Treat-to-Target in RA: No Increase in AEs Save
Implementing a treat-to-target approach for the care of rheumatoid arthritis (RA) did not result in an increase in adverse events or resource use, a post-hoc analysis of a randomized trial showed.
In an analysis that included more than 300 patients, any adverse event was reported in 10.2% of visits before the treat-to-target intervention and in 8.8% of visits during the intervention, according to Daniel H. Solomon, MD, of Brigham and Women's Hospital in Boston, and colleagues.
And during the 9 months before the intervention, there were a mean of 4 visits to a rheumatologist compared with 3.6 visits during the intervention (P=0.02), the researchers reported online in Arthritis Care & Research.
Treat-to-target has become an accepted approach in RA, requiring that patients and providers establish a target, measure disease activity at each visit, and adjust treatments until the target is met.
A randomized trial was conducted at 11 rheumatology centers to test implementation of this approach using a learning collaborative intervention. The 9-month intervention increased treat-to-target implementation from 11% at baseline to 57%.
A treat-to-target approach has also been tried in other conditions, but has been associated with an increase in adverse events. For example, in a trial of a treat-to-target approach for diabetes, an elevated risk of both hypoglycemia and death was observed with a target for glycated hemoglobin below 6% compared with a standard goal of 7% to 7.9%. In addition, a meta-analysis of hypertension trials found a significantly increased risk for severe hypotension (RR 2.68, 95% CI 1.21-5.89, P=0.015) with a treat-to-target approach.
Therefore, to see if similar undesirable outcomes could be linked to the use of a treat-to-target approach in rheumatology, Solomon and colleagues conducted a post-hoc analysis of data from six of the sites that participated in their earlier randomized trial of the learning collaborative intervention. Patients from those sites originally were randomized to a wait-list control group for 9 months and then the intervention for the subsequent 9 months.
At least 30 patients from each of the six sites who had been seen during the 3 months prior to the intervention and the last 3 months of the intervention were chosen randomly for analysis.
Adverse events of interest included rashes, alopecia, oral ulcers, infections, liver function abnormalities, cytopenias, renal insufficiency, cancer, and gastrointestinal effects.
The researchers examined the medical records of 321 patients in the pre-intervention period and 315 during the intervention. Participants' mean age was 60 years, 81% were women, and three-quarters were seropositive. The number of patients being treated with biologics was similar before the intervention (40.8%) and during the intervention (38.7%), and the percentages with joint erosions also were similar (53.4% versus 52.6%).
Among specific adverse events, slightly more patients had liver function abnormalities (0.8% versus 0.3%), and mucocutaneous events (1.7% versus 0.8%) before the intervention, while infections were slightly higher during the intervention (12.1% versus 9.4%) and gastrointestinal symptoms were observed in 2.2% during both periods.
"The lack of an increase in adverse events should provide some reassurance to providers and patients," Solomon and colleagues observed.
With regard to healthcare resource use, more rheumatology visits before the intervention included monitoring of laboratory tests (90% versus 52.7%, P<0.001) and diagnostic imaging (15.4% versus 8.9%, P<0.001).
Healthcare resource use appeared to decline slightly during the intervention. "It may be that using a more systematic treat-to-target approach reduced the need for the use of the resources we measured," the authors noted. "However, it may be that the slight improvement in disease activity that we observed during treat-to-target was associated with a reduced need for resources," they added.
A limitation of this analysis was the inclusion of patients from only six rheumatology practices.
The study was supported by the National Institutes of Health and the Rheumatology Research Foundation.
The authors reported financial relationships with Amgen, Pfizer, Bristol-Myers Squibb, Genentech, AbbVie, Corrona, Roche, TissueGene, and Samumed.