Introduction
Subcutaneous infliximab (IFX-SC) is available in France since February 2021. Beyond pivotal studies enabling marketing authorization, real-world data are needed to assess usage, efficacy and safety of IFX-SC. The aim of RIPOSTE study is to evaluate the real-world use of IFX-SC in France. We present here results from data extracted between 2021 and 2023.
Aims & Methods
This study is based on data from the French administrative health databases (SNDS). All patients with at least one IFX-SC or intravenous (IV) delivery between February 1, 2021 and December 31, 2023, were included, regardless of indication. Diagnoses of Crohn's disease (CD) and ulcerative colitis (UC) were based on published algorithms1. Four patient groups were defined: (1) IFX-IV incident user (no administration of IFX-IV during look-back period); (2) IFX-IV prevalent user (at least one administration of IV IFX during look-back period); (3) IFX-SC initiation group (patients who received less than 3 infusions of IFX-IV before initiating IFX-SC); (4) IFX-SC switch group (patients who had received at least 3 infusions of IFX-IV before initiating IFX-SC). Patients were followed from the 1st IFX infusion until IFX discontinuation, initiation of another advanced therapy, death, or December 31, 2023. Discontinuation of infliximab was defined as no new delivery within 3 months of the end of estimated exposure. Persistence of IFX-SC was assessed by the Kaplan-Meier method. Concomitant exposure of immunosuppressant (IS) and the occurrence of serious adverse events were assessed.
Results
A total of 55,230 patients received at least one IFX delivery between February 1, 2021, and December 31, 2023, including 36,778 treated only with IFX-IV and 18,452 with IFX-SC. Among patients treated by IFX-SC, 10,566 (57.3%) had CD, including 2,356 (22.3%) in initiation , and 4,393 (23.8%) had UC, including 1086 (24.7%) in initiation . Switch population involved 8210 CD patients (61.5%) and 33017 UC patients (24.8%). Mean age at cohort entry was 39.82 years (SD, 14.63) in CD and 43.36 years (SD, 15.80) in UC, with 51.14% and 55.03% of women, respectively. IS was combined with initiated IFX-SC in 65.75 % of CD and 59.48% of UC patients. More than 25% of IFX-SC initiated patients did not receive any IFX-IV while 68.2% received 2 IFX-IV infusions. In IFX-SC population, 10.22% of CD and 29.5% of UC patients were concomitantly diagnosed with ankylosing spondylitis (AS). In CD, the 23-month persistence rate was 55% for IFX-IV incident users, while rates were higher in patients treated with IFX-SC, 64% (initiation) and 73% (switch group) (p<0.001). In UC, the 23-month persistence rates were higher in both IFX-SC groups (initiator: 58%; switch: 74%) compared to IFX-IV incident users (44%) (p<0.001) (Table1). Regarding safety, cumulative incidence rate of severe infections at 12 months was numerically higher in IFX-IV group compared to IFX-SC (6% vs 2% in UC; 5% vs 3% in CD).
Table 1: Persistence rate (%) between IFX-SC and IFX-IV for IBD patients
| | CD cohort | UC Cohort |
SC incident
N= 2,356
p<0.001
| SC switch
N= 8,210
p<0.001
| IV incident
N= 4,391
p<0.001 | SC incident
N= 1,086
p<0.001
| SC switch
N= 3,307
p<0.001
| IV incident
N= 2,999
p<0.001
|
| 3 months | 0.91 | 0.94 | 0.92 | 0.89 | 0.94 | 0.87 |
| 6 months | 0.84 | 0.89 | 0.82 | 0.79 | 0.89 | 0.73 |
| 12 months | 0.73 | 0.82 | 0.68 | 0.7 | 0.83 | 0.56 |
| 18 months | 0.66 | 0.76 | 0.6 | 0.63 | 0.77 | 0.48 |
| 23 months | 0.64 | 0.73 | 0.55 | 0.58 | 0.74 | 0.44 |
Conclusion
Based on data from the entire French population, IBD patients who switched from IFX-IV to IFX-SC may benefit from a better persistence. Further analyses including propensity score matching to control for residual confounding are ongoing.
References
- Kirchgesner J, Lemaitre M, Rudnichi A, et al. Therapeutic management of inflammatory bowel disease in real-life practice in the current era of anti-TNF agents: analysis of the French administrative health databases 2009-2014. Aliment Pharmacol Ther 2017;45:37–49.
Disclosure
Funding : Celltrion Healthcare France