A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.
A recently published study demonstrates that sarilumab improves patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.
Vibeke Strand, MD, and her coauthors, in a study sponsored by Sanofi and Regeneron, evaluated the effects of the monoclonal antibody administered together with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) based on PROs in the TARGET trial.
The authors note that PROs are important supplemental endpoints that can help in evaluating responses to treatment for RA. While clinical measures of RA, including the American College of Rheumatology (ACR) response criteria, include PROs, such measures rarely assess fatigue, ability to work, health-related quality of life, or health status.
In the TARGET trial, which included the assessment of PROs, 546 adults with moderate to severe RA who did not respond adequately to, or did not tolerate, anti-TNF treatments were randomized to receive placebo, 150 mg of sarilumab, or 200 mg of sarilumab every 2 weeks together with csDMARDs. The PROs addressed in the study included measures of pain, fatigue, function, participation, and health status. The methods used to assess these areas included:
Changes from baseline at weeks 12 and 24 were analyzed using a mixed model for repeated measures that tested the least square mean (LSM) changes from baseline, between each active treatment group and the placebo group, at weeks 12 and 24. Post hoc analyses included percentages of patients who reported improvements greater than or equal to minimum clinically important differences and scores greater than or equal to normative values.
Sarilumab in both doses, in combination with csDMARDs, resulted in greater improvements from baseline versus placebo together with csDMARDs:
Among patients who were employed outside the home:
The researchers concluded that, in patients for whom treatment with anti-TNF agents was inadequate or not tolerated, 150-mg and 200-mg doses of sarilumab, given together with csDMARDs, resulted in clinically meaningful patient-reported benefits in terms of pain, fatigue, function, participation, and health status at week 12 and week 24, and that mean changes from baseline translated into clinically meaningful benefits on an individual patient level.
Strand, during a recent Peer Exchange™ panel discussion at The Center for Biosimilars®, said, “In general, I think we’re learning a lot more about the biologic products, and that translates also into learning how we might have better precision medicine—how there might be individual variability and what the appropriate therapy is for a patient. We’re still just cracking that nut, but I think it’s one of the things to look forward to.”