Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology

Macaluso, Fabio Salvatore; Papi, Claudio; Orlando, Ambrogio; Festa, Stefano; Pugliese, Daniela; Bonovas, Stefanos; Pansieri, Claudia; Piovani, Daniele; Fiorino, Gionata; Fantini, Massimo; Caprioli, Flavio; Armuzzi, Alessandro; Bertani, Lorenzo; Bezzio, Cristina; Bodini, Giorgia; Bossa, Fabrizio; Buda, Andrea; Calabrese, Emma; Furfaro, Federica; Leone, Salvatore; Mocciaro, Filippo; Onali, S.; Pastorelli, Luca; Previtali, Enrica; Principi, Mariabeatrice; Renna, Sara; Ribaldone, Davide Giuseppe; Rispo, Antonio; Rizzello, Fernando; Saibeni, Simone; Sampietro, Gianluca; Savarino, Edoardo; Testa, Anna; Variola, Angela; Ardizzone, Sandro; Biancone, Livia; Cappello, Maria; Castiglione, Fabiana; Ciccocioppo, Rachele; Comberlato, Michele; Costa, Francesco; D’Incà, R.; Danese, Silvio; Sabatino, Antonio Di; Fries, Walter; Gionchetti, Paolo; Latella, Giovanni; Manguso, Francesco; Mastronardi, Mauro; Meucci, Gianmichele; Milla, Mónica; Scribano, Maria Lia; Vecchi, Maurizio

doi:10.1016/j.dld.2023.01.155

Cited by 24 publications

(12 citation statements)

References 44 publications

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“…18,19 The conflicting results from these RCTs regarding the benefit of TDM in IBD have hindered the widespread adoption of TDM in clinical guidelines (see Tables, Supplemental Digital Content 1, http://links.lww.com/TDM/A735 and http://links.lww.com/ TDM/A736). [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] The American Gastroenterological Association conditionally recommended reactive TDM based on very low-quality evidence. 21 The European Crohn's and Colitis Organization guidelines recommend neither proactive nor reactive TDM.…”

Section: Conflicting Evidence On the Role Of Tdmmentioning

confidence: 99%

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Alsoud,

Moes,

Wang

et al. 2024

Therapeutic Drug Monitoring

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Background: Infliximab, an anti–tumor necrosis factor monoclonal antibody, has revolutionized the pharmacological management of immune-mediated inflammatory diseases (IMIDs). This position statement critically reviews and examines existing data on therapeutic drug monitoring (TDM) of infliximab in patients with IMIDs. It provides a practical guide on implementing TDM in current clinical practices and outlines priority areas for future research. Methods: The endorsing TDM of Biologics and Pharmacometrics Committees of the International Association of TDM and Clinical Toxicology collaborated to create this position statement. Results: Accumulating data support the evidence for TDM of infliximab in the treatment of inflammatory bowel diseases, with limited investigation in other IMIDs. A universal approach to TDM may not fully realize the benefits of improving therapeutic outcomes. Patients at risk for increased infliximab clearance, particularly with a proactive strategy, stand to gain the most from TDM. Personalized exposure targets based on therapeutic goals, patient phenotype, and infliximab administration route are recommended. Rapid assays and home sampling strategies offer flexibility for point-of-care TDM. Ongoing studies on model-informed precision dosing in inflammatory bowel disease will help assess the additional value of precision dosing software tools. Patient education and empowerment, and electronic health record–integrated TDM solutions will facilitate routine TDM implementation. Although optimization of therapeutic effectiveness is a primary focus, the cost-reducing potential of TDM also merits consideration. Conclusions: Successful implementation of TDM for infliximab necessitates interdisciplinary collaboration among clinicians, hospital pharmacists, and (quantitative) clinical pharmacologists to ensure an efficient research trajectory.

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Section: Conflicting Evidence On the Role Of Tdmmentioning

confidence: 99%

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Alsoud,

Moes,

Wang

et al. 2024

Therapeutic Drug Monitoring

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“…Calculation of standard IFX and WMT expenses IFX is given intravenously as an induction dose of 5 mg/kg at weeks zero, two, and six followed by a sustained dose of 5 mg/kg every 8 weeks if patients keep the state of clinical response to it. 24 According to guidelines, 25,26 a T-SPOT test (an interferon (IFN)-γ release assay of tuberculosis) and colonoscopy need to be done each year, and some laboratory tests (TORCH [A set of pathogenic microorganisms of toxoplasmosis, rubella, cytomegalovirus, herpes, and other agents], hepatitis B virus, live function, blood routine, erythrocyte sedimentation rate [ESR], electrocardiogram, fecal calprotectin, and quantitative polymerase chain reaction [qPCR] for CDI; Supplementary Table S1, http://links. lww.com/JCMA/A221) should finish every hospitalization.…”

Section: Clinical Assessment and Outcomementioning

confidence: 99%

Comparison between washed microbiota transplantation and infliximab: Medical cost during long-term management in patients with inflammatory bowel disease

Zhang,

Huang,

et al. 2023

Journal of the Chinese Medical Association

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Background: Both infliximab (IFX) and fecal microbiota transplantation (FMT) have shown the efficacy for inflammatory bowel disease (IBD). However, there has no head-to-head study on the cost-value of the such treatments on IBD. This study aimed to compare the medical costs using IFX and the new method of FMT (washed microbiota transplantation, WMT) in the long-term management for IBD under the current health economic condition in China. Methods: Patients with IBD who underwent initial WMT via upper gastrointestinal endoscopy, mid-gut tube, or colonic transendoscopic enteral tubing at a university hospital between April 2013 and August 2021 and achieved the long-term sustainment with WMT or WMT combined with mesalazine until August 2022 were recruited in the real-world. The costs and hospitalizations were analyzed among two therapies mentioned above and IFX standard therapy. The charge of WMT was stable in the long term at our center, and the charge of IFX came from virtual statistics publicized by China Healthcare Security. Results: 60 eligible patients with IBD were included in the study. The long-term costs of patients using WMT monotherapy annually or per hospitalization were lower than those on WMT combined with mesalazine respectively (p < 0.001, respectively). The cumulative costs of IFX at the time of 0.52 and 0.85 years exceeded that of the above WMT respectively (p < 0.001, respectively). Besides, patients on WMT monotherapy paid 51.1k CNY annually in the non-sustain phase but cut down the costs by 7.2k CNY and duration of hospitalization by 5.1 days per hospitalization when reaching the goal of sustainment. Conclusion: This study demonstrated that WMT could dramatically reduce the cost and duration of hospitalizations in the long-term sustainment in the current Chinese IBD cohort. Compared with IFX, WMT could be a good way for the patients with IBD achieving long-term sustainment and saving medical costs.

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“…20 In recent years, new treatment algorithms have evolved towards increasing use of IMMs and anti-TNFα agents in the postoperative setting to prevent recurrence. [21][22][23][24] The post-operative use of IMMs and anti-TNFα agents has been advocated either as early intensive primary prophylaxis of recurrence in high-risk patients, either as endoscopic-driven strategy based on an early endoscopic assessment of recurrence within 6-12 months after surgery and adjustment of therapy according to the severity of endoscopic recurrence. 25,26 Both strategies may represent a 'surrogate' model of true early treatment because aggressive medical therapy is started in a pre-symptomatic phase of the post-operative disease course.…”

Section: Introductionmentioning

confidence: 99%

Crohn's disease after surgery: Changes in post‐operative management strategies over time and their impact on long‐term re‐operation rate—A retrospective multicentre real‐world study

Aratari,

Scribano,

Pugliese

et al. 2024

Aliment Pharmacol Ther

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SummaryBackgroundFew data are available addressing the impact of post‐operative management of Crohn's disease (CD) on long‐term clinical course.AimTo assess the evolution of post‐operative management strategies over the last 40 years and their impact on the re‐operation rate of CD.MethodsWe included 657 patients with CD who had undergone their first radical ileo‐caecal resection between 1980 and 2020. Three cohorts were defined according to year of surgery: cohort 1 (1980–1998; n = 198), cohort 2 (1999–2009; n = 218) and cohort 3 (2010–2020; n = 241). We estimated exposure to immunomodulators and anti‐TNFα agents after surgery and rates of re‐operation using Kaplan–Meier survival analyses. We used Cox proportional hazards regression to assess the association of clinical variables with time to re‐operation.ResultsImmunosuppressants, (IMMs) and anti‐TNFα exposure within 5 years after surgery increased significantly from cohort 1 to cohort 2 and cohort 3 (IMMs: 1.6%, 38.2% and 28.0%, respectively, p < 0.001; anti‐TNFα: 0.0%, 20.7% and 52.0%, respectively, p < 0.001). There was no significant difference across cohorts regarding the cumulative probability of re‐operation within 5 and 10 years. Multivariate analysis identified IMMs/anti‐TNFα exposure before the first surgery (HR 9.15; 95% CI 2.77–30.21) and post‐operatively (HR: 0.24; 95% CI 0.07–0.74) as variables associated with the risk of re‐operation. However, these associations had a time‐varying effect and become non‐significant after 5 and 2 years after surgery, respectively.ConclusionDespite increased post‐operative use of IMMs and anti‐TNFα agents in the last two decades, the impact of these strategies on the risk of long‐term re‐operation rate has been modest.

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Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology

Cited by 24 publications

References 44 publications

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Comparison between washed microbiota transplantation and infliximab: Medical cost during long-term management in patients with inflammatory bowel disease

Crohn's disease after surgery: Changes in post‐operative management strategies over time and their impact on long‐term re‐operation rate—A retrospective multicentre real‐world study

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