Multicenter Study "Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection" Drug Levels Measured by SHIKARI® ELISA Kits From Matriks Biotek®

Multicenter Study by University Hospitals from Denmark, Australia and New Zealand.

Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection

Gastroenterology. Jul;151(1):110-9, 2016

Background & Aims

Little is known about in utero exposure to and postnatal clearance of anti–tumor necrosis factor (anti-TNF) agents in neonates. We investigated the concentrations of adalimumab and infliximab in umbilical cord blood of newborns and rates of clearance after birth, and how these correlated with drug concentrations in mothers at birth and risk of infection during the first year of life.

Methods

We performed a prospective study of 80 pregnant women with inflammatory bowel diseases at tertiary hospitals in Denmark, Australia, and New Zealand from March 2012 through November 2014: 36 received adalimumab and 44 received infliximab; 39 received concomitant thiopurines during pregnancy. Data were collected from medical records on disease activity and treatment before, during, and after pregnancy. Concentrations of anti-TNF agents were measured in blood samples from women at delivery and in umbilical cords, and in infants for every 3 months until the drug was no longer detected.

Results

The time from last exposure to anti-TNF agent during pregnancy correlated inversely with the concentration of the drugs in the umbilical cord (adalimumab: r = -0.64, P = .0003; infliximab: r = -0.77, P < .0001) and in mothers at time of birth (adalimumab, r = -0.80; infliximab, r = -0.80; P < .0001 for both). The median ratio of infant:mother drug concentration at birth was 1.21 for adalimumab (95% confidence interval [CI], 0.94–1.49) and 1.97 for infliximab (95% CI, 1.50–2.43). The mean time to drug clearance in infants was 4.0 months for adalimumab (95% CI, 2.9–5.0) and 7.3 months for infliximab (95% CI, 6.2–8.3; P < .0001). Drugs were not detected in infants after 12 months of age. Bacterial infections developed in 4 infants (5%) and viral infections developed in 16 (20%), all with benign courses. The relative risk for infection was 2.7 in infants whose mothers received the combination of an anti-TNF agent and thiopurine, compared with anti-TNF monotherapy (95% CI, 1.09–6.78; P = .02).

Conclusions

In a prospective study of infants born to mothers who received anti-TNF agents during pregnancy, we detected the drugs until 12 months of age. There was an inverse correlation between the time from last exposure during pregnancy and drug concentration in the umbilical cord. Infliximab was cleared more slowly than adalimumab from the infants. The combination of an anti-TNF agent and thiopurine therapy during pregnancy increased the relative risk for infant infections almost 3-fold compared with anti-TNF monotherapy. Live vaccines therefore should be avoided for up to 1 year unless drug clearance is documented, and pregnant women should be educated on the risks of anti-TNF use.

You can reach the article from following link

http://www.gastrojournal.org/article/S0016-5085(16)30054-3/abstract

Also 39 peer reviewed journal articles done by SHIKARI® ELISA kits from

http://matriksbiotek.blogspot.com.tr/2016/12/publications-done-by-using-shikari.html 

SHIKARI® Q-RITUX and S-ATR ELISA Kits for quantitative measurement of rituximab and anti-rituximab antibodies

Rituximab

It is a medication used to treat certain autoimmune diseases and types of cancer. Specifically it is used for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, idiopathic thrombocytopenic purpura, and pemphigus vulgaris.

Rituximab destroys both normal and malignant B cells that have CD20 on their surfaces and is therefore used to treat diseases which are characterized by having too many B cells, overactive B cells, or dysfunctional B cells.

SHIKARI^® Q-RITUX  ELISA KIT 

ELISA kit for the measurement of rituximab in serum and plasma samples. The kit utilizes double monoclonal antibody technology for capturing and detection of the drug in a sandwich ELISA method with very high specifity. Kit is optimized for covering  Cmax and Cmin values of the drug  and suitable for trough level measurement. All reagents are ready to use and the test is very simple to perform. There is no cross reaction with any other proteins present in naïve human serum. In addition, there is no cross reaction with the other therapeutic immunoglobulins tested (infliximab (Remicade®), etanercept (Enbrel®), adalimumab (Humira®), bevacizumab (Avastin®) and trastuzumab (Herceptin®) )

 

SHIKARI^® S-ATR  ELISA KIT 

It is the only ELISA kit on the market for the quantitative measurement of anti-rituximab antibodies in serum and plasma samples.  All reagents are ready to use and the test is very simple to perform. Kit allows to follow patients ADA levels along with trough levels of the drug and to make decision on dosage and and dosage intervals of the drug. Kit also includes optimized confirmation reagent to eliminate false positive reactions if any.

For more information on all products 

http://matriksbiotek.com 

For pricing and any questions send an e-mail to

info@matriksbiotek.com

Formation of anti-drug antibodies to biological drugs can be transient, case of infliximab

Measurement of biological drug trough levels and antibody to biological drug gained high importance during the course of treatment. Recently, Matriks Biotek® developed quantitative measurement of anti-drug antibodies for adalimumab (Humira®), infliximab (Remicade®) and its biosimilar  CT-P14 (Remsima®) 

For further information visit our new website www.matriksbiotek.com 

The blind escalation treatment protocol of the Samsung Medical Center for infliximab

According to article:

“When patients have a poor response to infliximab (IFX) therapy, physicians should measure serum IFX trough levels (TLs) and the presence of antibody to infliximab (ATIs). Patients who have poor responses and subtherapeutic IFX TLs can regain the response after dose intensification. Patients who have ATIs are likely to have no response after dose intensification; however, in our study one patient regained the response after dose intensification and his ATIs disappeared. Thus, ATIs can be transient. Therefore, an individual IFX treatment according to the results of IFX TLs, ATIs, and the clinical response should be considered.”

Reference:

Choi SY, Kang B, Lee JH, Choe YH. Clinical Use of Measuring Trough Levels and Antibodies against Infliximab in Patients with Pediatric Inflammatory Bowel Disease. Gut Liver. Sep 9 2016.

Serum IFX TLs and ATIs were determined with Q-INFLIXI ELISA quantitative analyses  and Q-ATI ELISA quantitative analyses (Matriks Biotek, Ankara, Turkey).

New protocol of the Samsung Medical Center for treating nonresponders (infliximab)

General Scheme for biological drug surveillance

Matriks Biotek® is the first company to produce and commercialize SHIKARI® ELISA kits for for measurement of TLs and ADAs of biological drugs since 2008.

Ask for very competative pricing and custom ELISA development for your biosimilar drug at  info@matriksbiotek.com