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Abstract Number: 2424

Macrophage Activation Syndrome in Systemic Juvenile Idiopathic Arthritis Patients Treated with Canakinumab: Results from Phase 3 Trial Program

Alexei A. Grom1, Hermine I. Brunner1, Nicolino Ruperto2, Alberto Martini2, Daniel Lovell1,3, Virginia Pascual4, Karine Lheritier5, Karolynn Leon6, Ken Abrams6 and Norman Ilowite7, 1PRCSG, Cincinnati, OH, 2PRINTO-Istituto Gaslini, Genova, Italy, 3Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 4Baylor Institute for Immunology Research, Dallas, TX, 5Novartis Pharma AG, Basel, Switzerland, 6Novartis Pharmaceuticals Corporation, East Hanover, NJ, 7Pediatrics, Albert Einstein College of Medicine, Bronx, NY

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: interleukins (IL) and macrophage activation syndrome, Systemic JIA

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Session Information

Date: Tuesday, November 10, 2015

Session Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:
Macrophage activation syndrome (MAS),
a potentially fatal complication of systemic juvenile idiopathic arthritis
(SJIA), was reported as an adverse event in both canakinumab and placebo group
patients in Phase III trials.1 This prompted the formation of an independent
expert MAS Adjudication Committee (MASAC), to develop a methodology to identify
and adjudicate potential MAS events. Here, we report frequency of MAS as
adjudicated by the MASAC, in canakinumab-naïve SJIA patients2 from
the Phase III, trial program.  

 

Methods: Potential MAS events were identified by periodic
searches of the canakinumab SJIA clinical study safety and lab databases for
MASAC-specified screening AE terms and lab criteria. MAS events were then
adjudicated blinded to treatment by the MASAC as either probable, possible, or
unlikely MAS, or insufficient information loosely based on the diagnostic
criteria by Ravelli et al.3

 

Results: MASAC identified 72 potential cases for
adjudication. Twenty one events in 19 patients were adjudicated as Probable MAS
and 10 events in 9 patients as Possible MAS. Of the 21 Probable MAS events, 19
occurred in the canakinumab and 2 in the placebo group. The time period between
the first injection of canakinumab and the onset of MAS ranged between 3 to 1359
days (median, 531 days). The rate for MASAC adjudicated Probable MAS was 2.8/100
patient-years and 7.7/100 patient-years for the canakinumab and placebo groups
(Table), respectively with no statistically significant difference between
groups (diff=-4.9, 95% CI, -15.6, 5.9). Three patients (canakinumab, n=2;
placebo, n=1) died due to complications of MAS and full recovery was reported
in the remaining patients.

Table. Exposure adjusted incidence rate of events adjudicated as
Probable MAS

 

Canakinumab*

Placebo

Difference canakinumab – placebo (95% confidence interval)

Number Probable MAS adjudicated events

19

2

 

Patient- years exposure

668.61

26

 

Rate of Probable MAS adjudicated events/ 100 PTY

2.8

7.7

-4.9 (-15.6, 5.9)

*Clinical program included studies: Phase II; Phase
III Trial 1; Phase III Trial 2; Phase III Trial 2

extension; MAS = macrophage activation syndrome; MASAC
= MAS Adjudication Committee

Conclusion: Canakinumab does not appear to have an effect on the
frequency of macrophage activation syndrome or modify its clinical features.

Reference:

1.    
Ruperto et al. N Engl J
Med
. 2012;367:2396-406.

2.    
Ruperto et al. Ann Rheum
Dis.
2015;74(2):608.

3.    
Ravelli A, et al. J
Pediatr
. 2005;146(5):598-604.


Disclosure: A. A. Grom, Novartis, Roche, 5; H. I. Brunner, Novartis, Roche, Pfizer, UCB, Celgene, Regeneron, Amgen, Astrazeneca, GSK, BMS, 5,Novartis, Roche, 8; N. Ruperto, Abbott, BMS, "Francesco Angelini", GlaxoSmithKline (GSK), Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, Wyeth, 2,Abbott, AbbVie, Amgen, Biogenidec, Astellas, Alter, AstraZeneca, Boehringer, BMS, CD-Pharma,Celgene, CrescendoBio, EMD Serono,Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Servier, Takeda, Vertex, 8; A. Martini, Abbott, BMS, "Francesco Angelini", GlaxoSmithKline (GSK), Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, Wyeth, 2,Abbott, Abbvie, Amgen, Biogenidecm Bristol MyersSquibb, Astellas, Behringer, Italfarmaco, Janssen, MedImmune, Novartis, NovoNordisk, Pfizer, Sanofi, Roche, Servier, Takeda., 8; D. Lovell, National Institutes of Health, 2,Astra-Zeneca, Bristol Meyers Squibb, AbbVee, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Biogen, Takeda, Genentech, Glaxo Smith Kline, Boehringer Ingelheim, Celgene, Jannsen, 5,Genentech, Roche, Novartis, 8; V. Pascual, Novartis, 7; K. Lheritier, Novartis, 1,Novartis, 3; K. Leon, Novartis Pharmaceutical Corporation, 3; K. Abrams, Novartis, 1,Novartis, 3; N. Ilowite, Novartis, Sobi, Pfizer, 5.

To cite this abstract in AMA style:

Grom AA, Brunner HI, Ruperto N, Martini A, Lovell D, Pascual V, Lheritier K, Leon K, Abrams K, Ilowite N. Macrophage Activation Syndrome in Systemic Juvenile Idiopathic Arthritis Patients Treated with Canakinumab: Results from Phase 3 Trial Program [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/macrophage-activation-syndrome-in-systemic-juvenile-idiopathic-arthritis-patients-treated-with-canakinumab-results-from-phase-3-trial-program/. Accessed January 24, 2021.
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