Is Kevzara Approved for Monotherapy?
Yes, Kevzara (sarilumab) can be used alone without methotrexate. The FDA approves it as monotherapy for adults with moderately to severely active rheumatoid arthritis (RA) who have not responded adequately to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.[1][2]
When Is Methotrexate Typically Combined?
Kevzara is most often used with methotrexate or other DMARDs for patients whose RA remains active despite DMARD treatment. Monotherapy applies when DMARDs are inappropriate or not tolerated, as shown in clinical trials like MOBILITY and TARGET.[1][3]
What Do Clinical Trials Show for Monotherapy?
In the TARGET trial, Kevzara monotherapy reduced RA symptoms in patients intolerant to or unresponsive to methotrexate, achieving ACR20 response rates of 41-49% at 200 mg every two weeks versus 24% for placebo.[2][3] Long-term data confirm sustained efficacy without methotrexate in these cases.
Common Patient Concerns with Monotherapy
Patients on monotherapy report similar side effects to combination therapy, including infections, injection-site reactions, and elevated liver enzymes. Monitoring remains essential, especially for those with infection risks.[1] Some switch to monotherapy due to methotrexate intolerance like nausea or liver issues.
Who Makes Kevzara and Availability?
Sanofi and Regeneron co-develop and market Kevzara. No generic or biosimilar versions exist yet; U.S. patents extend into the 2030s.[4]
[1]: FDA Kevzara Label
[2]: Kevzara Prescribing Information
[3]: TARGET Trial Results
[4]: DrugPatentWatch.com - Kevzara Patents