United European Gastroenterol J. 2023 Jun;11(5):410-422.doi: 10.1002/ueg2.12384. Epub 2023 May 4.

Julian Panés ¹, Séverine Vermeire ², Geert R D'Haens ³, Silvio Danese ⁴, Fernando Magro ^5 6, Maciej Nazar ⁷, Manuela Le Bars ⁸, Marjolein Lahaye ⁹, Lioudmila Ni ¹⁰, Ivana Bravatà ¹¹, Daniel R Gaya ¹², Laurent Peyrin-Biroulet ^13 14, Axel Dignass ¹⁵; STARDUST study group

Author information

¹Department of Gastroenterology, Hospital Clinic of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

²Department of Gastroenterology & Hepatology, University Hospitals Leuven, Leuven, Belgium.

³Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

⁴Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.

⁵Department of Pharmacology & Therapeutics, Institute for Molecular and Cell Biology, Faculty of Medicine University of Porto, Porto, Portugal.

⁶Department of Gastroenterology, Hospital de São João, Porto, Portugal.

⁷Janssen-Cilag Polska Sp. z o.o., Warsaw, Poland.

⁸Janssen-Cilag, Issy-les-Moulineaux, France.

⁹Janssen-Cilag BV, Breda, The Netherlands.

¹⁰Janssen Cilag Russia, Moscow, Russian Federation.

¹¹Janssen-Cilag, Milan, Italy.

¹²Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.

¹³University of Lorraine, INSERM, NGERE, Nancy, France.

¹⁴Groupe Hospitalier Privé Ambroise Paré - Hartmann, Paris IBD Center, Neuilly sur Seine, France.

¹⁵Department of Medicine I, Agaplesion Markus Hospital, Frankfurt/Main, Germany.

Abstract

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.