Does experience with rituximab treatment of rheumatoid arthritis (RA) in daily clinical practice confirm the results of controlled randomized studies?
This is a retrospective data-analysis of the first 50 patients from one center with rituximab treatment for RA. The patients received at least one cycle of 2 rituximab infusions (1000 mg, respectively) within 2 weeks. Clinical assessment was performed 3-5 months after the first infusion.
The patients were older (mean age, 59 years) as compared to previously published controlled studies. The DAS28 was lower (5.5). The mean prednisolone dose was high (13.4 mg/d). The rheumatoid factor was positive in 88% of patients. Only six patients would have fulfilled inclusion criteria for controlled studies such as prednisolone dose <or=10 mg/d, concomitant methotrexate treatment, previous TNF-inhibitor treatment, or absence of malignancy. Nevertheless, indications were compatible with recently published German Rheumatology Society recommendations on rituximab treatment. A total of 62% of patients achieved EULAR response, 20% good response and 10% remission. Response was greater in patients with concomitant methotrexate treatment (88% versus 53%). The results were independent of sex, presence of anti-CCP antibodies, ANA, and previous TNF-inhibitor treatment. Only three patients had pathologic infusion reactions at the first infusion and one patient at the second infusion.
Rituximab proved to be effective, particularly when combined with methotrexate. Most patients differed considerably from those who had entered randomized controlled studies. Recently published German Rheumatology Society recommendations proved to be feasible as they reflect daily clinical practice. Results of controlled studies could be confirmed.