Tight control, treat-to-target not superior to usual care for ASAS-HI score in axial SpA
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Tight control and treat-to-target, although cost-effective, are not superior to usual care for improving ASAS-HI scores in patients with axial spondyloarthritis, according to a speaker at ACR Convergence 2020.
“Recommendations for a treat-to-target and tight control strategy in axial spondyloarthritis are available, but we believe that their implementation in clinical practice is actually pretty poor,” Anna Molto, MD, of Cochin Hospital, in Paris, told attendees at the virtual meeting. “One of the reasons for this might be actually that there is poor evidence in favor of the utility of such a strategy in patients with axial spondyloarthritis.”
To examine the benefit of tight control strategies compared with usual care in patients with axial SpA, Molto and colleagues conducted a 1-year, prospective, cluster-randomized, controlled trial, including 160 participants from 18 centers. The participants — all diagnosed with axial SpA and meeting ASAS criteria — had been previously unresponsive to NSAIDs and were biologic DMARD-naïve, with a ASDAS score of more than 2.1 at inclusion. All included patients were randomized 1-to-1 to receive either tight control or usual care.
Patients in the tight control arm were treated according to a strategy pre-specified by the scientific committee based on current axial SpA recommendations, aimed at a target of a ASDAS score of less than 2.1. This strategy also involved visits every 4 weeks. Meanwhile, in the usual care group, treatment decisions were made at the rheumatologist’s discretion, with visits every 12 weeks. The primary outcome was the percentage of patients with a more than 30% improvement in ASAS health index (ASAS-HI) score during a follow-up period of 1 year. Other outcomes included disease activity, quality of life and treatment.
The statistical analysis included two models for all outcomes, to take into account the cluster-randomization design. The first was a two-level mixed model with two random effects, to estimate the percentage of responders per the change of the outcome over follow-up. The second model was developed by including the imbalanced variables observed at baseline into the first. The researchers assessed cost effectiveness by estimating the baseline- and cluster-adjusted incremental cost per quality-adjusted life-year (QALY) gained for tight control compared with usual care.
In all, 72 participants in each group attended the 1-year visit.
According to the researchers, 47.3% of patients in the tight-control group achieved a significant improvement in ASAS-HI at the 1-year visit, compared with 36.1% of those who received usual care. Despite the results slightly favoring tight control, the difference between the two groups was not statistically significant in either model, Molto said. In addition, all other outcomes demonstrated a trend in favor of tight control, she said.
The percentage of biologic DMARDs was significantly higher in the tight control arm, at 56.2% compared with 27.2% among those treated with usual care. The number of infections was comparable in both groups — 15 for tight control and 16 for usual care — with two severe infections reported in the usual care group. Lastly, tight control resulted in an additional 0.04 QALY, and saved 265 ($313) compared with usual care. Tight control demonstrated a 67% probability of being cost-effective at a threshold of 20,000 ($23,637) per QALY.
“Usual care was shown to be a very good treatment in this trial,” Molto said. “However, statistical significance was not achieved for the primary efficacy endpoint, which was a significant improvement at 1 year in the ASAS health index. Overall, the efficacy outcomes, there was a general trend in favor of T2T. In addition, the safety profile was comparable to the usual care, and treat-to-target was cost effective at a threshold of 20,000 per QALY, both despite significantly greater rate of prescriptions for biologics in the T2T arm.”
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Molto A. Abstract 1444. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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