Yara Nasser1, Rémi Labetoulle1, Ines Harzallah1, Anne-Emmanuelle Berger1, Xavier Roblin2, Stephane Paul3. 1. Laboratoire d'Immunologie et d'Immunomonitoring, CIC Inserm 1408, GIMAP EA3064, CHU Saint-Etienne, Saint-Etienne, France. 2. Service de Gastro-Entérologie-Hépatologie, CHU de Saint-Etienne, Saint-Etienne, France. 3. Laboratoire d'Immunologie et d'Immunomonitoring, CIC Inserm 1408, GIMAP EA3064, CHU Saint-Etienne, Saint-Etienne, France. stephane.paul@chu-st-etienne.fr.
Abstract
OBJECTIVE: The primary objective is to assess whether the POC assays to measure infliximab residual trough level in the serum of IBD patients were non-inferior to the ELISA techniques available on the market, and to determine which of them was the most robust. The second is to compare three different ELISA kits for monitoring anti-infliximab antibodies (ATI). METHODS: The assays were carried out on patients' sera using four ELISA kits from four different suppliers (three with a monoclonal antibody and one polyclonal) and two rapid techniques provided by BÜHLMANN (Quantum Blue®) and R-Biopharm (Ridaquick) for monitoring infliximab levels. ATI were measured by three ELISA sets (Grifols, Theradiag, and R-Biopharm) which have different positivity limits and different units. RESULTS: We measured infliximab residual level and ATI in the serum of 90 IBD patients (85 treated with infliximab and five with adalimumab). All of the infliximab assays were very well correlated when analyzed with Spearman nonparametric correlation (0.93 ≤ r ≤ 0.99), and the two POC assays were also excellently correlated (r = 0.98). The ATI monitoring kits revealed a correlation ranging from 0.73 to 0.96 when comparing positive and negative patients. When normalizing the quantitative values between the different ELISA tests (expressed arbitrarily by using multiples of the positivity limits defined by each supplier), the Spearman r coefficient ranged from 0.81 to 0.93. CONCLUSION: The available evidence allows us to conclude that all of the infliximab monitoring assays correlate well and may be used for IFX monitoring; albeit variations in measured IFX concentration among different assays remain present, these assays could be interchangeable. The ATI monitoring techniques are all capable of detecting ATI-positive patients, but because of the difference in the positivity limits and the measurement units, it is better to follow a patient rate with one definite kit.
OBJECTIVE: The primary objective is to assess whether the POC assays to measure infliximab residual trough level in the serum of IBDpatients were non-inferior to the ELISA techniques available on the market, and to determine which of them was the most robust. The second is to compare three different ELISA kits for monitoring anti-infliximab antibodies (ATI). METHODS: The assays were carried out on patients' sera using four ELISA kits from four different suppliers (three with a monoclonal antibody and one polyclonal) and two rapid techniques provided by BÜHLMANN (Quantum Blue®) and R-Biopharm (Ridaquick) for monitoring infliximab levels. ATI were measured by three ELISA sets (Grifols, Theradiag, and R-Biopharm) which have different positivity limits and different units. RESULTS: We measured infliximab residual level and ATI in the serum of 90 IBDpatients (85 treated with infliximab and five with adalimumab). All of the infliximab assays were very well correlated when analyzed with Spearman nonparametric correlation (0.93 ≤ r ≤ 0.99), and the two POC assays were also excellently correlated (r = 0.98). The ATI monitoring kits revealed a correlation ranging from 0.73 to 0.96 when comparing positive and negative patients. When normalizing the quantitative values between the different ELISA tests (expressed arbitrarily by using multiples of the positivity limits defined by each supplier), the Spearman r coefficient ranged from 0.81 to 0.93. CONCLUSION: The available evidence allows us to conclude that all of the infliximab monitoring assays correlate well and may be used for IFX monitoring; albeit variations in measured IFX concentration among different assays remain present, these assays could be interchangeable. The ATI monitoring techniques are all capable of detecting ATI-positive patients, but because of the difference in the positivity limits and the measurement units, it is better to follow a patient rate with one definite kit.
Authors: Aurélien Amiot; Anne Hulin; Mehdi Belhassan; Chantal Andre; Charlotte Gagniere; Yann Le Baleur; Jean-Pierre Farcet; Jean-Charles Delchier; Sophie Hüe Journal: Clin Res Hepatol Gastroenterol Date: 2015-06-29 Impact factor: 2.947
Authors: Konstantinos Papamichael; Karen A Chachu; Ravy K Vajravelu; Byron P Vaughn; Josephine Ni; Mark T Osterman; Adam S Cheifetz Journal: Clin Gastroenterol Hepatol Date: 2017-03-30 Impact factor: 11.382
Authors: L I Bader; S M Solberg; S H Kaada; N Bolstad; D J Warren; S Gavasso; C G Gjesdal; C A Vedeler Journal: Scand J Immunol Date: 2017-09 Impact factor: 3.487
Authors: Casper Steenholdt; Mark A Ainsworth; Michael Tovey; Tobias W Klausen; Ole O Thomsen; Jørn Brynskov; Klaus Bendtzen Journal: Ther Drug Monit Date: 2013-08 Impact factor: 3.681
Authors: C L M Krieckaert; S C Nair; M T Nurmohamed; C J J van Dongen; W F Lems; F P J G Lafeber; J W J Bijlsma; H Koffijberg; G Wolbink; P M J Welsing Journal: Ann Rheum Dis Date: 2013-11-21 Impact factor: 19.103
Authors: Charlotte Krieckaert; Borja Hernández-Breijo; Johanna Elin Gehin; Guillaume le Mélédo; Alejandro Balsa; Meghna Jani; Denis Mulleman; Victoria Navarro-Compan; Gertjan Wolbink; John Isaac; Astrid van Tubergen Journal: RMD Open Date: 2022-06
Authors: Maurizio Benucci; Valentina Grossi; Mariangela Manfredi; Arianna Damiani; Maria Infantino; Paolo Moscato; Luigi Cinquanta; Elisa Gremese; Barbara Tolusso; Luca Petricca; Anna Laura Fedele; Stefano Alivernini; Fabiola Atzeni; Giovanni Minisola; Roberto Verna Journal: Ann Lab Med Date: 2020-03 Impact factor: 3.464