Reconstructing the pyramid in rheumatoid arthritis. An urgent need.

© Copyright CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 2001. R h e u m atoid art h ritis (RA) is a cri ppling disease that affects 0.5 – 1% of the population and leads many patients to stop working within 10 years from the disease onset (1). Most people become disabled during the course of the disease (2, 3). The total direct cost per year is enormous. It has been estimated to range between $8,209 and $85,469 per patient in the US (1), and to be about $1 billion for the whole rheumatoid population in Italy (4). The indirect costs are much higher and when the direct and indirect costs and the loss of earning power are added together, the total burden has been calculated to be around $5 billion in Italy, a cost much higher than that of other chronic diseases such as multiple scl e ro s i s (MS) or chronic obstructive pulmonary diseases (COPD). In a disease with such a high burden, any new therapeutic option is viewed with much hope as a new possibility of improving pain, function and the quality of life and better controlling the disease (5). The appearance on the market of biologicals against T N F , wh i ch were shown to rapidly improve synovitis, even in poor responders to conventional tre at m e n t s , had a tre m e n d o u s impact on patients and on the rheumatological community (6). These agents h ave a high cost, h oweve r, and any health care system must face two main q u e s t i o n s : (1) Wh i ch patients should receive these drugs? and (2) Is it possible to identify those patients with a poor prognosis – high joint damage, poor function, high disability – early on in the disease course? These points are crucial in order to treat the right patient, i.e. the one with the most aggre s s ive disease, and not to overtreat the wrong patient, i.e. the one with disease that will respond to conventional therapeutic approaches. The definition of the possible inclusion criteria is crucial because the most aggressive disease, the one leading patients to hospitalization, has been calculated to represent 43 – 75% of the direct costs of rheumatoid patients (7, 8). While in oncology the neoplastic disease threatens the patient's life, in rheumatology the patient's worst outcome is not survival [although the life span is substantially reduced in patients with > 30 swollen joints at disease onset (9)], but a poor personal and social life, disability, perhaps multiple surgical interventions over the ye a rs , and loss of working capacity and earnings lasting years or decades. In these cases the cost to society is not very different between an oncology patient and a severely affected rheumatoid patient. The cost of one year of treatment with a biological anti-TNF has been estimated to range between $7,000 $25,000, while one year of treatment for breast cancer with taxanes has been estimated to ra n ge between $12,000 $20,000. The conventional treatment for breast cancer ranges between $2,400 $2,800 and in oncology the step-up approach is usual. In purely economic terms, the health care system should support those treatments offering the most efficacious drug, i.e. capable of reducing the loss of working capacity, disability, h o s p i t a l i z ation and surgical interve ntions,once the disease has been defined to be resistant aggre s s ive / p rogre s s ive (10).