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Abstract Number: 180

Safety of Canakinumab in a Large Cohort of Patients with Cryopyrin-Associated Periodic Syndrome: Results From the ß-Confident Registry

H. Hoffman1, J. B. Kuemmerle-Deschner2, P. Hawkins3, T. van der Poll4, Ulrich A. Walker5, B. Rauer6, J. M. Nebesky6 and H. Tilson7, 1University of California at San Diego, San Diego, CA, 2Division of Pediatric Rheumatology, Department of Pediatrics, University Hospital Tuebingen, Tuebingen, Germany, 3University College London Medical School, London, United Kingdom, 4Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands, 5Rheumatology, Universitäts-Poliklinik, Felix-Platter Spital, Basel, Switzerland, 6Novartis Pharma AG, Basel, Switzerland, 7The University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: inflammation and interleukins (IL), Muckle-Wells syndrome

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Session Information

Title: Miscellaneous Rheumatic and Inflammatory Diseases: Periodic Fever Syndromes

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Cryopyrin-associated periodic syndrome (CAPS) is an extremely rare autoinflammatory disorder associated with overproduction of interleukin-1β (IL-1β). Canakinumab, a fully human, selective, anti-IL-1β monoclonal antibody, is approved for the treatment of CAPS (including familial cold autoinflammatory syndrome [FCAS] and Muckle-Wells syndrome [MWS]). In order to enhance long term data, the β-Confident Registry, a global, prospective, observational study, is monitoring safety and disease progression in patients treated with canakinumab over a 5-year period.

Methods:

CAPS patients receiving canakinumab as part of their routine medical care are included in the registry. Data are collected during routine clinical assessments (no mandatory visits), and the registry is updated every 6 months. Assessments include adverse events (AEs); physician’s global assessment of autoinflammatory disease activity; and C-reactive protein (CRP) and serum amyloid A (SAA) levels. Data reported here are adverse events through 18 months of follow-up (cut-off date, March 2012). Additional safety data will be updated with the presentation, as available.

Results:

Since December 2009, 229 patients with CAPS and other autoinflammatory diseases have enrolled. Selected baseline characteristics are shown in the Table. Overall, 59 AEs (25.8%) were reported in 29 patients (12.7%). Infections were the most common AE, with 12 AEs (5.2%) reported in 8 patients (3.5%), and upper respiratory type infections accounted for most. CNS disorders were the second most common AE, with 7 AEs (3.1%) reported in 5 patients (2.2%), and headache accounted for most. 11 Serious AEs (4.8%) were reported in 8 patients (3.5%), including 1 malignancy (rectal adenocarcinoma in a 76 yo MWS patient) and 2 infections (pneumonia in a 40 yo female CAPS patient with later hospital discharge; aseptic meningitis in a 25 yo female CINCA patient with recovery). There was only 1 permanent canakinumab discontinuation, due to patient preference.

Conclusion:

Consistent with the earlier 12-month assessment, the safety of canakinumab treatment at 18 months was maintained and no unexpected safety signals were reported.

Table: Baseline characteristics of enrolled patients

 

Overall

(N=229)

FCAS

(n=35)

MWS

(n=135)

NOMID

(n=18)

Others

(n=29)

Age groups:

< 18y

74

7

33

11

18

≥ 18y

155

28

102

7

11

Sex:

Male

107

12

68

10

15

Female

122

23

67

8

14

NLRP3 mutation, n(%)

Yes

183 (79.9)

35 (100.0)

126 (93.3)

15 (83.3)

7 (24.1)

No

16 (7.0)

0

3 (2.2)

1 (5.6)

12 (41.4)

Unknown/missing

30 (13.1)

0

6 (4.4)

2 (11.1)

10 (34.5)

Mean disease duration, months

312

403

316

154

228

History of rash/ arthralgia/ headache/ conjunctivitis, %

79/81/55/58

100/94/54/63

81/80/59/67

89/94/89/67

76/93/38/28

Prior canakinumab treatment, n

191

28

117

17

29

Prior treatment duration, Median (range), wk.

87.3 (8.9–139.4)

85.1 (8.9–126.3)

87.3 (8.9–139.4)

82.9 (43.9–122.0)

65.4 (13.3–139.4)

Prior number of injections/patients, mean±SD

6.4±4.4

4.3±2.7

6.8±3.9

8.6±5.2

6.1±6.2

FCAS, familial cold autoinflammatory syndrome; MWS, Muckle-Wells syndrome; NOMID, neonatal-onset multisystem inflammatory disease

 


Disclosure:

H. Hoffman,

Novartis,

5,

Regeneron,

5,

Sobi Biovitrum,

5;

J. B. Kuemmerle-Deschner,

Novartis,

2,

Norartis,

5,

Novartis,

7;

P. Hawkins,
None;

T. van der Poll,

Novartis,

5;

U. A. Walker,

Novartis ,

5;

B. Rauer,

Novartis ,

3;

J. M. Nebesky,

Novartis ,

3;

H. Tilson,

Bio Soteria,

5,

Bristol-Myers Squibb,

5,

Gilead,

5,

GlaxoSmithKline,

5,

HealthCore ,

5,

Kendle ,

5,

Merck ,

5,

Novartis ,

5,

Glaxo SmithKline,

1,

Procter & Gamble ,

1,

Other non-pharmaceutical holdings,

1.

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