Abstract Background There is little evidence regarding the predictive factors associated with mucosal healing in patients with moderate ulcerative colitis (UC) treated with steroids. The aim of this study was to analyse the association between the speed of improvement in clinical variables with calprotectin levels and endoscopic mucosal healing once a conventional course of steroids has been completed. Methods All patients in the GETECCU prospective randomised CECUM clinical trial who completed the endoscopic assessment at eight weeks were included. Clinical variables were collected at 7 days, and at 4 and 8 weeks: presence of rectal bleeding, urgency and nocturnal stools, Mayo and Walmsley sub-scores, and faecal calprotectin levels. Endoscopic mucosal healing at week 8 was defined as an endoscopic Mayo score of 0. Group differences were compared and the association between early clinical response and final mucosal healing was analysed using descriptive statistics and logistic regression models adjusted for baseline clinical variables. Results Of the 75 patients included in the CECUM study, 58 underwent endoscopy at week 8. Forty-eight per cent were women with a median age of 49 (range 19–79), 98 per cent were non-smokers, 52 per cent had extensive colitis and 32 per cent had previously received steroids. The mucosal healing rate at eight weeks was 29% (17 of 58). In the univariate analysis, disappearance of rectal bleeding at week 4, use of topical therapy and calprotectin levels 250 at day 7 and 150 at 4 weeks were associated with mucosal healing (p 0.05). In the multivariate logistic regression, independent factors associated with mucosal healing were topical treatment at 7 days (OR 9.96; 95% CI 1.51–65.83; p = 0.017), faecal calprotectin levels 250 µg/g at 7 days (OR 5.48; 95% CI 1.28–23.45; p = 0.022) and calprotectin levels 150 µg/g at 4 weeks (OR 5.15; 95% CI 1.13–23.32; p = 0.034). Conclusion Early normalisation of calprotectin and the use of topical treatment during the first week are independent predictors of mucosal healing in steroid-treated UC with moderate activity. These results reinforce the value of calprotectin as a non-invasive clinical decision marker and, furthermore, support the use of combined topical treatment when initiating oral steroids. Conflict of interest: Mañosa Ciria, Miriam: Personal Fees: Abbvie, FAES Pharma, Ferring, Jannsen, MSD, Pfizer, Tillots and Lilly Llao Guardia, Jordina: I have received financial support from AbbVie, Tillots, Adacyte, Jansen, Alfasigma and Lilly for educational activities. Piñero, Gisela Soledad: GP has served as a speaker or has received education funding or advisory fees from Adacyte, AbbVie, Kern Pharma, Ferring, Alfasigma. Calafat Sard, Margalida: No conflict of interest Martin Arranz, Eduardo: Personal Fees: Olympus and Janssen Non-financial Support: Support for conference attendance, education or research from Abbvie, Pfizer, Janssen Zabana, Yamile: Personal Fees: AbbVie, Adacyte Therapeutics, Alfa-Sigma, Amgen, Boehringer Ingelheim, Dr Falk Pharma, FAES Pharma, Fresenius Kabi, Ferring, Galapagos, Janssen-J & J, Kern Pharma, Lilly, MSD, Pfizer, Sanofi, Sandoz, Takeda, Tillots Pharma Non-financial Support: Shire, Otsuka, Almirall Navarro Llavat, Mercedes: No conflict of interest Teller, Marta: No conflict of interest Garcia Planella, Esther: No conflict of interest Busquets Casals, David: No conflict of interest Monfort Miquel, David: No conflict of interest Juan-Ramón , Pineda: No conflict of interest Gutiérrez Casbas, Ana: No conflict of interest Villoria Ferrer, Alberto: No conflict of interest Menchen Viso, Luis Alberto: No conflict of interest Bastida Paz, Guillermo: No conflict of interest Garcia Alonso, Francisco Javier: I have acted as a speaker for Abbvie, Lilly and Johnson and Johnson Rivero Tirado, Montserrat: No conflict of interest Chaparro, María: Grants: Pfizer, Janssen, Biogen, Abbvie, Lilly Personal Fees: Pfizer, Faes, Lilly, Abbvie, Janssen Riestra Menéndez, Sabino: No conflict of interest Merino Ochoa, Olga: No conflict of interest Rodríguez-Lago, Iago: No conflict of interest Barreiro-de Acosta, Manuel: MBA has been speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Alphasigma, Lilly, Pfizer, Sandoz, Biocon, Abivax, Fresenius, Faes Farma, Ferring, Tillots, Chiesi, Adacyte, Diasorin, Oncostellae and SunRock. Rodríguez-Fortúnez, Patricia: No conflict of interest Domènech Moral, Eugeni: Personal Fees: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Biogen, Celltrion, Gilead, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots. Other: I have served as a speaker, or has received research or education funding or advisory fees from AbbVie, Adacyte Therapeutics, Alfasigma/Galapagos Biogen, Celltrion, Ferring, Gilead, GoodGut, Imidomics, Janssen, Kern Pharma, Lilly, MSD, Pfizer, Roche, Takeda, Tillots.
Ciria et al. (Thu,) studied this question.