Benefits outweigh risks when switching biologics for rheumatoid arthritis
Click Here to Manage Email Alerts
Patients with rheumatoid arthritis who achieve only a partial response with adalimumab demonstrate a low risk for worsened symptoms and a high likelihood of meaningful improvement when switching to sarilumab, according to data.
“Despite widespread guidelines recommending a treat-to-target treatment strategy in rheumatoid arthritis, patients may decline to escalate therapy as encouraged by their rheumatology provider,” Jeffrey Curtis, MD, MS, MPH, of the University of Alabama at Birmingham, told Healio. “While the reasons for not doing so are probably multifactorial, patients changing from one biologic to another may fear they would lose a partial response, and that the new medication would work less well than the old.”
To investigate the effects of switching from adalimumab (Humira, AbbVie) to sarilumab (Kevzara, Sanofi/Regeneron) in patients with RA who failed to achieve low disease activity with the former drug, Curtis and colleagues conducted an open-label extension of the MONARCH study. According to the researchers, MONARCH investigated adalimumab monotherapy compared with sarilumab monotherapy over 24 weeks. The extension included two groups of patients from the initial MONARCH study randomized to receive adalimumab and sarilumab.
To be eligible for MONARCH, patients needed to be aged 18 years or older, with a 28-joint Disease Activity Score, using erythrocyte sedimentation rate (DAS28-ESR), of more than 5.1, and a C-reactive protein score of 8 or more mg per liter. Participants were additionally required to have had RA for 3 or more months, have at least six swollen joints on the 66-joint swollen joint count, and at least eight tender joints on the 68-joint tender joint count.
Patients were assessed for “meaningful” symptom worsening or improvement at 12 and 24 weeks, the researchers wrote in the Journal of Clinical Rheumatology. Measurements included the clinical disease activity index, the DAS28-ESR, the health assessment questionnaire disability index, the simple disease activity index, the physician global assessment, the patient global assessment, a 28-joint swollen joint count and a 28-joint tender joint count.
The open-label extension included a total of 320 patients, of whom 155 were switched from adalimumab to sarilumab. Of those who switched, 59% were considered to be partial responders to adalimumab.
After 24 weeks of therapy, 4% to 17% of partial responders demonstrated worsening symptoms using the lower thresholds the researchers used to quantify worsening, whereas 2% to 12% had symptom worsening based on higher thresholds. Meanwhile, at the same time frame, 47% to 78% and 2% to 66% of patients saw an improvement in their symptoms based on lower and higher threshold levels, respectively.
“When switching mechanism of action from one biologic to another — in this case, a TNF inhibitor to an IL-6R inhibitor — the likelihood that patients meaningfully worsened was low — eg 5% — whereas the likelihood that they meaningfully improved was appreciably higher,” Curtis said.
“This study is important in that it gives providers and patients confidence that there is an appreciable upside and minimal downside when switching from one biologic to another in pursuit of low disease activity or remission in RA,” he added. “Exploring the reasons that patients may fear to change their treatments is an important component of shared decision making, and this study provides quantitative information about the low likelihood of worsening when changing therapies.”
Collapse
Click Here to Manage Email Alerts