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. 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.

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References

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