A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease

Jürgen Schölmerich; Klaus Fellermann; Frank W Seibold; Gerhard Rogler; Jost Langhorst; Stefanie Howaldt; Gottfried Novacek; Andreas Munk Petersen; Oliver Bachmann; Harald Matthes; Norbert Hesselbarth; Niels Teich; Jan Wehkamp; Jochen Klaus; Claudia Ott; Karin Dilger; Roland Greinwald; Ralph Mueller; International TRUST-2 Study Group

doi:10.1093/ecco-jcc/jjw184

A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease

Jürgen Schölmerich, Klaus Fellermann, Frank W Seibold, Gerhard Rogler, Jost Langhorst, Stefanie Howaldt, Gottfried Novacek, Andreas Munk Petersen, Oliver Bachmann, Harald Matthes, Norbert Hesselbarth, Niels Teich, Jan Wehkamp, Jochen Klaus, Claudia Ott, Karin Dilger, Roland Greinwald, Ralph Mueller, International TRUST-2 Study Group

Institut for Klinisk Medicin

37 Citationer (Scopus)

151 Downloads (Pure)

Abstract

Background and Aims: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease [CD]. Methods: Adults with active CD [n = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks' follow-up. Primary endpoint was the rate of clinical remission [Crohn's Disease Activity Index [CDAI] < 150] at end of treatment, ie at Week 12 or withdrawal. Secondary endpoints included the course of clinical remission, rate of clinical response, change in CDAI, change in markers of inflammation, mucosal healing, and Physician's Global Assessment. Results: Clinical remission at Week 12 occurred in 38.5%, 35.2%, and 47.2% of TSO 250, TSO 2500, and TSO 7500 patients, respectively, and in 42.9% of placebo recipients. TSO induced a dosedependent immunological response. There was no response regarding laboratory markers of inflammation. Other secondary efficacy variables also showed no advantage of TSO over placebo for treatment of active CD. Administration of TSO did not result in any serious adverse drug reaction. Review of non-serious suspected adverse drug reactions following TSO did not reveal any safety concerns. Conclusions: Administration of 250-7500 TSO fortnightly over 12 weeks was safe and showed a dose-dependent immunological response, but no TSO dose showed a clinically relevant effect over placebo for induction of clinical remission or response in mildly-to-moderately active, ileocolonic CD.

Originalsprog	Engelsk
Tidsskrift	Journal of Crohn's and Colitis
Vol/bind	11
Udgave nummer	4
Sider (fra-til)	390-399
Antal sider	10
ISSN	1873-9946
DOI	https://doi.org/10.1093/ecco-jcc/jjw184
Status	Udgivet - 1 apr. 2017

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10.1093/ecco-jcc/jjw184Licens: CC BY-NC

documentForlagets udgivne version, 393 KBLicens: CC BY-NC

Citationsformater

Schölmerich, J., Fellermann, K., Seibold, F. W., Rogler, G., Langhorst, J., Howaldt, S., Novacek, G., Petersen, A. M., Bachmann, O., Matthes, H., Hesselbarth, N., Teich, N., Wehkamp, J., Klaus, J., Ott, C., Dilger, K., Greinwald, R., Mueller, R., & International TRUST-2 Study Group (2017). A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease. Journal of Crohn's and Colitis, 11(4), 390-399. https://doi.org/10.1093/ecco-jcc/jjw184

Schölmerich, J, Fellermann, K, Seibold, FW, Rogler, G, Langhorst, J, Howaldt, S, Novacek, G, Petersen, AM, Bachmann, O, Matthes, H, Hesselbarth, N, Teich, N, Wehkamp, J, Klaus, J, Ott, C, Dilger, K, Greinwald, R, Mueller, R & International TRUST-2 Study Group 2017, 'A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease', Journal of Crohn's and Colitis, bind 11, nr. 4, s. 390-399. https://doi.org/10.1093/ecco-jcc/jjw184

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T1 - A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease

AU - Schölmerich, Jürgen

AU - Fellermann, Klaus

AU - Seibold, Frank W

AU - Rogler, Gerhard

AU - Langhorst, Jost

AU - Howaldt, Stefanie

AU - Novacek, Gottfried

AU - Petersen, Andreas Munk

AU - Bachmann, Oliver

AU - Matthes, Harald

AU - Hesselbarth, Norbert

AU - Teich, Niels

AU - Wehkamp, Jan

AU - Klaus, Jochen

AU - Ott, Claudia

AU - Dilger, Karin

AU - Greinwald, Roland

AU - Mueller, Ralph

AU - International TRUST-2 Study Group

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Background and Aims: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease [CD]. Methods: Adults with active CD [n = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks' follow-up. Primary endpoint was the rate of clinical remission [Crohn's Disease Activity Index [CDAI] < 150] at end of treatment, ie at Week 12 or withdrawal. Secondary endpoints included the course of clinical remission, rate of clinical response, change in CDAI, change in markers of inflammation, mucosal healing, and Physician's Global Assessment. Results: Clinical remission at Week 12 occurred in 38.5%, 35.2%, and 47.2% of TSO 250, TSO 2500, and TSO 7500 patients, respectively, and in 42.9% of placebo recipients. TSO induced a dosedependent immunological response. There was no response regarding laboratory markers of inflammation. Other secondary efficacy variables also showed no advantage of TSO over placebo for treatment of active CD. Administration of TSO did not result in any serious adverse drug reaction. Review of non-serious suspected adverse drug reactions following TSO did not reveal any safety concerns. Conclusions: Administration of 250-7500 TSO fortnightly over 12 weeks was safe and showed a dose-dependent immunological response, but no TSO dose showed a clinically relevant effect over placebo for induction of clinical remission or response in mildly-to-moderately active, ileocolonic CD.

AB - Background and Aims: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease [CD]. Methods: Adults with active CD [n = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks' follow-up. Primary endpoint was the rate of clinical remission [Crohn's Disease Activity Index [CDAI] < 150] at end of treatment, ie at Week 12 or withdrawal. Secondary endpoints included the course of clinical remission, rate of clinical response, change in CDAI, change in markers of inflammation, mucosal healing, and Physician's Global Assessment. Results: Clinical remission at Week 12 occurred in 38.5%, 35.2%, and 47.2% of TSO 250, TSO 2500, and TSO 7500 patients, respectively, and in 42.9% of placebo recipients. TSO induced a dosedependent immunological response. There was no response regarding laboratory markers of inflammation. Other secondary efficacy variables also showed no advantage of TSO over placebo for treatment of active CD. Administration of TSO did not result in any serious adverse drug reaction. Review of non-serious suspected adverse drug reactions following TSO did not reveal any safety concerns. Conclusions: Administration of 250-7500 TSO fortnightly over 12 weeks was safe and showed a dose-dependent immunological response, but no TSO dose showed a clinically relevant effect over placebo for induction of clinical remission or response in mildly-to-moderately active, ileocolonic CD.

KW - Journal Article

U2 - 10.1093/ecco-jcc/jjw184

DO - 10.1093/ecco-jcc/jjw184

M3 - Journal article

C2 - 27707789

SN - 1873-9946

VL - 11

SP - 390

EP - 399

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

IS - 4

ER -

A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease

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