4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017

BackgroundAdalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.PurposeTo assess injection-site pain, the ease of use and patient preference between two delivery systems of adalimumab.Material and methodsPatients were enrolled in an open-label, single-arm, sequential trial from March 2017 to September 2017.Inclusion criteriaAt 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.ResultsTwenty-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