Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Mar;6(1):47-60.
doi: 10.1007/s40744-018-0134-2. Epub 2018 Dec 13.

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

Alain Saraux  1   2 , Christophe Hudry  3 , Elena Zinovieva  4 , Hélène Herman-Demars  4 ; Self-I Investigators group
Collaborators, Affiliations

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

Alain Saraux et al. Rheumatol Ther. 2019 Mar.

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 < 0.001).

Conclusions: Although this study did not demonstrate non-inferiority of AI versus PFS, compliance was excellent in the two groups, and AI, which was preferred by patients, is a valuable alternative to PFS for administration of MTX.

Trial registration: ClinicalTrials.gov identifier, NCT02553018.

Funding: Nordic Pharma SAS.

Keywords: Auto-injector; Compliance; Methotrexate; Rheumatoid arthritis; Satisfaction.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Acceptability. Patients were asked on acceptability at M6 visit using a self-questionnaire with questions answered with a five-point Likert scale. Acceptability encompassed ease of use, satisfaction, pleasantness, motivation for further utilization, reassurance, treatment-related burden, stress during injection, and pain during injection. AI auto-injector, PFS prefilled syringe
Fig. 2
Fig. 2
MTX administration. At M6, patients were asked on whether MTX was self-administered (green) or administered with the help of healthcare professionals (yellow) or family and friends (orange). AI auto-injector, PFS prefilled syringe
See this image and copyright information in PMC

References

    1. Guillemin F, Saraux A, Guggenbuhl P, et al. Prevalence of rheumatoid arthritis in France: 2001. Ann Rheum Dis. 2005;64(10):1427–1430. doi: 10.1136/ard.2004.029199. - DOI - PMC - PubMed
    1. Jacobs JW. Lessons for the use of non-biologic anchor treatments for rheumatoid arthritis in the era of biologic therapies. Rheumatology. 2012;51(suppl_4):iv27–iv33. - PubMed
    1. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76:960–977. doi: 10.1136/annrheumdis-2016-210715. - DOI - PubMed
    1. Choi HK, Hernán MA, Seeger JD, et al. Methotrexate and mortality in patients with rheumatoid arthritis: a prospective study. Lancet. 2002;359(9313):1173–1177. doi: 10.1016/S0140-6736(02)08213-2. - DOI - PubMed
    1. Wasko MCM, Dasgupta A, Hubert H, et al. Propensity-adjusted association of methotrexate with overall survival in rheumatoid arthritis. Arthritis Rheumatol. 2013;65(2):334–342. doi: 10.1002/art.37723. - DOI - PMC - PubMed

Associated data

LinkOut - more resources