Study Uses PROs to Determine Efficacy of Sarilumab for Rheumatoid Arthritis

August 9, 2017

Patient-reported outcomes have demonstrated the impact of sarilumab as an effective management treatment for patients with rheumatoid arthritis.

Patient-reported outcomes (PROs) have demonstrated the impact of sarilumab as an effective management treatment for patients with rheumatoid arthritis (RA).

A new study published in RMD Open utilized PROs from the TARGET trial in patiets with RA who had inadequate response or intolerance to tumor necrosis factor inhibitors (TNF-IR) to evaluate the effects of the anti-interleukin-6 receptor monoclonal antibody, sarilumab, when treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Researchers gave patients with TNF-IR RA either a placebo or sarilumab 150 mg or 200mg every 2 weeks plus csDMARDs for 24 weeks. The PROs were then used to evaluate bodily pain, physical functioning, social functioning, general health perceptions, vitality, role emotion, and mental health. The study also included other PROs that evaluated the effects of RA on a patient’s productivity and work, such as the Work Productivity Survey-Rheumatoid Arthritis (WPS-RA).

“A main strength of this trial was the use of PROs covering a wide range of symptoms and impact of RA, including disease-specific and generic measures to comprehensively evaluate patients' perspectives and to place them in the context of the general population,” the researchers wrote. “Another is inclusion of the WPS-RA, which captures household work productivity as well as participation in family/social and leisure activities that are overlooked in other productivity measures.”

The results revealed that most patients (92.3%) had failed a previous agent because of inadequate responses and 42% of those patients had a primary failure to the prior TNF. At baseline, the PROs suggested that RA had a significant effect on productivity, and patents often missed more than 5 days of family, social, or leisure activities within one month.

Improvements in pain from baseline were found to be significantly greater with sarilumab than the placebo at week 24. Among the Health Assessment Questionnaire Disability Index, the Medical Outcomes SF-36 Health Survey, and WPS-RA PROs, there were greater improvements reported with sarilumab.

“These analyses from the TARGET [randomized controlled trial] complements the clinical efficacy and safety data previously reported, and demonstrates that treatment with sarilumab + csDMARDs resulted in patient-reported benefits that were clinically meaningful in pain, fatigue, function, participation and health status,” the authors concluded.