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

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.

Factors associated with medication adherence in a longitudinal study of rheumatoid arthritis patients

“…Patients were reviewed every 3‐6 weeks initially and then every 3‐6 months once the goal of therapy had been reached. If the goal of therapy was not achieved, further DMARD(s) (including leflunomide, gold by injection, cyclosporine A and/or biological DMARDs) were added sequentially …”

Treating rheumatoid arthritis to target: physician and patient adherence issues in contemporary rheumatoid arthritis therapy

“…Physician resistance to change their practice toward some aspects of T2T recommendations (especially frequency of disease monitoring and the use of composite disease activity measures to guide treatment decisions) remains an issue . Busy clinical practice, lack of confidence in composite outcome measures, inadequate understanding of the T2T recommendations, and poor physician‐patient communication were also noted as reasons for physician unwillingness to adopt some T2T recommendations . Practical challenges after implementations of the strategy : The reasons for physician nonadherence to T2T strategies are varied, but can be broadly characterized as patient related (eg, resistance to modify therapy when indicated), physician/disease (eg, persistent disease, relying on clinical scenario rather on composite disease activity measures), therapy related (eg, side effects of medicines), and/or as a result of comorbid conditions . In addition, health care system related factors such as awaiting laboratory results or delays to the approval for use of biological DMARDs or other logistic reasons may also play a role .…”

“…Busy clinical practice, lack of confidence in composite outcome measures, inadequate understanding of the T2T recommendations, and poor physician‐patient communication were also noted as reasons for physician unwillingness to adopt some T2T recommendations . Practical challenges after implementations of the strategy : The reasons for physician nonadherence to T2T strategies are varied, but can be broadly characterized as patient related (eg, resistance to modify therapy when indicated), physician/disease (eg, persistent disease, relying on clinical scenario rather on composite disease activity measures), therapy related (eg, side effects of medicines), and/or as a result of comorbid conditions . In addition, health care system related factors such as awaiting laboratory results or delays to the approval for use of biological DMARDs or other logistic reasons may also play a role . For example, in study by Wabe et al, patient‐related factors including poor concordance with prescribed therapy, reluctance to modify therapy, social issues, and physician/disease factors (eg, limited treatment options, persistent disease, delaying therapy intensification, and seeing whether adjustment is needed at later time) were the main reasons for nonadherence , whereas in the DREAM study, discordance between the disease activity and the physician in measuring disease activity status was the primary reason for nonadherence .…”

Drs. Waljee and Chung reply

“…Moreover, current guidelines advocate a "treat-to-target approach" in which disease activity is regularly assessed, and medical therapy is aggressively titrated to a predefined target disease activity state, either remission or low disease activity 5 . For some conditions, such as peptic ulcer disease, medical therapy has nearly supplanted the need for surgical intervention 6 .…”