TY - JOUR
T1 - Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn's disease
T2 - Results of the HOT-TOPIC trial after 1-year follow-up
AU - Lansdorp, Corine A.
AU - Buskens, Christianne J.
AU - Gecse, Krisztina B.
AU - Löwenberg, Mark
AU - Stoker, Jaap
AU - Bemelman, Willem A.
AU - D’Haens, Geert R. A. M.
AU - van Hulst, Rob A.
N1 - Funding Information: We would like to thank the Instituut voor Hyperbare Geneeskunde/the Da Vinci Clinic, Hyperbaar Geneeskundig Centrum Rijswijk and Antonius Hypercare Sneek for their cooperation and facilitation of the treatment of the study population with hyperbaric oxygen therapy. This work was supported by a Grant from the European Crohn's and Colitis Organisation and this Grant funded the research. The funder did not have any role in the study design, collection, management, analysis or interpretation of data, nor writing of the report or the decision to submit the report for publication. Funding Information: We would like to thank the Instituut voor Hyperbare Geneeskunde/the Da Vinci Clinic, Hyperbaar Geneeskundig Centrum Rijswijk and Antonius Hypercare Sneek for their cooperation and facilitation of the treatment of the study population with hyperbaric oxygen therapy. This work was supported by a Grant from the European Crohn's and Colitis Organisation and this Grant funded the research. The funder did not have any role in the study design, collection, management, analysis or interpretation of data, nor writing of the report or the decision to submit the report for publication. Funding Information: Corine A. Lansdorp has no conflict of interests to declare. Christianne J. Buskens has received speakers honoraria from Takeda and Tillotts. She has an unrestricted grant from Boehringer Ingelheim, and is part of the advisory board of Johnson&Johnson energy devices. Krisztina B. Gecse has received consultancy fees and/or speaker's honoraria from AbbVie, Celltrion, Ferring, Immunic Therapeutics, Janssen, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda and Tillotts. Mark Löwenberg has served as speaker and/or principal investigator for: Abbvie, 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, Achmea healthcare and ZonMW. Jaap Stoker has a research agreement with Takeda on a non‐related topic. Willem A. Bemelman has served as speaker for Takeda, Johnson and Johnson and Braun. He has received research grants from Braun and Vifor. Geert R.A.M. D’Haens has served as advisor for Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, 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, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill; Robarts Clinical Trials, 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. Rob A. van Hulst has no conflict of interests to declare. Publisher Copyright: © 2021 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.
PY - 2022/3/1
Y1 - 2022/3/1
N2 - Background: Previously published short-term results (week 16) of this trial showed a significant improvement in clinical, radiologic and biochemical outcomes in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen therapy. Objective: To assess the long-term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease. Methods: Crohn's disease patients with high perianal fistula(s) failing conventional treatment >6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received 40 hyperbaric oxygen sessions and outcomes were assessed at week 16 and week 60. Results: Twenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (co-primary outcomes) decreased from 7.5 (95% CI 6–9) to 4 (95% CI 3–6, p < 0.001) and 9.2 (95% CI 7.3–11.2) to 7.3 (95% CI 6.9–9.7, p = 0.004), respectively. At week 60, the respective scores remained significantly lower than baseline: 4 (95% CI 3–7, p < 0.001) and 7.7 (95% CI 5.2–10.2, p = 0.003). Perianal disease activity index score of 4 or less (representing inactive perianal disease) was observed in 13 patients at week 16 and 12 patients at week 60. Using fistula drainage assessment, 12 and 13 patients showed a clinical response at week 16 and 60, respectively, and clinical remission was achieved in four patients for both time points. At week 16, a statistically significant biochemical improvement (C-reactive protein and faecal calprotectin levels) was found, but this effect was no longer significant at week 60. Conclusions: The clinical and radiologic improvement of perianal fistula in Crohn's disease, that was found at week 16 after treatment with hyperbaric oxygen therapy, is maintained at 1-year follow-up.
AB - Background: Previously published short-term results (week 16) of this trial showed a significant improvement in clinical, radiologic and biochemical outcomes in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen therapy. Objective: To assess the long-term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease. Methods: Crohn's disease patients with high perianal fistula(s) failing conventional treatment >6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received 40 hyperbaric oxygen sessions and outcomes were assessed at week 16 and week 60. Results: Twenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (co-primary outcomes) decreased from 7.5 (95% CI 6–9) to 4 (95% CI 3–6, p < 0.001) and 9.2 (95% CI 7.3–11.2) to 7.3 (95% CI 6.9–9.7, p = 0.004), respectively. At week 60, the respective scores remained significantly lower than baseline: 4 (95% CI 3–7, p < 0.001) and 7.7 (95% CI 5.2–10.2, p = 0.003). Perianal disease activity index score of 4 or less (representing inactive perianal disease) was observed in 13 patients at week 16 and 12 patients at week 60. Using fistula drainage assessment, 12 and 13 patients showed a clinical response at week 16 and 60, respectively, and clinical remission was achieved in four patients for both time points. At week 16, a statistically significant biochemical improvement (C-reactive protein and faecal calprotectin levels) was found, but this effect was no longer significant at week 60. Conclusions: The clinical and radiologic improvement of perianal fistula in Crohn's disease, that was found at week 16 after treatment with hyperbaric oxygen therapy, is maintained at 1-year follow-up.
KW - Crohn's disease
KW - fistulising
KW - hyperbaric oxygen therapy
KW - inflammatory bowel disease
KW - perianal fistulas
KW - therapy-refractory
UR - http://www.scopus.com/inward/record.url?scp=85124509754&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85124509754&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/35146959
U2 - https://doi.org/10.1002/ueg2.12189
DO - https://doi.org/10.1002/ueg2.12189
M3 - Article
C2 - 35146959
SN - 2050-6406
VL - 10
SP - 160
EP - 168
JO - United European gastroenterology journal
JF - United European gastroenterology journal
IS - 2
ER -