ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2272

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

Daniel J Lovell1, N Ruperto2, N Tzaribachev3, A Zeft4, Rolando Cimaz5, V Stanevica6, Gerd Horneff7, John F. Bohnsack8, Thomas A. Griffin9, R Carrasco10, Maria Trachana11, Jason A Dare12, I Foeldvari13, Richard K Vehe14, TA Simon15, Hermine I. Brunner16 and Alberto Martini2, 1Cincinnati Children’s Hosp. Medical Center, Cincinnati, OH, 2Istituto G. Gaslini Pediatria II Reumatologia, Genova, Italy, 3University Medical Center Schleswig-Holstein, Bad Bramstedt, Germany, 4Cleveland Clinic, Cleveland, OH, 5Azienda Ospedaliero-Universitaria 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, 10Specially For Children, Austin, TX, 11Hippokration General Hospital, Thessaloniki, Greece, 12University of Arkansas for Medical Sciences, Little Rock, AR, 13Hamburg Centre for Pediatric Rheumatology, Hamburg, Germany, 14University of Minnesota, Minneapolis, MN, 15Bristol-Myers Squibb, Princeton, NJ, 16Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: ,

Session Information

Date: Tuesday, November 7, 2017

Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects Poster III: Juvenile Arthritis

Session Type: ACR Poster Session C

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

Background/Purpose: Abatacept is an FDA- and EMA-approved biologic that is widely used in children with juvenile idiopathic arthritis (JIA). The purpose of this long-term ongoing registry is to describe the longitudinal effectiveness and safety of SC and IV abatacept 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 pts with JIA currently on or starting abatacept in this longitudinal registry. Planned duration of follow-up is 10 years (yrs) and data shown are those collected through March 31, 2017 (up to 4 yrs’ follow-up). Results: Overall, 354 pts with JIA were enrolled since January 2013, resulting in a total abatacept exposure of 364.5 pt-yrs (mean/median duration of abatacept treatment was 12.4/6.5 months), and 76 (22%) pts were new starters on abatacept (≤1 month of treatment), 76 (22%) had received abatacept for >1–≤6 months, 73 (20%) for >6–≤12 months and 129 (36%) for >12 months. SC abatacept was used in 80 (23%) pts and IV in 274 (77%); 4% of the pts were aged 2–5 yrs at enrollment.        Baseline: Of the 354 pts, 281 (79%) were female, mean/median age at enrollment was 13.0/13.6 yrs, and 15 (4%) were aged 2–5 yrs. JIA subtypes were: systemic (2%), oligoarticular (21%), polyarticular RF– (58%), polyarticular RF+ (9%), psoriatic (3%), enthesitis-related (3%) and undifferentiated (4%). At baseline, JIA duration was 5.4/4.4 yrs, mean/median active joint count was 2.9/0, a history of uveitis was recorded in 47 (13%) pts and 14 (4%) had active uveitis. Concomitant JIA medications were used by 81% of pts (58% MTX, 48% NSAIDs, 8% systemic steroids, 3% leflunomide, 4% hydroxychloroquine, <1% cyclosporine, 1% sulfasalazine).        Follow-up outcomes & safety. Clinical, functional and HRQoL scores are based on observed results for up to 4 yrs’ time in the registry (Table). In total, 23 serious AEs were reported (all single occurrences) in 23 pts (6% of study population), resulting in an overall serious AE rate per 100 pt-yrs on treatment of 6.3 (95% CI 4.1, 9.3). There were three events of special interest (ESI): acute uveitis, MRSA wound infection, infusion reaction; the ESI rate was 0.82/100 pt-yrs on treatment (95% CI 0.2, 2.2). No new autoimmune diseases, malignances or tuberculosis cases were reported. There was one death due to pre-existent cardiopulmonary disease considered unrelated to abatacept.

Conclusion: Abatacept was well tolerated and no new safety signals were observed. In this JIA cohort, abatacept demonstrated persistent effectiveness with low MD Global disease activity, low number of active joints and >30% of pts had clinical inactive disease.  

Table 1. Patient disposition at last registry visit

Endpoints

Baseline

(n=354)

3 months (n=286)

6 months (n=252)

12 months (n=231)

24 months (n=81)

36 months

(n=27)

42 months

(n=14)

MD Global

1.9/1.0

1.5/1.0

1.5/0.5

1.2/0.5

0.75/0.5

1.5/0.5

1.1/0.5

CID,1 %

33

32

38

48

52

37

29

JAMAR Functional2

6.3

5.2

5.3

4.5

2.9

3.7

4.2

JAMAR HRQoL

7.6

6.4

6.2

5.6

5.3

5.3

6.5

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, 0 = no functional limitation); JAMAR HRQoL=Juvenile Arthritis Multidimensional Assessment Report Health-Related Quality of Life Scale Child (range 0–15, 0 = best possible HRQoL); MD Global=MD Global Assessment of JIA Activity (VAS 0–10; 0=inactive); VAS=visual analog scale

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, NIAMS, 2,AstraZeneca, Bristol-Myers Squibb, AbbVie, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Biogen, Takeda, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Janssen, 5,Genentech and Biogen IDEC Inc., 8; N. Ruperto, BMS, Hoffman-La Roche, Janssen , Novartis, Pfizer, Sobi, 2,AbbVie, Ablynx, Amgen, AstraZeneca, Baxalta Biosimilars, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Eli-Lilly, EMD Serono, Hoffman-La Roche, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Servier, Sinergie, Takeda, 8,AbbVie, Ablynx, Amgen, AstraZeneca, Baxalta Biosimilars, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Eli-Lilly, EMD Serono, Hoffman-La Roche, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Servier, Sinergie, Takeda, 5; N. Tzaribachev, None; A. Zeft, None; R. Cimaz, None; V. Stanevica, None; G. Horneff, AbbVie, Pfizer, Chugai, Roche, Novartis, 8; J. F. Bohnsack, None; T. A. Griffin, None; R. Carrasco, BMS, Pfizer, 2,Genentech and Biogen IDEC Inc., 8,Forest Research, 6; M. Trachana, None; J. A. Dare, AbbVie, AstraZeneca, BMS, Horizon Pharma, Medac, Pfizer, Roche, UCB, 2; I. Foeldvari, Bayer, Genentech, Medac, Novartis, 5; R. K. Vehe, None; T. Simon, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1, 9; H. I. Brunner, Novartis, Genentech, Pfizer, UCB, Lilly, Jannsen, Ablynx, AbbVie, BMS, EMD Serono, AstraZeneca, 5,Genentech and Novartis, 8; A. Martini, AbbVie, Boehringer, Novartis, R-Pharm, 5.

To cite this abstract in AMA style:

Lovell DJ, Ruperto N, Tzaribachev N, Zeft A, Cimaz R, Stanevica V, Horneff G, Bohnsack JF, Griffin TA, Carrasco R, Trachana M, Dare JA, Foeldvari I, Vehe RK, Simon T, Brunner HI, Martini A. Long-Term Effectiveness and Safety of Abatacept in Juvenile Idiopathic Arthritis: Ongoing Results from the Abatacept in JIA Registry [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/long-term-effectiveness-and-safety-of-abatacept-in-juvenile-idiopathic-arthritis-ongoing-results-from-the-abatacept-in-jia-registry/. Accessed .

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