Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study.

Objective: To evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).

Methods: In this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12.

High-Dose Immunosupression and Stem Cell Transplantation in Severe Autoimmune Diseases.

High-dose chemotherapy followed by hematopoietic stem cell (SC) transplantation has been recently proposed as a new strategy for the treatment of severe autoimmune diseases. The rationale for using stem cell transplantation to treat autoimmune disease is based on the principle of complete ablation of an aberrant immune system followed by reconstitution of a new immune system deriving from graft. Three different approaches are being currently used: 1) allogeneic SC transplantation, 2) autologous SC rescue following "immunoablation", and 3) intensive immunosuppression alone.