What is the success rate of Rituxan (rituximab) in rheumatoid arthritis?
Rituxan (rituximab) is a monoclonal antibody, which works by targeting the CD20 protein antigen displayed on the surface of B-cells. It is used in the treatment of rheumatoid arthritis and also for a number of other conditions including non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GAP) and moderate to severe pemphigus.
Rituxan is used in combination with methotrexate in adults with moderately-to-severely-active rheumatoid arthritis who have inadequate response to one or more TNF (tumor necrosis factor) antagonist therapies.
Results from clinical trials show that treatment with Rituxan successfully improves patient outcomes including reducing symptoms, levels of fatigue and disability, and increasing health-related quality of life. It also slows the progression of structural damage in joints.
Rituxan plus methotrexate is better than methotrexate alone at improving symptoms
In clinical trials the ACR (American College of Rheumatology) response criteria measures how much a patient’s symptoms have improved between two set points in time. ACR20, ACR50 and ACR70 are commonly reported. Patients achieving ACR20, ACR50 and ACR70 show a ≥20%, ≥50% and ≥70% improvement in symptoms between the two set time points, respectively. The ACR criteria looks at the number of swollen and tender joints a patient has, c-reactive protein levels, erythrocyte sedimentation rates and other measures of pain, disability and disease activity.
Results from the phase III REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial, showed that significantly more patients treated with Rituxan and methotrexate achieved ACR20 (51% vs 18%), ACR50 (27% va 5%) and ACR70 (12% vs 1%) compared with patients treated with placebo and methotrexate after 24 weeks of treatment (p<0.0001). Patients enrolled in the trial had active, longstanding rheumatoid arthritis and had had an inadequate response to treatment with an anti-TNF agent.
European League against Rheumatism (EULAR) response criteria also showed 65% of patients who received Rituxan plus methotrexate achieved a moderate-to-good EULAR response compared with 22% of patients who received placebo plus methotrexate (p<0.0001).
A separate phase III trial called SUNRISE, in which patients received a second course (re-treatment) of Rituxan, also showed Rituxan plus methotrexate to be better than placebo plus methotrexate.
Fatigue, disability and health-related quality of life improved by Rituxan treatment
The REFLEX trial also measured how effective Rituxan is using FACIT-F, HAQ DI and SF-36 scores. Results showed that treatment with Rituxan plus methotrexate was better than placebo plus methotrexate when it came to improving fatigue, disability and health-related quality of life.
Rituxan plus methotrexate helps to slow the progression of structural damage in joints
An extension of the REFLEX trial has also shown that treatment with Rituxan helps to reduce the progression of structural damage in joints in patients with rheumatoid arthritis.
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