PErsistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission.
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Mathieu Nicolas, Hupé Marianne, Heluwaert Frédéric, Rivière Pauline, Hébuterne Xavier, Chupin Antoine, Abitbol Vered, Bouguen Guillaume, Vuitton Lucine, Gornet Jean-Marc, Montuclard Céline, Nancey Stéphane, Cadiot Guillaume, Wils Pauline, Gilletta Cyrielle, de Maissin Astrid, Altwegg Romain, Chanteloup Elise, Plastaras Laurianne, Ah Soune Philippe, Bourreille Arnaud, Stefanescu Carmen, Seksik Philippe, Simon Marion, Uzzan Mathieu, Andrau Pierre, Rouillon Cléa, Arondel Yves, Buisson Anthony, Peyrin-Biroulet Laurent, Mboup Bassirou, Vicaut Eric, Laharie David
Аннотация
METHODS: IBD patients in steroid-free clinical remission for at least 6 months on IV-IFX were enrolled in a prospective national French cohort when they switched to SC-IFX. Patients were assessed at inclusion and at weeks 12, 24, and 48. The primary endpoint was the persistence of SC-IFX at week 48. Secondary endpoints comprised steroid-free clinical remission at week 48, IV-IFX switch-back rate, and evolution of infliximab levels during the study period.
RESULTS: Among the 426 patients included (72.4% with Crohn's disease , 27.5% with ulcerative colitis; 45.1% female; median age 37 [interquartile range, 29-50] years; median disease duration of 12 years in Crohn's disease, 13 years in ulcerative colitis), 56% were on IV-IFX standard dosing (5 mg/kg 8-weekly) and 16% received combination therapy with an immunomodulator drug at baseline. At week 48, SC-IFX persistence was 95.4% (95% confidence interval, 93.3%-97.5%) and 86.9% of patients were on steroid-free clinical remission. Mean infliximab levels were 8.0 μg/mL at inclusion and 18.0 μg/mL at week 48 (P < .0001). Among the 19 (4.5%) patients who stopped SC-IFX, 6 (1.4%) switched back to IV-IFX. There were 222 adverse events reported in 42.4% of patients, and 12 led to treatment discontinuation, including 6 (1.4%) severe adverse events.
CONCLUSIONS: In this large multicenter prospective cohort, persistence at 1 year of SC-IFX was more than 95% of IBD patients switched in remission from IV-IFX, confirming excellent effectiveness and tolerance of SC-IFX.