Samsung Bioepis and Biogen Announce Pooled Analysis Results of Anti-TNF Biosimilars BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab) at EULAR 2018
- Pooled analysis is first of its kind, combining data from three Phase III trials that compared efficacy and safety of anti-tumor necrosis factor (anti-TNF) biosimilars to their reference biologics
- Study – which examined patients with moderate to severe rheumatoid arthritis – may help scientists answer critical questions about anti-TNF treatment among specific patient populations
- The potential role of anti-TNF biosimilars in managing autoimmune rheumatological diseases will be discussed at EULAR 2018
“Since BENEPALI and FLIXABI launched more than two years ago, they have played an increasingly important role in widening access to life-enhancing treatment options for patients and healthcare systems across Europe,” said
Data from three separate Phase III randomized, double-blind studies compared the efficacy and safety of BENEPALI in reference to etanercept (ETN); FLIXABI to infliximab (INF); and IMRALDI to adalimumab (ADL). The data were pooled and analyzed to assess the impact of anti-drug antibodies (ADAbs) on efficacy and tolerability, as well as radiographic progression by disease activity state.
Each clinical study had similar study designs and population demographics, and the same primary endpoint of ACR20 response rate. All patients included in the studies had been diagnosed with moderate to severe rheumatoid arthritis (RA) despite previous methotrexate treatment.
“This analysis presents a unique opportunity to compare the efficacy of three anti-TNFs in slowing the progression of joint erosion in patients with moderate to severe RA, as measured by radiographic progression,” said
Immunogenicity data from 1,710 patients with RA pooled from the three studies revealed that the incidence of ADAb was comparable between the biosimilars and their reference products – indicating that the biosimilars were equally effective as their biologic counterparts. In addition, efficacy and injection site reactions/infusion related reactions (ISR/IRR) were evaluated in relation to the presence of ADAb. Data suggested that the development of ADAb is associated with reduced clinical efficacy and increased incidence of ISR/IRR in patients with RA.
Radiographic data from 1,263 patients participating in the studies were collected and grouped based on patient’s disease activity state at the time of the primary endpoint assessment (Week 24 or Week 30). Radiographic progression was measured using the modified Total Sharp Score (mTSS) at Week 0 and Week 52 or Week 54. Overall, radiographic progression was minimal and comparable across all treatment groups. In addition, the pooled biosimilar group tended to have a lower mean change in mTSS compared with the pooled reference group, which slows down the progression of this disease.
The two abstracts being presented at EULAR 2018 are as follows:
- Abstract #THU0201 – A pooled analysis of three TNF-A inhibitor biosimilar studies in patients with rheumatoid arthritis comparing radiographic progression by disease activity states [Poster session:
June 14, 2018at 11:45]
- Abstract #THU0184 – Impact of immunogenicity on clinical efficacy and administration related reaction in TNF inhibitors: a pooled-analysis from three biosimilar studies in patients with rheumatoid arthritis [Poster tour:
June 14, 2018at 12:10]
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six late-stage candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between
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