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, Christophe Hudry, Elena Zinovieva, Hélène Herman-Demars, Self-I Investigators group, Lahouari Aouadi, Azzedine Arif, Heyliette Arty-Hue, Frederic Banal, Christopher Banse, Jean-Jacques Baron, Andre Basch, Valerie Berton, Salma Bitar, Alain Cantagrel, Pierre Cayla, Bernard Combe, Genevieve Cornaille-Lafage, Dominique Duplantier, Martine Elbaz Dellaroli, Veronique Ferrazzi, Rene-Marc Flipo, Jean Fulpin, Jean-Claude Gardiol, Cecile Guilyardi, Anissa Hacene, Christophe Hudry, Dominique Jarrige, Mireille Jourdan, Herve Laillet, François Lamer, Slim Lassoued, Geraldine Lupo-Mattatia, Eric Marzynski, Sylvie Melac-Ducamp, Pierre Monod, Claude Naim, Isabelle Negrier-Chassaing, Pierre Ngasseu, Dominique Plat, Daniele Prothery, Françoise Roch-Bras, Alain Saraux, Thierry Schaeverbeke, Karim Sebaa, Eric Senbel, Martin Soubrier, Gaëlle Sourisseau-Diverres, Dominique Soutif, Catherine Straus, Philippe Tauveron, Marie-Agnes Timsit, Valerie Vedere, Philippe Viu, Stephanie Werner-Leyval, Alain Saraux, Christophe Hudry, Elena Zinovieva, Hélène Herman-Demars, Self-I Investigators group, Lahouari Aouadi, Azzedine Arif, Heyliette Arty-Hue, Frederic Banal, Christopher Banse, Jean-Jacques Baron, Andre Basch, Valerie Berton, Salma Bitar, Alain Cantagrel, Pierre Cayla, Bernard Combe, Genevieve Cornaille-Lafage, Dominique Duplantier, Martine Elbaz Dellaroli, Veronique Ferrazzi, Rene-Marc Flipo, Jean Fulpin, Jean-Claude Gardiol, Cecile Guilyardi, Anissa Hacene, Christophe Hudry, Dominique Jarrige, Mireille Jourdan, Herve Laillet, François Lamer, Slim Lassoued, Geraldine Lupo-Mattatia, Eric Marzynski, Sylvie Melac-Ducamp, Pierre Monod, Claude Naim, Isabelle Negrier-Chassaing, Pierre Ngasseu, Dominique Plat, Daniele Prothery, Françoise Roch-Bras, Alain Saraux, Thierry Schaeverbeke, Karim Sebaa, Eric Senbel, Martin Soubrier, Gaëlle Sourisseau-Diverres, Dominique Soutif, Catherine Straus, Philippe Tauveron, Marie-Agnes Timsit, Valerie Vedere, Philippe Viu, Stephanie Werner-Leyval

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.

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

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Source: PubMed

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