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Efficacy and Safety of Anti-TNF-alpha Biosimilars Comparable to Reference Drugs in RA and AS


A recently published meta-analysis of the clinical efficacy, safety, and pharmacokinetics of anti-tumor necrosis factor (TNF)-alpha biosimilar agents concludes that the biosimilars had an overall comparable efficacy and safety profile compared with their reference agents in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS), supporting their use to treat these conditions.

The investigators searched electronic databases (PubMed/MEDLINE, Google Scholar, Scopus, EMBASE, and Cochrane Central Register of Controlled Trials) and abstracts from medical conferences for randomized controlled trials assessing the efficacy and safety of biosimilars of anti-TNF-alpha agents, compared with their reference agents, in patients with a variety of immune-mediated diseases. The analysis used 9 studies encompassing treatment outcomes in 3291 patients with RA and AS who used infliximab (5 studies), adalimumab (2 studies), and etanercept (2 studies).

One primary outcomes of the study was the rate of clinical response and adverse events among patients treated with biosimilars compared with their reference drugs. Risk ratios of American College of Rheumatology 20% (ACR20) and 70% (ACR70) response were calculated for RA patients, and Assessment of SpondyloArthritis International Society 20% (ASAS20) response rates were calculated for AS patients, respectively. Response rates were analyzed at short (12 to 16 weeks), medium (24 to 30 weeks), and long-term (48 to 54 weeks) intervals. The second outcome studied was the occurrence of anti-drug antibodies (immunogenicity) with the use of biosimilars compared with immunogenicity rates to reference agents at short (14 weeks), medium (up to 24 to 30-weeks or at 30 weeks), and long (48 to 54 weeks)-term periods. Immunogenicity is a concern because it can potentially limit clinical efficacy and safety.

The researchers write that their study is the first to comprehensively analyze and combine the available data by meta-analysis. They conclude that their study showed biosimilars of anti-TNF-alpha agents had overall similar clinical efficacy, safety, and immunogenicity compared with their reference agents in RA and AS up to 54 weeks of follow-up. The only exceptions were that biosimilars of infliximab were associated with an increased risk of upper respiratory tract infection and biosimilars of etanercept showed a significantly lower occurrence of anti-drug antibodies.

The authors believe that their study demonstrated that patients with RA and AS treated with biosimilars had no significant differences in the frequency of overall treatment-emergent adverse events, severe treatment-emergent adverse events, infusion reactions, malignancies, and infections compared with their respective reference biologics. “The results of our study support the use of biosimilars in the treatment of RA and AS,” they conclude.


Komaki Y, Yamada A, Komaki F, et al. Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-α agents in rheumatic diseases; A systematic review and meta-analysis [published online February 14, 2017]. J Autoimmun. http://dx.doi.org/10.1016/j.jaut.2017.02.003.

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