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Updated: Jun 24, 2026

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody (mAb) by Neutralizing TNF Using an In Vitro Bioanalytical Method
Published on: September 16, 2017
Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study
Giulia Nunziati1, Antonella DI Cesare1, Elia Rosi1
1Section of Dermatology, Department of Health Sciences, University of Florence, Florence, Italy.
Background:
In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated.
Methods:
We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period.
Results:
A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy.
Conclusions:
Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.
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