TY - JOUR
T1 - Ustekinumab improves health-related quality of life in patients with moderate-to-severe Crohn's disease
T2 - Results up to Week 104 of the STARDUST trial
AU - Panés, Julian
AU - Vermeire, S. verine
AU - D'Haens, Geert R.
AU - Danese, Silvio
AU - Magro, Fernando
AU - Nazar, Maciej
AU - le Bars, Manuela
AU - Lahaye, Marjolein
AU - Ni, Lioudmila
AU - Bravatà, Ivana
AU - Gaya, Daniel R.
AU - Peyrin-Biroulet, Laurent
AU - the STARDUST study group
AU - Dignass, Axel
N1 - Funding Information: Janssen‐Cilag Limited and the authors thank the patients who participated in STARDUST, and all study investigators and their research teams for their contributions. Under the direction of the authors and in accordance with Good Publication Practices, Pedro de Campos Silva, PhD, of Lumanity provided medical writing assistance. Janssen‐Cilag funded the study and participated in the study design, interpretation of data, review and approval of the publication. Medical writing and editorial support were provided by Lumanity, funded by Janssen. Publisher Copyright: © 2023 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.
PY - 2023/6
Y1 - 2023/6
N2 - Background: STARDUST is a phase 3b randomized controlled trial comparing two ustekinumab treatment strategies in patients with Crohn's disease (CD): treat-to-target (T2T) versus standard of care (SoC). Objective: We investigated the effect of a T2T or SoC ustekinumab treatment strategy on health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) over a 2-year follow-up period. Methods: At Week 16, adult patients with moderate-to-severe active CD were randomized 1:1 to either T2T or SoC treatment groups. We assessed changes from baseline in HRQoL measures (Inflammatory Bowel Disease Questionnaire [IBDQ], EuroQoL 5-dimension 5-level [visual analogue scale and index], Functional Assessment of Chronic Illness Therapy-Fatigue, Hospital Anxiety and Depression Scale-Anxiety and -Depression) and the WPAI questionnaire in two patient populations: randomized analysis set (RAS, patients randomized to either T2T or SoC at Week 16 and completed Week 48) and modified RAS (mRAS, patients who entered the long-term extension [LTE] period at Week 48). Results: At Week 16, 440 patients were randomized to T2T (n = 219) or SoC (n = 221) arms; 366 patients completed Week 48. Of these, 323 patients entered the LTE and 258 patients completed 104 weeks of treatment. In the RAS population, percentages of patients achieving IBDQ response and remission were not significantly different between treatment arms at Weeks 16 and 48. In the overall mRAS population, IBDQ response and remission increased over time from Weeks 16–104. In both populations, improvements from baseline in all HRQoL measurements were observed at Week 16 and maintained until either Week 48 or Week 104, respectively. In both populations, improvements from baseline in T2T and SoC arms at Weeks 16, 48 or 104 in WPAI domains were observed. Conclusion: Independent of treatment strategy (T2T or SoC), ustekinumab was effective in improving HRQoL measurements and WPAI over a period of 2 years.
AB - Background: STARDUST is a phase 3b randomized controlled trial comparing two ustekinumab treatment strategies in patients with Crohn's disease (CD): treat-to-target (T2T) versus standard of care (SoC). Objective: We investigated the effect of a T2T or SoC ustekinumab treatment strategy on health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) over a 2-year follow-up period. Methods: At Week 16, adult patients with moderate-to-severe active CD were randomized 1:1 to either T2T or SoC treatment groups. We assessed changes from baseline in HRQoL measures (Inflammatory Bowel Disease Questionnaire [IBDQ], EuroQoL 5-dimension 5-level [visual analogue scale and index], Functional Assessment of Chronic Illness Therapy-Fatigue, Hospital Anxiety and Depression Scale-Anxiety and -Depression) and the WPAI questionnaire in two patient populations: randomized analysis set (RAS, patients randomized to either T2T or SoC at Week 16 and completed Week 48) and modified RAS (mRAS, patients who entered the long-term extension [LTE] period at Week 48). Results: At Week 16, 440 patients were randomized to T2T (n = 219) or SoC (n = 221) arms; 366 patients completed Week 48. Of these, 323 patients entered the LTE and 258 patients completed 104 weeks of treatment. In the RAS population, percentages of patients achieving IBDQ response and remission were not significantly different between treatment arms at Weeks 16 and 48. In the overall mRAS population, IBDQ response and remission increased over time from Weeks 16–104. In both populations, improvements from baseline in all HRQoL measurements were observed at Week 16 and maintained until either Week 48 or Week 104, respectively. In both populations, improvements from baseline in T2T and SoC arms at Weeks 16, 48 or 104 in WPAI domains were observed. Conclusion: Independent of treatment strategy (T2T or SoC), ustekinumab was effective in improving HRQoL measurements and WPAI over a period of 2 years.
KW - Crohn's disease
KW - health-related quality of life
KW - standard of care
KW - tight monitoring
KW - treat-to-target
KW - ustekinumab
UR - http://www.scopus.com/inward/record.url?scp=85158857901&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ueg2.12384
DO - https://doi.org/10.1002/ueg2.12384
M3 - Article
C2 - 37139642
SN - 2050-6406
VL - 11
SP - 410
EP - 422
JO - United European gastroenterology journal
JF - United European gastroenterology journal
IS - 5
ER -