Tsinghua University, School of Medicine and led a study comparing the efficacy and safety of IBI303 and the originator drug adalimumab (Humira®) on ankylosing spondylitis (AS) patients. IBI303 is comparable and its launch by Innovent Biologics, Inc. is expected to reduce the medical expenditure of AS patients in China. A prominent Chinese investigator, Huji Xu, served as the PI.

What is IBI303?

An anti-tumor necrosis factor-alpha (anti-TNF-alpha) monoclonal antibody injection developed by Innovent Biologics, Inc. (Innovent) it is an adalimumab biosimilar. It is one of at least 12 such biosimilars. It has entered Phase III clinical trials for AS. IBI303 binds TNF with high affinity and blocks the downstream signal cascade, resulting in the effective treatment of autoimmune disease.

The Study

The Phase III clinical trial was a multi-center, randomized, double-blind, parallel-controlled trial that compared the efficacy and safety of IBI303 and the originator drug adalimumab on AS patients. The trial sponsor, Innovent, declared that it is the first large-scale head-to-head Phase III clinical trial comparing a biosimilar and adalimumab in AS patients. An interesting side notes: it is the first time a highly regarded top-tier medical journal featured the major Phase III clinical trial results of a China-developed biosimilar.

23 hospitals across China participated in the Phase III trial. All enrolled patients received at least four weeks of NSAIDs treatment and were either treatment ineffective, resistant or intolerable. Patients treated with either IBI303 or Humira® subcutaneous injection of 40 mg/0.8 ml once every two weeks for 22 weeks. The primary endpoint was the ASAS20 response rate at week 24. Tsinghua Medical University led the study.

The Results

Of the 438 participating patients, 220 were treated with IBI303 while those in the control group received Humira®. In addition to primary endpoints, the secondary endpoints were met including AS assessment points such as ASAS20 response rate at week 12, ASAS40 response rate at week 24, ASAS partial response rates, ASAS5/6 response rate, and BASDAI, etc.

Overall data indicate the comparable effects to the originator drug in terms of disease activity, improvement of physical functions, spinal mobility, tendonitis, overall patient assessment, and improvement of the quality of life. The safety and immunogenicity are comparable to those of Humira®.

Lead Research/Investigator

Huji Xu, Professor of Medicine, Tsinghua University and Second Military Medical University. Professor Xu is a founding Executive Dean of School of Clinical Medicine Tsinghua University and Vice President of Beijing Tsinghua Changgung Hospital Tsinghua University. Presently he is chair of the Department of Internal Medicine and heads rheumatology and immunology division in Shanghai Changzheng Hospital affiliated at SMMU.

Call to Action: Humira is the most successful drug on the market. This biosimilar is being tested in China for Ankylosing Spondylitis. The sponsor reports it has met its primary and secondary endpoints. Perhaps the biosimilar will be tested for other conditions in other countries. Interested in learning more reach out to the sponsor. TrialSite News can facilitate an introduction.

Source: Yahoo! Finance

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