Long-Term Effectiveness and Safety of Abatacept in Juvenile Idiopathic Arthritis: Interim Results from the Abatacept in JIA Registry

Daniel J Lovell¹, N Ruperto², S Spalding³, JA Dare⁴, R Cimaz⁵, V Stanevica⁶, RK Vehe⁷, N Tzaribachev⁸, G Horneff⁹, M Trachana¹⁰, TA Simon¹¹, HI Brunner¹² and A Martini², ¹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Istituto G. Gaslini Pediatria II Reumatologia, Genova, Italy, ³Cleveland Clinic, Cleveland, OH, ⁴University of Arkansas Medical Center, Little Rock, AR, ⁵Azienda Ospedaliero-Universitaria Meyer, Florence, Italy, ⁶Riga Stradins University, Riga, Latvia, ⁷University of Minnesota, Minneapolis, MN, ⁸Pediatric Rheumatology, Bad Bramstedt, Germany, ⁹Asklepios Klinik Zentrum für Allgemeine Paediatrie und Neonatologie, Sankt Augustin, Germany, ¹⁰Hippokration General Hospital, Thessaloniki, Greece, ¹¹Bristol-Myers Squibb, Hopewell, NJ, ¹²Division of Rheumatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Abatacept and juvenile idiopathic arthritis (JIA)

Session Information

Date: Monday, November 9, 2015

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters. Juvenile Arthritis and Miscellaneous Rheumatic Diseases

Session Type: ACR Poster Session B

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

Background/Purpose: Abatacept (ABA) is a widely approved and used
biologic in children with juvenile idiopathic arthritis (JIA). The purpose of
this study was to describe the longitudinal effectiveness and safety of ABA in
JIA patients (pts). Methods: Using a standardized protocol, clinical sites in the
Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology
International Trial Organization (PRINTO) enrolled JIA pts currently on or
starting ABA in this longitudinal registry. Planned duration of follow-up is 10 yrs. Visits are every
3 mths for Yr 1, every 6 mths for Yrs 2–5 and annually for Yrs 6–10. After
≥4 mths on ABA, pts remain in the registry even if ABA is stopped. Data
shown are those collected through March 26, 2015 (up to 2 yrs follow-up). Results: Overview. Of 146 JIA pts enrolled, 133 provided data for this analysis (6
had no data entry; 7 discontinued the study: 1 lost to follow-up, 1 withdrew consent,
3 moved to other site, 2 other). The total person-yrs of observation were 79.4:
67.9 yrs on ABA, 11.5 after ABA. In this
registry, 33% (44/133) of pts were new starts on ABA and 28% (38/133) were
biologic naïve; 39% had received ABA treatment for 0–1 yrs and 28% for 1–2 yrs. ABA was continued
during follow-up in 85% of pts (113/133). Reasons for ABA discontinuation were
inefficacy (18), surgery (1) and therapy complete (1). Baseline. 86% of pts were female, mean/median: age at enrollment was 13.4/13.8
yrs, disease duration was 5.9/5.4 yrs, height percentile (WHO standards for
healthy children) 47.9/52.8, weight percentile 50.8/48.2 and 3.0/1.0 active joints.
Baseline clinical, functional and HRQoL scores are shown in the Table. 15%
had a history of uveitis and 4% had active uveitis. JIA subtype was systemic
3%, oligoarticular 21%, polyarticular RF– 54%, polyarticular RF+ 10%, psoriatic
5%, enthesitis-related 2%, undifferentiated 6%. 86% were taking a concomitant
JIA medication (64% MTX, 49% NSAIDs, 17% systemic steroids, 5% leflunomide, 5% hydroxychloroquine,
1% cyclosporine, 1% sulfasalazine). ABA was given IV every 4 weeks in 83% and SC
weekly in 17%. Follow-up effectiveness. Results up to 2 yrs are shown in the Table. Follow-up safety. Eleven AEs were seen (10 serious; all single occurrences) in 10 pts
(8% of study population) for an AE rate of 12.6 per 100 pt-yrs of exposure (95%
CI 6.9, 21.0). There were 2 infections of special interest (1 non-serious,
candida esophagitis; 1 serious, methicillin-resistant Staphylococcus aureus
wound infection). 1/133 (<1%) discontinued ABA due to a safety event (anaphylaxis).
No new autoimmune diseases, deaths, malignances or tuberculosis cases were reported.

Table. Follow-up effectiveness
Endpoints	Baseline n=133	3 months n=76	6 months n=52	12 months n=49	24 months n=3
Clinical
MD Global	1.9/1.0	1.45/1.0	1.7/1.0	1.3/0.5	1.0/1.0
CID,¹ %	33	38	31	49	50
JADAS	7.3/4.5	6.6/4.5	6.3/3.5	6.8/2.5	2.0/1.0
JADAS ID, %	32	18	10	12	2
JAMAR Functional²	4.0/2.0	3.6/3.0	3.8/3.0	3.7/2.5	0.5/0.5
JAMAR HRQoL	6.5/3.0	5.9/5.0	6.4/6.0	5.3/3.0	1.4/1.0
Data are mean/median unless otherwise indicated CID=clinical inactive disease (Wallace criteria); JADAS=Juvenile Arthritis Disease Activity Score (range 0–91); JADAS ID=Juvenile Arthritis Disease Activity Score Inactive Disease (JADAS ≤1); JAMAR Functional=Juvenile Arthritis Multidimensional Assessment Report Functionality Scale Child (range 0–15); JAMAR HRQoL=Juvenile Arthritis Multidimensional Assessment Report HRQoL Scale Child (range 0–15); MD Global=MD Global Disease Activity (VAS 0–10); VAS=visual analog scale

Conclusion: In this JIA cohort, abatacept demonstrated persistent
effectiveness with low MD Global, low number of active joints and over 30% of
pts were in CID. Abatacept was well tolerated and no new safety signals were
seen.

1. Wallace
C, et al. Arthritis Care Res 2011;63:929–36. 2.
Filocamo G, et al. J Rheumatol 2011;38:938–53.

Disclosure: D. J. Lovell, National Institutes of Health, 2,Astra-Zeneca, Bristol-Myers Squibb, AbbVie, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Biogen, Takeda, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Janssen, 5; N. Ruperto, Abbott, Bristol-Myers Squibb, "Francesco Angelini", GlaxoSmithKline, Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi-Aventis, Schwarz Biosciences, Sobi, Xoma,Wyeth, 2,Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi-Aven, 5,Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi-Aven, 8; S. Spalding, None; J. Dare, AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, UCB Biosciences, 2; R. Cimaz, None; V. Stanevica, None; R. Vehe, None; N. Tzaribachev, UCB, Pfizer, Janssen, Roche, 2; G. Horneff, Pfizer, Abbvie, Roche, 2; M. Trachana, Novartis, Roche, Pfizer, 5,Novartis, Abbvie, Bristol-Myers Squibb, 2; T. Simon, Bristol-Myers Squibb, 3; H. Brunner, Pfizer, Bristol-Myers Squibb, UCB, Janssen, Amgen, Celgene, AstraZeneca, Novartis, Genentech, 5,Novartis, Genentech, 8; A. Martini, Abbott, Bristol-Myers Squibb, "Francesco Angelini", GlaxoSmithKline, Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi-Aventis, Schwarz Biosciences, Sobi, Xoma, Wyeth, 2.

To cite this abstract in AMA style:

Lovell DJ, Ruperto N, Spalding S, Dare J, Cimaz R, Stanevica V, Vehe R, Tzaribachev N, Horneff G, Trachana M, Simon T, Brunner H, Martini A. Long-Term Effectiveness and Safety of Abatacept in Juvenile Idiopathic Arthritis: Interim Results from the Abatacept in JIA Registry [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/long-term-effectiveness-and-safety-of-abatacept-in-juvenile-idiopathic-arthritis-interim-results-from-the-abatacept-in-jia-registry/. Accessed .

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