Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect

A. Voldsgaard; P. Bager; E. Garde; P. Åkeson; A.M. Leffers; C.G. Madsen; Christian Moliin Outzen Kapel; Stig Milan Thamsborg; Allan Knud Roepstorff; M. Melbye; Hartwig Roman Siebner; H.B. Søndergaard; F. Sellebjerg; Per Soelberg Sørensen

doi:10.1177/1352458514568173

Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect

A. Voldsgaard, P. Bager, E. Garde, P. Åkeson, A.M. Leffers, C.G. Madsen, Christian Moliin Outzen Kapel, Stig Milan Thamsborg, Allan Knud Roepstorff, M. Melbye, Hartwig Roman Siebner, H.B. Søndergaard, F. Sellebjerg, Per Soelberg Sørensen

40 Citations (Scopus)

Abstract

BACKGROUND: An observational study has suggested that relapsing-remitting multiple sclerosis patients with helminth infections have lower disease activity and progression than uninfected multiple sclerosis patients.

OBJECTIVE: To evaluate the safety and efficacy on MRI activity of treatment with TSO in relapsing MS.

METHODS: The study was an open-label, magnetic resonance imaging assessor-blinded, baseline-to-treatment study including ten patients with relapsing forms of multiple sclerosis. Median (range) age was 41 (24-55) years, disease duration 9 (4-34) years, Expanded Disability Status Scale score 2.5 (1-5.0), and number of relapses within the last two years 3 (2-5). Four patients received no disease modifying therapy, while six patients received IFN-β. After an observational period of 8 weeks, patients received 2500 ova from the helminth Trichuris suis orally every second week for 12 weeks. Patients were followed with serial magnetic resonance imaging, neurological examinations, laboratory safety tests and expression of immunological biomarker genes.

RESULTS: Treatment with Trichuris suis orally was well-tolerated apart from some gastrointestinal symptoms. Magnetic resonance imaging revealed 6 new or enlarged T2 lesions in the run-in period, 7 lesions in the early period and 21 lesions in the late treatment period. Two patients suffered a relapse before treatment and two during treatment. Eight patients developed eosinophilia. The expression of cytokines and transcription factors did not change.

CONCLUSIONS: In a small group of relapsing multiple sclerosis patients, Trichuris suis oral therapy was well tolerated but without beneficial effect.

Original language	English
Journal	Multiple Sclerosis Journal
Volume	21
Issue number	13
Number of pages	7
ISSN	1352-4585
DOIs	https://doi.org/10.1177/1352458514568173
Publication status	Published - 1 Nov 2015

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Voldsgaard, A., Bager, P., Garde, E., Åkeson, P., Leffers, A. M., Madsen, C. G., Kapel, C. M. O., Thamsborg, S. M., Roepstorff, A. K., Melbye, M., Siebner, H. R., Søndergaard, H. B., Sellebjerg, F., & Sørensen, P. S. (2015). Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect. Multiple Sclerosis Journal, 21(13). https://doi.org/10.1177/1352458514568173

Voldsgaard, A, Bager, P, Garde, E, Åkeson, P, Leffers, AM, Madsen, CG, Kapel, CMO , Thamsborg, SM, Roepstorff, AK, Melbye, M, Siebner, HR, Søndergaard, HB, Sellebjerg, F & Sørensen, PS 2015, 'Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect', Multiple Sclerosis Journal, vol. 21, no. 13. https://doi.org/10.1177/1352458514568173

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title = "Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect",

abstract = "BACKGROUND: An observational study has suggested that relapsing-remitting multiple sclerosis patients with helminth infections have lower disease activity and progression than uninfected multiple sclerosis patients.OBJECTIVE: To evaluate the safety and efficacy on MRI activity of treatment with TSO in relapsing MS.METHODS: The study was an open-label, magnetic resonance imaging assessor-blinded, baseline-to-treatment study including ten patients with relapsing forms of multiple sclerosis. Median (range) age was 41 (24-55) years, disease duration 9 (4-34) years, Expanded Disability Status Scale score 2.5 (1-5.0), and number of relapses within the last two years 3 (2-5). Four patients received no disease modifying therapy, while six patients received IFN-β. After an observational period of 8 weeks, patients received 2500 ova from the helminth Trichuris suis orally every second week for 12 weeks. Patients were followed with serial magnetic resonance imaging, neurological examinations, laboratory safety tests and expression of immunological biomarker genes.RESULTS: Treatment with Trichuris suis orally was well-tolerated apart from some gastrointestinal symptoms. Magnetic resonance imaging revealed 6 new or enlarged T2 lesions in the run-in period, 7 lesions in the early period and 21 lesions in the late treatment period. Two patients suffered a relapse before treatment and two during treatment. Eight patients developed eosinophilia. The expression of cytokines and transcription factors did not change.CONCLUSIONS: In a small group of relapsing multiple sclerosis patients, Trichuris suis oral therapy was well tolerated but without beneficial effect.",

author = "A. Voldsgaard and P. Bager and E. Garde and P. {\AA}keson and A.M. Leffers and C.G. Madsen and Kapel, {Christian Moliin Outzen} and Thamsborg, {Stig Milan} and Roepstorff, {Allan Knud} and M. Melbye and Siebner, {Hartwig Roman} and H.B. S{\o}ndergaard and F. Sellebjerg and S{\o}rensen, {Per Soelberg}",

year = "2015",

month = nov,

day = "1",

doi = "10.1177/1352458514568173",

language = "English",

volume = "21",

journal = "Multiple Sclerosis Journal",

issn = "1352-4585",

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TY - JOUR

T1 - Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect

AU - Voldsgaard, A.

AU - Bager, P.

AU - Garde, E.

AU - Åkeson, P.

AU - Leffers, A.M.

AU - Madsen, C.G.

AU - Kapel, Christian Moliin Outzen

AU - Thamsborg, Stig Milan

AU - Roepstorff, Allan Knud

AU - Melbye, M.

AU - Siebner, Hartwig Roman

AU - Søndergaard, H.B.

AU - Sellebjerg, F.

AU - Sørensen, Per Soelberg

PY - 2015/11/1

Y1 - 2015/11/1

N2 - BACKGROUND: An observational study has suggested that relapsing-remitting multiple sclerosis patients with helminth infections have lower disease activity and progression than uninfected multiple sclerosis patients.OBJECTIVE: To evaluate the safety and efficacy on MRI activity of treatment with TSO in relapsing MS.METHODS: The study was an open-label, magnetic resonance imaging assessor-blinded, baseline-to-treatment study including ten patients with relapsing forms of multiple sclerosis. Median (range) age was 41 (24-55) years, disease duration 9 (4-34) years, Expanded Disability Status Scale score 2.5 (1-5.0), and number of relapses within the last two years 3 (2-5). Four patients received no disease modifying therapy, while six patients received IFN-β. After an observational period of 8 weeks, patients received 2500 ova from the helminth Trichuris suis orally every second week for 12 weeks. Patients were followed with serial magnetic resonance imaging, neurological examinations, laboratory safety tests and expression of immunological biomarker genes.RESULTS: Treatment with Trichuris suis orally was well-tolerated apart from some gastrointestinal symptoms. Magnetic resonance imaging revealed 6 new or enlarged T2 lesions in the run-in period, 7 lesions in the early period and 21 lesions in the late treatment period. Two patients suffered a relapse before treatment and two during treatment. Eight patients developed eosinophilia. The expression of cytokines and transcription factors did not change.CONCLUSIONS: In a small group of relapsing multiple sclerosis patients, Trichuris suis oral therapy was well tolerated but without beneficial effect.

AB - BACKGROUND: An observational study has suggested that relapsing-remitting multiple sclerosis patients with helminth infections have lower disease activity and progression than uninfected multiple sclerosis patients.OBJECTIVE: To evaluate the safety and efficacy on MRI activity of treatment with TSO in relapsing MS.METHODS: The study was an open-label, magnetic resonance imaging assessor-blinded, baseline-to-treatment study including ten patients with relapsing forms of multiple sclerosis. Median (range) age was 41 (24-55) years, disease duration 9 (4-34) years, Expanded Disability Status Scale score 2.5 (1-5.0), and number of relapses within the last two years 3 (2-5). Four patients received no disease modifying therapy, while six patients received IFN-β. After an observational period of 8 weeks, patients received 2500 ova from the helminth Trichuris suis orally every second week for 12 weeks. Patients were followed with serial magnetic resonance imaging, neurological examinations, laboratory safety tests and expression of immunological biomarker genes.RESULTS: Treatment with Trichuris suis orally was well-tolerated apart from some gastrointestinal symptoms. Magnetic resonance imaging revealed 6 new or enlarged T2 lesions in the run-in period, 7 lesions in the early period and 21 lesions in the late treatment period. Two patients suffered a relapse before treatment and two during treatment. Eight patients developed eosinophilia. The expression of cytokines and transcription factors did not change.CONCLUSIONS: In a small group of relapsing multiple sclerosis patients, Trichuris suis oral therapy was well tolerated but without beneficial effect.

U2 - 10.1177/1352458514568173

DO - 10.1177/1352458514568173

M3 - Journal article

C2 - 25698173

SN - 1352-4585

VL - 21

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

IS - 13

ER -

Trichurs suis ova theraphy in relapsing multiple sclerosis is safe but without signals of beneficial effect

Abstract

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