Real-Life Patient Handling Studies for Autoinjectors and Prefilled Pens: Recent Regulatory Precedents
By Rhizome Team
For pharmaceutical and medical device companies developing combination products like autoinjectors or prefilled pens, understanding real-world usability is critical for regulatory submissions and product success.
Unlike simulated use studies where patients interact with devices using injection pads or dummy units, real-life patient handling studies (also called home use or actual use studies) involve patients actually performing injections with the device. These studies provide valuable insights into how patients interact with devices in authentic settings.
Identifying recent precedents for these studies can be challenging, so we asked Rhizome to compile a comprehensive list of real-life patient handling studies cited for autoinjectors or prefilled pens in the last five years across FDA and EMA regulatory submissions.
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Provide a list of the real-life patient handling studies, home use studies or actual use studies cited for an autoinjector or prefilled pen in the last five years.
Answer
Based on the provided FDA and EMA datasets, the following real-life patient handling studies, home use studies, or actual use studies (where patients performed real injections, not simulated use) have been cited for autoinjectors or prefilled pens in the last five years:
1. AVT02-GL-303 (Adalimumab Autoinjector, Libmyris/Hukyndra/Simlandi)
- Product: AVT02 (adalimumab) autoinjector
- Study: AVT02-GL-303
- Description: This was a real-life subject handling study in which subjects with moderate to severe active rheumatoid arthritis (RA) self-injected AVT02 subcutaneously in a single-arm, repeated-dose study. After initial training, all 107 subjects were able to self-inject successfully, as recorded by the Observer Assessment Tool (OAT) and the Participant Assessment Tool (PAT). No handling events were recorded. The study concluded that the autoinjector device can be used and self-injected to deliver the medicinal product to the target population.
- Citations: 29
2. CT-P17 3.2 (Yuflyma Adalimumab Autoinjector)
- Product: CT-P17 (Yuflyma, adalimumab) autoinjector
- Study: CT-P17 3.2
- Description: Phase III, open-label, single-arm, multiple-dose study to evaluate usability of subcutaneous autoinjector of CT-P17 in patients with moderate to severe active RA. A total of 62 RA patients were analyzed in terms of usability, with patients self-administering injections. The study population included both males and females, aged 19–70 years.
- Citations: 43
3. M16-005 (SKYRIZI Risankizumab Autoinjector)
- Product: SKYRIZI (risankizumab) autoinjector
- Study: M16-005
- Description: Multicenter, single-arm, open-label study to assess the usability of the risankizumab autoinjector combination product in adult patients with moderate to severe plaque psoriasis. Patients performed actual injections with the marketed device.
- Citations: 52
4. MIDAZOLAM Autoinjector (Study RLM-559-01)
- Product: Midazolam Hydrochloride Autoinjector
- Study: RLM-559-01
- Description: Subjects received actual injections with the autoinjector, and adverse events such as injection site pain were recorded, indicating real-life administration rather than simulated use.
- Citations: 47
5. Other Notable Mentions
- NGENLA (Somatrogon-ghla) Pen-Device Injector: An open-label, multi-dose actual use study was proposed to support licensure, but the FDA requested that the final combination product be used in pivotal Phase 3 trials instead. It is unclear if an actual use study was completed and cited, so this is not included as a confirmed study 12.
- Other products (e.g., WAINUA, SIMLANDI, ZEGALOGUE, ENTYVIO, BIMZELX, EBGLYSS, etc.): The referenced studies in the provided snippets are either simulated use/human factors studies or do not clearly describe actual use (real injection into patients).
Summary Table
| Product (Brand/Generic) | Study Identifier | Description of Actual Use Study | Citation |
|---|---|---|---|
| AVT02 (adalimumab) | AVT02-GL-303 | RA patients self-injected in repeated-dose study | 29 |
| CT-P17 (Yuflyma, adalimumab) | CT-P17 3.2 | RA patients self-injected in open-label study | 43 |
| SKYRIZI (risankizumab) | M16-005 | Psoriasis patients self-injected in open-label study | 52 |
| Midazolam Autoinjector | RLM-559-01 | Subjects received actual injections, AEs recorded | 47 |
Notes:
- Only studies explicitly described as involving real injections by patients (not simulated use) are included.
- Many human factors or usability studies in the datasets are simulated (using pads or dummies) and are not listed here.
- If further details are needed for a specific product, please specify.