Infliximab concentrations in two non-switching cohorts of patients with inflammatory bowel disease: originator vs. biosimilar

被引:1
作者
Martinez-Feito, Ana [1 ,2 ]
Bravo-Gallego, Luz Yadira [2 ,3 ,4 ]
Hernandez-Breijo, Borja [1 ]
Diez, Jesus [5 ]
Garcia-Ramirez, Laura [6 ]
Jaquotot, Marta [6 ]
Plasencia-Rodriguez, Chamaida [1 ]
Nozal, Pilar [2 ]
Mezcua, Araceli [2 ]
Martin- Arranz, Maria Dolores [6 ]
Pascual-Salcedo, Dora [1 ]
机构
[1] La Paz Univ Hosp Inst Hlth Res IdiPAZ, Immunorheumatol Grp, Madrid, Spain
[2] La Paz Univ Hosp, Immunol Unit, Madrid, Spain
[3] La Paz Inst Hlth Res IdiPAZ, Lymphocyte Pathophysiol Immunodeficiencies Grp, Madrid, Spain
[4] Ctr Biomed Network Res Rare Dis CIBERER U767, Madrid, Spain
[5] La Paz Univ Hosp, Biostat Sect, Madrid, Spain
[6] La Paz Univ Hosp Inst Hlth Res IdiPAZ, Unit Inflammatory Bowel Dis, Dept Gastroenterol, Innate Immun Grp, Madrid, Spain
关键词
EVIDENCE-BASED CONSENSUS; ULCERATIVE-COLITIS; DOUBLE-BLIND; MONOCLONAL-ANTIBODIES; INNOVATOR INFLIXIMAB; ANTIDRUG ANTIBODIES; PARALLEL-GROUP; CT-P13; EFFICACY; THERAPY;
D O I
10.1038/s41598-020-74235-1
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
Biosimilars are replacing originator compounds due to their similar effectiveness, safety and pharmacokinetics. Our objective was to compare the differences in pharmacokinetics and clinical outcomes between the originator infliximab (Ifx) and the biosimilar CT-P13 in a patient cohort with inflammatory bowel disease (IBD). Our cohort study included 86 patients from a historical and a prospective cohort from the start of infliximab treatment to 22 weeks later. Serum infliximab, antidrug antibody levels and other serum biomarkers were measured at weeks 0, 2, 6, 14 and 22. Remission outcomes were evaluated at weeks 14 and 22. Drug levels were measured prospectively and analysed using MANOVA. Of the 86 patients, 44 (51%) and 42 (49%) were administered the originator and CT-P13, respectively. Originator trough levels were higher than the biosimilar trough levels (35 vs. 21, 20.1 vs. 11, 6.6 vs. 2.9 and 4.3 vs. 1.7 mu g/mL at weeks 2, 6, 14 and 22, respectively). A post-hoc analysis demonstrated changes in mean serum drug levels over time (p<0.001) and according to the drug employed (p=0.001). At week 22, 13 (81%) patients administered the originator achieved clinical remission compared with 5 (19%) patients with the biosimilar (p=0.02). None of the patients administered the originator withdrew from the treatment compared with 7 for the biosimilar. During the study, there were significant differences in serum infliximab levels between the originator and the CT-P13 in the patients with IBD. The clinical outcomes were influenced by the type of compound administered.
引用
收藏
页数:9
相关论文
共 50 条
[41]   Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study [J].
Jung, Yoon Suk ;
Park, Dong Il ;
Kim, Young Ho ;
Lee, Ji Hyun ;
Seo, Pyoung Ju ;
Cheon, Jae Hee ;
Kang, Hyoun Woo ;
Kim, Ji Won .
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 2015, 30 (12) :1705-1712
[42]   Trough Concentrations of Infliximab Guide Dosing for Patients With Inflammatory Bowel Disease [J].
Vande Casteele, Niels ;
Ferrante, Marc ;
Van Assche, Gert ;
Ballet, Vera ;
Compernolle, Griet ;
Van Steen, Kristel ;
Simoens, Steven ;
Rutgeerts, Paul ;
Gils, Ann ;
Vermeire, Severine .
GASTROENTEROLOGY, 2015, 148 (07) :1320-+
[43]   Long-term effectiveness and safety of switching from originator to biosimilar infliximab in patients with Behcet's disease [J].
Lopalco, Giuseppe ;
Venerito, Vincenzo ;
Cantarini, Luca ;
Emmi, Giacomo ;
Prisco, Domenico ;
Iannone, Florenzo .
INTERNAL AND EMERGENCY MEDICINE, 2019, 14 (05) :719-722
[44]   Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study [J].
Kim, Nam Hee ;
Lee, Ji Hyun ;
Hong, Sung Noh ;
Yoon, Hyuk ;
Kang, Hyoun Woo ;
Lee, Suck-Ho ;
Im, Jong Pil ;
Cha, Jae Myung ;
Eun, Chang Soo ;
Kim, Ji Won ;
Choi, Chang Hwan ;
Park, Dong Il .
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 2019, 34 (09) :1523-1532
[45]   Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients [J].
Pierik, Marieke J. ;
van der Meulen, Andrea E. ;
van der Linde, Klaas ;
Lutgens, Maurice ;
Kuijvenhoven, Johan P. ;
Akol, Halil ;
Klompmaker, Ids J. ;
Sikkens, Michelle S. G. ;
van Megen, Yvonne J. B. ;
Stoop, Corinne M. ;
Bloemsaat-Minekus, Joanne P. J. ;
Dijkstra, Gerard .
CROHNS & COLITIS 360, 2022, 4 (03)
[46]   Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease [J].
Bernard, Edmond-Jean ;
Fedorak, Richard N. ;
Jairath, Vipul .
DIGESTIVE DISEASES AND SCIENCES, 2020, 65 (08) :2354-2372
[47]   Non-medical switch from the originator to biosimilar and between biosimilars of adalimumab in inflammatory bowel disease - a prospective, multicentre study [J].
Lontai, Livia ;
Gonczi, Lorant ;
Balogh, Fruzsina ;
Komlodi, Nora ;
Resal, Tamas ;
Farkas, Klaudia ;
Molnar, Tamas ;
Miheller, Pal ;
Golovics, Petra A. ;
Schafer, Eszter ;
Szamosi, Tamas ;
Ilias, Akos ;
Lakatos, Peter L. .
DIGESTIVE AND LIVER DISEASE, 2022, 54 (12) :1639-1645
[48]   Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13) in patients with inflammatory bowel disease [J].
María Fernanda Guerra Veloz ;
Federico Argüelles-Arias ;
Luisa Castro Laria ;
Belén Maldonado Pérez ;
Antonio Benítez Roldan ;
Raúl Perea Amarillo ;
Vicente Merino Bohórquez ;
Miguel Angel Calleja ;
ángel Caunedo álvarez ;
ángel Vilches Arenas .
World Journal of Gastroenterology, 2018, (46) :5288-5296
[49]   Real-world experience with biosimilar infliximab-adba and infliximab-dyyb among infliximab-naïve patients with inflammatory bowel disease in the Veterans Health Administration [J].
Patel, Shardool ;
Walsh, Jessica ;
Pinnell, Derek ;
Pei, Shaobo ;
Chen, Wei ;
Rojas, Jorge ;
Rathod, Anitha ;
Johnson, Jessica ;
Gawron, Andrew ;
Curtis, Jeffrey R. ;
Baker, Joshua F. ;
Cannon, Grant W. ;
Wu, David ;
Lai, Miao ;
Sauer, Brian C. .
MEDICINE, 2024, 103 (37)
[50]   Switching to Subcutaneous Infliximab Maintenance Therapy Is Effective in Patients with Inflammatory Bowel Disease [J].
Rautakorpi, Jaakko ;
Kolehmainen, Sara ;
Loyttyniemi, Eliisa ;
af Bjorkesten, Clas-Goran ;
Arkkila, Perttu ;
Sipponen, Taina ;
Salminen, Kimmo .
DIGESTIVE DISEASES AND SCIENCES, 2025, 70 (04) :1457-1466