Magnetic resonance imaging (MRI)-confirmed inflammatory activity may potentially be used as a trial end point when studying patients with early rheumatoid arthritis (RA), according to research published in Advances in Therapy. Researchers also indicate that achieving target inflammation levels in early RA is associated with a very low risk for structural damage progression.
Researchers conducted a post hoc analysis to assess the early RA outcomes based on MRI-determined synovitis, osteitis, and combined total inflammatory activity. Study investigators hoped to use these results to validate the use of these measurements as a predictive value of nonprogression.
Study data were pulled from the Assessing Very Early Rheumatoid arthritis Treatment (NCT01142726) trial, a phase-3b, randomized, active-controlled, 24-month trial with 3 treatment arms. Throughout the 12-month, double-blind treatment period, patients received either abatacept plus methotrexate, abatacept monotherapy, or methotrexate monotherapy. To conduct the post hoc analysis, MRI data were pooled from all 3 treatment arms; patients were stratified into 2 subgroups based on inflammation level.
The post hoc analysis cohort included 351 patients (77.8% women, mean age 47±12.6 years) with early RA; 78.6% and 67% also had 6- and 12-month MRI data available as well. Patients in this cohort also had highly active disease.
After adjusting for baseline Disease Activity Score in 28 Joints, the risk for structural damage progression — defined as erosion change from baseline >0.5 and greater than smallest detectable change — at follow up was significantly lower among patients with less severe inflammation vs more severe inflammation at baseline. Following by-treatment analyses, investigators found that patients with less severe inflammation at baseline had “significantly less progression from 0 to 12 months” compared with patients with more severe inflammation in most comparisons.
Patients with less severe inflammation had a lower unadjusted probability of disease progression from baseline to 12 months compared with patients with more severe inflammation. Unadjusted progression probability was also lower among these patients at 6 months.
Limitations to the study include the focus on early RA, meaning that results may not be generalizable to other populations, as well as the post hoc nature of the analysis.
“Further research is needed to determine whether these and other thresholds, such as those including tenosynovitis, on MRI are applicable and optimal across different populations of patients with RA,” the researchers concluded. “Additionally, an investigation into whether achievement of low MRI-detected inflammation is associated with optimization of patient-reported outcomes…could form the basis for a logical next study.”
Disclosure: This clinical trial was supported by Bristol-Myers Squibb. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Ahmad HA, Baker JF, Østergaard M, Ye J, Emery P, Conaghan PG. Determining MRI inflammation targets when considering a rheumatoid arthritis treat-to-target strategy: results of a randomized, placebo-controlled trial [published online July 5, 2019]. Adv Ther. doi: 10.1007/s12325-019-01020-6