Real-life results for Inflectra compared to Remicade

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Real-life results for Inflectra compared to Remicade

Biosimilars/Research | Posted 26/06/2015 0 Post your comment

Results of a post-marketing clinical study of infliximab biosimilar Inflectra demonstrated equivalent effectiveness compared to the originator biological (Remicade) in patients with rheumatoid arthritis and ankylosing spondylitis when switched from Remicade [1].

The study compared outcomes in 39 patients after a mean of four years of treatment with Remicade, with the outcomes of those same patients after a median of 11 months following a switch to the infliximab biosimilar Inflectra.

Patients’ symptom level and disease activity were available in the clinical database for pain, fatigue, patient global health (PtGlobal) and disease activity (PtAct), and doctor global assessment of activity (DrGlob) on 0-100 mm VAS, HAQ on 0-3, ESR and CRP. Time-dependent area under the curve (AUC) was computed to each variable for time elapsed before biological treatment, during treatment with Remicade and during treatment with Inflectra, including data from 100, 785 and 157 visits, respectively. Repeated measures were analysed using generalized estimating equations (GEE) models with an unstructured correlation structure.

The results of the study were presented at the European League Against Rheumatism (EULAR) 2015 Congress held in Rome, Italy, on 10–13 June 2015.

Patients’ symptom level and disease activity on AUC were similar during treatment with Remicade and Inflectra, and lower compared to values before biological therapies were initiated. Inflectra was also found to be well tolerated with a comparable safety profile to Remicade.

The authors therefore concluded that the effectiveness ‘appeared similar’ before and after the switch between the two treatments, and also stated that ‘no immediate safety signals were observed’.

In addition, the results of a meta-analysis of 14 randomized controlled trials assessing safety incidences in 1,454 patients, also presented at EULAR 2015, found no meaningful differences in safety (infections, serious infections, malignancies/lymphoma, infusion-related reactions) between patients treated with Inflectra and Remicade [2].

Conflict of interest
Some of the authors of the abstracts [1, 2] have received grant/research support from Samsung, Hospira or Celltrion or are employees of Celltrion. Some authors declared no conflict of interest. For full details of the authors’ conflicts of interest, see the abstracts [1, 2].

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Editor’s comment
It should be noted that data of the studies presented in this article were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

References
1. Sokka T, Kautiainen H. Clinical experience with infliximab biosimilar - switch from Remicade. EULAR 2015; 10-13 June 2015; Rome, Italy.
2. Park W, Yoo DH, Suh CH, et al. Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. EULAR 2015; 10-13 June 2015; Rome, Italy.

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Source: Clinical Trials Register, EULAR, Hospira