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.
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:
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%.
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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