Introduction

The most important factors for a successful colon capsule endoscopy (CCE) study are the quality of bowel preparation and the capsule excretion during battery life. Incomplete colonoscopy is one of the main indications for CCE.

Aims & Methods

The aim of this study was to analyze clinical and demographic factors for complete CCE after incomplete colonoscopy.
A retrospective single-center study was conducted, including patients consecutively submitted to CCE with previous incomplete colonoscopy. Complete examination was defined as visualization of hemorrhoidal plexuses during battery time. Demographic (gender and age) and clinical data (diabetes mellitus, hypertension, smoking, BMI, hypothyroidism, constipation, depression, opioid therapy, psychotropic medication and previous abdominal surgery) were collected.

Results

197 patients were analyzed, with a mean age of 67 years, 71.6% were women. The main reasons for incomplete colonoscopy were impassable angulation (54.8%) and irreducible loop (40.1%).
CCE was incomplete in 32.5% (n=64) of cases. Bowel preparation was inadequate in 30.5% (n=60).
Constipation was a risk factor for incomplete CCE study (OR 2.962; p=0.021, 95% CI 1.178-7.264), as well as obesity (OR 4.407; p=0.020, 95% CI 1.263-15.373).
The clinical indication for the examination did not show a statistically significant relationship with the rate of incomplete examinations (p=0.603). There were no statistically significant differences between the percentage of incomplete CCE in patients with incomplete colonoscopy due to impassable angulation versus irreducible loop (33.3% vs 33.3%, p=1.000).

Conclusion

Constipation and obesity are factors associated with a higher risk of incomplete CCE study. In these patients, intensification or alteration of the bowel preparation protocols used may be considered.

Introduction

A patency capsule (PC) test is advised before video capsule endoscopy (VCE) to prevent capsule retention in high-risk patients. Although up to 30% of patients cannot expel the PC within 30 hours and are ineligible for VCE, those without strictures, but with slow transit time, can safely undergo VCE. Currently there are no recommendations regarding PC protocol.

Aims & Methods

In this prospective cohort study, we aimed to evaluate the success rate of a 2^nd PC attempt with augmented pro-motility preparation protocol, in patients who previously failed to pass PC and to ascertain the risk factors for failure in PC test.

During 2019-2023, Patients who failed their initial PC test in our referral center were offered to undergo a 2^nd augmented pro-motility bowel preparation protocol (Table 1). Exclusion criteria: age<18 years, total colectomy or ileostomy and inability to sign informed consent. Patients were followed during the 2^nd PC test and the subsequent VCE for success rates and safety outcomes, i.e. VCE retention. Demographic and clinical characteristics were collected for assessing potential risk factors for 1^st PC failure and successful 2^nd PC by multivariate regression analysis.

Results

A total of 396 patients performed a PC test and were included in the study (age 45.4±18.6 years, male gender 47.7%). The indications for VCE were suspected/established Crohn's disease (86.1%); anemia/bleeding (8.3%) and radiologic findings (5.6%). Successful PC expulsion was documented in 323 (81.6%) patients, while 73 (18.4%) failed. A 2^nd attempt with augmented pro-motility protocol was accepted by 35/73 patients (48%) and rejected by 38/73 patients (52%). no clinico-demographic differences between the groups. Successful 2^nd PC attempt was documented in 20/35 patients (57%), with all of them completing VCE without adverse events. Failed 2^nd PC was documented in 15/35 patients (43%) without adverse events, while 3/15 performed tandem abdominal CT confirming PC in colon (i.e false failure) followed by uneventful VCE.

Performance of a 2^nd PC attempt reduced the failed PC rate by 57% (Absolute risk reduction) and the number needed to treat (NNT) is 1.8 for a successful 2^nd attempt. Multivariate regression for success with 2^nd PC vs. 1^st PC was limited by small numbers. However, diabetes mellitus showed a trend as a risk factor (9.6% in 1^st PC test success vs. 20% in 2^nd PC test success, OR 3.7, p=0.057, adjusted for age, gender, BMI and stools/day).

Conclusion

In this prospective cohort study, a novel augmented pro-motility PC test preparation protocol improved the success rate in patients who previously failed an initial PC test, without any adverse events. Subsequent abdominal CT should be considered in selected cases to further reduce false positive results. Patients with diabetes mellitus might benefit from performing the augmented protocol upfront, but further large-scale studies are required to establish that.

Table 1: Patency Capsule Preparation Protocols

Disclosure

Nothing to disclose

Introduction

The POWER study evaluated efficacy and safety of a single intravenous (IV) re-induction ustekinumab (UST) dose vs continued UST subcutaneous (SC) treatment in Crohn’s disease (CD) patients (pts) with secondary loss of response (LoR) to standard UST maintenance therapy. Here, we present Week (W)16 pharmacokinetics, exposure–response relationships, and immunogenicity analysis.

Aims & Methods

Adult pts with moderately–severely active CD who initially responded to UST IV induction therapy per label and later experienced LoR were included. LoR was defined as CD Activity Index (CDAI) score ≥220–≤450, plus elevated C-reactive protein (>3mg/L)/faecal calprotectin (>250mg/kg), or endoscopy performed ≤3 months before baseline (W0) with active CD. At W0, randomized pts received ~6mg/kg IV UST, or SC UST 90mg, followed by SC UST 90mg dosing at W8/16. Clinical assessments occurred at W0/8/16. Serum samples evaluated UST concentration (conc) and anti-drug antibodies (ADAs) at W0/8/16 using validated assays. Clinical response (CRes) and endoscopic remission (ERem) were evaluated based on CDAI and centrally read endoscopy, respectively, at W0/8/16. Efficacy outcomes were analyzed by W0 trough conc groups (undetectable, 0.17–<0.8, 0.8–<1.3, and ≥1.3µg/mL) and conc quartile groups (QGs) at W16 using a proprietary immunoassay.

Results

Serum UST conc data were obtained from 215 pts (SC, n=107; IV, n=108) with ≥1 blood sample collected. Similar at W0, median serum UST concs at W0 (1-hour post-dose)/8/16 were higher in the IV vs SC arm (Table). Based on W16 trough concs, 63.9% (69/108) of pts were in the ≥1.3µg/mL group in the IV arm, vs 41.1% (44/107) in the SC arm. The proportion of pts with W16 CRes in the ≥1.3µg/mL group was similar between arms; more pts were in W16 ERem in the IV vs SC arm. By W16 quartile analysis, CRes was numerically higher in the IV vs SC arm in QG1 and 4. More IV arm pts achieved ERem in QG4 vs QG1; a small number of pts in SC arm achieved ERem independent of QGs. Incidence of UST ADAs through W16 was low (SC, n=2; IV, n=0; 0.93% overall).

Conclusion

Although, IV re-induction resulted in higher serum concs and proportions of pts with high (≥1.3µg/mL) trough conc at W16; there did not appear to be an exposure-response relationship for CRes. However, quartile analysis showed a relationship between increased exposure in the IV arm and differences in ERem. This observation is consistent with the notion that pts with secondary LoR may benefit from single-dose re-induction.

Disclosure

S. Schreiber has received personal fees from AbbVie, Amgen, Arena, Biogen, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Dr Falk Pharma, Fresenius, Galapagos/Gilead, Hikma, I-Mab, Janssen, MSD, Mylan, Pfizer, Protagonist, ProventionBio, Takeda, and Theravance Biopharma. S. Lee served as a consultant for Applied Molecular Transport, Arena, Boehringer Ingelheim, Bridge Biotherapeutics, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Cornerstones Health, Eli Lilly and Company, Janssen, KCRN Research, Samsung Bioepis, and UCB; and received research grants from AbbVie, AbGenomics, Arena, Celgene, Janssen, Salix, Takeda, and UCB. C.J. van der Woude received grant support from Falk Benelux, Ferring, and Pfizer; received speaker fees from AbbVie, Takeda, Ferring, Dr Falk Pharma, and Pfizer; and served as a consultant for Janssen. I Marín-Jiménez has served as a consultant, advisory member, speaker or has received research funding from Abbvie, Chiesi, Faes Farma, Dr Falk Pharma, Ferring, Gebro Pharma, Hospira, Janssen, MSD, Otsuka Pharmaceutical, Pfizer, Shire, Takeda, Tillots, and UCB Pharma. D. Wolf has received honoraria as a speaker, consultant and/or advisory board member from AbbVie, Arena, Celgene/Bristol Myers Squibb, Janssen, Pfizer, and Takeda. E. Schnoy has received personal fees from AbbVie, Bristol Myers Squibb, Celltrion Healthcare, Dr Falk Pharma, Galapagos/Gilead, I-Mab, Janssen, Lilly, Pfizer, Pharmacosmos, Takeda, and Tillotts Pharma. B. Salzberg served as a consultant for Johnson and Johnson, and has received honoraria as a speaker from AbbVie, Bristol Myers Squibb, and Johnson & Johnson. M. Nazar is an employee of Janssen-Cilag Polska Sp. z o.o. and has restricted stocks. C. Busse, W. Langholff, C Gasink, T. Baker, B. Godwin and Adedokun O.J. report employment with/funding by Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson, and stock ownership in Johnson & Johnson. B. Feagan received grant/research support from AbbVie Inc., Amgen Inc., AstraZeneca/MedImmune Ltd., Atlantic Pharmaceuticals Ltd., Boehringer Ingelheim, Celgene Corporation, Celltech, Genentech Inc./Hoffmann-La Roche Ltd., Gilead Sciences Inc., GlaxoSmithKline (GSK), Janssen Research & Development LLC., Pfizer Inc., Receptos Inc./Celgene International, Sanofi, Santarus Inc., Takeda Development Center Americas Inc., Tillotts Pharma AG, and UCB; was a consultant for Abbott/AbbVie, AdMIRx Inc., Akebia Therapeutics, Allergan, Amgen, Applied Molecular Transport Inc., Aptevo Therapeutics, Asta Pharma, AstraZeneca, Atlantic Pharma, Avir Pharma, Biogen Idec, BioMx Israel, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Galapagos, Galen/Atlantica, GiCare Pharma, Gilead, Gossamer Pharma, GSK, Inception IBD Inc., Intact Therapeutics, Johnson & Johnson/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nestlé, Nextbiotix, Novo Nordisk, ParImmune, Parvus Therapeutics Inc., Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Qu Biologics, Rebiotix, Receptos, Roche/Genentech, Salix Pharma, Shire, Sienna Biologics, Sigmoid Pharma, Sterna Biologicals, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd., and Zyngenia; was a member of the speakers’ bureau for Abbott/AbbVie, Johnson & Johnson/Janssen, Lilly, Takeda, Tillotts, and UCB Pharma; a member of the scientific advisory board for Abbott/AbbVie, Allergan, Amgen, AstraZeneca, Atlantic Pharma, Avaxia Biologics Inc., Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Galapagos, Genentech/Roche, Johnson & Johnson/Janssen, Merck, Nestlé, Novartis, Novo Nordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Sterna Biologicals, Takeda, Teva, TiGenix, Tillotts Pharma AG, and UCB Pharma; and was a Senior Scientific Officer for Robarts Clinical Trials Inc.

Introduction

Clinical remission and mucosal healing have been advocated as treatment goals for patients with ulcerative colitis (UC). Novel molecularly targeted drugs for the treatment of UC have enabled to target not only clinical remission but also endoscopic remission and even histologic remission.
Recently, the usefulness of novel image enhanced endoscopy (IEE) such as texture and color enhancement imaging (TXI) and red dichromatic imaging (RDI) have been reported in endoscopic evaluation of UC. We aimed to verify the usefulness of the novel IEE in prediction of maintenance of clinical remission in UC patients.

Aims & Methods

Patients with UC in clinical remission who underwent colonoscopy with IEE from March 2021 to December 2023 at our hospital were enrolled in this prospective study.
Disease activities in six segments (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum) were assessed using white-light imaging (WLI), TXI and RDI. Endoscopic evaluation of disease activity using WLI was performed using Mayo endoscopic score (MES) and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). IEE evaluation was performed using predefined TXI score (0-2: 2 indicates maximum severity) and RDI score (1-4: 4 indicates maximum severity) for UC. MES of ≤1 and UCEIS of ≤1 were defined as endoscopic remission. With IEE, TXI score 0-1 and RDI score 1 were defined as endoscopic remission in accordance with previous reports. We evaluated the correlation of those scores by Spearman’s rank correlation coefficient. Moreover, relationships between endoscopic remission of WLI, TXI and RDI, and maintenance of clinical remission were evaluated by Kaplan-Meier analysis. Relapse was defined as worsening of clinical symptoms that required additional medical therapies for UC.

Results

Total 117 patients with UC were enrolled. Of these, 17 were excluded because adequate images could not be obtained. Therefore, total 100 patients were assessed. The median MES, UCEIS, TXI, and RDI scores were 1 (range 0-3), 1 (range 0-5), 2 (range 1-3) and 2 (range 1-4), respectively. The average follow-up period was 10.1 months, and 8 cases showed clinical relapse during the observation period.
Evaluation of endoscopic images at each colonic site revealed that UCEIS (P<0.001), TXI score (P<0.001), and RDI score (P<0.001) were significantly associated with MES, respectively. In addition, scores at the most inflamed area showed a positive correlation between MES and UCEIS (r=0.91, P<0.001), MES and TXI (r=0.73, P<0.001), and MES and RDI (r=0.77, P<0.001).
In Kaplan-Meier analysis, MES remission (log-rank, P=0.245), UCEIS remission (log-rank, P=0.701), and RDI remission (log-rank, P=0.827) were not significantly associated with subsequent maintenance of clinical remission. On the other hand, TXI remission (log-rank, P=0.045) was significantly associated with subsequent maintenance of clinical remission.

Conclusion

TXI score and RDI score were significantly associated with existing endoscopic score. In particular, TXI remission was significantly associated with subsequent maintenance of clinical remission. Novel IEE may be useful option in prediction of maintenance of remission in UC patients.

Introduction

Eosinophilic esophagitis (EoE) is a chronic type 2 inflammatory disease with increasing incidence and prevalence. Patients with EoE usually present with symptoms of dysphagia that impact their quality of life. In the 3-part, Phase 3 LIBERTY EoE TREET study (NCT03633617), dupilumab improved histologic, symptomatic, and endoscopic aspects of EoE up to 52 weeks.

Aims & Methods

The aim of this analysis was to assess the effect of dupilumab on symptoms of dysphagia in the 28-week extended treatment period of LIBERTY EoE TREET in patients who switched from placebo to dupilumab at 24 weeks. In Parts A and B, patients received dupilumab 300 mg or placebo weekly (qw) for 24 weeks. Patients who completed Parts A and B entered Part C - a 28-week extended treatment period in which all patients received dupilumab 300 mg qw; patients entering Part C remained blinded to their treatment in Parts A and B. Dysphagia Symptom Questionnaire (DSQ) score and number of days with dysphagia (assessed using the DSQ) were calculated over a 14-day period. Percent change in DSQ score and in number of days with dysphagia from Week 24 through Week 52 vs the Week 24 baseline were assessed for patients who switched from placebo to dupilumab 300 mg qw at Week 24 and or continued on dupilumab 300 mg.

Results

Mean (SD) DSQ score after 24 weeks of placebo was 24.7 (19.6) and 21.5 (18.4) in Parts A (n=37) and B (n=37), respectively. Significant improvements in DSQ score were observed within 4 weeks of the switch to dupilumab 300 mg qw (mean percent reduction: 31.5% and 29.9%). After 28 weeks (at Week 52), mean percent reduction in DSQ score was 63.6% and 59.7%. After 24 weeks of placebo, mean (SD) days with dysphagia was 6.6 (4.7) and 6.0 (4.7) in Parts A and B, respectively. At Week 52, there was a 63.2% and 46.8% mean reduction in the number of days with dysphagia.

Conclusion

In patients who initially received 24 weeks of placebo, weekly treatment with dupilumab 300 mg resulted in rapid (within 4 weeks) and sustained (up to 28 weeks) improvement in symptoms of dysphagia as assessed by the DSQ score. The magnitude of the improvement in dysphagia observed after switching from placebo to dupilumab was similar to that seen at 4 weeks in patients who originally initiated dupilumab in Parts A and B of the study.

Disclosure

Dellon ES. Abbott, Abbvie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Dr. Falk Pharma, Eli Lilly, EsoCap, Eupraxia, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, Upstream Bio – consultant. Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, Shire/Takeda – research funding. Allakos, Aqilion, Holoclara, Invea – educational grants.
Chehade M. Adare Pharma Solutions/Ellodi, Allakos, AstraZeneca, BMS, Nexstone Immunology, Phathom, Recludix Pharma, Regeneron Pharmaceuticals Inc., Sanofi, and Shire/Takeda ‒ consultant. Adare Pharma Solutions/Ellodi, Allakos, AstraZeneca, Celgene/BMS, Danone, Regeneron Pharmaceuticals Inc., and Shire/Takeda ‒ research funding.
Bredenoord AJ. Alimentiv, Aqilion, AstraZeneca, Dr. Falk Pharma, Eupraxia, Laborie, Medtronic, Reckitt, Regeneron Pharmaceuticals Inc., and Sanofi ‒ consultant. Dr Falk Pharma, Norgine, Nutricia, Sanofi, SST, Regeneron Pharmaceuticals Inc., and Thelial ‒ research funding. Alimentiv, Aqilion, AstraZeneca, Dr Falk Pharma, Eupraxia, Laborie, Medtronic, Reckitt, Regeneron Pharmaceuticals Inc., and Sanofi ‒ speaker fees.
Spergel JM. Allakos, DBV Technologies, Novartis, Regeneron Pharmaceuticals Inc., and Shire/Takeda – consultant. DBV Technologies and Regeneron Pharmaceuticals Inc. ‒ research grant support.
Xia C, McCann E, Khodzhayev A, Radwan A. Regeneron Pharmaceuticals Inc. – employees and shareholders.
Tilton ST, Pela T, Jacob-Nara JA. Sanofi – employee, may hold stock and/or stock options in the company.

Introduction

Pancreatic serous cystic neoplasms, benign lesions with distinct histologic appearance and very low malignant potential, represent 1-2% of pancreatic cysts.¹ Microcystic serous cystadenoma (SCA) is the most common subtype.² It may have a solid appearance on cross sectional imaging, which is only diagnostic in 50% of cases.³ In the absence of characteristic features on imaging, EUS-guided fine-needle aspiration (FNA) is the next diagnostic method of choice for large microcystic SCAs. However, cytology is often inconclusive and usually enough fluid is not attainable for chemistry analysis.⁴ Previous case series have shown that fine-needle biopsy (FNB) may be an effective method for diagnosing SCAs⁴; however, these studies were limited in patient number. We present a case series of 23 patients who underwent FNB for the diagnosis of suspected microcystic SCAs.

Aims & Methods

A single-center retrospective review of the electronic health record was performed on patients who underwent EUS to evaluate a solitary pancreatic lesion on cross sectional imaging. If EUS imaging was suggestive of a microcystic lesion and fluid aspiration was expected to be non-diagnostic or not feasible due to the small cystic components, the decision was made to pursue an FNB intraoperatively. FNB was performed on all patients using a 22-gauge fork tip biopsy needle, using either a transgastric or transduodenal approach. The acquired tissue was placed in formalin, underwent standard histologic handling, and was reviewed by an expert gastrointestinal pathologist. SCAs were diagnosed histologically by tight acinar tubules bordered by cuboidal cells with clear cytoplasms and round nuclei.

Results

A total of 23 patients were included (18 female). The mean age was 69.5 ± 12.2 years and the mean cyst size in its largest diameter was 33.3 ± 14 (range of 8-60mm). Seven of the lesions were in the tail, 8 in the body, and 8 in the head/genu. Histological diagnosis of SCA was established in 78% (18/23) of the lesions and no further surveillance or imaging was recommended for these patients. A mean number of 1.4 ± 0.63 (range of 1-3 passes) of passes were obtained. In one of the patients, only one pass was obtained due to intra-lesional bleeding after initial needle puncture. The patient did not require admission or any further intervention. There were no other adverse events noted, including bleeding and/or pancreatitis.

Conclusion

Our case series demonstrates that EUS-guided FNB is a safe and feasible method for diagnosing microcystic SCAs, despite previous literature suggesting high intraprocedural bleeding. This may be a cost-effective approach, since after the diagnosis is confirmed, follow-up imaging and surveillance is not needed. This may also prevent unnecessary surgical intervention in cases of larger lesions where EUS-guided FNA was non-diagnostic.

References

1. Kimura W, Moriya T, Hirai I, et al. Multicenter study of serous cystic neoplasm of the Japan pancreas society. Pancreas. 2012;41(3):380-387. doi:10.1097/MPA.0b013e31822a27db
2. Reid MD, Choi HJ, Memis B, et al. Serous Neoplasms of the Pancreas. American Journal of Surgical Pathology. 2015;39(12):1597-1610. doi:10.1097/PAS.0000000000000559
3. Tseng JF, Warshaw AL, Sahani D V, Lauwers GY, Rattner DW, Fernandez-del Castillo C. Serous cystadenoma of the pancreas: tumor growth rates and recommendations for treatment. Ann Surg. 2005;242(3):413-419; discussion 419-21. doi:10.1097/01.sla.0000179651.21193.2c
4. Manfrin E, Perini C, Di Stefano S, et al. Pseudo solid-appearing pancreatic serous microcystic adenomas: Histologic diagnosis with the EUS core biopsy fork-tip needle. Endosc Ultrasound. 2019;8(5):334-341. doi:10.4103/eus.eus_11_19

Disclosure

No conflict of interest to disclose.

Introduction

Per the STRIDE II consensus, mucosal healing and normalization of quality of life are considered long-term treatment goals in ulcerative colitis (UC). Results from Phase 2/3 induction and maintenance trials (U‑ACHIEVE and U‑ACCOMPLISH) showed that patients with moderately to severely active UC treated with upadacitinib (UPA) had significant improvements in these outcomes individually. However, there is a need to understand better the extent to which patients treated with UPA can achieve both treatment goals jointly within one year of maintenance therapy.

Aims & Methods

In the U-ACHIEVE and U-ACCOMPLISH trials, patients with a clinical response after 8-week induction treatment with UPA 45 mg QD were re-randomized 1:1:1 to UPA 15 mg QD, UPA 30 mg QD or placebo (PBO) QD. Long-term treatment goals were determined based on the percentage of patients who achieved the composite endpoint of endoscopic remission (ER), complete symptom resolution (CSR), and Inflammatory Bowel Disease Questionnaire (IBDQ) remission at the end of induction week 8 and maintenance week 52. ER was defined as an endoscopic score of 0; CSR as stool frequency subscore ≤1, rectal bleeding subscore of 0, no bowel urgency, no abdominal pain; and IBDQ remission as IBDQ total score ≥170. The response rate between PBO and UPA was calculated using the Cochran-Mantel-Haenszel test, adjusting for baseline characteristics. The percentage of patients who maintained vs achieved ER+CSR+IBDQ remission during maintenance week 52 was also calculated.

Results

At induction week 8, a significantly greater percentage of patients treated with UPA 45 mg achieved ER+CSR+IBDQ remission vs PBO (6.4% vs 0.9%, respectively, p<0.001, Table). At maintenance week 52, the percentage of induction responders who achieved ER+CSR+IBDQ remission reached 18.3% with UPA 30 mg and 13.1% with UPA 15 mg vs 4.5% with PBO (p<0.001). Of the patients who achieved ER+CSR+IBDQ remission by week 0 of maintenance, 42.1% (8/19), 23.5% (4/17), and 22.2% (4/18) in the UPA 30 mg, UPA 15 mg, and PBO groups, respectively, sustained the composite endpoint at week 52. Among patients who did not achieve this composite endpoint by week 0 of maintenance, 16.2% (35/214), 12.3% (26/208), and 2.9% (6/205) in the UPA 30 mg, UPA 15 mg, and PBO groups, respectively, achieved it at week 52.

Conclusion

Results of this post hoc analysis indicate that the rigorous, long-term treatment goals of ER+CSR+IBDQ remission can be achieved with UPA in some patients with moderately to severely active UC by week 8 of induction. By maintenance week 52, nearly one in five patients treated with UPA 30 mg and approximately one in eight patients treated with UPA 15 mg achieved the stringent target. Sustained maintenance treatment with UPA results in an increasing proportion of patients achieving or maintaining these long-term goals of treatment after only one year.

Disclosure

J Panes received financial support for research from AbbVie and Pfizer; consultancy fees/honorarium from AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celsius, Celltrion, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Morphic, Nestlé, Origo, Pandion, Pfizer, Progenity, Prometheus, Protagonist, Revolo, Robarts, Sanofi, Takeda, Theravance and Wasserman; reports payment for lectures including service on speaker bureau from Abbott, Ferring, Janssen, Pfizer and Takeda; and reports payment for development of educational presentations from Abbott, Janssen, Pfizer Roche and Takeda.
R Panaccione has received consulting fees, speaker fees, research/educational support from, and/or advisory board member for AbbVie, Abbott, Alimentiv (formerly Robarts), Amgen, Arena, AZ, BI, BMS, Celgene, Celltrion, Cosmos, Eisai, Elan, Ferring, Galapagos, Genentech, Gilead, GSK, Janssen, Lilly, Merck, Mylan, Oppilan, Pandion, Pfizer, Progenity, Protagonist, Roche, Satisfai, Sandoz, Schering-Plough, Shire, Sublimity, Theravance, Takeda, and UCB.
MC Dubinsky has received consultancy fees from AbbVie, Allergan, Amgen, BI, Celgene, Gilead, Janssen, Lilly, Pfizer, Prometheus, Roche, Takeda, and UCB; and is a shareholder of Trellus Health.
Y Ishiguro has received a research grant from Mitsubishi Tanabe Pharmaceutical; speaker/consultation fees from AbbVie, Janssen, Daiichi-Sankyo, Kissei Pharmaceutical and EA Pharma.
J Tran is currently a contractor at AbbVie and a funded PhD candidate at the University of Washington.
D Ilo, J Eccleston, Y Sanchez Gonzalez are full-time employees of AbbVie and may hold AbbVie stock and/or stock options.
B Feagan is a consultant, member of the speakers bureau, and/or member of the scientific advisory board for AbbVie, AbolerIS, AgomAB, Allianthera, Amgen, AMT, AnaptysBio, Arena, Atomwise, Avoro Capital Advisors, Axio, BI, BioJamp, Biora, Boxer, Celgene/BMS, Celsius, Connect BioPharma, Cytoki, Disc Medicine, Duality, EcoR1, Equillium, Ermium, First Wave, First Word Group, Galapagos, Galen Atlantica, Genentech/Roche, Gilead, Gossamer, GSK, Hinge Bio, Hot Spot, Imhotex, Immunic, Index, JAKAcademy, Janssen, Japan Tobacco, Kaleido, Landos, Leadiant, L.E.K. Consulting, Lenczner Slaght, LifeSci Capital, Lilly, Lument AB, Millennium, MiroBio, Morgan Lewis, Morphic, Mylan, OM Pharma, Origo BioPharma, Orphagen, Pandion, Pendopharm, Pfizer, Prometheus, Play to Know AG, Progenity, Protagonist, PTM, Q32 Bio, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres, Silverback, Surrozen, Takeda, Teva, Thelium, Tigenix, Tillotts, Ventyx, VHSquared, Viatris, Ysios, Ysopia, and Zealand; is a stock shareholder for Gossamer; is an employee of Western University; and is Senior Scientific Director of Alimentiv Inc.