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Table 4 Efficacy outcomesa from the extension phase of the study: weeks 12 to 82 (intention-to-treat population)

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

Parameter W12 W24 W36 W48 W60 W72 W84
ACR, number (percentage) of patients n = 27 n = 7 n = 9 n = 8 n = 8 n = 9 n = 8
   ACR20b 15 (56%) 6 (86%) 7 (78%) 5 (63%) 6 (75%) 6 (67%) 7 (88%)
   ACR50b 9 (33%) 2 (27%) 4 (44%) 3 (38%) 6 (75%) 3 (33%) 5 (63%)
   ACR70 3 (11%) 1 (14%) 2 (22%) 1 (13%) 3 (38%) 2 (22%) 2 (25%)
   ACR90 0 (0%) 0 (0%) 1 (11%) 0 (0%) 2 (25%) 1 (11%) 1 (13%)
ACRn n = 27 n = 7 n = 9 n = 8 n = 8 n = 9 n = 8
   Mean ± SD 31.6 ± 33.5 36.0 ± 29.0 45.9 ± 32.3 30.9 ± 36.7 58.3 ± 31.4 35.6 ± 41.3 50.9 ± 38.0
   Median 42.9 40.7 45.5 40.0 64.9 39.7 55.0
   Range -40.0–87.5 -16.7–73.0 -3.8–93.3 -20.0–70.9 10.0–93.3 -27.8–97.4 -17.6–98.8
CRP, number (percentage) of patients n = 28 n = 7 n = 12 n = 9 n = 7 n = 9 n = 8
   Improvement > 50% 14 (50%) 5 (71%) 9 (75%) 6 (67%) 3 (43%) 6 (68%) 5 (63%)
   25% < improvement ≤ 50% 3 (11%) 0 (0%) 1 (8%) 0 (0%) 3 (43%) 1 (11%) 1 (13%)
   0% < improvement ≤ 25% 5 (18%) 1 (14%) 1 (8%) 1 (11%) 1 (14%) 1 (11%) 1 (13%)
   Stable 3 (11%) 1 (14%) 1 (8%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
   Deterioration 3 (11%) 0 (0%) 0 (0%) 2 (22%) 0 (0%) 1 (11%) 1 (13%)
DAS28 n = 24 n = 4 n = 5 n = 6 n = 7 n = 7 n = 4
   Mean ± SD 4.6 ± 1.3 5.2 ± 1.7 4.4 ± 1.9 4.7 ± 2.1 3.3 ± 1.5 3.5 ± 1.5 3.1 ± 1.6
   Median 4.4 4.9 4.1 4.4 2.6 3.0 2.5
   Range 0.5–7.0 3.6–7.5 2.3–7.5 2.7–8.7 1.7–5.3 1.6–6.1 1.9–5.5
   DAS28 < 2.6, number (percentage) of patients 1 (4%) 0 (0%) 1 (20%) 0 (0%) 4 (57%) 1 (14%) 2 (50%)
   DAS28 ≤ 3.2, number (percentage) of patients 1 (4%) 0 (0%) 1 (20%) 2 (33%) 4 (57%) 4 (57%) 3 (75%)
  1. aResults from extension phase are preliminary. bPrimary efficacy outcome. American College of Rheumatology (ACR) results are presented as the cumulative number of patients reaching each ACR level. ACR20/50/70/90, American College of Rheumatology 20%/50%/70%/90% improvement criteria; ACRn, index of improvement in rheumatoid arthritis; DAS28, disease activity score using 28 joint counts; CRP, C-reactive protein; SD, standard deviation; W, week.