Marion Allouchery1, Cécile Tomowiak2,3, Stéphanie Guidez2,3, Vincent Delwail2,3, Paul Delaunay1, Claire Lafay-Chebassier1,4, Francesco Salvo5,6, Marie-Christine Pérault-Pochat1,4. 1. Pharmacologie Clinique et Vigilances, CHU de Poitiers, Poitiers, France. 2. Onco-Hématologie et Thérapie Cellulaire, CHU de Poitiers, Poitiers, France. 3. INSERM CIC 1402, CHU de Poitiers, Poitiers, France. 4. Laboratoire de Neurosciences Expérimentales et Cliniques, INSERM U1084, Université de Poitiers, Poitiers, France. 5. Bordeaux Population Health Research Center, Pharmacoepidemiology research team, INSERM U1219, Université de Bordeaux, Bordeaux, France. 6. Pharmacologie Médicale, Pôle de Santé Publique, CHU de Bordeaux, Bordeaux, France.
Abstract
AIMS: To provide real-life data on patterns of use and safety of ibrutinib. METHODS: A cohort study including all patients initiating ibrutinib between 21 November 2014 and 21 November 2018, and followed for 1 year was conducted. Patient characteristics, ibrutinib use and adverse drug reactions (ADRs) were collected from medical records. Kaplan-Meier analysis estimated the probability of developing ibrutinib-associated serious ADRs (SADRs) with a 95% confidence interval (CI). A Cox proportional hazards model was used to investigate factors associated with SADR occurrence. RESULTS: In total, 102 patients were included in the study. The median age was 70.3 years (interquartile range 64.7-75.6), the male/female gender ratio was 2.9. Almost half the patients (47.1%) were prescribed ibrutinib for chronic lymphocytic leukaemia (CLL). Forty-three patients (42.1%) permanently discontinued ibrutinib in the first year, mostly for progression (51.2%) or ADRs (32.6%). Forty-eight patients (47.1%) experienced at least one ibrutinib-associated SADR. Haematological, infectious and vascular disorders were the most frequent SADRs. The probability of developing ibrutinib-associated SADR was 35.1% (95% CI 26.3-45.7%) at 3 months, 44.8% (35.2%; 55.8%) at 6 months and 54.3% (44.0%; 65.2%) at 12 months. Age ≥80 years (hazard ratio [HR] 2.03; 95% CI 1.02-4.05) and CLL (HR 1.81; 95% CI 1.01-3.25) were significantly associated with a higher risk of SADR occurrence. CONCLUSION: This study found a high cumulative incidence of ibrutinib-associated SADRs within the first year of treatment. In view of the risk of SADR, patients aged ≥80 years or treated for CLL deserve special attention.
AIMS: To provide real-life data on patterns of use and safety of ibrutinib. METHODS: A cohort study including all patients initiating ibrutinib between 21 November 2014 and 21 November 2018, and followed for 1 year was conducted. Patient characteristics, ibrutinib use and adverse drug reactions (ADRs) were collected from medical records. Kaplan-Meier analysis estimated the probability of developing ibrutinib-associated serious ADRs (SADRs) with a 95% confidence interval (CI). A Cox proportional hazards model was used to investigate factors associated with SADR occurrence. RESULTS: In total, 102 patients were included in the study. The median age was 70.3 years (interquartile range 64.7-75.6), the male/female gender ratio was 2.9. Almost half the patients (47.1%) were prescribed ibrutinib for chronic lymphocytic leukaemia (CLL). Forty-three patients (42.1%) permanently discontinued ibrutinib in the first year, mostly for progression (51.2%) or ADRs (32.6%). Forty-eight patients (47.1%) experienced at least one ibrutinib-associated SADR. Haematological, infectious and vascular disorders were the most frequent SADRs. The probability of developing ibrutinib-associated SADR was 35.1% (95% CI 26.3-45.7%) at 3 months, 44.8% (35.2%; 55.8%) at 6 months and 54.3% (44.0%; 65.2%) at 12 months. Age ≥80 years (hazard ratio [HR] 2.03; 95% CI 1.02-4.05) and CLL (HR 1.81; 95% CI 1.01-3.25) were significantly associated with a higher risk of SADR occurrence. CONCLUSION: This study found a high cumulative incidence of ibrutinib-associated SADRs within the first year of treatment. In view of the risk of SADR, patients aged ≥80 years or treated for CLL deserve special attention.
Authors: Maria Stefania Infante; Ana Fernández-Cruz; Lucia Núñez; Cecilia Carpio; Ana Jiménez-Ubieto; Javier López-Jiménez; Lourdes Vásquez; Raquel Del Campo; Samuel Romero; Carmen Alonso; Daniel Morillo; Margarita Prat; José Luis Plana; Paola Villafuerte; Gabriela Bastidas; Ana Bocanegra; Ángel Serna; Rodrigo De Nicolás; Juan Marquet; Carmen Mas-Ochoa; Raúl Cordoba; Julio García-Suárez; Alessandra Comai; Xavier Martín; Mariana Bastos-Oreiro; Cristina Seri; Belén Navarro-Matilla; Armando López-Guillermo; Joaquín Martínez-López; José Ángel Hernández-Rivas; Isabel Ruiz-Camps; Carlos Grande Journal: Cancer Med Date: 2021-09-23 Impact factor: 4.452