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Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis.
Brunner, Hermine I; Ruperto, Nicolino; Ramanan, Athimalaipet V; Horneff, Gerd; Minden, Kirsten; Calvo Penades, Inmaculada; Alexeeva, Ekaterina; Cleary, Gavin; Stern, Sara M; Kone-Paut, Isabelle; Maldonado Velázquez, María Del Rocío; Rabinovich, C Egla; Remesal, Agustin; Silva, Clovis Artur; Nikishina, Irina; Zucchetto, Mauro; Brockwell, Laura; Gordon, Oliver; Nagel, Sandra; De Benedetti, Fabrizio.
Afiliación
  • Brunner HI; Pediatric Rheumatology Collaborative Study Group (PRCSG), University of Cincinnati, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
  • Ruperto N; IRCCS Istituto Giannina Gaslini, UOC Servizio Sperimentazioni Cliniche Pediatriche/Gaslini Trial Centre, PRINTO, Genoa, Italy.
  • Ramanan AV; Bristol Royal Hospital for Children and Translational Health Sciences, University of Bristol, Bristol, UK.
  • Horneff G; Department of General Paediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.
  • Minden K; Department of Pediatric and Adolescent Medicine, University Hospital of Cologne, Cologne, Germany.
  • Calvo Penades I; German Rheumatism Research Centre Berlin, Berlin, Germany.
  • Alexeeva E; Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité Universitätsmedizin, Berlin, Germany.
  • Cleary G; Paediatric Rheumatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain.
  • Stern SM; National Medical Research Center of Children's Health, Moscow, Russia.
  • Kone-Paut I; First Moscow State Medical University, Moscow, Russia.
  • Maldonado Velázquez MDR; Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
  • Rabinovich CE; Division of Pediatric Rheumatology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.
  • Remesal A; European Reference Network for Immunodeficiency, Autoinflammatory, Autoimmune, and Paediatric Rheumatic Diseases (ERN-RITA) Member, Pediatric Rheumatology and, Bicêtre Hospital AP-HP, Centre de Référence des Maladies Autoinflammatoires et des Amyloses (CéRéMAIA), Paris, France.
  • Silva CA; Hospital Infantil de México Federico Gómez, Distrito Federal, México.
  • Nikishina I; Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.
  • Zucchetto M; Pediatric Rheumatology Unit, University Hospital La Paz, Madrid, Spain.
  • Brockwell L; Pediatric Rheumatology Unit, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
  • Gordon O; Pediatric Department, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation.
  • Nagel S; Parexel International, Milan, Italy.
  • De Benedetti F; Roche Products Ltd, Welwyn Garden City, UK.
Rheumatology (Oxford) ; 63(9): 2535-2546, 2024 Sep 01.
Article en En | MEDLINE | ID: mdl-38552315
ABSTRACT

OBJECTIVE:

To investigate the safety and efficacy of subcutaneous tocilizumab (SC-TCZ) treatment in a long-term extension (LTE) of clinical trials in polyarticular or systemic juvenile idiopathic arthritis (pJIA or sJIA).

METHODS:

Patients with pJIA or sJIA from two open-label, 52-week phase 1b core trials of SC-TCZ who had adequate response per investigator assessment entered the LTE and continued SC-TCZ treatment according to body weight-based dosing regimens until commercial availability or up to 5 years. Pharmacokinetics, pharmacodynamics, and efficacy were assessed for up to 3 years, and safety for up to 5 years in the LTE.

RESULTS:

Forty-four patients with pJIA and 38 patients with sJIA entered the LTE. Tocilizumab trough concentrations were maintained within the range expected to provide clinical benefit (mean values pJIA, ∼10 µg/ml; sJIA, ∼75 µg/ml over 3 years). Pharmacodynamic parameters (interleukin-6, soluble interleukin-6 receptor, erythrocyte sedimentation rate, C-reactive protein) were maintained throughout the LTE at levels achieved in the core trials. Inactive disease per American College of Rheumatology provisional criteria was reported for 90% (17/19) and 53% (8/15) of patients with pJIA and 91% (10/11) and 92% (12/13) of patients with sJIA in the <30 and ≥30 kg body weight groups, respectively. Serious adverse events in the LTE were reported in six patients with pJIA (13.6%; five serious infections) and five patients with sJIA (13.2%; one serious infection).

CONCLUSION:

Patients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile. CLINICAL TRIAL REGISTRATION clinicaltrials.gov, NCT02165345.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Juvenil / Antirreumáticos / Anticuerpos Monoclonales Humanizados Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Juvenil / Antirreumáticos / Anticuerpos Monoclonales Humanizados Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido