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Abstract Number: 1607

Two Year Follow-Up On Biologics Use In 13 Centers- Data From The International Registry For Biologics In Systemic Lupus Erythematosus

Ronald F. van Vollenhoven1, Melinda Mild2, Søren Jacobsen3, S. Bernatsky4, Daniel J. Wallace5, Sang-Cheol Bae6, Manuel Ramos-Casals7, Francisco J. García-Hernández8, R. Ramsey-Goldman9, Andrea Doria10, Marta Mosca11, Michelle A. Petri12, M Ayala-Gutiérrez13, J.G. Hanley14 and for The SLICC group15, 1Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), the Karolinska Institute, Stockholm, Sweden, 2Department of medicine, Karolinska Institutet, Stockholm, Sweden, 3Department of Rheumatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, 4Divisions of Rheumatology and Clinical Epidemiology, McGill University Health Centre, Montreal, QC, Canada, 5Cedars-Sinai Medical Center, Los Angeles, CA, 6Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 7Laboratorio de Enfermedades Autoinmunes Josep Font, Hospital Clínic, Barcelona, Spain, 8Internal Medicine, Hospital Virgen del Rocío, Sevilla, Spain, 9Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, 10Rheumatology Unit - Department of Medicine, University of Padova, Padova, Italy, 11Rheumatology Unit, University of Pisa, Pisa, Italy, 12Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 13Unidad de Enfermedades Autoinmunes, Servicio de Medicina Interna, Hospital Carlos Haya, Malaga, Spain, 14Division of Rheumatology, Halifax, NS, Canada, 15Department of Medicine, the Karolinska Institute, Stockholm, Sweden

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Biologics, registries and rituximab, SLE

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Session Information

Session Title: Systemic Lupus Erythematosus - Clinical Aspects II: Central Nervous System Manifestations, Therapeutics

Session Type: Abstract Submissions (ACR)

Background/Purpose: Only one biologic agent has been approved for use in SLE, but some are used off-label in various settings. To obtain systematic information regarding this, members of the SLICC group initiated the International Registry for Biologics in SLE (IRBIS). The entire registry contains data from 28 centers. Here, data are presented from 13 centers for which two-year follow-up was available on patients for whom a biologic was initiated in 2010-2011. The purpose with this study was to analyse the use of biologics in SLE, and assess the results achieved over the first two years after initiation.

Methods: IRBIS investigators provided retrospective data on all patients treated with a biologic for SLE at their center in 2010-2011. Standardized case report forms were used to collect demographic, disease-specific and treatment data at the time of biologic initiation and at yearly follow-ups.

Results: In the entire cohort, 455 patients were treated with rituximab (84%), belimumab (10%), epratuzumab (5%), and anti-tumor necrosis factor agents (abatacept, etanercept and adalimumab, each <1%). The major organ manifestations leading to biologic treatment were lupus nephritis (LN, 44%), hematological (17%), musculoskeletal (16%), skin disease (10%), CNS (4%) and other (9%). Reasons for choosing the biologic were disease-control (73%), steroid-sparing (5%) or both (23%). At biologic initiation mean disease duration (±SD) was 9.5±7.9 years, and mean age was 42.2±12.5. Most patients (91%) were female. Prior to biologic treatment, most patients (91%) had been treated with one or more immunosuppressives (ISs). Just over half (57%) had used 1-2 ISs, 21% had used three, and 13% had used 4-6 ISs.

At two-year follow-up (n=120), SLE disease activity (SLEDAI) and corticosteroid (CS) dose were significantly lower versus baseline (SLEDAI: 9.4±5.3 to 3.1±2.5; CS dose: 10.7±13.9 to 4.8±5.9 mg; mean±SD paired analyses, p<0.0001 for both comparisons). SLICC damage-index remained unchanged.

At baseline, concomitant CS was used in 91% of patients compared to 61% at follow-up. There were six deaths, none attributed to the biologic. In almost half of patients (48%) there was at least one adverse event reported over the indicated follow-up period, of which 5% were attributed to the biologic agent. Serious adverse events included 6 infections, 4 opportunistic infections, posterior reversible encephalopathy syndrome (3), allergic reactions (4).

Conclusion: Rituximab was the biologic used most commonly in this international cohort of patients who were started on biologics in 2010-2011. Biologics were used for a range of SLE manifestations. At two-year follow-up both lupus activity and concomitant corticosteroid dosage had decreased significantly and corticosteroids had been discontinued in 30% of patients.


Disclosure:

R. F. van Vollenhoven,

AbbVie, BMS, GSK, Merck, Pfizer, Roche, UCB,

2,

AbbVie, AstraZeneca, Biotest, BMS, GSK, Lilly, Merck, Pfizer, Roche, UCB, Vertex,

5;

M. Mild,
None;

S. Jacobsen,
None;

S. Bernatsky,
None;

D. J. Wallace,

Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, GlaxoSmithKline, Human Genome Sciences Inc, MedImmune, Novo Nordisk and UCB Pharma,

5;

S. C. Bae,
None;

M. Ramos-Casals,
None;

F. J. García-Hernández,
None;

R. Ramsey-Goldman,

Exagen,

5;

A. Doria,
None;

M. Mosca,
None;

M. A. Petri,

UCB Pharma,

2,

UCB Pharma,

5;

M. Ayala-Gutiérrez,
None;

J. G. Hanley,
None;

F. T. SLICC group,
None.

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