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Respir Med. 2018 May;138S:S7-S13. doi: 10.1016/j.rmed.2018.02.009. Epub 2018 Feb 19.

Efficacy and safety of infliximab biosimilar Inflectra® in severe sarcoidosis.

Author information

1
Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital, Nieuwegein, The Netherlands. Electronic address: m.schimmelpennink@antoniusziekenhuis.nl.
2
Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital, Nieuwegein, The Netherlands.
3
Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital, Nieuwegein, The Netherlands; Division Laboratory and Pharmacy, Department of Clinical Pharmacy, University Medical Center Utrecht, The Netherlands.
4
Division Laboratory and Pharmacy, Department of Clinical Pharmacy, University Medical Center Utrecht, The Netherlands.
5
Department of Nuclear Medicine, St Antonius Hospital, Nieuwegein, The Netherlands.
6
Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital, Nieuwegein, The Netherlands; Division of Heart&Lungs, University Medical Center, Utrecht, The Netherlands.

Abstract

BACKGROUND:

Infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-α) is effective third-line therapy in severe sarcoidosis. The originator product of Infliximab, Remicade®, is expensive, limiting universal access. Recently, a less expensive biosimilar of infliximab, Inflectra®, has become available, but the efficacy and tolerability has not been studied in sarcoidosis.

METHODS:

In this retrospective cohort study, 29 patients treated with the infliximab biosimilar Inflectra®, were analysed. Patients received Inflectra® intravenously monthly at a dose of 5 mg/kg. We measured trough levels before every infusion. Before and after 6 months of induction therapy pulmonary function and disease activity were evaluated using Standardised Uptake Value (SUV) of the 18F-fluorodeoxyglucose by positron emission tomography (18F-FDG PET), soluble interleukin-2 receptor (sIL-2R), angiotensin converting enzyme (ACE) and health-related quality of life (HRQOL).

RESULTS:

In patients with pulmonary sarcoidosis as main treatment indication (n = 15) the predicted FVC improved with 8.1%, p < 0.05. Furthermore, in the whole group HRQoL improved significantly (p < 0.001), whereas SUVmax and sIL-2R significantly reduced (p < 0.001 and p = 0.001 respectively). Hospitalisation due to infections occurred in four patients. None of the patients discontinued Inflectra® due to side-effects. Furthermore, all patients had detectable trough levels indicating development of neutralizing antibodies.

CONCLUSION:

Infliximab biosimilar Inflectra® seems effective in the treatment of refractory sarcoidosis with a comparable safety profile to the reference product Remicade®. Inflectra® can be considered as an alternative and less expensive option for patients with refractory sarcoidosis.

KEYWORDS:

Biosimilar; Inflectra(®); PET-scan; Sarcoidosis; TNF-α inhibitor

PMID:
29496351
DOI:
10.1016/j.rmed.2018.02.009
[Indexed for MEDLINE]

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