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Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life

Gregory Pugnet 1, 2, 3 Christian Pagnoux 3 Benjamin Terrier 4, 3 Elodie Perrodeau 5, 6 Xavier Puéchal 3 Alexandre Karras 7 Chahéra Khouatra Olivier Aumaître 8 Pascal Cohen 3 François Maurier 9 Olivier Decaux 10 Jacques Ninet 11 Pierre Gobert Thomas Quemeneur 12 Claire Blanchard-Delaunay Pascal Godmer Pierre-Louis Carron Pierre-Yves Hatron 13 Nicolas Limal Mohamed Hamidou 14 Maïzé Ducret Eric Daugas 15 Thomas Papo 16 Bernard Bonnotte 17 Alfred Mahr 18 Philippe Ravaud 6 Luc Mouthon 3 Loïc Guillevin 3
Abstract : OBJECTIVES: To investigate the effects on health-related quality of life (HRQOL) and functional capability of rituximab vs azathioprine for ANCA-associated vasculitis (AAV) maintenance therapy. METHODS: In a 24-month phase III randomised-controlled trial, 115 patients over time received rituximab or azathioprine for AAV maintenance therapy. Mean changes of 36-item Short-form Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) scores from baseline were analysed. RESULTS: Mean improvements of HAQ scores, from baseline to month 24 were significantly better for the rituximab (0.16 points lower) than the azathioprine group (p=0.038). As demonstrated by SF-36, study patients' baseline HRQOL was significantly impaired compared with age- and sex-matched US norms. At month 24, mean changes from baseline of SF-36 physical component score tended to be better for the rituximab group (+3.95 points, p=0.067) whereas mean changes from baseline of the SF-36 mental component score were significantly better for the azathioprine group (+4.23 points, p=0.041). CONCLUSIONS: Azathioprine-treated patients' for AAV maintenance therapy showed a decline in physical abilities when compared to RTX at M24 in the MAINRITSAN trial. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01302407
Contributor : Laurent Jonchère <>
Submitted on : Thursday, April 14, 2016 - 11:21:41 AM
Last modification on : Wednesday, August 19, 2020 - 11:18:09 AM

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  • HAL Id : hal-01302407, version 1
  • PUBMED : 27049404

Citation

Gregory Pugnet, Christian Pagnoux, Benjamin Terrier, Elodie Perrodeau, Xavier Puéchal, et al.. Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life. Clinical and experimental rheumatology, Clinical and Experimental Rheumatology Sas, 2016, 34 (3), pp.S 54-59. ⟨hal-01302407⟩

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