Fernando Bermejo1, Laura Jiménez1, Alicia Algaba1, Milagros Vela2, Guillermo Bastida3, Olga Merino4, Alicia López-García5, Luigi Melcarne6, Iago Rodríguez-Lago7, Saioa de la Maza8, Abdel Bouhmidi9, Manuel Barreiro-de Acosta10, Pilar López-Serrano11, Marta Carrillo-Palau12, Francisco Mesonero13, Beatriz Orts14, Daniel Bonillo1, Alicia Granja1, Iván Guerra1. 1. Hospital Universitario de Fuenlabrada, Instituto de Investigación Sanitaria del Hospital La Paz (IdiPaz), Madrid, Spain. 2. Complejo Hospitalario Universitario Ntra. Sra. de Candelaria, Santa Cruz de Tenerife, Tenerife, Spain. 3. Hospital Universitario y Politécnico La Fe, CIBEREHD, Health Research Institute La Fe, Valencia, Spain. 4. Hospital Universitario de Cruces, Vizcaya, Spain. 5. Hospital del Mar and Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain. 6. Hospital Universitari Parc Taulí, Sabadell, Spain. 7. Hospital Galdakao-Usansolo and Biocruces Bizkaia Health Research Institute, Galdakao, Vizcaya, Spain. 8. Hospital Universitario Basurto, Bilbao, Vizcaya, Spain. 9. Hospital de Santa Bárbara, Puertollano, Cuidad Real, Spain. 10. Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain. 11. Hospital Universitario Fundación Alcorcón, Madrid, Spain. 12. Hospital Universitario de Canarias, Tenerife, Spain. 13. Hospital Universitario Ramón y Cajal, Madrid, Spain. 14. Hospital General Universitario de Alicante, Alicante, Spain.
Abstract
BACKGROUND: A significant percentage of patients treated with ustekinumab may lose response. Our aim was to evaluate the short-term efficacy and safety of intravenous re-induction with ustekinumab in patients with Crohn's disease who have lost the response to the treatment. METHODS: This is a retrospective, observational, multicenter study. Treatment efficacy was measured at week 8 and 16; clinical remission was defined when the Harvey-Bradshaw Index was ≤4 points, and clinical response was defined as a decrease of ≥3 points in the index compared with the baseline. Adverse events and treatment decisions after re-induction were also collected. RESULTS: Fifty-three patients from 13 centers were included. Forty-nine percent had previously failed to respond to 2 biological treatments, and 24.5% had failed to respond to 3. The average exposure time to ustekinumab before re-induction was 17.7 ± 12.8 months. In 56.6% of patients, the administration interval had been shortened to every 4 to 6 weeks before re-induction. At week 8 and 16 after re-induction, 49.0% (n = 26) and 43.3% (n = 23), respectively, were in remission, whereas 64.1% (n = 34) and 52.8% (n = 28) had a clinical response. Patients who achieved remission at week 16 had lower C-reactive protein levels than those who did not respond (2.8 ± 1.6 vs 12.5 ± 9.5 mg/dL; P = 0.001). No serious adverse events related to re-induction were observed. CONCLUSION: Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn's disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.
BACKGROUND: A significant percentage of patients treated with ustekinumab may lose response. Our aim was to evaluate the short-term efficacy and safety of intravenous re-induction with ustekinumab in patients with Crohn's disease who have lost the response to the treatment. METHODS: This is a retrospective, observational, multicenter study. Treatment efficacy was measured at week 8 and 16; clinical remission was defined when the Harvey-Bradshaw Index was ≤4 points, and clinical response was defined as a decrease of ≥3 points in the index compared with the baseline. Adverse events and treatment decisions after re-induction were also collected. RESULTS: Fifty-three patients from 13 centers were included. Forty-nine percent had previously failed to respond to 2 biological treatments, and 24.5% had failed to respond to 3. The average exposure time to ustekinumab before re-induction was 17.7 ± 12.8 months. In 56.6% of patients, the administration interval had been shortened to every 4 to 6 weeks before re-induction. At week 8 and 16 after re-induction, 49.0% (n = 26) and 43.3% (n = 23), respectively, were in remission, whereas 64.1% (n = 34) and 52.8% (n = 28) had a clinical response. Patients who achieved remission at week 16 had lower C-reactive protein levels than those who did not respond (2.8 ± 1.6 vs 12.5 ± 9.5 mg/dL; P = 0.001). No serious adverse events related to re-induction were observed. CONCLUSION: Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn's disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.
Authors: Valerie Heron; Steven Li Fraine; Nicola Panaccione; Sophie Restellini; Pascale Germain; Kristina Candido; Charles N Bernstein; Talat Bessissow; Alain Bitton; Usha K Chauhan; Peter L Lakatos; John K Marshall; Pierre Michetti; Cynthia H Seow; Greg Rosenfeld; Remo Panaccione; Waqqas Afif Journal: J Can Assoc Gastroenterol Date: 2022-05-26