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IMPACT OF USTEKINUMAB ON EXTRAINTESTINAL MANIFESTATIONS AND IMMUNOMEDIATED DISEASES IN A COHORT OF PATIENTS WITH ULCERATIVE COLITIS IN REAL LIFE: THE ULISES STUDY

María Chaparro 1, Sandra Hermida 1, Diana Acosta 1, Agnès Fernández-Clotet 2, Manuel Barreiro de Acosta 3, Alvaro Hernández Martínez 4, Teresa Arroyo Villarino 5, Luis Menchén 6, Carmen Muñoz Villafranca 7, Monica Sierra 8, SABINO RIESTRA MENENDEZ 9, Irene García de la filia Molina 10, Enrique Montil Miguel 11, Patricia Ramírez de la Piscina Urraca 12, María Dolores Martín-Arranz 13, Alexandra Ruiz-Cerulla 14, Jose Fernando Muñoz Nuñez 15, Ramón Pajares Villarroya 16, Beatriz Sicilia Aladrén 17, Ángel Ponferrada-Díaz 18, Elena Gomez 19, Horacio Alonso-Galán 20, Maria Jose Cabello Tapia 21, Pilar Varela Trastoy 22, Mª Teresa Diz-Lois Palomares 23, Leticia Gimeno 24, Lucía Márquez-Mosquera 25, Cynthia Ramírez 26, Carmen Dueñas Sadornil 27, Belen Herreros 28, Oscar Nantes Castillejo 29, Montserrat Rivero 30, Belen Botella 31, Pedro Genaro Delgado-Guillena 32, María Pilar López-Serrano 33, Iago González Lama 34, Jose Luis Fernandez Forcelledo 35, Teresa de Jesús Martínez-Pérez 36, David Monfort Miquel 37, MAría del Carmen Rodríguez Grau 38, Jose Maria Huguet 39, Rosa Eva Madrigal Dominguez 40, Pau Sendra Rumbeu 41, Sandra Torra Alsina 42, Manuel Van Domselar 43, Yolanda Ber Nieto 44, Santiago Frago-Larramona 45, Carmen López 46, Javier P. Gisbert 1

Affiliations

1 Hospital Universitario de La Princesa, IIS-Princesa, Universidad Autónoma de Madrid (UAM) and CIBEREHD, Madrid, Spain

2 Hospital Clinic of Barcelona, Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and CIBERehd, Barcelona, Spain

3 Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain

4 Hospital Universitario Torrecárdenas, Almeria, Spain

5 Hospital Clínico Universitario Lozano Blesa, IIS Aragón and CIBEREHD, Zaragoza, Spain

6 Hospital General Universitario Gregorio Marañón, Madrid, Spain

7 Hospital Universitario de Basurto, Bilbao, Spain

8 Complejo Asistencial Universitario de León, León, Spain

9 Hospital Universitario Central de Asturias and ISPA, Oviedo, Spain

10 Hospital Universitario Ramón y Cajal, Madrid, Spain

11 Hospital Universitario Miguel Servet, Zaragoza, Spain

12 Hospital Universitario de Araba, Araba, Spain

13 Hospital Universitario la Paz, Madrid, Spain

14 Hospital Universitario de Bellvitge, L' Hospitalet de Llobregat, Spain

15 Hospital Universitario de Salamanca, Salamanca, Spain

16 Hospital Universitario Infanta Sofía, Madrid, Spain

17 Hospital Universitario de Burgos, Burgos, Spain

18 Hospital Universitario Infanta Leonor, Madrid, Spain

19 Hospital Universitario Juan Ramón Jiménez, Huelva, Spain

20 Hospital Universitario Donostia and Instituto Biodonostia, San Sebastián, Spain

21 Hospital Universitario Virgen de las Nieves, Granada, Spain

22 Hospital Universitario de Cabueñes, Gijón, Spain

23 Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

24 Hospital General Universitario de Castellón, Castellón, Spain

25 Hospital del Mar, Barcelona and IMIM, Barcelona, Spain

26 Hospital Universitario Galdakao-Usansolo, Galdakao, Spain

27 Hospital Universitario de Cáceres, Cáceres, Spain

28 Hospital Marina Baixa, Alicante, Spain

29 Hospital Universitario de Navarra (HUN) and IdiSNA, Pamplona, Spain

30 Hospital Universitario de Valdecilla and IDIVAL, Santander, Spain

31 Hospital Universitario Infanta Cristina, Madrid, Spain

32 Hospital de Mérida, Mérida, Spain

33 Hospital Universitario Fundación Alcorcón, Alcorcón, Spain

34 Hospital Universitario Puerta de Hierro, Majadahonda, Spain

35 Hospital Sierrallana, Torrelavega, Spain

36 Hospital Virgen de la Luz, Cuenca, Spain

37 Consorci Sanitari de Terrassa, Terrassa, Spain

38 Hospital Universitario del Henares, Coslada, Spain

39 Hospital General Universitario de Valencia, Valencia, Spain

40 Hospital Clínico Universitario de Valladolid, Valladolid, Spain

41 Hospital Comarcal de Inca, Inca, Spain

42 Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain

43 Hospital Universitario de Torrejón, Torrejón, Spain

44 Hospital San Jorge, Huesca, Spain

45 Hospital Santa Barbara, Soria, Spain

46 Hospital Virgen de la Concha, Zamora, Spain

Summary

AI Generated

In a multicenter cohort of 376 heavily pre-treated ulcerative colitis patients, ustekinumab was associated with improvement in disease-activity-related extraintestinal manifestations while some non-disease-related immune-mediated conditions worsened, and new-onset extraintestinal manifestations occurred in 4% of patients.

Among 65 patients with active extraintestinal manifestations or immune-mediated diseases at ustekinumab start, outcomes varied by condition: peripheral arthropathy showed 23% remission and 31% improvement, psoriasis showed 64% remission and 9% improvement, while rheumatoid arthritis showed 50% worsening and axial spondyloarthropathy showed 38% worsening.
New extraintestinal manifestations or immune-mediated diseases developed in 15 patients (4%) after starting ustekinumab, most commonly peripheral arthropathy (1.6%) and other conditions (1.6%).
The study population was heavily pre-treated with 91% having prior multiple surgeries score greater than 2, 96% previously exposed to biologics, and 25% having failed anti-TNF, vedolizumab, and tofacitinib.
Authors concluded that improvement was observed in manifestations related to ulcerative colitis activity, while conditions not related to disease activity such as axial spondyloarthropathy, uveitis, and rheumatoid arthritis worsened, and ustekinumab treatment did not appear associated with increased risk of developing new extraintestinal manifestations or immune-mediated diseases.

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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

A significant proportion of patients with inflammatory bowel diseases (IBD) have extraintestinal manifestations (EIM), which may be very disabling. The presence of EIM and immunomediated diseases (IMIDs) may influence the selection of the biologic agent. On the other hand, biologic agents have been associated with the onset of IMIDs.

Aims & Methods

Aim: To evaluate the impact of ustekinumab on EIMs and IMIDs in a cohort of ulcerative colitis (UC) patients in real life.
Methods: Retrospective, multicenter study including UC patients who had received the first ustekinumab dose at least 16 weeks before the inclusion. Patients were followed-up from the first ustekinumab dose to treatment discontinuation or last visit, whichever came first. The evolution of previous EIMs and IMIDs was evaluated based on clinicians’ judgment. The onset of new EIMs and IMIDs under ustekinumab treatment was recorded.

Results

376 patients have been included so far (91% had PMS >2 at ustekinumab initiation, 96% had been previously exposed to biologics, and 25% had failed to anti-TNF, vedolizumab and tofacitinib). Median follow-up was 12 months (m). A total of 122 patients (32%) had previous EIM and/or IMIDs at ustekinumab start. A total of 80 patients (21%) had at least one EIM and/or IMIDs inactive at ustekinumab start, being the most frequent ones peripheral arthropathy (5%), axial spondyloarthropathy (3%) and psoriasis (3%). Some patients worsened from these conditions: a patient (6%) with peripheral arthropathy (partial response of UC), 2 (15%) patients with axial spondyloarthropathy (one in remission and one non-responder), a patient (33%) with rheumatoid arthritis (non-responder) and a patient (20%) with uveitis (non-responder). A total of 65 patients (17%) had active EIM and/or IMIDs at ustekinumab start; the outcomes of these patients are summarized in table 1. A total of 15 patients (4%) developed EIM and/or IMIDs after ustekinumab start: 6 (1.6%) patients developed peripheral arthropathy, 2 (0.5%) patients erythema nodosum, a patient (0.3%) was diagnosed with primary sclerosing cholangitis, a patient (0.3%) was diagnosed with vasculitis, and 6 (1.6%) patients developed other conditions.

EIM and/or IMIDs active at ustekinumab start
	n (%)	Outcome attributable to ustekinumab treatment
Peripheral arthropathy	35 (9)	8 (23%) remission, 11 (31%) improvement, 16 (46%) no change
Psoriatic arthritis	2 (0.5)	1 (50%) improvement, 1 (50%) no change
Rheumatoid arthritis	4 (1)	2 (50%) no change, 2 (50%) worsening
Primary sclerosing cholangitis	3 (0.8)	2 (67%) no change, 1 (33%) worsening
Erythema nodosum	5 (1.33)	3 (60%) remission, 2 (40%) no change
Axial spondyloarthropathy	8 (2)	3 (38%) remission, 1 (12%) improvement, 1 (12%) no change, 3 (38%) worsening
Psoriasis	11 (3)	7 (64%) remission, 1 (9%) improvement, 3 (27%) no change
Others	10 (2.6)	2 (20%) remission, 4 (40%) improvement, 4 (40%) no change

Conclusion

In patients with active EIM at the start of ustekinumab treatment, improvement of those related to disease (UC) activity was observed. Other EIM and IMIDs not related to disease activity (axial spondyloarthropathy, uveitis, or rheumatoid arthritis) worsened. Treatment with ustekinumab does not appear to be associated with an increased risk of developing EIM or IMIDs.

Disclosure

This is an investigator-initiated study with financial support from Janssen (CNTO1275UCO4008).

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

Medical therapy in IBD: A potpourri of options (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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