Background/Purpose:

It is possible to optimize and reduce the individual dose of biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in patients with rheumatic diseases, in combination with tight control strategies, while maintaining adequate disease control.¹ Nevertheless, most rheumatologists in daily clinical practice do not apply these strategies. As the potential benefit for both patients (side-effects) and society (costs) is large, we aimed to implement dose optimization strategies in real clinical practice.

Methods:

This pilot implementation study was conducted at the rheumatology department of a general hospital in the Netherlands between May and October 2014. Both rheumatologists working in this center were eligible for participation. The implementation strategy comprised three steps: 1) education, feedback, and the development of guidelines on bDMARD dose optimization and tight control based treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthropathy (SpA), 2) individualized treatment advices of all patients using bDMARDs (written in the electronic health record of individual patients) followed by 3) monitoring and feedback after three and six months. To determine the effectiveness of this strategy, the percentage of patients with measured disease activity was assessed, i.e., the Disease Activity Score in 28 joints (DAS28 ), or the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). In addition, mean DAS28 and BASDAI scores and the percentage of patients using a reduced dose of their bDMARD were calculated. All outcomes were assessed at baseline (directly after step 1) and three and six months thereafter.

Results:

Both rheumatologists participated in this study and were present during the implementation of  steps 1 through 3.  At baseline, 275 patients (mean age 56 years ± 16 years; 56% female) were using a bDMARD, the most commonly prescribed bDMARDs were adalimumab (41%), etanercept (23%) and tocilizumab (13%). The majority of patients were diagnosed with RA (63%), SpA (17%), and PsA (15%). Disease activity measures and dose reduction data are listed in table 1.

Table 1 Outcomes on DAS28, BASDAI and bDMARD use

*Outcome only assessed in RA patients. ^ΞOutcome only assessed in SpA patients. ^†Outcome assessed in all patients.

Extrapolating the percentage of patients that received a reduced dose of bDMARD at six months, we estimated that total annual savings of 500,000 euros could be realized by biological dose optimization in this cohort.

Conclusion:

Based on the promising results of this pilot study, implementation of tight control based biological dose optimization may become a feasible and successful strategy in daily clinical practice, resulting in improved quality of care and a sizable reduction in bDMARD use.

References

¹Van Herwaarden et al. BMJ 2015.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-protocolized-tight-control-and-biological-dose-optimization-in-daily-clinical-practice-results-of-a-pilot-implementation-study/