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AB0511 Rituximab in rheumatoid arthritis – interim analysis of the non-interventional bridging study
  1. A. Krause1,
  2. P.M. Aries2,
  3. H.-M. Lorenz3,
  4. U. Müller-Ladner4,
  5. J. Kandenwein5,
  6. J. Wendler6
  1. 1Abteilung Rheumatologie und Klinische Immunologie, Klinik für Innere Medizin Berlin Buch, Berlin
  2. 2Rheumatologische Schwerpunktpraxis, Hamburg
  3. 3Rheumatologie, Medizinische Universitätklinik, Heidelberg
  4. 4Department of Rheumatology and Clinical Immunology, Kerckhoff Clinic, Bad Nauheim
  5. 5Roche Pharma AG, Grenzach-Wyhlen
  6. 6Rheumatologische Schwerpunktpraxis, Erlangen, Germany

Abstract

Objectives 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 a prospective, non-interventional study with a duration of observation of 6 months for each patient and in case of retherapy 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 Up to now baseline data of 765 patients are available. 73.2% of the patients are female, 40.3% smoker or ex-smoker. 60.3% had positive anti-CCP antibodies and 73.5% positive rheumatoid factors (RF). The mean age was 60.6 years, the mean baseline DAS28 was 5.3. Patients suffered from RA since 12.9 years in mean. 67.7% of the patients received a pretreatment with DMARD+TNFi, another 6.3% received other biologics. 24.7% received only DMARDs and 1.2% only TNFi. In case of TNFi pretreatment, 54.8% of the patients received one, 34.1% two, 10.2% three and 0.9% four pretreatments.

In 328 of the 765 patients with active RA (DAS28>3.2 at baseline) a duration of observation of at least 24 weeks was documented. 286 of these patients were seropositive, 29 seronegative (13 no data). All 328 patients received the first RTX infusion, 323 patients also the second. The dosage was 1000 mg in 97.3% and 97.8% of the patients, respectively. The scores for pain intensity, HAQ and DAS 28 are shown in Table 1 for RF-positive and RF-negative patients. The mean improvement of DAS 28 after 24 weeks was -1.7, even in patients with high BMI (25 kg/m2 or higher). At week 24, the DAS28 was available for 181 patients: LDA (low disease activity) was achieved in 29.3%, remission in 17.7%; a moderate EULAR response was achieved in 50.3% and a good in 25.4% of the patients. In total, 355 AEs were reported in 183 of the 765 patients incl. 40 serious adverse drug reactions.

Table 1. Mean pain intensity (VAS patient), HAQ and DAS28 (BSG) scores

Conclusions Following RTX therapy, improvements of all activity parameters beginning at week 6 with a peak after 18 weeks could be shown in intensively pretreated patients suffering from severe RA. The safety results corresponded to expectations. The study confirms the significant benefit of RA therapy with RTX in daily clinical practice.

Disclosure of Interest A. Krause Consultant for: Roche Pharma, Speakers Bureau: Roche Pharma, P. Aries Consultant for: Roche Pharma, Speakers Bureau: Roche Pharma, H.-M. Lorenz Consultant for: Roche Pharma, Speakers Bureau: Roche Pharma, U. Müller-Ladner Consultant for: Roche Pharma, Speakers Bureau: Roche Pharma, J. Kandenwein Employee of: Roche Pharma, J. Wendler Consultant for: Roche Pharma, Speakers Bureau: Roche Pharma

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