AIM

To summarize the current consensus on the definition of remission and the endpoints employed in clinical trials.

METHODS

A bibliogragraphic search was performed from 1946 to 2016 sing online databases (National Library of Medicine’s PubMed Central Medline, OVID SP MEDLINE, OVID EMBASE, the Cochrane Library and Conference Abstracts) with key words:(“ulcerative colitis”) AND (“ulcerative colitis endoscopic index of severity” OR “UCEIS”) AND (“remission”) as well as (“ulcerative colitis”) AND (“ulcerative colitis disease activity index”) OR “UCDAI” OR “UC disease activity index” OR “Sutherland index”) AND (“remission”).

RESULTS

The search returned 37 and 116 articles for the UCEIS and UCDAI respectively. For the UCEIS, 12 articles were cited in the final analysis of which 9 validation studies have been identified. Despite the UCEIS has been more extensively validated in all three aspects (validity, responsiveness and reliability), it has been little employed to monitor disease in randomised clinical trials. For the UCDAI, 37 articles were considered for the final analysis. Although the UCDAI is only partially validated, 29 randomised clinical trials were acknowledged to use the UCDAI to determine endpoints and disease remission, though no clear protocol was identified.

CONCLUSION

Although the UCEIS has been more widely validated than the UCDAI, it has not been reflected in the monitoring of disease activity in clinical trials. Conversely, the UCDAI has been used in numerous large clinical trials to define their endpoints and disease remission, however, it is challenging to determine the best possible outcomes due to a lack of homogeneity of the clinical trial protocols. Before determining a gold standard index, international agreement on remission is urgently needed to advance patient care.