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
. 2025 Aug 8.
doi: 10.1111/apt.70312. Online ahead of print.

Frequency and Effectiveness of Dose Escalation and De-Escalation of Biologic Therapy in Inflammatory Bowel Disease: The RAINBOW-IBD Study of ENEIDA

Cristina Rubín de Célix  1 , Elena Ricart  2 , M Dolores Martín-Arranz  3 , Ruth de Francisco  4 , Francisco Javier García-Alonso  5 , Francisco Mesonero  6 , Fernando Gomollón  7   8 , Luisa de Castro  9 , Laura Ramos  10 , Santiago García-López  11 , Lara Arias  12 , Miriam Mañosa  13 , Eva Iglesias  14 , Xavier Calvet  15   16   17 , Carles Suria Bolufer  18 , María José Casanova  19 , José Lázaro Pérez-Calle  20 , Antonio Giordano  21 , Mónica Sierra-Ausín  22 , Isabel Vera  23 , Mercè Navarro-Llavat  24 , Rufo Lorente  25 , Marta Piqueras  26 , Montserrat Rivero  27 , Jordi Guardiola  28 , María Esteve  29 , Ana Fuentes Coronel  30 , Iago Rodríguez-Lago  31 , Ángel Ponferrada-Díaz  32 , Yolanda Ber  33 , Carlos Tardillo  34 , Lucía Márquez  35   36 , Daniel Carpio  37 , Carlos Taxonera  38 , Fernando Bermejo  1 , David Busquets  39 , Blau Camps  40 , Ana Gutiérrez  41 , Mariana Fe García-Sepulcre  42 , Manuel Barreiro-de Acosta  43 , Ignacio Marín-Jiménez  44 , José M Huguet  45 , Luis Ignacio Fernández-Salazar  46 , Jordina Jaó  47 , Cristina Rodríguez-Gutiérrez  48 , Carlos Martínez-Flores  49 , Luis Bujanda  50 , Alfredo J Lucendo  51   52 , Eva Sesé  53 , Pilar Robledo Andrés  54 , Daniel Ginard  55 , Pablo Vega  56 , Joan Riera  57 , Ramón Pajares  58 , Manuel Van Domselaar  59 , Pedro Almela  60 , Teresa Martínez Pérez  61 , Carmen Muñoz-Villafranca  62 , Pilar Varela  63 , Federico Argüelles-Arias  64 , Pilar Nos  65 , Guillermo Alcaín  66 , Luis Hernández  67 , Hipólito Fernández  68 , Fernando Muñoz  69 , Pau Gilabert  70 , Victor Manuel Navas-López  71 , Patricia Ramírez de la Piscina  72 , Lidia Buendía Sánchez  73 , Jesús Legido Gil  74 , Gemma Valldosera  75 , Rosa Ana Muñoz  76 , Santiago Frago  77 , Eugeni Domènech  12 , María Chaparro  19 , Javier P Gisbert  19
Affiliations

Frequency and Effectiveness of Dose Escalation and De-Escalation of Biologic Therapy in Inflammatory Bowel Disease: The RAINBOW-IBD Study of ENEIDA

Cristina Rubín de Célix et al. Aliment Pharmacol Ther. .

Abstract

Background: Real-world data on dose escalation/de-escalation in inflammatory bowel disease (IBD) are scarce.

Aims: To assess the frequency, effectiveness and durability of escalation/de-escalation of infliximab, adalimumab, golimumab, vedolizumab and ustekinumab in IBD, and to identify factors influencing relapse and drug discontinuation and re-escalation efficacy.

Methods: We included patients from the ENEIDA registry of GETECCU who were exposed to biologics and analysed escalations/de-escalations. We assessed the impact of variables on durability, drug discontinuation and relapse after escalation/de-escalation.

Results: Of 19,720 patients on biologics, 5096 (26%) underwent dose escalation. Frequency of escalation per patient-year was 5% (infliximab), 7% (adalimumab), 7% (golimumab), 10% (vedolizumab) and 12% (ustekinumab). Clinical remission was recaptured in 32%-49% of patients. Durability of escalation (24 months) ranged from 66% to 88%. Drug discontinuation was associated with previous biologic exposure and disease duration (infliximab), monotherapy (adalimumab) and ulcerative colitis (ustekinumab). There were 669 de-escalations. The frequency per patient-year was 6%, 9%, 5%, 6% and 3% for infliximab, adalimumab, golimumab, vedolizumab and ustekinumab. Maintenance of remission after de-escalation was observed in 75%-100%. Durability of de-escalation (12 months) was 82%-90%. Factors associated with relapse were biologic exposure (infliximab) and age at de-escalation (adalimumab). Re-escalation benefited most patients.

Conclusions: In the long term, some patients with IBD need biologic escalation, which frequently recaptures durable clinical remission. De-escalation is feasible in some patients. Re-escalation is generally effective after relapse.

Keywords: biologics; dose escalation; inflammatory bowel disease.

PubMed Disclaimer

References

    1. C. Gomez‐Labrador, E. Ricart, M. Iborra, et al., “Trends in Targeted Therapy Usage in Inflammatory Bowel Disease: TRENDY Study of ENEIDA,” Pharmaceutics 16 (2024): 629.
    1. L. Guberna, O. P. Nyssen, M. Chaparro, and J. P. Gisbert, “Frequency and Effectiveness of Empirical Anti‐TNF Dose Intensification in Inflammatory Bowel Disease: Systematic Review With Meta‐Analysis,” Journal of Clinical Medicine 10 (2021): 2132.
    1. L. Peyrin‐Biroulet, S. Danese, M. Argollo, et al., “Loss of Response to Vedolizumab and Ability of Dose Intensification to Restore Response in Patients With Crohn's Disease or Ulcerative Colitis: A Systematic Review and Meta‐Analysis,” Clinical Gastroenterology and Hepatology 17 (2019): 838–846.e2.
    1. E. Shmidt, G. Kochhar, J. Hartke, et al., “Predictors and Management of Loss of Response to Vedolizumab in Inflammatory Bowel Disease,” Inflammatory Bowel Diseases 24 (2018): 2461–2467.
    1. R. S. Dalal, J. C. Pruce, and J. R. Allegretti, “Long‐Term Outcomes After Ustekinumab Dose Intensification for Inflammatory Bowel Diseases,” Inflammatory Bowel Diseases 29 (2022): 830–833.

Grants and funding