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Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch fromremicade (infliximab) in patients with established rheumatic disease. report of clinical experience based on prospective observational data

Research output: Contribution to journalArticle

Elena Nikiphorou, Hannu Kautiainen, Pekka Hannonen, Juha Asikainen, Arto Kokko, Tuomas Rannio, Tuulikki Sokka

Original languageEnglish
Pages (from-to)1677-1683
Number of pages7
JournalEXPERT OPINION ON BIOLOGICAL THERAPY
Volume15
Issue number12
DOIs
E-pub ahead of print7 Nov 2015

King's Authors

Abstract

Objective: To gain clinical experience on the effectiveness and safety of switching from infliximab-Remicade(INX) to infliximab-biosimilar-CT-P13 (INB) in patients with established rheumatic disease. Methods: Patients receiving INX treatment at a rheumatology clinic consented to switching from INX to INB. Patient reported outcomes (PROs), disease-activity, and inflammatory markers were recorded at every visit. Generalized estimating equation models and time-dependent area under the curve (AUC) before/during INX and INB treatments were employed. Results: Thirty-nine consecutive patients [mean (SD) age 53(11), 17 F] with various rheumatic diseases were switched to INB after a mean (SD) of 4.1 (2.3) years on INX. Thirty-one patients were on concomitant methotrexate. At a median (range) of 11 (7.5-13) months following the first administration of INB, AUCs for disease activity and PROs were similar for INX and INB. They were better compared to those prior to INX. Eleven patients (28.2%) discontinued INB, due to INX antidrug antibodies detected prior to INB infusion (n = 3); latent tuberculosis (n = 1); new-onset neurofibromatosis (n = 1); subjective reasons with no objective deterioration of disease (n = 6). Conclusion: The clinical effectiveness of INB in both PROs and disease-activity measures was comparable to INX during the first year of switching, with no immediate safety signals. Subjective reasons (negative expectations) may play a role among discontinuations of biosimilars. Larger patient numbers and longer follow-up are necessary for confirming this clinical experience.

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