Changes in efficacy outcomes
| Variable patient cohort | LEF | SSZ | PL/PL-SSZ |
| ESR (mm/1st h) | (129, 76, 58) | (132, 74, 56) | (91, 37, 25) |
| 0–6 | 3-150 3-151−7.4 (23.2) | 3-150−16.6 (24.0) | 3.4 (24.8) |
| 0–12 | 3-151−12.4 (28.0) | −20.5 (23.3) | −19.8 (24.3) |
| 0–24 | −16.1 (27.3) | −15.0 (26.8) | −14.8 (22.6) |
| CRP (mg/l) | (130, 78, 57) | (130, 72, 54) | (90, 35, 23) |
| 0–6 | 3-150−23 (35) | 3-150−11 (29) | −20 (37) |
| 0–12 | −27 (39) | −16 (27) | −11 (32) |
| 0–24 | −27 (43) | −13 (30) | −11 (32) |
| RF (U/l) | (122, 72, 49) | (121, 67, 49) | (82, 36, 21) |
| 0–6 | 3-150−143 (378) | 3-150−152 (392) | 31 (221) |
| 0–12 | −168 (544) | −120 (328) | −107 (145) |
| 0–24 | −158 (297) | −200 (478) | −89 (186) |
| Morning stiffness (min) | (130, 78, 58) | (132, 74, 57) | (91, 36, 25) |
| 0–6 | 3-150−93 (250) | 3-150−42 (158) | −7 (172) |
| 0–12 | −133 (245) | −57 (106) | −70 (92) |
| 0–24 | −117 (123) | −67 (79) | −39 (70) |
| Pain (mm VAS) | (130, 77, 60) | (132, 74, 57) | (91, 35, 25) |
| 0–6 | 3-150−27.3 (29.7) | 3-150−19.8 (25.5) | −8.8 (29.9) |
| 0–12 | −35.5 (26.7) | −24.1 (29.3) | −28.7 (24.0) |
| 0–24 | −41.7 (27.5) | −26.6 (28.0) | −23.8 (27.9) |
| HAQ score | (116, 66, 51) | (113, 62, 45) | (81, 32, 21) |
| 0–6 | 3-150 3-151−0.50 (0.53) | 3-150−0.29 (0.46) | −0.04 (0.49) |
| 0–12 | −0.58 (0.52) | −0.41 (0.49) | −0.29 (0.43) |
| 0–24 | 3-151−0.65 (0.48) | −0.36 (0.53) | −0.20 (0.46) |
| Disability index | (116, 66, 51) | (113, 62, 45) | (81, 32, 21) |
| 0–6 | 3-150 3-151−0.66 (0.69) | 3-150−0.41 (0.65) | −0.09 (0.61) |
| 0–12 | −0.67 (0.55) | −0.53 (0.54) | −0.39 (0.56) |
| 0–24 | −0.89 (0.67) | −0.60 (0.72) | −0.30 (0.56) |
| Larsen score | (91, 61, 28) | (77, 52, 27) | (60, 23, 10) |
| 0–6 | 3-1500.01 (0.03) | 3-1500.01 (0.03) | 0.05 (0.09) |
| 0–12 | 0.02 (0.04) | 0.02 (0.04) | 0.06 (0.12) |
| 0–24 | −0.07 (0.33) | −0.03 (0.24) | −0.03 (0.23) |
ESR = erythrocyte sedimentation rate; CRP = C reactive protein; RF = rheumatoid factor; LEF = leflunomide; SSZ = sulfasalazine; PL = placebo; PL-SSZ = PL group switched to SSZ.
↵3-150 p<0.05 v placebo;
↵3-151 p<0.01v sulfasalazine; numbers in parentheses denote patients in 6, 12, and 24 month cohorts.
CRP baseline: 0–6 (LEF = 45, SSZ = 34, PL = 41), 0–12 (LEF = 45, SSZ = 31, PL-SSZ = 26), 0–24 (LEF = 45, SSZ = 32, PL-SSZ = 29).
ESR baseline: 0–6 (LEF = 55.7, SSZ = 50.5, PL = 52.3), 0–12 (LEF = 55.6, SSZ = 47.7, PL-SSZ = 50.0), 0–24 (LEF = 55.4, SSZ = 48.8, PL-SSZ = 48.3).
RF baseline: 0–6 (LEF = 352, SSZ = 378, PL = 321), 0–12 (LEF = 372, SSZ = 341, PL-SSZ = 282), 0–24 (LEF = 306, SSZ = 400, PL-SSZ = 297).
Morning stiffness baseline: 0–6 (LEF = 143, SSZ = 110, PL = 98), 0–12 (LEF = 172, SSZ = 101, PL-SSZ = 96), 0–24 (LEF = 145, SSZ = 100, PL-SSZ = 80).
Pain baseline: 0–6 (LEF = 63, SSZ = 55, PL = 59), 0–12 (LEF = 64, SSZ = 53, PL-SSZ = 58), 0–24 (LEF = 63, SSZ = 55, PL-SSZ = 55).
HAQ baseline: 0–6 (LEF = 1.14, SSZ = 0.98, PL = 1.09), 0–12 (LEF = 1.15, SSZ = 0.91, PL-SSZ = 0.89), 0–24 (LEF = 1.10, SSZ = 0.91, PL-SSZ = 0.82).
Disability index baseline: 0–6 (LEF = 1.89, SSZ = 1.70, PL = 1.82), 0–12 (LEF = 1.66, SSZ = 1.40, PL-SSZ = 1.38), 0–24 (LEF = 1.86, SSZ = 1.63, PL-SSZ = 1.50)
Larsen score baseline: 0–6 (LEF = 1.48, SSZ = 1.39, PL = 1.49), 0–12 (LEF = 1.39, SSZ = 1.41, PL-SSZ = 1.37), 0–24 (LEF = 1.43, SSZ = 1.39, PL-SSZ = 1.56).