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J Autoimmun. 2017 May;79:4-16. doi: 10.1016/j.jaut.2017.02.003. Epub 2017 Feb 13.

Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-α agents in rheumatic diseases; A systematic review and meta-analysis.

Author information

1
Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, The University of Chicago Medicine, Chicago, USA.
2
Department of Internal Medicine, University of Nevada, Reno, USA.
3
Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA.
4
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
5
Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, The University of Chicago Medicine, Chicago, USA. Electronic address: asakurab@medicine.bsd.uchicago.edu.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of biosimilars of anti-tumor necrosis factor (TNF)-α agents compared to their reference agents in immune mediated diseases.

METHODS:

Electronic databases were searched for randomized controlled trials (RCTs) assessing the efficacy and safety of biosimilars of anti-TNF-α agents compared to their reference agents in patients with various immune mediated diseases. The outcomes were the rates of clinical response and adverse events among patients treated with biosimilars compared to their reference agents. Additionally, occurrence of anti-drug antibodies with the use of biosimilars was compared to the reference agents.

RESULTS:

Nine studies reporting outcomes in 3291 patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) were identified (5 infliximab, 2 adalimumab, and 2 etanercept). No RCTs in other diseases were found. Biosimilars of infliximab showed similar rates of clinical response compared to the reference agent in RA and AS. Frequency of anti-drug antibody and adverse events were similar except for a slightly, but significantly, higher risk of upper respiratory tract infections with biosimilar (RR 1.54, P = 0.047, 95% confidence interval (CI) = 1.01-2.37). Biosimilar of adalimumab showed no differences among any outcomes compared to the reference agent. Biosimilars of etanercept showed no differences for clinical response and frequency of adverse events, but showed a significantly lower rate of anti-drug antibodies at 24-30 weeks (RR 0.05, P <0.0001%, 95% CI = 0.01-0.21).

CONCLUSION:

In the present study, biosimilars of anti-TNF-α agents had an overall comparable efficacy and safety profile compared to their reference agents in RA and AS supporting their use for these conditions.

KEYWORDS:

Anti-TNF-α; Biosimilar; Immune mediated disease; Meta-analysis; Systematic review

PMID:
28209290
DOI:
10.1016/j.jaut.2017.02.003
[Indexed for MEDLINE]

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