Laure Gossec1, Agnès Danré2, Bernard Combe3, Xavier Le Loët4, Jaques Tebib5, Jean Sibilia6, Xavier Mariette7, Maxime Dougados8. 1. Sorbonne universités, UPMC université Paris 06, 75005 Paris, France; Institut Pierre-Louis d'épidémiologie et de santé publique, 75646 Paris cedex 13, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 47-83, boulevard de l'Hôpital, 75013 Paris, France. Electronic address: laure.gossec@psl.aphp.fr. 2. Sorbonne universités, UPMC université Paris 06, 75005 Paris, France; Institut Pierre-Louis d'épidémiologie et de santé publique, 75646 Paris cedex 13, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 47-83, boulevard de l'Hôpital, 75013 Paris, France. 3. Montpellier I University, Lapeyronie University Hospital, UMR5535, 34295 Montpellier, France. 4. Inserm U905, Rouen University Hospital, 76031 Rouen, France. 5. Centre hospitalier Lyon Sud, 69495 Pierre-Benite, France. 6. Université de Strasbourg, hôpitaux universitaires de Strasbourg, 67000 Strasbourg, France. 7. Inserm U1012, université Paris-Sud 11, hôpital Bicêtre, AP-HP, 94270 Le Kremlin-Bicêtre, France. 8. Rheumatology B Department, Paris-Descartes University, Cochin Hospital, AP-HP, Paris, France.
Abstract
OBJECTIVE: Patient-reported outcomes (PROs) reflect treatment efficacy from the patients' perspective. The objective was to assess PROs improvement with rituximab in rheumatoid arthritis. METHODS:Patients with long-standing rheumatoid arthritis received rituximab 1000mg twice at 2 weeks interval, and were assessed over 6 months. PROs including physical PROs (pain, functional assessment, physical quality of life) and mental or mixed aspects (fatigue, sleep and mental quality of life) were assessed. Standardized response means were calculated. Early improvement in PROs was used to predict EULAR response at 6 months. RESULTS: For the 175 patients (mean age 54.6±10.6 years, mean disease duration 12.9±9.3 years), the plateau of efficacy of rituximab on PROs was reached at week 12, and the effect was more prominent on physical PROs (e.g., pain standardized response means -0.75 [95% confidence interval -0.91; -0.60]), than on sleep (-0.43; [-0.56; -0.29]). It was not possible to accurately predict 6-month EULAR response by early improvement in PROs. CONCLUSION:Rituximab was effective on PROs with an early effect. PROs reflecting physical aspects were more modulated by this biologic than other PROs (fatigue, sleep or mental quality of life). Links between sleep difficulties, fatigue and RA should be further studied.
RCT Entities:
OBJECTIVE:Patient-reported outcomes (PROs) reflect treatment efficacy from the patients' perspective. The objective was to assess PROs improvement with rituximab in rheumatoid arthritis. METHODS:Patients with long-standing rheumatoid arthritis received rituximab 1000mg twice at 2 weeks interval, and were assessed over 6 months. PROs including physical PROs (pain, functional assessment, physical quality of life) and mental or mixed aspects (fatigue, sleep and mental quality of life) were assessed. Standardized response means were calculated. Early improvement in PROs was used to predict EULAR response at 6 months. RESULTS: For the 175 patients (mean age 54.6±10.6 years, mean disease duration 12.9±9.3 years), the plateau of efficacy of rituximab on PROs was reached at week 12, and the effect was more prominent on physical PROs (e.g., pain standardized response means -0.75 [95% confidence interval -0.91; -0.60]), than on sleep (-0.43; [-0.56; -0.29]). It was not possible to accurately predict 6-month EULAR response by early improvement in PROs. CONCLUSION:Rituximab was effective on PROs with an early effect. PROs reflecting physical aspects were more modulated by this biologic than other PROs (fatigue, sleep or mental quality of life). Links between sleep difficulties, fatigue and RA should be further studied.
Authors: Leslie R Harrold; Ani John; Jennie Best; Steve Zlotnick; Chitra Karki; YouFu Li; Jeffrey D Greenberg; Joel M Kremer Journal: Clin Rheumatol Date: 2017-07-17 Impact factor: 2.980
Authors: Jose Antonio Pereira da Silva; Laure Gossec; Catia Duarte; Eduardo José Ferreira Santos; Ricardo J O Ferreira; Tore K Kvien; Maxime Dougados; Maarten de Wit Journal: RMD Open Date: 2021-02