Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.

Biologics use in SLE in 23 Centers - Data from the International Registry for Biologics In SLE (IRBIS).

van Vollenhoven1,  R.F., Jacobsen2,  Søren, Wallace3,  Daniel, Hanly4,  John G., Petri5,  Michelle, Isenberg6,  David A., Bernatsky7,  Sasha

Karolinska University Hospital, Stockholm, Sweden
Hospital de Cruces, Bizkaia, Spain
Hospital Virgen del Rocío, Sevilla, Spain
Hospital Miguel Servet, Zaragoza, Spain
Hospital San Cecilio, Granada, Spain
Hospital Son Dureta, Palma de Mallorca, Spain
Hospital Carlos Haya, Málaga, Spain
Karolinska Institutet, Stockholm, Sweden
Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey
Northwestern University Feinberg School of Medicine, Chicago, IL
Univ of Manitoba, Winnipeg, MB
Rigshospitalet - 4242, Copenhagen, Denmark
Careggi Hospital- Florence, Florence, Italy
University of Szeged, Szeged, Hungary
University of Padova, Padova, Italy
University of Debrecen Medical and Health Sciences Center, Debrecen, Hungary
Rheumatology Unit, Catholic University, Roma, Italy
Escola Paulista de Medicina - Universidade Federal de São Paulo, Sao Paulo, Brazil
Cedars-Sinai/UCLA, Los Angeles, CA
Dalhousie University and Capital Health, Halifax, NS
Johns Hopkins Hospital, Baltimore, MD
University College London, London WC1E 6JF, United Kingdom
McGill UHC/RVH, Montreal, QC
Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea
Hospital Clínic, Barcelona, Spain


Only one biologic agent has been approved for use in SLE, but some are used off-label in various settings. In order to obtain information systematically regarding this, members of the SLICC group initiated the International Registry for Biologics in SLE (IRBIS). The objective of this study was to analyse the use of biologics in SLE, and assess results achieved with the most commonly used off-label biologic, rituximab (RTX).


IRBIS investigators were asked to provide retrospective data on all patients treated with a biologic for SLE at their center. Standardized case report forms were used to collect demographic, disease-specific and treatment data at the time of biologic initiation and at yearly follow-up. Data from the first 23 reporting centers are presented.


359 patients were treated off-label with RTX, and additional groups of patients were exposed to belimumab (n=44, trial-extension), epratuzumab (n=21, trial-extension), abatacept (n=4), etanercept (n=3) and adalimumab (n=1). For the RTX treated group, age (mean±SD) was 41.3±13.3 and 91% were female. The majority (76 %) were Caucasian, and smaller proportions were Southeast Asian, Asian/Indian, African-American, Latino, Afro-Caribbean or other (each <10%). Disease duration when RTX was initiated was 9.2±7.8 years. SLEDAI at start was 11.3±7.6, SLICC-damage index 1.4±1.5 and glucocorticoid dosage 17.0±15.2 mg. At baseline, concomitant glucocorticoids were used in 91% of the patients compared to 75% at follow-up. Previous treatments (n=300) include cyclophosphamide (n=144), mycophenolate mofetil (n=117), azathioprine (n=114), methotrexate (n=56) and other immunosuppressives (ISs, n=76). Most patients (78%) had been treated with one or two different ISs prior to RTX, 20% had been treated with three ISs and the remaining 2% with four or five ISs. Two different dosing regimens for RTX were used: 375 mg/m2 × 4 (52%) and 1000 mg × 2 (48%). Concomitant cyclophosphamide was used in 39% of patients. The major organ manifestations leading to RTX treatment were lupus nephritis (LN, 48%), hematological (21%), musculoskeletal (9%), skin disease (9%), CNS (4%) and other (9%). Disease-control (n=84%) and disease-control plus steroid-sparing (16%) were given as reasons for choosing a biologic. At 1-year follow-up (n=123, 1 year ±3.5 months) both SLEDAI and GC dose had decreased to 4.2±3.5 (n=106) and 7.9±7.0 mg (n=89), respectively (paired samples, p<0.0001 for both comparisons). Exclusion of patients started on additional immunosuppressives (n=24) did not change SLEDAI or GC dose significantly. SLEDAI at baseline was higher in LN than in non-LN patients but similar at follow-up. Overall, 1000 mg × 2 was used more often but both dosing regimens appeared equally effective in LN.


Rituximab was the off-label biologic used most commonly in this multi-center international lupus cohort and was used for LN as well as for a range of other SLE manifestations. At one-year follow-up both lupus activity and concomitant glucocorticoid dosage had decreased even when no other immunosuppressive treatments had been introduced. The two RTX dosing regimes appeared equally effective for LN treatment.

To cite this abstract, please use the following information:
van Vollenhoven, R.F., Jacobsen, Søren, Wallace, Daniel, Hanly, John G., Petri, Michelle, Isenberg, David A., et al; Biologics use in SLE in 23 Centers - Data from the International Registry for Biologics In SLE (IRBIS). [abstract]. Arthritis Rheum 2011;63 Suppl 10 :609

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