TY - JOUR
T1 - Anakinra in Patients With Systemic Juvenile Idiopathic Arthritis
T2 - Long-term Safety From the Pharmachild Registry
AU - Giancane, Gabriella
AU - Papa, Riccardo
AU - Vastert, Sebastiaan
AU - Bagnasco, Francesca
AU - Swart, Joost F
AU - Quartier, Pierre
AU - Antón, Jordi
AU - Kamphuis, Sylvia
AU - Sanner, Helga
AU - Glerup, Mia
AU - De Benedetti, Fabrizio
AU - Tsitsami, Elena
AU - Remesal, Agustin
AU - Moreno, Estefania
AU - De Inocencio, Jaime
AU - Myrup, Charlotte
AU - Pallotti, Chiara
AU - Koné-Paut, Isabelle
AU - Franck-Larsson, Karin
AU - Malmström, Håkan
AU - Cederholm, Susanna
AU - Pistorio, Angela
AU - Wulffraat, Nico
AU - Ruperto, Nicolino
AU - Paediatric Rheumatology International Trials Organisation (PRINTO)
N1 - Copyright © 2022 by the Journal of Rheumatology.
PY - 2022/4
Y1 - 2022/4
N2 - OBJECTIVE: To evaluate the long-term safety profile of anakinra in patients with systemic juvenile idiopathic arthritis (sJIA).METHODS: Data from patients with sJIA enrolled in the Pharmachild registry (ClinicalTrials.gov: NCT03932344) prior to September 30, 2018, and treated with anakinra were analyzed. The study endpoints were the occurrence of non-serious adverse events (SAEs) of at least moderate severity and SAEs, including macrophage activation syndrome (MAS), and the duration of anakinra treatment with reasons for discontinuation. All endpoints were analyzed overall by 6-month time windows, and in different treatment sets represented by those patients treated continuously with anakinra for at least 12, 18, and 24 months (set-12, -18, and -24, respectively).RESULTS: Three hundred six patients were enrolled. Of these patients, 46%, 34%, and 28% had been treated for at least 12, 18, and 24 months, respectively. Two hundred and one AEs, mostly represented by infections, were reported for 509.3 patient-years (PY) with an overall incidence rate (IR) of 39.5 per 100 PY. Among 56 SAEs (IR 11.0/100 PY), 23.2% were infections and 19.6% MAS episodes. The IR of AEs was higher during the first 6 months of anakinra treatment, followed by decreasing IRs in the long-term treatment sets. Treatment discontinuation occurred in 76% of patients, most frequently in the first 6 months, because of inefficacy (43%), remission (31%), or AEs/intolerance (15%). No deaths or malignancies occurred during anakinra treatment.CONCLUSION: The results of the present study confirm the long-term safety profile of anakinra in patients with sJIA and demonstrate an overall decreasing incidence of AEs over time. [ClinicalTrials.gov: NCT01399281 and NCT03932344].
AB - OBJECTIVE: To evaluate the long-term safety profile of anakinra in patients with systemic juvenile idiopathic arthritis (sJIA).METHODS: Data from patients with sJIA enrolled in the Pharmachild registry (ClinicalTrials.gov: NCT03932344) prior to September 30, 2018, and treated with anakinra were analyzed. The study endpoints were the occurrence of non-serious adverse events (SAEs) of at least moderate severity and SAEs, including macrophage activation syndrome (MAS), and the duration of anakinra treatment with reasons for discontinuation. All endpoints were analyzed overall by 6-month time windows, and in different treatment sets represented by those patients treated continuously with anakinra for at least 12, 18, and 24 months (set-12, -18, and -24, respectively).RESULTS: Three hundred six patients were enrolled. Of these patients, 46%, 34%, and 28% had been treated for at least 12, 18, and 24 months, respectively. Two hundred and one AEs, mostly represented by infections, were reported for 509.3 patient-years (PY) with an overall incidence rate (IR) of 39.5 per 100 PY. Among 56 SAEs (IR 11.0/100 PY), 23.2% were infections and 19.6% MAS episodes. The IR of AEs was higher during the first 6 months of anakinra treatment, followed by decreasing IRs in the long-term treatment sets. Treatment discontinuation occurred in 76% of patients, most frequently in the first 6 months, because of inefficacy (43%), remission (31%), or AEs/intolerance (15%). No deaths or malignancies occurred during anakinra treatment.CONCLUSION: The results of the present study confirm the long-term safety profile of anakinra in patients with sJIA and demonstrate an overall decreasing incidence of AEs over time. [ClinicalTrials.gov: NCT01399281 and NCT03932344].
KW - Antirheumatic Agents/adverse effects
KW - Arthritis, Juvenile/drug therapy
KW - Humans
KW - Interleukin 1 Receptor Antagonist Protein/adverse effects
KW - Registries
KW - Treatment Outcome
KW - systemic juvenile idiopathic arthritis
KW - anakinra
KW - long-term adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85127481080&partnerID=8YFLogxK
U2 - 10.3899/jrheum.210563
DO - 10.3899/jrheum.210563
M3 - Journal article
C2 - 35105709
SN - 0315-162X
VL - 49
SP - 398
EP - 407
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 4
ER -