Wednesday, 20 Nov 2019

You are here

Biomarker Combo Predicts TNF Inhibitor Responses

Based on clinical trial data, patients starting tumour necrosis factor-alpha inhibitors (TNFi) have roughly a two-thirds chance of achieiving a good clinical response.  French investigators have studied a series of potential biomarkers and surmised that the combination of baseline prealbumin, platelet factor 4 and S100A12 can predict a 78% response to TNFi in rheumatoid arthritis (RA) patients.

They sought to identify potential of protein biomarkers that could be used to predict clinical response to TNFi by studying a cohort of RA patients and measuring baseline blood levels of C-reactive protein, platelet factor 4, apolipoprotein A1, prealbumin, α1-antitrypsin, haptoglobin, S100A8/A9 and S100A12 proteins in bDMARD naive patients at the time of TNFi initiation.

The best fit for a predictive clinical response was seen with a combination of biomarkers (prealbumin, platelet factor 4 and S100A12) that could predict TNFi responses with a sensitivity of 78%, specificity of 77%, positive predictive values (PPV) of 72%, negative predictive values (NPV) of 82%, positive likelihood ratio (LR + ) of 3.35 and negative likelihood ratio (LR-) of 0.28.

TNFi responders had lower levels of prealbumin and S100A12 and higher levels of platelet factor 4 were good predictors for response to TNFi treatment with either Infliximab, etanercept or adalimumab

Further studies in a larger, wider RA population are needed to confirm the utility of using such protein assays. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Psoriasis Risk Increased with TNF Inhibitors in Juveniles

Children with inflammatory diseases who were treated with tumor necrosis factor (TNF) inhibitors had a higher rate of incident psoriasis than those not exposed to these biologics, a single-center retrospective study found.

The Shame Behind Adalimumab Biosimilars

JAMA has an article this week on the shift from biologic drugs to less expensive therapeutic biosimilar agents. The impact of biosimilars can be easily represented by the shift from adalimuamb - a biologic with nearly $19 billion in sales in 2018 - to any one of the four FDA approved biosimilars for adalimumab (see the daily download for slides on new adalimumab and other biosimilars).

Pain Persists Despite TNF Inhibitor Use

Control of pain in patients with rheumatoid arthritis (RA) often focuses on control of inflammation as a means to better control pain. However, a new claims data study shows that while anti-tumor necrosis factor inhibitor (TNFi) may lower the use of opioids, the reduction is nominal, suggesting that a substantial amount of pain is not adequately addressed by TNFi - a potent anti-inflammatory approach.

Adalimumab and Pregnancy Outcomes

A prospective study of birth outcomes to mothers exposed to adalimumab (ADA) between 2004 and 2016 was conducted by Organization of Teratology Information Specialists (OTIS) Research Center at the University of California San Diego, and showed that ADA exposure was not associated with an increased risk for any of the adverse outcomes examined.

Enbrel Patent Battle Won by Amgen

The ugly, legal, financial underbelly of US biosimilar drug development showed up in court last Friday, when a U.S. judge upheld two of Amgen's patents for Enbrel, thwarting a legal challenge by Novartis/Sandoz over its etanercept-szzs biosimilar, Erelzi. 

Sandoz won FDA approval for their etanercept biosimilar in 2016, but has not been able to market Erelzi because of Amgen’s extended patent protection (till 2029).