Postvaccination Antibody Titer Data in CAPS Patients Aged 28 Days to 4 Years Treated with Canakinumab: Results of an Open-Label Phase 3 Trial

Paul Brogan¹, Michaël Hofer², Jasmin B. Kuemmerle-Deschner³, Bernard R. Lauwerys⁴, Antonio Speziale⁵, Ken Abrams⁶, Karolynn Leon⁶, Xiaoling Wei⁷ and Ronald Laxer⁸, ¹Department of Paediatric Rheumatology, UCL Institute of Child Health and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom, ²Unité Romande de Rhumatologie Pédiatrique, Hospitalier Universitaire Vaudois, Lausanne, Switzerland, ³University Hospital Tuebingen, Tuebingen, Germany, ⁴Cliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels, Belgium, ⁵Novartis Pharma AG, Basel, Switzerland, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁷Novartis Pharma, Beijing, NU, China, ⁸University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Autoinflammatory Disease, canakinumab and interleukins (IL)

Session Information

Date: Sunday, November 8, 2015

Title: Miscellaneous Rheumatic and Inflammatory Diseases Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:
Patients
with autoinflammatory diseases treated with
immunosuppressive agents reportedly experience an increased risk of serious
infections.¹ Therefore, these patients are
likely candidates for vaccinations, such as those against the influenza virus
and meningococcal infections. A previous report has shown that treatment with canakinumab (CAN) does not affect antibody production after
vaccination in healthy volunteers²; however, no data are available
in patients with cryopyrin-associated periodic
syndrome (CAPS) receiving standard childhood vaccines. Here we assess the
presence of protective antibody levels following immunization with inactivated
vaccines in patients with CAPS.

Methods: Patients aged 28 days to 4 years
received CAN at 2 to 12 mg/kg (based on body weight) every 4 or 8 weeks for 56
weeks. Vaccination response was evaluated using postvaccination
antibody titers at 0 to 14 (predose assessment), 28,
and 57 days after vaccination. Patients were considered assessable for an
antibody response to a specific vaccination if they had a predose
and at least one postdose antibody titer measurement.
However, for patients with adequate predose antibody
titers without any difference at subsequent antibody titer measurements, the
specific patient vaccination was deemed non-assessable.

Results: Of 17
patients, 7 (aged 5-60 months) received ≥1 vaccinations
against Corynebacterium diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani,
influenza type A, influenza type B, Haemophilus influenza B, Streptococcus
pneumoniae, or hepatitis B. The Table summarizes predose antibody titers and the last measured antibody
titer during the study for each patient and corresponding vaccination. Of 31
unique patient vaccination cases, only 18 were assessable for a vaccination
response, whereas for the remaining 13, patient-vaccination was not deemed
assessable. For all 18 (100%) assessable cases, postvaccination
antibody titers increased to protective levels compared to the predose measurement. All the 31 vaccination cases showed
protective level antibody titers at the last assessment in the study. No CAPS
flares were reported with vaccination.

Table.
Summary of vaccination assessments

Conclusion: Canakinumab appears to have no effect on antibody
production against standard childhood nonlive
vaccines.

References:

1. Doran, M.F., et al. Arthritis Rheum. 2002;46:2287-93.

2.
Chioato A., et al. Clin Vaccine Immunol.
2010;17:1952-57.

Disclosure: P. Brogan, Roche Pharmaceuticals and SOBI, 5; M. Hofer, Abbvie, 2,Abbvie and Novartis Pharmaceutical Corporation, 5; J. B. Kuemmerle-Deschner, Novartis Pharmaceutical Corporation, 8,Novartis and Sobi, 5; B. R. Lauwerys, None; A. Speziale, Novartis, 3; K. Abrams, Novartis, 1,Novartis, 3; K. Leon, Novartis Pharmaceutical Corporation, 3; X. Wei, Novartis Pharmaceutical Corporation, 3; R. Laxer, None.

To cite this abstract in AMA style:

Brogan P, Hofer M, Kuemmerle-Deschner JB, Lauwerys BR, Speziale A, Abrams K, Leon K, Wei X, Laxer R. Postvaccination Antibody Titer Data in CAPS Patients Aged 28 Days to 4 Years Treated with Canakinumab: Results of an Open-Label Phase 3 Trial [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/postvaccination-antibody-titer-data-in-caps-patients-aged-28-days-to-4-years-treated-with-canakinumab-results-of-an-open-label-phase-3-trial/. Accessed .

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