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)

1 Service Médecine Interne et immunologie clinique [CHU Toulouse]
2 Service Médecine interne et immunopathologie clinique [CHU Toulouse]
3 Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
4 DHU - I2B - Departement Hospitalo- Universitaire - Inflammation, Immunopathologie, Biothérapie [Paris]
5 CRESS - U1153 - Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques
6 CRESS (U1153 / UMR_A_1125 / UMR_S_1153) - Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité
7 Service de Néphrologie et Hémodialyse [CHU HEGP]
8 Service de Médecine Interne [CHU Clermont-Ferrand]
9 Service de médecine interne
10 IGDR - Institut de Génétique et Développement de Rennes
11 Service de Médecine Interne
12 VALENCIENNES - Med Int - Département de Médecine Interne
13 Service de médecine interne [Lille]
14 Service de médecine interne [Nantes]
15 Immunopathologie rénale, récepteurs et inflammation
16 Hôpital Bichat - Claude Bernard
17 LNC - Lipides - Nutrition - Cancer (U866)
18 Hôpital Saint-Louis

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

Domains: Life Sciences [q-bio]

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, 2016, 34 (3), pp.S 54-59. ⟨hal-01302407⟩