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Purpose: Medication delivery device design impacts treatment satisfaction, adherence, and compliance in patients receiving biologics. This survey assessed autoinjector attributes that are important to patients, and assessed patient perceptions and preferences between an adalimumab biosimilar autoinjector (Hyrimoz® SensoReady® Pen [SDZ-ADL pen]) and the reference adalimumab autoinjector (Humira® Pen [ref-ADL pen]) in patients with rheumatoid arthritis (RA) or Crohn's disease (CD) in Canada. Patients and Methods: In this survey, adult patients were recruited for web-assisted telephone interviews. Patients had ≥ 3 months' experience with the ref-ADL pen and 1-12 months' experience with the SDZ-ADL pen. Results: The survey included 120 patients with RA (n = 32) or CD (n = 88). Mean experience with the ref-ADL pen was 7 years for RA or 5 years for CD vs 9 months with the SDZ-ADL pen. The most important autoinjector attributes were the ability to use the pen independently and the ease and simplicity of self-injection. When comparing the two autoinjectors, patients significantly preferred the SDZ-ADL pen over the ref-ADL pen for nearly every attribute evaluated, with the greatest differences reported for visual and audible feedback mechanisms, ease of self-injection, and ability to use the device independently. Overall, 82% of patients preferred the SDZ-ADL pen over the ref-ADL pen, with buttonless activation and less injection pain being the main drivers for this preference. Conclusion: Patients with RA or CD indicated a preference for the SDZ-ADL pen over the ref-ADL pen, independent of the duration of use of the pen. The preference for a biosimilar device within 1 year of switching provides reassurance of rapid patient acceptance of biosimilars and may simplify the switching process. These results confirm the importance of ensuring autoinjector design supports independent self-administration of medication and align with previous data showing high patient satisfaction with the SDZ-ADL pen.
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WHAT IS THIS SUMMARY ABOUT?: This plain language summary explains, in simple terms, the results of a study from 2022 discussing a biosimilar medicine called GP2017 (called SDZ-ADL in this summary, sold as Hyrimoz®). This medicine is used to treat people with inflammatory conditions. This study investigated a new, high-concentration formulation of GP2017 (SDZ-ADL-HCF) in order to show that the high concentration option acts the same way in the body as SDZ-ADL. SDZ-ADL-HCF has been submitted for regulatory approval to health authorities on the basis of this study and was recently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for people with the inflammatory conditions that SDZ-ADL is used to treat. This newly developed formulation provides the option for receiving injections less often with reduced volumes which can have a positive impact on the injection experience and increase patient convenience. WHAT WAS THE AIM OF THE CURRENT STUDY?: This study looked at the pharmacokinetics of SDZ-ADL and SDZ-ADL-HCF, meaning it compared how the active medicine behaved in the body at different times after the injection of each of the formulations. The study also looked at how each formulation was recognized by the body's immune system (known as immunogenicity), and the side effects associated with each formulation. This study was randomly assigned and double-blinded, meaning that neither the participants nor the researchers knew which formulation each participant received. This reduces the risk of bias in the results. WHAT WERE THE FINDINGS FROM THE CURRENT STUDY?: The study found that an injection of SDZ-ADL-HCF resulted in similar amounts of the medicine being present within the blood as an injection of SDZ-ADL. This information was needed for the approval of SDZ-ADL-HCF. Participants also experienced similar immune reactions and the number of participants with side effects was similar between both concentrations of medicine. The results confirmed that SDZ-ADL-HCF behaves in the same way in the body and is expected to have the same treatment effects as SDZ-ADL, while at the same time offering an improved formulation with a more positive injection experience and increased patient convenience.