THU0495 Effectiveness of childhood vaccinations in caps patients treated with canakinumab: results from an open-label phase 3 extension study. (15th June 2017)

• Record Type: Journal Article
• Authors: Brogan, P; Hofer, M; Kuemmerle-Deschner, J; Lauwerys, B; Speziale, A; Wei, X; Laxer, R
• Is Part Of: Annals of the rheumatic diseases. Volume 76(2017)Supplement 2
• Page Start: 393
• Page End: 393
• Publication Date: 2017-06-15
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-eular.3349
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Canakinumab (CAN) has been shown not to impair antibody production following vaccination in children in an open-label phase 3 study (NCT01302860 ). 1 Here we present the results from the extension of this study. Objectives: To evaluate the presence of protective antibody levels following immunisation with inactivated vaccines in CAPS patients during extension study. Methods: Patients who completed the core study were allowed to continue into the extension study on the standard dosing regimen of 2 mg/kg subcutaneous CAN every 8 weeks or on last dose/dosing regimen received in the core study. Vaccination response was evaluated using post-vaccination antibody titres at 4 and 8 weeks after immunisation. Patients were considered assessable for an antibody response to a specific vaccination if they had a measurement of antibody titre 0–14 days post-vaccination (pre-vaccination assessment) and at least 1 subsequent measurement of antibody titre at 4 weeks and/or 8 weeks post-vaccination. However, for patients with adequate pre-dose antibody titres and maintained during the trial, the specific patient vaccination was deemed non-assessable. Results: During the extension phase, of 17 patients (≤6 years), 4 received 8 types of vaccinations against Corynebacterium diphtheriae, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, influenza type A and type B, Haemophilus influenzae B, Streptococcus pneumoniae, or hepatitis B. Of 20 unique patient-vaccination cases, 17 were assessable for a vaccination response, whereas for the remaining 3, pre-dose antibody titre was not available. For 16 (94.1%) assessable cases, post-vaccination antibody titres increased above protective levels. For one patient who received Tetravec formulation (diphtheria, tetanus and acellular pertussis combination), the response observed for 1 (vaccination against Clostridium tetani ) of the 3 vaccines included in Tetravac represented optical density rather than antibody concentrations and hence considered non-evaluable. For 19/20 patient-vaccinations, including those without pre-dose antibody titres, protective levels were observed during the study, which were maintained throughout the extension study. Conclusions: Canakinumab appeared to have no effect on post-vaccination antibody production following the administration of non-live vaccines in CAPS patients. References: Brogan P, et al. Arthritis Rheumatol. 2015;67:(S10). Disclosure of Interest: P. Brogan Grant/research support from: Novartis, Roche and SOBI, Consultant for: Novartis, M. Hofer Consultant for: Novartis, J. Kuemmerle-Deschner Grant/research support from: Novartis, SOBI, Baxalta, Consultant for: Novartis, B. Lauwerys: None declared, A. Speziale Employee of: Novartis, X. Wei Employee of: Novartis, R. Laxer Grant/research support from: Novartis for Database funding