ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2437

Experience with Tocilizumab for Treatment of 56 Children with Systemic Juvenile Idiopathic Arthritis in the German JIA Biologics Register

Gerd Horneff1, Gerd Ganser2, Johannes Peter Haas3, Toni Hospach4, Ralf Trauzeddel5, Hans-Iko Huppertz6, J B. Kuemmerle-Deschner7, Kirsten Minden8 and BIKER Registry Study Group, 1Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, 2Pediatric Rheumatology, Sankt Josef Stift, Sendenhorst, Germany, 3German Centre for Rheumatology in Children and Young People, Garmisch-Partenkirchen, Germany, 4Pediatrics, Olgahospital, Klinikum Stuttgart, Stuttgard, Germany, 5HELIOS Klinikum Berlin-Buch Klinik fuer Kinder- und Jugendmedizin, Berlin, Germany, 6PRINTO, IRCCS G. Gaslini, Genoa, Italy, 7Pediatrics, University Hospital Tuebingen, Tuebingen, Germany, 8DRFG, Berlin, Germany

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , ,

Session Information

Date: Tuesday, November 10, 2015

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Tocilizumab (TOC) has become a valuable option for treatment of systemic juvenile idiopathic arthritis (sJIA), which significantly improved the outcome of patients. The aim of the German BIKER registry is surveillance of biologics. The purpose of this interim analysis is to evaluate the efficacy and safety under practical conditions in childhood.

Methods: Documentation of pts’ characteristics, pervious/concomitant therapy, disease activity parameters and adverse events. Treatment with TOC was followed prospectively. Efficacy was assessed by PedACR criteria and JADAS10 remission and minimal disease activity (MDA). Safety was compared to a cohort of pts treated with sJIA methotrexate only and a cohort with poly JIA treated with TOC.

Results: 56 JIA pts (54% female) started TOC. The mean/median age at baseline was 9.3/9.7, disease duration 4.9/4.1 years. 44 previous biologic therapies were performed 3 pts (Anakinra 14, Canakinumab 1,Etanercept 25, Adalimumab 3, Abatacept 1). 26 pts were biologics naïve. The initial concomitant treatment in consisted of NSAIDs 63.3%, steroids 70%, methotrexate 63.3%, other DMARDs (n=6).

Clinical response rates are given in table 1. Reported adverse events were compared to a cohort of 79 pts with polyarticular JIA and 58 sJIA pts receiving MTX onlym, both recruited and followed in parallel. 122 adverse events (AE, 83.3/100 PY) were reported, 12 (9.0/100 PY) were serious. Infections were the most frequent AE (48), 3 were serious. Opportunistic infections including TB did not occur. There were 4 events of macrophage activation syndrome in sJIA pts with TOC, none in polyJIA and 1 in sJIA controls. All resolved. Rates of other adverse events of special interest are shown in table 2. Therapy was discontinued in 32 (57%) sJIA pts due to remission (15/27%), inefficacy (7/13%), patient request (5/9%), intolerance (4/7%) and other (1/2%). No patients died.

Conclusion: sJIA pts achieved high ACR response rates upon treatment with TOC. JADAS-MDA was frequently reached. JADAS remission was achieved in about half of pts. While more serious adverse events were reported in sJIA than in controls, overall tolerability was good. Only a small portion discontinues therapy because of intolerance or side effects while remission is the leading cause of discontinuation of treatment.

Table 1: Treatment response until month 12

 

Baseline

Month 3

Month 6

Month 12

Pts with active joints (n/%)

34/64.2%

7/22.3%

10/27.8%

9/30%

Pts with organomegaly (n/%)

5/10.2%

1/3.3%

0

0

Pts with serositis (n/%)

3/6.1%

0

0

0

Pts with fever (n/%)

2/4.1%

0

0

1/3.4%

JADAS 10 (mean/median)

8.7/9.4

4.9/4.5

2.2/0.7

3.5/1.0

JADAS-MDA (n/%)

12/29.3%

12/50.0%

24/80%

118/66.7%

JADAS-Remission (n/%)

7/17.1%

7/29.2%

17/56.7%

14/51.9%

JIAACR30 (%)

n.a.

66.7%

59.5%

67.7%

JIAACR50 (%)

n.a.

63.3%

54.1%

61.3%

JIAACR70 (%)

n.a

53.3%

54.1%

54.8%

JIAACR 90 (%)

n.a.

40.0%

37.8%

41.9%

Table 2: Incidence of adverse events of special interest

 

sJIA

TOC

(n=56; 73 PY)

pJIA

TOC

(n=78; 59 PY)

RR (95%CI)

P (Wald-test)

sJIA

MTX

RR (95%CI)

P (Wald-test)

(n=58; 124 PY)

SAE, all

n (rate/100PY)

10(13.7)

2(3.4)

4.04 (0.9-18.4)

0.07

3(2.4)

5.7(1.6-21)

0.008

SAE-Infection;

n (rate/100PY)

3(4.1)

1(1.7)

2.4 (0.3-23.3)

0.69

0

¥

Hypersensitivity; n (rate/100PY)

3(4.1)

1(1.7)

2.4 (0.3-23.3)

0.44

1(0.8)

5.1 (0,5-49)

0.16

MAS;

n (rate/100PY)

4(5.5)

0

¥

1(0.8)

6.8(0.8-619

0.09

Cytopenias;

n (rate/100PY)

2(2.7)

3(5.1)

0.5 (0.1-3.2)

0.49

0

¥

Hepatic events; n (rate/100PY)

1(1.4)

0

¥

5/(4.0)

0.3(0.0-2.9)

0.32

Disclosure: G. Horneff, None; G. Ganser, None; J. P. Haas, None; T. Hospach, None; R. Trauzeddel, None; H. I. Huppertz, None; J. B. Kuemmerle-Deschner, None; K. Minden, None.

To cite this abstract in AMA style:

Horneff G, Ganser G, Haas JP, Hospach T, Trauzeddel R, Huppertz HI, Kuemmerle-Deschner JB, Minden K. Experience with Tocilizumab for Treatment of 56 Children with Systemic Juvenile Idiopathic Arthritis in the German JIA Biologics Register [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/experience-with-tocilizumab-for-treatment-of-56-children-with-systemic-juvenile-idiopathic-arthritis-in-the-german-jia-biologics-register/. Accessed .

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