Introduction

Exclusive enteral nutrition (EEN) is a well-established first line therapy in paediatric Crohn’s disease and is as effective as corticosteroids but without the harmful adverse effects (1; 2; 3). EEN is an emerging therapeutic option in adult Inflammatory Bowel Disease (IBD), however there are concerns about poor tolerability and compliance. The Western Health IBD team has been using EEN in adult IBD patients with active severe disease. The study aims to examine the tolerability, compliance and efficacy of EEN and provide a unique insight into the patient perspective.

Aims & Methods

Patients with IBD, either Crohn's Disease (CD) or Ulcerative Colitis (UC) who initiated EEN at Western Health, Australia between 1/12/2020 and 30/3/2023 were included in the study. The standard course of EEN consists of exclusive consumption of an oral nutrition supplement and water for at least 4 weeks. A retrospective audit of patients’ basic demographic data, disease phenotype and clinical outcomes was conducted. Fisher’s exact test was used to assess differences between the cohort who completed ≥4 weeks of EEN and those who did not. Comparison of patients’ clinical outcomes pre- and post-EEN was conducted with the Wilcox signed-rank test to assess efficacy of EEN. Patients were invited to participate in an online survey regarding their compliance and views of EEN efficacy and tolerability.

Results

24 IBD patients with active disease were included; 21 with CD and 3 with pan UC. There were 16 males and the median age was 44.5 (IQR 35.5) years old. 10 patients had fistulising CD, 13 had stricturing disease and 8 had perianal disease. 7 patients reported previous surgical intervention. At time of initiation of EEN, 12 patients were on corticosteroids and 14 were on biologic therapy. 17 out of 24 patients who started EEN completed ≥ 4 weeks of therapy.
Fisher’s exact tests for age, sex, smoking history, concurrent steroid use, CDAI or faecal calprotectin did not reveal statistically significant associations (p<0.05) with patients’ ability to complete ≥4 weeks of EEN.
The Wilcox signed-rank test showed a statistically significant reduction in the median Crohn’s Disease Activity Index (CDAI), albumin and haemoglobin in CD patients. Median reduction in CDAI was 137 (n=14,z=3.296,p=<0.001). Median improvement of albumin was 5g/L (n=16,z=2.67,p=0.008), median improvement of haemoglobin was 8g/L (n=16,z=-2.304,p=0.021). In the small UC cohort, there was no change in Partial Mayo Scores before and after EEN.
Patient perspective surveys were completed by 11 of the 19 invited patients. 7 patients reported that the EEN diet was successful in achieving their goal and they would repeat the diet if it was recommended. Patient goals included delaying surgery, avoiding steroids and improving symptoms. Overall satisfaction was measured with a linear analogue scale, the median score was 8 (IQR 5.5). Compliance analysis revealed 6 patients reported never straying from the EEN diet, 4 patients consumed non-recommended food or drink once or twice in the time period and 1 patient did this roughly once per week.

Conclusion

Our small single centre study provides supportive evidence that EEN is effective and well tolerated in adult IBD patients. 70% of patients completed at least 4 weeks of EEN. There is a statistically significant improvement in CD patient clinical outcomes. There was a high level of patient satisfaction, as well as high patient compliance. In the future, this form of dietary intervention could be more widely accepted in management of IBD patients with moderate to severe disease.

References

1. Exclusive enteral nutrition versus corticosteroids for treatment of pediatric Crohn's disease: a meta-analysis. Yu Yu, Kang-Chen Chen, Jie Chen. 2019, World Journal of Pediatrics.
2. Use of exclusive enteral nutrition in adults with Crohn’s disease: A review. Catherine L Wall, Andrew S Day, and Richard B Gearry. 2013, World Journal of Gastroenterology.
3. Enteral nutritional therapy for induction of remission in Crohn's disease. Neeraj Narula, Amit Dhillon, Dongni Zhang, Mary E Sherlock, Melody Tondeur, Mary Zachos. 2018, Cochrane Database Syst Rev.

Introduction

Upadacitinib has shown to be more effective than placebo for treating extraintestinal manifestations (EIM) in post-hoc analyses. However, real-world data on the effectiveness of upadacitinib in patients with inflammatory bowel disease (IBD) and EIMs are lacking.

Aims & Methods

A multicenter, retrospective and observational study was conducted at 19 Spanish hospitals. Patients with IBD and active EIMs when initiating upadacitinib were eligible. The primary outcome was EIM improvement at weeks 8-12. The EIM assessment was based on the physician's subjective evaluation and categorized into clinical remission, partial response, nonresponse and worsening. EIM improvement was defined as either clinical remission or partial response. Axial arthropathy, peripheral arthropathy, pyoderma gangrenosum, erythema nodosum, sweet syndrome, aphthous stomatitis, uveitis, episcleritis, primary sclerosing cholangitis and bronchiectasis were considered. In patient experiencing >1 EIM, all had to be resolved or improved to be considered. If not, the worst outcome was recorded. Patients’ visits were scheduled at weeks 0, 8-12, and 6 months. Multivariate analysis was performed to find factors associated with EIM improvement at w8-12.

Results

A total of 160 patients were included, 120 patients with Crohn’s Disease (75.6%), 90 females (56.3%) with a median age of 46.6 years (IQR 37.9-56.7). Upadacitinib was initiated in one hundred twenty-six (78.8%) patients due to EIMs and luminal activity and 35 patients (21.3%) exclusively due to EIMs. All patients were bio-experienced with 84 patients previously treated with ≥3 biologics (52.5%). Baseline EIMs assessment was for at least 1 EIM in 107 patients (66.9%), 42 patients presented 2 EIMs (26.3%) while 11 patients (6.9%) experienced ≥ 3 EIMs.
At w8-12, 99 patients (61.9%) achieved EIM improvement, 40 patients (25 %) clinical remission, 58 patients (36.9%) partial response, 58 patients (36.5 %) nonresponse and worsening in 3 patients. Patients initiating Upadacitinib due to exclusively active EIMs was associated with EIM improvement at weeks 8-12 (OR 2.99 95% CI 1.06-8.42; p=0.04). IBD clinical remission at w8-12 was achieved in 75 patients (61%).
Evaluation at 6 months was available for 103 patients, 73 patients (70.9%) presented EIM improvement, 41 patients (39.8%) clinical remission, 32 patients (31.1%) partial response, 20 patients (19.4%) nonresponse and 10 patients (9.7%) worsening. IBD clinical remission at 6 months was achieved in 51 patients (62.2%).
During the follow-up, Upadacitinib was ceased in 27 patients (16.9%). Adverse events were detected in 39 patients (24.3%) and 7 patients (4.4%) experienced worsening of previous inactive EIMs.

Conclusion

Upadacitinib was highly effective in the short term for treating bio-experienced patients with active EIMs, particularly for patients without luminal activity

Disclosure

No conflict

Introduction

‘Biologic therapies’ are the mainstay treatment for moderate to severe Inflammatory Bowel Disease (IBD), resulting in fewer hospitalisations, adequate treatment response and mucosal healing. ^[1] Adalimumab, Golimumab, Ustekinumab & Risankizumab are administered subcutaneously (SC), Infliximab and Vedolizumab are administered intravenously (IV), and have additionally been available SC since 2020. SC Infliximab was used during the pandemic to limit exposure to hospitals & reduce risk of Covid-19, ^[2] as well as for convenience.

Aims & Methods

We explore patient’s views of IV and SC administered treatments via a paper-based survey for those patients who were on IV treatment when attending for infusions, and a telephone survey on patients with IBD who have been on SC treatment.

Results

IV survey

• 122 completed the survey.
• 50/122 (41.0%) were on Vedolizumab (41.0%), 64 (52.5%) Infliximab, 8 (6.6%) others / didn’t specify.
• 25/120 (20.8%) had been on IV therapy for 2-6 months, 17 (14.2%) for 7-12 months, 29 (24.2%) for 1-3 years, 21 (17.5%) for 3-5 years, 21 (17.5%) for >5 years.
• 107/120 (89.2%) rated treatments as easy, 13 (10.8%) intermediate, 0 difficult.
• 25/112 (22.3%) were previously on SC injections. Of this group: 15/24 (60.0%) favoured the IV route, 9 (36.0%) favoured the SC route.
• 4/15 who favoured the IV route “did not like to inject themselves” or “found it difficult”. 3/15 preferred IV route as they were being monitored.
• 104/110 (94.5%) attended all scheduled blood tests, 4 (3.6%) attended most of them
• 106/109 (97.2%) attended all OP appointments, 2 (1.8%) attend most
• 91/111 (82.0%) had no concerns, 10 (9.0%) had concerns over side effects (SE)
• 31/104 (29.8%) reported SE.
• 6/29 (20.7%) stated SE not affected their quality of life (QoL), 12 (41.4%) little impact QoL, 10 (34.5%) moderate impact, 1 (3.4%) severe impact.
• 96/105 (91.4%) would recommend IV route

• 106/113 (93.8%) completed the survey..
• 54/106 patients were on Adalimumab (50.9%), 24 (22.6%) Ustekinumab, 13 (12.2%) Vedolizumab , 13 (12.3%) Infliximab, 2 (1.9%) Golimumab
• 10/106 (9.4%) for 1-6 months, 21 (19.8%) for 6-12 months, 33 (31.1%) for 1-3yrs, 21 (19.8%) for 3-5 years and 20 (18.9%) for >5 years.
• 89/106 (83.9%) rated treatment administration as easy, 10 (9.4%) intermediate, 2 (1.9%) difficult
• 59/106 (55.7%) were previously on IV infusions. Of this group: 43/59 (72.9%) favoured the SC route, 8 (13.6%) favoured IV, and 8 (13.6%) no preference.
• 24/43 who favoured who favoured SC route stated ‘convenient”, “easy”, “not have to attend hospital” as reasons.
• 86/106 (81.1%) attended all scheduled blood tests, 5 (4.7%) attended most of them,
• 102/106 (96.2%) attended all OP appointments, 3 (2.8%) attend most,
• 68/106 (64.2%) had no concerns, 21 (19.81%) concerned about fewer face to face episodes
• 40/106 (37.7%) reported SE. 8 (20%) skin reactions
• 11/40 (27.5%) stated SE not affected their quality of life (QoL), 14 (35%) little impact QoL, 9 (22.5%) moderate impact, 6 (15%) severe impact.
• 87/106 (82.1%) recommend SC route

Conclusion

The survey found that both IV and SC treatments were easy to administer for the vast majority (89.2% & 84.9%), For patients on SC therapy who previously had IV infusions, 75.6% preferred SC as “convenient”, “easy” and “no (need to attend) hospital”. For patients on IV therapy who previously had SC, 60.0% preferred IV as “did not ned to self inject / found it difficult”, and “preferred monitoring”. Overall there are high levels of satisfaction with 91.4% of patients on IV treatment, and 82.1% of patients on SC treatment recommend their current route of administration.

References

1. E J Mao, G S Hazlewood, G G Kaplan, L Peyrin-Biroulet, and A N Ananthakrishnan, Systematic review with meta-analysis: comparative efficacy of immunosuppressants and biologics for reducing hospitalisation and surgery in Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther, 45: 3-13. https://doi.org/10.1111/apt.13847
2. P J Smith, L Critchley, D Storey, et al, Efficacy and Safety of Elective Switching from Intravenous to Subcutaneous Infliximab [CT-P13]: A Multicentre Cohort Study, Journal of Crohn's and Colitis, Volume 16, Issue 9, September 2022, Pages 1436-46. https://doi.org/10.1093/ecco-jcc/jjac053

Introduction

Ustekinumab (UST) is a monoclonal antibody that inhibits the p40 subunit of IL-12 and IL-23, approved for the treatment of Crohn's Disease (CD) and Ulcerative Colitis (UC). Its administration is intravenous during induction and subcutaneous during maintenance. Several studies have assessed the efficacy of reinduction and intensification of this treatment in patients with loss of response. However, there are few studies evaluating the effectiveness of intravenous UST for maintenance.

Aims & Methods

The aim of the study is to evaluate the efficacy and safety of maintenance with intravenous UST in patients with Inflammatory Bowel Disease (IBD).
Observational, retrospective, and single-center study. All patients receiving maintenance with intravenous UST until June 2023 were reviewed. Clinical response was evaluated with Harvey-Bradshow Index for CD and partial Mayo for UC. Biochemical response was evaluated with calprotectin and C-reactive protein.

Results

A total of 29 patients with IBD (24 CD and 5 UC) were included. The mean follow-up of patients was 449 days (74-948). The cohort's characteristics are summarized in Table 1.
In all cases, intravenous maintenance was performed with UST 130mg/4 weeks. In 4 cases (13.8%), maintenance was initiated directly with intravenous UST. In 9 (31%) patients due to primary failure to UST and in 16 (55.2%) patients due to secondary failure.
The clinical response to intravenous UST maintenance in patients with CD at week 8 and 16 and at one year of follow-up was 87.5% (n=21/24), 83.3% (n=20/24), 73.3% (n=11/15) respectively. For UC, the response was 60% (n=3/5) at week 8 and 16 and at one year. The drug survival was 723 days (± 74) (Figure 1). No predictive variable for treatment response was identified. Two patients (both with CD) experienced recurrent respiratory infections as an adverse effect, without the need to discontinue UST.

Conclusion

Maintenance treatment with intravenous UST can be useful and safe in patients with severe IBD and/or failure of subcutaneous UST maintenance.

Introduction

A significant proportion of patients with inflammatory bowel disease (IBD) have concomitant rheumatological manifestations. On the other hand, patients with spondyloarthritis (SpA) often report gastrointestinal symptoms, some of them being associated to IBD. However, the exact prevalence of this disorder is still controversial, and the optimal approach to its diagnosis remains unknown.

Aims & Methods

Our main was to determine the prevalence of undiagnosed IBD in patients with axial SpA (radiographic and non-radiographic) and psoriatic arthritis (PA). EISER is a multicenter, nationwide, observational, and cross-sectional study where 13 Spanish hospitals participated. Patients ≥18 years-old diagnosed with PA or SpA according to the CASPAR or ASAS criteria, respectively, were selected. Patients receiving biologics or systemic steroids at baseline or within the previous 30 days were not included. Regarding patients older than 50 years, only those without valid colonoscopy in the previous 3 years were included. Rheumatologist performed a baseline visit and collected demographic, clinical, and treatment data. Fecal calprotectin (FC) was determined by the Quantum Blue rapid test and this was followed by a gastroenterologist consultation. A complete colonoscopy was indicated on all patients with symptoms, FC≥80 µg/g without NSAIDs, or 160 µg/g if they were on NSAIDs. Capsule endoscopy or magnetic resonance enterography were performed in those with no findings on colonoscopy.

Results

A total of 559 patients were included (51% men; mean 52.2 years; mean disease duration of SpA/PA was 12.3 years). The most frequent rheumatological disease was radiographic SpA (37%), followed by peripheral APs (36%). Abnormal FC was observed in 47% and 53% of patients with PA and EspAx (80% radiographic-SpA vs 20% non-radiographic-SpA), respectively. Mean FC levels were higher among radiographic-SpA (395 µg/g) compared to the rest of the groups (306 µg/g for non-radiographic-SpA and 306 µg/g in PA). Overall, 11,5% had gastrointestinal symptoms, with the most common being abdominal pain (16%) and chronic diarrhea (11%). In total, 189 colonoscopies were performed, 40% demonstrating at least one abnormal finding, mostly aphthous ulcers (66%), superficial ulcers (21%) and erythema (14%), and they were mainly located in the terminal ileum (41%). Finally, 23 patients were diagnosed with IBD (4.4%), mostly with radiographic-SpA (83%), followed by peripheral PA (8.7%) and non-radiographic-SpA and axial PA (4.3% each). All patients but two were diagnosed with CD (91.3%), with 1 case of unclassified IBD (4.3%) and 1 with nonspecific ileitis (4.3%).

Conclusion

FC levels in patients with SpA and PA, followed by an appropriate endoscopic and/or radiological diagnostic algorithm, allows the identification of a relevant subgroup of patients with previously undiagnosed IBD