Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background/Aims: Studies on elective switching to the subcutaneous (SC) formulation of infliximab revealed comparable efficacy and safety and higher infliximab level than those exhibited by intravenous (IV) infliximab. However, no studies have reported on the effectiveness of SC switching in ulcerative colitis (UC) patients who experienced IV infliximab failure during maintenance treatment. Methods: This retrospective study included UC patients who had been switched to SC infliximab because of IV infliximab failure, between January 2021 and January 2023. Group A was defined as having clinically and biochemically active UC (secondary loss of response), and group B consisted of patients with stable symptoms but biochemically active UC. Results: Twenty-three patients met the inclusion criteria: 15 in group A and eight in group B. The serum infliximab levels significantly increased after SC switching in both groups. The electively switched group also exhibited increased infliximab levels after SC switching. Patients in group A showed improved partial Mayo score with a significant decrease in fecal calprotectin and C-reactive protein after switching. In group B, the fecal calprotectin level significantly decreased without clinical relapse after switching. A high proportion of patients (≥80%) in both groups achieved clinical and/or biochemical responses at the last follow-up. During the follow-up period, only two patients in group A discontinued SC infliximab, and only one complained of severe injection site reaction. Conclusions: In UC patients who experience IV infliximab failure during maintenance treatment, switching to SC infliximab may be a promising option because of better efficacy and safety.
Abstract
Background/Aims: Studies on elective switching to the subcutaneous (SC) formulation of infliximab revealed comparable efficacy and safety and higher infliximab level than those exhibited by intravenous (IV) infliximab. However, no studies have reported on the effectiveness of SC switching in ulcerative colitis (UC) patients who experienced IV infliximab failure during maintenance treatment. Methods: This retrospective study included UC patients who had been switched to SC infliximab because of IV infliximab failure, between January 2021 and January 2023. Group A was defined as having clinically and biochemically active UC (secondary loss of response), and group B consisted of patients with stable symptoms but biochemically active UC. Results: Twenty-three patients met the inclusion criteria: 15 in group A and eight in group B. The serum infliximab levels significantly increased after SC switching in both groups. The electively switched group also exhibited increased infliximab levels after SC switching. Patients in group A showed improved partial Mayo score with a significant decrease in fecal calprotectin and C-reactive protein after switching. In group B, the fecal calprotectin level significantly decreased without clinical relapse after switching. A high proportion of patients (≥80%) in both groups achieved clinical and/or biochemical responses at the last follow-up. During the follow-up period, only two patients in group A discontinued SC infliximab, and only one complained of severe injection site reaction. Conclusions: In UC patients who experience IV infliximab failure during maintenance treatment, switching to SC infliximab may be a promising option because of better efficacy and safety.
참고문헌 (42)
- Torres J, "Crohn’s disease", Lancet, 389, pp.1741~1755 (2017)
- Ungaro R, "Ulcerative colitis", Lancet, 389, pp.1756~1770 (2017)
- Baumgart DC, "Newer biologic and small-molecule therapies for inflammatory bowel disease", N Engl J Med, 385, pp.1302~1315 (2021)
- Raine T, "ECCO guidelines on therapeutics in ulcerative colitis : medical treatment", J Crohns Colitis, 16, pp.2~17 (2022)
- Torres J, "ECCO guidelines on therapeutics in Crohn’s disease : medical treatment", J Crohns Colitis, 14, pp.4~22 (2020)
- Feuerstein JD, "AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis", Gastroenterology, 158, pp.1450~1461 (2020)
- Feuerstein JD, "AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease", Gastroenterology, 160, pp.2496~2508 (2021)
- Turner D, "STRIDE-II : an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease(STRIDE)Initiative of the International Organization for the Study of IBD(IOIBD) : Determining Therapeutic Goals for Treat-to-Target strategies in IBD", Gastroenterology, 160, pp.1570~1583 (2021)
- Na SY, "IBD Research Group of the Korean Association for the Study of Intestinal Diseases. Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis", Intest Res, 21, pp.61~87 (2023)
- Koh SJ, "Korean clinical practice guidelines on biologics for moderate to severe Crohn's disease", Intest Res, 21, pp.43~60 (2023)
- Parigi TL, "Evolution of infliximab biosimilar in inflammatory bowel disease : from intravenous to subcutaneous CT-P13", Expert Opin Biol Ther, 21, pp.37~46 (2021)
- Schreiber S, "Randomized controlled trial : subcutaneous vs intravenous infliximab CTP13maintenance in inflammatory bowel disease", Gastroenterology, 160, pp.2340~2353 (2021)
- Buisson A, "Effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases : the REMSWITCH study", Clin Gastroenterol Hepatol, 21, pp.2338~2346 (2023)
- Schultheiss JP, "Loss of response to anti-TNFα agents depends on treatment duration in patients with inflammatory bowel disease", Aliment Pharmacol Ther, 54, pp.1298~1308 (2021)
- Yamamoto-Furusho JK, "Incidence of suboptimal response to tumor necrosis factor antagonist therapy in inflammatory bowel disease in newly industrialised countries : the EXPLORE study", Dig Liver Dis, 52, pp.869~877 (2020)
- Otake H, "Long-term clinical and real-world experience with Crohn's disease treated with antitumor necrosis factor-α antibodies", Intest Res, 20, pp.464~474 (2022)
- Albshesh A, "CT-P13 : a review on a biosimilar to infliximab in the treatment of inflammatory bowel disease", Expert Opin Biol Ther, 19, pp.971~978 (2019)
- : a multicentre cohort study, "J Crohns Colitis", 2022, 1436~1446
- Caron B, "Letter : treatment with subcutaneous CT-P13 in Crohn’s disease patients with intravenous infliximab failure", Aliment Pharmacol Ther, 55, pp.508~509 (2022)
- Park SH, "Long-term prognosis of Crohn’s disease and its temporal change between 1981 and 2012 : a hospital-based cohort study from Korea", Inflamm Bowel Dis, 20, pp.488~494 (2014)
- Noh SM, "Association of faecal calprotectin level and combined endoscopic and radiological healing in patients with Crohn’s disease receiving anti-tumour necrosis factor therapy", J Crohns Colitis, 14, pp.1231~1240 (2020)
- Bertin D, "Monitoring of infliximab trough levels and anti-infliximab antibodies in inflammatory bowel diseases : a comparison of three commercially available ELISA kits", Cytokine, 126, pp.154859~ (2020)
- Herbers J, "How to deal with nondetectable and outlying values in biomarker research : best practices and recommendations for univariate imputation approaches", Compr Psychoneuroendocrinol, 7, pp.100052~ (2021)
- Zubin G, "Predicting endoscopic Crohn’s disease activity before and after induction therapy in children : a comprehensive assessment of PCDAI, CRP, and fecal calprotectin", Inflamm Bowel Dis, 21, pp.1386~1391 (2015)
- Little RD, "Therapeutic drug monitoring of subcutaneous infliximab in inflammatory bowel disease : understanding pharmacokinetics and exposure response relationships in a new era of subcutaneous biologics", J Clin Med, 11, pp.6173~ (2022)
- Papamichael K, "Association between serum infliximab trough concentrations during maintenance therapy and biochemical, endoscopic, and histologic remission in Crohn’s disease", Inflamm Bowel Dis, 24, pp.2266~2271 (2018)
- Ungar B, "Optimizing anti-TNF-αtherapy : serum levels of infliximab and adalimumab are associated with mucosal healing in patients with inflammatory bowel diseases", Clin Gastroenterol Hepatol, 14, pp.550~557 (2016)
- Kennedy NA, "Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn’s disease : a prospective, multicentre, cohort study", Lancet Gastroenterol Hepatol, 4, pp.341~353 (2019)
- Seow CH, "Trough serum infliximab : a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis", Gut, 59, pp.49~54 (2010)
- "Measurement of infliximab and anti-infliximab antibody levels can help distinguish maintenance versus loss of response", Gastroenterol Hepatol (N Y), 8, pp.131~134 (2012)
- Su CG, "Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease", Gastroenterology, 125, pp.1544~1546 (2003)
- Ternant D, "Infliximab pharmacokinetics in inflammatory bowel disease patients", Ther Drug Monit, 30, pp.523~529 (2008)
- Adedokun OJ, "Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis", Gastroenterology, 147, pp.1296~1307 (2014)
- Fasanmade AA, "Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis", Eur J Clin Pharmacol, 65, pp.1211~1228 (2009)
- Loftus EV Jr, "Therapeutic drug monitoring for subcutaneous infliximab? Too early to conclude", Clin Gastroenterol Hepatol, 21, pp.2193~2194 (2023)
- Kumar P, "Serum albumin is the strongest predictor of anti-tumor necrosis factor nonresponse in inflammatory bowel disease in resource-constrained regions lacking therapeutic drug monitoring", Intest Res, 21, pp.460~470 (2023)
- Hanzel J, "Population pharmacokinetics of subcutaneous infliximab CT-P13 in Crohn’s disease and ulcerative colitis", Aliment Pharmacol Ther, 54, pp.1309~1319 (2021)
- Remy C, "Inflammatory bowel disease patients’ acceptance for switching from intravenous infliximab or vedolizumab to subcutaneous formulation : the Nancy experience", J Clin Med, 11, pp.7296~ (2022)
- Singh A, "Use of thiopurines in inflammatory bowel disease : an update", Intest Res, 20, pp.11~30 (2022)
- Kim ES, "Factors contributing to the preference of Korean patients with Crohn’s disease when selecting an anti-tumor necrosis factor agent(CHOICE Study)", Gut Liver, 10, pp.391~398 (2016)
- Allen PB, "How do patients with inflammatory bowel disease want their biological therapy administered?", BMC Gastroenterol, 10, pp.1~ (2010)
- Hart L, "Faecal calprotectin predicts endoscopic and histological activity in clinically quiescent ulcerative colitis", J Crohns Colitis, 14, pp.46~52 (2020)
