Switch pattern of biological drugs for the treatment of inflammatory bowel diseases through the VALORE distributed database network

Study identification

• EU PAS number:
  EUPAS1000000412
• Study ID:
  1000000412
• Official title and acronym:
  Switch pattern of biological drugs for the treatment of inflammatory bowel diseases through the VALORE distributed database network
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Due to their high cost, biological drugs threaten the sustainability of the Italian National Health Service and, therefore, it is crucial to ensure their appropriate use in clinical practice. Since 2006, following the patent expiry of some biologic drugs, the first biosimilar drugs have been introduced in the European market. They are defined by the European Medicines Agency as biologic drugs similar to the originator in terms of quality, efficacy and safety. In the context of inflammatory bowel diseases (IBDs) such as Crohn disease and ulcerative colitis, a large number of biosimilars concerning anti-TNF alpha inhibitors (adalimumab and infliximab) have been marketed, while for other more recent biological drug classes such as interleukin or integrin inhibitors patent expiry has not been occurred yet. ; ; Switching between biological drugs, both originator and biosimilar, in patients affected by IBD is a frequent phenomenon in clinical practice (from 5 to 30% during the first year of therapy). Moreover, in September 2022 EMA stated that biosimilars are comparable to their reference products in terms of safety and immunogenicity and are therefore interchangeable. However, for a single molecule numerous biosimilars are marketed and switching patterns among biological drugs might be very various and complex. Nonmedical switching could also lead patients to a nocebo effect if not well motivated to patients who know little about biosimilars. For these reasons, it is essential to explore what is happening in clinical practice in patients affected by IBDs.
• Study status:
  Planned

Research institutions and networks

Institutions

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

Study timelines

Date when funding contract was signed

Planned:01/01/2019

Study start date

Planned:01/09/2024

Data analysis start date

Planned:01/10/2024

Date of final study report

Planned:30/06/2025

Sources of funding

More details on funding

Agenzia Italiana del farmaco - progetti di farmacovigilanza multiregionali 2014-2016

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable