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 1 Baseline Characteristics of the Patients in the two groups

	Rituximab Group (n = 20)	Leflunomide Group (n = 19)	P value
Mean Age in Years(+/−SD)	44.15(±12)	48.2(±10)	0.318
Female sex(%)	16(80%)	18(95%)	0.169^a
Mean Disease duration in months(+/−SD)	67.9 (±80)	102.8 (±63)	0.034
Mean number of swollen joints (+/−SD)	9.35(±4)	7.58(±4)	0.074
Disease activity Score (DAS) (+/−SD)	6.88(±1)	6.43(±0.5)	0.067
Mean methotrexate dose in mg	17	16	0.67
Prednisolone dose	8.0 mg	7.76 mg	0.730
Patients who were on sulphasalazine and or hydroxychroloquine	20	19	NT
Patients with erosions on plain X Ray	4 (20%)	5 (26%)	0.640
HAQ score	8.23 (±3.36)	8.07 (± 3.37)	0.843
Tender joint count	16.35(± 6.31)	12.89(5.62)	0.955
Pain score (out of 100)	68.50 (±22.64)	72.53 (±15.70)	0.723
Patient assessment score (out of 100)	67.4 (±19.02)	64.37 (± 15.18)	0.743
Physician assessment score (out of 100)	68.85(±16.96)	64.05 (± 15.09)	0.3539
ESR*	71.90 (±36.41)	62.05 (±28.92)	0.473
CRP**	30 (0-600)	18 (0-140)	0.20
RF***	256 (0-1024)	128 (0-512)	0.524

n number of patients, SD Standard Deviation, RF Rheumatoid Factor, NA Not applicable. P values for difference between means were compared using Mann Whitney U test ^aFor comparison of gender, Chi-square test was used for categorical variable. *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. NT- Not tested (significance cannot be tested since one value is 100%)

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