Genentech Submits Supplemental Application for Actemra to Prevent Structural Joint Damage in Patients with Rheumatoid Arthritis

Strategic Insights -

Genentech, Inc., a leading biotechnology company, has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Actemra (tocilizumab) to prevent structural joint damage and improve physical function in adults with moderately to severely active rheumatoid arthritis (RA). This application is based on positive results from the Phase III LITHE trial, which demonstrated that patients receiving Actemra in combination with methotrexate had significantly less damage to their joints compared to those receiving methotrexate alone. The trial showed that patients treated with Actemra 8mg/kg plus methotrexate suffered 81% less damage to their joints compared to those treated with methotrexate alone at Week 104.

Key Takeaways:

  • The LITHE trial, a randomized, double-blind, placebo-controlled study, evaluated the efficacy of Actemra plus methotrexate in preventing structural joint damage and improving physical function over two years.
  • Patients receiving Actemra in combination with methotrexate had significantly less damage to their joints compared to those receiving methotrexate alone, with a 81% reduction in joint damage at Week 104.
  • The trial also showed significant improvement in physical function in patients receiving Actemra plus methotrexate compared to those receiving methotrexate alone, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).
  • The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, high blood pressure, and increased liver enzymes.
  • Actemra is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
  • The extensive Actemra clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States.

Statistics:

  • 81% reduction in joint damage at Week 104 for patients treated with Actemra 8mg/kg plus methotrexate compared to those treated with methotrexate alone.
  • 63.6% reduction in Total-Sharp Genant Score at Week 104 for patients treated with Actemra 4mg/kg plus methotrexate compared to those treated with methotrexate alone.
  • 144.1 units decrease in HAQ-DI AUC change from baseline for patients treated with Actemra 8mg/kg plus methotrexate at Week 52.
  • 128.4 units decrease in HAQ-DI AUC change from baseline for patients treated with Actemra 4mg/kg plus methotrexate at Week 52.
  • 58.1 units decrease in HAQ-DI AUC change from baseline for patients treated with methotrexate alone at Week 52.

Sources:

  • Clinical Trials Week editors from staff and other reports.
  • Genentech, Inc. via NewsRx.com.
  • U.S. Food and Drug Administration (FDA).
  • Roche Group.
  • Chugai Pharmaceutical Co.