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• W4309309487 abstract "We thank Little and colleagues for their interest and we read with consideration their letter to the editor entitled “Can Subcutaneous Infliximab Replace Dose-Intensified Intravenous Administration In Inflammatory Bowel Disease,” after the publication of our results of the REMSWITCH study.1Buisson A. et al.Clin Gastroenterol Hepatol. 2023; 21: 2338-2346.e3Abstract Full Text Full Text PDF Scopus (6) Google Scholar In this study, we concluded that switching from intravenous (IV) to subcutaneous (SC) infliximab 120 mg every 2 weeks is feasible, safe and well-accepted, leading to a low risk of relapse in patients with inflammatory bowel disease including those with escalated IV doses. In addition, we suggested that patients receiving 10 mg/kg/4 weeks should be switched to higher SC dose (240 mg every 2 weeks) because of a high risk of relapse in this specific subgroup. We also identified that fecal calprotectin >250 μg/g at baseline and absence of serum level increase between IV and SC regimen were significantly associated with relapse, leading to consider SC dose escalation in practice. In their letter, Little and colleagues question the factors associated with the risk of relapse in the REMSWITCH study.1Buisson A. et al.Clin Gastroenterol Hepatol. 2023; 21: 2338-2346.e3Abstract Full Text Full Text PDF Scopus (6) Google Scholar They suggested that elevated values of fecal calprotectin at baseline could not be independently associated with the risk of relapse but could be driven by the initial IV regimen. We disagree with this hypothesis. Fecal calprotectin is established as a predictor of relapse regardless of the clinical situation.2Mao R. et al.Inflamm Bowel Dis. 2012; 18: 1894-1899Crossref PubMed Scopus (224) Google Scholar, 3Boschetti G. et al.Am J Gastroenterol. 2015; 110: 865-872Crossref PubMed Scopus (105) Google Scholar, 4Buisson A. et al.J Crohns Colitis. 2019; 13: 1012-1024Crossref PubMed Scopus (28) Google Scholar More specifically in this study, it is expected that the subgroup who required the maximal intensification of IV infliximab (10 mg/kg/4 weeks) had the higher proportion of patients with elevated fecal calprotectin at baseline (69.2% in the REMSWITCH study) because in all the other subgroups, an abnormal value of calprotectin leads to therapeutic escalation in routine practice (only 13% of remaining patients with abnormal fecal calprotectin value at baseline of the REMSWITCH study).1Buisson A. et al.Clin Gastroenterol Hepatol. 2023; 21: 2338-2346.e3Abstract Full Text Full Text PDF Scopus (6) Google Scholar However, we performed a sensitivity analysis excluding the patients treated with 10 mg/kg every 4 weeks, and we confirmed that fecal calprotectin >250 μg/g was significantly associated with the risk of relapse (27.3% vs 5.9%; P = .016).1Buisson A. et al.Clin Gastroenterol Hepatol. 2023; 21: 2338-2346.e3Abstract Full Text Full Text PDF Scopus (6) Google Scholar However, focusing on the subgroup of patients with increased fecal calprotectin (>250 μg/g), receiving 10 mg/kg every 4 weeks was associated with higher risk of relapse compared with the 3 other IV regimens (63.6% vs 33.3% for 10 mg/kg every 6 weeks, 20.0% for 10 mg/kg every 8 weeks, and 17.6% for 5 mg/kg every 8 weeks).1Buisson A. et al.Clin Gastroenterol Hepatol. 2023; 21: 2338-2346.e3Abstract Full Text Full Text PDF Scopus (6) Google Scholar These data are in line with our multivariable model, taking into account potential multicollinearity, and confirmed that the level of fecal calprotectin and the initial IV regimen are independently associated with the risk of relapse. Little and colleagues also wonder about the evolution of serum infliximab level after the switch. They underlined that the group previously receiving 10 mg/kg/4 week was the only group to have decreased median drug levels at all 3 visits. The inverse relationship between the low risk of relapse in patients with less-intensified IV doses despite elevated level of fecal calprotectin and the higher increase of serum level after the switch in the group receiving the lowest IV doses could mean that the switch from 5 mg/kg/8 weeks to 120 mg SC every other week could reduce the level of fecal calprotectin and then the risk of relapse. It is in line with data from the pivotal study and real-world cohorts.5Schreiber S. et al.Gastroenterology. 2021; 160: 2340-2353Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar, 6Smith P.J. et al.J Crohns Colitis. 2022; 16: 1436-1446Crossref PubMed Scopus (13) Google Scholar, 7Argüelles-Arias F. et al.Rev Esp Enferm Dig. 2022; 114: 118-119PubMed Google Scholar Questions are also raised about specific subgroups, such as patients suffering from obesity or perianal lesions. In the REMSWITCH study, some physicians refused to offer the switch to some patients with perianal lesions and we did not analyze the available data on clinical and magnetic resonance imaging evaluations of perianal activity. Specific substudies are currently in progress to address these relevant questions. Finally, Little and colleagues stated that the REMSWITCH study also highlights the utility of SC dose-intensification to 240 mg 2-weekly to recapture response (93% of clinical remission). We agree that these very encouraging data warrant confirmation with a longer follow-up. The long-term data of the REMSWITCH study will be available at the beginning of 2023. The authors thank CHU Clermont-Ferrand (DRCI) for its recurrent support, Celltrion Healthcare, and all the participants and coauthors of the REMSWITCH study. Can Subcutaneous Infliximab Replace Dose-Intensified Intravenous Administration in Inflammatory Bowel Disease?Clinical Gastroenterology and HepatologyVol. 21Issue 9PreviewWe read with interest the recently published REMSWITCH study by Buisson et al.1 The authors report a large, multicenter cohort study evaluating clinical and pharmacologic outcomes following the switch from a range of maintenance intravenous (IV) infliximab regimens to subcutaneous (SC) CT-P13.1 Relapse was defined as clinical relapse or an increase in fecal calprotectin (FCP) ≥150 μg/g and data were collected at 3 visits up to 24 weeks. All 133 patients were in clinical remission and a quarter received concomitant immunomodulation. Full-Text PDF" @default.
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