Figure 2

Study design of the PBO + MTX group ( n = 199) in the LITHE biomarker study. Patients with <20% improvement (escape patients) at Week 16 were given 4 mg/kg TCZ + MTX every four weeks from Week 16. At Week 28 PBO + MTX patients who had received 4 mg/kg TCZ + MTX were evaluated and patients with <20% were given 8 mg/kg TCZ + MTX every four weeks. Responders to TCZ (>20% improvement) remained on 4 mg/kg TCZ + MTX for the rest of the study. If patients who went on to 8 mg/kg TCZ + MTX did not respond after three doses, they were excluded from the remainder of the study, but were included in the Week 24 analysis. Dashed line: First rescue therapy. Dotted line: Second stage rescue therapy. MTX, methotrexate; PBO, placebo; TCZ, tocilizumab