P0184Improvement in fatigue but not joint pain and stiffness in Inflammatory Bowel Disease patients treated with advanced therapies: Interim findings from IBD-RESPONSE

Abstract Background Many patients with IBD experience extraintestinal symptoms such as fatigue, joint pain and stiffness, which may affect quality of life and be overlooked in clinical practice. These extraintestinal symptoms remain poorly characterised, particularly in relation to therapeutic response. Methods IBD-RESPONSE is a UK-wide, multi-centre observational study investigating predictors of response to advanced therapies. Patient-reported outcome (PRO) measures were collected before treatment and at week 14, including PRO-2 (used to calculate clinical response/remission), PROMIS Fatigue (8a), and a modified Axial Spondyloarthritis Disease Activity Score (ASDAS) for joint pain and stiffness which incorporates a CRP value. The ASDAS was completed by patients irrespective of having a rheumatological diagnosis. In this interim analysis of 531 patients, changes in extraintestinal symptom burden between baseline and week 14 were assessed using Wilcoxon signed-rank tests. Results Median (IQR) baseline PROMIS-8a fatigue T-score across the cohort was 62.3 (57.5 - 68.6), whilst a score of 50 represents the United States (US) general population mean 1. Based on the modified ASDAS-CRP score, 57.5% of patients were classified as having high or very high joint pain and stiffness at baseline, whilst only 10.4% of these patients had a rheumatological diagnosis. Whilst there was a significant improvement in fatigue from baseline to week 14 in treatment non-responders (median change in PROMIS T-score IQR = -2.05 -6.08 - 2; p 0.001), the largest changes were seen in responders (median IQR = -4.6 -9.3 – 1.05, p 0.001) and those in clinical remission (median IQR = -5.6 -13.1 – 0; p 0.001). Improvements were observed in both CD and UC patients, however, fatigue remained above the US general population mean at week 14 for those classed as responders or in remission across both CD (median IQR T-score = 57.5 49.2 - 65.3) and UC (median IQR T-score = 53.6 49.2 - 61.3). In contrast, joint pain and stiffness showed no significant improvement amongst treatment non-responders (median change in ASDAS-CRP IQR = -0.26 -0.82 – 0.51; p = 0.48), responders (median IQR = -0.14 -0.585 – 0.337, p = 0.51) or those in clinical remission (median IQR = -0.5 -1.02 – 0.72, p = 0.49) and remained elevated even among participants without a rheumatological diagnosis. Conclusion Advanced therapies in IBD reduce fatigue but do not fully restore it to population norms. Joint pain and stiffness are prevalent in IBD and persists despite clinical response to therapy. These findings highlight the need for comprehensive evaluation and management of extraintestinal symptoms alongside intestinal inflammation. Reference: 1 Cella D, Riley W, Stone A, et al; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179-1194. doi:10.1016/j.jclinepi.2010.04.011 Conflict of interest: Dr. Beck, Lauren: No conflict of interest Watson, Hannah: No conflict of interest Young, Greg: GRY is supported by the National Institute of Health Research (NIHR) Newcastle Wyatt, Nicola: Nicola J. Wyatt acknowledges previous research support from an NIHR Academic Clinical Fellowship (2021-2023) and is currently supported by a Wellcome 4Ward North PhD Fellowship award. Ahmad, Tariq: Tariq Ahmad reports grants, personal fees and non-financial support from F. Hoffmann-La Roche AG, Biogen Inc, Abbvie, Janssen, Celltrion Healthcare, Galapagos NV, Immundiagnostik, Takeda, ARENA, Gilead, Adcock Ingram Healthcare, Pfizer, Genentech, Tillotts. Allerton, Dean: No conflict of interest Bates, Georgina: No conflict of interest Buckley, Amy: No conflict of interest Collins, Sonya: No conflict of interest Dong, Chaonan: No conflict of interest Doona, Mary: No conflict of interest Doyle, Jennifer: No conflict of interest Fachal, Laura: No conflict of interest Harris, Bradley: No conflict of interest Hart, Ailsa: Grant: Takeda Personal Fees: Abbvie, Amgen, Arena, AZ, Falk, Celltrion, Eli Lilly, Ferring, Genentech/ Roche, GSK, Pfizer, Takeda, Napp, Pharmacosmos, Janssen (J & J), Bristol-Myers Squibb, Gilead, Galapagos, Alfasigma Hildreth, Victoria: No conflict of interest Irving, Peter Miles: Grant: MSD, Pfizer, Takeda, Celltrion, Galapagos Personal Fees: AbbVie, Arena, BMS, Boomerang Medical, Celgene, Celltrion, Falk Pharma, Ferring, Galapagos, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Roche, Sandoz, Samsung Bioepis, Sapphire Medical, Sandoz, Shire, Takeda, Tillotts, Topivert, VH2, Vifor Pharma, Warner Chilcott Jacques, Katherine: No conflict of interest Jostins-Dean, Luke: No conflict of interest Kennedy, Nicholas Alexander: Grant: Dr Kennedy’s department has received research funding from AbbVie, Biogen, Celgene, Celtrion, Galapagos, MSD, Napp, Pfizer, Pharmacosmos, Roche and Takeda Personal Fees: Dr Kennedy has served as a speaker and/or advisory board member for AbbVie, Amgen, BMS, Falk, Ferring, Galapagos, Janssen, Mylan, Pharmacosmos, Sandoz, Takeda and Tillotts Non-financial Support: Dr Kennedy has had support to attend meetings from AbbVie, Falk, Janssen and Tillotts Khan, Uzma: No conflict of interest Lees, Robert: No conflict of interest Lees, Charlie: Consultancy and lecture fees: Abbvie, Oshi Health, Gilead, Pfizer, Takeda, Janssen, Shire, Samsung Bioepis, Dr Falk, GSK, Galapagos, Trellus Health, Iterative Scopes, Fresnius Kabi Lindsay, James: Investigator Initiated Research Grant: Takeda, Abbvie, Gilead Personal Fees: I have received fees for speaking and may have received support to attend academic conferences from: Abbvie UK/Global, Bristol Myers Squib, Cornerstones US, Gilead, Galapagos, Lilly, MSD UK, Ferring UK, Ferring Intl., Celltrion, Takeda, Pfizer, Janssen, Tillotts, Other: I serve of the advisory board of Abbvie UK/Global, Alpini, Astra Zeneca, Engytix, Galapagos, Gilead, GSK, Lily, MSD, Ferring UK, Ferring Intl., Celltrion, Takeda, Pfizer, Janssen, Shattucks Laboratory, Marchesi, Julian: No conflict of interest Martin, Cristina: No conflict of interest McGregor, Naomi: No conflict of interest Mulligan, Robert: Robert J. Mulligan acknowledges research support from Open Targets, Wellcome Trust, European Bioinformatics Institute (EMBL-EBI), Genentech, GlaxoSmithKline, Merck Sharp and Dohme, Pfizer, and Sanofi and support for educational meeting attendance from Ferring. Parkes, Miles: Grant: Gilead, Pfizer, AstraZeneca, Galapagos, Lilly, Takeda Powell, Nick: Grant: Takeda, BMS, Pfizer, Astra-Zeneca Personal Fees: Abbvie, Abivax, Allergan, Astra-Zeneca, Bristol-Myers Squibb, Celgene, Celltrion, Dr Falk Pharma UK Ltd, Ferring, Galapagos, GSK, Janssen, MSD, Roche, Pfizer, Sobi, Takeda, Tillotts Raine, Timothy: Grant: Abbvie, Takeda Personal Fees: TR has received research/educational grants and/or speaker/consultation fees from Abbvie, Alfasigma, Arena, Aslan, AstraZeneca, Boehringer-Ingelheim, BMS, Celgene, Domain Therapeutics, Eli Lilly, Ferring, Galapagos, Gilead, GSK, Heptares, LabGenius, Janssen, MonteRosa, Mylan, MSD, Novartis, Numab, Pfizer, Roche, Sandoz, Scientia, Takeda, UCB and XAP therapeutics Satsangi, Jack: Grant: Grants to Oxford University from Helmsley Trust & European Community. Speight, Ally: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AbbVie, Lilly, Dr Falk Pharma Janssen Support for attending meetings and/or travel: AbbVie, Dr Falk Pharma Janssen, Tillott’s pharmaceuticals Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: BSG IBD Section Committee (unpaid) Stewart, Christopher: No conflict of interest Strickland, Michelle: No conflict of interest</jat