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Randomized Controlled Trial
. 2017 Feb;76(2):355-363.
doi: 10.1136/annrheumdis-2015-208786. Epub 2016 Apr 29.

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

Dae Hyun Yoo  1 , Nenad Prodanovic  2 , Janusz Jaworski  3 , Pedro Miranda  4 , Edgar Ramiterre  5 , Allan Lanzon  6 , Asta Baranauskaite  7 , Piotr Wiland  8 , Carlos Abud-Mendoza  9 , Boycho Oparanov  10 , Svitlana Smiyan  11 , HoUng Kim  12 , Sang Joon Lee  12 , SuYeon Kim  12 , Won Park  13
Affiliations
Randomized Controlled Trial

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

Dae Hyun Yoo et al. Ann Rheum Dis. 2017 Feb.

Abstract

Objectives: To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.

Methods: This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group).

Results: Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).

Conclusions: Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years.

Trial registration number: NCT01571219; Results.

Keywords: Anti-TNF; DMARDs (biologic); Rheumatoid Arthritis; Treatment.

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Conflict of interest statement

DHY and WP: consultation for CELLTRION. AB reports personal fees from Abbvie and grants from Samsung Bioepis and Abbvie, outside the submitted work; HUK, SJL and SYK are full-time employees of CELLTRION.

Figures

Figure 1
Figure 1
Patient disposition in the PLANETRA extension study. All patients who enrolled in the extension study (n=158 and 144 in the maintenance and switch groups, respectively) were included in the ITT population. EC, ethics committee; ITT, intent-to-treat; MoH, Ministry of Health; RP, reference product.
Figure 2
Figure 2
Proportion of patients with rheumatoid arthritis with (A) an ACR20 response, (B) an ACR50 response and (C) an ACR70 response in the maintenance* and switch** groups of the PLANETRA extension study (efficacy population with non-responder imputation approach). CI values are the 95% CIs of the treatment difference. *Patients treated with CT-P13 during the 54 weeks of the main study and the 48-week extension study. **Patients treated with reference product during the 54 weeks of the main study and then switched to CT-P13 during the 48-week extension study. ACR, American College of Rheumatology.
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