A Prospective Observational Study on the Efficacy and Safety of Infliximab-Biosimilar (CT-P13) in Patients With Takayasu Arteritis (TAKASIM)

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Abstract

Objectives: Infliximab (IFX) is widely used in patients with refractory Takayasu arteritis (TAK). Recently, the IFX-biosimilar CT-P13 has been introduced for the treatment of inflammatory diseases. The aim of this study was to assess the efficacy and safety of CT-P13 in patients with refractory TAK.

Methods: In this prospective, open-label, single-center trial, TAK patients either already on treatment with IFX-originator (switch group) or never treated with IFX (naïve group) received CT-P13 for 52 weeks. The primary outcomes of the study were: (i) number of patients with active disease at month 6; (ii) incidence of treatment-emergent adverse events at month 12. Disease activity was assessed at month 6 and month 12 by clinical evaluation (ITAS-2020, ITAS-ESR, and ITAS-CRP scores) and imaging assessment [magnetic resonance angiography (MRA) and (18F)-FDG-PET].

Results: 23 patients were recruited (21 switch, 2 naïve). At baseline, 7 patients (32%) were classified as active. At month 6, one patient voluntarily dropped out and 7 patients were still active (30%), including one patient started on a different bDMARD at month 2 due to poor disease control. Mean daily dose of prednisone equivalent was significantly lower than baseline (4.2 ± 1.9 mg vs. 4.8 ± 2.1 mg, p = 0.009). At month 12, another patient was excluded because of pregnancy desire. Five patients were classified as active (24%), including two patients started on a different bDMARD at month 2 and month 6. Mean daily dose of prednisone equivalent was significantly lower than baseline (3.3 ± 2.6, p = 0.034). No patient experienced side effects during CT-P13 infusion. Overall, one patient experienced grade 1 adverse event and 9 patients experienced grade 2 adverse events. In no case hospitalization was required. CT-P13 retention rate was 90.9% at month 6 and 90.4% at month 12.

Conclusion: In this study, the use of IFX-biosimilar CT-P13 in patients with refractory TAK showed satisfying efficacy and safety profile.

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Since the publication of the European League Against Rheumatism (EULAR) recommendations for the management of large vessel vasculitis (LVV) in 2009, several relevant randomised clinical trials and cohort analyses have been published, which have the potential to change clinical care and therefore supporting the need to update the original recommendations. Using EULAR standardised operating procedures for EULAR-endorsed recommendations, the EULAR task force undertook a systematic literature review and sought opinion from 20 experts from 13 countries. We modified existing recommendations and created new recommendations. Three overarching principles and 10 recommendations were formulated. We recommend that a suspected diagnosis of LVV should be confirmed by imaging or histology. High dose glucocorticoid therapy (40–60 mg/day prednisone-equivalent) should be initiated immediately for induction of remission in active giant cell arteritis (GCA) or Takayasu arteritis (TAK). We recommend adjunctive therapy in selected patients with GCA (refractory or relapsing disease, presence of an increased risk for glucocorticoid-related adverse events or complications) using tocilizumab. Methotrexate may be used as an alternative. Non-biological glucocorticoid-sparing agents should be given in combination with glucocorticoids in all patients with TAK and biological agents may be used in refractory or relapsing patients. We no longer recommend the routine use of antiplatelet or anticoagulant therapy for treatment of LVV unless it is indicated for other reasons. We have updated the recommendations for the management of LVV to facilitate the translation of current scientific evidence and expert opinion into better management and improved outcome of patients in clinical practice.

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Author and article information

Contributors

Corrado Campochiaro: URI : http://loop.frontiersin.org/people/571547/overview

Alessandro Tomelleri: URI : http://loop.frontiersin.org/people/523357/overview

Maria Picchio: URI : http://loop.frontiersin.org/people/257177/overview

Elena Baldissera: URI : http://loop.frontiersin.org/people/422140/overview

Lorenzo Dagna: URI : http://loop.frontiersin.org/people/164656/overview

Journal

Journal ID (nlm-ta): Front Med (Lausanne)

Journal ID (iso-abbrev): Front Med (Lausanne)

Journal ID (publisher-id): Front. Med.

Title: Frontiers in Medicine

Publisher: Frontiers Media S.A.

ISSN (Electronic): 2296-858X

Publication date (Electronic): 27 September 2021

Publication date Collection: 2021

Volume: 8

Electronic Location Identifier: 723506

Affiliations

[1] ¹Unit of Immunology, Rheumatology, Allergy and Rare Diseases, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Hospital , Milan, Italy

[2] ²Vita-Salute San Raffaele University , Milan, Italy

[3] ³Unit of Radiology, IRCCS San Raffaele Hospital , Milan, Italy

[4] ⁴Unit of Nuclear Medicine, IRCCS San Raffaele Scientific Institute , Milan, Italy

Author notes

Edited by: Enrique Roberto Soriano, Italian Hospital of Buenos Aires, Argentina

Reviewed by: Emilia Inoue Sato, Federal University of São Paulo, Brazil; Haner Direskeneli, Marmara University, Turkey

*Correspondence: Corrado Campochiaro campochiaro.corrado@ 123456hsr.it

This article was submitted to Rheumatology, a section of the journal Frontiers in Medicine

†These authors have contributed equally to this work and share first authorship

Article

DOI: 10.3389/fmed.2021.723506

PMC ID: 8502860

PubMed ID: 34646844

SO-VID: cb9d8420-4711-4daf-afaa-0ff27a1caed2

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 10 June 2021

Date accepted : 02 September 2021

Page count

Figures: 2, Tables: 1, Equations: 0, References: 17, Pages: 7, Words: 4979

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