Biologic Therapies: From Complexity to Clinical Practice in a Changing Environment

This symposium took place on 27th October 2015 as part of the United European Gastroenterology (UEG) Week 2015 in Barcelona, Spain Chairperson Remo Panaccione1 Speakers Remo Panaccione,1 Geert D’Haens,2 Brian Feagan3

1. Department of Medicine, University of Calgary, Calgary, Alberta, Canada
2. Inflammatory Bowel Disease Center, Academic Medical Center, Amsterdam, Netherlands
3. Robarts Research Institute, University of Western Ontario, University Hospital, London, Ontario, Canada

Disclosure: Remo Panaccione has been a consultant for Abbvie/Abbott, Amgen, Aptalis, AstraZeneca, Baxter, BMS, Celgene, Cubist, Eisai, Ferring, Gilead, Janssen, Merck, Robarts, Salix, Samsung, Shire, Centocor, Elan, GlaxoSmithKline, UCB, Pfizer, and Takeda. He has participated in speaker’s bureaux for Abbvie, Abbott, Aptalis, AstraZeneca, Ferring, Janssen, Merck, Prometheus, Shire, and Takeda; and advisory boards for Abbvie, Abbott, Amgen, Aptalis, AstraZeneca, Baxter, Eisai, Ferring, Genentech, Jansen, Merck, Schering-Plough, Shire, Centocor, Elan, GlaxoSmithKline, UCB, Pfizer, Bristol-Myers Squibb, Takeda, Cubist, Celgene, and Salix. He has received research/educational support from Abbvie, Abbott, Ferring, Janssen, and Takeda. Geert D’Haens has served as advisor for Abbvie, Ablynx, Actogenix, Amakem, Amgen, AM Pharma, AstraZeneca, Avaxia, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Cosmo, Covidien, Elan, Ferring, DrFALK Pharma, Centocor/Jansen Biologics, Engene, Ferring, Galapagos, Gilead, GlaxoSmithKline, Hospira, Medimetrics, Millenium/Takeda, Mitsubishi Pharma, Merck Sharp & Dohme, Mundipharma, Novo Nordisk, Otsuka, Pfizer, Protein Design Laboratories, Prometheus laboratories/ Nestlé, Receptos, Robarts Clinical Trials, Salix, Sandoz, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, UCB, Versant, and Vifor; and received speaker fees from Abbvie, Ferring, Jansen Biologics, Merck Sharp & Dohme, Mundipharma, Norgine, Shire, Takeda, Tillotts, UCB, and Vifor. Brian Feagan has been a consultant for Abbott/AbbVie, Actogenix, Akros, Albireo Pharma, Amgen, AstraZeneca, Avaxia Biologics Inc., Avir Pharma, Axcan, Baxter Healthcare Corp., Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, GiCare Pharma, Gilead, Given Imaging Inc., GlaxoSmithKline, Ironwood Pharma, Janssen Biotech (Centocor), Johnson & Johnson/ Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nektar, Nestlé, Novo Nordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, VHsquared Ltd., Warner-Chilcott, Wyeth, Zealand, and Zyngenia. He has participated in speaker’s bureaux for Abbott/AbbVie, Johnson & Johnson /Janssen, Takeda, Warner-Chilcott, and UCB Pharma; and advisory boards for Abbott/AbbVie, Amgen, AstraZeneca, Avaxia Biologics Inc., Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, Johnson & Johnson /Janssen, Merck, Nestlé, Novartis, Novo Nordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Takeda, Teva, TiGenix, Tillotts Pharma AG, and UCB Pharma. He has received grants/research support from Abbott/ AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb (BMS), Janssen Biotech (Centocor), Johnson & Johnson /Janssen, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, and UCB Pharma.
Acknowledgements: Writing assistance was provided by Dr Vanessa Lane, Medical Writing Limited.
Support: The symposium was jointly organised and funded by Abbvie. All authors received honoraria for preparation and delivery of their presentations. The publication of this article was funded by Abbvie. The paper is an interpretation of the views of the speakers, but is not written by them. The views and opinions expressed are those of the authors and not necessarily those of Abbvie.
Citation: EMJ Gastroenterol. 2015;4[1]:50-57.

Meeting Summary

This symposium provided an opportunity for global experts to discuss the challenges posed by the introduction of biosimilars. The impact of the manufacturing process on clinical outcomes, maintaining treatment responses over the long term, and issues surrounding patient management in a changing environment were addressed.

The symposium was opened by Prof Panaccione describing the evolution of inflammatory bowel disease (IBD) treatment in the last 20 years and how biologics have improved outcomes. Prof D’Haens provided an explanation of the complexity surrounding biologic drug development and the hurdles facing drug manufacturers when ensuring high quality and consistently performing products over time. Prof Panaccione discussed the clinical challenges in balancing the transition from induction to maintenance therapy in order to provide a clinically relevant and sustained response to therapy. He also discussed the evidence for long-term outcomes with adalimumab for IBD. Prof Feagan highlighted the issues faced by clinicians treating patients with biologics, including the ability to switch between biologics without loss of efficacy or impact on safety, and the need to consider interchangeability between biologic therapies and the potential risk and impact of immunogenicity.

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