Higher patient global assessment threshold improves RA remission criteria agreement
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A higher threshold for patient global assessment — 2 cm rather than 1 cm — increases agreement between Boolean and index-based rheumatoid arthritis remission criteria, according to data published in Arthritis & Rheumatology.
These data follow the American College of Rheumatology and EULAR’s 2011 endorsement of provisional Boolean- and index-based criteria for RA remission, with the former including the 1 cm threshold. In the current study, the researchers propose that the revised ACR/EULAR remission criteria, with the higher threshold, be adopted for future clinical trials and as a clinical practice target.
“Since their publication, arguments have been made claiming that remission definitions may, on the one hand, be too stringent, with the risk of overtreatment if used as treatment targets, or, on the other hand, too lenient, proposing addition of imaging confirmation of remission,” Paul Studenic, MD, PhD, of the Karolinska Institute, in Stockholm, and colleagues wrote.
“A particular matter of debate was the requirement of achieving a [patient global assessment (PtGA)] score of 1; the stringent threshold for the PtGA has been criticized, because some patients do not achieve it despite the absence of tender and swollen joints and an elevated CRP level,” they added. “Moreover, the agreement between the Boolean and index definitions was only moderate, primarily due to the PtGA threshold. ... To circumvent the strictness of the 1.0 rule for PtGA and to increase the agreement with SDAI-defined remission, a higher PtGA threshold has been proposed.”
According to the researchers, a prior study analyzing alternative Boolean definitions of remission, demonstrated that a threshold of 2 cm — characterized by the researchers as “Boolean 2.0” — resulted in higher agreement with the index-based definition while maintaining the “strong association between remission and subsequent good functional and radiographic outcomes,” the researchers wrote.
To externally validate this revised set of Boolean remission criteria for patients with RA, Studenic and colleagues collected information from four randomized trials comparing biologic disease-modifying antirheumatic drugs with methotrexate or placebo. The trials included in the analysis tested golimumab (Simponi Aria, Janssen), tocilizumab (Actemra, Genentech) and rituximab (Rituxan, Genentech). Each of the four trials tested patient global assessments using a 100 mm visual analog scale.
The researchers increased the Boolean threshold for a passing patient global assessment score by increments of 0.5 centimeters, from 1 cm through 2.5 cm. These were labeled as “Boolean 1.0,” “Boolean 1.5,” “Boolean 2” and “Boolean 2.5.” Additionally, “Boolean X” was designated as a criteria without the patient global assessment.
The analysis included data from 1,101 patients with early RA and 947 patients with established RA. The percentage of patients who achieved remission at 6 months was higher when measured with Boolean 2.0 compared with Boolean 1.0 — 14.8% vs. 20.6% — in patients with early RA. This was also true among patients with established RA — 4.2% vs. 6%. In addition, agreement with simple disease activity index and clinical disease activity index criteria was higher in Boolean 2.0 than Boolean 1.0.
“The ACR/EULAR 2011 initiative on remission criteria was undertaken to harmonize the definition of the term ‘remission’ and thus to facilitate the fair assessment and comparison of remission rates in clinical trials and clinical practice (e.g., for different health care settings or providers),” Studenic and colleagues wrote. “It will be helpful to further study the performance of the revised criteria in trials using other antirheumatic drugs, such as JAK inhibitors, and in other countries and ethnic groups, since RA severity and the interpretation of the PtGA may vary across ethnicities.
“We validated the results of the performance of the Boolean2.0 and the provisionally endorsed index-based remission definitions,” they added. “With the validation of the threshold of 2 cm for the PtGA, we propose that these revised ACR/EULAR remission criteria be adopted both for future clinical trials and as a target in clinical practice.”
References:
- Emery P, et al. Ann Rheum Dis. 1995;doi:10.1136/ard.54.12.944.
- Smolen JS, et al. Ann Rheum Dis. 2016;doi: 10.1136/annrheumdis-2015-207524).
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