title: Trichuris suis ova therapy 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.
authors.affiliation: Danish Multiple Sclerosis Center, Copenhagen University Hospital, Denmark.
authors.forename: A
authors.initials: A
authors.lastname: Voldsgaard
authors.affiliation: Department of Epidemiology Research, Statens Serum Institut, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Bager
authors.affiliation: Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Denmark.
authors.forename: E
authors.initials: E
authors.lastname: Garde
authors.affiliation: Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Åkeson
authors.affiliation: Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Denmark.
authors.forename: A M
authors.initials: AM
authors.lastname: Leffers
authors.affiliation: Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Denmark.
authors.forename: C G
authors.initials: CG
authors.lastname: Madsen
authors.affiliation: Faculty of Life Sciences, University of Copenhagen, Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Kapel
authors.affiliation: Faculty of Life Sciences, University of Copenhagen, Denmark/Deceased.
authors.forename: A
authors.initials: A
authors.lastname: Roepstorff
authors.affiliation: Faculty of Life Sciences, University of Copenhagen, Denmark.
authors.forename: S M
authors.initials: SM
authors.lastname: Thamsborg
authors.affiliation: Department of Epidemiology Research, Statens Serum Institut, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Melbye
authors.affiliation: Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Siebner
authors.affiliation: Danish Multiple Sclerosis Center, Copenhagen University Hospital, Denmark.
authors.forename: H B
authors.initials: HB
authors.lastname: Søndergaard
authors.affiliation: Danish Multiple Sclerosis Center, Copenhagen University Hospital, Denmark.
authors.forename: F
authors.initials: F
authors.lastname: Sellebjerg
authors.affiliation: Danish Multiple Sclerosis Center, Copenhagen University Hospital, Denmark pss@rh.dk.
authors.forename: P Soelberg
authors.initials: PS
authors.lastname: Sørensen
mesh_terms: D000328:Adult; D000818:Animals; D018450:Disease Progression; D004802:Eosinophilia / Q000469:parasitology; D005260:Female; D041981:Gastrointestinal Tract / Q000469:parasitology; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000276:immunology / Q000628:therapy*; D012008:Recurrence; D061147:Therapy with Helminths / Q000009:adverse effects* / Q000379:methods*; D014258:Trichuris / Q000276:immunology*; D055815:Young Adult
keywords: MRI; TSO; Trichuris suis ova; helminths; multiple sclerosis; safety