Abstract Background Evidence on how therapeutic strategies and mucosal healing affect quality of life (QoL) in ulcerative colitis (UC) remains limited. Aim: To evaluate the influence of treatment intensification or escalation on QoL in UC patients with mucosal healing (Mayo 0 or 1). Methods We conducted a prospective, multicenter study promoted by GETECCU from November 2022 to November 2024. Eligible patients had UC in clinical remission (partial Mayo ≤2 for ≥3 months) and surveillance colonoscopy showing Mayo 0 or 1 endoscopic activity. At inclusion we recorded C-reactive protein (CRP), fecal calprotectin (FC), QoL instruments (IBDQ-9, IBD-Control), and the therapeutic intervention performed. Patients were reassessed at 6 and 12 months to capture clinical relapse and QoL impact. Effect estimates used simple and multivariable logistic regression and are presented as odds ratios (OR) with 95% confidence intervals (CI). Results A total of 234 patients from 13 Spanish centers were included, 186 and 45 with Mayo 0 and 1 endoscopic subscores, respectively. Mayo 1 patients had higher FC (155.5 ± 20.91 vs 78.13 ± 24.98 µg/g; p 0.001) and higher rates of treatment modification (12 (26.7%) vs 8 (4.3%); p 0.001) and intensification/addition of treatment (14 (26.7%) vs 0 (0%); p 0.001); other baselines were similar. At 6 months follow-up (n = 206), 16 (7.7%) relapsed, more in Mayo 1 (8 (19.5%) vs 8 (4.8%); p = 0.005). Relapsing patients had higher FC (372.43 ± 14.23 vs 119.78 ± 19.11 µg/g; p 0.001) and worse QoL (IBDQ-9: 47.07 ± 9.8 vs 52.62 ± 8.61; p = 0.017; IBD-Control: 11.71 ± 4.96 vs 14.53 ± 2.72; p = 0.012). Patients with Mayo 1 required treatment intensification or escalation more often than those with Mayo 0 (5 (15%) vs. 8 (4.8%); p = 0.033). At 12 months follow-up (n = 196), 19 (9.7%) relapsed, again more often with Mayo 1 (8 (21.6%) vs 11 (6.9%); p = 0.012), with higher FC (748.78 ± 14.69 vs 131.48 ± 22.85 µg/g; p 0.001) and poorer QoL (IBD-Control: 13.54 ± 3.17 vs 15.42 ± 2.29; p = 0.001). Predictors of relapse at 6 and 12 months identified by simple logistic regression are shown in Table 1. In multivariate logistic regression, having a Mayo endoscopic subscore of 1 at inclusion was an independent risk factor for clinical relapse at 6 months (Wald = 7.71; OR = 4.93; 95% CI 1.59–15.2; p = 0.006) and at 12 months (Wald = 7.12; OR = 4.25; 95% CI 1.47–12.28; p = 0.008). Conclusion Patients with a Mayo endoscopic subscore of 1 have a higher risk of relapse, higher inflammatory burden as measured by FC and poorer QoL, requiring treatment intensification or escalation more frequently than those with Mayo 0. Therefore, mucosal healing should probably be considered achieved only in patients with an endoscopic Mayo subscore of 0. 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Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol. 2015;110(9):1324-38. doi: 10.1038/ajg.2015.233. Conflict of interest: Dr. Alonso, Inmaculada: No conflict of interest Carrillo Palau, Marta: No conflict of interest Martín González, Marta: No conflict of interest Vicente Lidon, Raquel: No conflict of interest Corsino, Pilar: No conflict of interest Sicilia Aladren, Beatriz: Dra. B. Sicilia has received support for conference attendance, speaker fees, research support and consulting fees of Abbvie, FAES, Chiesi, Dr. Falk, MSD, Tillots Pharma, Khern Pharma, Janssen, Pfizer, Takeda and Lilly. Arias Garcia, Maria Lara: No conflict of interest Bouhmidi, Abdel: No conflict of interest Lavín Expósito, Cristina: No conflict of interest Rueda Garcia, Jose Luis: José Luis Rueda García has received financial support for traveling and educational activities from Kern Pharma, Abbvie, Johnson & Johnson, Pfizer, Eli Lilly, Takeda, Ferring, Tillotts Pharma, Faes Farma, Norgine and Casen and he has received fees as a speaker from Abbvie, Johnson & Johnson, Pfizer, Eli Lilly and Takeda. Martin Arranz, Maria Dolores: No conflict of interest Dueñas, Carmen: No conflict of interest Varela Trastoy, Pilar: No conflict of interest Casanova, María José: María José Casanova, has received education funding from Pfizer, Takeda, Janssen, MSD, Dr. Falk, Shire, Ferring, Galápagos and Abbvie, and research funding from Lilly. Porto Silva, María Del Sol: none Valor de Villa, Jose Ramón: No conflict of interest García, María José: Other: MJ García has received financial support for travelling and educational activities from Janssen, Pfizer, Abbvie, Takeda and Ferring. Tardillo Marin, Carlos Alberto: No conflict of interest Brunet, Eduard: 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.
Alonso et al. (Thu,) studied this question.