Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study BioDrugs. 2024 Sep 25. doi: 10.1007/s40259-024-00681-2. Online ahead of print. Guillaume Bouguen 1, Laure Gossec 2 3, Vered Abitbol 4, Eric Senbel 5 6, Guillaume Bonnaud 7, Xavier Roblin 8, Yoram Bouhnik 9, Stéphane Nancey 10, Nicolas Mathieu 11, Jérôme Filippi 12, Lucine Vuitton 13, Stéphane Nahon 14, Azeddine Dellal 15, Alice Denis 16, Lucile Foulley 16, Caroline Habauzit 17, Salim Benkhalifa 16, Hubert Marotte 18 |
Author information 1Rennes University Hospital, Rennes University, INSERM, CIC1414, NUMECAN (Nutrition Metabolism and Cancer) Institute, Rennes, France. 2Sorbonne University, INSERM, Pierre Louis Institute of Epidemiology and Public Health, Paris, France. 3Department of Rheumatology, AP-HP, Pitié-Salpêtrière Hospital, Paris, France. 4Department of Gastroenterology, Cochin University Hospital, AP-HP, Université Paris Cité, Paris, France. 5Medical practice, Marseille, France. 6Department of Rheumatology, Ste Marguerite University Hospital, Marseille, France. 7Gastroenterology, Ambroise Paré Clinic, Toulouse, France. 8Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France. 9Institut des MICI, Paris IBD Center, Private Hospital Group of Ambroise Paré-Hartmann, Neuilly sur Seine, France. 10Department of Gastroenterology, Hospices Civils de Lyon, Lyon-Sud Hospital, University Claude Bernard Lyon 1 and INSERM U1111, CIRI, Lyon, France. 11MICI institut privé, Clinic of Cèdres, Echirolles, France. 12Gastroenterology, Saint-Jean Clinic, Cagnes-sur-Mer, France. 13Department of Gastroenterology, Besançon University Hospital, UMR Right INSERM, Franche-Comté University, Besançon, France. 14Gastroenterology Unit, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France. 15Department of Rheumatology, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France. 16Medical Affairs, Celltrion Healthcare France S.A.S., 9-15 rue Rouget de Lisle, 92130, Issy-les-Moulineaux, France. 17Medical Affairs, Celltrion Healthcare France S.A.S., 9-15 rue Rouget de Lisle, 92130, Issy-les-Moulineaux, France. Caroline.Habauzit@celltrionhc.com. 18Jean Monnet Saint-Etienne University, Saint-Etienne University Hospital, Mines Saint-Etienne, INSERM, SAINBIOSE U1059, Saint-Etienne, France. Abstract Background and objectives: Biosimilars are cost-effective alternatives to reference products for patients with inflammatory bowel diseases (IBD) and chronic inflammatory rheumatic diseases (CIRD), but patient beliefs can affect adherence to the transition. This study aimed to explore patient experience and satisfaction after switching to CT-P17, a high-concentration (100 mg/mL), citrate-free adalimumab biosimilar. Patients and methods: This observational, multicenter, prospective French study included adult patients with IBD or CIRD who switched to CT-P17 from reference adalimumab (R-ADA; 100 mg/mL) or a low-concentration adalimumab biosimilar (ADA-BioS; 50 mg/mL). Patients completed online questionnaires to assess treatment perceptions, satisfaction, and tolerance at study inclusion (under previous treatment) and over 3 months of CT-P17 treatment. The primary criterion was overall patient satisfaction, which was assessed with the question, "What is your global satisfaction with the CT-P17 injection?", using a 7-point Likert scale. Multivariate logistic regression analysis was performed to identify factors associated with increased treatment satisfaction after switching to CT-P17. Results: The total analysis population included 232 patients (IBD 72.0%, CIRD 28.0%). Median patient age was 57.0 years (interquartile range [IQR] 46.0-63.0), 50.4% were men, and median disease duration was 9 years (IQR 5-16). Approximately half of the cohort (51.2%) switched to CT-P17 from an ADA-BioS (including 19.4% from an ADA-BioS with citrate) and half (48.7%) from R-ADA. The proportion of patients who were satisfied with treatment was stable between baseline (under previous treatment) and 3 months (under CT-P17). More patients reported increased satisfaction after switching to CT-P17 from an ADA-BioS (22.7% vs 8.0% when switching from R-ADA; p = 0.002), or from an ADA-BioS containing citrate (28.9% vs 12.3% when switching from a citrate-free ADA-BioS; p = 0.008). Independent prognostic factors for increased satisfaction were previous treatment with an ADA-BioS (odds ratio [OR] 2.88 [95% confidence interval 1.17-7.08]; p = 0.021) and pain at the injection site under previous treatment (OR 1.26 [1.08-1.47]; p = 0.004). Significantly fewer patients reported pain, redness, itching, and hematoma after 3 months of CT-P17 treatment versus baseline (p < 0.001). Conclusions: The majority of patients had stable or increased treatment satisfaction after switching from R-ADA or an ADA-BioS to CT-P17. In particular, switching to CT-P17 from a low-concentration ADA-BioS or an ADA-BioS containing citrate was associated with increased patient satisfaction. An improvement in overall tolerance with CT-P17 versus previous adalimumab treatment was also reported. Trial registration: ClinicalTrials.gov identifier NCT05427942, registered June 22, 2022. |
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