Horizon Europe 2022 funding to research on personalised treatment with biologic drugs

"We are proud to provide analyses of serum drug and anti-drug antibody concentrations in such a prestigious and ambitious European collaboration", says senior consultant and research group leader Nils Bolstad.

Rheumatoid arthritis is a chronic inflammatory disease that constitutes a significant burden to patients and society. The last two decades has seen a revolution in the treatment of rheumatoid arthritis and other inflammatory diseases, related to the use of efficient biologic drugs. After the introduction of biologic drugs, remission has become a realistic treatment goal in many debilitating, potentially devastating, chronic inflammatory diseases. Recombinant monoclonal antibodies and fusion proteins targeting tumor necrosis factor alpha, collectively called TNF inhibitors, are the most important type of biologic drugs used in the treatment of these patients. Although many patients experience good treatment responses and few side effects from TNF inhibitors, some patients do not respond to treatment. In addition, some patients experience serious adverse events caused by immunologic reactions to the drugs (which are foreign proteins) and formation of anti-drug antibodies. These challenges mean that strategies to improve treatment with TNF inhibitors are needed.

The Tumour Marker Group at the Department of Medical Biochemistry, OUH-Radiumhospitalet, is part of the European SQUEEZE consortium, which in total receives more than NOK 100 million from the EU through the Horizon Europe 2022 call. The funds are earmarked research on improving treatment of rheumatoid arthritis, where personalised treatment with biologic drugs is an important focus.  

Fewer disease flares

The research group at OUH-Radiumhospitalet has developed automated immunoassays for many biologic drugs used to treat patients with inflammatory diseases, in close collaboration with leading clinical researchers. These collaborations have generated important insights into drug concentrations and anti-drug antibodies and how these parameters are related to clinical outcome. In a landmark randomised clinical trial published in JAMA in December 2021, the NOR-DRUM B trial, patients who had their treatment with the TNF inhibitor infliximab adjusted based on measurements of drug levels and anti-drug antibodies had fewer disease flares than patients receiving standard infliximab therapy. The Horizon Europe 2022 funding enables the researchers to test similar treatment strategies for other TNF inhibitors used to treat patients with rheumatoid arthritis in Europe.

"We look forward to continuing our productive collaboration with the rheumatologists at REMEDY/Diakonhjemmet Hospital, but also with other European centres of excellence in rheumatology and inflammation research. We will generate new knowledge on personalized treatment with important drugs, and make sure the knowledge and experience we have in Norway in this field also benefit patients in other European countries", says senior consultant Johanna E. Gehin.

From left: researcher David J. Warren, consultant Johanna E. Gehlin, pharmacist Rolf A. Klaasen and consultant Nils Bolstad. Photo: Lars Petter Devik.

Links:

JAMA article:
Syversen SW, Jørgensen KK, Goll GL, Brun MK, Sandanger Ø, Bjørlykke KH, Sexton J, Olsen IC, Gehin JE, Warren DJ, Klaasen RA, Noraberg G, Bruun TJ, Dotterud CK, Ljoså MKA, Haugen AJ, Njålla RJ, Zettel C, Ystrøm CM, Bragnes YH, Skorpe S, Thune T, Seeberg KA, Michelsen B, Blomgren IM et al. (2021)
Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial
JAMA, 326 (23), 2375-2384
DOI 10.1001/jama.2021.21316, PubMed 34932077

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