Table 1 Baseline characteristics, overall disposition and dosing history, according to initial dosage
Parameter | Masitinib 3 mg/kg per day (n = 22) | Masitinib 6 mg/kg per day (n = 18) | Total population (n = 40) |
|---|---|---|---|
Demographic (intent-to-treat population) | |||
Age, years | |||
Mean ± SD | 54.0 ± 12.2 | 55.5 ± 9.2 | 54.7 ± 10.8 |
Range | 27.0–75.0 | 34.0–69.0 | 27.0–75.0 |
Weight, kg | |||
Mean ± SD | 67.1 ± 12.8 | 69.2 ± 20.5 | 68.1 ± 16.5 |
Range | 49.0–88.0 | 50.0–136.0 | 49.0–136.0 |
Gender | |||
Male | 3/22 (13.6%) | 6/18 (33.3%) | 9/40 (22.5%) |
Female | 19/22 (86.4%) | 12/18 (66.7%) | 31/40 (77.5%) |
Clinical (intent-to-treat population) | |||
Disease duration in years, mean ± SD | 11.8 ± 5.9 | 10.7 ± 8.1 | 11.3 ± 6.9 |
Tender joints, mean ± SD | 24.7 ± 11.1 | 32.2 ± 16.3 | 28.1 ± 14.0 |
Swollen joints, mean ± SD | 15.3 ± 10.4 | 22.1 ± 12.0 | 18.4 ± 11.5 |
Patient pain assessment, mean ± SD | 67.4 ± 19.2 | 68.6 ± 27.4 | 67.9 ± 23.0 |
Patient assessment of DA, mean ± SD | 69.4 ± 24.9 | 73.0 ± 22.9 | 71.0 ± 23.8 |
Physician assessment of DA, mean ± SD | 66.4 ± 19.5 | 66.8 ± 18.8 | 66.6 ± 18.9 |
HAQ score, mean ± SD | 1.9 ± 0.6 | 2.2 ± 0.5 | 2.0 ± 0.6 |
CRP (mg/litre), mean ± SD | 26.2 ± 28.4 | 62.3 ± 57.6 | 42.3 ± 46.9 |
DAS28, mean ± SD | 6.1 ± 0.8 | 7.1 ± 1.1 | 6.5 ± 1.0 |
DMARD failures (percentage) | |||
Anti-TNFα | 8/22 (36.4%) | 12/18 (66.7%) | 20/40 (50.0%) |
Other | 14/22 (63.6%) | 6/18 (33.3%) | 20/40 (50.0%) |
Patient disposition (randomised population) | |||
Masitinib 3 mg/kg per day (n = 22) | Masitinib 6 mg/kg per day (n = 21) | Total population (n = 43) | |
Early study discontinuation | 7/22 (31.8%) | 9/21 (42.9%) | 16/43 (37.2%) |
Insufficient therapeutic effect | 1/7 (14.3%) | 1/9 (11.1%) | 2/16 (12.5%) |
Protocol violation | 0/7 (0.0%) | 0/9 (0.0%) | 0/16 (0.0%) |
Adverse event | 6/7 (85.7%) | 7/9 (77.8%) | 13/16 (81.3%) |
Consent withdrawn | 0/7 (0.0%) | 1/9 (11.1%) | 1/16 (6.3%) |
End of study without extension | 5/22 (22.7%) | 1/21 (4.8%) | 6/43 (14.0%) |
Entered extension phase | 10/22 (45.4%) | 11/21 (52.3%) | 21/43 (48.9%) |
Dosing adjustment (intent-to-treat population over 12-week study phase) | |||
Masitinib 3 mg/kg per day (n = 22) | Masitinib 6 mg/kg per day (n = 18) | Total population (n = 40) | |
No dose adjustment | 10/22 (45%) | 8/18 (44%) | 18/40 (45%) |
Increase by 1.5 mg/kg per day | 6/22 (27%) | 3/18 (17%) | 9/40 (23%) |
Increase by 3.0 mg/kg per day | 2/22 (9%) | 5/18 (28%) | 7/40 (18%) |
Increase by 4.5 mg/kg per day | 3/22 (14%) | 0/18 (0%) | 3/40 (8%) |
Othera | 1/22 (5%) | 2/18 (11%) | 3/40 (8%) |