“Is tofacitinib a biologic agent?”
I often get this question from colleagues, patient advocates and members of the pharmaceutical industry. The task of keeping track of new medications has become more perplexing as new targets and new ways of treating rheumatic conditions become available. Way back in 2006, when I started training in rheumatology, we just categorized disease modifying anti-rheumatic drugs (DMARDs) as either traditional (tDMARD) or biologic (bDMARD). It was pretty simple then – old medications = tDMARDs, new medications (those which were studied in recent drug trials) = bDMARD. But as with my starting question, how would you classify tofacitinib?
JS Smolen and group proposed a new way of grouping these DMARDs. Traditional DMARDs like methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, gold salts and others would be referred to as conventional synthetic DMARDS (csDMARDs). Drugs previously under bDMARDs would now be classified as biologic original DMARDS (boDMARDs). “Generic” preparations of the original bMARDs, which are expected to show therapeutic equivalence with the original DMARDs, are to be called biosimilar DMARDs (bsDMARDs). Therefore when we refer to bDMARDs, this encompasses both original and biosimilar DMARDs. Drugs like tofacitinib, fostamatinib, baricitinib and apremilast are to be referred to as targeted synthetic DMARDs (tsDMARDs) which is constituted by medications developed to target a particular molecular structure. Both csDMARDs and tsDMARDs would be grouped together as synthetic DMARDs.
The proposed nomenclature is intended to distinguish the different types of DMARDs in clinical studies and review articles.Reference: Smolen JS, van der Heijde D, et al. Proposal for a new nomenclature of disease modifying anti-rheumatic drugs. Ann Rheum Dis 2014; 73: 3-5.