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. 2022 Jul 19;12(7):1174.
doi: 10.3390/jpm12071174.

Predicting Loss of Efficacy after Non-Medical Switching: Correlation between Circulating TNF-α Levels and SB4 in Etanercept to SB4 Switchers and Naïve Patients with Rheumatic Disease

Maurizio Benucci  1 , Arianna Damiani  1 , Edda Russo  2 , Francesca Li Gobbi  1 , Valentina Grossi  3 , Amedeo Amedei  2 , Maria Infantino  3 , Mariangela Manfredi  3
Affiliations

Predicting Loss of Efficacy after Non-Medical Switching: Correlation between Circulating TNF-α Levels and SB4 in Etanercept to SB4 Switchers and Naïve Patients with Rheumatic Disease

Maurizio Benucci et al. J Pers Med. .

Erratum in

Abstract

Background: We investigated how the non-medical switching (NMS) between Etanercept (ETN)/originator and SB4/biosimilar affects treatment efficacy in a rheumatic disease (RD) cohort, evaluating some laboratory parameters as loss of efficacy predictors after NMS.

Methods: We enrolled 124 patients with RD (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis): 79 switchers from ETN/originator to SB4 and 45 naïve patients receiving SB4 (first biological treatment). At baseline, 6 (T1), and 12 months (T2), clinical and laboratory parameters were evaluated.

Results: In naïve patients, TNF-α significantly increased at T1 in responders (NR) and non-responders (NNR). TNF-α was lower in NNR than in NR at T1 and T2. In NR and NNR, drug levels (DL) increased between T1 and T2. However, DLs were lower in NNR than in NR at T1 and T2. TNF-α was higher in switcher responders (SR) than in non-responders (SNR) at T1 and T2. In SNR, DLs were higher at baseline than in SR, but they decreased significantly at T1 and T2.

Conclusions: We observed a decrease in DL and TNF-α levels after NMS in SNR. Moreover, in naïve patients, DL and TNF-α levels were higher in NR than in NNR. Monitoring DL and TNF-α levels may represent a future precision medicine approach to predict loss of efficacy after NMS.

Keywords: Etanercept/SB4; biosimilars; disease activity; loss of efficacy; non-medical switching; precision medicine; rheumatic disease.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
TNF-α levels in naïve patients and switcher responders and non-responders. The plus/star symbol (+) represent p-value = < 0.001.
Figure 2
Figure 2
Levels of ETN in naïve patients and switcher responders and non-responders. The plus/star symbol (+) represent p-value = < 0.001.
See this image and copyright information in PMC

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