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

SHIKARI® S-ATA v2 ELISA kit for quantification of anti drug antibodies to ADALIMUMAB (HUMIRA®) with confirmation

Matriks Biotek® to introduce SHIKARI® S-ATA v2 ELISA kit to measure anti-adalimumab antibody levels and confirmation of the results in the same kit. 

Adalimumab (Humira^®) is a fully humanized monoclonal antibody against TNF-α, and is approved for the treatment of RA and Crohn's disease (CD).  Even though it is fully humanized, adalimumab does not eliminate the risk of immunogenicity in both CD and RA patients.

Generation of antibodies-to-adalimumab (ATA) in the serum is associated with lower serum adalimumab concentrations and reduced response rate to treatment. 

 SHIKARI® Q-ADA v1 kit together with SHIKARI® S-ATA v2 ELISA kit can give definitive information about patient status when evaluated with different tests and clinical status of the patient. By knowing the trough level of the drug e.g. if it is below the Cmin of the drug and there is anti-drug antibodies then the course of treatment should be changed accordingly. Adalimumab dose can be escalated, other drugs can be added to treatment and end up with switching to another biological if necessary. By following patient’s adalimumab and anti-adalimumab drug (ATA) levels. Methotrexate or leflunomide prevents the development of neutralizing Abs against adalimumab so knowing and following up of anti-adalimumab drug levels will be highly valuable in the course of treatment. 

One of the major concern when detecting anti-adalimumab drug (ATA) levels is false positivity of the results. SHIKARI® S-ATA v2 ELISA kit can detect 30 ng/ml of ATA and to eliminate false positivity optimized Confirmation Regeant is added to the test system for convenience. 

You can find related and all 38 peer reviewed publications done by SHIKARI® ELISA kits at http://matriksbiotek.blogspot.com.tr/2016/12/publications-done-by-using-shikari.html

For product insert please refer to 
http://matriksbiotek.com/files/manuals/S-ATA.pdf