POS1558 LONG-TERM SAFETY OF CANAKINUMAB IN AUTOINFLAMMATORY PERIODIC FEVER SYNDROMES – 48-MONTH DATA FROM THE RELIANCE REGISTRY
2023-05-30

<h3>Background</h3> Autoinflammatory periodic diseases (AID) can be treated with the interleukin-1β inhibitor canakinumab (CAN). CAN has been shown to be safe and effective in controlled trials and routine clinical practice. <h3>Objectives</h3> In this study general safety parameters in patients with canakinumab in cryopyrin-associated periodic syndromes (CAPS), familial Mediterranean fever (FMF), hyper-IgD syndrome/mevalonate kinase deficiency (HIDS/MKD) and tumor necrosis factor receptor-associated periodic syndrome (TRAPS) on CAN therapy were investigated in routine clinical practice. <h3>Methods</h3> RELIANCE is a prospective, non-interventional, observational study in Germany enrolling pediatric (age ≥2 years) and adult patients with a clinically confirmed diagnosis of AID who routinely receive CAN. Efficacy and safety parameters are recorded at baseline and assessed at 6-month intervals. <h3>Results</h3> Data from N=232 patients (N=229 with baseline visit yet documented) diagnosed with autoinflammatory diseases enrolled in the RELIANCE registry between October 2017 and December 2022 were included in the present interim analysis. Median age of the total study cohort was 20.0 years (2−80 years), 52% were female and median duration of CAN treatment before study entry was 2 years (0−15 years). During the study, 898 adverse events (AE) occurred in N=164 patients (71%). Among the most common AE classified as suspected adverse drug reactions (ADR) were decreased neutrophil count (8 events, IR 1.46), increased inflammatory markers (12 events, IR 2.19), nasopharyngitis (14 events, IR 2.55), and pyrexia (17 events, IR 3.10). In N=35 patients (15%), a total of 98 serious adverse events (SAE) were reported. Of these events, 31 SAE were classified as suspected adverse drug reactions (SADR; Table 1). During the last 3 years of observation within the study, incidence rates (IR) decreased from 76.21 to 51.44 (ADR) and 7.44 to 5.66 (SADR). Patients receiving greater than standard dose CAN experienced higher levels of ADR/SADR compared to patients under less than standard and standard dosing. How much high dosage or severeness of disease contribute to this phenomenon remains unclear. AE related dose reductions have not been reported. <h3>Conclusion</h3> The 48-month interim data of the RELIANCE study confirm sustained safety of long-term treatment with CAN in the entire study population. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> J. B. Kuemmerle-Deschner Consultant of: Novartis, AbbVie, Sobi, Grant/research support from: Novartis, AbbVie, Sobi, Jörg Henes Consultant of: Novartis, AbbVie, Sobi, Roche, Janssen, Boehringer-Ingelheim, Grant/research support from: Novartis, Roche, Birgit Kortus-Goetze Consultant of: Novartis, Prasad Oommen Grant/research support from: Novartis, Anne Pankow: None declared, Tilmann Kallinich Speakers bureau: Roche, Tobias Krickau Speakers bureau: Novartis, Consultant of: Novartis, Grant/research support from: Novartis, Catharina Schuetz Grant/research support from: Novartis, Gerd Horneff Speakers bureau: AbbVie, Bayer, Chugai, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, Grant/research support from: AbbVie, Chugai, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, Ivan Foeldvari Consultant of: Novartis, Jürgen Rech Speakers bureau: AbbVie, Biogen, BMS, Chugai, GSK, Janssen, Lilly, MSD; Mylan, Novartis, Roche, Sanofi, Sobi, UCB, Consultant of: AbbVie, Biogen, BMS, Chugai, GSK, Janssen, Lilly, MSD, Mylan, Novartis, Roche, Sanofi, Sobi, UCB, Grant/research support from: Novartis, Sobi, Frank Weller-Heinemann: None declared, Ales Janda: None declared, Markus Hufnagel Grant/research support from: Novartis, Florian Meier Speakers bureau: Novartis, Frank Dressler Consultant of: Abbvie, Mylan, Novartis, Pfizer, Grant/research support from: Novartis, Michael Borte Grant/research support from: Pfizer, Shire, Ioana Andreica Speakers bureau: Abbvie, Chugai, Novartis, UCB, MSD, Lilly, Sobi, Astrazeneca, Amgen, Pfizer, Gilead, Paid instructor for: Astrazeneca, UCB; Consultant Abbvie, Chugai, Novartis, UCB, Galapagos, Takeda, Astrazeneca, Lilly, Boehringer Ingelheim, Amgen, Sobi, Peter Wasiliew Grant/research support from: Novartis, Michael Fiene: None declared, Daniel Windschall: None declared, Julia Weber-Arden Employee of: Novartis, Norbert Blank Consultant of: Novartis, Sobi, Lilly, Pfizer, Abbvie, BMS, MSD, Actelion, UCB, Boehringer-Ingelheim, Roche, Grant/research support from: Novartis, Sobi.