Background: Self-injection of biological agents has become a general practice in the treatment of rheumatoid arthritis (RA). Self-injectable biological agents differ in shape, needle thickness, drug fluid volume, and so on. These differences may affect patients’ evaluations of self-injection devices. Five kinds of anti-tumor necrosis factor (TNF) agents can be administered by self-injection in clinical practice in Japan. Information on patients’ evaluations of self-injection devices is important in choosing the agent for the treatment of RA among several agents with the same mechanism of action.
Objectives: The aim of this retrospective cross-sectional study was to compare patient evaluations of anti-TNF self-injection devices in the treatment of RA.
Methods: RA patients in whom etanercept (ETN) pen 50 mg (Embrel Pen) was switched to ETN biosimilar (BS) 50 mg (ETN-BS [MA]), adalimumab (ADA) syringe 40 mg (Humira syringe) was switched to ADA pen 40 mg (Humira pen), golimumab (GLM) syringe 50 mg (Simponi syringe) was switched to GLM autoinjector (Simponi AI), and certolizumab pegol (CZP) syringe (Cimzia syringe) was switched to CZP autoclicks (Cimzia AC) were asked to answer an originally developed questionnaire (Toyohashi Self-injection Assessment Questionnaire [T-SAQ]; Table 1) before and after switching agents. T-SAQ included 18 questions. A score of 0 indicated “best” and 4 indicated “worst” for each question, with a highest possible score of 72. The patients’ characteristics and T-SAQ scores before and after switching agents were investigated. A statistical analysis of the difference in T-SAQ score between before and after switching was performed using the Wilcoxon signed-rank test. A P value < 0.05 was considered significant.
Results: The patients were divided into groups according to the agents they received with switching as follows: switchers from ETN pen to ETN-BS, n = 32; switchers from ADA syringe to ADA pen, n = 28; switchers from GLM syringe to GLM-AI, n = 25; and switchers from CZP syringe to CZP-AC, n = 10. The total T-SAQ scores were as follows, respectively: ETN pen and ETN-BS, 23.5 and 19.0; ADA syringe and ADA pen, 25.8 and 14.9; GLM syringe and GLM-AI, 23.8 and 17.4; and CZP syringe and CZP-AC, 30.6 and 18.8. The total T-SAQ was significantly improved after switching to the pen devices in all the switching groups. In the switchers from ETN pen to ETN-BS, the scores for questions 5, 10, 11, 12, 16, 17, and 18 were significantly improved after switching. The total T-SAQ scores were significantly improved for questions 1, 2, 3, 4, 5, 7, 11, 12, 13, 15, 16, and 17 in the switchers from ADA syringe to ADA pen, for questions 1, 2, 5, 7, 10, 16, and 17 in the switchers from GLM syringe to GLM-AI, and for questions of 1, 2, 3, 4, 5, 7, 11, and 15 in the switchers from CZP syringe to GLM-AC.
Conclusion: The pen devices were favorably assessed by the RA patients in whom syringe devices were switched to pen devices for the same agent. The total T-SAQ score improved in the RA patients in whom ETN pen was switched to ETN-BS probably because the thickness of the needle was thinner in the ETN-BS than in the ETN pen. The total T-SAQ score for the ADA pen was lowest probably because the thinnest needle was used (29 gauge) and the amount of drug fluid is smallest (0.4ml). The total T-SAQ score for the CZP syringe was the lowest probably because the thickest needle was used (25 gauge).
Disclosure of Interests: None declared
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