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Table 2 Clinical Responses at Weeks 24 and mean DAS at baseline

From: Leflunomide is equally efficacious and safe compared to low dose rituximab in refractory rheumatoid arthritis given in combination with methotrexate: results from a randomized double blind controlled clinical trial

ACR Response Rituximab Group (n = 20) Leflunomide Group(n = 19) P value
No ACR response 3 (15%) 3 (16%) 0.93
ACR 20 17 (85%) 16(84%) 0.93
ACR 50 12 (60%) 12 (64%) 0.79
ACR 70 7 (35%) 6(32%) 0.84
Mean DAS at base line 6.88 (±0.93)a 6.43(±0.46)b .067*
Mean DAS at 24 weeks 3.26 (±0.74)a 3.25 (±1.02)b 0.84*
DAS remission <2.6 4 (20%) 5 (26%) 0.640
DAS low activity <3.2 8 (40%) 8 (42%) 0.894
DAS Moderate activity(3.2-5.1) 12 (60%) 11 (58%) 0.894
DAS High activity (>5.1) 0 (0%) 0 (0%) NT
EULAR response moderate 12 (60%) 11(58%) 0.894
EULAR good response 8 (40%) 8 (42%) 0.894
HAQ score 2.872 (±2.087) 2.132 (±1.240) 0.388
Tender joint count 1.80 (± 2.26) 1.16 (1.74) 0.564
Pain score 23.70 (±22.64) 22.7 (±18.20) 0.499
Physician global assessment score 11.75 (±10.51) 15.74 (±17.62) 0.983
Patient global assessment score 20.25(±16.12) 20.0 (±15.81) 0.927
Anti-Pneumococcal antibody (units/ml) 132.05 (±81.3) 116.7 (±82.1) 0.429
Anti tetanus antibody 0.760 (±0.43) 0.842(±0.32) 0.7414#
CD3 1624.4 (±847.1) 1811.1 (±837.5) 0.50#
CD19 42.38 (±62.6) 209 (±164.6) 0.0002#
CD27 10.1 (±8.7) 49.38 (±37.9) 0.0061#
ESR* 28.05(±16.55) 30.42(±18.42) 0.535
CRP** 6 (0-84) 3(0-54) 0.7
RF*** 84(0- 372) 60 (0-720) 0.92
  1. ACR American College of Rheumatology, DAS Disease activity Scores, EULAR European League Against Rheumatism good response criteria, NT Not Tested. *ESR was measured in mm/h. **Assay cut off for CRP = 6 mg/L and tested using particle agglutination test, ***Assay cut off for RF = 20 IU/ml and tested using particle agglutination test. Anti tetanus antibody <0.01 IU/ml - Non protective, 0.01– 0.09 IU/ml - No reliable protection Anti pneumococcal anti body - Minimum accepted level 20 U/ml Binary outcomes were compared using chi-square test #Numeric outcomes were compared using Mann Witney U test aDAS at baseline and at 24 weeks in rituximab group, p < 0.001 based on paired t-test bDAS between baseline and at 24 weeks, in leflunomide group, p < 0.001 based on paired t-test