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Tocilizumab shows low immunogenic potential

02 Jan 2017

Use of tocilizumab—through the intravenous (TCZ-IV) or subcutaneous (TCZ-SC) route and either as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)—carries a low risk of immunogenicity in rheumatoid arthritis (RA), a study has shown.

Researchers pooled data from five TCZ-SC and eight TCZ-IV phase III clinical trials and 1 TCZ-IV clinical pharmacology safety study (>50,000 samples) to evaluate the immunogenicity profile of the agent. The overall population comprised 8,974 RA patients in total.

Antidrug antibody (ADA) measurements were performed following TCZ-SC or TCZ-IV treatment as monotherapy or in combination with csDMARDs, and after dosing interruptions or in TCZ-washout samples. The correlation of ADAs with clinical response, adverse events or pharmacokinetics (PK) was estimated.

ADAs developed in 1.5 percent of patients in the TCZ-SC cohort and in 1.5 percent in the TCZ-IV cohort. ADA development was comparable between patients who received TCZ as a monotherapy and those who received TCZ in combination with csDMARDs (0.7 to 2.0 percent).

ADA development was not associated with pharmacokinetic or safety events, such as anaphylaxis, hypersensitivity or injection-site reactions. Furthermore, there were no reports of loss of TCZ efficacy in patients who developed ADAs.

The low immunogenicity of TCZ might be attributed to the downregulation of B cell activities due to the inhibition of IL-6 signalling, as well as to molecule-related factors—including mAb structure (eg, a specific molecular structure with an idiotype of low immunogenic potential) and manufacturing processes.

In light of the finding that the incidence of ADA development is low among TCZ-treated RA patients, regardless or route of administration and whether used as monotherapy or in combination with csDMARDS, routine ADA testing is unnecessary for the clinical use of TCZ in RA management.

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Most Read Articles
Pearl Toh, 10 Jan 2018
A study finds no evidence that using pharmaceutical aids alone for smoking cessation helps improve the chances of successful quitting despite promising results in previous randomized trials and routine prescription of such drugs to help quit smoking.
Elvira Manzano, 16 Jan 2018
Cancer patients at risk for recurrent venous thromboembolism (VTE) are less likely to experience recurrence with rivaroxaban compared with dalteparin, the Select-D trial has shown, ushering in a new standard of care (SoC) for cancer-related VTE.
3 days ago
Rates of immunization particularly in a primary care setting can be improved by constant patient reminders and recall systems, a recent study has found.
4 days ago
It appears that urgent repeat endoscopic retrograde cholangiopancreatography (ERCP) predicts failure of plastic stent treatment for biliary strictures (BS) following liver transplant, according to a study.