1. Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study
- Author
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Alain, Saraux, Christophe, Hudry, Elena, Zinovieva, Hélène, Herman-Demars, Stephanie, Werner-Leyval, Michel, Geneviève, Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Institut rhumatologique de Paris 8, Département Médical [Paris] (Nordic Pharma SAS), Nordic Pharma SAS [Paris], Nordic Pharma SAS., Self-I Investigators group : Aouadi L, Arif A, Arty-Hue H, Banal F, Banse C, Baron JJ, Basch A, Berton V, Bitar S, Cantagrel A, Cayla P, Combe B, Cornaille-Lafage G, Duplantier D, Dellaroli ME, Ferrazzi V, Flipo RM, Fulpin J, Gardiol JC, Guilyardi C, Hacene A, Hudry C, Jarrige D, Jourdan M, Laillet H, Lamer F, Lassoued S, Lupo-Mattatia G, Marzynski E, Melac-Ducamp S, Monod P, Naim C, Negrier-Chassaing I, Ngasseu P, Plat D, Prothery D, Roch-Bras F, Saraux A, Schaeverbeke T, Sebaa K, Senbel E, Soubrier M, Sourisseau-Diverres G, Soutif D, Straus C, Tauveron P, Timsit MA, Vedere V, Viu P, Werner-Leyval S., Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Medical Department Nordic Pharma, Paris
- Subjects
medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,[SDV.IMM] Life Sciences [q-bio]/Immunology ,[SDV]Life Sciences [q-bio] ,Satisfaction ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,Rheumatology ,Quality of life ,Auto-injector ,Internal medicine ,medicine ,Immunology and Allergy ,030212 general & internal medicine ,Rheumatoid arthritis ,skin and connective tissue diseases ,ComputingMilieux_MISCELLANEOUS ,Syringe ,Original Research ,030203 arthritis & rheumatology ,Group study ,business.industry ,medicine.disease ,Auto-Injector ,3. Good health ,[SDV] Life Sciences [q-bio] ,Methotrexate ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,lcsh:RC925-935 ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,Compliance ,medicine.drug - Abstract
INTRODUCTION:The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA).METHODS:We conducted a randomized, open-label, parallel group study comparing AI to pre-filled syringe (PFS). Adult patients with RA (ACR/EULAR 2010) receiving MTX (orally or by injection) for at least 3 months were allocated to AI or PFS for 6 months and then were allocated to AI for 6 further months. Two co-primary endpoints were defined at M6: percentage of patients with compliance at least 80%; change in functional capacity assessed by Health Assessment Questionnaire (HAQ). Secondary endpoints included quality of life (RaQoL), RA activity (DAS28), and acceptability. Local safety at injection site was assessed at each visit.RESULTS:Two-hundred and sixty-five patients were randomized. The main analysis was conducted on per protocol set (99 AI and 98 PFS). Compliance was 96.2% in AI and 98.9% in PFS. Good complier rates were 89.9% and 94.9%, thus a difference of - 5.0% (- 18.9%; 8.9%). HAQ remained stable in both groups. No difference was found on RaQoL, change in RA activity, and safety profile. Autonomy, acceptability, and patient satisfaction were better with AI, and patients having had the experience of both AI and PFS preferred AI (p, ClinicalTrials.gov identifier, NCT02553018.
- Published
- 2018