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The standard dose of rituximab which is generally used in rheumatoid arthritis (RA) is 1000 mg but recent studies have shown that a low dose i. e. 500 mg of rituximab is also effective.
Leflunomide, an FDA
approved DMARD which helps to inhibit T-cell proliferation among patients with
active rheumatoid arthritis. A randomised, double-blind controlled clinical
trial was conducted which reflects leflunomide efficacy and safety and was as
efficacious as rituximab which is a former RA treatment drug.
The standard dose of
rituximab which is generally used in rheumatoid arthritis (RA) is 1000 mg but
recent studies have shown that a low dose i. e. 500 mg of rituximab is also
effective. Efficacy of low dose rituximab in rheumatoid arthritis (RA)
refractory to first-line non-biologic Disease Modifying Anti Rheumatic Drugs
(DMARDs), compared to leflunomide was unknown. In a tertiary care referral
setting, a randomised, double-blind controlled clinical trial was conducted to
compare the safety andefficacy of low-dose rituximab-methotrexate combination
with the leflunomide-methotrexate combination.
Patients on 10-20 mg/week
methotrexate with a Disease Activity Score (DAS) > 3.2 were randomly
allocated to rituximab 500 mg on days 1 and 15 or leflunomide 10-20 mg/day. The
primary end-point for the study was ACR20 response at 24 weeks. The sample of
40 had 70% power to detect a 30% difference. ACR50, ACR70, DAS, EULAR good
response, CD3 + (T cell), CD19 + CD27+ (memory B cell) and CD19 + (B cell)
counts, pneumococcal and tetanus antibody levels were secondary endpoints.
Baseline characteristics
were comparable in the both groups. At week 24, ACR20 was 85% vs 84% with p =
0.93, ACR50 was 60% vs. 64% with p = 0.79 and ACR70 was 35% vs 32% with P =
0.84, in rituximab and in leflunomide groups respectively. Serious adverse
events were similar. With rituximab there was significant reduction in B cells
(p < 0.001), memory B cells (p < 0.001) and pneumococcal antibody levels
(P < 0.05) without significant changes in T cells (p = 0.835) and tetanus
antibody levels (p = 0.424) at 24 weeks. With leflunomide, significant
reduction in memory B cells (p < 0.01) and pneumococcal antibody levels (p
< 0.01) occurred without significant changes in B cells (P > 0.05), T
cells (P > 0.05) or tetanus antibody levels (P > 0.05).
The combination of
Leflunomide-methotrexate is as efficacious as the low-dose
rituximab-methotrexate combination at 24 weeks, in RA patient's refractory to
initial DMARDs. The high responses seen in both groups have favourable cost
implications for patients in developing countries. Changes in immune parameters
with leflunomide are novel and need further characterisation.
BMC Musculoskelet Disord. 2017 Jul 19;18(1):310.
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.
Wijesinghe H et al.
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