Evidence map›Paper›PMID 39322802›Full record

Observational studyBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2024

Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study.

Guillaume Bouguen, Laure Gossec, Vered Abitbol, Eric Senbel, Guillaume Bonnaud, Xavier Roblin, Yoram Bouhnik, Stéphane Nancey, Nicolas Mathieu, Jérôme Filippi and 8 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05427942 (YUflyma®), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05427942 unknown statusnot on this map

YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study

TypeobservationalSponsorCelltrion HealthCare FranceRan2022 to 2023Enrolled300ConditionsRheumatoid Arthritis, Ankylosing Spondylarthritis, Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis, Psoriatic ArthritisArmsAdalimumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Guillaume BouguenRennes University Hospital, Rennes University, INSERM, CIC1414, NUMECAN (Nutrition Metabolism and Cancer) Institute, Rennes, France.
Laure GossecSorbonne University, INSERM, Pierre Louis Institute of Epidemiology and Public Health, Paris, France.
Vered AbitbolDepartment of Gastroenterology, Cochin University Hospital, AP-HP, Université Paris Cité, Paris, France.
Eric SenbelMedical practice, Marseille, France.
Guillaume BonnaudGastroenterology, Ambroise Paré Clinic, Toulouse, France.
Xavier RoblinDepartment of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France.
Yoram BouhnikInstitut des MICI, Paris IBD Center, Private Hospital Group of Ambroise Paré-Hartmann, Neuilly sur Seine, France.
Stéphane NanceyDepartment of Gastroenterology, Hospices Civils de Lyon, Lyon-Sud Hospital, University Claude Bernard Lyon 1 and INSERM U1111, CIRI, Lyon, France.
Nicolas MathieuMICI institut privé, Clinic of Cèdres, Echirolles, France.
Jérôme FilippiGastroenterology, Saint-Jean Clinic, Cagnes-sur-Mer, France.
Lucine VuittonDepartment of Gastroenterology, Besançon University Hospital, UMR Right INSERM, Franche-Comté University, Besançon, France.
Stéphane NahonGastroenterology Unit, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France.
Azeddine DellalDepartment of Rheumatology, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France.
Alice DenisMedical Affairs, Celltrion Healthcare France S.A.S., 9-15 rue Rouget de Lisle, 92130, Issy-les-Moulineaux, France.
Lucile FoulleyMedical Affairs, Celltrion Healthcare France S.A.S., 9-15 rue Rouget de Lisle, 92130, Issy-les-Moulineaux, France.
Caroline HabauzitMedical Affairs, Celltrion Healthcare France S.A.S., 9-15 rue Rouget de Lisle, 92130, Issy-les-Moulineaux, France. Caroline.Habauzit@celltrionhc.com.
Salim BenkhalifaMedical Affairs, Celltrion Healthcare France S.A.S., 9-15 rue Rouget de Lisle, 92130, Issy-les-Moulineaux, France.
Hubert MarotteJean Monnet Saint-Etienne University, Saint-Etienne University Hospital, Mines Saint-Etienne, INSERM, SAINBIOSE U1059, Saint-Etienne, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesBiosimilars 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

methodsThis 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.

resultsThe 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).

conclusionsThe 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 registrationClinicalTrials.gov identifier NCT05427942, registered June 22, 2022.

Indexed as

AdalimumabBiosimilar PharmaceuticalsPatient SatisfactionAdultAgedDrug SubstitutionFemaleHumansInflammatory Bowel DiseasesMaleMiddle AgedProspective StudiesRheumatic DiseasesAdalimumabBiosimilar Pharmaceuticals

Identifiers

PMID39322802
PMCPMC11530508

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.