Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.

Early Treatment with Rituximab (RTX) in Newly Diagnosed Systemic Lupus Erythematosus (SLE) Patients: A Steroid Sparing Regimen.

Ezeonyeji2,  Amara N., Isenberg1,  David A.

UCL Div of Medicine, Room 331, 3rd Floor, London, United Kingdom
University College London Hospital NHS Trust, London, United Kingdom


The efficacy of a RTX as induction therapy enabling long-term steroid therapy reduction or withdrawal has recently been reported in patients with lupus nephritis by Pepper et al.1 We describe a RTX/Azathiaprine (AZA) based steroid sparing regimen given in 9 newly diagnosed mostly non-renal patients with SLE.

Patients and Methods:

Nine female patients fulfilling at least 4 of the revised ACR criteria for the diagnosis of SLE were treated. Mean age at time of B cell depletion therapy was 39 years, Mean duration of symptoms prior to treatment was 16.5 months (range 4–96). Eight were treated with two intra-venous (iv) infusions of RTX (1000mg) and methylprednsiolone (2 × 100mg) and one iv 750mg infusion of cyclophosphamide (CYC). One patient received 375mg/m2 equivalence RTX over 3 weeks with CYC. Post treatment all patients received AZA and any steroid treatment rapidly weaned [table 1]. The British Isles Lupus Assessment Group (BILAG) disease activity index was used for both individual organ system assessment and as a global index. The patients full blood count, serum creatinine (Cr), serum C3, immunoglobulin G (IgG), erythrocyte sedimentation rate (ESR), anti-dsDNA and circulating B lymphocytes (CD19+) count were tested at baseline, 1, 3, 6 and 12 months post treatment.

Table 1. Patient characteristics: prednisolone; pred, weeks; wks

PatientDisease manifestation at baselineTherapy pre-RTXTherapy post-RTX
1Headache, rash, pleurisy, proteinuriaPred 30 mg ¯ over 8 weeks for flarePred 40 mg ¯ over 4 wks
2Rash, lymphadenopathy, angioedema, fevers, [uarr] anti-dsDNA, lymphopenia, ¯ C3Depomedrone 120mg i.m.Pred 20mg ¯ over 8 wks at 2 months for flare
3Rash, headache, alopecia, aicca symptoms, ¯ C3, lymphopenia,NoneNone
4*Rash, headache, thrombocytopenia, anaemia, proteinuria [uarr] anti-dsDNA, lymphopenia, ¯ C3AZA (stopped) & Pred 2.5 mg Pred 30mg ¯ over 2 wks for thrombocytopeniaPred 60mg ¯ over 8 wks
5Rash, livido reticularis, serositis, oral ulcers, proteinuria, [uarr] anti-dsDNA, lymphopenia, ¯ C3.Pred 40mg statPred 40mg ¯ over 12 wks AZA
6Polyarthritis, [uarr] anti-dsDNA, lymphopenia, ¯ C3Pred 7.5mg for 2 wksAZA
7Skin rash, raynauds, alopecia, pleurisy, [uarr] anti-dsDNA, lymphopenia.Pred 7.5mg for 12 wksAZA
8Rash, alopecia, raynands, arthralgia, ¯ C3NoneAZA
9Polyarthritis, [uarr] anti-dsDNA, lymphopeniaAZA for colitisAZA


All patients achieved B cell depletion (CD 19 < 0.005 ×109/l. at 1 month). Patient 3 re-populated at 6 months but did not flare. The mean BILAG global score fell from 12.1 (SD 8.6) (n=9) at baseline to 7.4 (SD 4.7) (n=7) at 1 month, 3.9 (SD 2.3) (n=7) at 3 months, 3.5(SD 1.3) (n=4) at 6 months, and 1.5 (SD 0.7) (n=2) at 1 year. Patients 7 achieved improvement of BILAG grades A®D for mucocutaneous manifestations by 3 months and patient 2 and 8 by one year although patient 2 had a musculoskeletal flare at 2 months requiring steroid treatment. No patient developed any major sustained deterioration i.e. new A or D®B scores. Manifestations such as rash, arthritis, fever, thrombocytopenia and pleurisy responded well. Mean ESR fell from 76 to 32.9 at 1 month (n=9). Anti-dsDNA antibody levels fell by >50% in 3 patients. Serum C3 level did not change significantly except for patient 7 where it rose from 0.4 to 1.04 (NR 0.8 to 1.8g/l) by 3 months. Cr was stable throughout. In patient 1 and 5, urine protein: creatinine ratio (PCR) was stable at 6 and 3 months respectively although patient 5 required a renal biopsy as the PCR was 236 mg/mmol at 3 months. PCR fell from 104 to 15 mg/mmol by 1 month in patient 4. Mean total serum IgG fell modestly from 20.3 to 13.8 g/l.

Adverse Events:

Treatment was safe and well tolerated. There were no adverse events on follow up.


A RTX/AZA protocol as a steroid sparing regimen is safe and effective in newly diagnosed patients with SLE.


(1)Pepper, R, et al Nephrol Dial Transplant. 2009 12:3717–23.

To cite this abstract, please use the following information:
Ezeonyeji, Amara N., Isenberg, David A.; Early Treatment with Rituximab (RTX) in Newly Diagnosed Systemic Lupus Erythematosus (SLE) Patients: A Steroid Sparing Regimen. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1153
DOI: 10.1002/art.28919

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