adalimumab may help to better position them in the therapeutic algorithm for moderate-to-severe CD. Study: Data were collected from medical records of patients with CD aged ≥18 years initiating treatment with adalimumab or vedolizumab between May 2014 and July 2017. Adjusted analyses were performed using inverse probability weighting to account for differences in baseline characteristics. Cumulative rates for clinical effectiveness outcomes and treatment persistence were estimated using Kaplan-Meier analyses. Disease-related exacerbations, serious adverse events (SAEs), and serious infections (SIs) were also assessed. Results: Data from 218 vedolizumab- and 144 adalimumab-treated patients were analyzed. Adjusted cumulative rates of clinical remission were greater with vedolizumab than with adalimumab (66.3% vs. 46.4%; P=0.006). Probability of treatment persistence was higher with vedolizumab (89.3% vs. 77.5%; P=0.024); probabilities of clinical response (68.5% vs. 61.1%; P=0.586) and mucosal healing (67.7% vs. 56.0%; P=0.562) were similar. SAEs were less likely to occur with vedolizumab [hazard ratio, 0.45 (95% confidence interval, 0.22-0.93)]; however, the likelihood of SIs [0.27 (0.06-1.20)], CD exacerbations [0.91 (0.56-1.47)], and CD-related surgeries [1.55 (0.21-11.15)] was comparable between the 2 groups. Conclusions: In a real-world setting, biologic-naive patients with CD treated with vedolizumab demonstrated a greater likelihood of drug persistence and achieving clinical remission, with equivalent rates of response and mucosal healing versus adalimumab-treated patients.

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The Effect of Early vs Delayed Initiation of Adalimumab on Remission Rates in Patients With Crohn’s Disease With Poor Prognostic Factors: The MODIFY Study

Cited by 3 publications

References 37 publications

Predictors and optimal management of tumor necrosis factor antagonist nonresponse in inflammatory bowel disease: A literature review

Predictors and optimal management of tumor necrosis factor antagonist nonresponse in inflammatory bowel disease: A literature review

Early Biologic Treatment Decreases Risk of Surgery in Crohn’s Disease but not in Ulcerative Colitis: Systematic Review and Meta-Analysis

Real-world Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-naive Patients With Crohn’s Disease

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