First experience with biosimilar infliximab CT-P13 in patients with inflammatory rheumatic diseases in the Czech Republic in the ATTRA national registry


Authors: K. Pavelka 1;  K. Jarošová 1;  D. Suchý 2;  M. Uher 3;  K. Hejduk 3
Authors‘ workplace: Revmatologický ústav Praha 1;  Oddělení klinické farmakologie Fakultní nemocnice Plzeň 2;  Institut biostatistiky a analýz, Lékařská fakulta, Masarykova univerzita Brno 3
Published in: Čes. Revmatol., 24, 2016, No. 1, p. 15-30.
Category: Original article

Overview

Biosimilar infliximab CT-P13, developed by Korean company Celltrion, is the first EMA approved biosimilar agent. In double-blind studies in rheumatoid arthritis and ankylosing spondylitis biosimilar infliximab was equally effective and had the same safety profile as the original infliximab.

CT-P13 was introduced into clinical practice in the Czech Republic at the end of 2013. All the patients have been treated according to the indications of the Czech Society for Rheumatology at the centers of biological treatment and enrolled in the ATTRA registry. The aim of this study was to evaluate the first year of experience with the CT-P13 agent in the ATTRA national registry.

Results:
A total of 100 patients with rheumatoid arthritis (RA) were enrolled in the registry. Analysis was then performed on 93 adult patients. The mean age of these patients was 54 years and the disease duration was 10 years. Disease activity was high, the average baseline DAS 28 was 5.7 ± 0.8, number of swollen joints was 8.8 ± 4.3 and CRP levels were 28.1 ± 22.5 mg / l. After nine months of treatment there was a significant decrease in all monitored parameters. At the start of treatment 73.3% of patients had high disease activity according to EULAR and 26.7% of patients had moderate activity. After nine months of treatment 87.5% of patients were in remission, 93.7% had low activity, 6.3% had moderate activity, and none of the patients had high disease activity. The treatment survival after nine months was 78.0%.

Seventy-two patients were enrolled in the registry of ankylosing spondylitis (AS) and 68 adult patients thereof were further analyzed. Their average age was 44 years and disease duration of 9 years. Disease activity at the start of treatment was high, and the average BASDAI was 6.2 ± 1.7 and CRP levels were 31.1 ± 26.7 mg / l. After nine months of treatment BASDAI decreased to 0.9 ± 1.4, and quality of life improved (HAQ decreased from 1.1 ± 0.6 to 0.4 ± 0.5). There were improvements in all dimensions of quality of life according to SF-36.

In the group of RA patients 21 adverse events and 7 serious adverse events were reported. In patients with AS there were 7 adverse events and no serious adverse event. No new signals of toxicity were reported.

Conclusion:
First experience with biosimilar CT-P13 in the ATTRA national registry is positive. No new signals of toxicity were reported.

Key words:
Biosimilar infliximab CT-P13, inflammatory rheumatic diseases


Sources

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Labels
Dermatology & STDs Paediatric rheumatology Rheumatology
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