Biological therapies such as tumour necrosis factor α (TNF-α) blockers are widely used in clinical practice to treat many diseases including rheumatoid arthritis, psoriatic arthritis and plaque psoriasis.1 The administration of biological drugs is usually via subcutaneous self-injection, which has many advantages over intravenous infusions.2 Its advantages include improved flexibility in administration, reduced infusion time and, above all, the possibility of self-administration by the patient or her/his caregivers. The problems that can occur with self-administration concern patient compliance; patients must be adequately educated in self-administration to ensure optimal adherence to therapy and to overcome any resistance related to needle phobia.2 A range of devices, including prefilled syringes (PFS) and prefilled pens (PFP), has been developed to meet the needs of patient compliance.2 These devices have their own special features but are often chosen on the basis of market availability. For this reason, it is necessary to study the different degree to which the products are accepted by patients. Although several studies have investigated patient compliance to a specific device, a standard questionnaire for evaluating the preference of the pharmaceutical form for long-term administration has not been designed to date.3 4 We designed a specific survey called ‘PrefillEd Pen-SyriNge’ (PEPSIN) which we tested in a pilot study of 10 patients to examine possible differences between the two types of devices for self-administration.
Our pilot study began with the analysis and examination of the two proposed devices: PFS and PFP. PFS is an injection system consisting of a needle and a syringe which is prefilled with the appropriate dose of drug and is ready to use.4 The structural features of the syringe (such as the plunger and needle cap) are designed to help the patient handle the device correctly, but the mechanism is not automated and a margin of error remains. On the other hand, PFP is designed to automate the injection process; usually, administration involves pushing a button, after which a hidden needle is activated and the injection takes place. To ensure successful injection, the device contains a viewing window to observe the progress.5
Once the web-based questionnaire was designed, we submitted it to patients treated with TNF-α blockers at the University-City Hospital of Padova because, for this pharmacological class, there are a large number of medicinal products available in both PFSs and PFPs. We collected medical information on the primary pathology and adherence to treatment. With the purpose of standardising user preference, patients were asked to choose the main reason for their choice among several possibilities already reported in the scientific literature. Table 1 shows the structure of the questionnaire. After collecting information on the first 10 consecutive patients, a second version of the questionnaire was released which included a section for additional preferences on a specific comment. The pilot test showed that the questionnaire easily collected precise information on preferences, so we believe it can be applied to collect data on a larger number of patients. In this way the test could be useful in identifying trends in preferences in the form of the medication.
Table 1.
Structure of the questionnaire proposed to patients
| Patient’s medical data | Drug used in therapy | ||||
| Age | Continuous therapy (yes/no) | ||||
| Sex (M/F) | Biological drug | Adalimumab | □ | ||
| Primary pathology | Rheumatoid arthritis | □ | Etanercept | □ | |
| Crohn’s disease | □ | Golimumab | □ | ||
| Plaque psoriasis | □ | Certolizumab | □ | ||
| Psoriatic arthritis | □ | Abatacept | □ | ||
| Ankylosing spondylitis | □ | ||||
| Ulcerative colitis | □ | Preference | Prefilled syringes (PFS) | □ | |
| Juvenile idiopathic arthritis | □ | Prefilled pens (PFP) | □ | ||
| Crohn’s disease in paediatric patient | □ | No preference | □ | ||
| Uveitis | □ | ||||
| Primary reason for preference (select only one item): | |||||
| Less pain | □ | ||||
| Non-needle vision | □ | ||||
| Fewer haematomas after administration | □ | ||||
| Rapidity | □ | ||||
| Habit | □ | ||||
| Manageable for carrying | □ | ||||
| Feeling of effectiveness of the treatment | □ | ||||
Footnotes
Contributors: FV takes responsibility for the manuscript as a whole. LP and CB conceived and designed the study. LP, FT and FT enrolled patients and collected and compiled data. DM performed the statistical analysis. LP, CB, FT, DM, FT and FV analysed and interpreted the data. LP and DM wrote the manuscript. FV commented and revised the report. All authors read and approved the final manuscript.
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests: None declared.
Provenance and peer review: Not commissioned; internally peer reviewed.
Ethics statements
Patient consent for publication
Consent obtained directly from patient(s)
Ethics approval
This study involves human participants and was approved by the ethics committee of the University Hospital of Padua on 16 December 2021 (code AOP2395). Participants gave informed consent to participate in the study before taking part.
References
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