Background/Purpose:  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. The objective of this study was to evaluate the presence of protective antibody levels following immunization 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 titers at 4 and 8 weeks after immunization. Patients were considered assessable for an antibody response to a specific vaccination if they had a measurement of antibody titer 0-14 days post-vaccination (pre-vaccination assessment) and at least 1 subsequent measurement of antibody titer at 4 weeks and/or 8 weeks post-vaccination. However, for patients with adequate pre-dose antibody titers 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 diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, influenza type A and type B, Haemophilus influenza 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 titer was not available. For 16 (94.1%) assessable cases, post-vaccination antibody titers 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 titers, protective levels were observed during the study, which were maintained throughout the extension.

Conclusion: Canakinumab appeared to have no effect on post-vaccination antibody production following the administration of non-live vaccines in CAPS patients. References: 1.Brogan P, et al. Arthritis Rheumatol. 2015;67:(S10).

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-of-childhood-vaccinations-in-caps-patients-treated-with-canakinumab-results-from-an-open-label-phase-iii-extension-study/