Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

Stephan Miehlke; Daniela Aust; Emese Mihaly; Peter Armerding; Günther Böhm; Ole Bonderup; Fernando Fernández-Bañares; Juozas Kupcinskas; Lars Kristian Munck; Kai Uwe Rehbehn; Tanju Nacak; Roland Greinwald; Andreas Münch; BUG-1/LMC Study Group

doi:10.1053/j.gastro.2018.08.042

Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

Stephan Miehlke, Daniela Aust, Emese Mihaly, Peter Armerding, Günther Böhm, Ole Bonderup, Fernando Fernández-Bañares, Juozas Kupcinskas, Lars Kristian Munck, Kai Uwe Rehbehn, Tanju Nacak, Roland Greinwald, Andreas Münch, BUG-1/LMC Study Group

Institut for Klinisk Medicin

17 Citationer (Scopus)

Abstract

Background & Aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis. Methods: Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8. Results: The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P =.01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P =.09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P =.02) or placebo (21%; P =.008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group. Conclusions: In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.

Originalsprog	Engelsk
Tidsskrift	Gastroenterology
Vol/bind	155
Udgave nummer	6
Sider (fra-til)	1795-1804.e3
ISSN	0016-5085
DOI	https://doi.org/10.1053/j.gastro.2018.08.042
Status	Udgivet - 2018

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10.1053/j.gastro.2018.08.042

http://www.gastrojournal.org/article/S001650851834931X/pdfLicens: CC BY-NC-ND

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Miehlke, S., Aust, D., Mihaly, E., Armerding, P., Böhm, G., Bonderup, O., Fernández-Bañares, F., Kupcinskas, J., Munck, L. K., Rehbehn, K. U., Nacak, T., Greinwald, R., Münch, A., & BUG-1/LMC Study Group (2018). Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis. Gastroenterology, 155(6), 1795-1804.e3. https://doi.org/10.1053/j.gastro.2018.08.042

Miehlke, S, Aust, D, Mihaly, E, Armerding, P, Böhm, G, Bonderup, O, Fernández-Bañares, F, Kupcinskas, J, Munck, LK, Rehbehn, KU, Nacak, T, Greinwald, R, Münch, A & BUG-1/LMC Study Group 2018, 'Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis', Gastroenterology, bind 155, nr. 6, s. 1795-1804.e3. https://doi.org/10.1053/j.gastro.2018.08.042

@article{e6e29d93a2bd4f47b59f1e9b4fcbfec8,

title = "Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis",

abstract = "Background & Aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis. Methods: Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8. Results: The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P =.01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P =.09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P =.02) or placebo (21%; P =.008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group. Conclusions: In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.",

keywords = "5-Aminosalicylic Acid, Corticosteroid, Intraepithelial Lymphocytes, Microscopic Colitis",

author = "Stephan Miehlke and Daniela Aust and Emese Mihaly and Peter Armerding and G{\"u}nther B{\"o}hm and Ole Bonderup and Fernando Fern{\'a}ndez-Ba{\~n}ares and Juozas Kupcinskas and Munck, {Lars Kristian} and Rehbehn, {Kai Uwe} and Tanju Nacak and Roland Greinwald and Andreas M{\"u}nch and {BUG-1/LMC Study Group}",

year = "2018",

doi = "10.1053/j.gastro.2018.08.042",

language = "English",

volume = "155",

pages = "1795--1804.e3",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "Elsevier",

number = "6",

}

TY - JOUR

T1 - Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

AU - Miehlke, Stephan

AU - Aust, Daniela

AU - Mihaly, Emese

AU - Armerding, Peter

AU - Böhm, Günther

AU - Bonderup, Ole

AU - Fernández-Bañares, Fernando

AU - Kupcinskas, Juozas

AU - Munck, Lars Kristian

AU - Rehbehn, Kai Uwe

AU - Nacak, Tanju

AU - Greinwald, Roland

AU - Münch, Andreas

AU - BUG-1/LMC Study Group

PY - 2018

Y1 - 2018

N2 - Background & Aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis. Methods: Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8. Results: The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P =.01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P =.09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P =.02) or placebo (21%; P =.008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group. Conclusions: In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.

AB - Background & Aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis. Methods: Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8. Results: The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P =.01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P =.09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P =.02) or placebo (21%; P =.008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group. Conclusions: In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.

KW - 5-Aminosalicylic Acid

KW - Corticosteroid

KW - Intraepithelial Lymphocytes

KW - Microscopic Colitis

U2 - 10.1053/j.gastro.2018.08.042

DO - 10.1053/j.gastro.2018.08.042

M3 - Journal article

C2 - 30195447

AN - SCOPUS:85057561240

SN - 0016-5085

VL - 155

SP - 1795-1804.e3

JO - Gastroenterology

JF - Gastroenterology

IS - 6

ER -

Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

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