Steven A Hendler1, Benjamin L Cohen2, Jean-Frédéric Colombel2, Bruce E Sands2, Lloyd Mayer3, Shradha Agarwal4. 1. Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 2. Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 3. Division of Clinical Immunology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 4. Division of Clinical Immunology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. shradha.agarwal@mssm.edu.
Abstract
BACKGROUND: Inadequate response to infliximab [IFX] therapy in Crohn's disease [CD] may necessitate dose intensification. We evaluated safety and efficacy of high-dose IFX [HD IFX] [greater than 10mg/kg every 8 weeks] in CD and characterized predictors of response to HD IFX intensification. METHODS: Electronic medical records were queried for CD patients between 2010 and 2012 who received HD IFX and were reviewed for history, medications, laboratory data, efficacy, and safety. RESULTS: In all, 86 patients received HD IFX for CD at doses between 10 and 22.5mg/kg every 4 to 7 weeks. In early HD IFX therapy [week 1-16], 25.8% and 59.1% experienced full and partial response, respectively. In later HD IFX therapy [week 38-100], 27.9% and 34.4% experienced full and partial response, respectively. Median serum IFX levels increased from 1.7 to 7.3 µ/mL [p = 0.017], and median C-reactive protein [CRP] values decreased from 20.5 at baseline to 4.7 mg/L after 16 weeks [p < 0.001]. Baseline CRP values were significantly elevated in the group that responded at 1-16 weeks compared with nonresponders [22.0 vs 3.5mg/L, p < 0.01]. HD IFX therapy was discontinued in 26% and 7.3% of patients for inadequate response and adverse events, respectively. Eleven cases of infection required hospitalization for a serious infection rate of 7.41 events per 100 patient-years. CONCLUSIONS: HD IFX therapy may benefit CD patients who have failed standard doses of IFX. HD IFX therapy may be associated with more serious adverse events compared with standard dosing. Baseline CRP value may predict clinical response to HD IFX.
BACKGROUND: Inadequate response to infliximab [IFX] therapy in Crohn's disease [CD] may necessitate dose intensification. We evaluated safety and efficacy of high-dose IFX [HDIFX] [greater than 10mg/kg every 8 weeks] in CD and characterized predictors of response to HDIFX intensification. METHODS: Electronic medical records were queried for CDpatients between 2010 and 2012 who received HDIFX and were reviewed for history, medications, laboratory data, efficacy, and safety. RESULTS: In all, 86 patients received HDIFX for CD at doses between 10 and 22.5mg/kg every 4 to 7 weeks. In early HDIFX therapy [week 1-16], 25.8% and 59.1% experienced full and partial response, respectively. In later HDIFX therapy [week 38-100], 27.9% and 34.4% experienced full and partial response, respectively. Median serum IFX levels increased from 1.7 to 7.3 µ/mL [p = 0.017], and median C-reactive protein [CRP] values decreased from 20.5 at baseline to 4.7 mg/L after 16 weeks [p < 0.001]. Baseline CRP values were significantly elevated in the group that responded at 1-16 weeks compared with nonresponders [22.0 vs 3.5mg/L, p < 0.01]. HDIFX therapy was discontinued in 26% and 7.3% of patients for inadequate response and adverse events, respectively. Eleven cases of infection required hospitalization for a serious infection rate of 7.41 events per 100 patient-years. CONCLUSIONS:HDIFX therapy may benefit CDpatients who have failed standard doses of IFX. HDIFX therapy may be associated with more serious adverse events compared with standard dosing. Baseline CRP value may predict clinical response to HDIFX.
Authors: Travis Piester; Adam Frymoyer; Megan Christofferson; Helen Yu; Dorsey Bass; K T Park Journal: Inflamm Bowel Dis Date: 2018-01-18 Impact factor: 5.325
Authors: Walter Reinisch; Krisztina Gecse; Jonas Halfvarson; Peter M Irving; Jørgen Jahnsen; Laurent Peyrin-Biroulet; Gerhard Rogler; Stefan Schreiber; Silvio Danese Journal: Inflamm Bowel Dis Date: 2021-01-01 Impact factor: 5.325
Authors: Ashish Srinivasan; Robert Gilmore; Daniel van Langenberg; Peter De Cruz Journal: Therap Adv Gastroenterol Date: 2022-02-02 Impact factor: 4.409
Authors: Jan Marsal; Manuel Barreiro-de Acosta; Irina Blumenstein; Maria Cappello; Thomas Bazin; Shaji Sebastian Journal: Front Med (Lausanne) Date: 2022-06-15
Authors: Anuj Bohra; Qurat-Al-Ain Rizvi; Charlotte Yuen Yu Keung; Abhinav Vasudevan; Daniel R van Langenberg Journal: World J Gastroenterol Date: 2020-09-28 Impact factor: 5.742