Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX-SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments

Background: The introduction of biologic disease-modifying anti-rheumatic in clinical practice has dramatically improved the clinical outcomes of individuals with rheumatoid arthritis (RA). We do IFX-SIRIUS Study I are evaluating whether to switch from originator infliximab (IFX) for its biosimilar, CT-P13, not least in maintaining a nonclinical relapse to continue treatment with the originator of IFX in patients with RA achieving clinical remission.

This is the next big issue whether the activity of the disease can be maintained in good condition after the termination of the CT-P13 because no evidence was available about the clinical value of stopping biosimilars in patients with RA. Thus, we will evaluate whether conditions will be maintained without clinical relapse after discontinuation of CT-P13 in patients with RA, achieving clinical remission or low disease activity during IFX-SIRIUS Study I.


Methods / design: This was an intervention, multicenter, open-label, single-arm clinical trial with 48 weeks follow-up. Patients with RA treated with CT-P13 and ongoing nonclinical relapse during IFX-SIRIUS Study I would be included. Patients will discontinue CT-P13 after the study period of IFX-SIRIUS Study I. We will evaluate disease activity with clinical disease activity index and musculoskeletal ultrasound (MSU). The primary endpoint was the proportion of patients who do not have clinical relapses during the study period. important secondary endpoint was the change from baseline score of MSU. We will also comprehensively analyzed the serum levels of several biomarkers, such as cytokines and chemokines. In addition, if the clinical relapses in patients after discontinuation of CT-P13, we will evaluate the effectiveness and safety of CT-P13 restart.


Discussion: The results of the study are expected to demonstrate the clinical benefit of the termination of the CT-P13 and the effectiveness and safety of CT-P13 restart after clinical relapse. The strength of this study was to prospectively evaluate the effectiveness of treatment with not only clinical disease activity index but MSU findings are also standard in some centers. We will investigate whether the parameter at the beginning of nonclinical can predict relapse after discontinuation of CT-P13 by integrating multilateral assessment, ie, patient characteristics, clinical indices of disease activity, MSU findings, and serum biomarkers.

 Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX-SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments
Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX-SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments

Quality Assurance for Biological Medicines Optimize HER2 + Breast Cancer Treatment: Insights from the development of biosimilar Trastuzumab SB3

SB3 is biosimilar trastuzumab that has been approved for use in the treatment of 2-positive breast cancer is the human epidermal growth factor and human epidermal growth factor 2-positive gastric cancer. antibody-dependent cell cytotoxicity is one of several important quality attributes of trastuzumab.

Data from developing SB3 supports the hypothesis relationship between the activity of antibody-dependent cell cytotoxicity and clinical outcomes in terms of response rates and long-term survival. Analytical methods currently utilizing advanced technology allows the detection of small changes in other quality attributes that influence cellular cytotoxicity antibody-dependent, such as glycosylation and FcγRIIIa binding.

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The use of such methods to monitor the batch-to-batch consistency enables the production of biosimilars trastuzumab with consistent quality. Trastuzumab biosimilars like SB3 because it has the potential to increase the accessibility of trastuzumab-based therapy without compromising effectiveness or safety.