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SHORT-TERM EFFECTIVENESS AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS: REAL-WORLD EVIDENCE FROM THE ENEIDA REGISTRY OF GETECCU

Ana Gutiérrez-Casbas 1, Cristina Rodríguez Gutiérrez 2, Jose Maria Huguet 3, Manuel Barreiro de Acosta 4, Rosario Antón Ausejo 5, Yolanda Ber Nieto 6, Sonsoles Olivares 7, María Dolores Martín-Arranz 8, Monica Sierra 9, Maria Luisa De Castro Parga 10, Fernando Bermejo 11, Andrea Coatina 12, Pilar Varela Trastoy 13, Lucía Madero 14, Oscar Moralejo Lozano 15, Ignacio Marín-Jiménez 16, Ana Maria Trapero-Martínez 17, Agnès Fernández-Clotet 18, José Joaquín Ramirez Palanca 19, SABINO RIESTRA MENENDEZ 20, Daniel Sebastian Ceballos Santos 21, Yamile Zabana 22, Daniel Robles-Osa 23, Rosa Gómez-Espín 24, Francisco Rodriguez-Moranta. 25, Noemí Manceñido Marcos 26, Juan Angel Ferrer 27, Ainara Elorza 28, Ángel Ponferrada-Díaz 29, Orlando Garcia-Bosch 30, Elena Betoré 31, Marta Isabel Calvo Moya 32, Natalia Marcos Carrasco 33, Mariam Aguas 34, María Angeles Mejías 35, Eduard Brunet 36, Margarita Menacho 37, Eva Sesé 38, Luis Hernández Villalba 39, David Busquets Casals 40, manuela sampedro 41, Lucía Márquez-Mosquera 42, Raquel Mena 43, Daniel Martín-Rodríguez 44, María Teresa Diz-Lois Palomares 45, Eugeni Domenech Morral 46, Iago Rodríguez-Lago 47

Affiliations

1 Hospital General Universitario Dr Balmis Alicante. ISABIAL. CIBERehd, Alicante, Spain

2 Hospital Universitario de Navarra and Instituto de Investigación Sanitaria de Navarra (IdisNa), Navarra, Spain

3 Consorcio Hospital General Universitario de València, Valencia, Spain

4 Complexo Hospitalario Universitario de Santiago de Compostela and Santiago de Compostela Health Research Institute, Santiago de Compostela, Santiago de Compostela, Spain

5 Hospital Clínico Universitario de Valencia, Valencia, Spain

6 Hospital Clínico Universitario “Lozano Blesa”, IIS Aragón and CIBEREHD, Zaragoza., Zaragoza, Spain

7 Hospital Universitario 12 Octubre de Madrid, Madrid, Spain

8 Hospital Universitario La Paz de Madrid, Madrid, Spain

9 Complejo Asistencial Universitario de León, León, Spain

10 Complexo Hospitalario Universitario de Vigo (CHUVI), Sergas. Grupo de Investigación en Patología Digestiva, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur), Vigo, Spain

11 Hospital Universitario de Fuenlabrada, Madrid, Spain

12 Hospital Miguel Servert de Zaragoza, Zaragoza, Spain

13 Hospital Universitario de Cabueñes, Asturias, Spain

14 Hospital General Universitario Dr Balmis Alicante.ISABIAL, Alicante, Spain

15 Complejo Hospitalario de Toledo, Madrid, Spain

16 Hospital Gregorio Marañón, Madrid, Spain

17 Hospital Universitario de Jaén, Jaen, Spain

18 Hospital Clínic Barcelona. Fundació Recerca Clínic Barcelona-Institut Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and CIBEREHD, Barcelona, Barcelona, Spain

19 Hospital Lluis Alcanyis (Xativa), Algemesí, Spain

20 19Hospital Universitario Central de Asturias and Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Oviedo, Spain

21 Hospital Universitario de Gran Canaria Dr. Negrín and HUGCDN, Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

22 Hospital Universitari Mútua Terrassa. CIBERehd., Terrassa, Spain

23 Complejo Asistencial Universitario de Palencia, Palencia, Spain

24 Hospital Universitario Reina Sofía de Murcia, Murcia, Spain

25 Hospital Universitari de Bellvitge and Institut d’Investigació Biomédica de Bellvitge, L’Hospitalet de Llobregat, L’Hospitalet de Llobregat, Barcelona, Spain

26 Hospital Universitario Infanta Sofía. Facultad de Medicina, Universidad Europea de Madrid, San Sebastian de los Reyes, Madrid, Spain

27 Hospital Fundacion Alcorcon, Alcorcon, Spain

28 Hospital Universitario de Galdakao, Biobizkaia Health Research Institute, Galdakao, Galdakao, Spain

29 Hospital Universitario Infanta Leonor, Madrid, Spain

30 Complex Hospitalari Universitari Moisès Broggi. Sant Joan Despí, Sant Joan Despí, Spain

31 Hospital Universitario San Jorge, Huesca, Spain

32 Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain

33 Hospital Universitario Río Hortega, Valladolid, Spain

34 La Fe Universitary And Politecnic Hospital, Valencia, Spain

35 Hospital General Universitario de Ciudad Real, Ciudad Real, Spain

36 Parc Taulí, Hospital Universitari, Institut d´Investigació i Innovació Parc Taulí, Departament de Medicina, Universitat Autònoma de Barcelona, and CIBEREHD, Sabadell, Sabadell, Spain

37 Hospital Universitario de Tarragona Juan XXIII, Tarragona, Spain

38 Hospital Universitario Arnau de Vilanova, Lleida, Spain

39 Hospital de los Santos Reyes, Aranda de Duero, Spain

40 H. DE GIRONA DR. J. TRUETA/ICO GERONA, Girona, Spain

41 Hospital de Mataró, Mataró, Spain

42 Hospital de Mar, Barcelona and Hospital del Mar Research Institute, Barcelona, Spain

43 Hospital Universitari Consorci Sanitari de Terrassa, Terrassa, Spain

44 Hospital Infanta Cristina, Parla, Spain

45 Hospital Universitario de A Coruña (CHUAC), A Coruña, Spain

46 Hospital Germans Trias i pujol. CIBERehd, Badalona, Barcelona, Spain

47 Hospital Universitario de Galdakao, Biobizkaia Health Research Institute, Galdakao, Bilbao, Spain

Summary

AI Generated

Real-world study of 171 ulcerative colitis patients from 43 Spanish hospitals shows mirikizumab achieved 30% clinical remission at week 12 in a highly treatment-refractory population.

Clinical remission rates were 26% at week 8 and 30% at week 12, with clinical response rates of 44% and 45% respectively, in patients with median partial Mayo score 5 at baseline.
The cohort was highly refractory with 89% prior anti-TNF exposure, 69% vedolizumab, 54% ustekinumab, 40% JAK inhibitors, and 54% exposed to more than 2 mechanisms of action.
Prior exposure to only 1 mechanism of action was associated with significantly higher week-12 remission rates compared to 2 or more mechanisms (65% vs 25% and 27%, p=0.04 and p=0.02).
Faecal calprotectin decreased significantly from 557 ug/g at baseline to 160 ug/g at week 12 (p=0.001), with hospitalization rate 5.8% and colectomy rate 1.7%.
Safety profile was favorable with 10% reporting adverse events and only one severe event; this real-world data is most relevant for clinicians managing highly treatment-experienced ulcerative colitis patients.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Mirikizumab (MIRI) has shown promising results in ulcerative colitis (UC) based on the data from the pivotal clinical trials (LUCENT). However, these results still need to be validated in clinical practice.

Aims & Methods

This study aims to assess the short-term real-world effectiveness and safety of MIRI in patients with UC.
All patients with UC who received MIRI and without previous colectomy included in the prospectively-maintained ENEIDA registry were included. Clinical disease activity was assessed by partial Mayo score (pMS). The primary outcome was clinical remission (defined as pMS ≤2 with no subscore >1 and no rectal bleeding) at week 8 and 12, alongside its safety profile.

Results

A total of 171 patients from 43 Spanish hospitals were included (mean age of 49.5 years [SD 18], 54% male, median disease duration of 128 months [SD 97], 55% non-smokers, 62% extensive colitis. Concomitant therapy at baseline included 44% with steroids and 7.6% with immunosuppressants. Prior advanced therapies exposure was: 89% Anti-TNF, 69% vedolizumab, 54% ustekinumab, and 40% JAK inhibitors, with 54% exposed to > 2 mechanisms of action (MoA). At baseline patients had a median pMS 5 (IQR, 4-7) and faecal calprotectin of 557 ug/g (IQR, 120-1000). All but one patient started MIRI 300 mg iv every 4 weeks. Mean follow-up was 5.3 (SD 4.4) months. Clinical response and clinical remission at week 8 were 44% and 26%, respectively, and this increased up to 45% and 30% at week 12. Clinical remission rate at week 12 was higher among those with prior exposure to 1 MoA vs 2 or more than 2 (65%, 25%, 27% respectively, p=0.04, p=0.02). Previous exposure to ustekinumab was associated with a numerically lower, not statistically significant, rate of clinical remission at week 12 (28% vs. 38%, p=0.4). Faecal calprotectin significantly decreased at week 12 (160 ug/g [IQR, 54-852], p=0.001). The overall hospitalization and colectomy rates were 5.8% and 1.7% respectively. MIRI was generally well tolerated, with 10% of patients reporting at least one adverse event, but only one of them categorized as severe.

Conclusion

MIRI demonstrated its real-life effectiveness in the short-term, even in a highly-refractory cohort. Prior advanced therapy exposure to more than one MoA significantly impacts the effectiveness of MIRI during the induction. Safety was consistent with the known profile of this drug.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Real-world evidence in ulcerative colitis (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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