UEG's educational platform for gastroenterology education bringing recordings, courses, guidelines, and more together in one place.

UEG Week Berlin 2025 Recordings Gut Guide online

Rate for better recommendations!

Your feedback helps us show you more of what you like and less of what you dislike!

More of this!

We will show you more similar content.

Not for me!

We won't suggest this again.

Bookmark!

Save this content for later!

New to myUEG? Create an account! Log In with myUEG account

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

REAL WORLD EVIDENCE OF USTEKINUMAB IN ULCERATIVE COLITIS: SHORT AND LONG-TERM EFFECTIVENESS AND SAFETY: THE ULISES STUDY

Free for all myUEG account holders. Your access level is set automatically based on your occupation. Medical professionals get full access to all content. If you are a non-medical user, you can only access UEG Week content from congresses you attended.

Not sure what you can access? Learn more about account types.

Introduction

Primary aim: To assess the retention rate of ustekinumab treatment in patients with ulcerative colitis (UC).
Secondary aims: To assess the short-term effectiveness, the durability of response, and the tolerability of ustekinumab in clinical practice.

Aims & Methods

Retrospective, multicenter study including UC patients who had received the first ustekinumab dose at least 16 weeks before inclusion. Patients were followed-up from the first ustekinumab dose to treatment discontinuation or last visit, whichever came first. Only patients with active disease [Partial Mayo Score (PMS)>2] at ustekinumab start were considered in the effectiveness analysis. Clinical effectiveness was based on PMS. Patients who stopped ustekinumab before their last visit were considered non in remission at subsequent time points (negative imputation).

Results

376 patients have been included so far (91% had PMS >2 at ustekinumab start, 96% had been exposed to biologics, and 25% had failed to anti-TNF, vedolizumab and tofacitinib). At baseline, 50% of patients were under mesalamine, 24% under steroids, and 6% under thiopurines. 74% of patients started the maintenance treatment with 90 mg every-8-weeks, and 5% with 90 mg every-12-weeks subcutaneously; 8% of patients received ustekinumab intravenously as maintenance treatment from the beginning. 100 patients (27%) withdrew ustekinumab during follow-up [median=12 months (m)]. Incidence rate of ustekinumab discontinuation was 21% per patient-year of follow-up. The probability of maintaining ustekinumab was 98% at 1 m, 90% at 6 m, 78% at 12 m, 71% at 18 m, and 66% at 24 m. Main reasons for ustekinumab withdrawal were primary non-response (42%) and loss of response (30%). Anaemia at baseline (HR=1.7, 95%CI=1.1-2.6) was associated with higher risk, while concomitant treatment with mesalamine was associated with lower risk (HR=0.6, 95%CI=0.4-0.9), of ustekinumab discontinuation. The proportion of patients in clinical remission (CR) was 37% at week (w) 4, 49% at w 8, and 48% at w 16. To have moderate-severe vs. mild disease activity at baseline (OR=0.2, 95%CI=0.1-0.4) and to have failed to both anti-TNF and vedolizumab (OR=0.6, 95%CI=0.4-0.9) were associated with lower CR at week 16. A total of 83 (31%) patients among those with active disease at baseline and with at least response during the induction, lost response during a median follow-up of 12 months (IQR=6-18 months). The probability of maintaining response was 82% at 6 m, 72% at 12 m, and 61% at 24 m. The incidence rate of loss of response was 27% per patient-year of follow-up. In the multivariate analysis, to have achieved CR during the induction was the only variable associated with lower risk of loss of response (OR=0.5, 95%CI=0.3-0.9). The dose was escalated in 61% of patients with loss of response, and 82% improved (53% had CR); an intravenous reinduction was given in 19%, and 50% improved (31% had CR). The proportion of patients in CR during follow-up was 58% at 12 m, 48% at 24 m, and 41% at 36 m. A total of 69 patients (18%) had at least one adverse event, being infections the most frequent ones (8%). Ustekinumab was withdrew in 5 (1.3%) patients.

Conclusion

In the largest study performed so far on ustekinumab in UC in real life, ustekinumab has shown to be effective in inducing remission even in highly refractory UC patients. A relevant proportion of patients discontinue the treatment, mostly due to primary failure and loss of response. Dose escalation is effective to regain response after loss of efficacy. The safety profile is similar to that previously reported.

Disclosure

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

REAL WORLD EVIDENCE OF USTEKINUMAB IN ULCERATIVE COLITIS: SHORT AND LONG-TERM EFFECTIVENESS AND SAFETY: 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, José Fernando Muñoz 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, Belén Herreros 28, Oscar Nantes Castillejo 29, Montserrat Rivero 30, Belen Botella 31, Pedro Genaro Delgado-Guillena 32, Pilar López Serrano 33, Linda Katharina Dünser 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 41, Sandra Torra Alsina 42, Manuel Van Domselar 43, Yolanda Ber Nieto 44, Santiago Frago-Larramona 45, Carmen López 46, Javier Gisbert 1

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

2 Hospital Clinic of Barcelona, 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, San Sebastián de los Reyes, 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, 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 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, Madrid, 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

Event

UEG Week Copenhagen 2023

Topics

IBD Surgery

Submission format

Abstract

Session

Unsolved issues in IBD outcome

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

STANDARD VERSUS DOUBLE DOSE OF HEPATITIS B VACCINE IN INFLAMMATORY BOWEL DISEASE: A RANDOMIZED TRIAL

Not sure what you can access? Learn more about account types.

Introduction

Response to hepatitis B vaccine (HBV) is variable in inflammatory bowel disease (IBD) patients with seroconversion rates of 34-89%. Strategies suggested to improve the seroconversion rates are double dose, accelerated schedule, or addition of booster dose with variable results. This study compared the standard (20 µg) dose and double (40 µg) dose of HBV vaccination in IBD patients.

Aims & Methods

Patients of IBD were randomized to 1:1 to receive standard or double dose of HBV at 0, 1 and 6 months. Anti-HBs titers were assessed at 1 month after the third dose. Response was defined as an adequate immune response (AIR, anti-HBs titer >10 mIU/mL) and effective immune response (EIR, anti-HBs titer >100 mIU/mL). Total mayo score and Crohn’s disease activity index (CDAI) was used to identify the active disease. IBD medications with immunosuppressive effects were categorized as immunomodulators, corticosteroids, tofacitinib and biologic group. Multivariable logistic regression analysis was done to identify the predictors of AIR and EIR.

Results

Eighty-eight patients of IBD were randomized to receive standard (45, 51.1%) or double (43, 48.9%) dose of HBV. 79 of 88 patients had ulcerative colitis (UC) and 9 had Crohn’s disease (CD). 49 (55.7%) patients had active disease while 39 (44.3%) were in remission. At the end of the study, total 63 (71.61%) patients achieved AIR and 51 (60%) achieved EIR. AIR (88.4 % vs. 55.6 %, p 0.001) and EIR (69.8% vs. 46.7%, p = 0.028) rates were significantly higher with double dose compared to standard dose of HBV. Patients with active IBD had higher AIR (87.5% vs. 44%, p = 0.001) and EIR (70.8% vs. 32%, p = 0.007) rates with double dose of HBV. Patients with IBD in remission also had higher AIR (89.5% vs. 70%) and EIR (78.4% vs. 65%) rates with double dose of HBV, though statistically non-significant.
Multivariable analysis identified the use of double dose of HBV {odds ratio (OR) 10.865, 95% confidence interval (CI): 2.418-48.817} and biologic (OR 0.022, 95% CI: 0.001-0.421) as predictors to achieve AIR. Similarly, double dose of HBV (OR 3.0, 95% CI: 1.087-8.280) and use of biologic (OR 0.074, 95% CI: 0.006-0.931) also predicted the EIR.

Conclusion

Double dose of HBV vaccine demonstrated a superiority over standard dose of vaccine for achieving both AIR and EIR. Use of biologic impaired the response. Double dose of HBV should be used in IBD patients to improve the seroconversion rates.