New strategies for patenting biological medicines used in rheumatoid arthritis treatment.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by an inflammatory process, with a global prevalence ranging from 0.3% to 1%. The overall cost of RA drugs is estimated in $20 billion worldwide and projected to grow to $36 billion by 2021. The current RA treatment strategy consists of the aggressive therapy directed to specific targets, after diagnostic confirmation and the stepped therapy directed by the stage of the disease, aiming at the clinical remission. Conventional (methotrexate, sulfasalazine, leflunomide) and biological (infliximab, adalimumab, tocilizumab) disease-modifying antirheumatic drugs may fail, produce only partial responses, or unwanted side effects, and consequently new antirheumatic drugs are being developed to overcome these limitations. AREAS COVERED: In this review, the authors described the technological trends and the main players involved in the R&D process related to biological compounds employed in the treatment of RA, using patent documents as a source of technological information. EXPERT OPINION: Current treatments for RA still mainly target the immune system, different inflammatory targets, and mediators. Other types of therapies have also been developed, such as vaccines and gene therapies. Despite these new techniques, the main compounds of interest remain the antibodies anti-TNF-α and anti-CD20, with novelties regarding preparation methods and combination targets.