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Table 3 Summary of efficacy outcomes at week 12 with subgroup analysis according to previous treatment failure

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

Parameter PP OCs ITT LOCF
  All patients Resistance to
anti-TNFα
Resistance to MTX All patients Resistance to
anti-TNFα
Resistance to
MTX
ACRa (n = 27) (n = 14) (n = 23) (n = 39) (n = 19) (n = 32)
   ACR20 15/27 (55.6%) 8/14 (57.1%) 14/23 (60.9%) 21/39 (53.8%) 10/19 (52.6%) 17/32 (53.1%)
   ACR50 9/27 (33.3%) 4/14 (28.6%) 9/23 (39.1%) 10/39 (25.6%) 4/19 (21.1%) 9/32 (28.1%)
   ACR70 3/27 (11.1%) 1/14 (7.1%) 3/23 (13.0%) 3/39 (7.7%) 1/19 (5.3%) 3/32 (9.4%)
ACRn       
   Mean ± SD 31.6 ± 33.5 28.1 ± 32.1 36.6 ± 31.6 23.0 ± 37.5 18.7 ± 36.8 24.1 ± 38.8
   Median 42.9 44.3 46.9 25.7 20.6 32.7
   Range -40.0–87.5 -40.0–72.2 -40.0–87.5 -62.5–87.5 -62.5–72.2 -62.5–87.5
CRP (n = 28) (n = 14) (n = 23) (n = 35) (n = 17) (n = 29)
   Improvement > 50% 14/28 (50.0%) 7/14 (50.0%) 12/23 (52.2%) 19/35 (54.3%) 9/17 (52.9%) 16/29 (55.2%)
   25% < improvement ≤ 50% 3/28 (10.7%) 1/14 (7.1%) 2/23 (8.7%) 4/35 (11.4%) 2/17 (11.8%) 3/29 (10.3%)
   0% ≤ improvement ≤ 25% 5/28 (17.9%) 1/14 (7.1%) 3/23 (13.0%) 5/35 (14.3%) 1/17 (5.9%) 3/29 (10.3%)
   Stability 3/28 (11%) 3/14 (21%) 3/23 (13%) 3/35 (9%) 3/17 (18%) 3/29 (10%)
   Deterioration 3/28 (11%) 2/14 (14%) 3/23 (13%) 4/35 (11%) 2/17 (12%) 4/29 (14%)
DAS28 (n = 24) (n = 13) (n = 20) (n = 34) (n = 18) (n = 28)
   Mean ± SD 4.6 ± 1.3 5.1 ± 1.2 4.6 ± 1.4 4.8 ± 1.5 5.2 ± 1.1 4.8 ± 1.5
   ΔDAS28 2.0 1.8 2.1 1.7 1.7 1.8
   Range 0.5–7.0 3.3–7.0 0.5–7.0 0.5–7.0 3.3–7.0 0.5–7.0
   DAS28 < 2.6 1/24 (4.2%) 0/28 (0%) 1/20 (5.0%) 2/34 (5.9%) 0/18 (0%) 2/28 (7.1%)
   DAS28 ≤ 3.2 1/24 (4.2%) 0/28 (0%) 1/20 (5.0%) 2/34 (5.9%) 0/18 (0%) 2/28 (7.1%)
  1. aPrimary efficacy outcome. American College of Rheumatology (ACR) results are presented as the cumulative number of patients reaching each ACR level. Population sizes could vary with respect to an efficacy endpoint due to the fact that, for some patients, all efficacy data under treatment were missing (no data imputation was possible in this case). ACR20/50/70, American College of Rheumatology 20%/50%/70% improvement criteria; ACRn, index of improvement in rheumatoid arthritis; anti-TNFα, anti-tumour necrosis factor-alpha; CRP, C-reactive protein; DAS28, disease activity score using 28 joint counts; ΔDAS28, the change in disease activity score using 28 joint counts from baseline; ITT, intention-to-treat; LOCF, last observation carried forward; MTX, methotrexate; OC, observed case; PP, per protocol population; SD, standard deviation.