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Ann Rheum Dis. 2018 Jan;77(1):21-29. doi: 10.1136/annrheumdis-2016-210456. Epub 2017 May 15.

Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial.

Author information

1
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
2
Istituto Giannina Gaslini, Pediatria II - Rheumatologia, PRINTO, Genoa, Italy.
3
Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany.
4
Department of Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.
5
Hospital Pediatry, State Pediatric Medical Academy, Saint Petersburg, Russian Federation.
6
Centre of Pediatrics, Vilnius University, Vilnius, Lithuania.
7
Regional Unit of Rheumatology and Osteoporosis, Central Hospital "Dr. Ignacio Morones Prieto" and Faculty of Medicine, Universidad Autónoma de San Luis Potosí, Mexico, San Luis Potosí, Mexico.
8
Department of Rheumatology, Children's Hospital of Los Angeles, Los Angeles, California, USA.
9
Children's Health of RAMS and IM Sechenov First Moscow State Medical University, Moscow, Russian Federation.
10
Hospital Universitario, Universidad Autónoma de Nuevo León, Nuevo León, Mexico.
11
Samara Regional Clinical Hospital, Samara, Russian Federation.
12
Randall Children's Hospital at Legacy Emanuel, Portland, Oregon, USA.
13
Hospital Infantil de Mexico Federico Gomez, Distrito Federal, Mexico.
14
Pediatric Department, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation.
15
Department of Rheumatology, The Hospital for Sick Children, Toronto, Canada.
16
ZNA Jan Palfijn, Antwerpen, Belgium.
17
Medical University of Łódź, Łódź, Poland.
18
Hospital Pequeno Principe, Curitiba, Brazil.
19
Department of Pediatric Rheumatology, Charité University Medicine, Berlin, Germany.
20
Department of Paediatric Immunology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
21
University Children's Hospital, Wien, Austria.
22
Klinikum Eilbek, Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany.
23
Pôle de pathologies rhumatismales systémiques et inflammatoires, Université catholique de Louvain, Institut de Recherche Clinique, Brussels, Belgium.
24
Nucleo de Estudos da Saúde do Adolescente, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil.
25
Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.

Abstract

OBJECTIVE:

This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA).

METHODS:

In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety.

RESULTS:

Among 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1% of all injections. PK analysis confirmed adequate golimumab dosing for polyJIA.

CONCLUSION:

Although the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred.

CLINICAL TRIAL REGISTRATION:

NCT01230827; Results.

KEYWORDS:

anti-tumour necrosis factor; biologics; golimumab; juvenile idiopathic arthritis

PMID:
28507219
PMCID:
PMC5754736
DOI:
10.1136/annrheumdis-2016-210456
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: HIB has served as a consultant and steering committee member for Janssen Research & Development, a consultant for AstraZeneca, Pfizer and Takeda and received research support from Novartis, Roche and UCB. NR served on the speaker’s bureau and as a consultant for AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogen Idec, Boehringer, BMS, Celgene, CrescendoBio, EMD Serono, F. Hoffmann-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Servier, Takeda and UCB Biosciences GmbH. DJL has served as a consultant for Boehringer Ingelheim, Celgene, Janssen Research & Development and Novartis, as a trial investigator for AbbVie, Bristol-Myers Squibb, Janssen Research & Development, Roche, Pfizer and UBC and received research support from the National Institutes of Health. NRP received fees from AbbVie and Roche. FS received research support from Janssen. KM received research support from Pfizer, AbbVie, Roche and Deutsche Kinder-Rheumastiftung and fees from AbbVie, Genzyme, Medac, Pfizer and Pharm-Allergan. IN received fees from AbbVie, Bristol-Myers Squibb, Novartis, Pfizer and Roche and grants from Pfizer and Roche. EA received research support from AbbVie, Bristol-Myers Squibb, Janssen, Novartis, Pfizer and Roche and fees from AbbVie, Bristol-Myers Squibb, Medac, Merck Sharp & Dohme, Novartis, Pfizer and Roche. KEG, ZX, JHL, LK, SLL and MJL are employees of Janssen Research & Development, LLC and own stock in Johnson & Johnson. AM received speaking and consulting fees from AbbVie, Boehringer, Celgene, CrescendoBio, Janssen, MedImmune, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Vertex and Servier. Nothing to disclose: NT, GH, VGC, CAM, AR, DJK, EDS, VP, MRMV, ES, MB, ARK, VK, RJ, WE, IF, BRL.

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