P0647Rapid enhancement of Quality of Life after ustekinumab initiation in patients with Ulcerative Colitis: Results from a prospective study using the SIBDQ-9

Abstract Background Quality of life is a key therapeutic target in ulcerative colitis (UC), reflecting both symptom control and overall well-being. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ-9) is a validated tool for assessing Health-Related Quality of Life. This study aimed to evaluate early changes in SIBDQ-9 following ustekinumab (UST) initiation in patients with UC. Methods A multicenter, prospective observational study was conducted in patients aged ≥18 years with moderate-to-severe UC (partial Mayo score ≥6) who initiated UST 6 mg/kg between June 2023 and September 2024. The SIBDQ-9 questionnaire was collected at baseline and at weeks 4, 8, and 16 after initiation of UST. Clinical remission was defined as a partial Mayo score ≤2, and biochemical remission as a fecal calprotectin (FC) level 150 µg/g. Data are expressed as mean ± SD. Differences in SIBDQ-9 scores over time were assessed using repeated-measures ANOVA, and group comparisons with Student’s t-test or one-way ANOVA, as appropriate. Results A total of 54 patients were included across 14 hospitals in Spain. Of these, 29 (53.7%) were men, with a mean age of 54 (± SD 16.1) years. Thirty (55.6%) patients had pancolitis, 20 (37%) had left-sided colitis, and 4 (7.4%) had proctitis. Mean SIBDQ-9 scores increased progressively after treatment initiation: baseline 55.25 ± 6.22, week 4 61.34 ± 7.25, week 8 63.83 ± 10.21 and week 16 66.30 ± 9.41 (Figure 1). Paired comparisons versus baseline showed statistically significant improvement at all time points (p 0.001 for week 4, week 8 and week 16). When stratified by clinical remission status, mean SIBDQ-9 at week 4, week 8 and week 16 was significantly higher in patients achieving remission than in non-remitters (week 4: p = 0.014; week 8 and week 16: p 0.001). Comparison of SIBDQ-9 means according to biochemical remission showed no significant differences at week 8 (p = 0.25) nor at week 16 (p = 0.089). There were no significant differences in baseline quality-of-life scores by sex (p = 0.98) or by line of therapy (first/second/third line) (p = 0.81). Analysis of IBDQ-9 subindices at week 16 demonstrated a consistent improvement across all item scores compared with baseline, indicating a global enhancement in patient-reported quality of life; the largest improvements were observed in item 1 (bowel frequency) and item 6 (general well-being) (Figure 2). Conclusion Treatment with UST was associated with a rapid and sustained improvement in quality of life as measured by the SIBDQ-9, with progressive increases from baseline to week 16. Patients achieving clinical remission reported significantly higher quality-of-life scores, while no differences were observed according to FC normalization. Conflict of interest: Bastón Rey, Iria: Personal Fees: Iria Bastón Rey has received financial support for travelling and educational activities from or has served as an advisory board member for Abbvie, Johnson & Johnson, Takeda, Pfizer, Alfasigma, Ferring, Faes Farma and Otsuka Pharmaceutical and Adacyte. Garcia-Alvarado, María: No conflict of interest García Morales, Natalia: No conflict of interest Fernández Suárez, Brais: No conflict of interest Latras Cortés, Irene: No conflict of interest Ferreiro Iglesias, Rocio: RF-I has served as a speaker, or has received research or education funding from AbbVie, Takeda, MSD, Pfizer, Janssen, Adacyte, Ferring, Casen Recordati, Palex, Tillotts Pharma, Dr. Falk, Chiesi, Faes Farma, Alphasigma. Santos Fernández, Javier: No conflict of interest Tejido Sandoval, Coral: Has received support for congress and conference attendance from Abbvie, Ferring, Johnson & Johnson, Pfizer, Takeda, Tillots Pharma, Dr Falk Pharma and FAES. Has received speaker fees from Johnson & Johnson . Vazquez Rey, Teresa: No conflict of interest Garcia Alonso, Francisco Javier: I have acted as a speaker for Abbvie, Lilly and Johnson and Johnson Guerrero Montañes, Alberto: No conflict of interest Molina Arriero, Gema: No conflict of interest Velayos Jimenez, Benito: No conflict of interest Ruiz Barcia, María Jesús: No conflict of interest Ibañez Garcia, Mercedes: No conflict of interest Porto Silva, María Del Sol: No conflict of interest Tejerizo Garcia, Laura: No conflict of interest Ucha Abal, Patricia: No conflict of interest Marti Marques, Eva: No conflict of interest Nieto-García, Laura: No conflict of interest Gomez Hidalgo, Rocio: No conflict of interest Muñoz Nuñez, J Fernando: 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.