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.
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