Fig. 1

Study design. X, drop-out. *CD, confirmed deterioration. Defined as change from baseline on two consecutive visits in Physician’s Global Disease Activity VAS worsening ≥ 2 cm and MMT-8 worsening ≥ 20%, OR global extra-muscular activity worsening ≥ 2 cm on the MDAAT VAS, OR any three of five CSM (core set measures, excluding enzymes) worsening by ≥ 30%). **Physician’s Global Disease Activity (GDA) value of 0–3 (mild), 4–6 (moderate), 7–10 (major). #Placebo patients having confirmed deterioration at week 16 continued in open-label part