Strategic plan to introduce tests for anti-drug antibodies against biopharmaceuticals in routine medical care
| Reference number | |
| Coordinator | Karolinska Institutet - Klinisk och experimentell neuroimmunologi |
| Funding from Vinnova | SEK 2 804 991 |
| Project duration | December 2017 - December 2021 |
| Status | Completed |
Purpose and goal
The goal was to find a sustainable model for transferring tests of ADA for a number of different drugs from pharmaceutical companies to routine has been successful. In collaboration with companies, we have set up ADA tests and in collaboration with clinics, we have evaluated these and found clinical thresholds and algorithms for how to test and interpret the answers. The tests are made directly available through the healthcare´s TakeCare or by ordering directly from the research lab.
Expected results and effects
Awareness of ADA has resulted in an increased number of samples in the routine lab. We can show that 40% of patients with biological drugs could improve efficacy of treatment by adjusting the dose or changing drugs. A better routine for identifying these individuals by using immunological tests would optimize care, improve patients’ health, and ensure that the right medication is given to the right person. A better routine would also allow even drugs with some immunogenicity to be approved, if ADA-positive individuals can be screened out at an early stage.
Planned approach and implementation
We have investigated several drugs and patient groups in fruitful collaborations with Karolinska University Hospital, Sahlgrenska Hospital, Uppsala University and the UK. Pharma companies have been involved to some degree, but overall it has been a challenge to increase the companies´ interest in evaluating ADA for their drugs. Companies that produce ADA kits for the pharmaceutical industry have also been difficult to engage. Mapping of the financing continues in collaboration with Innovations place, Precisions medicine Task Force, SciLifeLab and Karolinska Trial Alliance.