Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years.

Nasir Wabe,Leah Mcwilliams,Susanna M Proudman,Cindy Hall,Robert G Metcalf,Leslie G Cleland,Mihir D Wechalekar,Michael J Sorich,Anita Lee,Llewellyn Spargo,Michael D Wiese

doi:10.1186/s13075-015-0562-0

Abstract

IntroductionTreat-to-target (T2T) strategies using a protocol of pre-defined adjustments of disease-modifying anti-rheumatic drugs (DMARDs) according to disease activity improve outcomes for patients with rheumatoid arthritis (RA). However, successful implementation may be limited by deviations from the protocol. The aim of this study was to determine the prevalence of protocol deviation, explore the reasons and identify subsets of patients in whom treatment protocols are more difficult to follow.MethodsIn this retrospective cohort study, treatment-naïve patients with RA of less than one year’s duration, attending a dedicated early arthritis clinic between 2001 and 2013, were followed for three years from initiation of combination therapy with conventional DMARDs which was subsequently modified according to a T2T protocol. At each clinic visit, whether deviation from the protocol occurred, the type of deviation and the reasons for deviation were assessed. The relationship between protocol deviations and baseline variables was determined using linear regression analysis.ResultsIn total, 198 patients contributed 3,654 clinic visits. The prevalence of protocol deviations was 24.5% and deviation in at least at one clinic visit was experienced by 90.4% of patients. The median time to first deviation was 30 weeks. Continuing existing treatment rather than intensifying therapy was the most common type of deviation (59.9%). Patient and physician related factors were the most common reasons for deviation, each accounting for 24.7% of deviations, followed by toxicities (23.3%) and comorbidities (20.0%). The prevalence of protocol deviations was lower among patients who achieved remission after three years (13.1%; 162 deviations out of 1,228 visits) compared with those who were not in remission (30.9%; 523/1692) (P <0.0001). On multivariate analysis, only body mass index (P = 0.003) and helplessness score (P = 0.04) were independent predictors of protocol deviations although the predictive power of the model was not strong (R2 = 0.17).ConclusionsDeviation from a T2T protocol occurred in one quarter of visits, indicating that applying the T2T approach is feasible in clinical practice. Failure to escalate dose when indicated was commonly encountered, and just under half of the observed deviations were related to either toxicities or comorbidities and were therefore justifiable on clinical grounds.

Highlights

Treat-to-target (T2T) strategies using a protocol of pre-defined adjustments of disease-modifying anti-rheumatic drugs (DMARDs) according to disease activity improve outcomes for patients with rheumatoid arthritis (RA)
As the T2T strategy involves frequent assessments of disease activity [10] and application of predefined dose modification criteria (DMC), it may not be feasible outside the clinical trial setting, or the benefits reported in trials may not be realised in the clinic
Setting and study design Between September 2001 and December 2013, consecutive patients attending the Royal Adelaide Hospital Early Arthritis Clinic were included if they were diagnosed with RA according to the 1987 revised American College of Rheumatology (ACR) [12] or 2010 ACR/European League Against Rheumatism (EULAR) criteria [13], and were 18 years of age or older, with active disease and DMARD-naïve

Summary

Introduction

Treat-to-target (T2T) strategies using a protocol of pre-defined adjustments of disease-modifying anti-rheumatic drugs (DMARDs) according to disease activity improve outcomes for patients with rheumatoid arthritis (RA). Treating rheumatoid arthritis (RA) with disease modifying anti-rheumatic drugs (DMARDs) according to a treat-to-target (T2T) strategy is more effective than traditional routine care [1,2,3,4,5]. Adherence to T2T recommendations could be influenced by factors relating to the patient, the physician, the disease, medication or other co-morbid conditions. A physician could deviate from T2T recommendations if his or her assessment of a patient’s disease activity status differed from that determined by composite disease activity measures [9] or patient preference could influence willingness to change therapy when indicated [9,10,11]. Irreversible joint damage, contraindications and/or past adverse drug reactions to DMARDs, comorbidities and logistic issues are recognised barriers to changing treatment in clinical practice [8]

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