ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2421

Experience with Adalimumab for Treatment of 568 Juvenile Idiopathic Arthritis Patients in the German JIA Biologics Register

Gerd Horneff1, Gerd Ganser2, Ivan Foeldvari3, Johannes Peter Haas4, Toni Hospach5, Ralf Trauzeddel6, Frank Weller-Heinemann7, J B. Kuemmerle-Deschner8, Angelika Thon9 and BIKER study group, 1Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, 2Pediatric Rheumatology, Sankt Josef Stift, Sendenhorst, Germany, 3Rheumatology, Scleroderma, Hamburg, Germany, 4German Centre for Rheumatology in Children and Young People, Garmisch-Partenkirchen, Germany, 5Pediatrics, Olgahospital, Klinikum Stuttgart, Stuttgard, Germany, 6HELIOS Klinikum Berlin-Buch Klinik fuer Kinder- und Jugendmedizin, Berlin, Germany, 7PRINTO, Genoa, Italy, 8Pediatrics, University Hospital Tuebingen, Tuebingen, Germany, 9Kinderklinik der Medizinischen Hochschule Hannover, Hannover, 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: Adalimumab (ADA) has become a valuable option for treatment of juvenile idiopathic arthritis (JIA), which significantly improves 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.

Methods: Treatment with ADA was followed prospectively by documentation of pts’ characteristics, pervious/concomitant therapy, disease activity parameters and adverse events. The efficacy was assessed by PedACR criteria and JADAS10. A control cohort not treated with biologics was established in parallel.

Results: 568 JIA pts (67.2% fem.) started ADA. The mean/median age at baseline was 12.6/13.3, disease duration 5.8/4.9 years. The RF-Polyarthritis was the most frequent JIA category (200pts), followed by extended Oligo (143), ERA (74), persistent Oligo (47), RF+Poly (45), PsA (35), systemic JIA (15), and unclass. JIA (9). Pretreatments were performed with steroids 59.3%, methotrexate 91%, sulfasalazine 12.1%, azathioprine 9.9%, leflonomide (7.2%), antimalarials 5.6%, and other DMARDs (n=47) as well as 347 therapies with other biologicals (313 with Etanercept). The initial concomitant treatment was carried out using NSAIDs 57.7%, steroids 31.3%, methotrexate 59.0% and other DMARDs (n=69). A JIAACR30/50/70/90 response was reached by 69%/66%/51%/35% after 12 months. A JADAS remission (JADAS10≤1) at month 3/6/12/18/24 was reached by 29%/34%/29%/37%</36% and a JADAS-MDA by 53%/59%/54%/56%/59%. Response rates according to the JIA categories are given in table 1.

416 adverse events were reported (57.2/100 PY), 32 (4.4/100 PY) were serious. Infections were the most frequent AE (n=133), 6 were SAE. Opportunistic infections including TB did not occur. 142 patients had had a history of uveitis before baseline. There were 30 uveitis flares. A single patient had a first uveitis upon ADA. Rates of adverse events of special interest are shown in table 2. In 168 patients (29.6%) the therapy was discontinued. Reasons reported were (several same time) remission 39 (6.9%), inefficacy 99 (17.4%), patient request 77 (13.6%), intolerance 34 (5.9%) and 21 (3.7%) other. No patients died.

Conclusion: JIA patients achieved high ACR response rates upon treatment with ADA, a JADAS-MDA was frequently reached as well. A JADAS remission was achieved only in part. Overall tolerability was good. Only a small portion discontinues therapy because of intolerance or side effects.

Table 1: JADAS10 at baseline and treatment response at month 12

 

sJIA

RF-PA

RF+PA

Pers.OA

Ext.OA

ERA

PsA

JADAS baseline Mean/Median

8.2/5.0

12.7/12.8

15.4/14.6

6.7/4.4

10.4/10.4

10.4/9.7

10.9/9.4

JADAS M12 (Mean/Median)

2.1/0.4

5.1/2.9

7.8/6.5

2.7/1.9

5.6/3.0

3.8/2.5

5.4/4.4

JADAS MDA M12

80%

57.1%

10%

72.2%

54.5%

59.3%

40%

JADAS Remission M12

60%

32.4%

10%

38.9%

30.9%

33.3%

10%

JIA-ACR 30 M12

100%

69.3%

75.0%

45.5%

73.8%

64.5%

81.8%

JIA-ACR 50 M12

100%

65.9%

75.0%

45.5%

66.2%

61.3%

81.8%

JIA-ACR 70 M12

80%

54.5%

58.3%

18.2%

50.8%

51.6%

72.7%

JIA-ACR 90 M12

60%

37.5%

25.0%

13.6%

29.2%

51.6%

36.4%

Table 2: Incidence of adverse events of special interest

ADA (723 PY)

MTX (3099 PY)

RR (95%CI)

P (Wald-test)

SAE, n/rate/100PY

32/4.43

47/1.52

2.92(1.86-4.57)

<0.0001

SAE-Infection; n/rate/100PY

18/2.49

10/0.32

7.72(3.56-16.7)

<0.0001

Herpes zoster; n/rate/100PY

3/0.41

6/0.19

2.14(0.54-8.57)

0.28

Uveitis; n/rate/100PY

30/4.15

49/1.58

2.62(1.67-4.13)

<0.0001

Psoriasis; n/rate/100PY

6/0.83

0/0.0

¥

<0.0001

Malignancy; n/rate/100PY

2/0.28

3/0.10

2.86(0.48-17.1)

0.25

Disclosure: G. Horneff, None; G. Ganser, None; I. Foeldvari, None; J. P. Haas, None; T. Hospach, None; R. Trauzeddel, None; F. Weller-Heinemann, None; J. B. Kuemmerle-Deschner, None; A. Thon, None.

To cite this abstract in AMA style:

Horneff G, Ganser G, Foeldvari I, Haas JP, Hospach T, Trauzeddel R, Weller-Heinemann F, Kuemmerle-Deschner JB, Thon A. Experience with Adalimumab for Treatment of 568 Juvenile Idiopathic Arthritis Patients in the German JIA Biologics Register [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/experience-with-adalimumab-for-treatment-of-568-juvenile-idiopathic-arthritis-patients-in-the-german-jia-biologics-register/. Accessed .

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