In Gastroenterology, Rapid Tests, Therapeutic drug monitoring

Inflammatory Bowel Diseases (IBD): Infliximab rapid test makes possible direct and individual therapy optimization

Berlin, Darmstadt, March 19, 2018 – Pfizer and R-Biopharm concluded a cooperation agreement at the beginning of the year. The agreement centers on the RIDA®QUICK IFX Monitoring infliximab rapid test developed by R-Biopharm. Physicians can use this rapid test to check the infliximab trough concentrations of their IBD patients directly at the point of care within 20minutes and adjust the infliximab dose, if needed. Pfizer offers the RIDA®QUICK IFX Monitoring test to gastroenterology, internists, and IBD specialty practices, giving physicians an innovative option for performing therapeutic drug monitoring in the doctor´s office.

For IBD drugs such as Pfizer’s Inflectra™ to be effective, a certain concentration of the active ingredient infliximab (IFX) must be present in the patient’s blood. Measuring the IFX concentration is, therefore, an important part of the therapy. “This is precisely where our cooperation is targeted,” says Lars Christensen, Biosimilars Business Unit Head at Pfizer, Germany. “We want to show physicians the advantages of therapeutic drug monitoring (TDM) in their practice and thus support them in treating their IBD patients.” Through TDM with RIDA®QUICK IFX Monitoring from R-Biopharm AG, physicians can monitor the IFX drug concentration independently and at the point of care. The rapid result allows physicians to adjust the dose immediately, if necessary.

Until now laboratory-based ELISA assays were used to measure the IFX trough concentration, so the results took several days and were therefore not available until after the drug infusion. Dose optimization would not be possible until the next infusion was due – usually eight weeks after testing. “We are very pleased that Pfizer is now able to offer our rapid test to gastroenterology practices and thus expedite the therapeutic drug monitoring of infliximab,” states Tilmann Bur, Division Director of Clinical Diagnostics at R-Biopharm.

The cooperation with R-Biopharm is an important step for Pfizer toward individualizing treatment of patients in Germany who suffer from chronic inflammatory bowel diseases. Monitoring the active ingredient dose to maintain a certain minimum concentration of infliximab in the maintenance phase of therapy is important, because although patients may be receiving an identical dose, they can still have different IFX drug concentrations due to individual pharmacokinetics. TDM allows for individually tailored therapy and more effective use of the active ingredient.

About Pfizer and Inflectra™:

Pfizer is one of the world’s leading biopharmaceutical companies and has been selling the biosimilar Inflectra™ (infliximab) in Germany since February 1, 2015.

The TNF-alpha inhibitor Inflectra™ is an important pillar in the treatment of inflammatory bowel diseases (IBD).

About R-Biopharm’s rapid test:

RIDA®QUICK IFX Monitoring is a rapid test system for the quantitative measurement of infliximab (IFX) and its biosimilar Inflectra™ in human serum and plasma. The immunochromatographic lateral flow test is highly specific and delivers results within only 20 minutes. It also makes point-of-care testing easy, requires only minimal laboratory equipment, and can be used for single tests. The test format was developed and validated together with KU Leuven, Belgium. Monitoring of infliximab helps to optimize treatment for IBD patients and improve therapy results.

Pfizer – working together for a healthier world

Many things can change for people when they get sick; it is often the start of a difficult journey. More than 10,000 researchers and approximately 97,000 employees are working at Pfizer to help people on this journey. They develop, produce, and distribute innovative medicines and vaccines as well as some of the world’s most widely known over-the-counter products.

Headquartered in New York, the company generated USD 52.5 billion in fiscal year 2017. In Germany, Pfizer currently employs around 2,500 employees at three locations: Berlin, Freiburg, and Karlsruhe.

R-Biopharm – for reliable diagnostics

R-Biopharm AG (Darmstadt, Germany) is a globally active life science company and a leading provider of reliable test systems for clinical diagnostics, companion diagnostics, and for analyzing human food & animal feedstuffs.

Since 1988, R-Biopharm has been developing innovative products of the highest quality, reliability, and efficiency. A strong sense of responsibility, long-standing experience and a network consisting of more than 20 affiliated companies and subsidiaries in Europe, the US, Brazil, Latin America, China, India, and Australia, as well as more than 120 distribution partners, make R-Biopharm a prime partner for clients from retail, industry, and public institutions looking for answers and solutions for current diagnostic challenges.

Contact and additional information:

Pfizer Deutschland GmbH

R-Biopharm AG

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