Response to rituximab treatment at 6 months (primary endpoint)
Definition of improvement | Improved/treated, n (%) | 95% CI |
Patients’ improvement at 6 months | ||
≥2 MRC or 1 INCAT or 4 RODS centile points | 13/17 (76.5) | 50.1 to 93.2 |
≥4 MRC or 1 INCAT or 4 RODS centile points | 10/17 (58.8) | 32.9 to 81.6 |
Patients’ improvement at 6 months in each score | ||
Definition of improvement | Improved/treated, n (%) | |
INCAT<1 point | 7/17 (41.2) | |
RODS>4 centile points | 7/17 (41.2) | |
MRC>2 points | 9/16 (56.3) | |
MRC>4 points | 4/16 (25.0) | |
≥20% improved in at least one among MCV, DL, amplitude or duration of CMAP in at least 2 motor nerves | 6/15 (40.0)* | |
≥MCID threshold in at least one among mean CMAP duration, mean MCV, CB, CMAP duration of the most affected motor nerve30 | 11/15 (73.3)* |
*Not available in two patients.
CB, conduction block; CMAP, compound motor action potential; DL, distal latency; INCAT, Inflammatory Neuropathy Cause and Treatment Disability Scale; MCID, minimum clinical important difference; MCV, motor conduction velocity; MRC, Medical Research Council; RODS, Rasch Overall Disability Scale.