CIDP01 efficacy results
| Outcome | Placebo (n=17) | Rozanolixizumab (n=16) | Difference versus placebo |
| Change from baseline to week 13 (day 85), LSM (SE) or LSM difference versus placebo (90% CI) | |||
| iRODS centile metric score | 3.4 (2.6) | 2.0 (3.2) | –1.5 (–7.5 to 4.5) |
| Adjusted INCAT disability score | –0.6 (0.2) | –1.0 (0.3) | –0.4 (–0.9 to 0.0) |
| Maximum grip strength (clinician assessed) | 13.27 (3.79) | 10.86 (4.41) | –2.41 (–11.09 to 6.28) |
| Maximum grip strength (patient assessed) | 8.1 (4.5) | 6.9 (5.4) | –1.2 (–12.0 to 9.5) |
| CIDP relapse up to week 13, n (%) or LSM difference versus placebo (90% CI)* | |||
| Combined | 9 (53) | 8 (50) | –0.03 (–0.32 to 0.26) |
| iRODS | 6 (35) | 7 (44) | 0.09 (–0.20 to 0.36) |
| Adjusted INCAT disability score | 8 (47) | 7 (44) | –0.03 (–0.32 to 0.25) |
| Maximum grip strength | 7 (41) | 6 (38) | –0.04 (–0.32 to 0.24) |
| Time to CIDP relapse (days), HR (90% CI)* | |||
| Combined | – | – | 0.97 (0.43 to 2.15) |
| iRODS | – | – | 1.36 (0.55 to 3.40) |
| Adjusted INCAT disability score | – | – | 0.96 (0.41 to 2.24) |
| Maximum grip strength | – | – | 1.04 (0.42 to 2.61) |
*Data presented are for patients worsening for each individual disability measure, with ‘combined’ referring to the patients who worsened according to any individual measure. A patient withdrawing from the study for any reason, having missing data or administered rescue medication before week 13 was considered relapsed.
CIDP, chronic inflammatory demyelinating polyradiculoneuropathy; INCAT, Inflammatory Neuropathy Cause and Treatment; iRODS, inflammatory Rasch-built Overall Disability Scale; LSM, least squares mean.