Middle-term prognosis in patients with ulcerative colitis who achieved clinical and endoscopic remission by budesonide rectal foam.

Adult Anti-Inflammatory Agents / administration & dosage Budesonide / administration & dosage Colitis, Ulcerative / diagnosis Endoscopy Female Humans Male Middle Aged Prognosis Remission Induction Retrospective Studies Treatment Outcome

Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2019
Historique:
received: 13 05 2019
accepted: 15 07 2019
entrez: 6 8 2019
pubmed: 6 8 2019
medline: 10 3 2020
Statut: epublish

Résumé

Budesonide foam is effective in inducing clinical remission in ulcerative colitis (UC) patients with active proctosigmoiditis. The aim of this study was to evaluate the duration of remission and predictors of relapse in UC patients who achieved clinical remission and mucosal healing by 6-week treatment with topical budesonide. This is a retrospective, observational, multicenter study with a 2-year follow-up period. UC patients who were treated with budesonide foam in phase 2 or phase 3 clinical trials and achieved both clinical remission and mucosal healing were enrolled. Among 84 patients who met the eligibility criteria, 60 participated in the study. Eighteen of the 60 patients (30.0%; 95% confidence interval [CI]: 18.9-43.2) experienced no relapse (i.e., maintenance of remission) during the 2-year follow-up period. The median relapse-free survival time was 0.82 years (95% CI: 0.51-1.52). Of 37 patients with a Mayo endoscopic subscore of 0 after inducing remission with budesonide foam, 25 (67.6%) relapsed within 2 years. Patients with a disease duration of <1 year experienced a worse clinical outcome than patients with a disease duration of >5 years, and the hazard ratio was 2.38 (95% CI: 1.04-5.45). This is the first study to evaluate the short- to middle-term prognosis in UC patients who achieved mucosal healing with topical preparations. After inducing remission by budesonide foam, treatment for maintaining remissions and strict follow-up may be needed for patients with shorter disease duration.

Sections du résumé

BACKGROUND
Budesonide foam is effective in inducing clinical remission in ulcerative colitis (UC) patients with active proctosigmoiditis. The aim of this study was to evaluate the duration of remission and predictors of relapse in UC patients who achieved clinical remission and mucosal healing by 6-week treatment with topical budesonide.
METHODS
This is a retrospective, observational, multicenter study with a 2-year follow-up period. UC patients who were treated with budesonide foam in phase 2 or phase 3 clinical trials and achieved both clinical remission and mucosal healing were enrolled.
RESULTS
Among 84 patients who met the eligibility criteria, 60 participated in the study. Eighteen of the 60 patients (30.0%; 95% confidence interval [CI]: 18.9-43.2) experienced no relapse (i.e., maintenance of remission) during the 2-year follow-up period. The median relapse-free survival time was 0.82 years (95% CI: 0.51-1.52). Of 37 patients with a Mayo endoscopic subscore of 0 after inducing remission with budesonide foam, 25 (67.6%) relapsed within 2 years. Patients with a disease duration of <1 year experienced a worse clinical outcome than patients with a disease duration of >5 years, and the hazard ratio was 2.38 (95% CI: 1.04-5.45).
CONCLUSION
This is the first study to evaluate the short- to middle-term prognosis in UC patients who achieved mucosal healing with topical preparations. After inducing remission by budesonide foam, treatment for maintaining remissions and strict follow-up may be needed for patients with shorter disease duration.

Identifiants

DOI: 10.1371/journal.pone.0220413 PMID: 31381615 PMC: PMC6681969
pubmed: 31381615
doi: 10.1371/journal.pone.0220413
pii: PONE-D-19-13503
pmc: PMC6681969
doi:

Substances chimiques

Anti-Inflammatory Agents 0
Budesonide 51333-22-3

Types de publication

Clinical Trial, Phase I Clinical Trial, Phase II Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0220413

Commentaires et corrections

Type : ExpressionOfConcernIn

Déclaration de conflit d'intérêts

Makoto Naganuma (MN) has received grants/personal fees from EA Pharma Co., Ltd., and Mochida Pharmaceutical Co., Ltd., personal fees from Kissei Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., JIMRO Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Pfizer Japan Inc., and AbbVie GK, and personal fees/non-financial support from Thermo Fisher Scientific Inc. Fumihito Hirai (FH) has received grants/personal fees from Kissei Pharmaceutical Co., Ltd., personal fees from EA Pharma Co., Ltd. Kiyonori Kobayashi (KK) has received grants/personal fees from EA Pharma Co., Ltd., personal fees from Kissei Pharmaceutical Co., Ltd. Kenji Watanabe (KW) has received grants/personal fees from EA Pharma Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., JIMRO Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., Astellas Pharma Inc., and Covidien Japan Inc, Nippon Kayaku Co., Ltd., Janssen Pharmaceutical K.K., Pfizer Japan Inc., and AbbVie GK. KW has received personal fees from Kissei Pharmaceutical Co., Ltd. KW has received personal fees and other from Olympus Corporation. Ken Takeuchi (KT) personal fees from EA Pharma Co., Ltd., and Kissei Pharmaceutical Co., Ltd. Nobuo Aoyama (NA) has received grants/personal fees from EA Pharma Co., Ltd. Hiroshi Nozawa Cover Letter (HN) has received grants/personal fees from EA Pharma Co., Ltd. Satoshi Motoya (SM) has received grants/personal fees from Eisai Co., Ltd., AbbVie GK, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., and Janssen Pharmaceutical K.K. Toshihide Ohmori (TO) has received grants/fees from EA Pharma Co., Ltd. Akio Harada (AH) has received grants/fees from EA Pharma Co., Ltd. Yushi Nagai (YN) has received other from EA Pharma Co., Ltd., and Kissei Pharmaceutical Co., Ltd. Takayuki Abe (TA) has received other from EA Pharma Co., Ltd., and Kissei Pharmaceutical Co., Ltd. Takanori Kanai (TK) has received research grants/advisory fees/lecture fees from Ajinomoto Co., Inc., Takeda Pharmaceuticals Co., Ltd., Bristol-Myers Squibb Company, and MSD K.K., research grants/advisory fees from EIDIA Co., Ltd., research grants and lecture fees from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Kyorin Pharmaceutical Co., Ltd., Pfizer Japan Inc., Yakult Honsha Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Zeria Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Astellas Pharma Inc., Mochida Pharmaceutical Co., Ltd., AstraZeneca Plc, Ono Pharmaceutical Co., Ltd., and EA Pharma Co., Ltd., grants from Eisai Co., Ltd., Biofermin Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co., Ltd., JIMRO Co., Ltd., Nippon Kayaku Co., Ltd., Daiichi Sankyo Co., Ltd., Tsumura & Co., Taiho Pharmaceutical Co., Ltd., Toray Industries, Inc., Toa Pharmaceuticals Co., Ltd., Mylan Pharmaceuticals Inc., Japan Blood Products Organization, Toa Shinyaku Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Smoking Research Foundation, Kyowa Hakko Kirin Co., Ltd., Asahi Kasei Medical Co., Ltd., FUJIFILM RI Pharma Co., Ltd., Thermo Fisher Scientific Inc., EN Otsuka Pharmaceutical Co., Ltd., Ezaki Glico Co., Ltd., RPM Co., Ltd., Yakult Bio-Science Foundation, and the Public Health Research Foundation, advisory fees from GlaxoSmithKline K.K., and lecture fees from ASKA Pharmaceutical Co., Ltd. Mamoru Watanabe (MW) has received grants/personal fees from Takeda Pharmaceutical Co., Ltd., Eisai Co., Ltd., Astellas Pharma Inc., Nippon Kayaku Co., Ltd., Mochida Pharmaceutical Co., Ltd., Pfizer Japan Inc., Kissei Pharmaceutical Co., Ltd. MW has received grants/personal fees and other from Mitsubishi Tanabe Pharma Corporation, Zeria Pharmaceutical Co., Ltd., EA Pharma Co., Ltd. MW has received grants from Kaken Pharmaceutical Co., Ltd., Alfresa Pharma Corporation, Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Ayumi Pharmaceutical Corporation, Miyarisan Pharmaceutical Co., Ltd. MW has received grants and other from MSD K.K. MW has received personal fees from Janssen Pharmaceutical K.K., Celltrion Healthcare Co., Ltd., Celgene K.K., Eli Lilly Japan K.K. MW has received personal fees and other from JIMRO Co., Ltd., Gilead Sciences, Inc. MW has received other from Asahi Kasei Medical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., AbbVie GK, Kyowa Hakko Kirin Co., Ltd., Toray Industries, Inc., Chugai Pharmaceutical Co., Ltd., and Fujirebio Inc. Yoji Yamada (YY) and Katsutoshi Inagaki (KI) are employees of EA Pharma Co., Ltd. Naoki Shimizu (NS) is employee of Kissei Pharmaceutical Co., Ltd. The commercial affiliations with Kissei Pharmaceutical Co., Ltd., and EA Pharma Co., Ltd., do not alter the adherence to PLOS ONE policies on sharing data and materials. The authors do not have any other competing interests in form of consultancy, patents, products in development, or marketed products, etc.

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Auteurs

Makoto Naganuma (M)

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
ORCID: 0000-0002-4244-3243

Fumihito Hirai (F)

Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.

Kiyonori Kobayashi (K)

Department of Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.

Kenji Watanabe (K)

Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan.
ORCID: 0000-0002-3781-4724

Ken Takeuchi (K)

Division of Gastroenterology and Hepatology, IBD Center, Tsujinaka Hospital Kashiwanoha, Chiba, Japan.

Nobuo Aoyama (N)

Gastrointestinal Endoscopy and Inflammatory Bowel Disease Center, Aoyama Medical Clinic, Hyogo, Japan.

Hiroshi Nozawa (H)

Matsushima Clinic, Kanagawa, Japan.

Satoshi Motoya (S)

IBD Center, Sapporo Kosei General Hospital, Hokkaido, Japan.

Toshihide Ohmori (T)

Ohmori Toshihide Gastro-Intestinal Clinic, Ageo, Japan.

Akio Harada (A)

Yokoyama Memorial Hospital, Nagoya, Japan.

Yushi Nagai (Y)

Data Management Office, Clinical and Translational Research Center, Keio University School of Medicine, Tokyo, Japan.
ORCID: 0000-0002-4477-9744

Takayuki Abe (T)

School of Data Science, Yokohama City University, Yokohama, Japan.
Keio University School of Medicine, Tokyo, Japan.

Yoji Yamada (Y)

Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.

Katsutoshi Inagaki (K)

Medical Science Group, Medical Department, EA Pharma Co., Ltd., Tokyo, Japan.

Naoki Shimizu (N)

Medical Research Department, Kissei Pharmaceutical Co., Ltd., Tokyo, Japan.

Takanori Kanai (T)

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.

Mamoru Watanabe (M)

TMDU Advanced Research Institute, Tokyo Medical and Dental University, Tokyo, Japan.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Middle-term prognosis in patients with...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-inflammatoires › Middle-term prognosis in patients with...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Prégnanes › Prégnènes › Prégnènediones › Budésonide › Middle-term prognosis in patients with...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies gastro-intestinales › Maladies intestinales › Maladies inflammatoires intestinales › Rectocolite hémorragique › Middle-term prognosis in patients with...
questionsmedicales.fr › Procédures de chirurgie opératoire › Interventions chirurgicales mini-invasives › Endoscopie › Middle-term prognosis in patients with...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Middle-term prognosis in patients with...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Middle-term prognosis in patients with...
questionsmedicales.fr › Diagnostic › Pronostic › Middle-term prognosis in patients with...
questionsmedicales.fr › Thérapeutique › Induction de rémission › Middle-term prognosis in patients with...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études rétrospectives › Middle-term prognosis in patients with...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Middle-term prognosis in patients with...