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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
- Source :
- Rheumatology and Therapy, Rheumatology and Therapy, 2019, 6 (1), pp.47-60. ⟨10.1007/s40744-018-0134-2⟩, Rheumatology and Therapy, Springer, 2019, 6 (1), pp.47-60. ⟨10.1007/s40744-018-0134-2⟩, Rheumatology and Therapy, Vol 6, Iss 1, Pp 47-60 (2018)
- Publication Year :
- 2018
- Publisher :
- Springer Science and Business Media LLC, 2018.
-
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<br />ClinicalTrials.gov identifier, NCT02553018.
- 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
Subjects
Details
- ISSN :
- 21986584 and 21986576
- Volume :
- 6
- Database :
- OpenAIRE
- Journal :
- Rheumatology and Therapy
- Accession number :
- edsair.doi.dedup.....8c448f2388551b000581eb0ffb183d84