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Clinical Bridging From Prefilled Syringe to On-body Injector for Risankizumab in Crohn's Disease
Yinuo Pang1, Ronilda D'Cunha1, Afroz Shareef Mohammad1
1Clinical Pharmacology, AbbVie, Inc, North Chicago, Illinois, USA.
Clinical Therapeutics
|November 6, 2023
Summary
The risankizumab on-body injection (OBI) system demonstrated bioequivalence and safety comparable to the prefilled syringe, supporting its approval for Crohn's disease treatment. Skin adhesion and tolerability were also confirmed.
Area of Science:
- Pharmacology and Therapeutics
- Gastroenterology
- Drug Delivery Systems
Background:
- Crohn's disease (CD) requires effective treatment options.
- The risankizumab on-body injection (OBI) system offers a novel administration method.
- Bridging data is crucial for supporting new drug delivery systems in clinical practice.
Purpose of the Study:
- To present the clinical development bridging strategy and data supporting the risankizumab OBI system for moderate to severe CD.
- To evaluate the pharmacokinetic (PK) and tolerability of risankizumab administered via OBI.
- To establish bioequivalence (BE) between the OBI and the prefilled syringe (PFS) used in pivotal trials.
Main Methods:
- A pilot PK study assessed risankizumab bioavailability and injection site pain with varying administration rates/volumes via subcutaneous (SC) injection in healthy subjects.
- A pivotal BA/BE study compared the relative bioavailability of the OBI to the PFS in healthy subjects.
- An OBI adhesive study evaluated device adhesion and skin tolerability on the abdomen and thigh over time in healthy subjects.
Main Results:
- The pilot PK study indicated similar risankizumab exposures across different SC administration parameters, supporting OBI development.
- The pivotal BA/BE study confirmed bioequivalence between the OBI and PFS, with comparable AUCs and no clinically meaningful difference in Cmax.
- No new safety risks were identified, and immunogenicity did not impact the PK profile or safety of the OBI. The adhesive study showed good device adhesion and skin tolerability.
Conclusions:
- The clinical bridging strategy successfully demonstrated the comparability and safety of the risankizumab OBI system.
- The data supports the marketing application and approval of the risankizumab OBI for treating moderately to severely active Crohn's disease.
- The OBI system provides a viable and well-tolerated alternative for risankizumab administration in CD patients.
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