Noticia de Contratación

Medication nonadherence is common in patients receiving biologic anti–tumor necrosis factor (anti-TNF) treatment and is associated with increased disease activity and disease flares, loss of responsiveness to anti-TNF treatment, poorer quality of life, increased healthcare expenditures, and higher disability in patients. Patients with inflammatory conditions and nurses tend to prefer autoinjectors over prefilled syringes, studies have shown, as autoinjectors may be easier to use, more convenient, and less painful than syringes, which can increase adherence.

A recent study aimed to evaluate patients’ and nurses’ preferences for the autoinjector for the biosimilar adalimumab marketed as Imraldi in the European Union versus autoinjectors of reference adalimumab (Humira) or reference etanercept (Enbrel). The authors said head-to-head comparative studies of the biosimilar's autoinjector versus other autoinjectors of biologic anti-TNF therapies are needed to determine whether the biosimilar's autoinjector attributes improve patient and nurse satisfaction. Improving satisfaction could improve adherence as well, which could increase treatment efficacy and reduce costs.

The biosimilar's device features a nonslip surface and a rounded 4-sided shape, clicks audibly to indicate the start and end of dose administration, has a button-free initiation mechanism, has small needle size, and has a large medication-viewing window with an indicator to confirm that the injection is complete.

There were 2 face-to-face surveys of patients as well as nurses experienced with educating patients. The first study compared the autoinjectors of biosimilar and reference adalimumab, and the second compared the autoinjectors of biosimilar adalimumab and reference etanercept. 

Only nurses with sufficient experience administering autoinjector devices and training patients how to use them were eligible to take part. Patients were aged 18 to 65 years and had a diagnosis of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, or Crohn disease. They were required to have been injecting the reference adalimumab themselves via an autoinjector for at  least 3 months; prior experience with the biosimilar or etanercept autoinjectors was not required for enrollment.

Overall, 101 nurses (United Kingdom, n = 50; Germany, n = 51) and 151 patients (United Kingdom, n = 90; Germany, n = 61) participated in the studies.

In the first study, 85% of nurses and 78% of patients preferred the biosimilar's autoinjector over the reference adalimumab autoinjector (P  < .001). In the second study, 86% of nurses and 79% of patients preferred the biosimilar's autoinjector over the etanercept autoinjector (P  < .001). Survey respondents preferred the biosimilar's autoinjector for its ergonomics, ease of use, ease of grip, and button-free initiation mechanism.

Most nurses indicated they would recommend the biosimilar's autoinjector over the reference adalimumab or etanercept autoinjectors, and most patients indicated they would choose the biosimilar's autoinjector over either reference autoinjector to continue treatment. For patients, results were consistent irrespective of age, country, or condition; for nurses, results were consistent regardless of country, specialty, or prior familiarity with the etanercept autoinjector.

There were 2 main limitations to the survey:

• Participants’ prior experience with the reference products' autoinjectors may have negatively or positively biased their responses (eg, some participants may feel more comfortable with a known device, while others may be drawn to something new).
• The study order may have biased the biosimilar adalimumab versus the etanercept autoinjector study results, as the questionnaire for evaluation of the biosimilar versus reference adalimumab autoinjector always took place first, with the questionnaire for evaluation of the biosimilar adalimumab autoinjector versus etanercept autoinjector taking place second, after a break. The same group participated in both studies, and they may have realized in the second half of the study that the biosimilar was the focus.

The study was funded by Biogen, part of Samsung Bioepis, maker of Imraldi, and 2 of the 3 authors are employed by the company.