A 3-year interim analysis of post-marketing all-patient surveillance of canakinumab in Japanese patients with cryopyrin-associated periodic syndrome

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  • Hosono Kumiko
    Medical Devision, Immuno & Derm Medical Franchise, Novartis Pharm K.K.
  • Okami Nina
    Development Division, Re-Examination Dept. Neurosci Retina Immuno & Derma Re-Examin Group, Novartis Pharm K.K.
  • Sasajima Takayoshi
    Development Division, Re-Examination Dept. DM/Bios Group, Novartis Pharm K.K.
  • Uehara Manabu
    Development Division, Clinical Development Data Sciences & Scientific Operations Dept Statistical Re-porting Group, Novartis Pharm K.K.
  • Yokota Shumpei
    Yokohama City University

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Other Title
  • クリオピリン関連周期性症候群患者を対象としたカナキヌマブの製造販売後調査成績（中間集計）

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    A post-marketing all-patient surveillance of canakinumab (Ilaris® s.c. 150 mg) is under way to assess its safety and efficacy in Japanese patients with cryopyrin-associated periodic syndrome. We report an interim analysis 3 years post-launch of all patients who received canakinumab in daily medical practice. A total of 55 patients were registered at 36 clinics or hospitals, with 48 included in a data lock as of 31 December 2014. 47/48 were included in the safety population, with one was excluded for off-label use. The mean age of the patients at treatment initiation was 20.8 years. Majority of patients has MWS (n=22), followed by NOMID (n=18) and FCAS (n=7). Adverse drug reactions (ADRs) were reported in 34.0% of the patients. Nasopharyngitis (8.5%) and upper respiratory tract infection (6.4%) were most frequent. Five patients experienced nine serious ADRs (two events of gastrointestinal haemorrhage and one event each of bronchitis, bronchopneumonia, subcutaneous abscess, streptococcal infection, neutropenia, dizziness postural, and deafness transitory), all of which resolved. Forty-six patients were included in the efficacy population, with 28 started receiving canakinumab after launch. At each time-point (24 to 104 weeks), 80-90% of the patients remained flare free after the most recent remission. The remaining 18 patients started canakinumab in the clinical trial; at all time-points after switch to the marketed product, a similar percentage of patients had no flare after the most recent remission. The interim analysis showed no additional risks of canakinumab and relapse suppression was maintained in many of the patients. We will continue to assess the safety and efficacy of canakinumab through this surveillance.

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