ArticleRheumatology and therapy2026
Safety and Effectiveness of Canakinumab in Patients with Systemic Juvenile Idiopathic Arthritis in Japan: A Post-Marketing Surveillance Study.
Article in Rheumatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionCanakinumab was approved in Japan for the treatment of patients with systemic juvenile idiopathic arthritis (sJIA) in 2018, following an open-label, single-arm phase III study performed in 19 Japanese patients with sJIA. Given this limited sample size, Japanese regulatory authorities required an all-case post-marketing surveillance study as part of the approval conditions, aiming to assess the long-term safety and effectiveness of canakinumab in Japanese patients with sJIA in clinical practice and characterise the clinical course of any cases of macrophage activation syndrome (MAS).
methodsThis was a multicentre, central registration, all-case, uncontrolled, open-label, special drug use investigation, including all patients who received canakinumab for the treatment of sJIA between 2 July 2018 and 20 December 2024. Patients were treated according to the investigators' routine clinical practice and observed for up to 104 weeks.
resultsThe safety analysis population included 125 patients with a median duration of treatment (including interruptions) of 710.0 (range 1-729) days and median total number of doses of 25.0 (range 1-29). Adverse events (AEs) occurred in 91 out of 125 patients (72.8%), with the most common being relapse, worsening or exacerbation of Still's disease (24 patients, 19.2%), followed by upper respiratory tract inflammation (18 patients, 14.4%). Serious related AEs occurred in 22 patients (17.6%), with the most common being haemophagocytic lymphohistiocytosis (HLH; 5 patients, 4.0%). A total of ten MAS-related AEs were reported; all were cases of HLH and were considered serious, and all were resolved or were resolving at the time of reporting. Effectiveness outcomes, including glucocorticoid tapering, disease activity reduction and inflammatory marker normalisation, were durable through 2 years of treatment.
conclusionCanakinumab showed a favourable long-term safety profile and sustained effectiveness in Japanese patients with sJIA inadequately controlled by existing therapies. No new safety concerns emerged, and the safety profile was comparable to that observed in the earlier phase III study.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.