Assessment of endoscopic response using pan-enteric capsule endoscopy in Crohn’s disease; the Sensitivity to Change (STOC) study

Abstract

Background

The potential use of pan-enteric capsule endoscopy (pan-CE) to evaluate mucosal changes during treatment has not been evaluated. We aimed to assess the ability of pan-CE to measure changes in mucosal disease activity before and after starting biologic treatment in Crohn’s disease patients.

Methods

In this two-center prospective study, patients with clinical and biochemical signs of active Crohn’s disease underwent pan-CE before and 8 to 12 weeks after treatment initiation with infliximab, adalimumab or vedolizumab. Endoscopic disease activity was assessed using the simple endoscopic score for Crohn’s disease (SES-CD) and the Crohn’s disease endoscopic index of severity (CDEIS), expanded with two segments (i.e., the jejunum and pre-terminal ileum). Occurrence of endoscopic remission (i.e., absence of ulcers) and endoscopic response (i.e., 50% decrease in SES-CD and CDEIS scores compared to baseline) was assessed and the standardized effect size was calculated.

Results

Twenty-two patients (50% females) completed the study. Endoscopic remission was observed in 6 out of 22 (27%) patients and 13/22 patients (59%) showed an endoscopic response for both the SES-CD and CDEIS score. Median SES-CD and CDEIS scores decreased from 16.0 (IQR 10.0 − 24.0) to 6.0 (IQR 2.8 − 12.0, p = .001) and from 7.1 (IQR 4.6 − 11.2) to 3.0 (IQR 0.9 − 6.0, p = .001), respectively. The standardized effect size was 1.44 and 1.24 for the SES-CD and CDEIS, respectively. No adverse events related to pan-CE were reported.

Conclusion

Pan-CE was a useful technique to assess changes in mucosal disease activity in Crohn’s disease patients.

Keywords:

• Crohn’s disease
• capsule endoscopy
• endoscopic disease activity
• treatment response
• biologicals

Acknowledgements

We want to thank the patients for their participation We thank Ils van de Schoot for helping collecting the study data.

Disclosure statement

AV has nothing to disclose.

PB has received financial support for research from AbbVie, Mundipharma, Pfizer, Janssen, Amgen and Mylan; lecture fees from AbbVie, Takeda, Pfizer and Janssen; advisory board fees from Abbvie, Arena pharmaceuticals, BMS, Takeda, Hospira, Janssen, MSD, Mundipharma, Roche, Pfizer, Sandoz, Galapagos, PSI-CRO and Pentax.

JdJ has nothing to disclose.

LP received advisory board fees from Janssen-Cilag, Sandoz and Takeda; presentation fees from AbbVie and Ferring; grant support from Takeda; and personal fees (congress support) from AbbVie, Ferring, Norgine and Takeda.

KG has received grants from Pfizer Inc and Celltrion; consultancy fees from AbbVie, Arena Pharmaceuticals, Galapagos, Gilead, Immunic Therapeutics, Janssen Pharmaceuticals, Novartis, Pfizer Inc., Samsung Bioepis and Takeda; speaker’s honoraria from Celltrion, Ferring, Janssen Pharmaceuticals, Novartis, Pfizer Inc, Samsung Bioepis, Takeda and Tillotts.

MD MD reports advisory fees from Echo Pharma and Robarts Clinical Trials, Inc., speaker fees from Janssen, Merck & Co., Inc., Pfizer, Takeda and Tillotts Pharma, and nonfinancial support from Dr. Falk Pharm.

CP received grant support form Takeda, consulancy fees from Takeda, Shire, and Pliant, and speaker’s fees from Tillotts and Pfizer.

GD has served as advisor for Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, Alimentiv, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics; Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma; Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences; Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lument, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor; received speaker fees from Abbvie, Biogen, Ferring, Galapagos/Gilead, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millenium/Takeda, Tillotts and Vifor.

ML has served as speaker and/or principal investigator for: Abbvie, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Robarts Clinical Trials, Takeda, Tillotts, Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Dr Falk, Galapagos, Achmea healthcare and ZonMW.

Conferences presentation

This study was presented at the Digestive Disease Week 2021: ‘Fr039: PAN-ENTERIC CAPSULE ENDOSCOPY TO ASSESS MUCOSAL HEALING IN CROHN’S DISEASE; SENSITIVITY TO CHANGE (STOC) STUDY’, and at the 16th congress of ECCO 2021: ‘P353 Pan-enteric capsule endoscopy enables assessment of mucosal healing after biologic treatment initiation in Crohn’s disease’