Effectiveness and probability of full disease control with canakinumab in familial Mediterranean fever: real-world data from the AIDA Network.

Authors

Antonio Vitale, Valeria Caggiano, Jessica Sbalchiero, Abdurrahman Tufan, Gaafar Ragab, Giuseppe Lopalco, Piero Portincasa, Donato Rigante, Sulaiman M Al-Mayouf, Ali Şahin, Nilüfer Tekgöz, Elena Verrecchia, Lampros Fotis, Patrizia Barone, Petros P Sfikakis, Ezgi Deniz Batu, Carla Gaggiano, Seza Ozen, Cemal Bes, Nergis Akay, Elif Kilic Konte, Ece Aslan, Zeynep Torunoglu, Burak Karakaya, Derya Yildirim, Hamit Kucuk, Antonino Noto, Mohamad Khalil, Ludovico Luca Sicignano, Alhanouf Alsaleem, Abdullah Alsonbul, Arif Babayiğit, Elmas Semanur, Katerina Kourtesi, Santi Papa, Katerina Laskari, Rabia Deniz, Annachiara Alemanno, Maria Cristina Maggio, José Hernández-Rodríguez, Veronica Gomez-Caverzaschi, Amato De Paulis, Ilaria Mormile, Emma Aragona, Fabrizio Bronte, Romina Gallizzi, Antonella Insalaco, Alma Nunzia Olivieri, Emre Bilgin, Nilay Erdik, Moustafa Ali Saad, Ángel Robles-Marhuenda, Alberto Lo Gullo, Alessandro Conforti, Fernando Tornero Romero, Benson Ogunjimi, Seher Sener, Micol Frassi, Giovanni Conti, Alberto Cauli, Marcello Govoni, Angelo Valerio Marzano, Chiara Moltrasio, Ewa Więsik-Szewczyk, Samar Tharwat, Abdelhafeez Moshrif, Anastasios Karamanakos, Elmas Semanur, Alberto Balistreri, Bruno Frediani, Claudia Fabiani, Özgür Kasapçopur, Luca Cantarini

Published in

Rheumatology (Oxford, England). Jul 13, 2026. Epub Jul 13, 2026.

Abstract

To assess the effectiveness of canakinumab (CAN) in controlling clinical and laboratory inflammation by achieving complete control of cardinal disease manifestations and full normalization of laboratory inflammatory markers.
Data were obtained from the international AutoInflammatory Disease Alliance (AIDA) network registry, dedicated to monogenic autoinflammatory diseases. The assessment included both retrospective and prospective real-world data.
In total, 158 FMF patients treated with CAN were enrolled. Complete clinical-laboratory response was observed in 45.6% of patients at 3 months, 58.6% at 12 months, and 55.2% at the last follow-up, after a mean treatment duration of 45 months. Partial response occurred in 16.5%, 12.5%, and 16.8% at the same timepoints, respectively. Complete absence of clinical manifestations was observed in > 80% of patients at each timepoint. Inflammatory markers normalized significantly by the 3-month assessment. The probability of achieving and maintaining complete response and full laboratory control appeared higher in patients reaching these outcomes by 3 months, although it remained substantial in other patients as well. Complete response was associated with a relapsing-remitting disease course and fewer annual attacks. Nearly all patients maintained stable organ damage scores, and therapy discontinuation due to inefficacy was rare (≤6%).
CAN is effective in achieving rapid and sustained clinical and laboratory control in FMF, including stringent endpoints of complete response. Early effectiveness may favour better long-term outcomes, but delayed achievement of complete response and full laboratory control is not uncommon. This study confirms CAN as an effective, and durable therapeutic option in FMF.

PMID:
42444147
Bibliographic data and abstract were imported from PubMed on 14 Jul 2026.

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