Novartis conducts head-to-head study of Cosentyx, Xiumele and Adalimumab biosimilars

January 10, 2018 Source: Sina Pharmaceutical

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On January 9, Novartis Pharmaceuticals said that the company's SURPASS study has begun. This is a CosentyxÂ® (secukinumab) and adalimumab (adalimumab) biosimilar drug (in Sandoz development) head-to-head control for ankylosing spondylitis ( AS) Clinical trial of treatment. The SURPASS study was the first head-to-head controlled trial to evaluate the superiority of Cosentyx compared to adalimumab biosimilars in AS patients. The SURPASS study is currently recruiting patients and was enrolled in the first patient in November 2017.

Novartis also announced that the EXCEED study has also begun. This is a clinical trial of Cosentyx and HumiraÂ® (adalimumab) head-to-head control for psoriatic arthritis (PsA) treatment, and patients are enrolled. The EXCEED study was the first large double-blind and Humira head-to-head clinical trial to treat patients with PsA to assess the superiority of Cosentyx's ACR 20 at 52 weeks. Both SURPASS and EXCEED are part of the Cosentyx Large Rheumatology Clinical Program.

Dr. Robert LandewÃ©, professor of clinical and immunology at the Zuyderland Medical Center in Heerlen, the Netherlands, said: "The EXCEED and SURPASS head-to-head study aims to address major clinical issues, namely the resolution of residual uncertainty in PsA and AS treatment. Head to head The trials provide the most reliable data to help advance clinical practice and are key to clinical decision making. In this case, these data will increase the body of evidence to emphasize the clinical benefits of different biologic treatment pathways."

Vas Narasimhan, Head of Global Drug Development and Chief Medical Officer of Novartis, said: "Cosentyx's clinical efficacy and safety data are very good and have been confirmed in the application of more than 125,000 patients worldwide. Many patients with PsA Because they are subject to constant pain and fatigue, making them unable to enjoy normal life and the risk of long-term loss of exercise, these patients should receive the best treatment. We hope that the EXCEED and SURPASS trials can provide decision-making for doctors and patients. A valuable answer."

Cosentyx is the first biological agent to specifically target IL-17A. IL-17A is a pro-inflammatory factor that plays a leading role in PsA and AS, while PsA and AS are autoimmune diseases at risk of loss of activity. About 40% of patients with PsA experience irreversible joint damage and permanent body deformities. In patients with AS, inflammation of the ankle joint and new bone formation in the spine are associated with elevated levels of IL-17A, and severe cases progress to irreversible spinal fusion.

Cosentyx is the first and only fully humanized IL-17A monoclonal antibody approved for the treatment of AS, PsA and psoriasis, which has demonstrated rapid and sustained efficacy and consistently good safety profile. So far, Cosentyx has been used in more than 125,000 patients worldwide. (Sina Pharmaceutical Compilation / David)

Article reference source: Novartis advances head-to-head superiority trials of CosentyxÂ® versus HumiraÂ®* and proposed biosimilar adalimumab**

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