Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study

被引:1
|
作者
Fernandez-Cano, Maria Carmen [1 ,2 ]
Fernandez-Cano, Antonio Jesus [3 ]
Martin-Rodriguez, Maria Mar [1 ]
Sanchez-Capilla, Antonio Damian [1 ]
Cabello-Tapia, Maria Jose [1 ]
Redondo-Cerezo, Eduardo [1 ,2 ]
机构
[1] Virgen Nieves Univ Hosp, Gastroenterol & Hepatol Unit, Granada 18014, Spain
[2] Univ Granada, Doctoral Programme Clin Med & Publ Hlth, Fac Med, Granada 18012, Spain
[3] Consortium Developing Informat & Knowledge Soc An, Citizen Innovat Dept, Granada 18016, Spain
关键词
adalimumab; drug switching; multiswitching; interchangeability; inflammatory bowel disease; persistence; biosimilar; CROHNS-DISEASE; REFERENCE PRODUCT; BI; 695501; SAFETY; THERAPY; EFFICACY;
D O I
10.3390/jcm13020556
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Adalimumab biosimilar experience is still recent. Interchangeability differences could reduce persistence times. Our goal was to compare biosimilar persistence differences with a reference. A retrospective observational study was performed in three groups divided according to the adalimumab received. The primary outcome measure was persistence, represented with Kaplan-Meier analysis, and we secondarily evaluated security, efficacy, and biomarkers. We obtained approval from the regional ethical committee, and the study was conducted following the Helsinki Declaration as revised in 2013. Data from 104 patients were collected: 50 received the biosimilar, 29 received the reference, and 25 switched from the original to the biosimilar. After a follow-up of 12 months, the biosimilar's persistence was higher, without differences in mild adverse events per group. In contrast, there were differences in severe events, with the switched group's frequency being higher. Biomarkers were reduced at similar proportions in all groups, and 43% had a clinical response at week 20 without differences. Adalimumab biosimilars are a valuable option for IBD based on clinical equivalence that are less expensive than the original drug. Their use does not have a detrimental influence on disease, although there are a few nuances in terms of interchangeability. These results support increasing confidence in using biosimilars, thus promoting the better sustainability of health systems.
引用
收藏
页数:16
相关论文
共 50 条
  • [41] Osteoporosis, osteopenia, and inflammatory bowel disease: lessons from a real-world study
    Pellicano, Rinaldo
    Ribaldone, Davide G.
    POLISH ARCHIVES OF INTERNAL MEDICINE-POLSKIE ARCHIWUM MEDYCYNY WEWNETRZNEJ, 2018, 128 (7-8): : 411 - 413
  • [42] Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID
    Caron, Benedicte
    Seksik, Philippe
    Buisson, Anthony
    Wils, Pauline
    Savoye, Guillaume
    Stefanescu, Carmen
    Laharie, David
    Guillo, Lucas
    Abitbol, Vered
    Bonnet, Joelle
    Altwegg, Romain
    Vuitton, Lucine
    Moussata, Driffa
    Bourreille, Arnaud
    Biron, Amelie
    Gilletta, Cyrielle
    Fumery, Mathurin
    Nahon, Stephane
    Nancey, Stephane
    Camara, Houda
    Peyrin-Biroulet, Laurent
    GETAID PREFERADA tudy Grp
    THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, 2024, 17
  • [43] SPOSAB ABP 501: A Sicilian Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Adalimumab Biosimilar ABP 501
    Macaluso, Fabio Salvatore
    Cappello, Maria
    Busacca, Anita
    Fries, Walter
    Viola, Anna
    Costantino, Giuseppe
    Magnano, Antonio
    Vinci, Elisa
    Ferracane, Concetta
    Privitera, Antonino Carlo
    Piccillo, Giovita
    Belluardo, Nunzio
    Giangreco, Emiliano
    Romano, Claudio
    Citrano, Michele
    Graziano, Francesco
    Garufi, Serena
    Bertolami, Carmelo
    Ventimiglia, Marco
    Scrivo, Barbara
    Teresi, Giulia
    Renna, Sara
    Rizzuto, Giulia
    Casa, Angelo
    Orlando, Ambrogio
    JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 2021, 36 (11) : 3041 - 3049
  • [44] Retention Rate, Persistence and Safety of Adalimumab in Inflammatory Bowel Disease: A Real-Life, 9-Year, Single-Center Experience in Italy
    Alessandro Sartini
    Eleonora Scaioli
    Elisa Liverani
    Matteo Bellanova
    Luigi Ricciardiello
    Franco Bazzoli
    Andrea Belluzzi
    Digestive Diseases and Sciences, 2019, 64 : 863 - 874
  • [45] Informed consent in inflammatory bowel disease: a necessity in real-world clinical practice
    Kyriakos, Nikolaos
    Papaefthymiou, Apostolis
    Giakoumis, Marios
    Iatropoulos, George
    Mantzaris, Gerasimos
    Liatsos, Christos
    ANNALS OF GASTROENTEROLOGY, 2021, 34 (04): : 466 - 475
  • [46] Pregnancy in Inflammatory Bowel Disease: Data from a Real-World Cohort in Germany
    Ayoub, Mousa
    Muzalyova, Anna
    Ebigbo, Alanna
    Nagl, Sandra
    Roemmele, Christoph
    Classen, Johanna
    Wanzl, Julia
    Fleischmann, Carola
    Ayoub, Sami
    Tadic, Vidan
    Schlottmann, Jakob
    Schnoy, Elisabeth
    JOURNAL OF CLINICAL MEDICINE, 2024, 13 (24)
  • [47] A propensity score-weighted comparison between adalimumab originator and its biosimilars, ABP501 and SB5, in inflammatory bowel disease: a multicenter Italian study
    Barberio, Brigida
    Cingolani, Linda
    Canova, Cristina
    Barbieri, Giulia
    Sablich, Renato
    Urbano, Maria Teresa
    Bertani, Lorenzo
    Costa, Francesco
    Bodini, Giorgia
    Demarzo, Maria Giulia
    Ferronato, Antonio
    Buda, Andrea
    Melatti, Piera
    Massimi, Davide
    Savarino, Edoardo Vincenzo
    Zingone, Fabiana
    THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, 2021, 14
  • [48] Efficacy of vedolizumab and ustekinumab in pediatric-onset inflammatory bowel disease: A real-world multicenter study
    Rebus, Soleynne
    Coopman, Stephanie
    Djeddi, Djamal
    Vanrenterghem, Audrey
    Dupont, Claire
    Lacotte, Edouard
    Ley, Delphine
    JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION, 2025, 80 (01): : 113 - 123
  • [49] Efficacy of adalimumab for the management of Inflammatory Bowel Disease in the Clinical Setting
    Trinder, Matthew W.
    Lawrance, Ian C.
    JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 2009, 24 (07) : 1252 - 1257
  • [50] Long-term safety and effectiveness of azathioprine in the management of inflammatory bowel disease: A real-world experience
    Yewale, Rohan, V
    Ramakrishna, Balakrishnan S.
    Doraisamy, Babu Vinish
    Basumani, Pandurangan
    Venkataraman, Jayanthi
    Jayaraman, Kayalvizhi
    Murali, Ananthavadivelu
    Premkumar, Karunakaran
    Kumar, Akkim Sathish
    JGH OPEN, 2023, 7 (09): : 599 - 609