Background Clinical routine data on the efficacy and safety of rituximab (RTX) in patients suffering from severe active rheumatoid arthritis (RA) are assessed in the German BRIDGING study.
Methods BRIDGING is an ongoing prospective, non-interventional study observing RTX treatment for 6 months. The study collects treatment data and relevant data on the course of RA such as activity scores, pain intensity and adverse events (AE). In total, the documentation of 1,600 patients is intended.
Results After 4 years of study conduct, baseline data of 1622 patients with a mean age of 60.4 years are available. 72.4% are female, 40.3% smokers or ex-smokers. The mean baseline DAS28 was 5.3. 67.6% received pre-treatment with DMARD+TNFi, another 7.0% other medications in addition, 24.1% received DMARDs only and 0.8% only TNFi as pre-treatment. 96.7% of the patients took concomitant medications, mostly corticosteroids (86.2% systemic, 82.3% topical) and antiinfectives (84.1%).
996 of the 1622 patients had active RA (DAS28>3.2 at baseline) and a documented duration of observation of at least 24 weeks. The majority of these 996 patients were seropositive (861; 102 were seronegative; 33 no data). Non-smokers had a lower rate of positive anti-CCP (61.3%) than smokers (71.4%) and ex-smokers (68.3%). All 996 patients received the first RTX infusion, 910 patients also the second. Most patients (96.7%) received 1000 mg RTX per infusion.
The scores for pain intensity, HAQ, and DAS28 are shown in Table 1. The DAS28 values at week 24 were available for 461 patients. Mean improvement of DAS28 after 24 weeks was 1.6. LDA (low disease activity) was reached in 30.4%, remission in 16.7%. Moderate and good EULAR response was achieved in 46.6% and 27.3% of patients, resp. DAS28 improvement was neither dependent on pre-treatment, overweight or smoking, nor was it affected by tuberculosis, solid tumors or lymphoma as concomitant diseases.
In total, 1342 AEs were reported in 541 of the 1622 patients incl. 112 serious RTX adverse drug reactions (ADRs). Among these were 22 serious infectious ADRs, representing a rate of 4.0 per 100 patient years. There was no case of newly acquired tuberculosis. Since start of the study in 2010, 8 of the 1622 patients have died, thereof 2 patients ≥1 year after the end of their observation period.
Conclusions Showing improvements of all RA activity parameters in extensively pre-treated patients, the daily clinical practice data of the BRIDGING study confirm the benefit of RTX treatment in patients with severe RA. The safety results correspond with the known safety profile of RTX.
Disclosure of Interest A. Krause Consultant for: Roche Pharma AG, P.-M. Aries Consultant for: Roche Pharma AG, H.-M. Lorenz Consultant for: Roche Pharma AG, U. Mueller-Ladner Consultant for: Roche Pharma AG, G. Neeck: None declared, H. Rusch Employee of: Roche Pharma AG, J. Wendler Consultant for: Roche Pharma AG