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THE EFFECT OF APPENDECTOMY ON THE CLINICAL COURSE OF ULCERATIVE COLITIS (ACCURE): PRELIMINARY RESULTS OF AN INTERNATIONAL, RANDOMIZED, CLINICAL TRIAL

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THE EFFECT OF APPENDECTOMY ON THE CLINICAL COURSE OF ULCERATIVE COLITIS (ACCURE): PRELIMINARY RESULTS OF AN INTERNATIONAL, RANDOMIZED, CLINICAL TRIAL

Eva Visser 1, Lianne Heuthorst 1, Shri Pathmakanthan 2, Manon E. Wildenberg 3, Geert R. D'Haens 4, Marcel G. W. Dijkgraaf 3, Wilhelmus A. Bemelman 1, Thomas D. Pinkney 5, Christianne Johanna Buskens 1

Affiliations

1 Amsterdam University Medical center, location AMC, Amsterdam, Netherlands

2 Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom

3 Amsterdam University Medical Center, Amsterdam, Netherlands

4 Amsterdam University Medical Center - Inflammatory Bowel Disease Centre, Amsterdam, Netherlands

5 University of Birmingham, Birmingham, United Kingdom

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Abstract

Introduction

Emerging evidence indicates an immunomodulatory role of the appendix in ulcerative colitis (UC). Previous studies suggest a beneficiary effect for appendectomy in inducing and maintaining remission. Therefore, appendectomy might be considered as an alternative treatment in these patients.

Aims & Methods

Aim: To evaluate the efficacy of appendectomy in maintaining remission in UC patients.
Methods: Adult patients with established UC in complete clinical and endoscopic remission (defined as Mayo score <3 with endoscopic subscore of 0 or 1) after being medically treated for disease relapse within 12 months prior to randomization were enrolled in the Netherlands and United Kingdom. Patients were randomized (1:1) to undergo additional appendectomy (intervention group) or continue current medical therapy (control group). The primary outcome was the one-year UC relapse rate, defined as a total Mayo-score score ≥5 with endoscopic subscore of 2 or 3. To detect a clinically relevant decrease in relapse rate from 40% to 20%, 82 patients per study arm were needed. Trial progress and safety reports with accumulated number of (serious) adverse events in both groups were presented to the Data Safety Monitoring Board (DSMB) annually, and therefore data are available. Last patient was included in August 2022, so the final analyses will commence in September 2023.

Results

Between September 2012 and September 2022, 198 patients were randomized. A total of 99 patients were included in the intervention group and 99 patients in the control group. The one-year follow-up data were complete for 183 patients in April 2023.
There were 86 males and 112 females, with a median age of 41 years (IQR 33-52). Baseline characteristics were comparable in both groups, with the majority of patients having been treated for either proctitis (38.9%) or left sided colitis (35.9%) (Table 1). A total of three serious adverse events (SAE) were reported in the appendectomy group, of which two were related to the surgical procedure (reintervention for mechanical ileus and postoperative hematoma) and one hospitalisation for clostridium infection. One SAE was reported within the first year in the control group (appendicitis). During follow up there were no colectomies in the appendectomy group, whereas three patients underwent colectomy for therapy-refractory disease in the control group. In addition, the one-year reported colitis-associated adverse event rate was significantly lower in the appendectomy group when compared to the control group (43.4% vs. 62.7%, P=0.01).

Table 1. Baseline characteristics of the patients included in the ACCURE-trial
Characteristic	Appendectomy (N=99)	Control (N=99)
Sex (female), n (% n/N)	57 (57.6)	55 (55.6)
Age (years), median (IQR)	41 (32-49)	42 (34-53)
Extent of disease Proctitis, n (% n/N) Left-sided colitis, n (% n/N) Pancolitis, n (% n/N)	38 (38.4) 35 (35.4) 26 (26.4)	39 (39.4) 36 (36.4) 24 (24.2)

Conclusion

Appendectomy in patients with UC has the possibility to decrease the rate of colitis-associated (serious) adverse events significantly. This suggests that the final analysis of the primary outcome parameter (relapse rate) in September 2023 could demonstrate that appendectomy is superior to standard medical therapy alone in maintaining remission in these patients.

Event

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

Sequential therapies in IBD: Raising the bar

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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Variable	Proactive N=164 (47.4%)	Reactive N=182 (52.6%)	P-value (univariate)	Total (N=346)
Smoking	67 (40.9%)	79 (43.4%)	P=0.057	146 (42.2%)
Montreal classification - +L4 - (p)B3	14 (8.5%) 69 (42.1%)	6 (3.3%) 53 (29.1%)	P=0.037 P=0.012	20 (5.8%) 122 (35.3%)
Preoperative immunomodulator	124 (75.6%)	97 (53.3%)	P<0.001	221 (63.9%)
Preoperative biologic	98 (59.8%)	78 (42.9%)	P=0.001	176 (50.9%)
Biochemical inflammation* and/or steroid use <4 weeks prior to surgery	101 (61.6%)	89 (48.9%)	P=0.018	190 (54.9%)
ePOR (Rutgeerts >i1)	68 (41.5%)	98 (53.8%)	P=0.021	166 (48.0%)
Colonic endoscopic activity	30 (18.3%)	47 (25.8%)	P=0.032	77 (33.5%)
cPOR	29 (17.7%)	65 (35.7%)	P<0.001	94 (27.2%)
sPOR	11 (6.7%)	24 (13.2%)	P=0.046	35 (10.1%)

Comparison	n	κ	Strength of Agreement	p-value	Condition	Endoscopic Activity	Endoscopic Remission
Endoscopic Remission 18–24m vs. IUS 18–24m	123	0.531	Moderate	<0.001	Active Inflammation	60	7
					Remission	21	35
					Total	81	42
Endoscopic Remission 18–24m vs. MRI 18–24m	140	0.324	Fair	<0.001	Active Inflammation	64	17
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Table. Achievement of Key Clinical and Endoscopic Outcomes During the Upadacitinib Maintenance Study at Week 52
Patients Achieving Outcome	PBO (n = 223)	UPA 15 mg (n = 221)	Adjusted difference vs PBO, % (95% CI)	UPA 30 mg (n = 229)	Adjusted difference vs PBO, % (95% CI)
Clinical endpoints Clinical remission, % Per CDAI^a Per SF/APS^b Maintenance of clinical remission^c, (%) Per CDAI Per SF/APS CR-100^d, % Corticosteroid-free clinical remission per CDAI^e, % Among all patients Among patients taking corticosteroids at induction baseline Corticosteroid-free clinical remission per SF/APS^e, % Among all patients Among patients taking corticosteroids at induction baseline	15. 2 15.2 21.2 21.6 17.0 14.8 6.3 15.2 6.3	36.2* 33.9* 48.5* 48.9* 38.9* 34.8* 33.8* 33.0* 32.5***	21.9 (14.5–29.3) 19.2 (12.2–26.3) 28.9 (18.8–39.1) 28.2 (18.0–38.3) 22.4 (14.6–30.1) 21.0 (13.7–28.3) 29.2 (18.1–40.3) 18.3 (11.3–25.4) 28.0 (17.0–39.0)	51.5* 49.3* 66.7* 60.7* 52.8* 50.7* 44.7* 48.0* 42.4***	36.1 (28.4–43.7) 33.5 (26.0–41.0) 44.6 (34.5–54.8) 38.2 (27.9–48.4) 35.5 (27.7–43.3) 35.7 (28.0–43.3) 37.0 (25.8–48.2) 32.2 (24.7–39.7) 36.7 (25.9–47.5)
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Composite endpoints Clinical remission per CDAI and endoscopic remission^h, % Clinical remission per SF/APS and endoscopic remission^h, %	3.6 4.1	15.0* 14.1*	12.0 (6.8–17.2) 10.3 (5.2–15.5)	26.2* 25.8*	22.6 (16.6–28.5) 21.4 (15.4–27.5)
APS, abdominal pain score; CDAI, Crohn’s Disease Activity Index; CR-100, clinical response 100; PBO, placebo; SF, stool frequency; UPA, upadacitinib. ***P < .001 vs PBO. ^aClinical remission per CDAI: CDAI < 150. ^bClinical remission per SF/APS: average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and both not greater than baseline. ^cMaintenance of clinical remission per CDAI or SF/APS: achievement of CDAI or SF/APS clinical remission among patients who had CDAI or SF/APS clinical remission at the end of induction. ^dCR-100: decrease of ≥ 100 in CDAI from baseline. ^eCorticosteroid-free clinical remission: Achievement of clinical remission per CDAI or SF/APS without corticosteroid use ≥ 90 days prior to week 52. ^fEndoscopic response: decrease in Simple Endoscopic Score for CD [SES-CD] > 50% from baseline of the induction study (or for patients with an SES-CD of 4 at baseline of the induction study, at least a 2 point reduction from baseline. ^gEndoscopic remission: SES-CD ≤ 4 and ≥ 2-point reduction from baseline, and no subscore > 1 in any individual variable.

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