Cluster-Randomized Trial of a Behavioral Intervention to Incorporate a Treat-to-Target Approach to Care of US Patients With Rheumatoid Arthritis

Abstract

Objective: To assess the feasibility and efficacy of implementing a treat-to-target approach versus usual care in a US-based cohort of rheumatoid arthritis patients.

Methods: In this behavioral intervention trial, rheumatology practices were cluster-randomized to provide treat-to-target care or usual care. Eligible patients with moderate/high disease activity (Clinical Disease Activity Index [CDAI] score >10) were followed for 12 months. Both treat-to-target and usual care patients were seen every 3 months. Treat-to-target providers were to have monthly visits with treatment acceleration at a minimum of every 3 months in patients with CDAI score >10; additional visits and treatment acceleration were at the discretion of usual care providers and patients. Coprimary end points were feasibility, assessed by rate of treatment acceleration conditional on CDAI score >10, and achievement of low disease activity (LDA; CDAI score ≤10) by an intent-to-treat analysis.

Results: A total of 14 practice sites per study arm were included (246 patients receiving treat-to-target and 286 receiving usual care). The groups had similar baseline demographic and clinical characteristics. Rates of treatment acceleration (treat-to-target 47% versus usual care 50%; odds ratio [OR] 0.92 [95% confidence interval (95% CI) 0.64, 1.34]) and achievement of LDA (treat-to-target 57% versus usual care 55%; OR 1.05 [95% CI 0.60, 1.84]) were similar between groups. Treat-to-target providers reported patient reluctance and medication lag time as common barriers to treatment acceleration.

Conclusion: This study is the first to examine the feasibility and efficacy of a treat-to-target approach in typical US rheumatology practice. Treat-to-target care was not associated with increased likelihood of treatment acceleration or achievement of LDA, and barriers to treatment acceleration were identified.

Figure 1

Study design. UC = usual care; T2T = treat‐to‐target; CDAI = Clinical Disease Activity Index score.

Figure 2

Study flow diagram. T2T = treat‐to‐target; UC = usual care; a = reasons for site exclusion were refusal to participate, inability to initiate in time to recruit, or lack of response to outreach; b = reasons for patient exclusion were low disease activity (T2T, n = 2; UC, n = 2) and missing Clinical Disease Activity Index score (UC, n = 1).

Figure 3

Outcomes in the treat‐to‐target (T2T) versus usual care (UC) groups at 12 months. A, Unadjusted response rates at 12 months. B, Odds ratio (OR) comparing response rates with T2T versus UC at 12 months, adjusted for clustering and patient baseline characteristics. 95% CI = 95% confidence interval; a = the primary feasibility outcome was the probability of treatment acceleration conditional on Clinical Disease Activity Index score >10; b = the primary efficacy outcome was overall achievement of low disease activity (LDA); c = the secondary efficacy outcome was achievement of LDA among patients who completed the study (analysis of those who completed); d = T2T versus UC adjusted for clustering by physician for the efficacy outcomes and for clustering by patient, physician, and practice site for the feasibility outcomes; e = adjusted for age, Hispanic ethnicity, Medicare insurance, rheumatoid factor seropositivity, disease duration, number of prior biologic agents, number of prior conventional synthetic disease‐modifying antirheumatic drugs, current biologic agent/small molecule use, and clustering.

Figure 4

Patterns of treatment acceleration over time. A, Proportion of all eligible acceleration visits at which treatment was accelerated. B, Proportion of eligible new acceleration visits at which treatment was accelerated. T2T = treat‐to‐target; UC = usual care; 95% CI = 95% confidence interval; a = total number of patient visits within the indicated time period with Clinical Disease Activity Index score >10 and no accelerations within the previous 3 months.