Real-world use of therapeutic drug monitoring of CT-P13 in patients with inflammatory bowel disease: A 12-month prospective observational cohort study - 08/01/20

Doi : 10.1016/j.clinre.2019.11.008

Nicolas Petitdidier ^a, Laurent Beaugerie ^b, Franck Carbonnel ^c, Anne Bourrier ^b, Xavier Treton ^d, Sylvie Rajca ^e, Georgia Malamut ^f, Vered Abitbol ^g, Matthieu Allez ^h, Anne-Laure Pelletier ⁱ, Lysiane Marthey ^j, Pauline Jouet ^k, Robert Benamouzig ^l, Xavier Amiot ^m, Yoram Bouhnik ^d, Aurelien Amiot ^a,⁎
^a Department of Gastroenterology, Henri Mondor Hospital, APHP, EC2M3-EA 7375, Paris Est-Créteil (UPEC) Val de Marne University, Creteil, France
^b Department of Gastroenterology, Saint Antoine Hospital, Paris 6 Pierre et Marie Curie University, Paris, France
^c Department of Gastroenterology, Bicetre Hospital, Paris Sud University, Kremlin-Bicetre, France
^d Department of Gastroenterology, Beaujon Hospital, Paris 7 Denis Diderot University, Clichy, France
^e Department of Gastroenterology, Louis Mourier Hospital, Paris 7 Denis Diderot University, Colombes, France
^f Department of Gastroenterology, European Georges Pompidou Hospital, Paris 5 Rene Descartes University, Paris, France
^g Department of Gastroenterology, Cochin Hospital, Paris 5 Rene Descartes University, Paris, France
^h Department of Gastroenterology, Saint-Louis, Paris 7 Denis Diderot University, Paris, France
ⁱ Department of Gastroenterology, Bichat Hospital, Paris 7 Denis Diderot University, Paris, France
^j Department of Gastroenterology, Antoine Beclere Hospital, Paris Sud University, Clamart, France
^k Department of Gastroenterology, Ambroise Pare Hospital, Paris Ouest University, Boulogne-Billancourt, France
^l Department of Gastroenterology, Avicenne Hospital, Paris Nord University, Bobigny, France
^m Department of Gastroenterology, Tenon Hospital, Paris 6 Pierre et Marie Curie University, Paris, France

^⁎Corresponding author. 51, Avenue du Marechal de Lattre de Tassigny, 94010 Creteil, France.51, Avenue du Marechal de Lattre de TassignyCreteil94010France

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Highlights

•	In a real-world setting, therapeutic drug monitoring of CT-P13 was applied in 70.7% of patients.
•	Therapeutic drug monitoring of infliximab was collected in a proactive approach in two-thirds of patients.
•	The presence of anti-CT-P13 antibody was observed in 15.9% of patients with a drug-sensitive assay.
•	The presence of ACA was associated with a lower rate of CT-P13 trough concentration.

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Summary

Background

Whether therapeutic drug monitoring (TDM) of infliximab should be implemented in daily practice is an ongoing controversy.

Aims

To assess the real-world use of TDM in an observational multicentre cohort study with consecutive patients with inflammatory bowel disease (IBD) treated with CT-P13.

Methods

Between September 2015 and December 2016, 364 patients with IBD were treated with CT-P13 in 13 gastroenterology departments and were followed up for 54 weeks. Disease activity, CT-P13 trough concentration and anti-CT-P13 antibody (ACA) were recorded.

Results

Steroid-free clinical remission rates at week 54 were 67.0% and 56.4% in patients with CD and UC, respectively. CT-P13 trough concentrations were measured in 70.7% of the patients. The mean CT-P13 trough concentration was 4.2±4.3μg/mL. The presence of ACA was observed in 53 (15.9%) patients. CT-P13 trough concentration was collected in a proactive approach in 62.8% of cases and in a reactive approach in 37.2%. Among patients who submitted to TDM, CT-P13 therapy was optimized in 88.7% of the reactive group and in 22.5% of the proactive group (P<0.001).

Conclusion

In a real-world cohort of patients with IBD treated with CT-P13, more than two-thirds of the patients underwent TDM. CT-P13 optimization was much less common in the proactive approach than in the reactive approach.

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Keywords : Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Infliximab, Biosimilar, CT-P13

Abbreviations : CD, UC, IBD, TNF, CRP