BACKGROUND: There is limited information regarding the acceptability of injection devices for biological agents. OBJECTIVES: The primary objective of the study was to investigate patients' perceptions on the acceptability of two devices delivering etanercept. The secondary objectives of the study were to explore whether patients' attributes are associated with preferences. METHODS: This was a multicentre, open-label, randomized, parallel-design study. Adult patients with psoriasis were randomized to receive etanercept 50 mg twice-weekly subcutaneously for 12 weeks, either as a pre-filled syringe or as a pre-filled pen. The primary outcome was the patient satisfaction at week 12 with the injection device, as measured on a 0-10-point Likert scale. The study was powered to demonstrate non-inferiority of a pen over a syringe for the primary endpoint. RESULTS: A total of 421 patients were randomized. Mean patient satisfaction at week 12 was 8.9 (±1.9) points in the pen group and 7.6 (±2.6) points in the syringe group. There was a statistically significant advantage for the pen compared with the syringe. Multiple correspondence analysis showed that very satisfied patients were the oldest and had had psoriasis for a longer duration, while less satisfied patients were the most anxious and depressed. PASI 75 response was achieved by 61% of patients in the pen group and 57% in the syringe group at week 12. CONCLUSIONS: This study showed higher patient satisfaction when injecting etanercept with a pen compared with a syringe. Factors associated with lower satisfaction are younger age, anxiety and depression.
RCT Entities:
BACKGROUND: There is limited information regarding the acceptability of injection devices for biological agents. OBJECTIVES: The primary objective of the study was to investigate patients' perceptions on the acceptability of two devices delivering etanercept. The secondary objectives of the study were to explore whether patients' attributes are associated with preferences. METHODS: This was a multicentre, open-label, randomized, parallel-design study. Adult patients with psoriasis were randomized to receive etanercept 50 mg twice-weekly subcutaneously for 12 weeks, either as a pre-filled syringe or as a pre-filled pen. The primary outcome was the patient satisfaction at week 12 with the injection device, as measured on a 0-10-point Likert scale. The study was powered to demonstrate non-inferiority of a pen over a syringe for the primary endpoint. RESULTS: A total of 421 patients were randomized. Mean patient satisfaction at week 12 was 8.9 (±1.9) points in the pen group and 7.6 (±2.6) points in the syringe group. There was a statistically significant advantage for the pen compared with the syringe. Multiple correspondence analysis showed that very satisfied patients were the oldest and had had psoriasis for a longer duration, while less satisfied patients were the most anxious and depressed. PASI 75 response was achieved by 61% of patients in the pen group and 57% in the syringe group at week 12. CONCLUSIONS: This study showed higher patient satisfaction when injecting etanercept with a pen compared with a syringe. Factors associated with lower satisfaction are younger age, anxiety and depression.
Authors: Peter Varunok; Eric Lawitz; Kimberly L Beavers; Gary Matusow; Ruby Leong; Nathalie Lambert; Coen Bernaards; Jonathan Solsky; Barbara J Brennan; Cynthia Wat; Anne Bertasso Journal: Patient Prefer Adherence Date: 2011-11-24 Impact factor: 2.711
Authors: Oliver von Richter; Andrej Skerjanec; Miguel Afonso; Sabine Sanguino Heinrich; Johann Poetzl; Heike Woehling; Maria Velinova; Annelize Koch; Dmitrij Kollins; Lars Macke; Guido Wuerth Journal: Br J Clin Pharmacol Date: 2016-12-16 Impact factor: 4.335
Authors: Andreas Schneider; Philipp Richard; Philippe Mueller; Christoph Jordi; Mary Yovanoff; Jakob Lange Journal: Patient Prefer Adherence Date: 2021-02-02 Impact factor: 2.711
Authors: K Callis Duffin; J Bagel; M Bukhalo; I J Mercado Clement; S L Choi; F Zhao; A Gill; B Pangallo; C Shuler; L Mallbris; K Jackson Journal: J Eur Acad Dermatol Venereol Date: 2016-08-08 Impact factor: 6.166