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Table 1 Baseline characteristics, overall disposition and dosing history, according to initial dosage

From: Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study

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   Consent withdrawn 0/7 (0.0%) 1/9 (11.1%) 1/16 (6.3%)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%)
  1. 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.