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Abstract Number: 2863

Long-Term Efficacy and Safety of Canakinumab in Patients with Colchicine-Resistant FMF (crFMF), Hids/Mkd and TRAPS: Results from the Pivotal Phase 3 Cluster Trial

Fabrizio De Benedetti1, Joost Frenkel2, Anna Simon3, Jordi Anton4, Helen J. Lachmann5, Marco Gattorno6, Seza Ozen7, Isabelle Koné-Paut8, Eldad Ben-Chetrit9, Magdalena Wozniak10, Xiaoling Wei11 and Eleni Vritzali12, 1IRCCS Ospedale Pediatrico Bambino Gesù, Roma, Italy, 2University Medical Center,Utrecht, Utrecht, Netherlands, 3General Internal Medicine, Radboud University, Nijmegen Medical Centre, Nijmegen, Netherlands, 4Unitat de Reumatologia Pediàtrica, Hospital Sant Joan de Déu, Barcelona, Spain, 5UCL Division of Medicine, UK National Amyloidosis Centre, London, United Kingdom, 6Pediatric Division, G Gaslini Institute, Genoa, Italy, 7Department of Pediatrics, Division of Rheumatology, Hacettepe University Faculty of Medicine, Ankara, Turkey, 8APHP, CHU de Bicêtre, University of Paris SUD, Paris, France, 9Rheumatology Unit, Hadassah—Hebrew University Medical Center, Jerusalem, Israel, 10Novartis Ireland Ltd, Dublin, Ireland, 11China Novartis Institutes for Biomedical Research Co., Ltd, Beijing, China, 12Novartis Pharma AG, Basel, Switzerland

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Autoinflammatory Disease, canakinumab and familial Mediterranean fever, Traps

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Session Information

Date: Tuesday, October 23, 2018

Session Title: 5T107 ACR Abstract: Pediatric Rheum–Clinical II: Treatment Update (2862–2867)

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Canakinumab (CAN), a selective, human anti-interleukin (IL)-1β  has demonstrated efficacy and safety in patients (pts) with colchicine-resistant familial Mediterranean fever (crFMF), hyper-IgD syndrome (HIDS)/mevalonate kinase deficiency (MKD), and tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS) in epochs 2 and 3 (E2 and E3) of the CLUSTER study (NCT02059291).1,2 Here, we evaluated the long-term maintenance of optimal control of disease activity (median of no or 1 flare and no up-titration) on every 4 weeks (q4w) and every 8 weeks (q8w) regimens of CAN and safety in pts with crFMF, HIDS/MKD and TRAPS through epoch 4 (E4) of the CLUSTER study.

Methods: The study comprised 4 epochs (E1–E4). The study design for E2 and E3 have been reported previously.1 After lead-in E1, E2, a 16–weeks (wk) randomized, double-blind, placebo (PBO)-controlled epoch, assessed the ability of CAN 150/300mg q4w to induce complete response (absence of flares). E3, a 24 wk open-label randomized withdrawal epoch, assessed whether responders to either doses in E2 could maintain clinical efficacy on PBO or a prolonged dosing interval (150/300mg q8w). Pts who did not maintain clinical response on PBO or q8w were up-titrated to 150/300mg q4w. E4, a 72–wk, open-label epoch, assessed the long-term maintenance of efficacy and safety in pts on q4w and q8w dose regimens. Safety assessments included adverse events (AEs) and serious AEs.

Results: At the end of E4 (Wk 112), the proportion of pts who maintained optimal control of disease activity following treatment with 150/300mg q4w or q8w in all 3 cohorts are shown in Figure 1. More HIDS/MKD pts required up-titration to maximum dose (300mg q4w). The majority of pts in all 3 cohorts had Physician Global Assessment <2 (no or minimal disease activity) and a median of 1 or no new flare (crFMF: 96.6%, HIDS/MKD: 83.3%, TRAPS: 94.3%). In all 3 cohorts, the median SAA levels decreased rapidly from baseline and remained suppressed through E4 (crFMF: 618 to 21 mg/L, HIDS/MKD: 2061 to 16 mg/L and TRAPS: 243 to 12 mg/L).  The most frequent AEs in E4, were infections and infestations (crFMF, 70.0%; HIDS/MKD, 86.4%; TRAPS, 81.1%) followed by gastrointestinal disorders (crFMF, 40.0%; HIDS/MKD, 65.2%;  TRAPS, 50.9%). No deaths were reported in this study. No new or unexpected safety issues were reported over 112 weeks (E1-E4) of CAN treatment.

Conclusion: CLUSTER study demonstrated that long-term treatment (up to Week 112) with canakinumab 150/300 mg, with up-titrations to q4w as necessary maintained optimal control of disease activity in crFMF, HIDS/MKD, and TRAPS patients. Majority of patients particularly in the HIDS/MKD cohort remained on the 150/300mg q4w at the end of Epoch 4. No new or unexpected safety issues were reported over 112 weeks of CAN treatment.  

References: 1De Benedetti F, et al. Arthritis Rheumatol. 2016;68 (suppl 10). 2De Benedetti F, et al. NEJM 2018;378:1908-19.  

 

 

 

 

 

 


Disclosure: F. De Benedetti, Novartis, Roche, Pfizer, SOBI, AbbVie, Novimmune, BMS, Sanofi, 2; J. Frenkel, Novartis and SOBI, 2; A. Simon, Novartis, Xoma/Servier, CSL Behring, 2,Novartis, Takeda, SOBI, Xoma, 5; J. Anton, None; H. J. Lachmann, Novartis, SOBI, Takeda, GSK, 5,Novartis, SOBI, 8; M. Gattorno, Novartis and SOBI, 2,Novartis and SOBI, 5; S. Ozen, None; I. Koné-Paut, None; E. Ben-Chetrit, Novartis, 5; M. Wozniak, Novartis, 3; X. Wei, Novartis, 3; E. Vritzali, Novartis, 3.

To cite this abstract in AMA style:

De Benedetti F, Frenkel J, Simon A, Anton J, Lachmann HJ, Gattorno M, Ozen S, Koné-Paut I, Ben-Chetrit E, Wozniak M, Wei X, Vritzali E. Long-Term Efficacy and Safety of Canakinumab in Patients with Colchicine-Resistant FMF (crFMF), Hids/Mkd and TRAPS: Results from the Pivotal Phase 3 Cluster Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/long-term-efficacy-and-safety-of-canakinumab-in-patients-with-colchicine-resistant-fmf-crfmf-hids-mkd-and-traps-results-from-the-pivotal-phase-3-cluster-trial/. Accessed April 13, 2021.
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