Tomohiko Yoshida1,2, Yasuhiro Otaki1,3, Naooki Katsuyama1,2, Michiko Seki1, Junko Kubota2. 1. Setagaya Rheumatology Clinic, Tokyo, Japan. 2. Rheumatology, Toshin Yoshida Internal Medicine, Nagano, Japan. 3. General Medical Education and Research Center, Teikyo University, Tokyo, Japan.
Abstract
Objectives: We aimed to evaluate the effect of change to the existing formulation of adalimumab (ADA) on pain and treatment motivation. Methods: We classified injection pain into the following categories: overall pain, pain at needle insertion, pain during drug injection, and pain 10 min after injection; we evaluated the effect of change to the existing formulation on pain using a visual analogue scale. In addition, a faces pain scale was used to evaluate the effect of change in injection pain intensity on treatment motivation. Results: Compared with the existing ADA formulation, the new formulation was associated with lower scores of overall pain (1.6 vs. 6.7), pain at needle insertion (1.8 vs. 4.7), pain during injection (1.6 vs. 7.0), and pain 10 min after the injection (0.4 vs. 3.1). All results showed a significant difference. p < .001. Paired t-tests were used. In the survey, 68% and 80% of the patients reported injection pain with influenza vaccine and the existing formulation, respectively; however, the proportion of the patients who experienced pain with the new formulation decreased to 20%.Conclusions: The new ADA formulation may alleviate the burden on RA patients and improve the quality of adherence to treatment, thereby influencing the RA treatment outcomes.
RCT Entities:
Objectives: We aimed to evaluate the effect of change to the existing formulation of adalimumab (ADA) on pain and treatment motivation. Methods: We classified injection pain into the following categories: overall pain, pain at needle insertion, pain during drug injection, and pain 10 min after injection; we evaluated the effect of change to the existing formulation on pain using a visual analogue scale. In addition, a faces pain scale was used to evaluate the effect of change in injection pain intensity on treatment motivation. Results: Compared with the existing ADA formulation, the new formulation was associated with lower scores of overall pain (1.6 vs. 6.7), pain at needle insertion (1.8 vs. 4.7), pain during injection (1.6 vs. 7.0), and pain 10 min after the injection (0.4 vs. 3.1). All results showed a significant difference. p < .001. Paired t-tests were used. In the survey, 68% and 80% of the patients reported injection pain with influenza vaccine and the existing formulation, respectively; however, the proportion of the patients who experienced pain with the new formulation decreased to 20%.Conclusions: The new ADA formulation may alleviate the burden on RApatients and improve the quality of adherence to treatment, thereby influencing the RA treatment outcomes.
Entities:
Keywords:
Adalimumab; biologics; injection site pain; motivation for treatment; rheumatoid arthritis