1842: Vaccination in Patients with Autoinflammatory Periodic Syndromes Under Canakinumab - Safety Data Interim Analysis of the RELIANCE Registry

Jasmin B. Kuemmerle-Deschner¹, Joerg Henes², Birgit Kortus-Goetze³, Tilmann Kallinich⁴, Prasad T. Oommen⁵, Juergen Rech⁶, Tobias Krickau⁷, Frank Weller-Heinemann⁸, Gerd Horneff⁹, Ales Janda¹⁰, Ivan Foeldvari¹¹, Catharina Schuetz¹², Frank Dressler¹³, Michael Borte¹⁴, Markus Hufnagel¹⁵, Florian Meier¹⁶, Michael Fiene¹⁷, Julia Weber-Arden¹⁸ and Norbert Blank¹⁹, ¹Department of Pediatrics, Division of Pediatric Rheumatology, University Hospital Tübingen, Tübingen, Germany, ²Center for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases (INDIRA), University Hospital Tübingen, Tübingen, Germany, ³Division of Nephrology, University of Marburg, Marburg, Germany, ⁴Charité - Universitätsmedizin Berlin, Nuremberg, Germany, ⁵Clinic of Pediatric Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany, ⁶University Clinic Erlangen, Erlangen, Germany, ⁷Friedrich-Alexander Universität Erlangen-Nürnberg (FAU), Pediatrics, Erlangen, Germany, ⁸Klinikum Bremen-Mitte, Prof. Hess Kinderklinik, Bremen, Germany, ⁹Pediatrics, Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, ¹⁰Department of Pediatrics, University Hospital Ulm, Ulm, Germany, ¹¹Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany, ¹²Pediatrics, Medizinische Fakultaet Carl Gustav Carus, Technische Universitaet Dresden, Dresden, Germany, ¹³Division of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany, ¹⁴ImmunoDeficiencyCenter Leipzig (IDCL), Hospital St. Georg gGmbH Leipzig, Germany, Leipzig, Sachsen, Germany, ¹⁵Division of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, University Hospital Medical Center Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany, ¹⁶Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt, Germany, ¹⁷Rheumatology Center Greifswald, Greifswald, Germany, ¹⁸Novartis Pharma GmbH, Nuernberg, Germany, ¹⁹Rheumatology, University Hospital Heidelberg, Heidelberg, Germany

Background/Purpose: Treatment of autoinflammatory periodic syndromes with the interleukin-1β inhibitor canakinumab (CAN) has been shown to be safe and effective in clinical trials and in practice. Patients are recommended to be vaccinated against common infections (including influenza, covid-19, pneumococcus) while on therapy, as is the general population. It is known from the literature that severe local and systemic inflammatory reactions can occur frequently in patients with immunosuppressive therapy, especially after pneumococcal vaccination. Therefore, in the present study, in addition to general safety parameters, the safety of the recommended vaccinations in patients with CAPS, FMF, HIDS/MKD and TRAPS under CAN therapy was investigated in clinical practice.

Methods: RELIANCE is a prospective, non-interventional observational study in Germany enrolling pediatric (age ≥2 years) and adult patients with a clinically confirmed diagnosis of autoinflammatory periodic syndrome who routinely receive CAN. Efficacy and safety parameters were recorded at baseline and assessed at 6-months intervals.

Results: The interim analysis includes data from N=199 patients with autoinflammatory diseases enrolled in the RELIANCE registry between October 2017 and December 2021. The mean age of the overall cohort is 24.4 years (2-79 years; N=104 female patients [53%]) and the median duration of CAN treatment before study entry was 2 years (0-12 years).

During the study, N=87 patients received a total of 130 vaccinations. Vaccination reactions were reported for N=16 patients, and N=8 patients were classified as suspected adverse drug reactions (Table 1). In no case was the vaccination reaction classified as severe.

Covid-19 vaccination was given to N=42 patients (N=6 Comirnaty, N=1 Spikevax, N=36 not reported; 1 patient received 2 different vaccines). Of these, vaccination reactions were reported for N=6 patients, which were not considered drug-related or classified as severe.

Conclusion: The interim data from the RELIANCE study confirm the safety of long-term treatment with canakinumab in the entire study population. Vaccination while on CAN therapy also did not reveal any new safety signals beyond known vaccine side effects.

Table 1: Overview of vaccinations and vaccination side effects in the RELIANCE study across all study indications (Nf199 patients).
Disclosures: J. Kuemmerle-Deschner, AbbVie/Abbott, Novartis, SOBI; J. Henes, Boehringer Ingelheim; B. Kortus-Goetze, Novartis; T. Kallinich, Roche; P. Oommen, Novartis; J. Rech, Novartis, SOBI, AbbVie/Abbott, Biogen, Bristol-Myers Squibb(BMS), Chugai, GlaxoSmithKlein(GSK), Janssen, Eli Lilly, Merck/MSD, Mylan, Roche, Sanofi, UCB; T. Krickau, Novartis; F. Weller-Heinemann, None; G. Horneff, Roche, Pfizer, Novartis, Merck/MSD, Eli Lilly, AbbVie/Abbott; A. Janda, None; I. Foeldvari, None; C. Schuetz, Novartis; F. Dressler, Novartis, AbbVie/Abbott, Mylan, Pfizer; M. Borte, Pfizer, Shire; M. Hufnagel, Novartis; F. Meier, Novartis; M. Fiene, None; J. Weber-Arden, Novartis; N. Blank, Novartis, SOBI, Lilly, Pfizer, AbbVie/Abbott, Bristol-Myers Squibb(BMS), Merck/MSD, Actelion, UCB, Boehringer-Ingelheim, Roche.