Introduction

In this 12-month maintenance period analysis of the FilgoColitis study, we report on clinical effectiveness and psychosocial outcomes in ulcerative colitis (UC) patients newly initiated on filgotinib (FIL) therapy in a real-world setting. In addition, this study attempts to define novel patient-based outcomes monitored by wearable devices.

Aims & Methods

FilgoColitis is a prospective, multicentre, non-interventional, 24-month observational study in patients with active UC and newly introduced FIL therapy. Disease activity (response: reduction of pMayo by >3 points from baseline to month 6 and a reduction of at least 30% or reaching remission at month 6; clinical remission (CR): pMayo ≤ 1 plus a bleeding subscore=0; steroid-free remission: CR and no systemic use of steroids or oral budesonide) and quality of life (QoL) (sIBDQ and EQ-5D) will be analysed. In a subset, physical activity will be analysed using two different wearable devices (Garmin® smartwatch and SensMotion® accelerometer) with complete wearable data available for the two days immediately following both baseline and month 12 (n=17).

Results

202 UC patients with a newly introduced filgotinib therapy were enrolled in the study. After excluding missing outcomes, six patients were excluded due to incomplete baseline data. Out of the participants with complete baseline data (n=196), 106 (54.1%) used at least one wearable device during the study. To validate the smartwatch, all steps measured in parallel by both the smartwatch and the conventional accelerometer system were compared halfway through the recruitment period and showed good agreement with a positive correlation of 0.88 (p<0.001). Of the 196 patients with UC at baseline, 59.7% were male, and the median time since diagnosis was 8.0 years. Before treatment with FIL, 84.2% of patients had received biologic or small molecule therapies, and 55.6% had used immunosuppressants. Treatment persistence of these 196 baseline FIL patients at month 12 was 59.7% (Kaplan-Meier analysis). Of these 140 patients with complete baseline and month 12 data were available for the 12-month effectiveness analyses. After 12 months of treatment with FIL, the rates of clinical remission and steroid-free remission were 44.3% and 41.4%, respectively (Table 1, mITT analyses with switchers as outcome failures). There was no significant difference in clinical remission between biologic-naïve and biologic-experienced patients (50.0% vs 43.4%). Looking at week-10 responders only, the remission rate at month 12 was 66.2%. QoL improved significantly, with median EQ-VAS scores increasing from 68 to 80 at month 12 (p<0.001), and sIBDQ scores improving from 41.0 to 56.0 (p<0.001). In patients who were in remission at month 12, the number of steps measured during the night was lower than in patients who were not in remission: 170 (75-272) vs 342 (94-620). This was consistent with patients' reports of nocturnal bowel movements (0% versus 33.4%).

Table 1. Effectiveness of filgotinib therapy in UC patients at month 12 (mITT)

Conclusion

In this real-world study, FIL demonstrated a clinical remission rate of 44.3% at month 12 in patients with active UC, demonstrating a further improvement compared to the induction phase (CR 29.2% at week 10). QoL was also significantly improved.

Disclosure

BB has received consulting fees from: AbbVie, MSD, Shire, Ferring, Hospira, Takeda, Movetis, Shield Therapeutics, Pfizer, Biogen, Janssen, Hexal, and Celgene, outside the submitted work. Financial support for lectures and teaching from: AbbVie, Ferring, MSD, Merckle, Falk, HLR, Shield Therapeutics, Pfizer, Celltrion, Takeda, Janssen, and Mundipharma, outside the submitted work. Grant and financial support for research from AbbVie and Ferring, outside the submitted work.
SPD does not have any relevant financial or non-financial interests to disclose.
TH does not have any relevant financial or non-financial interests to disclose.
WL does not have any relevant financial or non-financial interests to disclose.
MK has received personal fees from AbbVie, Ferring, BMS, Galapagos, Janssen, and Amgen, outside the submitted work.
RE has received personal fees from: Takeda, AbbVie, MSD, Biogen, Hexal, Amgen, Celltrion, and Viatris, outside the submitted work.
LZ does not have any relevant financial or non-financial interests to disclose.
AS does not have any relevant financial or non-financial interests to disclose.
PE has received personal fees from: AbbVie, BMS, Galapagos, Janssen, and Amgen, outside the submitted work.
JR does not have any relevant financial or non-financial interests to disclose.
SFS does not have any relevant financial or non-financial interests to disclose.
TW does not have any relevant financial or non-financial interests to disclose.
SS has received personal fees from AbbVie, Arena, BMS, Biogen, Celltrion, Celgene, IMAB, Gilead, HIMA, IMAB-Biopharma, MSD, Mylan, Pfizer, Fresenius, Janssen, Takeda, Theravance, Provention Bio, Protagonist, and Falk, outside the submitted work.

Introduction

The use of biologics has become an increasingly common treatment option for inflammatory bowel disease (IBD). However, data on maternal and fetal exposure to ustekinumab (UST) and vedolizumab (VDZ) remain scarce.

Aims & Methods

This systematic review and meta-analysis aimed to assess the safety of UST and VDZ in pregnant women with IBD. We systematically searched PubMed, Embase, and Cochrane Library databases in March 2025. The inclusion criteria were randomized and non-randomized studies comparing UST and VDZ for the treatment of IBD in pregnant patients and evaluating at least one predefined outcome of interest. Primary outcomes were spontaneous abortion and preterm delivery. Secondary outcomes included live birth, low birth weight, serious infections, neonatal intensive care unit (NICU) admission, and malignancies. Statistical analysis was performed using RStudio, applying a random-effects model to calculate the pooled risk ratios (RRs) for binary outcomes.

Results

This systematic review included six studies. Median maternal age ranged from 30 to 33 years, with similar distributions between groups. The average disease duration ranged from 8 to 14 years. Crohn’s disease was more prevalent in the ustekinumab group, while ulcerative colitis was more common in the vedolizumab group. No statistically significant differences were observed in spontaneous abortion (RR 1.66; 95% CI 0.89–3.10), preterm delivery (RR 0.60; 95% CI 0.31–1.16), live birth (RR 0.97; 95% CI 0.90–1.05), low birth weight (RR 0.65; 95% CI 0.31–1.40), serious infections (RR 1.34; 95% CI 0.39–4.66), NICU admission (RR 1.02; 95% CI 0.56–1.85), or malignancies (RR 1.25; 95% CI 0.67–2.32) between UST and VDZ treatments.

Conclusion

No significant differences were observed across the outcomes analyzed when comparing ustekinumab and vedolizumab for the treatment of pregnant patients with IBD.

Introduction

Vedolizumab (VDZ) is approved for moderate-to-severe inflammatory bowel disease (IBD; ulcerative colitis [UC] & Crohn’s disease [CD]).^1,2 While the subcutaneous (SC) formulation of VDZ is effective as maintenance treatment (mTx) in patients (pts) responding to intravenous (IV) VDZ induction treatment (Tx),^1,3 real-world data on Tx patterns of pts switching mTx from VDZ IV to SC or initiating mTx VDZ SC after IV induction are limited.

Aims & Methods

This prospective, non-interventional, multicentre (NCT05384080) study (conducted under the umbrella VARIETY protocol) enrolled adults with UC or CD initiating/undergoing induction with VDZ IV or continuing VDZ IV mTx, with the option to switch to VDZ SC mTx. The primary endpoint was real-world Tx patterns with VDZ, including Tx persistence. Additional endpoints assessed pt characteristics, pt-reported outcomes, and safety (adverse events [AEs]). Data were descriptively analysed.

Results

Overall, 162 enrolled pts (August 2022–June 2023; UC, n=103; CD, n=59) were included in the interim analysis. At enrolment, 127 (78.4%) received VDZ mTx (UC, n=78; CD, n=49) and 35 (21.6%), VDZ induction (UC, n=25; CD, n=10). The mean (SD) age was 38.2 (12.3) yrs, and time since IBD diagnosis was 10.7 (11.1) yrs. Majority of pts were male (96 [59.3%]), currently employed (124 [76.5%]), had never smoked (109 [67.3%]), and reported previous biologic therapy (95 [58.6%]). Demographic and IBD Tx history data were consistent across cohorts. At baseline, in pts with UC, the mean (SD) partial Mayo score was 1.8 (2.7); in pts with CD, the mean (SD) Crohn’s Disease Activity Index (CDAI) score was 90.6 (70.1). During the 1-yr study period, 20.0% (n=7; UC, n=2; CD, n=5) of pts in the induction and 51.2% (n=65; UC, n=40; CD, n=25) in the mTx cohort switched to VDZ SC. At week (W) 52, Tx persistence was 40.0% (n=14; UC, n=11; CD, n=3) and 77.2% (n=98; UC, n=61; CD, n=37) in the induction and mTx cohorts, respectively, and highest overall in mTx pts who switched to VDZ SC (86.2%; n=56; Table). The most common reason for Tx discontinuation was investigator decision (64.7%; n=33). For VDZ IV and SC, the mean (SD) number of doses per pt was 10.5 (7.6) and 23.8 (15.0), respectively. The median time from VDZ Tx initiation to SC Tx was 383 days (induction: 98 days; mTx: 434 days). In the induction cohort, the mean (SD) Work Productivity & Activity Impairment (WPAI) scores improved from 32.7 (24.1) at baseline (n=21) to 21.5 (31.2) at W52 (n=11), and the Short IBD Questionnaire (SIBDQ) scores improved from 44.1 (10.0) at baseline (n=34) to 51.0 (12.9) at W52 (n=15). In the mTx cohort, WPAI and SIBDQ results remained consistent over time. Fifty-three AEs were reported, including 4 serious AEs (malignancy, IBD flare requiring hospitalization, abdominal abscess, and unconsciousness). One AE of special interest (hypersensitivity reaction) was considered VDZ-related.

Conclusion

In this Polish real-world study, high Tx persistence was reported, especially in pts who switched to VDZ SC. No new safety signals were noted. Overall, the results were consistent with those from other VARIETY cohorts,⁴ although lower persistence was observed during induction. The small size of the induction cohort was a limitation of this study.

References

1. Sandborn WJ, et al. Gastroenterology. 2020;158:562–72.e12.
2. Loftus EV Jr, et al. Aliment Pharmacol Ther. 2020;52:1353–65.
3. Vermeire S, et al. J Crohns Colitis. 2022;16:27–38.
4. Novacek G, et al. J Crohns Colitis. 2024;18(suppl 1):i1506–7

Disclosure

Conflicts of interest: Agata Michalak received lectures fees and/or travel grants from AbbVie, Bayer, Biocodex and Takeda. Katarzyna Karłowicz received lecture fees, consultancy fees or travel educational grants from Bristol Myers Squibb, AbbVie, Polpharma, Takeda and Pfizer. Renata Talar-Wojnarowska received lecture fees and/or travel grants from AbbVie, Astellas, Ferring, Janssen and Takeda. Adam Fabisiak received fees and/or travel grants from Bristol Myers Squibb, Pro. Med. CS, Pfizer and Polpharma. Magdalena Achtenberg received lecture fees from Ferring. Piotr Eder received lecture fees and/or travel grants from Takeda, Ferring, Astellas, Pfizer and Janssen. Maria Kłopocka received payment for lectures from Janssen, Takeda, Ferring, Alfasigma and Pharmabest and travel/accommodation/meeting expenses from Ferring, Janssen, Takeda, Alfasigma and Pharmabest. Maciej Gonciarz received compensation and/or research/educational grants from Pfizer, Polfarma, Abbvie, BMS, Ewoppharma, Ferring, Astellas, Takeda, Jansen-Cilag, Celtrion, Johnson & Johnson, and Sanofi. Grażyna Rydzewska received speaker and consultant fees from AbbVie, AlfaSigma, AstraZeneca, Bayer, Biocodex, Bristol Myers Squibb, Ferring, Janssen, Lilly, Pro. Med. Pl., Recordati, Sanprobi, SOBI and Takeda and travel/accommodation meeting expenses from AbbVie, Ferring and Takeda. Eliza Majewska is a permanent employee of Takeda Pharma Sp. z o.o. Maria Kopertowska-Majchrzak, Tomasz Romańczyk, Halina Cichoż-Lach, Małgorzata Zwolińska-Wcisło, and Elżbieta Poniewierka declare no conflicts of interest.
Funding: The study was funded by Takeda Pharma Sp. z o.o.
Acknowledgements: Medical writing support was provided by Michelle Rebello, PhD, of Cactus Life Sciences (part of Cactus Communications) and funded by Takeda Pharma Sp. z o.o.

Introduction

Crohn’s disease (CD) is a chronic condition characterized by a relapsing-remitting course, often requiring intestinal resection. Postoperative management primarily aims to maintain clinical remission. The advent of biologic therapies has undoubtedly improved disease prognosis following initial surgery. However, access to this therapeutic class remains limited in lower-middle income countries such as Tunisia, necessitating the use of alternative agents, notably azathioprine (AZA), which has been widely used for this indication, albeit with controversial results.

Aims & Methods

This study aimed to evaluate the effectiveness of AZA in maintaining remission after a first intestinal resection in patients with ileal or ileocolonic Crohn’s disease, and to identify factors associated with treatment failure.
​We conducted a retrospective, descriptive, and analytical study in the gastroenterology department of Sahloul University Hospital in Sousse (Tunisia) over a 4-year period (2020–2024). We included all patients with ileal or right ileocolonic CD who underwent intestinal resection and received AZA in the postoperative period.

Results

A total of 66 patients were included, with a mean age at diagnosis of 31.50 ± 12.24 years and a male-to-female ratio of 1.06. The median interval between diagnosis and surgery was 21.5 months. During follow-up, AZA failure occurred in 63.6% of patients (n=42), with a mean time from surgery to failure of 44.71 ± 37.74 months. In univariate analysis, ileocolonic disease location (p=0.042), the total number of flares (p=0.007), and the number of severe flares (p<0.001) prior to surgery were significantly associated with AZA failure. Failure rates were also significantly higher in patients who underwent emergency surgery (p=0.007). Inflammatory resection margins (p<0.001) and severe inflammatory activity (p=0.007) were also significantly associated with treatment failure. In multivariate analysis, three independent risk factors were identified: the number of severe flares before surgery (p=0.031), preoperative inflammatory syndrome (p=0.008), and histopathological evidence of disease at the resection margins (p=0.004).

Conclusion

Our findings suggest that thiopurines remain a valuable therapeutic option in the management of Crohn’s disease, particularly in our setting, where access to alternative therapies is limited and associated with high costs.

Introduction

Resolution of pain, fatigue and other symptoms are key treatment goals for many patients (pts) with Crohn’s disease (CD);^1,2 however, time to symptomatic improvement in pts treated with vedolizumab (VDZ) has not been formally evaluated.

Aims & Methods

VOICE (NCT06249555) is a prospective, observational study in pts with CD aged ≥18 years initiating VDZ or anti-IL-23 antagonist treatment (tx) per product labelling as part of standard of care, with the main objective to explore the time course of response to VDZ as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) domain Short Form (SF) scores. Inclusion criteria include baseline PROMIS Pain Interference (PI)-SF T-score ≥55 (0.5 SD above general population). We enrolled pts via Takeda pt support program in Canada, with additional pts enrolled at US and Canada sites. Planned sample size is 300 pts (VDZ, 200; anti-IL-23 antagonist [reference group not for formal comparison], 100); planned follow-up is 52 weeks (wks), with PROMIS PI data reported weekly for the first 14 wks. The primary endpoint is time to the first meaningful clinical improvement in PROMIS PI-SF T-score, defined as ≥2-point decrease in PROMIS PI-SF T-score from baseline. We also collect data on improvement in 7 PROMIS domains with clinical improvement defined as 5-point (0.5 SD)³ change in T-score from baseline, Short Inflammatory Bowel Disease Questionnaire (SIBDQ; including SIBDQ improvement [≥9 point increase from baseline] and SIBDQ remission [score of ≥60]) and safety. Here, we report the results from pts with ≥1 VDZ dose and ≥1 post-baseline PI assessment included in the interim analysis (IA; prespecified to occur after 50 pts from VDZ group completed or discontinued before the wk 14 assessment to provide an early evaluation of tx response and safety).

Results

Overall, 64 pts with ≥1 VDZ dose and ≥1 post-baseline PROMIS PI assessment (mean±SD age, 43.1±17.0 years, 35.9% male, 92.2% White) were included in the IA. Disease duration (mean±SD) was 6.4±12.1 years; 84.4% of pts were anti-TNF-naïve. Data collection is ongoing for 57 pts (49 with and 8 without completed wk 14 PROMIS PI questionnaire); 7 pts discontinued from the study. The median time to achieve the first ≥2_-point decrease in PROMIS PI-SF T-score (in n=56 pts) was 12 days (95% CI, 6-13). Baseline PROMIS domain scores indicated notable impairment; by wk 14, improvements in mean PROMIS scores from baseline were observed in all 7 measured domains, with ≥5-point improvements in 4/7 domains (Table). At wk 14, 37.5% (24/64) and 7.8% (5/64) pts achieved SIBDQ improvement and remission, respectively. One pt had serious adverse events of appendicitis and diverticulitis, and another pt had a fatal event; none of these were related to VDZ tx.

Table. Summary of PROMIS domain T-scores

Conclusion

The IA results through wk 14 show an early improvement across multiple symptom domains and quality of life in pts with CD starting VDZ tx. Time to first ≥2-point decrease in PROMIS PI-SF T-score was short, with a benefit observed after 12 days from VDZ initiation. Study recruitment and data collection are ongoing.

References

1. Keefer L, et al. Gastroenterology. 2022;162(5):1439-1451.
2. Kitchen H, et al. Crohns Colitis 360. 2020;2(2):otaa033
3. Cella D, et al. Value Health. 2019;22(5):537-544.
4. Shaw BE, et al. Cancer. 2018;124(4):841-849.

Disclosure

This study was sponsored by Alimentiv, Inc.
V. Jairath reports consulting/advisory board fees from AbbVie, Alimentiv, Anaptyis Bio, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly, Endpoint Health, Enthera, Ensho, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, Gilde Healthcare, GlaxoSmithKline, Genentech, Gilead, Innomar, JAMP, Janssen, Merck, Metacrine, Mylan, MRM Health, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus Biosciences, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Sorriso, Spyre, Synedgen, Takeda, TD Securities, Teva, Topivert, Ventyx, Vividion; speaker’s fees from, Abbvie, Ferring, Bristol Myers Squibb, Galapagos, Janssen Pfizer Shire, Takeda, Tillotts and Fresenius Kabi.
M. Long reports consulting fees from AbbVie, Alimentiv, Bristol Myers Squibb, Intercept, Janssen, Lilly, Pfizer, Prometheus, Roivant, Syneos Health and Takeda; and research support from Lilly, Pfizer and Takeda.
M.D. Kappelman reports being a consultant to Eli Lilly and Takeda.
G. Radulescu and N. Li are employees of Alimentiv.
J.J. Wu, I. Romo Bautista, A. Insogna and C. Agboton are employees of Takeda and hold stock and/or share options in Takeda.
N. Narula has received advisory board/consulting honoraria from Abbvie, Amgen, Eli Lilly and Company, Ferring, Fresinius Kabi, Innomar Strategies, Iterative Health, Janssen, Novartis, Organon, Pfizer, Sandoz and Takeda.

Introduction

The increase in life expectancy has led to a more frequent performance of invasive procedures in older patients, including endoscopic retrograde cholangiopancreatography (ERCP). Elderly patients often present with multiple comorbidities and technical challenges, which may lead to the rejection of the procedure due to concerns about morbidity and mortality, as well as the potential futility of treatment. Few series address the safety and efficacy of ERCP in patients aged ≥95 years.

Aims & Methods

To compare the clinical characteristics, techniques, complications, and short- and long-term outcomes of super-elderly (≥95 years) and elderly (65-70 years) patients undergoing ERCP at La Paz University Hospital. A retrospective study was conducted, including all ERCP performed in super-elderly patients between 2018 and 2024. For the elderly group, an equal number of procedures performed during the same period were randomly selected and matched by sex. Data on demographics, comorbidities, indications, technical characteristics, complications, technical success rates and mortality at 30 days, 6 months and 12 months were collected and compared.

Results

A total of 92 procedures were included in each group, with 78.3% women in both groups. Super-elderly patients had a higher frequency of comorbidities, such as hypertension, heart failure, atrial fibrillation, chronic kidney disease and dementia (p<0.01). In terms of frailty, they had a significantly lower Barthel index compared to the elderly (p<0.001). ERCP indications were predominantly urgent in the super-elderly (cholangitis and biliary colic), while the elderly had a higher proportion of elective procedures such as planned choledocholithiasis and tumor-related causes (p<0.01). Most procedures in the super-elderly were performed in a hospital setting, while in the elderly, outpatient procedures predominated (p<0.001). Although no differences were observed in average hospital stay (p=0.59), the elderly had a higher proportion of procedures with 24-hour observation (p<0.001). In terms of techniques performed, the elderly group underwent more complex procedures such as cholangioscopy and radiofrequency ablation than the super-elderly. Technical success and procedure completion rates were similar (95.65% in the elderly and 96.74% in the super-elderly, p>0.05). Globally, immediate complications were slightly more frequent in the super-elderly (32.6%), although without significant differences compared to the elderly (25%, p=0.33); similarly for late complications. Regarding technique-related complications, despite the rates being comparable, the types of complications varied between the groups. In the elderly, mild pancreatitis predominated, whereas the super-elderly experienced a broader range of complications, including moderate pancreatitis, severe cholangitis and perforations, with a tendency towards greater severity, suggesting higher fragility in this group. Despite this, no statistically significant differences were observed in short- or long-term mortality. In the elderly, most deaths at 6 and 12 months were due to biliary causes (77.8% and 70%, respectively), primarily due to tumor-related processes. In the super-elderly, only 26.3% of deaths at 6 months and none at 12 months were due to biliary causes, reflecting the influence of additional comorbidities in this group.

Conclusion

Although super-elderly patients have a higher burden of comorbidities and frailty, the technical success and procedure completion rates are similar to those of 65-70-years-old. The indications and therapeutic approaches vary significantly between the two groups, with a higher proportion of urgent procedures in the super-elderly and a greater frequency of advanced techniques in the elderly. Despite differences in clinical characteristics, no significant differences in short- and long-term mortality were observed, suggesting that ERCP is safe and effective in both age groups, highlighting the importance of not rejecting the indication solely due to advanced age.

References

Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20. PMID: 31863440.