Table 1 |
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Baseline characteristics, overall disposition and dosing history, according to initial dosage |
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|
Parameter |
Masitinib 3 mg/kg per day (n = 22) |
Masitinib 6 mg/kg per day (n = 18) |
Total population (n = 40) |
|
|
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Demographic (intent-to-treat population) |
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|
Age, years |
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|
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 |
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|
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 |
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|
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) |
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|
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) |
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|
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) |
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|
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Consent withdrawn |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) |
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|
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%) |
|
|
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|
Active rheumatoid arthritis patients were randomly assigned to receive masitinib therapy at initial dosing levels of 3.0 or 6.0 mg/kg per day, administered per os for 12 weeks. Dose adjustment was permitted depending upon efficacy and safety assessments. Pain and disease activity were assessed using an EQ-5D (EuroQoL-5 Dimensions) visual analogue scale. aCombination of dose augmentation and/or diminution. Anti-TNFα, anti-tumour necrosis factor-alpha; CRP, C-reactive protein; DA, disease activity; DAS28, disease activity score using 28 joint counts; DMARD, disease-modifying antirheumatic drug; HAQ, Health Assessment Questionnaire; SD, standard deviation. |
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Tebib et al. Arthritis Research & Therapy 2009 11:R95 doi:10.1186/ar2740 |
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