Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Korábbi kezelés

• Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization;
• Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;
• Received rituximab treatment in the past 6 months before randomization;
• Received tocilizumab or eculizumab treatment within 3 months before randomization;
• Received IVIG or plasma exchange within 4 weeks before randomization;

Más betegség

• Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;
• Human immunodeficiency virus (HIV) infection;
• History of other tumor diseases.

Egyéb

• Unresected thymoma.

• Diagnosis of MG with anti-AChRantibody.
• MGFA Clinical Classification Class II, III, or IV.
• MG-ADL score of 5 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items.
• QMG score of 11 or greater.
• Subjects must be on:
  • Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;
  • Corticosteroids, with no dose increase within 4 weeks prior to randomization; or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.