Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2022 Nov 2;28(11):1725-1736.
doi: 10.1093/ibd/izab357.

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study

María Chaparro  1 , Iria Baston-Rey  2 , Estela Fernández-Salgado  3 , Javier González García  4 , Laura Ramos  5 , María Teresa Diz-Lois Palomares  6 , Federico Argüelles-Arias  7 , Eva Iglesias Flores  8 , Mercedes Cabello  9 , Saioa Rubio Iturria  10 , Andrea Núñez Ortiz  11 , Mara Charro  12 , Daniel Ginard  13 , Carmen Dueñas Sadornil  14 , Olga Merino Ochoa  15 , David Busquets  16 , Eduardo Iyo  17 , Ana Gutiérrez Casbas  18   19 , Patricia Ramírez de la Piscina  20 , Marta Maia Boscá-Watts  21 , Maite Arroyo  22 , María José García  23 , Esther Hinojosa  24 , Jordi Gordillo  25 , Pilar Martínez Montiel  26 , Benito Velayos Jiménez  27 , Cristina Quílez Ivorra  28 , Juan María Vázquez Morón  29 , José María Huguet  30 , Yago González-Lama  31 , Ana Isabel Muñagorri Santos  32 , Víctor Manuel Amo  33 , María Dolores Martín-Arranz  34 , Fernando Bermejo  35 , Jesús Martínez Cadilla  36 , Cristina Rubín de Célix  1 , Paola Fradejas Salazar  37 , Antonio López San Román  38 , Nuria Jiménez  39 , Santiago García López  40 , Anna Figuerola  41 , Itxaso Jiménez  42 , Francisco José Martínez Cerezo  43 , Carlos Taxonera  44 , Pilar Varela  45 , Ruth de Francisco  46 , David Monfort  47 , Gema Molina Arriero  48 , Alejandro Hernández Camba  49 , Francisco Javier García-Alonso  50 , Manuel Van Domselaar  51 , Ramón Pajares Villarroya  52 , Alejandro Núñez  53 , Francisco Rodríguez Moranta  54 , Ignacio Marín-Jiménez  55   56 , Virginia Robles Alonso  57 , María Del Mar Martín Rodríguez  58 , Patricia Camo-Monterde  59 , Iván García Tercero  60 , Mercedes Navarro Llavat  61 , Lara Arias García  62 , Daniel Hervías Cruz  63 , Sara Sulleiro  64 , Cynthia Novella  64 , Eugenia Vispo  64 , Manuel Barreiro-de Acosta  2 , Javier P Gisbert  1
Affiliations
Multicenter Study

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study

María Chaparro et al. Inflamm Bowel Dis. .

Abstract

Background: Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice.

Methods: A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety.

Results: A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever).

Conclusions: Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.

Keywords: Crohn’s disease; effectiveness; real-world evidence; safety; ustekinumab.

Plain language summary

This large retrospective study demonstrated the short- and long-term effectiveness and safety of ustekinumab in patients with Crohn’s disease in real-world clinical practice, including those with refractory disease.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
A and B, Survival curve of patients who maintained ustekinumab treatment over time and maintained clinical remission over time.
Figure 2.
Figure 2.
Ustekinumab retention based on the concomitant use of immunosuppressive therapy.
Figure 3.
Figure 3.
Short-term effectiveness of ustekinumab at weeks 8 and 16.
See this image and copyright information in PMC

References

    1. Baumgart DC, Sandborn WJ.. Crohn’s disease. Lancet. 2012;380:1590–1605. - PubMed
    1. Veauthier B, Hornecker JR.. Crohn’s disease: diagnosis and management. Am Fam Physician. 2018;98:661–669. - PubMed
    1. Wilson JC, Furlano RI, Jick SS, Meier CR.. Inflammatory bowel disease and the risk of autoimmune diseases. J Crohns Colitis. 2016;10:186–193. - PubMed
    1. Xavier RJ, Podolsky DK.. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007;448:427–434. - PubMed
    1. Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ.. The natural history of adult Crohn’s disease in population-based cohorts. Am J Gastroenterol. 2010;105:289–297. - PubMed

Publication types