StemCell Therapy

The Scandinavian countries may look rather similar when watching from a distance. However, if you zoom in on details, the differences become manifest.

This has been a returning truth in the more than ten years that the NORD-STAR collaboration has been running.

Initially, we saw the similarities: All countries (including the Netherlands, which joined the collaboration half-way through) had a history of high quality research in the field of rheumatoid arthritis and an idea of how to treat this debilitating and destructive inflammatory disease best. Investigator-initiated trials such as Fin-RACo and Neo-RACo (Finland), Swe-fot (Sweden), ARCTIC (Norway), CIMESTRA and OPERA (Denmark) and BeSt (The Netherlands) have contributed important knowledge to the field. Despite the modest sizes of our countries, our national quality registries (ARTIS, DANBIO, ICEBIO, NORDMARD, ROB-FIN) have informed clinicians around the world about treatment outcomes for real world patients with inflammatory arthritis. Moreover, in all countries biological drugs with different modes of action were widely available due to a tax-paid system for reimbursement.

Despite our previous research at the national level, we were stuck with an important, unanswered clinical question: What are the benefits and harms of the different biological therapies compared with active conventional treatment in patients with early rheumatoid arthritis?

The question had multiple aspects: The shorter term ability of the different therapies to induce remission was key. However, longer term results regarding the prevention of joint damage and safety profile were also important. Would there be differences in the flare rates between the drugs if treatment was de-escalated? Would spin-off projects based on the study biobank pave the way for more tailored treatments?

A cross-national collaboration was needed to answer these questions with sufficient statistical power. For our investigator-initiated trial, we needed more than 800 treatment-naive patients randomized to four different treatments, turning our study into one of the largest ever in rheumatoid arthritis.

This was when the differences between our countries became evident. Defining the active conventional therapy was a hard nut to crack in the planning of the design. Despite very similar EU-based legislation across the countries, bureaucratic obstacles challenged the approval from ethics, medical and data authorities. Securing public funding for the study infrastructure was an important milestone in the early phases, as was the willingness of two of three companies to provide us with free study drug.

We are proud to present the first results in The BMJ. Our 24-week results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for the biologic abatacept.

The NORD-STAR research network has solved challenges, coped with frustrations, shared the joy and excitement during the various phase of the project. Ten years so far, and probably ten more years before we have the last results.

We believe the currentand futureresults from the NORD-STAR trial and spin-off projects will provide the medical community with important insights on how to best care for patients with early rheumatoid arthritis.

Merete Lund Hetland, Professor in Rheumatology, Consultant, and Head of the DANBIO steering committee, Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.

Competing interests: Please see research paper for more details.

Read the original here:
Merete Lund Hetland: A cross country collaboration to assess the benefits and harms biological therapies for early rheumatoid arthritis - The BMJ -...

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