THU0503 Identification of optimal subcutaneous (SC) doses of tocilizumab in children with polyarticular-course juvenile idiopathic arthritis (PCJIA)

Background Efficacy and safety of intravenous (IV) tocilizumab(TCZ) have been shown in patients (pts) with pcJIA. 1 Objectives Determine appropriate dosing regimens of SC TCZ in pcJIA. Methods Pts were aged 1–17 y with pcJIA, inadequate response/intolerance to MTX and TCZ-naive or receiving TCZ IV with adequate disease control. TCZ SC was administered open label by body weight (BW)–based dosing modeled on IV dosing in pcJIA and SC dosing in adult rheumatoid arthritis: pcJIA pts Results 52 pts were enrolled; 27 min was similar between BW groups and higher than with TCZ IV (TCZ IV median C min : 3.2 μg/mL for 10mg/kg max was lower from SC than IV dosing. Changes in PD parameters for TCZ-naive pts were consistent with those for TCZ IV. JADAS-71 generally improved (Table), with trends consistent with those for TCZ IV. Infections were the most frequent adverse event (AE), reported in 36 pts; 2 serious infections occurred in 1 pt. Injection site reactionsoccurred in 15% pts in the Conclusions The BW-based TCZ SC dosing regimens for pcJIA provided adequate exposure to support efficacy comparable to that for TCZ IV, with an acceptable benefit-risk profile. References Brunner HI et al. Ann Rheum Dis 2014;74:1110–7. Disclosure of Interest F. De Benedetti Grant/research support from: Novartis, Roche, Pfizer, SOBI, AbbVie, Novimmune, BMS, Sanofi, N. Ruperto Consultant for: AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogenidec, Boehringer, BMS, Celgene, CrescendoBio, EMD Serono, Hoffmann-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Servier, Takeda, UCB Biosciences GmbH, Speakers bureau: AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogenidec, Boehringer, BMS, Celgene, CrescendoBio, EMD Serono, Hoffmann-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Servier, Takeda, UCB Biosciences GmbH, D. Lovell Grant/research support from: NIH, NIAMS, Consultant for: Astra-Zeneca, Bristol Meyers Squibb, AbbVie, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson& Johnson, Biogen, Takeda, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Janssen, A. Ramanan Speakers bureau: Roche, AbbVie, R. Cuttica Consultant for: Roche, Novartis, Lilly, GlaxoSmithKline, Bristol-MyersSquibb, Janssen, Speakers bureau: Roche, Novartis, Lilly, GlaxoSmithKline, Bristol-MyersSquibb, Janssen, J. Weiss: None declared, M. Henrickson: None declared, H. Schmeling Grant/research support from: Janssen, Pfizer, UCB Biosciences GmbH, J. Anton Grant/research support from: Roche, K. Minden Grant/research support from: AbbVie, Pfizer, Roche, Speakers bureau: AbbVie, Pfizer, Roche, Genzyme, Pharm-Allergan, J. Hsu Employee of: Roche, K. Bharucha Employee of: Genentech, S. Wimalasundera Employee of: Roche Products Ltd., A. Kadva Employee of: Genentech, R. Upmanyu Employee of: Roche Products Ltd., N. Mallalieu Shareholder of: Roche, Employee of: Roche, A. Martini Consultant for: Abbvie, Boehringer, Celgene, CrescendoBio, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi Aventis, Vertex, Servier, Speakers bureau: Abbvie, Boehringer, Celgene, CrescendoBio, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi Aventis, Vertex, Servier, H. Brunner: None declared