Assessing Remission in Clinical Practice

M. Mierau; M. Schoels; G. Gonda; J. Fuchs; D. Aletaha; J. S. Smolen

Disclosures

Rheumatology. 2007;46(6):975-979. 

In This Article

Abstract and Introduction

Abstract

Objective: Remission constitutes the best achievable state in patients zwith rheumatoid arthritis. We aimed at evaluating sustained remission in a large cohort of patients followed prospectively in clinical practice and to evaluate available instruments to define remission for their stringency in defining this state.
Patients and Methods: We analysed remission and sustained remission in 621 patients who had two consecutive and complete clinical observations; the average period between the two visits was 92 days (median; quartiles: 82; 105). Remission was evaluated according to modified ACR (mACR), 28 Joint Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) criteria. Sustained remission was defined as remission at both consecutive visits. Patients were treated with traditional disease- modifying antirheumatic drugs, mainly methotrexate, and partly with biological agents (∼11%).
Results: Remissions at any one of the two visits were seen in 33.5% of patients by SDAI or CDAI, 42.7% by DAS28, and 38.6% by mACR criteria (P < 0.01). Sustained remission was observed in much lower proportions of patients (between 16.7 and 19.6%, dependent on the instrument). Agreement between classifications of remission by κ-statistics was very good for SDAI vs CDAI, good for DAS28 vs SDAI or CDAI, and only moderate for mACR vs the three other scores. Residual swollen joints were observed in 15% of patients in DAS28 remission (range 1−9), 6% of patients in mACR remission (range 1- 18), but only ∼5% of patients in CDAI or SDAI remission (range 1−2) (P < 0.01).
Conclusion: Sustained remission can be observed in 17−20% of patients in clinical practice. CDAI and SDAI remission criteria are more stringent than DAS28 and mACR criteria, since they allow for lesser residual disease activity. Consequently, smaller proportions of patients are classified as in remission by SDAI and CDAI than by DAS28 and mACR criteria. Sustained remission is an achievable goal in clinical practice even with the most stringent of the definitions studied.

Introduction

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. RA disease activity and progression can be controlled by treatment with disease-modifying antirheumatic drugs (DMARDs). Therapeutic goals and strategies have changed over the last decade with high dose weekly methotrexate (MTX) portending the change in the treatment landscape before the era of biological agents.[1,2] Importantly, however, since high disease activity is associated with poor outcome of RA,[3–6] therapies have recently aimed at achieving low disease activity. In fact, two very recent trials targeting low disease activity states by changing treatment in conjunction with tight control strategies have revealed that this concept, when compared with less stringent strategies, improves functional and radiographic outcomes over the short term.[7,8] Nevertheless, even under such apparently ideal therapeutic settings, mean or median joint damage still increased significantly over time in states of low disease activity.[7–10] This suggests that such states might not constitute the optimal therapeutic aim. Indeed, a need to achieve remission has been recently advocated.[11–13]

On the other hand, the term remission is still ill-defined, and the various remission criteria allow different degrees of disease activity to be called remission.[14–19] Nevertheless, remission as a reflection of no, or at the most, minimal disease activity ought to ensure maximal reversal, preferably normalization of functional impairment and minimal progression of joint destruction, ideally halt and even healing of joint destruction.[10,20–22] This issue will need to be addressed thoroughly in future trials to learn if asymptomatic synovitis, which does exist according to sonographic studies,[23] is also associated with progression of joint damage. However, the vast majority of patients with absence of clinically discernible synovitis do not progress individually[24] and as a group irrespective of the type of therapy.[25]

Clinical trials are idealized situations in which, by virtue of study design and control of case record forms, adherence to study principles is high. Inclusion and exclusion criteria require studying a pre-selected group of patients, often greatly differing from most patients seen in clinical practice. In contrast, observational studies usually include all patients seen, irrespective of their disease activity, underlying comorbidity or therapy, and the data generated, therefore, reflect routine care situations. Routine clinical care is influenced by patient and physician preferences and potential biases. Thus, while controlled clinical trials provide first line evidence of efficacy and safety of a therapeutic or treatment strategy in a selected group of patients, observational studies inform on effectiveness in the long term.[26] Moreover, rather than allowing judgement on the relatively few patients engaged in successful arms of randomized controlled clinical trials, results of observational studies help understanding transpositions of new paradigms or treatment guidelines into daily care and the degree of benefit from such translation of study results into practice.

Currently, it is still insufficiently known how frequent patients achieve remission, this foremost desired state, under conditions of routine clinical care. Therefore, in the present study we aimed at determining remission by various validated indices among an observational RA patient cohort who underwent regular, prospective control examination employing mandatory use of a clinical database at every visit.

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