Introduction

Transition from intravenous to subcutaneous administration is a possible option in the treatment of inflammatory bowel disease (IBD) with Infliximab (IFX) or Vedolizumab (VDZ). The different formulation guarantees the same therapeutic efficacy without the need to carry out the treatment in hospital.

Aims & Methods

The aim of the study is to compare the adherence, quality of life, persistence on treatment and safety of patients with IBD after moving to subcutaneous Infliximab (ct-p13) versus Vedolizumab.
We performed a multicenter prospective, observational, study of patients with IBD who were receiving maintenance treatment with intravenous Infliximab and Vedolizumab from December 2021 to October 2022. All enrolled patients completed two questionnaires at T0 and after six months (T6) to investigate the quality of life by the short IBDQ questionnaire and the concerns and expectations related to the transition and to the different methods of drug administration by the six-item survey. Any adverse events, local and systemic, were evaluated for safety.
To adjust for confounding and selection bias, propensity score matching was performed for statistical analysis.

Results

In total, 108 out of 93 patients were replaced, 51 to subcutaneous Infliximab and 42 to subcutaneous Vedolizumab. Adhesion to therapy was comparable between the two groups (89.37% vs 82.35%, p 0,285). After six months, the persistence in therapy was also similar (84.3% vs 83.7%). Quality of life globally improved after six months (p=0.004), especially for the Infliximab group (p 0.004 vs p 0.333). The concern and expectations related to the transition also improved after six months of treatment (p 0.000), particularly for the Vedolizumab group (p 0.009 vs p 0.019). 8.6% of all patients experienced a local adverse reaction (pain, swelling, redness, hardening), and in particular 5.9% of Infliximab group and 11.9% of Vedolizumab group, while 4.3% of all patients reported a systemic reaction, without the need for hospitalization (Infliximab 3.9% vs Vedolizumab 4.7%).

Conclusion

Both subcutaneous treatments with Infliximab and Vedolizumab lead to comparable adherence and persistence in treatment, and a better quality of life for the Infliximab group. Patients receiving Vedolizumab showed greater concern about transitioning at baseline than in the Infliximab group. These worries improved after 6 months of treatment. Additionally, patients treated with Vedolizumab experienced more adverse reactions than those receiving Infliximab.

References

Introduction

Colorectal cancer (CRC) screening programmes have been shown effective in reducing CRC incidence and mortality. Risk stratification offers opportunities for further optimisation of screening programmes by better balancing the harms and benefits of screening. To this day, nearly all population screening programmes only differentiate their screening approach by age, resulting in a fixed upper age limit of screening. While further risk stratification based on prior faecal haemoglobin (f-Hb) concentration seems promising, studies are mainly limited to the target population of screening. Risk-stratified screening beyond the upper age limit might however be beneficial as well considering the increasing life expectancy and the benefit-risk ratio of screening widely varying amongst elderly.

Aims & Methods

This study assessed interval colorectal cancer (IC) risk in individuals that have reached the upper age limit of screening (75 years), and whether this risk differs by the f-Hb concentration of the last faecal immunochemical test (FIT). Individuals with a negative FIT (<47 µg Hb/g faeces) in their final CRC screening round were selected in the national screening database and linked to the Dutch cancer registry to check for a CRC diagnosis within 24 months of the negative FIT. IC risk was compared between different risk groups (sex, prior f-Hb concentration and screening round) and tested with a Chi-squared test. Associations between IC and explanatory factors were assessed using survival and Cox proportional hazards analyses. Factors associated with CRC stage were identified using a multivariable logistic regression analysis.

Results

A total of 311,655 individuals with a complete follow-up (24 months) after a negative FIT were included. Within this population, the overall IC risk was 21.6 per 10,000 individuals with a negative FIT. Individuals with detectable f-Hb (>0µg Hb/g faeces) in the final screening round developed IC more often than those without (HR 4.85, 95%CI: 4.18-5.63) (Table 1). Besides, they were also more likely to be diagnosed at an advanced rather than early stage of the disease (OR 1.45, 95%CI: 1.05-2.00). Individuals who had participated in three or four screening rounds had a lower IC risk than those who had participated once (HR 0.75, 95%CI: 0.56-0.99). Screening round was not associated with stage distribution and sex was not associated with IC nor stage distribution.

Table 1; Overview of IC risk, including results of a Cox regression analysis with IC as a dependent variable and sex, screening round and prior f-Hb concentration as independent variables

Conclusion

Our results indicate that a risk-stratified upper age limit in CRC screening based on prior f-Hb concentration may prevent CRC cases and CRC-related morbidity by early detection. While individuals with detectable f-Hb in their final FIT may benefit from additional screening, screening of the elderly is not without risks. Follow-up studies should therefore assess the benefit-risk ratio of a risk-stratified upper age limit and identify the optimal screening scenario.