Journal
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume 47, Issue 6, Pages 773-783Publisher
WILEY
DOI: 10.1111/apt.14514
Keywords
-
Funding
- AbbVie
- Takeda
- Bristol Meyers Squibb
- Genentech
- Glaxo Smith Kline
- Janssen
- Millennium Pharmaceuticals (Takeda)
- Novartis
- Pfizer
- Procter
- Gamble Pharmaceuticals
- Shire Pharmaceuticals
- UCB Pharma
- Given Imaging
- MSD
- Dr Falk Pharma
- PhotoPill
- Ferring
- Dr. Falk Pharma
- Hospira
- Tillots
- Johnson and Johnson
- Merck
- Mundipharma
- Tigenix
- Vifor
- Biogen
- Celgene
- Allergan
- Celltrion
- Sandoz
- Boehringer-Ingelheim
- Mitsubishi
- Norgine
- Therakos
- Pharmacosmos
- Pilege
- BMS
- UCB-pharma
- Biogaran
- Boerhinger-Ingelheim
- Lilly
- HAC Pharma
- Index Pharmaceuticals
- Amgen
- HAC-pharma
Ask authors/readers for more resources
Background: Several novel compounds are being developed for inflammatory bowel diseases (IBD). In addition, biosimilar drugs are being approved. An increasing number of head-to-head, superiority and non-inferiority trials in patients with IBD are expected in the future. The clinical relevance of the magnitude of the effect size is often debated. Aim: To better understand physicians' perspectives on the clinical meaningfulness of IBD trial results. Methods: We conducted an online survey among all IOIBD (International Organization for the Study of Inflammatory Bowel Diseases) members, asking their opinion on the clinical relevance of the results of IBD trials. Results: Forty-six IOIBD members responded to the survey (52.3%). In biologic-naive ulcerative colitis (UC) and Crohn's disease (CD) patients, most of the participants considered a 15% difference with placebo for clinical remission and endoscopic remission to be clinically relevant. In head-to-head trials, most of participants considerer a 10% difference between groups for clinical remission and endoscopic remission to be clinically relevant. Half of respondents considered 10% to be an adequate margin in non-inferiority trials. In bioequivalence studies, most of the participants considered adequate a +/- 5% difference between a biosimilar and the originator for pharmacokinetic parameters, efficacy, safety and immunogenicity. Regarding safety, the difference between two drugs considered clinically relevant varied from 1% to 5%, depending on the type of adverse event. Conclusions: This is the first survey exploring how physicians perceive IBD trial results, providing an estimation of the magnitude of the difference between treatment arms that may directly influence clinical practice.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available