Safety and Efficacy of Etanercept in 2000 Patients with Juvenile Idiopathic Arthritis (JIA) in the JIA Biologics Register

Gerd Horneff¹, Juergen Brunner², Johannes Peter Haas³, Gerd Ganser⁴, Ivan Foeldvari⁵, Toni Hospach⁶, Kirsten Minden⁷, Hans-Iko Huppertz⁸, Rolf M. Kuester⁹, Ralf Trauzeddel¹⁰, Angelika Thon¹¹ and BIKER Study Group, ¹Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, ²Universitätsklinik für Kinder- u. Jugendheilkunde, Innsbruck, Austria, ³German Centre for Rheumatology in Children and Young People, Garmisch-Partenkirchen, Germany, ⁴Pediatric Rheumatology, Sankt Josef Stift, Sendenhorst, Germany, ⁵Hamburger Zentrum für Kinder-und Jugendrheumatologie, Hamburg, Germany, ⁶Pediatrics, Olgahospital, Klinikum Stuttgart, Stuttgard, Germany, ⁷DRFG, Berlin, Germany, ⁸PRINTO, IRCCS G. Gaslini, Genoa, Italy, ⁹Asklepios Rheumazentrum Hamburg, Hamburg, Germany, ¹⁰HELIOS Klinikum Berlin-Buch Klinik fuer Kinder- und Jugendmedizin, Berlin, Germany, ¹¹Department of Pediatrics, Hannover, Germany

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: etanercept, juvenile idiopathic arthritis-enthesitis (ERA) and registry

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: Treatment with Etanercept (ETA) was followed prospectively. The purpose of this interim analysis is to evaluate efficacy/ safety of ETA in routine care settings.

Methods: Documentation of pts characteristics, previous/concomitant therapy, disease activity and adverse events. The efficacy was assessed by PedACR criteria and JADAS10 (remission and minimal disease activity, MDA). A control cohort not treated with biologics was established.

Results:

Until 31.12.2014, 2000 JIA pts (67.2% fem.) started ETA. The mean/median age at baseline was 9.4/8.2, disease duration 4.5/3.3 years. The RF-Polyarthritis was the most frequent JIA category (633pts), followed by extended Oligo (396), ERA (330), RF+Poly (171), PsA (149), systemic JIA (143), persistent Oligo (111) and unclass. JIA (67). Pretreatments were performed with steroids 55.5%, methotrexate 88.2%, sulfasalazine 16.6%, azathioprine 11.6%, antimalarials 10.4, and other DMARDs (n=379) as well as 62 therapies with other biologicals (n=35 adalimumab). The initial concomitant treatment was carried out using NSAIDs 81.1%, steroids 40.9%, methotrexate 70.4% and other DMARDs (n=313). A JIA-ACR30/50/70/90 response was reached by 81%/75%/61%/40% after 12 months. A JADAS remission (JADAS10≤1) at month 12/24/36/48/60 was reached by 28%/33%/33%/26%/33% and a JADAS-MDA by 49%/51%/46%/42%/45%. Response rates according to the JIA categories are given in the table.

1225 adverse events were reported (29.1/100 PY), 158 (3.8/100 PY) were serious. Infections were the most frequent AE (350), 29 were SAE. Opportunistic infections including TB did not occur. Rates of adverse events of special interest are shown in table 2. In 1055 patients (53%) the therapy was discontinued. Reasons reported were (>1 possible) remission 409 (20%), ineffectiveness 391 (17%), patient request 342 (17%), intolerance, 124 (6%) and 174 (9%) other. 5 patients died, none during or in connection with the treatment with ETA.

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

Table 1: Treatment response of pts reaching month 12

	sJIA n=81	RF-PA n=397	RF+PA n=116	Pers.OA n=63	Ext.OA n=242	ERA n=201	PsA n=91	Unclass JIA n=39
JIA-ACR 30	67.9%	84.1%	74.1%	77.8%	86.4%	81.1%	76.9%	87.2%
JIA-ACR 50	59.3%	75.8%	70.7%	68.3%	80.6%	77.1%	70.3%	87.2%
JIA-ACR 70	50.6%	59.7%	57.8%	55.6%	64.9%	66.2%	54.9%	76.9%
JIA-ACR 90	30.9%	39.5%	37.1%	36.5%	40.9%	48.8%	36.3%	51.3%
JADAS10 Start Mean/Median	18.1/20	17.5/17	19.1/18	10.8/10	12.9/12	12.1/11	11.8/11	13.9/13.5
JADAS10 (Mean/Median)	8.9/3.8	5.4/3.5	5.8/3.3	3.1/1.1	3.7/2.0	3.7/.4	4.0/2.3	3.9/1.6
JADAS MDA	50.0%	51.9%	52.1%	63.3	71.7%	65.1%	60.5%	67.6%
JADAS Remission	27.3%	30.9%	28.7%	46.9	38.5%	43.8%	34.2%	38.2%

Table 2: Rate of adverse events of special interest

	ETA (4199 PY)	MTX (3099 PY)	RR (95%CI)	P (Wald-test)
SAE, n/rate/100PY	158/3.79	47/1.52	2.48(1.79-3.43)	<0.0001
SAE-Infection n/rate/100PY	29/0.69	10/0.32	2.14(1.04-4.39)	0.038
Herpes zoster n/rate/100PY	17/0.40	6/0.19	2.09(0.82-5.30)	0..12
Uveitis n/rate/100PY	79/1.88	49/1.58	1.19(0.83-1.70)	0..33
CED n/rate/100PY	12/0.29	3/0.10	2.95(0.83-10.5)	0..094
Malignancy n/rate/100PY	7/0.17	3/0.10	1.72(0.44-6.66)	0.43

Disclosure: G. Horneff, None; J. Brunner, None; J. P. Haas, None; G. Ganser, None; I. Foeldvari, None; T. Hospach, None; K. Minden, None; H. I. Huppertz, None; R. M. Kuester, None; R. Trauzeddel, None; A. Thon, None.

To cite this abstract in AMA style:

Horneff G, Brunner J, Haas JP, Ganser G, Foeldvari I, Hospach T, Minden K, Huppertz HI, Kuester RM, Trauzeddel R, Thon A. Safety and Efficacy of Etanercept in 2000 Patients with Juvenile Idiopathic Arthritis (JIA) in the JIA Biologics Register [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/safety-and-efficacy-of-etanercept-in-2000-patients-with-juvenile-idiopathic-arthritis-jia-in-the-jia-biologics-register/. Accessed .

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