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AB0619 Safety of rapid rituximab infusion in systemic autoimmune diseases
  1. E. Nikolaeva1,
  2. S. Soloviev2,
  3. E. Nasonov3
  1. 1Intensive Care Unite
  2. 2Laboratory of Intensive therapy of rheumatologic diseases
  3. 3Federal State Budgetary Institution ”Research Institute of Rheumatology” of Russian Academy of Medical Sciences, Moscow, Russian Federation

Abstract

Background The use of Rituximab in vasculitis, systemic lupus erythematosus and some other systemic autoimmune diseases reduces activity of process. It also demonstrated the low rate of disease progression. The standard administration protocol for Rituximab takes 195-225 minutes. It complicates the work of medical personnel especially in patients with physical restrictions, joint contractures,skin lesions and with other problems. Oncology studies have shown that accelerate protocols of Rituximab infusion are safe, well tolerated and do not increase the risk of hypersensitivity reactions or infusion toxicity.

Methods We compared two infusion protocols: standard and 90-minute. From April till October, 2011 46 infusions had been done for patientswith severe process and high activity of systemic autoimmune diseases (30 - rheumatoid arthritis (RA), 5 - systemic lupus erythematosus (SLE), 4 - systemic scleroderma (SS), 2 - Sjogren’s disease,1 - Churg-Strausse syndrome, 3 - cryoglobulinemic vasculitis, 1 - Wegener’s granulomatosis) in a rapid protocol. The age of patients was 17–74 years. There were 40 women and 6 men.42 of them had a heavy concurrent diseases (9 - ischemic heart disease, 17 - arterial hypertension, 12 - arrhythmias, 3 - pulmonary hypertension, 6 - virus hepatitis, 2 - diabetis, 2 - gastric ulcer in anamnesis, 5 - anemia, 2 - cancer in anamnesis, 2 - amiloidosis, 2 - heart failure, 1 - respiratory failure). In all 45 patients the resources for therapy without Rituximab were exhausted.

Patients were premedicated with only 20 mg chloropyramine im (4 patients) or with100 to 500mg iv corticosteroids (44 patients).500 mg Rituximab was dissolved in 500 ml normal saline. The first infusion was performed in compliance with the recommended standard infusion protocol. No complications were observed. Next (2-6) infusions were performed within the period of 90 minutes.

Results We have registered 2 mild infusion reactions during the infusion (urticaria and difficulty of breath). Both reactions resolved after treatment with 8 mg iv dexamethasone. These two infusions were finished as per the standard protocol.Also within 24 hours after infusion we observed the following reactions: sore throat (1), headache (2), mild arterial hypertension (2), sleep disorder (1), agitation(1). All reaction were in RA-group. Fluctuations of blood pressure during infusion was ±10.2/6.3 mm Hg. 2 patients developed infections (upper respiratory tract infection) within 7 days. We have not get any significant correlation between possibility of adverse reactions development and corticosteroid premedication dose. B-cells depletion has developed for 3 days (mean) to the level of 0,1(mean) at SS and SLE.

Conclusions Based on the positive findings of this pilot study, we can resume that rapid Rituximab infusion are safe, well tolerated and can be routinely used in rheumatology practice. Now we have got the experience almost 80 rapid protocols infusions in our hospital.

No relevant financial disclosures.

Disclosure of Interest None Declared

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