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

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

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

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

ISSN: 1471-2474