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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


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

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