ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 282

Pharmacovigilance in Juvenile Idiopathic Arthritis Patients (PHARMACHILD) Treated with Biologic Agents and/or Methotrexate. Consolidated Baseline Characteristics from Pharmachild and Other National Registries

Joost F. Swart1, Alessandro Consolaro2, Gerd Horneff3, Kimme L. Hyrich4, Francesca Bovis5, Bo Magnusson6, Jose Melo-Gomes7, Ekaterina Alexeeva8, Stefano Lanni9, Gerd Ganser10, Violeta Vladislava Panaviene11, Jordi Anton12, Ivan Foeldvari13, Valda Stanevicha14, Susan Nielsen15, Ralf Trauzeddel16, Constantin Ailioaie17, Pierre Quartier18, Toni Hospach19, Gordana Susic20, Maria Trachana21, Frank Weller-Heinemann22, Alberto Martini23, Nico Wulffraat24 and Nicolino Ruperto25, 1Pediatric Rheumatology, Wilhelmina Children's Hospital/ UMC Utrecht, Utrecht, Netherlands, 2Pediatria II, Istituto Giannina Gaslini, Genova, Italy, 3Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany, 4Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, 5Pediatria II, PRINTO, PRINTO - Istituto Giannina Gaslini, Genoa, Italy, 6Pediatric Rheumatology, Karolinska University Hospital, Stockholm, Sweden, 7Pediatric Rheumatology, Lisbon, Portugal, 8Scientific Centre of Children’s Health of RAMS, Moscow, Russia, 9Pediatria II, Istituto Giannina Gaslini, Genoa, Italy, 10Pediatric Rheumatology, Sankt Josef Stift, Sendenhorst, Germany, 11Children‘s Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos, Vilnius, Lithuania, 12Hospital Sant Joan de Déu, Barcelona, Spain, 13Department of Pediatric Rheumatology, Hamburger Zentrum für Kinder und Jugendrheumatologie, Hamburg, Germany, 14Department of Paediatrics, Riga Stradins University, Riga, Latvia, 15University Clinic of Pediatrics II, Rigshospitalet, Copenhagen, Denmark, 16Pediatrics, Helios Clinics, Berlin, Germany, 17Department of Medical Physics, Alexandru Ioan Cuza University, Iasi, Romania, 18Necker-Enfants Malades Hospital, Paris, France, 19Pediatric Rheumatology, Olgahospital, Stuttgart, Germany, 20Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, Serbia, 21Aristotle University, Thessaloniki, Greece, 22Klinikum Bremen-Mitte, Bremen, Germany, 23PRINTO-IRCCS, Genova, Italy, 24Pediatric rheumatology, Wilhelmina Children's Hospital/ UMC Utrecht, Utrecht, Netherlands, 25Pediatria II,, Istituto Giannina Gaslini, Genoa, Italy

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects: Juvenile Idiopathic Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose The availability of methotrexate (MTX) and biological agents has provided a major change in the treatment of children with juvenile idiopathic arthritis (JIA). However, limited information exists on the safety of the current available treatements. An international registry named Pharmachild (European Union grant 260353) has been set up by the Pediatric Rheumatology International Trials Organisation (PRINTO)/Paediatric Rheumatology European Society (PRES). In parallel several national registries with the same purpose have been set up in different European Countries for the follow-up of these patients.

Methods We merged into a unified database the baseline demographic data of JIA patients treated with MTX or biologicals coming from the Pharmachild registry and from the national registries of Germany, United Kindgom, Sweden and Portugal. Events of special interest (ESI) and moderate/severe/serious adverse events (AE) related to the drugs were collected. Data are presented as frequencies (%) or medians with 1st and 3rd quartiles.

Results About 61% of the patients have been treated with biologicals alone or in combination with MTX, and 29% only with MTX. The events of special interest ranged from 0.1 to 15.0% and the other adverse events from 4.8% to 69.9%.

 

Pharmachild

N = 5571

NR UK

N = 1537

NR Germany

N = 3243

NR Portugal

N = 112

NR Sweden

N = 1403

TOTAL

N = 11866

Age at onset

5.4 (2.4 – 10.0)

–

7.2 (3.1-11.4)

N=3094

6.3 (2.5-10.9)

6.6 (2.7-11.1)

–

Age at JIA Diagnosis

6.2 (2.8 – 11.0)

5.5 (2.1-10.2)

N=1495

8.2 (4.0-12.3)

N=2067

7.3 (3.3-12.3)

–

–

Disease duration at the last available follow up

4.9 (2.5 – 8.2)

5.4 (2.7 – 8.8)

N=1383

5.2 (3.1-8.4)

N=3090

3.0 (0.5-9.6)

4.2 (2.2-7.7)

–

Therapy with MTX only

1365 (24.5)

503 (32.7)

1132/3134 (36.1)

0 (0.0)

408/1308 (31.2)

3408/11662 (29.2)

Therapy with only one Biologic Drug

204 (3.7)

31 (2.0)

104/3134 (3.3)

1 (0.9)

88/1308 (6.7)

428/11662 (3.7)

Therapy with only one Biologic Drug + MTX

2378 (42.7)

862 (56.1)

1545/3134 (49.2)

27 (24.1)

388/1308 (29.7)

5200/11662 (44.6)

Therapy with more than one Biologic

35 (0.6)

0 (0.0)

13/3134 (0.4)

6 (5.4)

43/1308 (3.3)

97/11662 (0.8)

Therapy with more than one Biologic + MTX

872 (15.6)

141 (9.2)

340/3134 (10.8)

78 (69.6)

8/1308 (0.6)

1439/11662 (12.3)

Nr. patients with ESI or moderate/severe/serious AE

1070 (19.2)

1093 (71.1)

1163(37.1)

27 (24.1)

11 (0.8)

3364 (28.4)

Nr. patients with ESI

496 (8.9)

230 (15.0)

249 (7.9)

5 (4.5)

2 (0.1)

982 (8.3)

Nr. patients with AE or moderate/severe/serious AE

729 (13.1)

1075 (69.9)

1069 (34.1)

24 (21.4)

68 (4.8)

2965 (25.0)

Conclusion Combination of information from different data sources is a recommended task and will provide a powerful tool for the future analysis of safety events coming from different registries.

Disclosure:

J. F. Swart,
None;

A. Consolaro,
None;

G. Horneff,

AbbVie, Pfizer, and Roche ,

2,

AbbVie, Novartis, Pfizer, and Roche,

8;

K. L. Hyrich,

Pfizer Inc,

9,

Abbott Immunology Pharmaceuticals,

9;

F. Bovis,
None;

B. Magnusson,
None;

J. Melo-Gomes,
None;

E. Alexeeva,

Roche Pharmaceuticals,

2,

Abbott Immunology Pharmaceuticals,

2,

Pfizer Inc,

2,

Bristol-Myers Squibb,

2,

Centocor, Inc.,

2,

Novartis Pharmaceutical Corporation,

2,

Merck Sharp & Dohme,

8,

Medac,

8;

S. Lanni,
None;

G. Ganser,

Pfizer Inc,

9,

Abbvie,

9;

V. V. Panaviene,

abbvie,

8,

Pfizer Inc,

2;

J. Anton,
None;

I. Foeldvari,

Novartis Pharma AG, Abbott, Chugai, Genzyme,

5;

V. Stanevicha,
None;

S. Nielsen,
None;

R. Trauzeddel,
None;

C. Ailioaie,
None;

P. Quartier,
None;

T. Hospach,
None;

G. Susic,
None;

M. Trachana,

Abbvie,

2,

Novartis Pharmaceutical Corporation,

2,

Printo,

2;

F. Weller-Heinemann,
None;

A. Martini,
None;

N. Wulffraat,
None;

N. Ruperto,
None.

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