Four Important Arthritis Studies
Four Important Arthritis Studies
The other 2 studies were presented by the group from Korea and Celltrion, which has a biosimilar infliximab that now has been reviewed by the European Medicines Agency. The decision is pending. This drug was the subject of the PLANETRA study in rheumatoid arthritis and the PLANETAS study in ankylosing spondylitis, both of which have been published recently online in the Annals of Rheumatic Diseases. The Annals articles reported the 30-week data in each of these studies, and at the meeting today there was an oral presentation of the 54-week results from the PLANETRA study in rheumatoid arthritis.
In this study, infliximab and the biosimilar, CTP13, were each administered in the typical dosing regimen at a concentration of 3 mg/kg to more than 600 patients with rheumatoid arthritis. The data were followed out to 54 weeks, and at week 54 the American College of Rheumatology 20 (ACR20) was highly similar between groups -- 57% in those treated with CTP13 and 52% in those treated with innovator infliximab, Remicade®. This was well within the margin of noninferiority that was predetermined for this study.
The ACR50 and ACR70 scores were also comparable between groups; for the ACR50, scores were 33.1% for CTP13 and 31.6% for the innovator infliximab, and ACR70 scores were 16.2% and 15.1%, respectively, for CTP13 and innovator infliximab. DAS28 remission was also achieved in biosimilar proportions -- 26.4% and 27.8%, respectively, for CTP13 and innovator infliximab. Furthermore, the proportion of patients reaching low disease activity was comparable. Of interest, patients with anti-drug antibodies had lower ACR response rates than did patients without the antibodies, as might be expected. Safety profiles were also comparable.
The PLANETAS study in ankylosing spondylitis was also extended up to week 54, and in this study responses were similar in terms of Assessments in Ankylosing Spondylitis 20 (ASAS20) and ASAS40 scores for both CTP13 and innovator infliximab, as had been observed at weeks 14 and 30 in the PLANETAS study.
In summary, the Celltrion infliximab biosimilar seems to have sustained efficacy at 54 weeks that is comparable to the data achieved at week 14 and week 30. With the preclinical package that has already been presented to the European Medicines Agency, it may well be the first biosimilar approved for clinical use in patients with a rheumatic disease.
We look forward to seeing more data about biosimilars presented at the ACR meeting in San Diego this fall and more published in the near future. Thank you very much for your attention, and I look forward to seeing you on Medscape.
Infliximab Biosimilar
The other 2 studies were presented by the group from Korea and Celltrion, which has a biosimilar infliximab that now has been reviewed by the European Medicines Agency. The decision is pending. This drug was the subject of the PLANETRA study in rheumatoid arthritis and the PLANETAS study in ankylosing spondylitis, both of which have been published recently online in the Annals of Rheumatic Diseases. The Annals articles reported the 30-week data in each of these studies, and at the meeting today there was an oral presentation of the 54-week results from the PLANETRA study in rheumatoid arthritis.
In this study, infliximab and the biosimilar, CTP13, were each administered in the typical dosing regimen at a concentration of 3 mg/kg to more than 600 patients with rheumatoid arthritis. The data were followed out to 54 weeks, and at week 54 the American College of Rheumatology 20 (ACR20) was highly similar between groups -- 57% in those treated with CTP13 and 52% in those treated with innovator infliximab, Remicade®. This was well within the margin of noninferiority that was predetermined for this study.
The ACR50 and ACR70 scores were also comparable between groups; for the ACR50, scores were 33.1% for CTP13 and 31.6% for the innovator infliximab, and ACR70 scores were 16.2% and 15.1%, respectively, for CTP13 and innovator infliximab. DAS28 remission was also achieved in biosimilar proportions -- 26.4% and 27.8%, respectively, for CTP13 and innovator infliximab. Furthermore, the proportion of patients reaching low disease activity was comparable. Of interest, patients with anti-drug antibodies had lower ACR response rates than did patients without the antibodies, as might be expected. Safety profiles were also comparable.
The PLANETAS study in ankylosing spondylitis was also extended up to week 54, and in this study responses were similar in terms of Assessments in Ankylosing Spondylitis 20 (ASAS20) and ASAS40 scores for both CTP13 and innovator infliximab, as had been observed at weeks 14 and 30 in the PLANETAS study.
In summary, the Celltrion infliximab biosimilar seems to have sustained efficacy at 54 weeks that is comparable to the data achieved at week 14 and week 30. With the preclinical package that has already been presented to the European Medicines Agency, it may well be the first biosimilar approved for clinical use in patients with a rheumatic disease.
We look forward to seeing more data about biosimilars presented at the ACR meeting in San Diego this fall and more published in the near future. Thank you very much for your attention, and I look forward to seeing you on Medscape.
