Article Text

Download PDFPDF
4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017
  1. N Herrero Muñoz,
  2. A Andrés Rosado,
  3. B Hernández Muniesa,
  4. C Bravo Lázaro,
  5. AB Fernández Román,
  6. A Pou Alonso,
  7. A Ontañón Nasarre,
  8. MDM García Gutiérrez,
  9. C Mayo López,
  10. M García Gil
  1. University Hospital of Fuenlabrada, Pharmacy Service, Fuenlabrada Madrid, Spain

Abstract

Background Adalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.

Purpose To assess injection-site pain, the ease of use and patient preference between two delivery systems of adalimumab.

Material and methods Patients were enrolled in an open-label, single-arm, sequential trial from March 2017 to September 2017.

Inclusion criteria

  • At least 6 months from the beginning of treatment with adalimumab pre–filled syringe and self–administration.

  • Informed consent had to be signed (Ethics committee approval: EC1061; Protocol Number: ADAP2017).

Two visits separated by an interval of 2 months were performed.

Patients were informed about the change of device from pre-filled syringe to pen in Visit 1.

To evaluate the ease of use, a validated questionnaire was performed. The questionnaire consisted of 15 questions about device design, inconvenients of self-administration, long injection time, handling and technique of administration (Likert-type scale: 1=very strongly disagree; 7=very strongly agree). Answers≥5 were considered acceptable (Visit 1: Syringe; Visit 2: Pen).

Patients rated their pain on a visual analogue scale (VAS) (0=none, 10=the worst pain) (Visit 1: Syringe; Visit 2: Pen).

Preference between devices was evaluated in Visit 2 by a single question with three possible answers (Pen/Syringe/Indifferent).

Sex, birth date, diagnosis and duration of treatment were recorded. STATA® was used for statistical analysis.

Results Twenty-seven patients were analysed:

  • Males (67.7%).

  • Median age: 43 years (18–73).

  • Diagnoses: psoriasis (33.3%); spondylitis (22.2%); Crohn’s disease (40.8%); psoriatic arthritis (3.7%).

  • Median treatment duration: 2.9 years (0.5–8.7).

A reduction in injection-site pain was observed after changing the device from pre-filled syringe to pen (Mean difference: −3.04 (CI 95%–4.21 to −1.86; p<0.001).

Ease of use (% acceptable answers):

  • Device design: Syringe: 81.5%; Pen: 100%.

  • Any inconvenience during self–administration: Syringe: 40.7%; Pen: 14.8%.

  • Long injection time: Syringe: 29.6%; Pen: 14.8%.

  • Ease handling: Syringe: 63.0%; Pen: 85.2%.

  • Ease technique of administration: Syringe: 77.8%; Pen: 96.3%.

Patient preferences:

  • Pen: 81.5% (22/27).

  • Syringe: 7.4% (2/27).

  • Indifferent: 11.1% (3/27).

Conclusion Auto-injection pen has proved superior to pre-filled syringe in injection-site pain, the ease of use and patient preference.

Limitations: the pen does not contain citrate, a pain-related excipient.

No conflict of interest

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.