THU0516 LONG-TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB ADMINISTRATION IN SYSTEMIC AND POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS

Background: Tocilizumab (TCZ) administered intravenously (IV) was effective for the treatment of polyarticular (p)JIA and systemic (s)JIA.1,2 Objectives: To evaluate the long-term safety and efficacy of subcutaneous (SC) TCZ in patients (pts) with pJIA or sJIA enrolled in a long-term extension (LTE) phase of two 52-week, open-label studies. Methods: Pts aged 1-17 years received body weight (BW)–based TCZ SC: pJIA pts who failed/could not tolerate MTX received TCZ 162 mg every 3 weeks for BW Results: Most pJIA (n=44) and sJIA (n=38) pts were female (72.7% and 55.3%) and white (88.6% and 84.2%); median (range) age was 9.0 (2-18) years. AE rates (Table) were similar regardless of BW. Most AEs were grade 1 or 2; grade ≥3 AEs were reported by 10/44 (20.8%) pJIA pts and 4/38 (10.5%) sJIA pts, most commonly nasopharyngitis (pJIA, 17/44 [38.6%]; sJIA, 11/38 [28.9%]). Other AEs reported in ≥15% of pts included arthralgia, gastroenteritis, cough, vomiting, diarrhea, pyrexia, headache, and oropharyngeal pain (pJIA) and upper respiratory tract infection, cough, pyrexia, arthralgia, and rash (sJIA). No opportunistic infections developed. Neutropenia AEs were reported by 6/44 (13.6%) pJIA pts and 7/38 (18.4%) sJIA pts. SAEs occurred in 5/44 (11.4%) pJIA pts (furuncle, appendicitis, pneumonia, eye pain/headache, infectious mononucleosis) and 2/38 (5.3%) sJIA pts (pneumonia, craniocerebral injury from a fall); only pneumonia (pJIA) was considered treatment related. Neutralizing anti-TCZ antibodies developed in 2 (4.7%) pJIA pts and no sJIA patients. No deaths were reported in the LTE study. Conclusion: In this LTE study in children with pJIA or sJIA, SC TCZ continues to have an acceptable tolerability profile with no new safety concerns. References: [1] Brunner HI et al. Ann Rheum Dis. 2015;74:1110-1117. [2] 2. De Benedetti F et al. N Engl J Med. 2012;367:2385-2395. Disclosure of Interests: Fabrizio De Benedetti Grant/research support from: Abbvie, SOBI, Novimmune, Roche, Novartis, Sanofi, Pfizer, Nicolino Ruperto Grant/research support from: The Gaslini Hospital, where NR works as full-time public employee, has received contributions (> 10.000 USD each) from the following industries in the last 3 years: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties., Consultant for: Received honoraria for consultancies or speaker bureaus (