Its because they simply don't know. Everyone responds
differently, studies using the new biologics are not accurate for long
term efficacy and overall disease modification. Although these
appear to be wonder drugs, the jury is still out and won't be known
with certainty for years yet.
Here is a portion of a clinically citated article regarding outcomes of
people with early RA. The bottom line is each of us will respond
differently, some will do worse, some will do better and there isn't a
good standard for predicting which of us those will be.
Adverse outcome is the suffering or loss of health experienced by an individual as a result of the process of disease [1], and in rheumatological research is normally quantified numerically, for example a radiological score denoting the severity of erosive disease. Patients with RA and those involved in their care and treatment also need other forms of information on how the disease may affect major aspects of their lives. Such details provide a basis for discussion with patients concerning practical issues and prognosis. Despite recommendations from a consensus group in 1989 [16] for a more wide ranging approach to outcome measurement, there is little in the rheumatological literature from prospective studies concerning cumulative disability and the effect of functional changes in early RA on major life events [5–7].
The clinical profiles of RA patients treated with conventional drug therapy over the first 5 yr in this study show that 40% of patients do relatively well (13% were in fact in clinical remission), 44% follow a relapsing/remitting course with variable but definite functional impairment, in comparison with a small proportion (around 16%) who do badly in terms of the effects of RA on functional ability and life events. Women, older age at onset (60 yr or more) and worse initial HAQ (>1.0) were each associated with worse outcomes. However, disease outcome at 5 yr in an individual patient with very early RA cannot be predicted with accuracy using simple clinical measures. A future study from this group examining genetic markers and detailed radiological scores is near completion and may improve on this.
These results were based on aggregated data from nine rheumatology units in different regions of England, but collected prospectively and in a standard format, and with the numbers included it is a reasonable assumption that these figures represent the variation in patterns of presentation and outcome at 5 yr found in early RA. Some of the differences seen between centres could be explained on the basis of minor differences in clinical practice (e.g. choice of second-line drugs), although some reflected major differences in availability of certain services (e.g. medical/rheumatology in-patient beds and physical therapy interventions). Others were due to population differences (e.g. employment). We have previously reported the adverse effects of lower socio-economic status on functional scores in RA [17], and these findings were broadly similar to published work in other countries [5, 18, 19].
The main strengths of this study include the chance to study RA from its earliest stages prior to the use of second-line drugs; the relatively few exclusion criteria (which are so restrictive in clinical trials), thus reflecting actual clinical practice, but which still allows valid comparisons using the appropriate subgroup analysis; regular yearly follow-up using standard assessments has ensured that data have been collected prospectively, and those lost to follow-up kept to a minimum but at least accounted for; little variation in disease duration because all patients have the same follow-up (5 yr from entry). Possible sources of bias in this study arise as a result of left censoring (milder RA not being referred to hospital out-patients and relatively more patients in remission who were lost to follow-up), right censoring (more severe RA not surviving 5 yr), and treatment effects. Five year follow-up has been achieved in 80%, and the 10% mortality at 5 yr was similar to comparable studies and only slightly increased when compared with population expected rates [20]. None the less, mortality was responsible for 10% of the original sample not included in the 5 yr outcome analysis, compared with 2.4% lost to follow-up because of very mild disease or remission. The severity of RA at 5 yr is likely to be underestimated in our study because the patients who died prior to 5 yr of follow-up did have worse disease at presentation. In three patients the cause of death was thought to be related to complications of RA or its treatment. Most patients received at least one DMARD, 84% within the first year, at a median of 7 weeks, and in 72% the same first drug was used, as was common practice in England in the late 1980s and early 1990s. Thus, although the subtle effects of different DMARDs tried first and subsequent changes cannot be accounted for, patients were being treated early in a conventional manner.
Detailed information from inception cohorts of RA with longitudinal follow-up of 5 yr or more with adequate numbers is sparse. There are, however, several published accounts of outcome in RA based on longitudinal studies with large numbers but with very variable disease duration at the time of recruitment, and these have reported progressive decline in clinical [21], radiological [22], physical function and health status measures over time [22, 23]. The major part of this decline occurred early (in the first 5 yr from first observation), followed by a more gradual decline [23], but late rapid deterioration has been described [24]. Wolfe and Cathey [19] found a trend towards improvement in some patients within the first years of observation in a longitudinal study, but that the underlying trend was towards progressive functional decline. None of these studies evaluated the time course of function in the early stages of RA, and so it is difficult to make valid comparisons, but all suggested major functional loss in most patients. Although the HAQ varied widely over time, functional outcome in our patients was better overall, and evidence for the rapid deterioration and marked reduction in functional capacity in early RA reported by Sherrer et al. [25] was fortunately only seen in small numbers. However, a small proportion of our patients did have poor 5 yr function (FGIII/IV 16%), and most of these patients already had poor HAQ scores at presentation (Fig. 2
Most of the few reported inception cohorts of RA from single centres with good follow-up used Steinbroker's functional grading as a measure of outcome. This may lack sensitivity for change (especially between FGII and III) but has been the most widely used in the past. The study from Memphis [26] reported on 50 early RA patients at 3–5 yr of whom 13 (26%) were in FGI and 10 (20%) in FGIII. Both the Middlesex [27] and Bath [28] studies reported on 100 patients each recruited within a year of onset of RA, with functional outcomes of around 60% in FGI and 13% in FGIII (at a mean follow-up of 4.5 and 3 yr, respectively). Our results are closest to a report of outcome in a small cohort of 63 Swedish patients [5], and in a study of second-line therapy in Scotland [29], although in the latter patients were highly selected on the basis of inclusion in clinical trials. Better outcomes have been noted in prospective studies of early RA compared with cross-sectional studies [4]. A recent editorial by Pincus and Callahan [30] reinforced the importance of properly conducted prospective studies of early onset RA which give a more complete picture of this condition.
Joint replacement or excision arthroplasty for RA was required in 11% of our patients by 5 yr of follow-up, with little difference between centres. Comparisons with other longitudinal studies are difficult because of differences in disease duration and changes in the type of and threshold for orthopaedic intervention in recent years, but a Swedish study in 1994 [5] reported a subgroup of 14% (nine patients) who required joint replacement within 5 yr.
Work disability has been addressed in studies mainly from the USA (cross-sectional studies) and northern Europe (longitudinal), most reporting work disability of 29–50% by around 5 yr [6, 7, 31–33]. The variation in results reflects the differences in study designs, social security arrangements and methods of ascertainment. In our patients, most patients in paid employment at presentation were still working (60%), work disability by 5 yr due to RA was 22%, and was higher in manual workers.
The identification of factors indicative of poor outcome early in the course of RA is crucial for tailoring treatment and supporting coping mechanisms. The strength and reliability of prognostic factors depend largely on the choice of outcome measure, with radiological damage more consistently predicted than function [4]. We have used clinical features most consistently associated with functional outcome, and although women and older age were both related to poor function at 5 yr, the HAQ at presentation had the strongest association.
The exact figures detailed in this report are derived from a ‘true to life’ setting of standard rheumatological management and drug treatments offered to early RA patients in hospital rheumatology departments in England in the 1990s. By illustrating the magnitude of functional change attributed to RA, these figures are important in planning for the kind and extent of services required for managing RA in early stages. Is it possible to compare and contrast RA outcomes in current practice in other parts of the UK and Europe, and even set targets for these when planning the management of RA? If all patients are followed-up regularly using registers (as with management of diabetes), and standard measures (e.g. HAQ) are recorded prospectively, valid comparisons could be achieved. The assessment of drug treatment effects is limited in observational studies because of non-random assignment of therapy. None the less, newer agents can only be described as ‘disease-modifying’ if they can be shown to alter cumulative disability in the long term. The ERAS database will permit a comparison of these new drugs with a well-described historical standard reflecting management and costs of RA during the 1990s.
http://rheumatology.oxfordjournals.org/cgi/content/full/39 /6/603
Allow me to add, this is a cited study in following studies regarding
outcomes. Newer studies that I have read have the same
conclusions with even more questionable prognosis indicators.
Some have 'leanings' based on particular data, new data since the study
above; however, nothing clincially conclusive.
sorry for the long posting...but felt this relevent information for us all who wonder a lot about our futures.
Thank you for sharing that...I found it fascinating! It would be interesting to read longitudianl results in several years on the biolics. Good read I saved it. It is a shame that not more commonality of the disease has been found so that the disease could be a bit more predictable. Sure would help in dx and treatment huh?
We have the "trial and error" disease. Minute by minute, day by day isn't it? The good thing is there is some predictability in the drugs....as in DMARDS, MTX, pred..ect. But hey they have been around for a loooong time! Researchers have made great strides with this disease in the past 10 or so years, too bad I won't be around for another 100 years to see the outcome and future research cause you know that even if a cure is not found, there will be more information on it without a doubt.
Again, thanks for sharing this.
bb
I think it's fascinating, too, although what they seem to know is that they