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

DJ Lovell¹, N Ruperto², N Tzaribachev³, A Zeft⁴, R Cimaz⁵, V Stanevica⁶, G Horneff⁷, J Bohnsack⁸, TA Griffin⁹, R Carrasco¹⁰, M Trachana¹¹, JA Dare¹², I Foeldvari¹³, RK Vehe¹⁴, TA Simon¹⁵, N Baker¹⁵, Hermine I. Brunner¹⁶ and A Martini², ¹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Istituto G. Gaslini Pediatria II Reumatologia, Genova, Italy, ³University Medical Center Schleswig-Holstein, Bad Bramstedt, Germany, ⁴Pediatric Rheumatology, Cleveland Clinic, Cleveland, OH, ⁵Pediatrics, Ospedale Pediatrico Anna Meyer, Florence, Italy, ⁶Riga Stradins University, Riga, Latvia, ⁷Asklepios Klinik Zentrum für Allgemeine Paediatrie und Neonatologie, Sankt Augustin, Germany, ⁸University of Utah School of Medicine, Salt Lake City, UT, ⁹Levine Children’s Hospital at Carolinas Medical Center, Charlotte, NC, ¹⁰Pediatric Rheumatology, Specially For Children, Austin, TX, ¹¹Hippokration General Hospital, Thessaloniki, Greece, ¹²University of Arkansas Medical Center, Little Rock, AR, ¹³Hamburg Centre for Pediatric Rheumatology, Hamburg, Germany, ¹⁴University of Minnesota, Minneapolis, MN, ¹⁵Bristol-Myers Squibb, Princeton, NJ, ¹⁶Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords: Abatacept, juvenile idiopathic arthritis (JIA) and pediatrics

Session Information

Date: Sunday, November 13, 2016

Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects - Poster I: Juvenile Idiopathic Arthritis, Uveitis

Session Type: ACR Poster Session A

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

Background/Purpose: Abatacept 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 abatacept in JIA patients.

Methods: Using a standardized protocol, clinical sites in the Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trial Organization (PRINTO) enrolled patients with JIA currently on or starting abatacept in this longitudinal registry. Planned duration of follow-up is 10 years and data shown are those collected through 31 March, 2016 (up to 3 years of follow-up).

Results: Overview. Of 315 enrolled patients with JIA, 308 contributed data. The total mean person-years of observation were 231.9 years on abatacept. In this registry, 35 (11%) patients were new starters on abatacept (≤ 1 month of treatment), 207 (67%) had received abatacept for 1 month–1 year, 52 (18%) for 1–2 years and 14 (4%) >2 years. During follow-up, 224 (73%) patients continued abatacept. Baseline. Of the 308 patients with data, 246 (80%) were female, mean/median age at enrollment was 13.2/13.8 years, disease duration was 5.4/4.4 years, and the active joint count was 2.7/0. Baseline clinical, functional and health-related quality of life scores are shown in Table 1 based on results up to 3 years. A history of uveitis was recorded in 40 (13%) patients and 12 (4%) had active uveitis. JIA subtype was: systemic (2%), oligoarticular (21%), polyarticular RF– (53%), polyarticular RF+ (10%), psoriatic (4%), enthesitis-related (4%), undifferentiated (6%). Concomitant JIA medication was taken by 86% of patients (64% MTX, 49% NSAIDs, 17% systemic steroids, 5% leflunomide, 5% hydroxychloroquine, 1% cyclosporine, 1% sulfasalazine). Follow-up safety. A total of 30 AEs were reported (18 serious; all single occurrences) in 25 patients (0.8% of study population), resulting in an overall AE rate of 12.9 per 100 patient-years (95% CI 8.8, 18.2). There were 12 infections of special interest (5.0/100 patient-years, 95% CI 2.8, 8.8). Two patients discontinued abatacept due to a safety event (anaphylaxis). No new autoimmune diseases, deaths, malignances or tuberculosis cases were reported.

Conclusion: In this JIA cohort, abatacept demonstrated persistent effectiveness with low MD global disease activity, low number of active joints and over 30% of patients were in clinical inactive disease. Abatacept was well tolerated and no new safety signals were observed. 1. Wallace C, et al. Arthritis Care Res 2011;63:929–36. 2. Filocamo G, et al. J Rheumatol 2011;38:938–53.

Table 1. Follow-up effectiveness
Endpoints	Baseline (n=308)	3 months (n=247)	6 months (n=215)	12 months (n=121)	24 months (n=35)
Clinical
MD Global	1.9/1.0	1.46/1.0	1.49/0.5	1.13/0.5	0.89/0.5
CID,¹ %	33	32	38	50	37
JAMAR Functional²	5.4/3.0	4.8/3.0	4.3/2.0	3.6/0.5	2.7/2.0
JAMAR HRQoL	6.9/6.0	6.0/5.0	5.6/4.0	4.9/3.0	5.1/4.0
Data are mean/median unless otherwise indicated CID=clinical inactive disease (Wallace criteria); JAMAR Functional=Juvenile Arthritis Multidimensional Assessment Report Functionality Scale Child (range 0–15); JAMAR HRQoL=Juvenile Arthritis Multidimensional Assessment Report Health-Related Quality of Life Scale Child (range 0–15); MD Global=MD Global Disease Activity (VAS 0–10); VAS=visual analog scale

Disclosure: D. Lovell, NIH, Bristol-Myers Squibb, AbbVie, Pfizer, Roche, 2,Genentech, 8,Novartis, Takeda, GSK, Boehringer Ingelheim, Celegene, 5; N. Ruperto, The Gaslini Hospital, which is the public Hospital where I work as full time public employee, has received contributions from the following industries: Abbott, Bristol-Myers Squibb,, 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; N. Tzaribachev, None; A. Zeft, None; R. Cimaz, None; V. Stanevica, None; G. Horneff, AbbVie, Pfizer, Chugai, Roche, Novartis, 8; J. Bohnsack, None; T. Griffin, None; R. Carrasco, BMS, Pfizer, 2,Genentech, 8; M. Trachana, None; J. Dare, AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, UCB, 2; I. Foeldvari, Bayer, Genentech, Novartis, Chugai, 5; R. Vehe, None; T. Simon, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; N. Baker, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; H. I. Brunner, BMS, Novartis, Genentech, Pfizer, Sanofi, Takeda, AstraZeneca, Janssen, 5,Novartis, Genentech, 8; A. Martini, The Gaslini Hospital, which is the public Hospital where I work as full time public employee, has received contributions from the following industries: Abbott, Bristol-Myers Squibb,, 2,Abbott, AbbVie, Amgen, Biogen IDEC, Bristol-Myers Squibb, Astellas, Boehringer, Italfarmaco, Janssen, MedImmune, Novartis, Novo Nordisk,, 5,Abbott, AbbVie, Amgen, Biogen IDEC, Bristol-Myers Squibb, Astellas, Boehringer, Italfarmaco, Janssen, MedImmune, Novartis, Novo Nordisk,, 8.

To cite this abstract in AMA style:

Lovell D, Ruperto N, Tzaribachev N, Zeft A, Cimaz R, Stanevica V, Horneff G, Bohnsack J, Griffin T, Carrasco R, Trachana M, Dare J, Foeldvari I, Vehe R, Simon T, Baker N, Brunner HI, Martini A. Long-Term Effectiveness and Safety of Abatacept in Juvenile Idiopathic Arthritis: Interim Results from the Abatacept in JIA Registry [abstract]. Arthritis Rheumatol. 2016; 68 (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-2/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-effectiveness-and-safety-of-abatacept-in-juvenile-idiopathic-arthritis-interim-results-from-the-abatacept-in-jia-registry-2/