London, United Kingdom—Routine ultrasound is not justified for the follow-up of patients with early rheumatoid arthritis (RA) treated with an aggressive treat-to-target strategy, according to results from the ARCTIC trial.
“A treatment strategy based on structured ultrasound assessments aiming for imaging remission does not lead to improved outcomes compared to a conventional strategy based on clinical and laboratory parameters alone,” stated presenting author Espen Haavardsholm, MD, PhD, Senior Researcher and Rheumatologist, Diakonhjemmet Hospital, Oslo, Norway. “Ultrasound is not cost-effective for assessing outcomes and may lead to over treatment. This is an important consideration for optimal use of resources.”
Dr Haavardsholm presented results from the ARCTIC trial at the 2016 European League Against Rheumatism (EULAR) Annual Congress in June.
“The cornerstone of RA care is early initiation of [disease-modifying anti-rheumatic drug (DMARD)] therapy, tight control of disease, defining response, and treating to target,” he noted. “Although complete remission is achievable in a majority of RA patients, subclinical inflammation [detectable on ultrasound] may be present. It is controversial whether strategies targeting imaging remission are feasible and cost-effective, and whether this approach improves outcomes.”
ARCTIC was an open-label, randomized, multicenter, controlled trial that included 238 patients with newly diagnosed RA who were naïve to DMARD treatment. Patients were randomized 1:1 to an ultrasound tight control (UTC) strategy that targeted clinical and imaging remission (defined as no ultrasound power-Doppler signal), or conventional tight control (CTC) strategy targeting clinical remission.
Patients in both arms were treated in accordance with a stepwise DMARD escalation strategy, starting with methotrexate, then triple therapy, then biologic DMARDs if the target was not reached. An ultrasound scoring system was used to assess 32 joints. Experienced sonographers performed the ultrasound examinations.
The primary end point was the number of patients who experienced a sustained clinical remission between 16 and 24 months, absence of swollen joints, and no evidence of progression of radiographic joint damage.
Remission was assessed by Disease Activity Score (DAS) <1.6, and radiographic progression was assessed using the Modified Sharp Score, both at 24 months.
Little difference in measured outcomes was seen between the 2 strategies, and patients randomized to UTC were stepped up to the next level of treatment more often than those in the CTC group.
“At the end of the study, 28.8% of those in the UTC group were being treated with biologics versus 17% in the CTC group, despite there being little or no difference in DAS score,” Dr Haavardsholm told listeners at EULAR 2016. “More patients in the UTC group also received more intra-articular injections.”
The primary end point was achieved in 22% of the UTC group, compared with 18.8% of the CTC group—a non significant difference. For individual components of the primary end point, no swollen joints were detected in 52.5% versus 54.5% of the UTC and CTC groups, respectively.
In the UTC and CTC groups, DAS remission at 16 to 24 months was observed in 54.2% and 51.8% of patients, respectively. No radiographic progression was observed at 16 to 24 months in 41.5% and 34.8% of patients in the same respective cohorts. At 24 months, the percentage of patients in DAS remission was practically identical (67.8% for UTC, and 67.0% for CTC).
According to EULAR criteria, a good/moderate response was observed at 24 months in 83.1% of the UTC cohort, and 80.4% of the CTC group. In addition, at 24 months, the Modified Sharp Score was similar between both groups (1 and 1.5 in the UTC and CTC groups, respectively).
At the end of the study, 53.4% of patients in the UTC group were on methotrexate, versus 71.4% in the CTC group (P = .004). Triple therapy was used by 17.8% versus 11.6% of patients in the same respective groups—a nonsignificant difference. Importantly, 28.8% of the UTC group versus 17% of the CTC group were on biologics, the most costly type of therapy (P = .03).
There were no differences in safety outcomes between the 2 groups, even though more biologics were used in the UTC group.
According to Dr Haavardsholm, ultrasounds confirm what clinicians are already aware of, and in the case of this study, inflammation that was detected via ultrasound only impacted the treatment of a small number of patients. He asserted that conventional treatment was good enough for this patient population.
- Haavardsholm EA, Aga AB, Olsen IC, et al. Ultrasound in the management of rheumatoid arthritis: results from the randomized controlled ARCTIC trial. Presented at: 2016 European League Against Rheumatism Annual Congress; June 8-11, 2016; London, United Kingdom. https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=302308. Accessed June 10, 2016.