Introduction

Many people with IBD experience fatigue, pain and faecal incontinence (FI), impacting quality of life (QoL). We developed an interactive digital online self-management intervention (IBD-BOOST) based on a theoretically informed logic model and cognitive behavioural techniques.

Aims & Methods

To evaluate IBD-BOOST we conducted a multi-centre two-arm parallel group randomised controlled trial (RCT) comparing IBD-BOOST with Care as Usual (CAU), recruiting patients from clinics and national registries who rated the impact of fatigue and/or pain and/or FI as ≥5/10. Those in the IBD-BOOST arm received 6 months access to the 12-session IBD-BOOST programme, a 30-minute telephone support call and weekly in-site email messages for 3 months. The UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months were dual primary outcomes (alpha=0.025 was considered statistically significant with two primary outcomes). Other secondary outcomes, including individual symptoms, were measured at 6 and 12 months. Complier-averaged causal effects (CACE), sensitivity and pre-specified subgroup analyses were conducted.

Results

780 participants were randomised, 432 with Crohn’s disease; 520 (66.7%) were female, mean age 49 years. At 6 months, both UK-IBDQ and GRSR were similar between the BOOST and CAU arms, p=0.19 for IBDQ and p=0.39 for GRSR. Adverse events were similar between groups. FI score and EQ5D utility score (secondary outcomes) were in favour of IBD-BOOST at 6 months, but pain and fatigue were no different. 57% of the intervention group completed a pre-defined minimum “dose” of 4 sessions (i.e. compliers). The CACE analysis suggested that compliers were more likely to report better QoL (p=0.03). Subgroup analysis of those meeting criteria for irritable bowel syndrome (IBS) at baseline, showed that IBD-BOOST was more effective in improving IBDQ and GRSR at 6 months when compared with CAU for the IBD-IBS group (p_interaction=0.015 and 0.046, respectively).

Conclusion

This large RCT found that IBD-BOOST did not improve IBDQ and GRSR in patients with IBD and fatigue and/or pain and/or FI relative to CAU. Participants reported less FI at 6 and 12 months. Those with IBD-IBS improved more than those without.

Trial registration: ISRCTN71618461

Introduction

Active inflammatory bowel disease in pregnancy is associated with an increased risk of adverse maternal and neonatal outcomes. Understanding patterns of disease activity may inform strategies for improving outcomes.

Aims & Methods

A retrospective cohort study was conducted of pregnancies managed through an IBD–antenatal clinic between August 2020 and January 2025. Patients were stratified into 2 groups based on disease activity during pregnancy. Active disease was defined using the Physician Global Assessment, symptoms, and biomarkers (CRP and/or FCP). Disease flare was defined by an increase in symptoms and/or biomarkers from their baseline. Disease activity was assessed pre-conception (within 6 months before pregnancy) during pregnancy and post-partum (up to 6 months post birth).

Results

Of 209 pregnancies (Table 1), 76.3% (n=158) were in remission and 23.7% (n=49) had active disease pre-conception. Among those with active disease, 81.6% (n=40) remained active into pregnancy, while 18.4% (n=9) achieved remission. Of those in remission at pre-conception, 73.4% (n=116) stayed in remission during pregnancy, and 24.7% (n=39) flared. 2 patients with no pre-conception data were active in pregnancy.
Of 125 patients in remission during pregnancy, 73.6% (n=92) stayed in remission post-partum and 12.0% (n=15) flared. Among 81 patients with active disease in pregnancy, 39.5% (n=32) remained active, and 53.0% (n=43) achieved remission post-partum.
Patients in remission through pregnancy had a higher mean BMI (24.5 vs 23.0 kg/m², p=0.027), were more likely to be of white ethnicity compared to minority ethnic groups (61.0% vs 38.4% p=0.0026), have a diagnosis of Crohn’s disease (58.6% vs 37.0%, p=0.0088), and be nulliparous (51.2% vs 35.0%, p=0.0414).
At conception, approximately 30% of patients in both groups were not receiving any treatment. During pregnancy, this proportion fell to 8.6% in the active group, reflecting therapy escalation. Use of biologics increased from 22.2% to 38.2% in the active group and remained stable at 36.0% in the remission group. Corticosteroid use was exclusive to the active disease cohort (6.2% at conception; 23.5% during pregnancy).
Active disease in pregnancy was associated with higher rates of adverse outcomes: gestational diabetes (12.3% vs 8.0%, p=0.001), fetal growth restriction (4.9% vs 0%, p=0.044), and low birth weight (<2500g: 14.6% vs 2.4%, p=0.015). While rates of small for gestational age infants were higher in the active group (9.9% vs 4.0%), this was not statistically significant.
Emergency c-sections were more common in the active group (29.9% vs 15.0%, p=0.03), while elective c-sections were more frequent in the remission group (27.5% vs 13.4%, p = 0.03). Women in remission more often had an intact perineum (63.6% vs 54.7%), while episiotomy was more frequent in those with active disease (18.8% vs 11.7%); both did not reach statistical significance.

Conclusion

This study underscores the impact of active IBD on maternal and neonatal outcomes.
Nearly 1 in 4 women in remission at preconception flared during pregnancy. This highlights the need for effective pre-conception counselling, access to disease monitoring tools, multidisciplinary management and timely treatment optimisation to sustain remission during pregnancy.

Disclosure

No disclosures

Introduction

Risankizumab is a selective IL23 inhibitor that was approved by the FDA for the treatment of moderately to severely active Crohn’s disease (CD) in June 2022. The effectiveness of risankizumab in ustekinumab-experienced patients is of particular interest due to a similar mechanism of action. Here, we present our one-year experience of risankizumab treatment in CD patients, with a focus on the comparison between ustekinumab-naïve and ustekinumab-experienced patients.

Aims & Methods

We prospectively followed patients with CD treated with risankizumab in our center and documented their clinical disease activity using Harvey-Bradshaw Index (HBI) score at baseline and at weeks 12, 26, and 52 after treatment initiation. We included patients who were treated for active luminal disease, defined as HBI≥5, fecal calprotectin (FCP) ≥250, steroid dependance or who had evidence of active disease per ileocolonoscopy or imaging in the effectiveness analysis. We excluded from the effectiveness cohort patients with ileostomy, J-pouch or surgery within the 6 months prior to risankizumab commencement. We recorded adverse events in all patients. Patients who stopped treatment due to ineffectiveness or intolerance were counted as non-responders for the purpose of remission-rate calculations at each time point.

Results

253 patients were treated with risankizumab and had at least 12 weeks of follow up. 153 patients were included in the effectiveness cohort. Demographics and patient characteristics are detailed in Table 1. At week 12, 71.3% (92/129) achieved clinical remission (CR), and 63.6% (82/129) achieved steroid-free clinical remission (SFCR). At week 26, 64.5% (60/93) and 62.4% (58/93) achieved CR and SFCR respectively. At 1 year, CR rate was 53.3% (40/75), and SFCR rate was 48% (36/75). Median FCP was 385.5µg/g (IQR 168.25-905, n=33) at baseline, 102.5µg/g (IQR 39-354, n=20) at week 12, 118µg/g (IQR 40-183, n=24) at week 26, and 63µg/g (IQR 19-122, n=16) at 1 year. 79.6% (74/93) remained on risankizumab 6 months after treatment initiation, and 64.3% (52/75) of patients remained on treatment at one year. In the effectiveness cohort, 47.7% (73/153) of patients were ustekinumab-naïve, and 53.3% (80/153) were ustekinumab-experienced. SFCR rates in ustekinumab-naïve and ustekinumab-experienced patients were 73.8% (45/61) vs. 54.4% (37/68) at week 12 (p=0.0282), 67.4% (31/46) vs. 57.4% (27/47) at week 26 (p=0.3936), and 54.1 (20/37) vs. 42.1% (16/38) at one year (p=0.3588), respectively.
Minor adverse events were documented in 12.6% (32/253) of patients, including fatigue, pruritus, nausea, joint pain, and upper-respiratory tract infection. One patient had a suspected allergic reaction to the first infusion and treatment was not continued. In 1.9% (5/253) of patients, treatment was discontinued d/t adverse events. No serious adverse events were observed.

Conclusion

In this large real-world experience in patients with CD, we found that risankizumab has excellent efficacy and safety, with notable effectiveness in ustekinumab-experienced patients.