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. 2023 Jul 25;5(4):otad040.
doi: 10.1093/crocol/otad040. eCollection 2023 Oct.

Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?

Karin Cerna  1   2 , Dana Duricova  1   3 , Martin Lukas  1   4   5 , Martin Kolar  1   4 , Nadezda Machkova  1 , Veronika Hruba  1 , Katarina Mitrova  1   6 , Kristyna Kubickova  1 , Marta Kostrejova  1   7 , Jakub Jirsa  1 , Kristyna Kastylova  1 , Stepan Peterka  1   8 , Gabriela Vojtechova  1   9 , Milan Lukas  1
Affiliations

Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?

Karin Cerna et al. Crohns Colitis 360. .

Abstract

Background: A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.

Methods: Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.

Results: Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0.

Conclusions: Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.

Keywords: Crohn’s disease; Inflammatory bowel disease; antibodies to infliximab; immunogenicity; infliximab; infliximab trough levels; subcutaneous; treatment persistence.

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Conflict of interest statement

K.C.: has consulted for Celltrion and Biogen. D.D.: has consulted for Takeda, AbbVie, Pfizer, and Janssen. M.L.: has consulted for Takeda and Pfizer. M.K.: has consulted for Pfizer. N.M.: has consulted for Takeda and Janssen. V.H.: has consulted for Biogen and Janssen. K.M.: has consulted for Takeda and Janssen. K.K.: has consulted for Abbott. M.K.: has consulted for Takeda and Janssen. J.J.: none. K.K.: none. G.V.: none. S.P.: none. M.L.: provided consultations and received fees for lectures by Celltrion, Abbvie, Janssen, Takeda, and Ferring.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
IFX-SC treatment process flowchart, Weeks 0–30. ATI, antibodies to infliximab; EOW, every other week; IFX, infliximab; IV, intravenous; SC, subcutaneous; TL, trough level; W, treatment week.
Figure 2.
Figure 2.
Medians of upward TL IFX and downward ATI dynamics during the first 30 weeks of IFX-SC treatment. ATI, antibodies to infliximab; IFX, infliximab; TL, trough level; W, treatment week.
Figure 3.
Figure 3.
Dynamics of CRP, FC, and HBI during the first 30 weeks of IFX-SC treatment. CRP, C-reactive protein; FC, fecal calprotectin; HBI, Harvey–Bradshaw Index; W, treatment week.
See this image and copyright information in PMC

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