FDA Approves Tofidence (tocilizumab-bavi) for Multiple Inflammatory Conditions and COVID-19
The FDA has approved Tofidence (tocilizumab-bavi), a biosimilar to tocilizumab, for multiple indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19 in hospitalized adults. This approval provides an additional treatment option for patients with these conditions. Tofidence is an interleukin-6 (IL-6) receptor antagonist that can be used alone or with methotrexate and other non-biologic DMARDs. The approval covers both adult and pediatric populations aged 2 years and older for the juvenile arthritis indications.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Tofidence (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist. It binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling.
Tofidence is indicated for: - Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs. - Giant Cell Arteritis (GCA): Adult patients with GCA. - Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active PJIA. - Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active SJIA. - Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
For RA: Starting dose 4 mg/kg IV every 4 weeks, increase to 8 mg/kg every 4 weeks based on clinical response. For GCA: 6 mg/kg IV every 4 weeks with glucocorticoid taper. For PJIA: <30 kg: 10 mg/kg IV every 4 weeks; ≥30 kg: 8 mg/kg IV every 4 weeks. For SJIA: <30 kg: 12 mg/kg IV every 2 weeks; ≥30 kg: 8 mg/kg IV every 2 weeks. For COVID-19: 8 mg/kg IV single infusion over 60 minutes. Doses exceeding 800 mg per infusion not recommended for RA or COVID-19; exceeding 600 mg per infusion not recommended for GCA. Do not initiate if ANC <2000/mm3 (RA/GCA/PJIA/SJIA) or <1000/mm3 (COVID-19), platelets <100,000/mm3 (RA/GCA/PJIA/SJIA) or <50,000/mm3 (COVID-19), or ALT/AST >1.5x ULN (RA/GCA/PJIA/SJIA) or >10x ULN (COVID-19).
Trial data not available in label.
Not reported in label.
Tofidence is a biosimilar to tocilizumab, providing an alternative for patients requiring IL-6 receptor blockade across multiple indications. It may be used alone or with methotrexate and other non-biologic DMARDs for RA, PJIA, and SJIA. Avoid concomitant use with biological DMARDs due to increased immunosuppression risk.
View Original Abstract ↓
Late-onset rheumatoid arthritis shows higher DAS28 scores and lower remission rates compared to young-onset disease in a meta-analysis
Meta-analysis compares treatment outcomes in older versus younger rheumatoid arthritis patients
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