Newly published data demonstrate sustained efficacy and safety profile of biosimilar infliximab in RA

Long term data from the pivotal phase III PLANETRA study over 102 weeks demonstrating the clinical efficacy and safety profile of biosimilar infliximab in RA patients, has been published in Annals of the Rheumatic Diseases this month.¹

Long term data from the pivotal phase III PLANETRA study over 102 weeks demonstrating the clinical efficacy and safety profile of biosimilar infliximab in RA patients, has been published in Annals of the Rheumatic Diseases this month.¹

In those patients who enrolled into the extension phase of the PLANETRA trial, biosimilar infliximab continued to be effective and well tolerated over two years in rheumatoid arthritis (RA) patients and these data also demonstrate comparability in the switch setting, in that biosimilar infliximab was efficacious and well tolerated when patients were switched from the reference infliximab at one year.¹ Data on the safety and immunogenicity profile of biosimilar infliximab was also collected during the 54-week phase of the PLANETRA study and found to be similar to reference infliximab.²

PLANETRA results at week 102:¹ A total of 302 of 455 patients who completed the main PLANETRA study continued to the extension phase, and these patients were evaluated over 102 weeks, starting from initial enrolment into the randomised portion of the study. The proportion of patients achieving a clinical response were maintained at similar levels to those in the original randomised blinded portion of the study. ACR20 response was achieved by 71.8% versus 71.7% of switch versus maintenance patients after 102 weeks, respectively. ACR50 and ACR70 response was also comparable between the two groups (51.4% versus 48.0% ACR50 response, 26.1% versus 24.3% ACR70 response in switch versus maintenance groups, respectively).

The proportion of patients with anti-drug antibodies and those with neutralising antibodies was similar between switch and maintenance groups. Treatment emergent adverse events (TEAEs) between the two treatment groups were also found to be similar, ≥1 TEAE was reported for 53.8% versus 53.5% (switch versus maintenance groups, respectively); treatment related TEAEs were reported in 18.9% versus 22.0% (switch versus maintenance groups, respectively). Serious adverse events (SAEs) occurred in 9.1% versus 7.5% of patients in the extension study (switch versus maintenance groups, respectively). Treatment related SAEs occurred in 2.8% versus 1.3% of patients in the extension study (switch versus maintenance patients, respectively).¹

“These data not only demonstrate that biosimilar infliximab is efficacious with a good tolerability profile over two years, but also that the efficacy profiles exhibited by those patients who switched from reference infliximab and those who remained on biosimilar infliximab were comparable,” comments Dr Dae-Hyun Yoo, lead investigator of the PLANETRA study.

Remsima^® was the first infliximab biosimilar available in Europe. An anti-tumour necrosis factor (anti-TNF) mAb like the reference product, it is indicated for the treatment of adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis, rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis and psoriasis.3 Biosimilar infliximab may be a cost effective option for over-burdened health systems which need to find savings, these data add to the growing body of evidence which builds the case for using value-based alternatives.

Mundipharma International Limited and its independent associated companies have distribution rights from Celltrion Healthcare Hungary Kft for Remsima in Germany, Italy, UK, Netherlands, Belgium and Luxembourg.

References

1. Yoo H et al. (2016). 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. Annals of the Rheumatic Diseases.
2. Yoo H et al. (2016) A Phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Research and Therapy.
3. Remsima SPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf (Last accessed April 2016)