DOP82 Biological Treatment Cycles in Crohn’s Disease
Noor, N.(1)*;Sousa, P.(2);Bettenworth, D.(3);Gomollon, F.(4);Lobaton, T.(5,6);Bossuyt, P.(7);Casanova, M.J.(8);Ding, N.(9);Dragoni, G.(10,11);Furfaro, F.(12);van Rheenen, P.(13);Chaparro, M.(8);Gisbert, J.(8);Louis, E.(14);Papamichael, K.(15);
(1)Addenbrooke's Hospital- Cambridge University Hospitals NHS Foundation Trust, Department of Gastroenterology, Cambridge, United Kingdom;(2)Viseu Unit- Tondela-Viseu Hospital Centre, Department of Gastroenterology, Viseu, Portugal;(3)University of Münster, Medical Faculty of the University of Münster, Münster, Germany;(4)Hospital Clínico Universitario Lozano Blesa, Department of Gastroenterology, Zaragoza, Spain;(5)University Hospital Ghent, Department of Gastroenterology, Ghent, Belgium;(6)Ghent University, Department of Internal Medicine and Pediatrics, Ghent, Belgium;(7)Imelda GI Clinical Research Centre, Department of Gastroenterology, Bonheiden, Belgium;(8)Instituto de Investigación Sanitaria Princesa IIS-Princesa- Universidad Autónoma de Madrid UAM- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd, Gastroenterology Unit- Hospital Universitario de La Princesa, Madrid, Spain;(9)University of Melbourne- St Vincent's Hospital, Department of Gastroenterology, Melbourne, Australia;(10)University of Florence, Department of Experimental and Clinical Biomedical Sciences 'Mario Serio'- Gastroenterology Research Unit, Florence, Italy;(11)Careggi University Hospital, IBD Referral Center- Gastroenterology Department, Florence, Italy;(12)IRCCS San Raffaele Hospital, Department of Gastroenterology and Endoscopy, Milan, Italy;(13)University Medical Center Groningen, Department of Paediatric Gastroenterology, Groningen, The Netherlands;(14)Liege University Hospital- CHU Liege, Department of Hepato-Gastroenterology and Digestive Oncology, Liege, Belgium;(15)Beth-Israel Deaconess Medical Center- Harvard Medical School, Center for Inflammatory Bowel Diseases- Division of Gastroenterology, Boston, United States;
Background
There are now a growing number of licensed biological therapies for patients with Crohn’s disease (CD) but given the costs of long-term maintenance treatment, as well as some concerns about potential side effects, there has been increasing interest in elective biological treatment discontinuation in selected patients, after a period of sustained remission. Following discontinuation, in cases of relapse, limited but reassuring evidence has suggested that remission may often be regained by retreatment with the same biological agent. Therefore, a concept has emerged where cycles of biological therapy might be used. If this treatment strategy were applied in a subgroup of patients at low-risk of relapse, cycling might allow lower, overall drug exposure but still enable appropriate disease control. However, currently, there remains uncertainty about the benefit-risk balance for using cycles of biological treatment in patients with CD.
Methods
An expert panel was convened by the European Crohn’s and Colitis Organisation (ECCO) to review the published literature and agree a series of consensus practice positions (CPPs) on the topic of biological treatment cycles (biocycling). An open-call was announced to all ECCO members, following which 15 individuals were selected based on their expertise, and three subgroups were formed. The panel aimed to provide evidence-based guidance to support shared decision-making.
Results
A total of 14 CPP consensus statements were developed following comprehensive review of the literature. The statements evaluated multiple different aspects of biological treatment discontinuation and cycling, including the risk of relapse after elective treatment discontinuation, predictors of likely relapse or remission, safety, patient preferences and pharmacoeconomic aspects. Discussion and a preliminary voting round took place, with subsequent revision of CPP statements and supporting text, followed by a further meeting with voting to agree on final statements.
Conclusion
With increasing focus on patient preferences, long-term safety and costs, elective biological treatment discontinuation may be considered for some patients with CD in remission. In cases of relapse, there have been reassuring findings on subsequent retreatment with the same biological agent. However, there is a need for more data to support routine elective treatment discontinuation and cycling in CD, especially for newer biological agents. In particular, randomised, controlled trials comparing biological cycling to current maintenance therapy strategies would be highly informative. Currently, discussions about biological treatment discontinuation and cycling should be individualised, to enable shared decision-making by patients with their clinicians.