MabThera® provides lasting treatment success to patients with RA
MabThera® - the first and only selective B cell therapy - provides patients with a real option to tackle the signs and symptoms of rheumatoid arthritis (RA), a severely debilitating disease.
Results from the pivotal Phase III REFLEX (Randomized Evaluation oF Long-term Efficacy of rituXimab in RA) trial showed that a greater proportion of patients with long-standing RA who received MabThera (rituximab) in combination with methotrexate (MTX) achieved a significant improvement in disease symptoms (American College of Rheumatology [ACR] 20) after 24 weeks, compared with placebo (51% of patients vs. 18% with placebo plus MTX).1 In all of the ACR core parameters measured to achieve the overall ACR20 response (including swollen and tender joint counts, as well as a number of different patient and physician assessments), the responses were consistently and significantly greater for patients receiving MabThera.
New evidence presented at EULAR 2006, showed for the first time that MabThera is able to significantly inhibit structural damage of joints caused by RA. X-ray evidence at 56 weeks showed that the progression of bone erosions and progression of narrowing of joint spaces in patients in the MabThera group were reduced by more than 50 % compared to patients receiving MTX alone (erosion scores of 0.59 and 1.32 respectively; joint space narrowing scores of 0.41 and 0.99 respectively and total Genant-modified Sharp scores of 1 and 2.31 respectively).2
Furthermore, treatment with MabThera in combination with MTX led to statistically significant improvements in patient reported outcomes (PROs) compared with MTX alone.2 In the REFLEX study, patients receiving MabThera reported significant reductions in pain and improvements in fatigue, disability and health-related quality of life. The results show that symptomatic improvements with MabThera are mirrored by improved patient outcomes.
REFLEX is a Phase III study evaluating the efficacy and safety of MabThera in combination with MTX in patients with long-standing and severe disease who had an inadequate response to, or were intolerant to, prior treatment with disease-modifying anti-rheumatic drugs (DMARDs), including one or more tumour necrosis factor (TNF) inhibitors.
For further details of the REFLEX data, please follow the link to the ACR and EULAR meeting eHighlight reports.
References
1. Cohen SB, Greenwald M, Dougados MR, et al. Efficacy and safety of rituximab in active RA patients who experienced an inadequate response to one or more anti-TNF alpha therapies (REFLEX study). Arthritis Rheum 2005;52 (9Suppl.):S677 (Abstract 1830).
2. Keystone EC, Burmester GR, Furie R, et al. Improved quality of life with rituximab plus methotrexate in patients with active rheumatoid arthritis who experienced inadequate response to one or more anti-TNF alpha therapies. Arthritis Rheum 2005;52 (9Suppl):S141 (Abstract 287).