SAT0490 MATCHED CONTROLLED SURVEILLANCE OF TOCILIZUMAB TREATMENT FOR POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS–AN INTERIM ANALYSIS. (13th June 2020)

• Record Type: Journal Article
• Authors: Klein, A.; Hospach, T.; Weller-Heinemann, F.; Hansmann, S.; Kuemmerle-Deschner, J.; Fasshauer, M.; Minden, K.; Foeldvari, I.; Rietschel, C.; Schwarz, T.; Trauzeddel, R.; Hufnagel, M.; Foell, D.; Berendes, R.; Boeschow, G.; Oommen, P.; Dressler, F.; Helling-Bakki, A.; Horneff, G.
• Is Part Of: Annals of the rheumatic diseases. Volume 79(2020)Supplement 1
• Page Start: 1201
• Page End: 1202
• Publication Date: 2020-06-13
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2020-eular.4363
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Tocilizumab (TOC) is approved for treatment of polyarticular juvenile idiopathic arthritis (pJIA). Data out of clinical practice are limited. Objectives: Long-term surveillance of patients initiating TOC treatment compared to a cohort of patients initiating a comparator biologic using the BIKER-registry. Methods: Baseline parameters, efficacy and safety parameters were compared. Efficacy outcomes were JADAS10 and joint counts. Functional status was determined with the Childhood Health Assessment Questionnaire disability-index (CHAQ-DI). Safety was assessed by adverse events (AE) reports. Results: Until January 2020, 152 patients have been recruited to each cohort. Patients starting on TOC were older at treatment start (12.1 vs. 10.1 years (y); p<0.0001) and had a longer disease duration (5.4y vs. 3.0y; p<0.0001). TOC was significantly more often a second-line biologic (84% vs 13%, p< 0.0001). Otherwise patients were comparable (Table 1 ). Upon TOC a substantial response to treatment with a significant reduction in JADAS 10 from 16.8 to 3.4 (p<0.0001) after 12 months was observed. There were no significant differences between patients from the TOC cohort and their matched controls regarding JIA ACR 30/50/70/90 criteria and active joint counts. JADAS 10, JADAS remission (REM) and minimal disease activity (MDA) was reached by comparable numbers in the TOC (37% and 58%) and the control cohort (37% and 60%). While the total number of AE was comparable between the TOC cohort (58/100PY) and in the control cohort (54/100PY; RR 1.1; 95%CI 0.9-1.4), more serious AE (SAE) were reported with TOC (4.8/100PY compared to 1.4/100PY; RR 3.5; 95% CI 1-10.9). Medically important infections and uveitis events were documented at significantly lower frequency in the TOC- (0.8/100PY) than in the control cohort (4.1/100PY; RR 0.2; 95% CI 0.04-0.9). SAE with TOC were suicidal intent (n=3), depression (n=2), exacerbation of JIA, abscess, gastrointestinal infection, abdominal pain, colitis, bone surgery and fracture (n=1). SAE in the control cohort were depression, osteomyelitis, gastrointestinal infection and superinfected eczema (n=1). No significant differences regarding cytopenia and elevated transaminases were observed. No gastrointestinal perforation, no vascular event, no malignancy and no death occurred. Conclusion: The efficacy of tocilizumab is comparable to that of alternative biologics. Tolerability was acceptable. As Tocilizumab was given as a second-line biologic in the vast majority of patients, comparisons between the cohorts have to be interpreted carefully. Observation in the registry is ongoing. Disclosure of Interests: Ariane Klein Consultant of: Celgene, Toni Hospach: None declared, Frank Weller-Heinemann: None declared, Sandra Hansmann Consultant of: Advisory board Novartis Pharma, Jasmin Kuemmerle-Deschner Grant/research support from: Novartis, Sobi, Consultant of: Novartis, Sobi, Speakers bureau: Novartis, Sobi, Maria Fasshauer Consultant of: Shire, CSL Behring, Kirsten Minden Consultant of: GlaxoSmithKline, Sanofi, Speakers bureau: Roche, Ivan Foeldvari Consultant of: Novartis, Christoph Rietschel Consultant of: Pfizer, Abbvie, Novartis, Chugai, and Sobi, Tobias Schwarz: None declared, Ralf Trauzeddel: None declared, Markus Hufnagel: None declared, Dirk Foell Grant/research support from: Novartis, Sobi, Pfizer, Speakers bureau: Novartis, Sobi, Rainer Berendes: None declared, Gundula Boeschow: None declared, Prasad Oommen Consultant of: Novartis, Frank Dressler: None declared, Astrid Helling-Bakki: None declared, Gerd Horneff Grant/research support from: AbbVie, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bayer, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche