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Consent withdrawn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%)


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.

Tebib et al. Arthritis Research & Therapy 2009 11:R95   doi:10.1186/ar2740

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