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Abstract Number: 1145

Use of Non-Etanercept Biologics in Children with Juvenile Idiopathic Arthritis: Results From the Biologics for Children with Rheumatic Diseases Study

Lianne Kearsley-Fleet1, Eileen Baildam2, Michael Beresford3, Rebecca Davies4, Helen E. Foster5, Katy Mowbray1, Taunton R. Southwood6, Wendy Thomson1 and Kimme L. Hyrich7, 1Arthritis Research UK Epidemiology Unit, Manchester Academic Health Science Centre, Manchester, United Kingdom, 2Paediatric Rheumatology, Alder Hey Children's Foundation NHS Trust, Liverpool, United Kingdom, 3University of Liverpool, Institute of Translational Medicine (Child Health), Alder Hey Children's Foundation NHS Trust, Liverpool, United Kingdom, 4Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, United Kingdom, 5Institute Cellular Medicine, Musculoskeletal Research Group, Newcastle upon Tyne, United Kingdom, 6Institute of Child Health, University of Birmingham and Birmingham Children's Hospital, Birmingham, United Kingdom, 7Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, biologic response modifiers, juvenile idiopathic arthritis (JIA) and prescribing trends

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Session Information

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects: Juvenile Idiopathic Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: The management of juvenile idiopathic arthritis (JIA) has been revolutionised by the introduction of biologic therapy, although the majority remain unlicensed for children. Until recently, etanercept (ETN) was the only choice of licensed therapy in the UK, with recent additions of adalimumab (age ≥ 4 years), abatacept (age ≥ 6 years) and tocilizumab (systemic arthritis). It is not yet known how and when non-ETN biologics are being prescribed in JIA. The purpose of this analysis was to describe the pattern of use of non-ETN biologics in children with JIA.

Methods: Since 2010, the Biologics for Children with Rheumatic Diseases (BCRD) study, an ongoing prospective observational cohort study, has been collecting detailed information on children <18 years newly starting a non-ETN biologic therapy for JIA. There are no other exclusion criteria.  At baseline, detailed demographic and disease information, including details of past biologic therapies, are collected. The use of non-ETN therapy as a first-line or subsequent biologic therapy was compared, including patterns of prescription, use under licensed indications, ILAR subtypes and disease activity/severity using non-parametric descriptive statistics.

Results: To 06/21/2012, 136 children across the UK had been recruited: median age 10 years, 65% female. The most common ILAR subtypes were systemic arthritis (26.5%) and rheumatoid factor (RF) negative polyarthritis (27.2%) (see Table). Sixty four patients (47.1%) were starting a non-ETN biologic as first-line biologic therapy, of which 33 (51.6%) were prescribed off-license. Off-license use was more common among first-line users (p=0.047), largely accounted for by infliximab and anakinra. All patients on anakinra had systemic arthritis, whereas only 67.7% of those were prescribed tocilizumab. Forty-eight percent of first line users versus 26% of subsequent users had a history of chronic anterior uveitis (p=0.028). Of those registered at the point of starting a subsequent biologic, 71% had received prior ETN. The majority had received only 1 prior biologic although 17 children had received 2 prior biologics, 3 children had received 3 and 1 child (RF negative) had received 5 previous biologics. Disease severity was moderate to high and largely comparable between first-line and subsequent biologic users, although subsequent biologic users had a higher limited joint count.

Conclusion: Many children are now receiving non-ETN biologics in the UK, although almost half of these are being prescribed off-license. Ongoing follow-up will help to address the question of best choice of biologic therapy for children with JIA, both as first-line and subsequent use, as well as determine the safety of these drugs in children, for which limited clinical experience exists.

 

Biologic Patients Characteristic, med(IQR) or n(%)

First Line

Subsequent

Total

p-value

n

64 (47.1)

72 (52.9)

136

 

Age at Registration, years

8.5 (4.5-12)

11.5 (8-14)

10 (6-13.5)

0.0006

Female

37 (57.8)

51 (70.8)

88 (64.7)

0.113

ILAR subtype

 

 

 

 

Systemic arthritis

19 (29.7)

17 (23.6)

36 (26.5)

0.001

Oligoarthritis: persistent

16 (25.0)

1 (1.4)

17 (12.5)

Oligoarthritis: extended

9 (14.1)

14 (19.4)

23 (16.9)

Polyarthritis: RF Negative

11 (17.2)

26 (36.1)

37 (27.2)

Polyarthritis: RF Positive

1 (1.6)

6 (8.3)

7 (5.2)

Enthesitis Related Arthritis

4 (6.3)

2 (2.8)

6 (4.4)

Psoriatic arthritis

2 (3.1)

5 (6.94)

7 (5.2)

Undifferentiated arthritis

1 (1.6)

0

1 (0.7)

Not Recorded

1 (1.6)

1 (1.4)

2 (1.5)

Biologic Drug at Registration

 

 

 

 

Adalimumab

25 (39.1)

25 (34.7)

50 (36.8)

0.002

Infliximab

18 (28.1)

14 (19.4)

32 (23.5)

Tocilizumab

11 (17.1)

20 (27.8)

31 (22.8)

Abatacept

1 (1.6)

9 (12.5)

10 (7.4)

Anakinra

9 (14.1)

1 (1.4)

10 (7.4)

Rituximab

0

3 (4.2)

3 (2.2)

Licensed Use

31 (48.4)

47 (65.3)

78 (57.4)

0.047

Prior Biological Treatment

 

 

 

 

1 previous

0

51

 

 

2 previous

0

17

 

 

3 previous

0

3

 

 

5 previous

0

1

 

 

Ever had Chronic Anterior Uveitis

31 (48.4)

19 (26.4)

50 (36.8)

0.028

Active Chronic Anterior Uveitis at Registration

25 (39.1)

17 (23.6)

42 (30.9)

0.141

Disease activity

 

 

 

 

Active joint count

2 (0-6)

3 (1-8.5)

2 (0-7)

0.1030

Limited joint count

1 (0-6)

3 (1-8)

2 (0-7)

0.0061

Physician Global Assessment (10cm VAS)

3.1 (1.5-4.9)

3 (1.8-6)

3 (1.8-5.5)

0.5603

Parent Global Assessment of Well-being (10cm VAS)

3 (0.8-5)

4.4 (2-6)

4 (1.1-5.9)

0.3414

CHAQ

1 (0.3-2)

1.3 (0.3-1.6)

1.1 (0.3-1.8)

0.8697

Pain (10cm VAS)

3.8 (0.5-6.1)

3.7 (1-6.6)

3.7 (0.8-6.5)

0.7833

ESR , mm/hr

10 (6-42)

14 (5-52)

12 (6-50)

0.6820

CRP mg/L

5 (3-20)

5 (4-28)

5 (3-20.4)

0.7292

 


Disclosure:

L. Kearsley-Fleet,
None;

E. Baildam,
None;

M. Beresford,
None;

R. Davies,
None;

H. E. Foster,
None;

K. Mowbray,
None;

T. R. Southwood,
None;

W. Thomson,
None;

K. L. Hyrich,
None.

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