Efficacy and safety of infliximab biosimilar Inflectra ® in severe sarcoidosis

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

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.

MeSH terms

  • Adult
  • Antibodies, Neutralizing / blood
  • Antirheumatic Agents / therapeutic use*
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Cohort Studies
  • Female
  • Fluorodeoxyglucose F18
  • Health Status
  • Hospitalization / statistics & numerical data
  • Humans
  • Infections / epidemiology
  • Infliximab / therapeutic use*
  • Male
  • Middle Aged
  • Peptidyl-Dipeptidase A / blood
  • Positron-Emission Tomography
  • Quality of Life
  • Radiopharmaceuticals
  • Receptors, Interleukin-2 / blood
  • Respiratory Function Tests
  • Retrospective Studies
  • Sarcoidosis, Pulmonary / blood
  • Sarcoidosis, Pulmonary / diagnostic imaging
  • Sarcoidosis, Pulmonary / drug therapy*
  • Sarcoidosis, Pulmonary / physiopathology
  • Severity of Illness Index
  • Treatment Outcome
  • Vital Capacity

Substances

  • Antibodies, Neutralizing
  • Antirheumatic Agents
  • Biosimilar Pharmaceuticals
  • Radiopharmaceuticals
  • Receptors, Interleukin-2
  • Fluorodeoxyglucose F18
  • Infliximab
  • Peptidyl-Dipeptidase A