Background The BRIDGING study collects clinical routine data on the efficacy and safety of rituximab (RTX) in patients suffering from severe active rheumatoid arthritis (RA).
Methods BRIDGING is an ongoing German prospective, non-interventional study with a duration of observation of 6 months for each patient and – in case of re-therapy – for another 6 months. Data to be recorded are treatment data, 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 As yet baseline data of 1327 patients are available. 72.5% of the patients are female, 40.2% smokers or ex-smokers. 57.2% had positive anti-CCP and 70.1% positive rheumatoid factors. The mean age was 60.1 years, the mean baseline DAS28 was 5.3. 68.9% received pre-treatment with DMARD+TNF, another 6.4% other medications in addition, 23.7% received only DMARDs and 0.8% only TNFi.
In 757 of the 1327 patients with active RA (DAS28>3.2 at baseline) a duration of observation of at least 24 weeks was documented. 635 of these patients were seropositive, 66 seronegative (56 no data). Non-smokers had a lower rate of positive anti-CCP (57.3%) than smokers (68.0%) and ex-smokers (65.2%). All 757 patients received the first RTX infusion, 693 patients also the second; the dosage was 1000 mg in 97.8% and 97.7% of patients, resp. The scores for pain intensity, HAQ and DAS 28 are shown in Table 1 for seropositive and seronegative patients. Mean improvement of DAS 28 after 24 weeks was 1.7.
DAS 28 improvement was not dependent on pre-treatment and not affected by tuberculosis, solid tumors or lymphoma as concomitant diseases or by smoking. At week 24 the DAS28 was available in 384 patients: LDA (low disease activity) was reached in 29.7%, remission in 16.4%; moderate and good EULAR response was achieved in 47.7% and 26.8% of patients, resp. In total, 948 AEs were reported in 394 of the 1327 patients incl. 89 serious RTX adverse drug reactions (ADRs). Among these were 19 serious infectious ADRs, representing a rate of 4.2 per 100 patient years. There was no case of newly acquired tuberculosis. One patient died during the observational period.
Conclusions Following RTX therapy, improvements of all activity parameters could be shown in extensively pre-treated patients suffering from severe RA. Safety results correspond with the known safety profile of RTX. The study confirms the benefit of RA patients from RTX therapy in daily clinical practice.
Disclosure of Interest: A. Krause Consultant for: Roche, P.-M. Aries Consultant for: Roche, H.-M. Lorenz Consultant for: Roche, U. Müller-Ladner Consultant for: Roche, G. Neeck: None Declared, H. Rusch Employee of: Roche Pharma AG, J. Wendler Consultant for: Roche