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Abstract Number: 676

Response to Rituximab in Patients with Refractory Systemic Lupus Erythematosus (SLE): Results from a National Multicentre Register

Emily Sutton1, Kath D. Watson2, David A. Isenberg3, Anisur Rahman4, David Jayne5, Caroline Gordon6, Ben Parker7, David P. D'Cruz8, Munther A. Khamashta9, Pamela Lutalo10, Peter Lanyon11, Benjamin Rhodes12, Bridget Griffiths13, Edward M. Vital14, Chee-Seng Yee15, Christopher Edwards16, Mohammed Akil17, Nicola Erb18, Athiveer Prabu19, Asad A. Zoma20, Neil McHugh21, Hazem Youssef22, Lee-Suan Teh23, Michael W. Beresford24 and Ian N. Bruce25, 1University of Manchester, Manchester Academic Health Science Centre, Arthritis Research UK Centre for Epidemiology, Manchester, United Kingdom, 2Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, United Kingdom, 3Centre for Rheumatology Research, Rayne Building, 4th Floor, Centre for Rheumatology, Department of Medicine, University College London, London, United Kingdom, 4Centre for Rheumatology Research, University College London, London, United Kingdom, 5Vasculitis and Lupus Clinic, Addenbrookes Hospital University of Cambridge, Cambridge, United Kingdom, 6Rheumatology Research Group, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, 7Institute of Inflammation and Repair School of Translation Medicine The University of Manchester, Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom, 8Louise Coote Lupus Unit, Guy's and St Thomas' Hospital, London, United Kingdom, 9Lupus Research Unit, The Rayne Institute, St Thomas Hospital, Kings College London School of Medicine, London, United Kingdom, 10Peter Gorer Department of Immunobiology, King's College London School of Medicine, London, United Kingdom, 11Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, 12Rheumatology, Queen Elizabeth Hospital, Birmingham, United Kingdom, 13Rheumatology, Freeman Hospital, Newcastle Upon Tyne, United Kingdom, 14NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds., United Kingdom, Leeds, United Kingdom, 15Department of Rheumatology, Doncaster and Bassetlaw Hospitals NHS Foundation Trust, Doncaster, United Kingdom, 16Tremona Road, NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, 17Rheumatology Department, Sheffield South Yorkshire, United Kingdom, 18Rheumatology, Russells Hall Hospital, Dudley, United Kingdom, 19Department of Rheumatology, Worcester Acute Hospitals NHS Trust, Worcester, United Kingdom, 20Rheumatology, Hairmyres Hospital, East Kilbride, United Kingdom, 21Rheumatology, Royal National Hospital, Bath, United Kingdom, 22Department of Rheumatology, NHS Grampian, Aberdeen, United Kingdom, 23Department of Rhuematology, Royal Blackburn Hospital, Blackburn, United Kingdom, 24Alder Hey Children's NHS Foundation Trust Hospital, Institute of Translational Medicine (Child Health), University of Liverpool, Liverpool, United Kingdom, 25Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: BILAG, registry, rituximab and treatment, SLE

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Session Information

Session Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Published efficacy data for rituximab in SLE are complex with positive single-centre case series and negative randomised controlled trials.  This may be due to heterogeneity of SLE or the populations, design and endpoints of trials.  The BILAG Biologic Registry (BILAG BR) is a national, multicentre, prospective study of safety and efficacy of biologics in SLE patients refractory to standard immunosuppressive therapy. The objective of the present analysis was to describe clinical response to rituximab at three and six-months post therapy.

Methods:

Patients with SLE (≥ 4 ACR 1997 criteria), ≥ 5 years old, refractory to conventional therapy and newly starting treatment with rituximab, from centres across the UK, were recruited into the BILAG BR. A comprehensive questionnaire collected information on concomitant medications, risk factors for infection, co-morbidities and SLE disease duration. Disease activity was measured using the BILAG 2004 Index and the SLEDAI2K at treatment initiation, 3 and 6 months post therapy.

Results:

Baseline, 3 and 6 month disease activity were collected for 80 patients (92.5% women) starting therapy with rituximab. The cohort included 44 (60.3%) white British patients. The median (interquartile range [IQR]) age and disease duration at baseline were 39.5 years (IQR 30.0, 47.3) and 5.7 years (IQR 2.5, 11.6) respectively. The most commonly involved BILAG 2004 index systems were mucocutaneous (33 [41.25%]), renal (28 [35.0%]) and musculoskeletal (25 [31.0%]). The baseline SLEDAI2K was 8 (IQR 4, 13.5). At 3 months follow-up, 47 (58.75%) patients showed an improvement in their overall BILAG 2004 index, 16 (20.0%) had persisting active disease and 12 (15.0%) had deteriorating disease. The majority of patients (11/12 [91.7%]) who deteriorated, did so in one system only. In the same follow-up period, 56 (70.0%) had an improved SLEDAI2K, 15 (18.75%) had no change and 9 (11.25%) worsened. Data at 6 months showed 39 (48.75%) with improvement, 18 (22.5%) with persistent disease and 16 (20.0%) deteriorating. In addition, there was a trend towards steroid dose being reduced over the 6 month period (Table 1).

Conclusion:

There was variability in the degree of response to rituximab with respect to both the magnitude and duration of response, in this cohort of SLE patients refractory to standard immunosuppression. Although nearly half of the cohort demonstrated significant reduction in disease activity across all systems at 6 months, there was a sub-group that worsened in either the original system involved, or developed activity in a new system. This may be explained some patients who initially responded to rituximab at 3 months, beginning to flare by 6 months post therapy. Further analysis will attempt to identify predictors of response in this cohort.

Table 1:

N = 80 unless otherwise stated

N (%)

Baseline   Characteristics

 

Female

74   (92.5)

Ethnicity (n = 73)

 

White British / other white

44   (60.3)

Indian / Pakistani / Bangladeshi

10 (13.7)

African Ancestry

10   (13.7)

Mixed (white/Caribbean) / other mixed

9 (12.3)

BILAG 2004 Index   score at baseline (n = 80)

 

≥1 A score and/or ≥2 B score

55 (68.8)

 

median (IQR)

Age at diagnosis (years)

30.0 (18.4, 40.2)

Age at baseline (years)

39.5   (30.0, 47.3)

Disease duration at baseline (years)

5.7 (2.5, 11.6)

Prednisolone dose at baseline (mg/day) (n = 70)

10 (8.0,   22.5)

Number of previous immunosuppressant therapies at baseline (n = 78)

2 (1, 3)

Baseline SLEDAI 2K score

8 (4,   13.5)

Baseline SLICC / ACR Damage Index (n=64)

0 (0, 1)

Patient   Follow-up

 

BILAG 2004 Index

3M: N (%)

6M: N (%)

Improvement

[All As to B/C/D; all Bs to C/D (allowing for 1≤B persisting)]

47   (58.75)

39   (48.75)

Persistent active   disease

[Any system still A or 2Bs as per previous time point]

16 (20.0)

18 (22.5)

Deterioration

[Any system to A from B/C/D or to B from C/D]

12   (15.0)

16   (20.0)

No Change /   Inactive

[Stable C/D/E with no new A or B]

5 (6.25)

7 (8.75)

SLEDAI2K (n=80)

3M

6M

Score at follow-up [median (IQR)]

4 (2, 6.5)

4 (2, 7)

Improve: N (%)

56   (70.0)

56   (70.0)

Persist: N (%)

15 (18.75)

13 (16.25)

Worsen: N (%)

9   (11.25)

11   (13.75)

 

 

 

Prednisolone dose at follow-up (mg/day) [median (IQR)]

10 (5,   13.75)

8.5 (5,   12.5)


Disclosure:

E. Sutton,

Roche Pharmaceuticals,

2,

GlaxoSmithKline,

2;

K. D. Watson,
None;

D. A. Isenberg,

Merck Serono,

5,

Eli Lilly and Company,

5,

UCB,

5;

A. Rahman,
None;

D. Jayne,

Roche/Genentech,

5,

Roche/Genentech,

2;

C. Gordon,

Merck Serono, UCB Pharma, Bristol-Myers Squibb, GlaxoSmithKline, MedImmune,

5,

Amgen, Roche,

9;

B. Parker,
None;

D. P. D’Cruz,

GlaxoSmithKline, Roche and Lilly,

5;

M. A. Khamashta,
None;

P. Lutalo,
None;

P. Lanyon,

Eli Lilly and Company,

9;

B. Rhodes,
None;

B. Griffiths,
None;

E. M. Vital,

Roche Pharmaceuticals,

8,

GSK,

8,

NIHR clinician scientist fellowship,

2;

C. S. Yee,
None;

C. Edwards,

Celgene Corporation, Pfizer Inc, Roche, and Samsung,

2,

Celgene Corporation, Pfizer Inc, Roche, and Samsung,

5,

Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche,

8;

M. Akil,
None;

N. Erb,
None;

A. Prabu,
None;

A. A. Zoma,
None;

N. McHugh,
None;

H. Youssef,
None;

L. S. Teh,
None;

M. W. Beresford,
None;

I. N. Bruce,
None.

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