P301 Ustekinumab improves health-related quality of life in patients with moderate-to-severe Crohn’s disease: results up to Week 48 of the STARDUST trial
Danese, S.(1);Vermeire, S.(2);D'Haens, G.(3);Panés, J.(4);Dignass, A.(5);Magro, F.(6,7);Nazar, M.(8);Le Bars, M.(9);Lahaye, M.(10);Ni, L.(11);Bravatà, I.(12);Gaya, D.R.(13);Peyrin-Biroulet, L.(14);
(1)Humanitas University, IBD Center, Milan, Italy;(2)University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium;(3)University of Amsterdam, Academic Medical Center, Amsterdam, The Netherlands;(4)Hospital Clinic of Barcelona- IDIBAPS- CIBERehd, Department of Gastroenterology, Barcelona, Spain;(5)Agaplesion Markus Hospital, Department of Medicine I, Frankfurt/Main, Germany;(6)Institute for Molecular and Cell Biology- Faculty of Medicine University of Porto, Department of Pharmacology & Therapeutics, Porto, Portugal;(7)Hospital de São João, Department of Gastroenterology, Porto, Portugal;(8)Janssen-Cilag Polska Sp. z .o.o., Medical Affairs, Warsaw, Poland;(9)Janssen-Cilag, Medical Affairs, Issy-les-Moulineaux, France;(10)Janssen-Cilag BV, Medical Affairs, Breda, The Netherlands;(11)Janssen Cilag Russia, Medical Affairs, Moscow, Russian Federation;(12)Janssen-Cilag, Medical Affairs, Milan, Italy;(13)Glasgow Royal Infirmary, Department of Gastroenterology, Glasgow, United Kingdom;(14)University Hospital of Nancy- University of Lorraine, INSERM Unité 954 and Department of Hepato-Gastroenterology, Houdemont, France
A treat-to-target (T2T) strategy may optimize inflammatory bowel disease management. The STARDUST trial compared a T2T maintenance strategy against standard of care (SoC) in Crohn’s disease (CD) patients treated with ustekinumab (UST). The primary endpoint, safety, and efficacy data of STARDUST have been published previously.1 Here we present results for health-related quality of life (HRQoL) measures and impact of UST on work and activities at Week (W)48 of UST maintenance, comparing T2T and SoC.
Adult patients with moderate–severely active CD received iv, weight-based UST ~6 mg/kg at W0 (baseline [BL]); then SC UST 90 mg at W8. At W16, CD activity index (CDAI) 70 responders were randomized (1:1) to either T2T (maintenance dosing, q12w or q8w, assigned based on endoscopic activity and further dose escalations up to q4w if clinical and biomarker-directed targets were not met) or SoC (maintenance based on EU SmPC; q12w or q8w based on clinical judgement). In this analysis we assessed changes from BL in the following HRQoL measures at W48: Inflammatory Bowel Disease Questionnaire (IBDQ), EuroQoL 5 Dimension 5 Level (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) tools, and Hospital Anxiety and Depression Scale – anxiety and depression subscales (HADS-A and -D) alongside the Work Productivity and Activity Impairment (WPAI) questionnaire; time lost from work was also recorded. Percentage of patients with IBDQ response (16‑point improvement from BL) and remission (IBDQ score ≥170) at W48 were also analysed.
Of 500 patients enrolled, 441 were randomized to T2T (n=220) or SoC (n=221); 79.1% and 87.3%, respectively, completed W48. At W48, the percentage of patients in T2T and SoC arms with IBDQ response (58.2% and 67.0%, respectively) and remission (45.0% and 53.4%, respectively) were similar (both p=ns). Similar changes from BL at W48 in IBDQ, EQ-5D-5L (visual analogue scale and index score), FACIT-F, HADS-A and -D and WPAI were noted in both treatment arms (Table 1). WPAI 7-Point Improvement from BL per domain at W48 are presented in Table 2. During the last 4 weeks preceding the visit at W48, patients in T2T and SoC arms on average lost 1.7 and 2.2 fewer days from work due to CD, respectively, compared to BL (p=ns). At W48, 62.3% and 72.3% were in employment in T2T and SoC arms, respectively (p=ns), compared to 61.8% and 63.5%, respectively at BL.
UST treatment improved HRQoL and work productivity and helped decrease time lost from work in patients with moderate-to-severe CD, regardless of T2T or SoC strategy. Improvements were generally maintained up to W48.
1. Danese S, et al. United European Gastroenterol J. 2020;8:1264–1265 (Abstract LB11).