Introduction

Inflammatory bowel disease (IBD) is often diagnosed in early adulthood and can lead to a substantial decline in quality of life. It has been suggested that patients with IBD are at increased risk of depression and anxiety disorders.
The IBD Disk is a validated 10-question, self-administered visual questionnaire that includes characterisation of psychosocial disease burden. Whether scores in these domains correlate with traditional measures, such as the Hospital Anxiety and Depression Scale (HADS), is not known.

Aims & Methods

The aim of this study was to assess the prevalence of anxiety and depression in IBD patients, and the correlation between IBD-Disk and traditional measures.
We conducted a cross-sectional study over 3 months between April and June 2023. IBD patients responded to the IBD-Disk and HADS questionnaires.
HADS Scores are out of 21; with 0–7 normal, 8–10 mild, 11–15 moderate and 16–21 severe.

Results

We enrolled 57 patients (50.9% men) with a median age of 38 years [31-48].
Thirty-eight patients (66.7%) had Crohn's disease (CD). It was ileal in 14 patients (36.8%), ileocolic in 15 (39.5%), and colonic in 9 (23.7%). Ano-perineal involvement was present in 36.8% of cases. Nineteen patients (33.3%) had ulcerative colitis. Pancolic involvement was noted in 13 patients (68.4%).
Thirteen patients were depressed (22.8%) and 16 patients were anxious (28.1%).
In univariate analysis, depression was significantly associated with clinical disease activity (p=0.002), hospitalization at the time of interview (p<0.001), anemia (p=0.01), elevated CRP (p=0.015), hypoalbuminemia (p=0.016) and corticoresistance profile (p=0.01).
Anxiety was significantly associated with clinical activity (p=0.043), hypoalbuminemia (p=0.023) and high CRP (p=0.043). In multivariate analysis, only hospitalization at the time of interview and corticoresistance were independent risk factors for depression (OR=15.169, p<0.001; OR=5.577, p=0.042 respectively). The only independent risk factor for anxiety was clinical disease activity (OR=3.437, p=0.049).
A significant correlation was noted between the IBD-Disk global score, the anxiety score and the depression score (respectively r=0.511 and r=0,524, p<0.001).

Conclusion

IBD patients tend to have a higher prevalence of depression and anxiety disorders than the general population. The IBD disk is an easy tool that correlates well with HADS scores. Its utilisation in clinic allows holistic assessment, particularly in patients with active disease.

Introduction

The need for effective therapies in moderate to severe Crohn's disease (CD) drives the comparative evaluation of biologic treatments. The current work uses an anchored Matching-Adjusted Indirect Comparison (MAIC) to assess the efficacy of guselkumab (GUS) relative to risankizumab (RZB) during the treatment induction phase. This MAIC is using data from five phase 3 placebo-controlled blinded clinical trials (GRAVITI, GALAXI 2, GALAXI 3, ADVANCE, MOTIVATE).

Aims & Methods

Adult patients with moderate to severe CD, as defined in GRAVITI, GALAXI 2/3, ADVANCE and MOTIVATE trials were included. An anchored MAIC was utilized, leveraging placebo as common comparator and following guidance from the National Institute for Health Care Excellence in UK. The analysis aligned pooled individual patient data for GUS with published data for RZB by matching exclusion criteria and patient baseline characteristics that could be treatment effect modifiers (eg Age, Sex, BMI, CDAI, disease location or prior biologic treatment failure). During induction, patients received GUS 200 mg intravenous or 400 mg subcutaneous at weeks 0, 4, and 8 or RZB 600 mg intravenous at weeks 0, 4, and 8. The endpoints of interest were symptomatic endpoints such as clinical remission, PRO-2 remission, clinical response, abdominal pain and stool frequency remission, as well as endoscopic response at week 12, which marks the end of the induction period.

Results

After matching, baseline characteristics were balanced between the GUS and RZB cohorts. In a mixed population of bio-naïve and bio-experienced patients, GUS demonstrated statistically significant results in comparison to RZB for PRO-2 remission, clinical response and abdominal pain remission (table 1). Clinical remission showed a trend in favor of GUS, endoscopic response and stool frequence remission were comparable to RZB. In patients with biologic treatment failure versus the MOTIVATE trial, results had been generally more in favor of GUS, while maintaining positive outcomes seen across mixed populations (ADVANCE & MOTIVATE). Results were also mostly consistent whether analyzing pooled GUS data or individual trials, eg from GRAVITI, against RZB.

Table 1: Results of GUS from pooled GRAVITI, GALAXI 2/3 vs. RZB for induction period at week 12

Conclusion

The anchored MAIC analysis demonstrates comparable to even superior efficacy of guselkumab over risankizumab in inducing symptomatic improvements in Crohn's disease patients. It also suggests that subcutaneous induction seems to be preferential over iv induction.

Disclosure

van Sanden S, Trevisan M, Strobl A and Wirth D are employees of J&J Innovative Medicines