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Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial

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Harvard

Kragsnaes, MS, Kjeldsen, J, Horn, HC, Munk, HL, Pedersen, JK, Just, SA, Ahlquist, P, Pedersen, FM, de Wit, M, Möller, S, Andersen, V, Kristiansen, K, Kinggaard Holm, D, Holt, HM, Christensen, R & Ellingsen, T 2021, 'Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial', Annals of the Rheumatic Diseases, bind 80, nr. 9, s. 1158-1167. https://doi.org/10.1136/annrheumdis-2020-219511

APA

Kragsnaes, M. S., Kjeldsen, J., Horn, H. C., Munk, H. L., Pedersen, J. K., Just, S. A., Ahlquist, P., Pedersen, F. M., de Wit, M., Möller, S., Andersen, V., Kristiansen, K., Kinggaard Holm, D., Holt, H. M., Christensen, R., & Ellingsen, T. (2021). Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial. Annals of the Rheumatic Diseases, 80(9), 1158-1167. https://doi.org/10.1136/annrheumdis-2020-219511

CBE

Kragsnaes MS, Kjeldsen J, Horn HC, Munk HL, Pedersen JK, Just SA, Ahlquist P, Pedersen FM, de Wit M, Möller S, Andersen V, Kristiansen K, Kinggaard Holm D, Holt HM, Christensen R, Ellingsen T. 2021. Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial. Annals of the Rheumatic Diseases. 80(9):1158-1167. https://doi.org/10.1136/annrheumdis-2020-219511

MLA

Vancouver

Author

Kragsnaes, Maja Skov ; Kjeldsen, Jens ; Horn, Hans Christian ; Munk, Heidi Lausten ; Pedersen, Jens Kristian ; Just, Søren Andreas ; Ahlquist, Palle ; Pedersen, Finn Moeller ; de Wit, Maarten ; Möller, Sören ; Andersen, Vibeke ; Kristiansen, Karsten ; Kinggaard Holm, Dorte ; Holt, Hanne Marie ; Christensen, Robin ; Ellingsen, Torkell. / Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis : an exploratory randomised placebo-controlled trial. I: Annals of the Rheumatic Diseases. 2021 ; Bind 80, Nr. 9. s. 1158-1167.

Bibtex

@article{dfb025b68f574185b9c56501c7abc63c,
title = "Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial",
abstract = "OBJECTIVES: Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA).METHODS: In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.RESULTS: Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)).CONCLUSIONS: In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA.TRIAL REGISTRATION NUMBER: NCT03058900.",
keywords = "arthritis, inflammation, psoriatic, therapeutics",
author = "Kragsnaes, {Maja Skov} and Jens Kjeldsen and Horn, {Hans Christian} and Munk, {Heidi Lausten} and Pedersen, {Jens Kristian} and Just, {S{\o}ren Andreas} and Palle Ahlquist and Pedersen, {Finn Moeller} and {de Wit}, Maarten and S{\"o}ren M{\"o}ller and Vibeke Andersen and Karsten Kristiansen and {Kinggaard Holm}, Dorte and Holt, {Hanne Marie} and Robin Christensen and Torkell Ellingsen",
note = "{\textcopyright} Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2021",
month = sep,
doi = "10.1136/annrheumdis-2020-219511",
language = "English",
volume = "80",
pages = "1158--1167",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "B M J Group",
number = "9",

}

RIS

TY - JOUR

T1 - Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis

T2 - an exploratory randomised placebo-controlled trial

AU - Kragsnaes, Maja Skov

AU - Kjeldsen, Jens

AU - Horn, Hans Christian

AU - Munk, Heidi Lausten

AU - Pedersen, Jens Kristian

AU - Just, Søren Andreas

AU - Ahlquist, Palle

AU - Pedersen, Finn Moeller

AU - de Wit, Maarten

AU - Möller, Sören

AU - Andersen, Vibeke

AU - Kristiansen, Karsten

AU - Kinggaard Holm, Dorte

AU - Holt, Hanne Marie

AU - Christensen, Robin

AU - Ellingsen, Torkell

N1 - © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/9

Y1 - 2021/9

N2 - OBJECTIVES: Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA).METHODS: In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.RESULTS: Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)).CONCLUSIONS: In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA.TRIAL REGISTRATION NUMBER: NCT03058900.

AB - OBJECTIVES: Although causality remains to be established, targeting dysbiosis of the intestinal microbiota by faecal microbiota transplantation (FMT) has been proposed as a novel treatment for inflammatory diseases. In this exploratory, proof-of-concept study, we evaluated the safety and efficacy of FMT in psoriatic arthritis (PsA).METHODS: In this double-blind, parallel-group, placebo-controlled, superiority trial, we randomly allocated (1:1) adults with active peripheral PsA (≥3 swollen joints) despite ongoing treatment with methotrexate to one gastroscopic-guided FMT or sham transplantation into the duodenum. Safety was monitored throughout the trial. The primary efficacy endpoint was the proportion of participants experiencing treatment failure (ie, needing treatment intensification) through 26 weeks. Key secondary endpoints were change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.RESULTS: Of 97 screened, 31 (32%) underwent randomisation (15 allocated to FMT) and 30 (97%) completed the 26-week clinical evaluation. No serious adverse events were observed. Treatment failure occurred more frequently in the FMT group than in the sham group (9 (60%) vs 3 (19%); risk ratio, 3.20; 95% CI 1.06 to 9.62; p=0.018). Improvement in HAQ-DI differed between groups (0.07 vs 0.30) by 0.23 points (95% CI 0.02 to 0.44; p=0.031) in favour of sham. There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)).CONCLUSIONS: In this first preliminary, interventional randomised controlled trial of FMT in immune-mediated arthritis, we did not observe any serious adverse events. Overall, FMT appeared to be inferior to sham in treating active peripheral PsA.TRIAL REGISTRATION NUMBER: NCT03058900.

KW - arthritis

KW - inflammation

KW - psoriatic

KW - therapeutics

UR - http://www.scopus.com/inward/record.url?scp=85105752748&partnerID=8YFLogxK

U2 - 10.1136/annrheumdis-2020-219511

DO - 10.1136/annrheumdis-2020-219511

M3 - Journal article

C2 - 33926922

VL - 80

SP - 1158

EP - 1167

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 9

ER -

ID: 67395679