Low Discontinuation Rate of Infliximab Treatment in Steroid-Dependent/Refractory Crohn’s Disease Patients

Abstract

Background: Many patients with moderate to severe Crohn’s disease (CD) are treated with infliximab (IFX). As most of these patients experience a long-lasting therapy, the outcome and withdrawal of IFX treatment are important clinical questions. Methods: In this retrospective study, we analyzed the treatment outcome in moderate to severe CD patients with a steroid-dependent/refractory disease course started on IFX. Withdrawal of IFX was evaluated in patients with deep remission defined as clinical (Harvey-Bradshaw Index ≤4), biochemical (fecal calprotectin [FC] ≤150 μg/g stool) over a period of 2 years, and endoscopic and histological remission before discontinuation of IFX. Results: After induction with IFX, clinical remission was observed in 45/109 patients (41.3%) and clinical response in 61/109 patients (56.0%). Only 8/109 patients (7.3%) achieved deep remission and therefore could be discontinued from IFX therapy. In 4 of these patients (50%), relapse was observed after discontinuation of IFX treatment. FC decreased in these 8 patients in deep remission from 652 ± 168 μg/g stool (mean ± SE) at baseline to 24.9 ± 8.1 μg/g stool at 14 weeks. When compared to patients in deep remission, FC had decreased significantly less at 14 weeks in patients in clinical remission after induction with IFX (n = 31; 154 ± 55 μg/g stool; p = 0.01), in patients with clinical response after induction achieving clinical remission during the maintenance phase (n = 11; 352 ± 67 μg/g stool; p = 0.004), or in patients with chronic active disease course on maintenance therapy (n = 50; 645 ± 93 μg/g stool; p < 0.001). Conclusion: A low discontinuation rate was observed for steroid-dependent/refractory moderate to severe CD patients with IFX treatment. As FC showed a more or less pronounced decrease depending on the response to the IFX treatment, monitoring of FC may become a noninvasive tool for tailoring biological therapy in CD patients.

Efficiency and safety of one-year anti-TNF-α treatment in Crohn’s disease: a Polish single-centre experience

“…In our study the same rate was achieved after only 9 months, and patients were treated for the same period of time. Another study has shown that half of the CD patients were in remission 17 months after the end of therapy [13]. The differences could be caused by another definition of remission (clinical/endoscopic, with or without the use of immunomodulators).…”

Systematic Review and Meta-analysis:Real-world Data Rates of Deep Remission With Anti-TNFα in Inflammatory Bowel Disease

“…Application of the exclusion criteria yielded fteen studies (9 manuscripts, 6 conference abstracts), encompassing a total of 1,212 patients (Table 1). [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] A diagnosis of CD was captured for 769 patients, and a diagnosis of UC was provided for 443 patients. 18,20,21 Nine studies were prospective in design, 16,18,19,21,23,24,[27][28][29] and seven were carried out at multiple institutions.…”

“…Two studies de ned deep remission (DR) beyond the minimum criteria of clinical remission and endoscopic remission -Magro 2016 included histologic remission de ned as a Geboe's score < 4, and Kaymak 2018 supplemented both histologic remission and two years of biochemical remission (fecal calprotectin < 150). 22,24 Two conference abstracts used the same cohort and reported rates of DR at different time points, therefore this cohort was only counted one time. 27,28 Ten studies featured only in iximab (IFX), 16, 18, 20-22, 24, 26-29 two used only adalimumab (ADA), 19,23 one study assessed golimumab, 30 and two studies incorporated both IFX and ADA.…”

“…2). 17,19,21,22,26 For one year, De Vos 2013 and Zhang 2016 only included patients already in clinical remission. 16,21 Sensitivity analysis with Zhang 2016 and De Vos 2013 removed demonstrated a 42.3% rate of deep remission at one year, and sensitivity analysis with Zhang 2016 removed at two year analysis had a deep remission rate of 27.8% ( Supplementary Fig.…”

“…Crohn's Disease (CD): Ten studies reported rates of DR in 769 patients with CD between eight weeks and 2 years. [17][18][19][20][21][22][25][26][27][28] At eight weeks, one study reported 18.9% DR. 20 17,19,21,22,26 DR in CD was reported at one year by ve studies (Fig. 3) and found to be 48.6% (95% CI: 32.8-64.7%) in 139/293 patients.…”