Is Kevzara Approved for Use with Methotrexate?
Yes, Kevzara (sarilumab) is approved for use with methotrexate in adults with moderately to severely active rheumatoid arthritis (RA) who have not responded adequately to one or more tumor necrosis factor antagonists. The recommended starting dose is Kevzara 200 mg subcutaneously every 2 weeks with methotrexate, unless patients cannot tolerate methotrexate.[1][2]
How Does This Combination Work in RA Treatment?
Kevzara, an interleukin-6 receptor inhibitor, targets inflammation differently from methotrexate, a disease-modifying antirheumatic drug (DMARD) that suppresses immune activity. Clinical trials showed the combination reduces RA symptoms more effectively than methotrexate alone, with ACR20 response rates of 71% for Kevzara 200 mg plus methotrexate versus 58% for methotrexate plus placebo.[2][3]
What Do Clinical Studies Show?
Phase 3 MOBILITY and TARGET trials confirmed efficacy and safety of Kevzara plus methotrexate:
- MOBILITY: 61% ACR20 response at 24 weeks for 200 mg dose vs. 33% placebo (both with methotrexate).
- TARGET: 55% ACR20 vs. 34% adalimumab (both with/without methotrexate).
No new safety signals emerged beyond individual drug profiles.[2][4]
Are There Dosing Adjustments?
Continue methotrexate at the lowest effective dose (typically 7.5-20 mg weekly). Reduce Kevzara to 150 mg if neutropenia (ANC 500-1,000/mm³), thrombocytopenia (50,000-100,000/mm³), or elevated liver enzymes occur. Discontinue if severe issues persist.[1][2]
What Risks Come with Combining Them?
Increased infection risk (e.g., upper respiratory, urinary tract) due to immunosuppression. Monitor for GI perforations (higher with prior diverticulitis), liver enzyme elevations, and lipid changes. Avoid live vaccines. Common side effects include neutropenia (9-16%) and injection-site reactions.[1][2][5]
Can It Be Used Without Methotrexate?
Yes, for patients intolerant to methotrexate. Trials showed similar efficacy (ACR20 around 50-60% for 200 mg monotherapy), but combination is preferred for optimal response.[2][3]
Who Makes Kevzara and What's the Status on Patents?
Sanofi and Regeneron market Kevzara. U.S. patents expire around 2032, with some formulation patents challenged; no generics until then per DrugPatentWatch.com.[6]
[1] Kevzara Prescribing Information, Sanofi/Regeneron, 2023.
[2] FDA Approval Label, Kevzara, 2017 (updated).
[3] Genovese et al., Arthritis Rheumatol, 2017.
[4] Burmester et al., Ann Rheum Dis, 2017.
[5] Kevzara Safety Data, TARGET Trial.
[6] DrugPatentWatch.com - Kevzara Patents